Manual Ace Elite Pro

INSTRUMENTATION LABORATORY ACL ELITE* / ELITE PRO System
Training Modules
PN 722277 Rev. BB (November 2010) Beckman Coulter, Inc. Miami Education Center Miami Lakes, FL 33014
* ACL Elite, HemosIL, and AccuTrak are registered Trademarks of Instrumentation Laboratories
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WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE THE 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 broke 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.
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PN 626394A (December 2003)
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REVISION STATUS
Revision A Revision B Revision BA Revision BB December 2005 August 2006 August 2009 Software release 3.0.5, Library 1.15 November 2010 Software release 3.01.04, Library 02.00.00
PN 722277BB (December 2010)
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IL ACL ELITE/ELITE PRO
COURSE GUIDE
TABLE OF CONTENTS
ACL ELITE / ELITE PRO Course Map3
Group Discussions....5
Reminders.....5
How Course Works.6-7 Course Modules Additional Information
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Miami Education Center
Page 2 of 8
PN 722277BB (December 2010) Miami Education Center
COURSE MAP
IL ACL ELITE/ELITE PRO SYSTEM TRAINING
T
Training
ADVANCED TOPICS ELECTIVE TOPICS FA

Factor Assay
MS
Mixing Studies
SSA
Setup Security Access
AT
AccuTrak
NL
New Lot
CT Copy Test
CCI
Clot Curve Interpretation
UT
Utility
HEP
Heparin Assay
REQUIRED TOPICS ES
Enable
LD
Liquid Definition
TS
Troubleshooting
INR
Setup
DD SS
Setup
MLT
Multi-Test Setup
D-Dimer
RT SA3
Reflex Testing
SA2
Sample Analysis
SQC
Setting up QC
Sample Analysis
RR
Replace Rotors
SA1
Sample Analysis
RQC2 M
Maintenance Running QC
RWE
Replace Wash R Emulsion
RQC1
Running QC
CAL
Calibration R-PT Fib RecombiPlasTin & Clauss Fibrinogen
IB
Instrument Basics
RI
Reagent Insert
PREREQUISITE TOPICS
PR
Prerequisite
PN 722277BB (November 2010) Miami Education Center
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PERSONAL PROGRESS SUMMARY

Name__________________
Prerequisite Topics
PR RI IB RQC1 SA1 SA2 SS ES LD MLT SQC M CAL RQC2 SA3 DD TS RWE RR RT INR Prerequisite Reagent Insert
Date Achieved
Sign-Off
Apps
___________
_______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______ _______
_____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____
Required Topics
___________ ___________ Instrument Basics ___________ Running Quality Control ___________ Sample Analysis 1 ___________ Sample Analysis 2 ___________ System Setup ___________ Enable/Disable Liquid Definition ___________ ___________ Multi-Test Setup ___________ Setup Quality Control ___________ Maintenance Calibrate: R-PT, R-FIB_ FIB-C ___________ ___________ Running Quality Control Sample Analysis 3 ___________ ___________ D-Dimer ___________ Troubleshooting ___________ Replace Wash R Emulsion ___________ Replace Rotor ___________ Reflex Testing ___________ INR Setup
Elective Topics
CT FA ** UT MS SSA CCI AT NL Copy Test Factor Assay Utility Mixing Studies Setup Security Access Clot Curve Interpretation AccuTrak New Lot HEP ** Heparin Assay
___________ ___________ ___________ ___________ ___________ ___________ ___________ ___________ ___________
_______ _______ _______ _______ _______ _______ _______ _______ _______
_____ _____ _____ _____ _____ _____ _____ _____ _____
Advanced Topics
T Training
___________
_______
_____
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PN 722277BB (November 2010) Miami Education Center
GROUP DISCUSSIONS
The following discussions take place in the discussion room (except for the time in the Customer Cafe).
Monday
Customer Cafe General Education Center Information Learn about classmates Safety: Personal Protective Equipment and Fire Evacuation Introduction to the course and materials Location of additional reference materials
Tuesday
Discussion: Software overview
Wednesday
Discussion: Clot Curve Presentation
Thursday
Last Day Course Evaluations Graduation
REMINDERS
Scheduled two fifteen minute breaks, one in the morning and one in the afternoon. Schedule dependent, lunch is between 45-60 minutes. Cleanup at the end of the day (about 10 minutes before leaving for the day). Daily answering any questions, make any announcements.
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HOW COURSE WORKS

This course is probably unlike any previous training, unless you have taken a criterion-referenced course before. What is criterion-referenced instruction? Criterion-referenced instruction is a self-paced learning with pre-specified performance criteria, Skill Checks verify achievement. Learners select the module, based on the course map provided, modules provide information and guidance. The learner may practice the skill until they feel confident. A Skill Check measures achieved stated objectives. The main features of training are: You do not relearn something already known You do not learn topics unnecessary to your job (However, make the best use of your time while you are here so that what you do is most beneficial for you and your lab.) You work at your own pace You practice a skill until confidence is achieved
Lets look at the makeup of this course
Course Map
The course map shows how each module of the course relates to other modules and to the course as a whole. It is a blueprint of the course, start at the bottom and work your way up. Before beginning to study a module, complete all prerequisites for that module (i.e., all modules shown by arrows that lead into your chosen module). Where no sequence is shown (i.e., there are no arrows leading into a module), you are free to study the modules in any order you please. Completing Prerequisite Topics and Required Topics for your instrument configuration, ensures mastering the basic course requirements. Choosing Elective Topics based on your particular training needs and time remaining.
There is ample time to complete all the required topics as well as some or all of the Elective Topics.
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Modules
Read the Objectives at the beginning of a new module. Complete the Skill Check for the module if you already know the task. (Note: read the module for understanding the terminology used or procedural surprises.) Read the module and complete the practice exercises for the new material presented in the module. Refer to additional resources provided for the module. Work through each module at your own pace. This is not a race. Some modules require you to work with a partner.
Resources
Each module lists the resources available to complete the topic. Consult any resource that is appropriate to your needs. You may use some or all of the resources. A Facilitator is always available to answer any questions you may have. Additional resources are available for your reference use. Your facilitator will show you where these are located. Feel free to refer to them at any time during the week. Some modules require you to work with a colleague or have a colleague review your work against a checklist. Each module has a criterion test called a Skill Check. Complete the Skill Check when you feel ready. To save yourself time, first make sure you can answer yes to these questions: Did I practice the skill(s) called for in the objective? Did I get a colleague sign-off the module? (if applicable) If, after reading the module you feel ready to complete the Skill Check without further study, do so. Skill Check performance is inadequate, you may be asked to complete a duplicate or similar Skill Check. Completing a Skill Check, the facilitator checks your work and signs your progress summary.
Personal Progress Summary

Ask your course facilitator to certify your module completion, by dating and initialing your Personal Progress Summary.
Master Progress Chart

Facilitators use a Master Progress Chart for tracking class progress. Entries on the Master Progress Chart mark module completion.
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RI
ACL ELITE/ELITE PRO
REAGENT / CALIBRATOR INSERT REVIEW

Objective
Given product inserts for any HemosIL Reagent and the Performance Guide Skill Checks provided in this module, you will: Identify Reagent/Calibration preparation procedures Identify Reagent/Calibration storage, handling and stability claims on a reagent insert Locate and identify the ISI for a PT reagent Locate and identify the calibration target values Identify limitations/interfering substances for specific reagents Identify test linearity ranges
NOTE: Your Facilitator will provide reagent inserts for this module.
Module Resources
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.1.12 HemosIL Reagent and Calibration Package Inserts
P/N 722277BB (December 2010) Miami Education Center
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ACL ELITE/ELITE PRO
Reagent Insert Review

Introduction
Every box of reagent comes with a reagent insert that explains the details of the reagent. These details include, but may not be limited to, the following: Insert Section Description 1. Intended Use Basic statement of what the reagent/calibrator test is used for. 2. Summary and Detailed description of the reagent/calibration. Theory and Principle methodology of the test and disease states in which performing the test may be indicated. 3. Composition Detailed description of each reagent/calibration, how it is supplied in the kit, and precautions and warnings 4. Preparation Instructions on how to prepare and handle each reagent/calibration in the kit. 5. Reagent Storage and Instructions on storage throughout the reagent/calibration Stability use. If a reagent requires a stir bar, it will be stated in this section. 6. Instrument/Test Specific procedure relating to the assay. Usually referred Procedures back to the individual instruments operators manual. 7. Specimen Collection Specific instructions relating to the assay, usually referred and Preparation back to CLSI (formerly NCCLS). 8. Additional Reagents Contains a list of all reagents and/or controls that are not and Control Plasmas included in the kit and must be purchased separately. 9. Quality Control Quality control statement and which controls are recommended for the assay 10. Results Units in which the assay is reported. 11. Limitations/Interfering A list and concentrations of the most common interfering Substances substance specific to the test. 12. Expected Values Normal range study information includes a description of the method of data collection for each. 13. Performance Includes control precision, control range, and correlation Characteristics data as well as a description of the method of data collection for each. May contain additional information specific to the test such as cut-off values. 14. Linearity When applicable, states assay/instrument linearity information as well as how to treat a sample result which is outside of the linear range. 15. Additional May include any additional test specific information such as Information heparin therapeutic ranges.
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ACL ELITE/ELITE PRO
Sample of a Reagent Insert
2 9
3 10 11 15
4 12
13
6 16
NOTE: Linearity (14) is not applicable to the Thrombin Time Test
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ACL ELITE/ELITE PRO
RI
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ACL ELITE/ELITE PRO
Performance Guide
Step 1 Action
Obtain HemosIL reagent package inserts, from your facilitator.
Complete the Skill Check.
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ACL ELITE/ELITE PRO
SKILL CHECK
1. Describe the preparation instructions for the PT reagent used in class (RecombiPlastin-R2G)? _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________
2. How long is this PT reagent (RecombiPlastin-R2G) stable on the ACL Elite/ElitePro? _______________________________________________________________ 3. What is the ISI for this PT reagent? __________ Where is the value found? _____________________________________________________________________ 4. What are the Limitations/Interfering Substances? What are the units of measure for the Limitations/Interfering Substances? ________________________________ ________________ ________________________________ ________________________________ ________________________________ ________________ ________________ ________________
5. What is the calibration target value for the D-Dimer reagent? _____________ Where is the value found? ______________________________________________________________ 6. What is the linearity of the D-Dimer test? ______________________________________ 7. Identify recommendation for a D-Dimer test exceeding linearity? _________________________________________________ _____________________________________________________________________ 8. What is the target value for the PT based Fibrinogen for this instrument and the reagent used in class? (RecombiPlastin-R2G) ________ Where is the value found? _________________________
Sign Off
Instructor
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IB INSTRUMENT BASICS OBJECTIVES
Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual and Quick Reference Guide you will: Locate the Working Area Navigate Menus and Sub-menus Identify the Status Area on the instrument Identify different Instrument Icons and their meanings Locate, Navigate and Review the functions of each of the Work Areas, Toolbars and Message Box Icons
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 3 ACL ELITE / ELITE PRO Quick Reference Guide, Components/Icons/Colors
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SOFTWARE TREE
ANALYSIS Multi Test Session Single Test Session Loadlist Session History
QC
CALIBRATION
DIAGNOSTIC
SETUP
UTILITY
Calibrate Review Calibration Analytical Reference
QC Setup / Review
Priming Cleaning Maintenance Temperature Control Needles Position Session Error History File Error History Logbook Service (dimmed)
Tests Multi-Test Liquids Interfaces System Configuration Security Audible Alarms Date / Time Units
Upgrade IL Library Backup / Restore Archive Software Save Rotor Map Save Trace Test / Material Debug (dimmed) Testing (dimmed)
View / Define Sort Test Interference Table Default Tests Reflex Tests
SW Identification SW Upgrade
Profiles Test Groups Test Group Profiles Sort Multi-Tests Default Multi-Test
Software Upgrade SW Master SW Slave SW REM Backup Upload Upload Upgrade
Host Printer Internal Barcode External Barcode Keyboard Network (dimmed) Modem (dimmed)
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POWER ON AND LOG ON TO THE SYSTEM

Power On the ACL ELITE / ELITE System. The power switch is on the left backside of the instrument. Move the switch to the | position. Wait for Login and Password screen. Classroom use only: The Login User Name is: Lab Manager, and The Password is: level 3. (lower case) Press Confirm to login. User Name
Lab Manager
Password
level 3
Confirm
OPERATOR INTERACTIONS
The operator interacts with the ACL ELITE / ELITE PRO System through the working area drop down menus and their sub-menu screens. Data input and information retrieval uses windows and dialogue (message) boxes. Information and instructions are entered into the system via a touch screen a standard PC keyboard or a mouse.
How To Use the Touchscreen

The touchscreen is used to select menu items and enter numeric data. Touch any area to be edited. Any dimmed object (menu, check box or button) is currently disabled and not available at that time. If numeric entry is enabled, a numerical keypad may open on the screen. Default or previously entered values will appear on the display. Editing functions are closed by selecting Confirm by touching another area of the screen. Cancel or
The eraser end of a pencil works well in place of your finger to make selections on the touchscreen.
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How To Use the Keyboard

The standard USA PC keyboard may be used in place of the touch screen to make menu selections and enter data. It is required for entry of alphanumeric data. Move the cursor on screen by pressing TAB to move forward or SHIFT-TAB to move backwards. To close editing functions and save changes, press ENTER or select another field. The ESC key closes the editing function without accepting the changes. Preexisting values will remain. Main and secondary menus may be selected using the keyboard. The menus are opened by pressing ALT + underlined letter. Select from the menu list using the arrow keys and then press ENTER. The keyboard function keys (F1-F10) are used to activate the functions on the bottom row of icons. Use Ctrl + F4 for keyboard Log off.
How To Use the Mouse

A serial mouse is used as a selecting or pointing device, replacing the touch screen. The USB port is the connectivity to a USB mouse to the analyzer. The mouse is used as a selecting device, replacing the use of the touch screen.
Note: If the USB mouse is ever disconnected the system must be rebooted for mouse recognition and operational.
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ACL ELITE/ELITE PRO SYSTEM DATABASE SCREEN

Key Screens Elements: Below are descriptions of the most significant items found within the ACL ELITE / ELITE PRO screen.
Instrument Status
Numerical value patients in Database
All
25 / 25
Working Area
Toolbar Area
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Instrument Status
The Status area is at the top of the LCD screen. The current date and time are displayed on the right and instrument status messages are displayed on the left. Instrument Status includes: INIT (BOOT/START-UP): indicates that the instrument is performing startup operations (Initializing). READY: indicates that there have been no errors detected, there are no analytical operations in progress and the instrument is ready to start. OPERATING: indicates that either an analytical function is in progress (i.e. calibration or sample analysis) or a diagnostic function is being performed. HOLD: identifies a system "pause" reached during an analytical session (i.e. STAT request, no rotors, etc.). FAILURE: indicates that the system has detected a malfunction of internal mechanisms (devices, temperature control, etc.). STAND-BY: the status into which the instrument moves automatically after 30 minutes of inactivity, the screen will darken.
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Screen Icons
Window Icons Command / Action Confirm Cancel (dimmed if Edit action not allowed) Print
i ti
(Host) Transmit Delete
d l t
Add to the list Remove an item from the list
Transfer an item from one list to another Details Information in different languages New Sample Extract Sample Data
ti
Note Patient Name Patient Details Save information to floppy disk
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Toolbar Icons
Toolbar Icons Commands / Actions Short Turn Around Time (STAT)/(PAUSE) Urgent sample Pressing this button opens a window that guides the operator. Confirmation is required Instrument Status Informs the operator about the status of the operation in progress Close/Open cover This operation is disabled if there is a possible interference with the instrument operation STOP Confirmation is required Resume Start or resume a run. Starts the operations paused due to a STAT request Data Base View The system goes back to the database view or Main screen Host Status This icon appears only during communication with the Host to inform the operator about the status of this action. Warning This icon appears when there is at least one warning. Press to open Warning List. Log Out Allows the operator to exit the screen. Confirmation is required Instrument Status (Icon active) Operating Hold
Operating Hold
Ready Hold
Ready Operating Hold Hold
Ready Operating Hold Ready Operating Hold Failure Ready Operating Hold Failure Ready Failure
tdi
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Icon
Meaning
QUALITY CONTROL: Indicates there are data (results) in the database.
QUALITY CONTROL: Indicates a failure in a quality control test result.
REAGENT VIAL ICON: Indicates the status of the reagent map. (Warning No reagent).
REAGENT VIAL ICON: Indicates the status of the reagent map. (Warning reagent low).
REAGENT VIAL ICON: Indicates the status of the reagent map. (Sufficient reagent).
ERROR. To call attention to high priority failures and fault messages.
WARNING. To deliver different kinds of messages, i.e. to warn the user of a not allowed/wrong operation, or of problems/errors detected by the instrument during or after an operation. QUESTION. To request confirmation by the user before starting an operation or before canceling an action
INFORMATION. To offer general information. In some boxes, but not always, the message is followed by a request for confirmation.
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Material Status Colors

Color Status Empty or Available Letter / Symbol Status
STAT
Not Programmed
Pending
Programmed
Complete
Processing
Not Programmed
Complete
Sample Processing
Pending
Quality Control
Warning or Errors
Low Volume
Empty
Empty Cup in Position
Sample not Identified
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Materials Map
Reagent Loading The Materials map displays a graphical representation of liquid positions on the instrument. The map displayed above represents an ACL Elite PRO only. An ACL Elite does not have positions R9-R12. The External Barcode Reader (optional hardware) can be used to load liquid reagents in the displayed materials map, or reagents are placed by selecting the icons Reset Volume and Start Timer. This is an optional operation defined by the user. The materials map screen displays the status of liquids currently onboard, with the following colored circle positions: Green Volume of liquid position is greater than the warning limit, stability is OK Orange Volume of liquid position is less than the warning limit or the onboard or lot number stability has expired. Red Instrument detects a shortage of liquid in the position. NOTE: Select Start / Resume a run. The materials map is not checked by the instrument sample arm liquid sensor for volume status. Always check the status of the reagents before starting a run, physically and color indication and make appropriate adjustments. The colors displayed are only visual alerts. The analysis proceeds regardless of color of the reagent position.
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Performance Guide
In the Interface/External Barcode setup menu user defines the following options: Reset Timer and / or Reset Reagent Volume when scanned. The pause timer enabled will override the use of the reset options when reagents are scanned. Ensure Pause Timer box is not enabled
Step 1 2 3 4 5
Action Load Reagents reconstituted and provided by facilitator From the drop down menu select Analysis Select Multi-Test Session Select Materials Map icon Using the External Barcode Scanner, scan barcode label on reagent bottle, load reagent in flashing position on the materials map The message Unknown lot number and expiration date indicates that the liquid details are incorrect in the software. Select Liquid Details icon to correct for current lot number and expiration date Complete the Skill Check using the workstation, the quick reference guide and/or the Instrument Basic Module reading
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SKILL CHECK
Name the following Icons and their function(s):
Window Icons Command
i ti
d l t
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Sign Off
Instructor
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RQC1
QUALITY CONTROL OBJECTIVES

Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual and Quick Reference Guide you will: Run HemosIL Normal Assayed, Low Fibrinogen Assayed and High Abnormal Assayed Controls for the following tests on the ACL ELITE / ELITE PRO:
R-PT R-FIB_
APTTSYS
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 3, Section 3.2 ACL ELITE / ELITE PRO Quick Reference Guide, Quality Control
RQC1 1 of 4
Running Quality Controls on IL ACL ELITE / ELITE PRO

Performance Guide: Analyze Quality Control
Step Action From the Working Area, Select Analysis, then select Multi-Test Session and choose Routine
Main Menu
1
Multi Test Session Single Test Session Loadlist Session History
2 3 4
Select Loadlist No. icon. Enter 20 into the loadlist number field. Press Enter on Keyboard Label 2.0 mL cups and place QC on the sample tray in the order indicated.
To ensure controls are in the proper order. Touch each position in the map to identify the control (loadlist 20: places QC levels in positions 1-3)
Select Materials Map icon the assigned position. 6
and ensure that all materials, are in
Use the external barcode reader to scan in your reagents displayed in map. If an error message appears identifying the scanned liquid as an unknown lot number and expiration date update the Liquid Details: lot number, expiration date and onboard stability.
On ACL ELITE, rotors must be manually loaded from the rotor stack storage area into the loading/analysis area. Press the rotor snap to properly seat and remove the rotor. A message will display ROTOR EXCHANGE NEEDED load a new rotor and confirm.
Note:
7
RQC1 2 of 4
Select Start or Run icon

Review Daily QC Results

Step Action Select the QC icon. Note: If any QC results are out of range, the QC icon will include a red alert (!) and an audible alarm will sound Select the QC icon to review QC results. The results are all listed on this list as soon as they become completed.
Print Today QC Cumulative
Print All QC Levey Jennings
Within range results are displayed in black, out of range results 2SD are displayed in blue and outside of the 3SD are displayed in red To print your daily quality control runs, select the Print Today QC icon. To print all QC in the QC list, select the Print All QC icon. This list should be cleared daily, results are still visible in each QC file To review a specific result and its accompanying QC file, place the cursor on the result and press the Cumulative Results icon. To view a Levey Jennings chart for a control, select the Plot and Statistics icon. Review and select Confirm
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RQC1 3 of 4
The Skill Check Consists of Showing Your Facilitator the Printed QC results from the QC List Screen.
Sign Off
Instructor
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SA1
ACL ELITE/ELITE PRO
SAMPLE ANALYSIS
OBJECTIVES
Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual, and Quick Reference Guide, you will: Analyze barcoded samples
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 3 ACL ELITE / ELITE PRO Quick Reference Guide, Process Samples
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ACL ELITE/ELITE PRO
Sample Analysis: Barcoded Samples, Host Simulated

Performance Guide
Step 1 2 Action Place tubes onto the sample tray. Ensure caps are removed and barcodes are facing outward From the Database View Screen, select Start
On ACL ELITE, rotors must be manually loaded. The instrument will prompt the user to load a new rotor. Message displays ROTOR EXCHANGE NEEDED. Depress the rotor snap located in the center of the rotor loading/analysis area to properly seat the rotor upon removal/replacement.
The Skill Check consists of showing printouts of the results to Your Facilitator. Be prepared to discuss any errors printed on these samples. What type of report did your instrument printout?
Sign Off
Instructor
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SA2
ACL ELITE/ELITE PRO
SAMPLE ANALYSIS 2 OBJECTIVES

Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual and Quick Reference Guide, you will: Analyze Samples using the following modes of analysis: Sample ID - Barcode Samples or Cups with No Host Communication Manual Entry using Loadlist Manual Entry to create a Loadlist from samples in the Database
MODULE RESOURCES
IL ACL ELITE / ELITE PRO Training Manual IL ACL ELITE / ELITE PRO Operators Manual, Chapter 3 IL ACL ELITE / ELITE PRO Quick Reference Guide: Pre-run Checklist, Process Samples, and Components/Icons/Colors
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ACL ELITE/ELITE PRO
Sample Analysis Barcoded Specimens - No Host Connection

Performance Guide:
Step Action Load sample tubes with or without barcodes and sample cups on the sample tray (Ensure that bar-coded tubes are oriented with the barcodes facing outward) Select Analysis Select Multi-Test Session 3 Note: The Multi-Test selected dictates what tests can be ordered and drives what liquids are required on the instrument. Selecting a Multi-Test does not automatically order any test. If a sample loaded has a test ordered that is not within the Multi-Test selected, the sample status will remain pending (designated with a P in the status column) Use from the sub menu to select Routine Select Read Bar Codes icon Sample tray will rotate, barcode reader reads any barcoded specimens while the tube/cup sensor detects presence of samples on tray Samples without barcode labels will generate the following message:
Warning: Error in Sample Identification
OK
(Acknowledge the message by selecting OK)
Select the quadrant that contains the unidentified sample (s) Select the first non-identified sample (yellow circle with a ?)
?
8 Use Program Sample icon to identify the selected unidentified sample. Complete the Patient Demographics and order Test(s)
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ACL ELITE/ELITE PRO
Step 9 10 Select Confirm
Action
Follow steps 6-8 to update any additional unidentified sample(s) to be analyzed To request identical Test(s) from the previous sample identified, select the Previous Program icon. If test(s) requested for the sample differ, select Test(s) from the enable test list Select Confirm Continue until all samples are programmed Select the Materials Map icon and confirm the following: All reagents are on board and in the correct position All lot numbers are correct and volumes updated All reagents have ample time- onboard stability Rotors and Wash-R-Emulsion are available Note: RED-warning for low volume, unable to proceed. ORANGE-warning for reagents volume or onboard stabilty Select Start icon
11
12 13
14
15
Note: A sample with an *(asterix or snowflake)on the database screen indicates the test for that sample has been repeated by the user
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ACL ELITE/ELITE PRO
Sample Analysis Manual Sample ID Entry- Using a Loadlist

Create a Loadlist
Step 1 2 3 Select Analysis Select Multi-Test or Single Test Select a Quadrant on the sample tray Click on any available position (gray color). Select ADD QC icon to add QC 5 6 Select Program Sample icon to enter first sample ID Enter QC level or patients demographic information as per your protocols and select the Test(s) to be run The tray positions display in dark blue with the letter P (pending) for sample, QC for quality control liquids and N (not programmed) for samples with no tests identified 7 Quadrant Action
To add additonal samples select the New Sample icon View screen and repeat steps 5 and 6 Select the Store Loadlist icon. Enter a loadlist number (1-20) Select Confirm icon
from the Database
10
Load all samples in the sample tray, confirm the materials map, and select the Start icon
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ACL ELITE/ELITE PRO
Create a Loadlist-Samples pending within the Database

Step 1 2 3 4 5 6 7 8 Select Analysis Select Loadlist Select Make a Loadlist, Select the number you want to assign to the new Loadlist Select Mark Pending (located bottom center of screen) Select Sample ID from List. A appears left of selected Sample ID Continue until all samples are identified for the loadlist Select Confirm icon A message will appear that 1 Loadlist was created regardless of the number assigned to Loadlist from step 3 Action
Using a Loadlist
Step Action From the Working Area, select Analysis, select Multi-Test Session, then select Routine Working area
Multi Test Session Single Test Session Loadlist Session History
2 3
Select Loadlist No. icon Created loadlist number is entered into number field. Load all samples in the sample tray, confirm the materials map, and select Start icon
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ACL ELITE/ELITE PRO
Skill Check
1. Barcode Reader detects the presence of a cup or a tube in the sample tray. True False (Do not forget the sensor) 2. What causes a materials map position to turn Red? Orange? Red-________________________________________________________ Orange-______________________________________________________ 3. How many loadlists can be stored? ________ 4. What would be some advantages of using the loadlist configuration? _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ 5 When would manual entry be beneficial? _______________________________________________________________
Sign Off
Instructor
SA2 6 of 6
SS
ACL ELITE/ELITE PRO
SYSTEM SETUP OBJECTIVES

Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual, Quick Reference Guide, and an installed printer you will: Perform the Setup for the following: System Configuration Interfaces Keyboard Internal Barcode Reader External Barcode Reader Printer

Host Audible Alarms Setup Date/Time
MODULE RESOURCES
ACL ELITE / ELITE PRO Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 4 ACL ELITE / ELITE PRO Quick Reference Guide, Components/Icons/Colors
SS 1 of 10
ACL ELITE/ELITE PRO
Setup System Configuration and Interfaces

Performance Guide:
Step Action From main menu drop down, Select Setup 1
Main Menu
Select System Configuration
Tests Multi-Tests Liquids Interfaces System Configuration Security Audible Alarms Date/Time Units
In System Configuration, define the Patient Database Listing Using the drop down arrow the choices are: Last entered is at the top Last entered is at the end By Sample ID order Ascending By Sample ID order Descending Select Last entered is at the top: Define the QC/AR Database Listing (Note: AR-Analytical Reference not used in USA/Canada) Using the drop down arrow the choices are: Last entered is at the top Last entered is at the end Select Last entered is at the top Define your Reflex Status Using the drop down arrow the choices are: Program reflex Only reflex test will show as pending Execute reflex before closing session Disable Select Execute Reflex Before Closing Session Ensure all Sensors are enabled by placing an (x) in each box for: Liquid Wash-R Emulsion REM Enable (HW Enable) (Only on the ACL ELITE PRO)
SS 2 of 10
ACL ELITE/ELITE PRO
Step 7
Action Current Language English Or Select the drop down box to change the language of your choice Default Screen Using the drop down arrow the choices are: Database view Multi-Tests Pre-Analysis Select Multi-Tests Pre-Analysis To modify or change any Setup Configurations, follow steps 1-8. Review and select Confirm icon
Keyboard Type
Step Action Select Setup/ Interfaces / Keyboard
Using the drop down arrow Set Keyboard type to USA
Main Menu
1
Tests Multi-Tests Liquids Interfaces System Configuration Security Audible Alarms Date/Time Units
Host Printer Internal External Keyboard
Set Numerical Keypad Using the drop down arrow the choices are: Disabled All Numerical Fields All Numerical Fields and Sample ID Select Disable Review and select Confirm icon
SS 3 of 10
ACL ELITE/ELITE PRO
Barcode Readers
Step 1 Action Select Setup/ Interfaces/ Internal Barcode Place an (x) in box to Enable the Internal Barcode Reader (Internal BCR). Four fields are visible with the corresponding four families of barcode types. These four families of barcode types can be activated along with their corresponding sub-categories based on the labels used in your facility or labeled tubes sent to your facility. Note: more than one family or barcode type can be enabled Codabar Select AIM Mod 16 Code 39 Select Mod 43 I 2 of 5 (Interleaved 2 of 5) Select USS Mod 10 Code 128 Select No Checksum (Note: No Checksum indicates Enabled) Review and Select Confirm icon. Select Setup/ Interfaces/ External Barcode Place an (x) in the box to Enable the External Barcode Reader (External BCR) Code 128 Use The Drop Down Box: Select: No Checksum Toggle on (X) Reset Reagent Volume When Scanned (Optional Selection) Toggle on (X) Reset Start Timer When Scanned (Optional Selection) Note: On Materials Map Pause Timer must be Deselected for these Resets to occur when reagents are scanned using the external barcode reader. 6 Review and Select Confirm icon.
3 4
SS 4 of 10
ACL ELITE/ELITE PRO
Printer
Step 1 Select Setup / Interfaces / Printer Printed Samples Using the drop down arrow the choices are: Any Analyzed Just Completed Select Just Completed 3 Printer Protocol Using the drop down arrow : Select: HP-PCL Report Type Using the drop down box the choices are: Sample Report Cumulative Report Select Cumulative Report Paper Dimension Using the drop down box choices are: A4 Letter Select Letter 6 Automatic Print Out Select the box (x) to Enable automatic print I (if desired) Paper Format Using the drop down boxthe choices are: Continuous Sheet Single Sheet Select Single Sheet Select Customize Header icon 8 Highlight each line and insert your Institution Name, the Instrument Serial Number (SN found underneath the keyboard-white sticker) and System ID (this is assigned upon installation; create a System ID number for your instrument in class).
SS 5 of 10
Action
ACL ELITE/ELITE PRO
Step
Action Sample Report Data To modify what information printed on your reports select the Enable/Disable icon for each: Instrument Name Normal Ranges Date & Time Note: () in the S Column, indicates Enabled
10
Review and select Confirm icon
SS 6 of 10
ACL ELITE/ELITE PRO
Host
Step 1 2 Select Setup / Interfaces / Host
Note: Contact your LIS Programmer for these settings.
Action
Select the Baud Rate to 2400 using the drop down box Configure Automatic Data Tx Use The Drop Down Box from the choices: Not Required Patient Sample Only QC, AR and Patient Samples
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION; instruments are not connected to a Host
Unique Instrument ID Select the box (x) to enable Unique Instrument ID. For each additional instrument in your lab, input a single-digit ID in the box provided. (Digits between 1-99 can be defined. Use option when multiple ACL ELITE instruments are located in the same laboratory.)
PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
Enable Host Query Select the box (x) to enable/disable

PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION; instruments are not connected to a Host
Delete Automatically after Transmission by selecting the check box, if applicable

PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
SS 7 of 10
ACL ELITE/ELITE PRO
Audible Alarms
The Audible Alarm setup screen allows laboratories to enable or disable an alarm for sounding for various system conditions. Three non-configurable alarm sounds are defined (A, B, or C). Alarm sounds at 60 second intervals for one hour. Step 1 Select Setup / Audible Alarms Action
Enabled () Sound: A,B,or C Cancel
Confirm Enable/ Disable
PLEASE FOR THIS CLASS; DO NOT MAKE ANY SELECTION
2 3
Enabled is a () under the Enable column Review and select Confirm icon Note: You can enable/disable 10 audible alarms.
SS 8 of 10
ACL ELITE/ELITE PRO
Setup Date/Time
Step Select Setup / Date / Time
Drop Down arrow
Action
Cancel
Date/Time
Confirm
Using the drop down arrow to select a Date Format the choices are: dd.mm.yyyy (European, and Canadian style) yyyy.mm.dd (Japanese style) mm.dd.yyyy (USA style) Select applicable date based on your style Two numeric fields are available to set date and time Note: Changing date to a previous date may impact results (Patient, QC, Calibration & AR) and the database FIFO (First In, First Out) operation. Results processed on dates furthest from the current system date will be the first ones to be automatically deleted-FIF. Follow the same procedure when changing the time to Daylight Savings Time (if applicable).The instrument will not automatically change during Daylight Savings
SS 9 of 10
ACL ELITE/ELITE PRO
Skill Check
1. What are the four internal family or barcode types on the instrument? _____________, ______________, _____________, ______________ 2. What are the options defined for Reflex Status in system setup? __________________________________ __________________________________ __________________________________ 3. Which Reflex Status setup selections eliminates operator from removing a sample if a reflex test needs completed? __________________________________ 4. What Keyboard type should be interfaced? __________________________________ 5. Only one internal barcode type can be enabled. True False
6. Why would multiple enabled internal barcode types be a benefit? ___________________________________________________________ 7. How many audible alarms can you Enable/Disable on the instrument? How many sounds are defined? Can you customize them? No. of Alarms:_________________________________ No. of Sounds:_________________________________ Customize:____________________________________
Sign Off
Instructor
SS 10 of 10
ACL 9000
ES
ENABLE, DISABLE, MODIFY AND SORT TESTS OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual and Training Manual you will: Enable, Modify and Sort Tests Define differences in units for Fibrinogen Test Understand the results of Disabling a test Identify the Mean Normal Range (MNR) Navigate to customize units displayed on Database View
MODULE RESOURCES
ACL ELITE / ELITE PRO Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 4
ES 1 of 8
Performance Guide Enable Tests:

The tests library contains up to 300 tests (200 are reserved by Instrumentation Laboratory, these default as disabled). 100 tests can be customized by the user. Up to 100 can be active or enabled at the same time, regardless of the mix. Each test in the setup submenu is identified by an abbreviation and unique Test ID. Step 1 2 3 Action From the working area, select Setup drop down Select Tests Select View/Define and cursor to the appropriate Test you wish to Enable or Disable. Deselecting Show Enabled (no x in box) shows all the tests available in the Software Library Select the Enable/Disable Enable the following Tests: Note: The underscore ( _ ) in the R-FIB_ and RFIBe_ indates USA units mg/dL. The test with no underscore means SI units g/L. 5 icon APTTSYS APTTSYSe FIB-C_ FIB-C l_ FIB-C h_ R-FIB_ R-FIBe_ R-PT R-PTe
6 7
Selecting Show Enabled enabled in step 5
narrows the list. Displays only the tests
Review that all tests are displayed in step 5 and select Confirm
ES 2 of 8
Modify Tests
Perform the following steps to show/hide the test result units displayed on the Database Screen or to change the Normal Ranges of the test(s). Step 1 2 Select Setup, Test, View/Define To modify a test, move your cursor or use touch screen to that test. Modify all tests in step 6 below to display the reporting units for the given test on the Database View Screen Select the Details icon Highlight or cursor to the reportable unit of measure you do not want on the Database View. Select the Ranges icon Go to Show in Sample List box, uncheck / deselect the box if you do not want the highlighted unit to appear; check / select (x) if you want this unit to appear; Note: Default is all units are selected Modify all Enabled Tests to Show in Sample List the following units displayed in the right column: Test APTTSYS APTTSYSe FIB-C_ FIB-C l_ FIB-C h_ R-FIB_ R-FIBe_ R-PT R-PTe Units s s mg/dL mg/dL mg/dL mg/dL mg/dL s, INR s, INR Action
3 4
7 8 9
A message appears Database Update in Progress after each test modified, Select OK each time Using steps 2-7, continue modifying all Enabled tests in step 6 table Review and Select Confirm
ES 3 of 8
Entering The Mean of Your Normal Range (MNR)

Step 1 Select Setup/ Test / View/Define Cursor to the test to be modified. 2 Hint: Any tests with Ratio as a unit must have a mean normal range (MNR) Note: In this class you enabled R-PT (PT test) and APTTSYS 3 Select the Details icon Select the Calculation Setup icon test in the Reference Value box. to enter the MNR for the selected Action
Note: Reference value from the standard test is automatically imported into any secondary related tests such as extended time tests (ieR-PTe)
R-PT
1st derivative
MNR = Reference Value
4
None
None
For classroom purposes only, enter a MNR of 11.8 for R-PT test and 30.0 for APTTSYS test Omission of the reference values will generate an error code W (Error in Algorithms, Ratios or Ranges.) 5 Review and select Confirm on all screens
ES 4 of 8
Sort Tests
Sorting Tests function allows a user to set the order tests appear on the Database Screen. The tests order dictates the order tests run in Profiles and displayed on a printed report. Step 1 2 Select Setup/Test/Sort Tests Cut/remove all tests in the Sorted List using the scissors icon Transfer the Enabled Tests to the Sorted Tests using the arrow icon ( in the Sorted column indicates the test(s) are in the Sorted Tests column). Sorted Enabled tests APTTSYS APTTSYSe FIB-C_ FIB-Cl_ FIB-Ch_ R-FIB_ R-FIBe_ R-PT R-PTe Sorted Tests R-PT R-PTe FIB-C_ FIB-Cl_ FIB-Ch_ APTTSYS APTTSYSe R-FIB_ R-FIBe_ Action
Review and select Confirm
on all screens
ES 5 of 8
Disabling a Test:
Step 1 2 3 Action Disable the R-PT test. A confirmatory message appears warning the consequence of disabling a test, answer Yes Refer to page ES 2 of 7; Re-Enable R-PT, modify units, verify MNR, and Sort the test Review and select Confirm on all screens
ES 6 of 8
Skill Check
1. How do you navigate between full test menu and the tests you enabled? ______________________________________________________________ 2. What does an underscore beside a R-FIB_ test mean? ______________________________________________________________ 3. Where do you enter the MNR (Mean of the Normal Range) of your lab? _____________________________________________________________ 4. Do you have to enter MNR into all associated PT tests? _____________________________________________________________ 5. Write the step sequence to customize units shown on the patient database view screen and on printed reports. _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ 6. What determines the order test results are displayed at the top of the database view screen? _____________________ 7. What message displays once a test is disabled? _______________________________________________________________ _______________________________________________________________ _______________________________________________________________
Instructor Tests Enabled ____

MNR____ Units____ Tests Sorted____
Sign Off
ES 7 of 8
ES 8 of 8
LD SETUP REAGENT AND LIQUID DEFINITIONS OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Quick Reference Guide and Reagent Package inserts, you will: Setup and Define Reagents and Liquids Locate Calibrations Values Define Dead Volume and Assigned Volumes
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 4 ACL ELITE / ELITE PRO Quick Reference Guide, Reagent Loading, Lot Change, and New Test Setup HemosIL Reagent/Calibration Package inserts
Note: The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use similar analytical systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the two systems.
LD 1 of 6
Setup Reagent and Liquid Definitions

Performance Guide
Step 1
Action Obtain a Reagent and Liquid Definition Table, located within the Package Insert Folders from your facilitator. The table includes: reagent name, lot number, expiration date and stability information Select from the Main Menu Setup / Liquids Note: To view the liquids corresponding to the enabled tests, select show enabled icon to condense the list Cursor or touch the appropriate liquid you want to define/modify Select the Lot Number box and enter the lot number from the table, bottle or package insert sheet Select the Expiration Date box the table, bottle or insert sheet and enter the expiration date from
2 3 4
Note: expiration date format based on format setup in Setup System module 6 Tab or touch the next box to be entered Note: by Tabbing you will not miss any entries Enter the reagent stability from the package insert. Enter a number followed by h for hours or d for days The Assigned Volume is the default volume in the Materials Map screen (when reset volume is selected). The assigned volume is based upon the liquid reagent vial size.
Note: PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
In the Warning Level box enter a value that is slightly more than the dead volume. The Dead volume level is defined in chapter 7, page 7.44 in the Operators Manual. A table displays the difference between volume of the reagent vial, minus the usable volume.
Note: PLEASE, FOR THIS CLASS, DO NOT MAKE ANY SELECTION
10
Repeat steps 3-9 for all remaining Liquids on table provided.
LD 2 of 6
Entering the ISI Value:

Step 1 2 3 4 5 6 7 Action Select the Liquid ID associated with the enabled PT test (RecombiPT) Cursor to Used By column(right side of screen) select the enabled PT test (R-PT) Select Assign Value icon Enter the ISI value from the Reagent Package Insert sheet Review and select Confirm A message will appear Liquid Parameters have been changed. Do you want to save them before proceeding? Select Yes
Note: It is not necessary to enter the ISI value for other subsequent PT tests. i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests. This value is imported.
Note: To only view the liquids corresponding to the enabled test select the Show Enabled icon
LD 3 of 6
Entering Calibrator Values

Step 1 2 Action From the Liquid Setup Screen select Cal Plasma In the Used by list (right side of screen) cursor to the appropriate test Enter the value indicated in the Calibration Plasma package insert sheet by selecting the Assign Value box Note: This box will only be activated if a test has been enabled requiring cal plasma for calibrating Enter the Fibrinogen assayed value for R-FIB_, and the FIB-C_. FIB_US Units (underscore) mg/dL Enter the value for the enabled R-PT test. (RPT = 100). The calibrator value for any PT test run in the laboratory should be set to 100 A message will appear Liquid Parameters have been updated. Do you want to save them before proceeding? Select Yes and continue to next test in the used by column Select Confirm once all values have been entered
6 7 8
LD 4 of 6
Skill Check
1. Under what liquid definition is the ISI value entered?___________________ 2. Where is the Fibrinogen Calibration value entered? _________________________________________________________
3. How is the Warning Volume determined? _________________________________________________________ _________________________________________________________ 4. Do you have to enter the ISI value into all associated PT tests (ie.extended or duplicate tests)?_________ 5. Where is the assigned volume entered for any reagent(s)? Where is this value obtained? ________________________________________________________ ________________________________________________________
Sign Off
Instructor
LD 5 of 6
LD 6 of 6
MLT
ACL ELITE/ELITE PRO
MULTI-TESTS OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training Module you will:
State the difference between Test Profiles, Test Groups and Test Group Profiles Identify the symbols representing Profiles, Test Groups, and Test Group Profiles in the Multi-Test Analysis dropdown menu Perform Setup of Test Profiles Use Sorting to visibly display test profiles defined in the system Identify Default Multi-Tests and Default Tests Locate and identify the number of Profiles and Test Groups available in the software State what determines the order tests are run within a Profile State the number of Profiles that can be defined State the number of Test Groups
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.1.5, and 4.1.7-4.1.11 ACL ELITE / ELITE PRO Quick Reference Guide, New Test Setup
MLT-1 of 8
ACL ELITE/ELITE PRO
The software allows users to define and view their own choice of Multi-Tests (Profiles or Test Group Profiles) Profiles contain one or more single tests Test Group Profiles are comprised of predefined Test Group combinations Up to 30 Multi-Tests Profiles can be created (code numbers from 1 to 99). Each Multi-Test Profile can contain a maximum of 20 test combinations. The actual number of tests added will be dependent upon available reagent positions Test Groups are defined in the software library. (Users can not change or delete these Test Groups) Predefined Test Groups are a combination of tests using the same wavelength, optical reference and acquisition cycle
Performance Guide
Define/Setup Profiles
Single tests are grouped or combined to form Profiles Step 1 2 3 4 5 Action Select Setup from the main working area Select Multi-Test Select Profiles Select New Profile icon Enter Routine in the Profile ID box Enter number 1 in the Profile Code box 6 Note: Starting at number 1 ensures that there is a continuous, consistent identification system (1-99). Profiles and Test Group Profiles share the same sequential numbering code From the Enabled Tests box, transfer the following tests: R-PT, APTTSYS, RFIB_, R-PTe, APTTSYSe, and R-FIBe_ , to Tests in Profile box using the arrow icon To delete a test from the Test in Profile select 8 Review setup and Confirm icon
MLT 2 of 8
ACL ELITE/ELITE PRO
Step 9 10 11 Select New Profile icon Enter DDimer in the Profile ID box
Action
Enter number 2 in the Profile Code box From Enabled Tests box, transfer the following tests: D-Dimer and DDh, to Tests in Profile box using the arrow icon To delete a test from the Test in Profile select icon
12
13 14 15 16
Review setup and Confirm Select New Profile icon Enter All in the Profile ID box In the Profile Code box enter number 3 From the Enabled Tests box, transfer the following tests: R-PT, APTTSYS, RFIB_, R-PTe, APTTSYSe, R-FIBe_ , D-Dimer and DDh to Tests in Profile box using the arrow icon To delete a test from the Test in Profile select icon
17
18
Review setup and Confirm
MLT 3 of 8
ACL ELITE/ELITE PRO
Sorting Multi-Tests
Profiles, Test Groups and Test Group Profiles that are not in the Sorted Multi Tests list will not be visible as available Multi-Tests under Analysis drop down menu. Step 1 2 Select Setup Select Multi-Tests Select Sort Multi-Tests. This opens a screen similar to: Action
Sorted Multi-Tests
Note: The 3 columns on the left side of the screen list Profiles, Test Groups and Test Group Profiles. A check mark on the left side indicates that item is a Sorted Multi-Test. The column on the right of the screen displays all Sorted Multi-Tests; this order is determined by the user.
MLT 4 of 8
ACL ELITE/ELITE PRO
Step
Action
Note: Profiles, Test Groups, and Test Groups Profiles that are not sorted will not be visible on the Analysis menu drop down selection.
Transfer the following Multi-tests to the Sorted Multi Tests list using the arrow icon, in the order displayed in the Sorted Multi-Test box.
Profiles
Test
Test
Group * * *
Group Profile * * *
Routine DDimer All
Sorted Multi-Tests
Routine DDimer All
*Make No Selections
Test Groups sessions

Test Groups are IL created and locked (you can not delete and sort). The tests combined in a Test Group use the same wavelength, optical reference and acquisition cycle.
Test Group Profile sessions

Test Group Profiles allows users to define and view their own choice of combined Test Groups to run in a different named, Multi-Tests, analytical session. Each Test Group Profile is assigned a Profile ID (maximum of eight alphanumeric characters). Note: The symbols displayed prior to the test groups names in the analysis drop down for the selected Multi-Test or Single Sessions have the following meaning: 5 Test Group Session- Predefined by IL Profile Session, tests combined and ran as batch testing, created by user Test Group Profiles Session-combined Test Groups created by user.
NOTE: No Test Groups and Test Group Profiles should appear in sorted Multi-Tests list 6 Review setup and Confirm
MLT 5 of 8
ACL ELITE/ELITE PRO
Default Multi-Tests
The Default Multi-Tests selection determines the tests available and the material map setup when using the Start icon on the Database View screen. Enabling a Default Multi-Test also activates on the Database View screen the following icons: Start and Materials Map creating navigational shortcuts
Step 1 2 3 Select Setup Select Multi-Tests Select Default Multi-Test
Action
Transfer one desired Enabled Multi Tests to the Default Multi Tests list using the arrow icon (For example: Routine) 4 Note: The Default Multi Tests selection activates the Start icon and the Materials Map icon on Database View Screen
Toggle on the Enable Default Multi-Test, Check (X) will appear within the box. 5 Note: The desired tests for a run still needs to be programmed on a sample even though the Default Multi-tests are enabled when not connected to a LIS (Chapter 4, pg 4.27-Operators Manual) Review setup and Confirm
MLT 6 of 8
ACL ELITE/ELITE PRO
Default Test
If enabled, Default Tests are programmed on sample IDs that do not have programmed test(s) in the internal database or after a host query. Step 1 Select Setup/ Tests/ Default Test Transfer the R-PT, Enabled Tests to the Default Tests list using the arrow icon 2 Note: Default tests will be added to a sample after the instrument checks the database and performs a host query. If host is down the Default Test selected will run on each sample that receives no information from the database or host query To Enable Default Tests, place a Check (X) in the Enable Default Test box Review setup and Confirm Action
3 4
MLT 7 of 8
ACL ELITE/ELITE PRO
Skill Check
1. What determines the order tests are run in a Profile? _____________________ 2. How many Profiles can be defined? ___________________ 3. What is the total number of test groups? _______________ Hint: Operators Manual Chapter 7 Assay and Instrument Specifications: page 7.47. 4. Sorted: Profiles, Test Groups, and Test Group Profiles will be visible under Analysis menu drop down selection as: a. Multi-Tests b. Single Test 5. Match the following: Test Group Test Group Profiles Profile Individual tests grouped to run in batch mode Combination of tests using the same wavelength, optical reference and acquisition cycle Grouped tests, run in a single named Multi Test
6. After running samples, some tests ordered on a sample were not run. What would you check?
__________________________________________________________ __________________________________________________________ __________________________________________________________
Sign Off
MLT 8 of 8
SQC
etupACL ELITE/ELITE PRO
SETUP QUALITY CONTROLS FILES AND A QUALITY CONTROL LOADLIST
OBJECTIVE
Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training Module and Quick Reference Guide you will: Setup quality controls Create and print a Loadlist for Quality Controls
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Manual ACL ELITE / ELITE PRO Operators Manual, Chapter 3 ACL ELITE / ELITE PRO Quick Reference Guide
PN722277Rev BB (December 2010) Miami Education Center
SQC 1 of 6
ACL ELITE/ELITE PRO
Setup Quality Control

Performance Guide:
Step 1 2 Select QC from the Main Menu Select Setup / Review Deselect the check box for Show Enable Action
Cursor up or down to select the appropriate liquid, define and Setup the following Quality Controls Files: Normal A High Abn A Fib Low (Lot Number, Expiration Dates, Target means and Target SD ranges will be provided by your facilitator) Answer Yes to any message that appears. Using steps 5- 12 Set Up the QC files following the chart below. (The A-annotates Assayed Controls and the U-annotates Unassayed Controls to the left of the named control level) Control Material
Normal
Test Stored
R-PT R-FIB_ APTT SYS Fib-C_ R-PT APTT SYS R-FIB_ Fib-C_
Unit
Sec mg/dL Sec mg/dL Sec Sec mg/dL mg/dL
SD Range
2 2 2 2 2 2 2 2
Normal A 5
High Abnormal
High Abn A
Fibrinogen Low
Fib. low
SQC 2 of 6
ACL ELITE/ELITE PRO
Step 6 7 8 Select Setup icon
Action
From the Enabled Test List, select a test by highlighting a test, use the arrow icon to move the test to the Configured Test list To edit the Configured Test list use the scissors icon delete a test from the list to remove or
For each test that you configure, input: (see Classroom Inserts for values) Units, each test Target Mean Target SD SD Range Note: Removing a test from this list deletes all the results from database Select QC Range Check flagged if out of range Select Flag Patient Results out-of-range is detected icon, the control will be checked and
10
icon to flag patient results when QC
11
Note: QC outside defined ranges will flag on cummulative patient printouts, therefore, always ensure QC flags are addressed prior to samples being processed. Print QC level Setup for your files (Do not have to do this in class, but could after you setup each level in your laboratory) Review and select Confirm Select Show Enabled created (X) to view only your quality control list
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SCQ 3 of 6
ACL ELITE/ELITE PRO
Setting Up a QC Loadlist
Step 1 2 3 4 5 6 Action From the main menu select Analysis, select Multi-Test Session and choose the Routine Profile Select Add QC QC material icon; QC liquid List is displayed select the appropriate
Repeat step 2 until all control materials are assigned Select Store Loadlist choice (1-20) Select Confirm Select Cancel icon and select the Loadlist Number of your (Returns you to the Multi-Test Pre-Analysis screen) to exit the screen
SQC 4 of 6
ACL ELITE/ELITE PRO
Skill Check
1. Show facilitator Quality Control Files and Loadlist. 2. What box is selected to narrow quality control liquid list (view only those quality controls you use)? _________________________________________________ 3. In QC Setup, what is the difference between the Liquid details of Normal A and Normal U?
____________________________________________________________
Instructor QC Files_______ Loadlist _______
Sign Off
SCQ 5 of 6
ACL ELITE/ELITE PRO
SQC 6 of 6
MAINTENANCE NEEDLE ALIGNMENT AND CLEANING PROCEDURE OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, an Operators Manual, Training Module and Quick Reference Guide you will:
Perform Daily, Weekly, Biweekly, Monthly and As Needed Maintenance Perform needle block replacement and positioning procedure
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual, Chapter 5 ACL ELITE / ELITE PRO Quick Reference Guide, Daily Maintenance
M 1 of 18
DIAGNOSTIC SOFTWARE OVERVIEW Note: For further information regarding the instruments Diagnostic menu, please
refer to the IL ACL ELITE / ELITE PRO System Operators Manual. Select Diagnostic; the following list displays: Priming Cleaning Maintenance Temperature Control Needles Position Session Error History File Error History Logbook Service (dimmed) - Only accessible to service
Priming
Primes the ACL diluter pistons and associated tubing with Wash-REmulsion. This should be done at the beginning and end of each shift and as part of daily maintenance Prime required after replacing Wash R Emulsion. Operator requested priming cycle lasts approximately 50 seconds, using 6mL of Wash R Emulsion The ACL auto primes every 30 minutes of inactivity, using approximately 0.9mL of Wash R Emulsion, during a 20 second period
M 2 of 18
RINTED 02/14/2011 10:16:00 AM IL ACL ELITE/ELITE PRO
Needles Cleaning Procedure

Materials needed: Four (4) 10mL bottles, Cleaning Solution and Factor Diluent Desired Cleaning solution must be placed in both positions R6 and R7 (Reagent positions: R6 for reagent line and R7 for sample line). Followed by Factor Diluent in both positions R6 and R7 Fill two (2) 10mL bottles with 8mL of Cleaning solution (Clean Solution per ILs recommendations) and two (2) 10mL bottles with 8mL of Factor Diluent Cleaning Solution (also called Clean A) 0.1Normal HCL (PN 9831700) is appropriate cleaning for weekly needle cleaning procedure Cleaning Agent (also called Clean B) Sodium Hypochlorite solution (PN 9832700) is the cleaning agent of choice for decontaminating the needles. Prepare Solution of 1:8 Dilution: One (1) part cleaning agent to seven (7) parts CLRW water Factor Diluent-(PN 9756600) used as a secondary step of daily needle cleaning procedure
13
13
The operator may define the configuration of the cleaning cycle by selecting:
PN722277BB Miami Education Center
Volume - volume of cleaning agent aspirated (in Ls). Minimum volume requirement 0 L and maximum volume limit 130 L. (Recommended volume is 130 L) Cycles No. number of cleaning cycles the ACL performs. The default is three cycles. One cycle is the minimum that can be run and five the maximum. (Recommended three (3) cycles) Washing at Completion- number of rinse cycles that occurs after the cleaning cycle has been completed. The default is five (5) rinse cycles with a minimum of one (1) rinse cycle and a maximum of five rinse cycles. (Range is 0-5, Recommended is 5) (December 2010) M 3 of 18
MAINTENANCE
Maintenance log within the software, can be used for monitoring the frequency and status of maintenance. A paper copy is also available including all maintenance procedures (see page M 17)
List of suggested maintenance operations
Suggested frequency for maintenance Displayed in Days
Print Delete Clear Select this button to automatically enter the current date in the Last Date field Allows 30 alphanumeric characters of free-text entry about the procedure in the Note field
Confirm
Note: If Maintenance log is used and the Date Field expires or becomes overdue a procedure displays Red, the Yellow Alert Triangle will illuminate, provides a warning and results will be flagged (M code). The Frequency is tracked by date not time
Temperature Control
Displays the real time, current temperatures and the acceptable limits of the rotor holder, peltier, rotor stack, and rotor transporter. Acceptable temperatures: Device Normal Range Rotor Holder Temperature 38.0-39.0 C (100.4-102.2 F) Peltier Temperature R1 - R4 10.0-16.0 C (50.0-60.8 F) Peltier Temperature R9 - R12 10.0 -16.0 C (50.0-60.8 F) ELITE PRO only Rotor Transport Temperature 34.0 - 40.0 C (50.0-60.8 F) Rotor Stack Temperature 34.0 - 40.0 C (50.0-60.8 F) M 4 of 18
Needles Position (see pages M 13-14 for needle alignment procedure)

Needles Position used to verify or complete the alignment of the needle block to the rotor on the rotor holder, as necessary. Selecting Needle Positioning completes a quick self-initialization, which moves the arm over the rotor area. The following screen is displayed:
Raises and lowers the arm over the rotor holder area Moves the rotor position on holder by 90 or turn
Refer to the alignment procedure, under As Needed, Needle Block

Replacement on pages M 11-14 or refer to the Operators Manual, Chapter 5
Session Error History

Screen displays errors or alarms during the current analytical session.
The most recent error of the session is on the top of the list. The instrument will store 200 errors. The errors display until a new session begins. At that time, the previous session errors are automatically removed and transferred to the File Error History log.
PN722277BB (December 2010) Miami Education Center
M 5 of 18
File Error History

Stores up to 100 errors and warnings that have occurred on the ACL ELITE / ELITE PRO System. FIFO-First In First Out. Lists the error/warning along with the date and time.
Service Only
Logbook
Records and stores operator actions or for example, change in QC range, modification in setup configuration, etc.
Allows 30 alphanumeric characters for free-text entry about each action in the Note field
M 6 of 18
PERFORMANCE GUIDE
Daily:
Step 1 Action Check Wash-R Emulsion- Replace the bottle when the level of liquid is 1.5 to 2.0 cm from the bottom approximately, a 100 mL volume will trigger alarm for low volume Check Liquid Waste Container- Check the level of the liquid in the waste container and empty if necessary as per your laboratory protocol Empty Rotor Waste Container-Check the amount of used rotors in the container and empty if necessary. (A sensor is located in the rear and is activated when the waste container is in place on ACL Elite PRO only) 3 Open the small door on the front right-hand side of the analyzer body to access the rotor waste container Grab the handle of the container and pull outwards to remove it Dispose of the used rotors found in the waste container Replace the waste container, handle facing out to activate the waste sensor, close door
Needle Cleaning Procedure-Performed to reduce protein buildup on the needles block assembly 4 From the working area select: Diagnostic / Cleaning Fill two (2) glass 10 mL vials with 0.1 normal HCl solution Clean A and place vials in reagent positions R6 and R7 Select the number of cycles, then Start Replace 0.1 normal HCL solution Clean A with two (2) 10mL vials of fresh Factor Diluent and Repeat entire procedure After entire cleaning cycles are completed return Clean A to R6 and perform Priming cycle
M 7 of 18
Step
Action Clean Waste Line/Verify Needle Position- Clean the waste line as needed, dependent upon daily workload of your laboratory (may be required daily) Open the reagent cover area From the working area select: Diagnostic /Needles Position Select Yes to open the rotor holder area. Once Needles are over Rotor Holder area, verify Needle Position, adjust only if needed (Refer to As Needed: Needle positioning procedure on page 12-13) Remove the Rinse Reservoir, clean weekly (See Rinse Reservoir cleaning procedure on page 9) Attach a suitable piece of tubing to a syringe (20mL recommended), fill with approximately 20mL reagent grade, deionized water. Insert the tubing into the waste line opening. Push the deionized water into the waste line opening and ensure the water flows freely through the waste line Repeat the procedure as necessary, to ensure removal of any potential buildup Replace the rinse reservoir Select and confirm with OK. This repositions the arm and returns the instrument to READY status
Perform Priming Procedure- Prime the instrument at the beginning and end of each working day or once per shift From the working area select: Diagnostic / Priming Visually inspect for the following: 6 1. If bubbles are present, pinch the chamber outlet tubing as the pistons are descending and release before the piston reaches the bottom. Repeat until the bubbles are gone 2. There are no blockages or leaks in the liquid flow path and that liquid is flowing freely from the reservoir to the dilutors and from the dilutors to the needles 3. The liquid is flowing freely down the waste line to the liquid waste container
M 8 of 18
Weekly:
Step Action General Instrument Cleaning Procedure 1 Clean all exposed surfaces of the instrument, the inside of the Autosampler, and the Rotor Compartment (excluding the rotor holder) using 0.1 N HCl (HemosIL Cleaning Solution PN 9831700), Clean A Rinse with Deionized Water and dry
Clean Rinse Waste Reservoir From the working area select: Diagnostic Needles Position 2
Rinse/Waste Reservoir
This causes the needle arm to move over the rotor holder. Remove the rinse reservoir and wash it with 0.1 normal HCl, Clean A, followed by rinsing with Deionized Water Place the reservoir back into its position Select position and confirm with OK. The needle arm returns to its home
M 9 of 18
Biweekly Maintenance:
Step Action Clean Rotor Holder and Optic Path Select to open the rotor holder cover. Using cotton tip applicators, lightly moistened with deionized water and clean the following areas:
Chromogenic Channel Sensor Filter Rotor Cover
LED Fiber Optic Surface
LED Sensor Surface
Surface of the Channel Sensor
Optical window on rotor holder Total (20)
all 20 optical windows in the rotor holder area the surface of the Channel Sensor the LED Sensor surface the LED Fiber Optic surface the Chromogenic Channel Sensor filter 2 3 4 5 Use a clean, dry cotton tip applicator to dry these areas after cleaning Clean around rotor holder with 2x2 gauze moistened with distilled water Close the rotor holder cover Reboot Analyzer- Select the log off icon wait a few seconds and power back on then power off instrument,
M 10 of 18
Monthly:
Step 1 Action Clean Air Filter- Remove the air filter from the right hand side of the instrument by pulling the air filter holder upwards Clean the filter using compressed air or by washing it in water and blowing dry. Put back in the holder and reinsert back into position. Do not put a wet filter on the ACL ELITE / ELITE PRO System
As Needed Maintenance:
Step Replace Needle Block: Select open the rotor cover icon to expose the rotor holder for alignment completed after replacement of needle block From the working area select: Diagnostic / Needles Position Moves the sample arm over the rotor holder 1 Loosen the white knob on the back of the sample arm, label sample tubing, the disconnect both tubings, disconnect the sensor cable and remove the needle block Insert the new needle block, connect the sensor cable, re-connect both tubes, and position the block higher than the arms top surface Follow the Needle Positioning Procedure to align the needle block correctly M 11 of 18 Action
Step
Action Needles Positioning: From the working area select: Diagnostic / Needles Position; when the dialogue box asks if you want to open cover select Yes (disregard if open) This moves the needle arm over the rotor holder Using the rotor snap, remove the rotor and insert the Needle Adjustment Tool onto the rotor holder with the white reference dots facing up
Select the Raise / Lower Needles Adjustment Tool
icon. This lowers the sample arm down to the
The needles should touch the upper surface of the tool. To adjust the height, loosen the white knob on the back of the needle arm and move the needle block up or down so that the needles are just touching the surface of the tool When the height is correct, tighten the white knob finger tight to ensure the needle height does not change, the probes should be within the white dots. NOTE: Alignment is to the rotor (see step7) not to this tool. This tool is only for height adjustment Select the icon to raise the needle arm
6 7
Use the rotor snap to properly remove the needles adjustment tool and replace with a new clean ACL rotor Select the icon. This lowers the needle block into the rotor. See picture for proper alignment within rotor (note: or biased slightly left)
M 12 of 18
Step
Action
Verify the needle block position is in the center of the rotor or slightly biased to the left of center as shown in previous step Select Select Select icon to raise the needle arm. icon, this moves the rotor a quarter turn to cuvette position 6. icon to lower the arm and repeat the same procedure.
10 11
12
Raise, Rotate, Lower, Look (90 or turn/rotation) Sequence is repeated in rotor positions 1, 6, 11 and 16 (all four quadrants)
13
If adjustments are required, loosen the white knob on the back of the needles arm and move it by turning the knob until needles are positioned in the center or slightly left within the cuvette wells. Recheck each quadrant Select icon to close the rotor holder cover and reinitialize sample arm
14
Step Maintenance Diskette: 1
Action
Performance of scandisk and defragmentation operation uses the Hard Drive Maintenance disk received in your Software packet to improve the overall performance of the system Log off, power down instrument, insert Maintenance Disk and power on. Allow software embedded on diskette to complete a scan and defragmentation, DO NOTHING until message appears: Hard Drive Maintenance Procedure Completed, please remove disk and reboot instrument. Remove diskette, power off, wait a few seconds, power on and log in to software
M 13 of 18
Step
Action Decontamination-Refer to Operators Manual Chapter 5, Section 5.2.7, page 5.28-5.29 This procedure should be used if instrument contamination is suspected or for QC recovery issues. This procedure is workload dependent and may be done as often as monthly (DO NOT perform this procedure in CLASS) The disinfecting agent used to perform this procedure is a 1:8 dilution of HemosIL Cleaning Agent PN 9832700, one part Cleaning Agent-Clean B to seven parts CLRW water
1 Caution: The use of undiluted IL Cleaning Agent, Clean B, may cause corrosion of metal parts. Chapter 5, Section 5.2 :
Step Clean LCD Screen 1
Action
As needed, to remove smudges or dirt build-up. Any standard glass cleaner, without ammonia, can be used to clean the touchscreen. Always spray the glass cleaner on a clean, soft cloth or towel and then clean the touchscreen. Avoid glass cleaner sprayed directly on the monitor; this could result in a leak within the nonsealed unit and cause damage (Elo-TouchSystems recommendations) Log Maintenance Diagnostics/Maintenance/Date/Note Note: Log is NOT done automatically, operator must document completion (Paper Maintenance Log Sheet available for all maintenance procedures on M 17)
M 14 of 18
Skill Check
1. What is the default cycle for the needles cleaning cycle? ____________ How often is this procedure performed? __________ 2. State the recommendations for the following maintenance procedures. Maintenance Procedure 1. Check Wash R-Emulsion 2. Clean Waste Line 3. Clean Needle Procedure 4. Clean Air Filter 5. Align Needles 6. Verify the Needles Alignment Interval
3. What is the frequency for using the maintenance disk? What is the purpose for this procedure? ___________________________________________________________ ___________________________________________________________
Instructor Maintenance log _______ Needles Alignment ________
Sign Off
M 15 of 18
M 16 of 18
ACL ELITE / ELITE PRO System Maintenance Log

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Month______________ Year ___________ Daily
Check Wash R-Emulsion Level
Empty Liquid Waste If Necessary
Empty Rotor Waste Container
Perform Needle Cleaning Procedure
Clean Waste Line, daily workload dependent Priming - Start of shift/day
Priming- End of shift/day
Weekly
Clean Instrument
Clean Rinse Reservoir
Biweekly
Reboot the Analyzer
Clean Rotor Holder and Optic Path
Monthly
Check and Clean Air Filter
As Needed Maintenance
Replace Needle
Needles Position
Perform Waste Line Bleaching
Decontamination Procedure
Clean LCD Screen
Hard Drive Maintenance Disk
Tech Initials M 17 of 18
PN722277BB (November 2010) Miami Education Center
M 18 of 18
PN 722277BA (August 2009) Miami Education Center
CAL
CALIBRATION OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, an Operators Manual, Training Module and Quick Reference Guide you will: Perform the Calibrations for: FIB-C_, R-PT and R-FIB_ using procedures in training modules Obtain an r2 value > 0.980 for R-PT Obtain an r2 value > 0.980 for FIB-C_, and R-FIB_
MODULE RESOURCES

ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Operators Manual Chapter 3, Section 3.4 ACL ELITE / ELITE PRO Quick Reference Guide, Calibration
CAL 1 of 6
The variables involved in a calibration, are the test-specific reagents and specific materials used for the test calibrated. The calibration procedure is common to all calibrated tests. Some calibrations are within run (In Session) and some are performed prior to sample analysis (Dedicated), with samples processed off a stored Calibration curve. Refer to the package insert for specifications on reagent preparation, storage and stability. Dedicated: A separate session is done to perform a calibration. The session is initiated by going to the calibration menu. In Session: The calibration is executed the first time with the sample run, and can then be re-used for later sample runs. (If Cal Plasma is present, a new calibration will be performed automatically. If no Cal Plasma is present, the stored calibration is used.) Each Rotor: Every time a rotor is loaded with samples the calibration must be done for that assay. Note: Refer to the Operators Manual in the Calibration section for further explanation of which tests are Dedicated, In Session, or Each Rotor.
Note: The ACL ELITE / ELITE PRO and the ACL8, 9 and 10000 use identical analytical systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the two systems.
CAL 2 of 6
CALIBRATION OF THE PT-FIBRINOGEN_ (RecombiPlastin)

Performance Guide
Step Action Note: Always ensure Daily Maintenance has been completed prior to Calibration-refer to M (Maintenance) Module. 1 Note: Ensure there is ample volume of Wash-R-Emulsion-refer to RWE module (Replace Wash-R-Emulsion). Select Diagnostic 2 3 4 5 Select Priming (To ensure there are no bubbles in the lines) From the working area select Calibration Select Calibrate From the Tests to Calibrate drop down menu select R-PT Select Materials Map icon, ensure all reagents and liquids are placed on the system as indicated; update volumes and expiration date of the reagents. Using a cup adapter, place reconstituted Cal Plasma in a labeled 2.0 ml cup Place a 10 mL vial of Fresh Factor Diluent according to materials map 7 Select Start
Once calibration is complete, review data and ensure that the r2 value is > 0.980 8 Note: If the r2 value is in red the calibration value is outside the limit, repeat calibration Recognize any errors that exist by selecting the Error View 9 Individual replicates may be omitted from the calibration by selecting Omit Replicate icon. Refer to the Operators Manual, chapter 3, page 3.68 for further explanation of omitting replicates points Successful calibration select Confirm
10
CAL 3 of 6
CALIBRATION OF THE FIB-C_ (Clauss Fibrinogen)

Performance Guide
Step Action Note: Always ensure Daily Maintenance has been completed prior to Calibration-refer to M (Maintenance) Module. 1 Ensure there is enough Wash-R-Emulsion-refer to RWE (Replace Wash-REmulsion) module. Select Diagnostic 2 3 4 5 Select Priming (To ensure no bubbles in the lines) From the working area select Calibration Select Calibrate From the Tests to Calibrate menu select FIB-C_ Select Materials Map icon and ensure all reagents and liquids are placed on the system as indicated; update volumes and expiration date of the reagents. Using a adapter place reconstituted Cal Plasma in a labeled 2.0 ml cup Place a 10 mL vial of Fresh Factor Diluent according to materials map 7 Select Start Upon completion review data and ensure that the r2 value is > 0.980 8 Note: If the r2 value is in red the calibration value is outside the limit, repeat calibration Recognize any errors that exist by selecting the Error View 9 Individual replicates may be omitted from the calibration by selecting Omit Replicate icon. Refer to the Operators Manual, Chapter 3, page 3.68 for further explanation of omitting replicates points Successful calibration, select Confirm
10
CAL 4 of 6
Skill Check
1. Your R-PT calibrated and the PT based Fibrinogen (R-FIB_) did not calibrate, what would you check or verify? _______________________________________________________________ _______________________________________________________________ 2. What could cause both R-PT and R-FIB_ calibrations to fail? _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ 3. Where in the software do you enter the Clauss Fibrinogen (FIB-C_) calibration value? What is that value? _______________________________________________________________ _______________________________________________________________ 4. Where would you obtain the Fibrinogen (R-FIB_) calibration value? _______________________________________________________________ _______________________________________________________________ 5. What is an acceptable r2 value for R-PT and R-FIB_ calibration? _______________________________________________________________ 6. Where can you find the acceptable r2 value? _______________________________________________________________ 7. Can you omit an individual replicate from the calibration? Can you restore omitted replicates? _______________________________________________________________ 8. Show your printouts from the Calibration to your facilitator.
Sign Off Instructor
CAL 5 of 6
CAL 6 of 6
RQC2
ACL ELITE/ELITE PRO
QUALITY CONTROL OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, an Operators Manual, Training Module and Quick Reference Guide you will: Run HemosIL Normal Control, High Abnormal Control, and Low Fibrinogen Control for the following tests on the ACL ELITE/ELITE PRO:
R-PT APTTSYS R-FIB_ FIB-C_
Review the QC results, make any corrections and repeat as necessary
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Manual ACL ELITE / ELITE PRO Operators Manual, Chapter 3 ACL ELITE / ELITE PRO Quick Reference Guide, Quality Control
RQC2 1 of 10
ACL ELITE/ELITE PRO
REVIEWING QUALITY CONTROL DATA

QC Review of Results
Select the QC Setup/Review or the QC icon to review the QC results
Quality Control List
Clear All
Clear Single
Print All QC
Print Today QC
Levey Jennings Charts
Cumulative Results
The QC List retains the last 100 QC results. To view any Levey Jennings charts and Cumulative Results, use the icons at the bottom of this database screen (Plot and Statistics and Cumulative Results) Use the Clear All icon daily to clear the QC list. All QC data will remain in the QC database file after it is cleared from the list Select the Print Today QC icon to print todays quality control runs
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ACL ELITE/ELITE PRO
Plot and Statistics

Select the QC material, select the Plot and Statistics icon on the QC List to display the Levy Jennings chart.
Defines the start and end dates
Returns data displayed to the last 30 days
Print
Cumulative Results
The QC Plot and Statistics screen displays the 30 day intervals of QC results
(use arrows at base of chart). QC results within range are displayed as a black , within 2SD are displayed as a violet blue o, and outside of 3 SD are displayed in red or
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ACL ELITE/ELITE PRO
Cumulative Results
To review all QC data for the selected enabled QC material, select from the QC List screen Cumulative Results icon or the QC Plot and Statistics screen.
View single result details
Add text note (up to 30 characters )
Cumulative Results
Omit selected result from statistics
Columns: F Flags; Calibration error codes (see pg. 6.23 Operators Manual) S Status; Transmitted to host or Local O Results Omitted cannot be restored
The QC Cummulative screen displays a running list of QC results. QC

results outside set ranges will display a Q in the F column to indicate QC has failed. A (checkmark) in the O column will indicate when a data point has been omitted from the statistical data.
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ACL ELITE/ELITE PRO
QC Host Communication
On the QC Setup/Review screen or the QC list screen, select QC Host Communication icon.
Host Communication screen
Once the transmission criteria are defined by the user, the transmission can be activated by selecting the icon
QC Extract Data
From the QC Setup/Review or QC List screen, select either the QC Cumulative Results or Plot and Statistics.
Quality Control Extract
To open the QC Extract Data screen, select the Extract Results icon (screen similar to Host Communication screen). The data configuration allows the user to select the date range for the QC results to be viewed. The Liquid ID/Test ID is also visible on the upper part of the screen.
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ACL ELITE/ELITE PRO
Running Quality Controls Performance Guide

Analyze Quality Control Step 1 2 Action Select Analysis from the working area, select Multi-Test Session, Routine Profile Check Loadlist Box icon. Enter the Loadlist number you Setup in SQC Module, press Enter on keyboard Label 0.5 or 2.0 mL cups and place QC on the sample tray in the order indicated. To ensure controls are in the proper order. Touch each position in the map to see which level of the control liquid is assigned to that position, or select Loadlist icon. QC within loadlist 1, will be displayed. Note: Tests run on the QC materials are automatically determined by the configured tests for that particular liquid and the tests allowed in the mode of analysis you are using Select Materials Map assigned position 4 icon and ensure that all materials are in their
If an error message appears identifying the scanned liquid as an unknown lot number and expiration date you should verify the current lot number used by selecting Liquid Details icon to update the liquid reagent information
On ACL ELITE rotors must be manually loaded. The instrument will prompt the user to load a new rotor. Message displays ROTOR EXCHANGE NEEDED. Depress the rotor snap located in the center of the rotor loading/analysis area to properly seat the rotor upon removal/replacement
Select Start icon
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ACL ELITE/ELITE PRO
Review QC Results Step Select the QC icon 1 Note: If any QC results are out of range, the QC icon will include a red alert (!), and an audible alarm will sound The QC list displays QC results completed. Within range results are displayed in black, out of range results are displayed in violet blue 2SD, and results outside of the 3SD are displayed in red
Quality Control List
Action
Clear All
Clear Single
Print All QC
Print Today QC
Levey Jennings Charts
Cumulative Results
Select Print Today QC icon to print your daily quality control runs 3 Select the Print All QC icon to print all QC on the QC list
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ACL ELITE/ELITE PRO
Step 4 5 6
Action Select the Cumulative Results icon to review a specific result and its accompanying QC file. Select the Plot and Statistics icon to view a Levy Jennings chart for a control. Review and select Confirm
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ACL ELITE/ELITE PRO
Skill Check
1. What is the total number of QC results in each statistic file? ___________________________________________________

Hint: Operators Manual Chapter 7 Assay and Instrument Specification: page 7.47
2. How many days of results are viewable on the Levy Jennings chart? ___________________________________________________ 3. What indicates a result is omitted in the Cumulative Results view? ____________________________________________________ 4. What symbol is displayed on the Plot and Statistic when data points are omitted from the Levy Jennings? ____________________________________ 5. Can you restore a result once it is omitted? Yes No
6. Can you Print your Daily Quality Control runs from the QC List Screen?______________ If yes, how? ________________________________ 7. What does QC invalid mean when printed on a cumulative report or in the cumulative data in a QC file?_______________________________
Sign Off
Instructor
RQC2 9 of 10
ACL ELITE/ELITE PRO
RQC2 10 of 10
SA3
ACL ELITE/ELITE PRO
SAMPLE ANALYSIS 3 OBJECTIVES

Given an ACL ELITE/ELITE PRO workstation, the Operators Manual, Training Manual, Quick Reference Guide, Reagents/Liquids, System Configuration, Interfaces Setup, and Tests: R-PT, R-Fib_ and APTTSYS enabled, you will: Analyze Samples using the following modes of analysis: Sample ID or Barcoded specimen using the STAT/Pause function Manual Entry Default Tests
MODULE RESOURCES
IL ACL ELITE / ELITE PRO Training Manual IL ACL ELITE / ELITE PRO Operators Manual, Chapter 3 IL ACL ELITE / ELITE PRO Quick Reference Guide: Pre-run Checklist, Process Samples, and Components/Icons/Colors
SA3 1 of 6
ACL ELITE/ELITE PRO
Sample Analysis Pause Session

Performance Guide Add a STAT sample
Step 1 2 3 4 5 Action To Pause the system during the analytical session, Select STAT/Pause icon (Ambulance) A message will appear Do you really want to hold the session? Answer Yes to this message A prompt will appear: STAT samples can be inserted now Select OK Add primary tubes or cups to the sample tray in the next available position Select Read Bar Code Select Start icon, allow the instrument to place and/or identify the cup/tube or barcoded specimen Select the Quadrant that contains the sample(s) added, touch the position and enter the Patient information and demographics per your facilites protocol, then order tests Select Confirm Select Start to resume 8 Note: the Running Man icon replaces the ambulance icon in the lower left corner, until the start icon is selected. The instument status will indicate HOLD in the upper right hand corner of the screen STAT was sucessfully resumed will be displayed, Select OK
All priority samples (STAT) are indicated in the database with a under the column
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ACL ELITE/ELITE PRO
Sample Analysis Manual Entry with Default Test Enabled

Performance Guide Program and Enable Default Test
Step 1 2 3 4 Select Setup/Tests/Default Tests Use the Arrow to select enabled tests to the Default List Action
Enable the Default Test by placing an X in the Enable Default Test box Review and select Confirm icon
Perform Analysis using Default Test

Step Select Multi-Test Session using 1 Note: The Multi-test selected dictates what tests can be ordered and drives what liquids are required to run the tests within the selected Multi-test. Selecting a Multi-test does not automatically order any test. If a sample loaded has a test ordered that is not within the Multi-test selected, the sample status will remain pending (designated with a P in the status column). Select Read Bar Codes icon Samples without barcode labels will generate the following message: Action
Warning: Error in Sample Identification
OK
Acknowledge the message by selecting OK

Quadrant
Select the Quadrant that contains the samples 4 Select the first non-identified sample (yellow with a ?)
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ACL ELITE/ELITE PRO
Step 5 6 7
Action Enter patients demographic information as per your protocols; do not select tests, remember- Default Tests are enabled Samples with barcode labels are identified when the do not select tests, remember- Default Tests are enabled Select Confirm icon is selected;
Continue until all samples are programmed
Select the Materials Map icon and confirm: 8

All reagents are on board and in the correct position All lot numbers are correct and volumes updated Rotors and Wash-R Emulsion are available
Review and select the Start icon
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ACL ELITE/ELITE PRO
Sample Analysis Manual Sample ID Entry- Using a Loadlist

Performance Guide Create a Loadlist
Step 1 2 3 4 5 6 Select Analysis Select Multi-Test or Single Test Select a Quadrant on the sample tray Click on an available position (gray color) (Note: Use ADD QC icon to add QC material) Select Program Sample icon to enter first sample ID Select the Test(s) to be run and enter patients demographic information as per your protocols The tray positions will be displayed in dark blue with the letter P (Pending) for samples and a QC for a quality control liquid To add additional samples, select the New Sample icon view screen, repeat step 6 Select the Store Loadlist icon, enter a loadlist number (1-20) Select Confirm icon Load all samples in the sample tray, confirm the materials map, and select the Start icon Quadrant Action
from the database
10
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ACL ELITE/ELITE PRO
Skill Check
1. When you are in a Multi-Test / Profile Mode, not connected to an LIS, and with no Default tests enabled; are tests automatically ordered? Yes No 2. Does the Barcode Reader alone, detect the presence of a cup or a tube in the sample tray? (Hint: Dont forget the sensor) Yes No 3. What causes a materials map position to turn red? ________________________________________________________ __________________________________________________________ 4. Can you re-start a session after adding a reagent liquid to the instrument? Yes No
1. What action(s) can be taken for a sample/reagent using the Pause Session icon? a) ___________________________ b) ___________________________ c) ___________________________ 2. Can you add a control using the Stat/ Pause icon? Yes No
Sign Off
Instructor
SA3 6 of 6
DD
ACL ELITE/ELITE PRO
D-DIMER OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training Module you will: Enable DDimer and DDh tests, create a Test Profile Create Reflex Rules Perform Calibration, with an acceptable r2 value for the Calibration Curve >0.980 Perform QC with two levels of D-Dimer controls
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Manual ACL ELITE / ELITE PRO Operators Manual, Chapter 7 ACL ELITE / ELITE PRO Quick Reference Guide New Test Setup
DD 1 of 8
ACL ELITE/ELITE PRO
D-Dimer Helpful Hints

Reagent Handling
Calibrator
D-Dimer calibrator is provided in the kit Calibrator is Lot specific Only use with appropriate lot and value from appropriate insert sheet All IL products should be used for this assay Do not use washed rotors CLSI CLRWater or equivalent should be used for reconstitution After the addition of the water, the material should sit at 15-25C for 30 min then gently inverted. Do not shake! Avoid foam and bubbles formation. (Follow reagent Reconstitution instructions in package insert) For optimal stability, remove reagents from the ACL ELITE / ELITE PRO and store at 2-8C in the original vial Calibrator should be placed in a 0.5 mL sample cup Reagent may be left in the original vials Stir bars not used Pooling of new reagent into older reagent should be minimized since this shortens the life of the new reagent stability
IL Products
Water
Reconstitution
Stability
Sample Cups
Reagent Vials
Old vs. New
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ACL ELITE/ELITE PRO
D-Dimer Helpful Hints-continued

Reportable Units
DD test reportable range is 200-1050ng/mL Any result below 200 should be reported as <200 Any result greater than 1050 should be repeated in the D-Dh test mode DDh test reportable range is 1000-5250ng/mL. Any result less than 1000 should NOT be reported from a D-Dh test
DD Test Mode
D-Dh Test Mode
Precision Issues
Typical CVs
Mean 310 732 1055

Bubbles
%CV 6.01% 2.42% 1.31%
Check for bubbles in the dilutor block. Debubble if necessary Check for bubbles in reagent vials and sample cups, remove if necessary Perform needles cleaning. Step 1 2 3 4 5 6 Action Place Clean A(0.1N HCl) in positions R6 and R7 From Main Menu, select Diagnostic, Cleaning Cycles No. 3 Select Start Replace Clean A with 2 vials of Factor Diluent and repeat Wipe both needles with alcohol wipe
Needles Cleaning
Optics
Clean optics for the Chromogenic Channel. Dont forget the 405 filter in the rotor holder cover
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ACL ELITE/ELITE PRO
D-Dimer Helpful Hints continued

Precision Issues, continued
Rinse Reservoir
Clean Rinse Reservoir. Step 1 2 3 4 5 6 Action From Main Menu, select Diagnostics, Needles Position At the Open Cover prompt, select Yes Once the needles move to the rotor holder area, remove the Rinse Reservoir Clean thoroughly with Clean A (0.1N HCl) Rinse with DI water and replace Reservoir Press the Stop icon to move the needles back to the Rinse Reservoir
Precision Run
Perform a precision run of 10 cups of the same sample (not done in this class) Verify the proper protocol for sample collection and handling, reference CLSI Guidelines Calculate CV and compare to Typical CVs * If problem persists, try new Latex and Buffer reagents (remove any bubbles) * Refer to Verification Manual PN 722276 for Precision Run acceptable CVs
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ACL ELITE/ELITE PRO
Control Recovery
Reconstitution
Reconstitute controls with CLSI CLRWater or equivalent as specified on the control vial and package inserts
Assayed Range
Cumulative mean of laboratory control should be within assayed range listed in package insert Establish a 2SD range around this mean Perform Needles Cleaning procedure Step 1 2 3 4 5 6 Action Place Clean A(0.1N HCl) in positions R6 and R7 From Main Menu, select Diagnostic, Cleaning Select Cycles No. 3 Select Start Replace Clean A with 2 vials of Factor Diluent and repeat Wipe both needles with an alcohol wipe
Needles Cleaning
Probe Alignment
Verify probe alignment using Maintenance Module of the ACL ELITE / ELITE PRO Training Guide Clean optics for the Chromogenic channel. Dont forget the 405 nm in the rotor holder cover Clean Rinse Reservoir Step Action 1 From Main Menu, select Diagnostics, Needles Position 2 At the Open Cover? prompt, select No. 3 Once the needles move to the rotor holder area, remove the Rinse Reservoir 4 Clean thoroughly with Clean A (0.1N HCl) 5 Rinse with DI water and replace Reservoir 6 Press the Stop icon to move the needles back to the Rinse Reservoir Recalibrate the D-Dimer assay with fresh Latex and Buffer, Rerun controls.
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Optics
Rinse Reservoir
Recalibrate
ACL ELITE/ELITE PRO
D-Dimer
Performance Guide
Step 1 2 3 4 5 6 7 8 Action Enable D-Dimer and D-Dh (Refer to ES module to enable/select units for tests) Select ng/mL and Offset for units Setup Test Profile containing D-Dimer and D-Dh (Refer to the MLT module to create new profile) Transfer the new Test Profile column to the Sorted Multi-Test Profiles list. (Refer to the MLT module performance guide to sort the profile). Select Setup / Liquids from the working area Enter the reagent information for all liquids used in the test (Refer to LD module for liquid set up) Assign the calibration value found within the DDimer package insert sheet for the DDimer Calibrator Review and select Confirm for all liquids Configure D-Dimer Controls (Refer to SQC module for QC setup) (Use values provided by facilitator for classroom) 10 11 12 Low D-Dimer Control (DDimer test only) High D-Dimer Control (DDimer test only)
Select Calibration, Calibrate and select DDimer from Tests to Calibrate drop down list. (Refer to CAL module for calibrations) Select Materials Map icon Review liquid positions, update volumes, check lot numbers, rotors etc. Select Start icon
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ACL ELITE/ELITE PRO
Step 13 14
Action Once calibration is complete, review data and ensure that the r2 value is > 0.980 To analyze D-Dimer test, follow same procedure for analyzing any sample (Refer to SA1 or SA2 modules)
Warning:
Do not reflex or run a D-Dimer high test for a D-Dimer result under 1000 ng/mL.
By enabling DDh test and a Reflex Rule the ACL ELITE / ELITE PRO System will automatically make a 1:5 dilution of the sample. Any result below 1000 ng/mL will dilute below the linear range of the D-Dimer test (200 ng/mL). Reflex Rule should read: D-Dimer is > 1050, then perform a D-Dh. Linearity: D-Dimer: 200 ng/mL-1050 ng/mL DDh: 1000 ng/mL-5250 ng/mL
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ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the D-Dimer Calibration Report and a run of controls. 2. What is the reportable range for the D-Dimer High test (DDH)? _____________________________ ng/ml 3. If the D-Dimer controls recovery is not acceptable, what can you check? Control Recovery A. B. C. D. E. F. G. 4. Do not reflex to a D-Dimer High test (DDH) if results of the D-Dimer test is under 1035ng/ml. Please explain Why? __________________________________________________________ __________________________________________________________ __________________________________________________________
Sign Off
Instructor
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TS
ACL ELITE/ELITE PRO
TROUBLESHOOTING OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module and Quick Reference Guide you will: Read, understand Chapter 6, Troubleshooting in the Operators Manual and answer the questions within the module
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 6 ACL ELITE / ELITE PRO System Training Guide ACL ELITE / ELITE PRO Quick Reference Guide, Troubleshooting, Errors, TS Calibrations
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ACL ELITE/ELITE PRO
Types of messages generated with system problems

Warnings: displays as a yellow icon in the lower right toolbar region. Selecting the warning icon allow viewing of description of error. Instrument may continue to run, with some limitations depending on problem. Alarm: warns user of problem requiring immediate attention. Some sub-functions and operations will still be available. Log off instrument, power off and on again; if error persists contact Call Center. Failure: message indicates a problem serious enough to prevent further use of instrument. Attempt to log off instrument (if serious enough may not be able to navigate in software), power off and on again; if error persists contact Call Center.
Troubleshooting steps:
1. Gather information (what, how, when.) 2. Identify the symptoms (only when we do ____ ) 3. Broadly Categorize (QC, sample tray, rotor area, temperature) 4. Isolate the issue and develop a plan (what can I do before calling Call Center?) 5. Correct the issue 6. Verify the corrective action (run QC, re-calibrate, run samples.) 7. Document (use for regulatory or future training for peers)
Coagulation Errors
Error Description Data Reduction Errors Temperature Errors Instrument Errors Calibration Errors Analytical Reference Errors QC Errors Parallelism Errors Materials Errors
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Abbreviated Flag R T E C A Q P M
Priority 1 (highest) 2 3 4 5 6 7 8 9 (lowest)

Errors on Algorithms, Ratio, Ranges W
ACL ELITE/ELITE PRO
PN 722277BA (December 2010) Miami Education Center
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ACL ELITE/ELITE PRO
Skill Checks:
1. Does a failure prevent you from using the instrument? __________________________ 2. What can cause the Peltier Temperature to be out of range? ______________________________________________________ ______________________________________________________ 3. What happens if you leave the cover to the rotor stack or holder area open? ______________________________________________________ ______________________________________________________ 4. Define an error code 7, and what action do you take, if encountered? ______________________________________________________ 5. a. What type of error is error code 14 and 30 when received for the D-Dimer test? b. Will a result be reported? c. What action can be taken, if encountered? a. ____________________________________________________ b. ____________________________________________________ c. ____________________________________________________ 6. Define the following messages: warning, alarm or failure and whether you can continue operating your instrument. Warning__________________________________________________ Alarm____________________________________________________ Failure____________________________________________________
Sign Off
Instructor
TS 4 of 4
RWE
ACL ELITE/ELITE PRO
REPLACE WASH-R-EMULSION OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module and Wash-R-Emulsion you will: Perform the replacement procedure and prime Wash-R-Emulsion Fluid Identify the alarm volume of Wash-R-Emulsion Fluid Discover what screen indicates the Wash-R-Emulsion volume Identify how results are transmitted when the Wash R Emulsion liquid sensor is disabled
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual Chapters 1, 2, 6 and 7 ACL ELITE / ELITE PRO System Training Manual
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ACL ELITE/ELITE PRO
Wash - R - Emulsion

Avoid spillage of the Wash-R-Emulsion when replacing on the system.

Wash-R-Emulsion is a silicon-based suspension, used as an internal and external wash solution for the needles. It washes the probes between aspiration of samples and/or reagents. This minimizes carryover and prevents contamination. It is also used as an optical reference to set 100% light scatter for the nephelometric channels. The ACL ELITE / ELITE PRO System compares all readings to this reference point. Wash - R- Emulsion is packaged in a plastic container containing 1000 mL. A sensor is located within the cap assembly, which monitors liquid level and alerts the user when liquid volume falls below 100 mL. If the Wash-R level is detected to be low, the Start icon will not be displayed in the Multi-test Analysis Screen or the Database View screen. Open and closed bottles are stable until the expiration date stated on the label. When replacing with the same lot number, prime once. When replacing with a different lot number, prime 3-4 times and recalibrate the PT-FIB curve. The new lot number and expiration date must be entered. Calibration schedule for PT-Fib based fibrinogens: At the installation of a new instrument or major service repair. With a change of the thromboplastin lot number. With a change of the Wash-R Emulsion lot number (only if reporting PTbased Fibrinogen). With a change of rotor lot number Alpha characters (only if reporting PTbased Fibrinogen). At the request of a Beckman Coulter representative. To follow the requirements of the appropriate regulatory agency.
Note: When the instrument is in standby, an automatic priming cycle is performed approximately every 30 minutes. The consumption of Wash-REmulsion is approximately 0.9 mL (3 strokes per single piston dilutor- total of 6 strokes; each single stroke of 0.15 mL).
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ACL ELITE/ELITE PRO
Replace and Prime Wash-R-Emulsion

Performance Guide
Step 1 2 3 Action Open cover by depressing the push latch in the Diluter Block/Wash-R-Emulsion area Remove the liquid level sensor cap assembly and place in front of the bottle area Remove empty bottle Place a new bottle of Wash-R-Emulsion with the cap ON and the opening to the left. (Note: Opening to the left, allows the cable from the board to Liquid Level Sensor Cap to maintain a parallel line with the back cover of the instrument. This orientation of the cable helps to avoid crimping or breakage of the sensor cable) Remove cap of new bottle, use the Wash-R-Emulsion reservoir region as leverage to unscrew new bottle cap, then replace the Liquid Level Sensor Cap on new bottle (Removing the cap on the new bottle after placing on the instrument prevents any spills to occur) Press cap down firmly, or until the cap snaps into position Prime the system, select Diagnostics, Priming. Ensure all bubbles dissipate in the diluter lines to the waste reservoir Verify the volume adjusts on the Materials Map screen, the upper right box displays Wash R level in mL
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Note: If the liquid and/or Wash-R Sensors are disabled, the system will not automatically transmit the results to the host. At the end of each run, a warning message will appear, instructing the operator to check the material and sample levels to ensure there is sufficient residual volume in all reagent and Wash R bottles. Once the check is performed then the results can be manually transmitted to the host. When the sensors are re-enabled, the auto transmission will resume. (Chapter 3, page 3.47 of Operators Manual)
PN 722277BB(December 2010) Miami Education Center
RWE 3 of 4
ACL ELITE/ELITE PRO
Skill Check
1. Approximately how many mLs of Wash-R-Emulsion triggers a low volume alarm? _______mL. 2. Where is the volume for Wash-R-Emulsion displayed?________________ 3. What does a Flush warning error message indicate and what corrective action should be taken? _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ 4. If the Wash R-Emulsion sensor is disabled, does the instrument automatically transmit results to the LIS (Host computer)? Yes No
If not what can you do to transmit the results? If yes, does the user require any action? _______________________________________________________________ _______________________________________________________________ _______________________________________________________________
Sign Off
Instructor
RWE 4 of 4
RR
ACL ELITE/ELITE PRO
REPLACE ROTORS OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module, Rotors and Rotor Insertion Tool you will: Replace or Add Rotors to the Rotor Stack using the Rotor Tool Locate the status / icons within Software indicating Rotors OK on the ACL ELITE PRO Identify the number of rotors the Rotor Stack can accommodate on the ACL ELITE
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, chapter 1, section 1.4.7 ACL ELITE / ELITE PRO System Training Manual
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ACL ELITE/ELITE PRO
Rotors
The twenty (20) cuvette units is called a rotor. Optical readings occur in the outer portion of the rotor There are two (2) compartments: a small inside area toward the center to hold sample and/or reagent and a larger outside one, which holds reagent only. There is a bridge that separates the reagent and sample until testing, acting as a partial dam or bridge between the two (2) compartments. When centrifugal action starts, the liquids within the inner well flow over the dam/bridge to mix with the reaction reagent in the outer well. The optical readings are then taken based on the acquisition time of the designated test.
Bridge Inner Well
Caution: Avoid touching the area of the rotor where Optical Readings occur
Outer Well
Each rotor has twenty measuring cuvette positions. Each individual cuvette is used for: control plasmas, patient samples or a reference blank. After incubation and mixing, the optical channels take readings while the rotor is spinning. This is known as Centrifugal Analysis At the start of each run the instrument checks each rotor position for light scatter to determine prior usage of the rotor When all cuvettes are used, the rotor is automatically discarded into a waste container by the system on the ACL ELITE PRO only On the ACL ELITE a message will display that rotor exchange is needed. Select open/close icon to raise or lower the analysis compartment. Replace the rotor by depressing the rotor snap and lifting the used rotor out of the analysis compartment. Replace with new rotor by depressing the rotor snap again to allow the rotor placement onto the analysis area
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ACL ELITE/ELITE PRO
Rotor Stack
Is located on the top of the analyzer on the right side Holds up to 12 rotors for a total of 240 usable test capacity On the Materials Map the upper right corner offers a display which indicates the status of rotors Is thermostatically controlled and insulated to maintain temperature range of 36-39C
Rotor Exchange Module (REM) (ACL ELITE PRO only, not applicable on the ACL ELITE)
Is located below the rotor stack cover Moves the bottom rotor in the stack to the rotor arm mechanism Robotic arm moves a new rotor to the rotor holder in the analysis compartment The rotor arm also removes used rotor from rotor holder to rotor waste container once fully utilized or when a user requests a new rotor
REM enabled/disable is located on the System Configuration screen Software for the REM is viewed from the Utility drop down menu, software and software identification. REM software should be 6.0 version
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ACL ELITE/ELITE PRO
On the ACL ELITE, rotors must be manually loaded from the rotor stack/storage area into the analysis compartment area. Depress the rotor snap on the center of the hub in the analysis compartment to properly seat and remove the rotor Always Use Rotor Snap to add or remove rotors
Rotor Waste Area

Used rotors are dropped inside a waste container by the rotor arm (on the ACL ELITE PRO only). On the ACL ELITE system, rotors are manually moved into the waste bin or discarded immediately into a designated biohazard waste container The rotor waste container is accessed by opening the door in the front right of analyzer. Waste container is removed then replaced after used rotors are disposed. Disposal of rotors is in accordance with the waste management procedure of the laboratory and in compliance with local waste regulations On the ACL ELITE PRO, the waste area has a micro-switch located in the rear of the compartment. When the waste container is removed the sensor will verify the presence/absence of the waste container. The waste container can accommodate eleven used rotors. Once the waste container is full, a message will be displayed Waste container is full or open. Please check and press RESUME or STOP The micro switch is unavailable on the ACL Elite, waste container should be checked as needed Warning: Cuvettes within the rotor are intended for one time use only. IL does not recommend or support the re-use of previously used or washed rotors.
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ACL ELITE/ELITE PRO
Replace Rotors
Performance Guide
Step 1 Action Using the Rotor Insertion Tool, depress the button on top, slide into keyed area of the rotor stacked in a new package of rotors and release button Remove the rotors from the package, using the tool displayed. Tearing the perforated orange strip on the packaged rotor stack as needed, to remove only rotors located on the Rotor Insertion Tool
Open the Rotor Stack cover Feed the Rotors into the Rotor Stack lining up the keyed slots on the rotors as a guide (ACL ELITE has no keyed slots within the rotor stack)
Slide down into position, hold down the rotors, depress the Rotor Insertion Tool button on the top, and remove from the rotor Note: Rotors must be flat and not on an angle
Close cover to rotor stack
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ACL ELITE/ELITE PRO
Skill Check
1. How many rotors will the rotor stack accommodate? ______________ 2. On the ACL ELITE PRO, where can find rotors OK message displayed?________________________________________________ 3. What message is displayed when cuvette waste is full on an ACL ELIE PRO? __________________________________________________________
Sign Off
Instructor
RR 6 of 6
RT
ACL ELITE/ELITE PRO
SETUP REFLEX TESTING OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual and Training
Module you will: Setup Reflex Rules Perform execution of Reflex Rules created Define the number of reflex rules stored in database Identify the number of tests each reflex rule can run Innumerate the number of criteria identified per reflex rule created
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 4 and 7 ACL ELITE / ELITE PRO Training Module
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ACL ELITE/ELITE PRO
Setup Reflex Testing Performance Guide

Step Action Using the steps 2-11 below, create the following Reflex Rules: A. If a R-PT sec is greater than or equal to 50 or gives a Coag Error 6,7,12 or 31. Then perform an R-PTe. B. If an APTTSYS sec is greater than or equal to 100 or gives a Coag Error 6, 7, 13 or 31. Then perform an APTTSYSe. C. If a R-PT INR greater than or equal to 4.0. Then perform an R-PT. D. If a D-Dimer ng/mL is greater than or equal to 1050. Then perform a D-Dh
2 3 4 5 6 7 8 9 10 11
Select Setup / Test / Reflex Test from the Main Menu To add a new rule select Add to List icon To add a condition to the rule select Add to List icon Cursor to the test and use drop down to select Test ID Select Units and choose unit required if applicable Select Comparison Choose: =, > or < Select either the Value or Error To select Value input the value in the box To select the Error code icon Cursor to error code desired and choose the Select icon (Multiple errors may be selected) Review and select Confirm
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ACL ELITE/ELITE PRO
Step 12 13 14
Action Repeat steps 4-11 to add other conditions to these Reflex Rule (if needed) From the Actions Tests list, transfer, using arrow icon, the test(s) you want to reflex to the Programmed Tests list Note: Up to ten actions (tests) can be defined Review and select Confirm Repeat steps 1-12 to create additional rules.
15
Note: When creating a rule with more than one condition, use the And/Or The choice(s) determine if both conditions need to be met (And), or just one (Or)
Modify an Existing Rule (Optional) Step 1 2 3 4 Action Cursor to the rule that you want to modify and select the Details Cursor to the condition to be modified and select the Details icon Repeat steps 3-14 above for any changes or modification Print out your reflex rules and review them icon
Disable a Rule (Optional) Step 1 2 3 4 Select the rule to be disabled Select the Enable/Disable icon A message window will appear Do you really want to Disable the selected Reflex Rule? Make the appropriate selection Action
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ACL ELITE/ELITE PRO
Perform Reflex Test Step 1 2 3 4 Action Analyze patients, provided by your facilitator, for both PT and APTT tests Analyze a D-Dimer patient, provided by your facilitator Select the appropriate Multi-test that has all tests within, verify this the proper Multi-test by reviewing your materials map prior to start of the run Review results of the Reflex or Extended Assays
Reflex Rules Examples 1. R-PT > 50 seconds 2. R-PT (sec) = error 6 3. R-PT (sec) = error 7 4. R-PT (INR) >= 4.0 5. APTTSYS > 110 seconds 6. APTTSYS (sec) = error 6,7 7. Fib-C < 70 mg/dL (or 7 g/L) 8. Fib-C > 700 mg/dL (or 7 g/L) 9. D-Dimer > 1050 ng/mL 10. VWF > 150 % then RPT-e then RPT-e then RPT-e then RPT then APTTSYS-e then APTTSYS-e Fib-C l Fib-C H D-D h VWF h
(Reference Operators Manual, Ch.4,pg 4.12)
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ACL ELITE/ELITE PRO
Skill Check
1. How many Reflex rules can be defined? Hint: Operators Manual Chapter 7 Assay and Instrument Specifications or Chapter 4 section 4.1.6 ________________________________________________ 2. How many conditions can be defined in each single rule? Hint: Operators Manual Chapter 7 Assay and Instrument Specifications ________________________________________________ 3. How many tests/actions can be generated by each single Reflex Rule? Hint: Operators Manual Chapter 7 Assay and Instrument Specifications ________________________________________________ 4. Show facilitator your reflex rules and patient printouts executing these reflex rules.
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Instructor
RT 5 of 6
ACL ELITE/ELITE PRO
RT 6 of 6
INR
ACL ELITE/ELITE PRO
INR SETUP OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Training Module, New Lot Information for PT reagent (or package insert), you will: Enter a New Lot number of RecombiPlastin Enter the New Mean Normal Range Enter the New ISI value Identify correct INR setup values Describe Mean Normal Range (MNR)
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 4 ACL ELITE / ELITE PRO Training Module ACL ELITE / ELITE PRO Easy Reference Guide, Lot Changes
Warning: If the INR calculation is not properly setup, erroneous patient results may be reported. If the product lot number changes, the new ISI value from the package insert must be entered. On the ACL ELITE / ELITE PRO, both the Database Screen and Patient Printouts will display the Ratio and INR units separately, if enabled. MNR number needs to be verified on each lot change of PT reagent as per your laboratory regulating agency.
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ACL ELITE/ELITE PRO
INR Setup
Performance Guide
Your laboratory has just received a new lot number of RecombiPlastin reagent. The new normal range study has been completed and this lot number is ready to be used for reporting patient results. Setup the new information on your instrument; refer to ES and LD modules. The new lot information is: Lot Number: N123456 Expiration date: 12/31/(current year) Mean Normal Range: 11.9 ISI: 0.89 Enter Mean Normal Range Step 1 2 3 4 5 Select Setup / Test / View/Define Cursor or select the test PT to be modified. (i.e. PT, PTHS, PTHS plus, PT-R, R-PT) Select R-PT for this class Select the Details icon Select the Calculation Setup icon and enter the Mean of your Normal Range (MNR) in the Reference Value box Review and select Confirm on all screens Action
Note: It is not necessary to enter the MNR value for other subsequent PT tests. i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests. This value is imported from the primary test.
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ACL ELITE/ELITE PRO
Entering the ISI Value Step 1 2 3 4 5 6 7 8 Select Setup / Liquids Select the Liquid ID (RecombPT) and cursor or touch the appropriate PT test in the Used By / Value ISI column i.e. R-PT Select the Assign Value icon Enter the ISI value from the reagent insert sheet Review and select Confirm A message will appear Liquid Parameters have been changed. Do you want to save them before proceeding? Select: Yes Run QC materials and samples to demonstrate new lot performance and accuracy of lot number changes made (no need to recalibrate for classroom purpose) Action
Note: It is not necessary to enter the ISI value for other subsequent PT tests. i.e. Extended (e), Duplicate (d), Extended Duplicate (ed) tests. The value is imported.
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ACL ELITE/ELITE PRO
Skill Check
1. What two values need verified for correct INR reporting? __________________________________________________________ 2. For any applicable test, where do you enter the MNR (Mean of the Normal Range)? __________________________________________________________ 3. For the PT reagent used in this class, where do you enter the ISI (International Sensitivity Index)? __________________________________________________________ 4. Is the MNR and ISI re-entered in all associated PT tests? __________________________________________________________ Why or why not? ___________________________________________________________ ___________________________________________________________ 5. How do you obtain a MNR (Mean of the Normal Range) based on your regulating agency? ___________________________________________________________
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Instructor
INR 4 of 4
CT
ACL ELITE/ELITE PRO
COPY TEST-NEW LOT CORRELATION SETUP OBJECTIVE

Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Training Manual, Quick Reference Guide and an installed Printer you will: Create/Copy and Edit a Test to Perform New Lot Testing Create a new liquid called NLR- PT Create a new liquid called NLPTTSys Create a new liquid called NL CaCl2 Create a new test called R- PTNL Create a new test called R- FIB_NL Create a new test called APTTSYSN Create a new liquid called DDLatexNL Create a new liquid called DDBufferNL Create a new liquid called DDCalNL Create a new test called DDimerNL Create new QC files Setup new QC materials Create a QC loadlist
MODULE RESOURCES
ACL ELITE /ELITE PRO Training Manual ACL ELITE /ELITE PRO Operators Manual, Chapter 4, Section 4.1.12 ACL ELITE /ELITE PRO Quick Reference Guide, Reagent Loading, Lot Change and New Test Setup HemosIL Reagent/Calibration Package Inserts
Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone.
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ACL ELITE/ELITE PRO
Performance Guide
Create a New Lot R-PT Reagent

This procedure is for new lots of R-PT (HemosIL R2G) and enable user to enable two different lots for the same reagents/tests (R-PT), for sole reason to complete correlations prior placing the new lot into use for daily analysis and result reporting. Step 1 2 3 4 5 6 7 8 9 10 11 12 Action From the main menu select Setup / Liquids Select the New Liquid icon Enter NLR-PT in the Liquid ID field Enter New Lot R-PT in the Extended Name field Start the new Liquid Code above 501. Enter Liquid Code 615 (IL uses many of the codes below this number for their own test liquids see Operators Manual) Enter the new Lot No.: ________ Expiration Date: ________On board Stability:________ Assigned Volume and Warning Volume will be vial dependent. Use a 10 mL vial. (See LD Module, page LD 3) Accessing Needle: Reagent Default Position: R4 Liquid Type: Reagent Check the Refrigerated box (and Stirred box, if applicable) Select Confirm x 2 *Note: ISI assignment is not completed until a new test is created and this new liquid is then assigned to the new test. Note: If a message appears A valid and unique liquid code is required This indicates that the number is used by another liquid, the system will not allow you to save this liquid. You must use a code that has not been previously defined; use a number greater than 501.
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ACL ELITE/ELITE PRO
Create/copying a New R-PT (R2G) Test

Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Step 1 2 3 4 5 6 7 8 9 10 11 12 13 Select Setup, Test, View / Define Cursor or touch to select the R-PT test Select the Copy Test icon Enter R-PTNL in the New Test ID and New Lot R-PT in the Extended Name Enter Test Code for Host: 616 (501-999 used for host communication) Enter Test Code: Same as Host Test Code (501-999 used for host communication) Select Confirm Disable Show Enabled box and Enable the test you created: R-PTNL Cursor to new test R-PTNL, select Test Details screen, use the to select the units that will be shown in the database view screen and on reports Verify the units from your current R-PT test have a checkmark in the show column Changes to units displayed are in Range Setup, also modify your laboratory established ranges as necessary Select Confirm Select the Details icon for the R-PTNL test for next step-Analysis Setup Action
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ACL ELITE/ELITE PRO
All of the changes to the new Copied Test parameters will be performed within Analysis Loading Setup parameters. This is the area of the test parameters where we define the loading sequence for the test. In addition, we will re-create the Reagent Aspiration, and Calibration Loading Setup parameters areas.
Analysis Loading Setup

Step 1 2 3 4 5 6 7 8 Action Select Analysis Loading Setup in the Test Details screen Cursor or touch to select Index Step 1 Sample Select the Details icon Select the Parameters icon (right of the Reagent Line) In the No Dilution Liquid ID box use the drop down arrow and change RPT to the new liquid ID NLR-PT Select Confirm A box will come up stating: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles Select YES Select Confirm x 2
Note: A message will appear concerning modified tests..wish to continue, select Yes.
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ACL ELITE/ELITE PRO
Calibration Loading Setup

Step 1 2 3 4 5 6 7 8 Action Select Calibration Loading Setup icon Cursor or touch to select Index step 1 for the Std 1 (Standard 1) Select the Details icon Select the Parameters icon to the right of the Reagent Line In the No Dilution Liquid ID box using the drop down menu and change RPT to the new liquid NLR-PT Select Confirm A box will come up stating: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles Select YES Select Confirm Cursor or touch to select Index step 2, for the Std 2 (standard 2), Repeat steps 2-8. Note: You may not get the same warning message from step 7, continue by selecting confirm Cursor or touch to select Index step 3, for the Std 3 (standard 3), Repeat steps 2-8. Note: You may not get the same warning message from step 7, continue by selecting confirm Select Confirm multiple times to exit, and select YES to any questions
10
11
Note: Verify the INR for the new PT test, by input of the MNR (Mean of the Number Range) under the Setup, Calculation Setup area, and the new ISI from the package insert under the Setup / Liquids area. Note: The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical analytical systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the two systems.
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ACL ELITE/ELITE PRO
Create/Copying a New R-FIB_ Test

Step 1 2 3 4 5 6 7 8 9 10 11 12 Select Setup, Test, View/Define Cursor to R-FIB_ Select the Print icon, to print the R-FIB_ test parameters Action
Select Yes to prompt Do you want to print the test report? Select the Copy Test icon to make an exact copy of R-FIB_ Name the New Test ID R-FIB_ NL and the Extended name New Lot R-FIB Give the new test a Test Code for Host and Test Code 654 (501-999 used for host communication) Select Confirm Enable the test you defined R-FIB_NL Cursor to new test R-FIB_NL, select Test Details screen, use the to select the units that will be show in the database view screen and on reports Changes to units displayed are in Range Setup, also modify your laboratory established ranges as necessary Use the drop down and Change Import Raw Data From to R-PTNL and Imports Calibration from None A message will appear That the use of imported raw data has been modified. Current parameters for the loadingwill be lost proceed? Select Yes to save changes. (Do not confirm, go to Editing the Parameters, page CT 7) NOTE: ALL parameters will be erased for this test and requires re-entry!
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CT 6 of 24
ACL ELITE/ELITE PRO
Editing the Parameters when Raw Data is imported:

Step 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Select Calculation Setup icon Verify Scope = Sample Change Algorithm Type to Delta Algorithm Ratio: use the drop down menu and select R=S/Std1 A message will appear that selecting a change will erase resultsconfirm? Press Yes to save the changes Select Define Parameters icon, right of Scope, to open Delta Algorithm screen Enable the 1st Smooth and enter value of 15 for Degree, and Enter Enable the 2nd Smooth and enter value of 9 for Degree, and Enter For the First Part of the Reaction Curve, enable Offset and enter 10 for Points For the Final Part of the Reaction Curve, enable Final and enter 10 for Points Select Curve Check Parameters icon Enable 1st Threshold Select the Threshold Parameters icon Check that Threshold Search Direction is selected to Forward Check Threshold Mode is selected to Absolute Enter the Value of 3 under the 1st Threshold Select Confirm Action
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ACL ELITE/ELITE PRO
Step 18 19 20
Action A message will appear: Selecting a new Parameter for the current list.. Do you confirm this new selection? Press Yes to save the changes Enable Saturation (x) Enable 2nd Threshold and enter the number 6 Enable Final Slope and enter the following:
21
a. b.
Points = 101 Value = 5
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Select Confirm A message will appear that selecting a change will erase resultsconfirm? Press Yes to save the changes Check the box Delta Correction (x) on the Delta Algorithm screen Select Correction Parameters box Enter the following Parameters: (Tab between each field) A message will appear stating that a new correction can cause inconsistency of results stored in Patient, AR, QC and Calibration databases.Do you confirm new selection? Select OK
25 1 Interval 2nd Interval 3rd Interval

st
Min 100.00 200.00 400.00
Max 200.00 400.00
M(coeff) 0.0023 0.0014
q(coeff) 0.7701 0.9479
New Corrective action message appears, answer OK 26 27 Select Confirm x 2 Select Calibration Setup icon
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ACL ELITE/ELITE PRO
Step
Action Select ALL Std on the left side of the screen and input the data in the table below for Std 1, Std 2 and Std 3 NOTE: A message will appear after every Dilution Ratio% for which parameters have been changed As a consequence the stored calibration will be erased confirm? Press Yes to save these changes Standards Std 1 Std 2 Std 3 Dilution Ratio % 100.00 50.00 25.00 CV 8.0 12.0 12.0
28
29 30 31 32 33
Response Type: use the drop down arrow menu and select Delta Check the box Check CV (x) to enable Check the box Outlier (x) to enable Final Unit use the drop down arrow and selects mg/dL A message will appear Selecting a result unit for the current test all results already stored in patient QC, AR and calibration databases will be erased. Do you confirm the new selection? Press Yes to save these changes Select Calibration Curve Setup button, and enter the following information:
34
X= r = x/Std1 Y= y Under Calibration Curve section enter the following information using the drop down arrow:
35 1st
Start Point Std 1
End Point Std 3
F(x) x
G(y) y
q (x) to enable
Translation Point Std 1
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ACL ELITE/ELITE PRO
Step
Action Under Calibration Curve Checks section enter the following information. Slope Range r > = st 0.0000 to 1000.0 1 Curve 0.980 Select the Define as Mandatory icon Select Std 2 and then select Define as Mandatory icon Select Std 3 and then select Define as Mandatory icon You should have a check mark () in each of the standards (Std1, Std2 and Std3) Press Confirm x 2 Scope Select Std 1 and press Define Parameters icon Enable the 1st Smooth and enter value of 15, select Enter Enable the 2nd Smooth and enter value of 9, select Enter For the First Part of the Reaction Curve, select Offset and enter 10 for Points For the Final Part of the Reaction Curve, select Final and enter 10 for Points Press the Curve Check Parameters icon Enable 1st Threshold Select the Threshold Parameter icon Check that Threshold Search Direction is selected to Forward Check Threshold Mode is selected to Absolute Enter the Value of 3 under the 1st Threshold
36
37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
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ACL ELITE/ELITE PRO
Step Select Confirm 53
Action
A message will appear Selecting a new Parameter Select Yes to save the changes Enable Saturation (x) Enable Final Slope and enter the following:
54
55
a. Points = 101 b. Value = 5
56 57
Enable 2nd Threshold and enter the number 4 Press Confirm A message will appear Selecting a change of curve check for the current test all results already stored in patient, QC, AR and calibration databases will be erased. Do you confirm? Select Yes to save these changes Select Confirm Select Std 2 and press Define Parameters icon Repeat steps 43-61 Select Std 3 and press Define Parameters icon Repeat steps 43-61 Select Confirm RFIB_NL until you are back at the initial Test Details screen for
58
59 60 61 62 63
64
Use the to select the unit that will be showing in the database 65 Select the Ranges icon and modify ranges as necessary Check the Show in Sample List box (x) if you want this unit to appear in the Database Screen. Uncheck the box if you do not want the unit to appear on database view and reports
66
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ACL ELITE/ELITE PRO
Step 67 68 RFIB_NL only show unit mg/dL
Action
Input the Test Range and Scale Range for Delta/Ratio/mg/dL Select the unit and press the Ranges box to input the ranges:
69
Delta R mg/dL Press Confirm
Test Range 0.000-400.000 80.000-700.000
Scale Range 0.000-999.000 0.000-10.000 0.000-3000.00
70 71 72 73
A message will appear Because of the modified setup.will be erased. Do you confirm the new selection? Press Yes to save these changes. A message appears Database Update in Progress Print the new RFIB_NL test definition and compare it to the original test definition R-FIB_ (printed previously) Do not forget to enter the calibrator value for the new Fibrinogen Assay RFIB_NL from the Cal Plasma package insert. Select Setup/ Liquids/ Cal Plasma Calibrate the new tests: NLR- PT and RFIB_NL
74 75
NOTE: All responsibility for parameter development and validation of a new or copied test belongs to the user alone.
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ACL ELITE/ELITE PRO
Create a New Lot APTTSYS and CACL Reagents

This procedure is to be used for new lots of APTT reagents (HemosIL APTTSYS and CACL),are created to enable two different lots for the same reagents/tests (APTTSYS), so correlations can be completed prior to use for daily analysis and result reporting. Step 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Action Select Setup / Liquids from the main menu Select the New Liquid icon Enter NLAPTTSY in the Liquid ID field Enter New APTT SynthASil in the Extended Name field Start the new Liquid Code above 501. You may enter Liquid Code 624 (IL uses many of the codes below this number for their own test liquids see Operators Manual) Lot No.: ________ Expiration Date: ________On board Stability:________ Assigned Volume and Warning Volume will be vial dependent. Use a 10 mL vial (See LD-3 Module for the table displaying volume assignments) Accessing Needle: Reagent Default Position: R3 Liquid Type: Reagent Check the Refrigerated box Select Confirm Select New Liquid Enter NLCACL2 in the Liquid ID field Enter New Lot CACL2 in the Extended Name field
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ACL ELITE/ELITE PRO
Step 16 17 18 19 20 21 22
Action Start the new Liquid Code above 501. You may enter Liquid Code 684 (IL uses many of the codes below this number for their own test liquids see Operators Manual). Lot No.: ________ Expiration Date: ________On board Stability:________ Assigned Volume and Warning volume will be vial dependent. Use a 10 mL vial. (See LD-3 Module (table displaying volume assignments) Accessing Needle: Sample Default Position: R7 Liquid Type: Reagent Select Confirm
Create/copying a New APTTSYS Test

Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Step 1 2 3 4 5 6 Select Setup, Test, View/Define Cursor or touch to select the APTTSYS test Select the Copy Test icon Enter APTTSYSN in the New Test ID and New APTTSythASil in the Extended Name Enter Test Code for Host: 692 (501-999 used for host communication) Enter Test Code: Same as Host Test Code (501-999 used for host communication) Action
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Step 7 8 9 10 11 12 Select Confirm
Action
Disable Show Enabled box and Enable the test you created: APTTSYSN Cursor to new test APTTSYSN, select Test Details screen, use the to select the units that will be show in the database view screen and on reports Changes to units displayed are in Range Setup, also modify your laboratory established ranges as necessary Select Calculation Setup, input the Reference Value for your lab (mean normal range) Select Confirm
All of the changes to the new Copied Test parameters will be performed within Analysis Loading Setup parameters. This is the area of the test parameters where we define the loading sequence for the test. In addition, we will re-create the Reagent Aspiration, and Calibration Loading Setup parameters areas.

Step 1 2 3 4 5 6 Action Select Analysis Loading Setup in the Test Details screen of APTTSYSN test Select Reagent Priming box Select Diluted Liquid ID (located in right column under the Reagent Line), change diluted liquid ID to CleanA Select Confirm A message will come up stating: A New material has been detected. Test will be removed from all profiles.. Select OK to save. Select Confirm
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ACL ELITE/ELITE PRO
Step 7 8 9 10 11 12 13 14 15 16
Action Cursor or touch to select Index step 1 for the Sample and select Details icon Press the Parameters icon to the right of the Reagent Line In the No Dilution Liquid ID box use the drop down menu and change APTTSYS to the new liquid NLAPTTSY Select Confirm A box will come up stating: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles Select YES Select Confirm Cursor or touch to select Index step 3 and select Details icon Select Parameters icon for the Sample Line In the No Dilution Liquid ID use the drop down menu to select NLCACL2 Select Confirm multiple times to exit and select YES to any questions
Interference Table
This test must be added to the Interference Table for reagent priming to occur, this improves the system performance and minimizes carryover between tests. Step 1 2 3 Action Select Setup / Tests / Interference Table For APTTSYSN, move the new lots identified as: R- PTNL and RFIB_NL assays from the Enabled Test List to the Interfering Test List. Select Confirm test? Select Yes A message appears: Do you want to save.modified
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ACL ELITE/ELITE PRO
Create a New Lot DDimer Reagents

This procedure is to be used for new lots of DDimer. Create to enable two different lots for the same reagents/tests for DDimer. Use for correlations, prior to use in daily analysis and result reporting. Step 1 2 3 4 5 Action Select Setup / Liquids from the main menu Select the New Liquid icon Enter DDBufferNL in the Liquid ID field Enter New DD Buffer in the Extended Name field Start the new Liquid Code above 501. You may enter Liquid Code 805 (IL uses many of the codes below this number for their own test liquids see Operators Manual). Lot No.: ________ Expiration Date: ________On board Stability:_xxd (d=days) Assigned Volume and Warning volume will be vial dependent. Use a 10mL vial (See LD-3 Module for the table displaying volume assignments) Accessing Needle: Sample Default Position: A6 Liquid Type: Solution, Fill in the Assigned Volume: _________and Warning Volume: _________ Select Confirm Select the New Liquid icon Enter DDLatexNL in the Liquid ID field Enter New DDLatex in the Extended Name field
6 7 8 9 10 11 12 13 14
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ACL ELITE/ELITE PRO
Step 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
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Action Start the new Liquid Code above 501. You may enter Liquid Code 853 (IL uses many of the codes below this number for their own test liquids see Operators Manual). Lot No.: ________ Expiration Date: ________On board Stability: xx d (d=days) Assigned Volume and Warning volume will be vial dependent. Use a 4 mL vial (See LD-3 Module for the table displaying volume assignments) Accessing Needle: Reagent Default Position: R3 Liquid Type: Reagent, Fill in the Assigned Volume:________ and Warning Volume:________ Check the Refrigerated box (and Stirred box, if applicable) Select Confirm x 2 From the Drop Down Menu Select Setup / Liquids Select the New Liquid icon Enter DDCalNL in the Liquid ID field Enter New Lot DDimer Cal in the Extended Name field Start the new Liquid Code above 501. You may enter Liquid Code 753 (IL uses many of the codes below this number for their own test liquids see Operators Manual). Lot No.: ________ Expiration Date: ________On board Stability: xxd (d=days) Assigned Volume and Warning volume will be vial dependent. Use a 1mL vial. (See LD-3 Module for the table displaying volume assignments) Accessing Needle: Sample Default Position: A5 Liquid Type: Calibrator, Fill in the Assigned Volume:________ and Warning Volume:________ Select Confirm x 2
ACL ELITE/ELITE PRO
Create/copying a New DDimer Test

Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Step 1 2 3 4 5 6 7 8 9 10 Select Setup, Test , View/Define Cursor or touch to select the DDIMER test Select the Copy Test icon Enter DDimerNL in the New Test ID and New Lot DDimer in the Extended Name Enter Test Code for Host: 650 (501-999 used for host communication) Enter Test Code: Same as Host Test Code (501-999 used for host communication) Select Confirm Disable Show Enabled box and Enable the test you created: DDimerNL Cursor to new test, DDimerNL, select Test Details screen, use the to select the units that will be show in the database view screen and on reports Changes to units displayed are in Range Setup, also modify your laboratory established ranges as necessary Select the Details icon for the DDimerNL test, select Calculation Setup define the reference value for your lab (mean normal range). Make no changes, but MUST go into this screen MUST Select Confirm (Note: Failure to select Confirm, an error occurs when attempt to calibrate the new lot) Action
11
12
All of the changes to the new Copied Test parameters will be performed within Analysis Loading Setup parameters. This is the area of the test parameters where we define the loading sequence for the test. In addition, we will re-create the Reagent Aspiration and Calibration Loading Setup parameters areas.
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ACL ELITE/ELITE PRO

Step 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Action Select Analysis Loading Setup in the Test Details screen of DDimerNL test Select Index Step 3, then details Select Parameters to the right of the Sample Line, do not change the in line dilution Select from the drop down selections within the Diluent Liquid ID, displayed under the In Line Dilution to the DDBufferNL Select Confirm A message will come up stating: A New material has been detected. Test will be removed from all profiles.. Select OK to save Select Confirm Select Parameters to the right of the Reagent Line, do not change the no dilution drop down Select from the drop down selections within the Liquid ID, displayed under the No Dilution to the DDLatexNL Select Confirm A box will come up stating: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles Select YES Select Confirm Select Confirm multiple times to exit, and select YES to any questions From the Test Details select Calibration Loading Setup Cursor to Index step #3, Scope Std 2,3, Select Details icon Select Parameters to the right of the Sample Line, do not change the no dilution drop down Select from the drop down selections within the Liquid ID, displayed under the No Dilution to the DDBufferNL
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ACL ELITE/ELITE PRO
Step 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 32 33 Select Confirm screen
Action and YES until return to Calibration Loading Setup
Cursor to Index step #4, Scope Std 1, Select Details icon Select Parameters to the right of the Sample Line, do not change the in line dilution drop down Within the Liquid ID, Select from the drop down selections and displayed as Diluent Liquid ID the DDBufferNL Within the Liquid ID, Select from the drop down selections and displayed as the Diluted Liquid ID the DDCalNL Select Confirm Confirm all messages with Yes
Select Parameters to the right of the Reagent Line, do not change the no dilution drop down Within the Liquid ID, select from the drop down selections and displayed as the Liquid ID the DDLatexNL Select Confirm and YES until Calibration Loading Setup screen
Cursor to Index step #5, Scope Std 2, Select Details icon Select Parameters to the right of the Sample Line, do not change the in line dilution drop down Select from the drop down selections within the Liquid ID, displayed under the Diluted Liquid ID the DDCalNL Select Confirm Select Parameters to the right of the Reagent Line, do not change the no dilution drop down Within the Liquid ID, select from the drop down selections and displayed under the Liquid ID the DDLatexNL Select Confirm and YES until Calibration Loading Setup screen
Cursor to Index step #6, Scope Std 3, Select Details icon

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Step 34
Action Repeat steps 28-32 above. Select Confirm multiple times to exit, and select YES to any questions until returned to Test Details Screen Select Calculation Setup, make no changes, however must select confirm or a message displays an inconsistency NOTE: This step is important, if missed user will not be able to calibrate new test
35
Utilize Copy Tests

Complete any Calibrations, set up new QC, Loadlists and Intereference Table for tests with reagent priming (PTT).
Step 1 2 3 4
Action Setup Multi-test Profile to include New and Old Tests, to collect correlation data Setup or create new QC files to include new tests Create Loadlist(s) with new test(s) to collect correlation data Create an Interference Table for all new APTT tests (see page 16)
Note: Verify the INR for the new PT test by input of the MNR (Mean of the Number Range) under the Setup, Calculation Setup area, and the new ISI from the package insert under the Setup / Liquids area. Note: The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical analytical systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the two systems.
Proceed to the Skill Check for this Module

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ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator or your application specialist the setup files that include: Tests created, Liquids created, Multi-tests created, QC levels, Interference Tables, Loadlists, the results obtained from Calibrating new lots as required and the Correlation Data accumulated.
Sign Off Instructor
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ACL ELITE/ELITE PRO
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HEP
ACL ELITE/ELITE PRO
LIQUID HEPARIN-XA OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, Quick
Reference Guide and Training Module you will: Enable Liq HEP test, create a Test Profile Perform Calibration, with an acceptable r2 value for the Calibration Curve >0.980 Perform QC with (2) two levels of Heparin controls per kit, total of (2) two kits
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Manual ACL ELITE / ELITE PRO Operators Manual ACL ELITE / ELITE PRO Quick Reference Guide, New Test Setup
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ACL ELITE/ELITE PRO
Principles of Procedure
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patients endogenous antithrombin. When the heparin antithrombin complex is formed, two competing reactions take place 1. Factor Xa is neutralized by the heparin-antithrombin complex 2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405nm and is inversely proportional to the heparin level in the sample In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture. (HemosIL Liquid Heparin package insert issued 06/2009, Instrumentation Laboratory)
Control Recovery
Reconstitution Reconstitute controls with CLSI CLRWater or equivalent as specified on the control vial and package inserts
Assayed Range
Cumulative mean of laboratory control should be within assayed range listed in package insert Establish a 2SD range around this mean Perform Needles Cleaning procedure Step 1 2 3 4 5 6 Action Place Clean A(0.1N HCl) in positions R6 and R7 From Main Menu, select Diagnostic, Cleaning Change Cycles No. from 3 to 5 Select Start Replace Clean A with 2 vials of Factor Diluent and repeat. Wipe both needles with an alcohol wipe.
Needles Cleaning
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ACL ELITE/ELITE PRO
Probe Alignment Optics
Verify probe alignment using Maintenance Module of the ACL ELITE / ELITE PRO Training Guide Clean optics for the Chromogenic channel Dont forget the 405 nm in the rotor holder cover Clean Rinse Reservoir Step 1 2 3 4 5 6 Action From Main Menu, select Diagnostics, Needles Position. At the Open Cover? prompt, select No. Once the needles move to the rotor holder area, remove the rinse reservoir. Clean thoroughly with Clean A (0.1N HCl) Rinse with DI water and replace. Press the Stop icon to move the needles back to the rinse reservoir.
Rinse Reservoir
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ACL ELITE/ELITE PRO
Xa Kit
Performance Guide
Step 1 2 3 6 7 8 Action Enable Liq HEP (Refer to ES module to enable/select units for tests) Select IU/mL units Select Setup / Liquids from the working area Enter the reagent information for all liquids used in the test (Refer to LD module for liquid set up) Five reagents in kit: HEP Cal 1, HEP Cal 2, HEP Cal 3, LHep FXa and LHep Sub. Assign the calibration values found within the Heparin Calibrator package insert sheet Review and select Confirm for all liquids Configure Heparin Controls (Refer to SQC module for QC setup) (Use values provided by facilitator for classroom) 9 10 11 12 LMW Low Control LMW High Control UFH Low Control UFH High Control
Select Calibration, Calibrate and select Liq Hep from Tests to Calibrate drop down list. (Refer to CAL module for calibrations) Select Materials Map icon Review liquid positions, update volumes, check lot numbers, rotors etc. Select Start icon
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ACL ELITE/ELITE PRO
Step 13 14
Action When calibration is complete, review data and ensure that the r2 value is > 0.980 To analyze Liq Hep test, follow same procedure for analyzing any sample (Refer to SA1 or SA2 modules)
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Skill Check
Show your facilitator the Liq HEP Calibration Report and a run of controls.
Sign Off
Instructor
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FA
ACL ELITE/ELITE PRO
FACTOR CALIBRATION AND ANALYSIS

OBJECTIVES Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and Training Module you will:
Perform Factor Assay Calibration and Analysis The acceptable r2 value for all segments of the curve > 0.980
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Manual ACL ELITE / ELITE PRO Operators Manual, Chapter 3 and 7 ACL ELITE / ELITE PRO Easy Reference Guide, New Test Setup
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ACL ELITE/ELITE PRO
FACTOR ASSAYS CALIBRATION for Non Parallelism Tests

This information is valid for all eight factor assays (VII, X, V, II, XII, XI, IX and VIII*) when using the IL tests library. The calibration curve for factors is divided into three segments: High Curve: Prepared using Cal Plasma with levels at 100%, 50% and 25%. Low Curve: Prepared using Low Cal F with levels ranging from 6.25%, 3.125% and 1.56%. Middle segment: connects the 25% from segment one and the 6.25% from segment three. *excludes Chromogenic Factor VIII Below is a summary of the six dilutions used by the ACL ELITE / ELITE PRO to perform a Factor Assay calibration when all three segments are performed. Dilution Ratio in % 100 50 25 6.25 Preparation Undiluted Calibration Plasma Cal Plasma - Dilution done automatically by the ACL ELITE / ELITE PRO . Cal Plasma - Dilution done automatically by ACL ELITE / ELITE PRO . Cal Low F - Manually prepared diluting the Calibration Plasma 1+15 with Factor Diluent. (1:16 Dilution) Note: Cal LowF is automatically prepared with the following selected test(s): FVIII SP/SS and FIX SP/SS Cal Low F - Dilution done automatically by the ACL ELITE / ELITE PRO Factors VIII SP, IX SP, VIII SS and IX SS (only). Cal Low F - Dilution done automatically by the ACL ELITE / ELITE PRO Factors VIII SP, IX SP, VIII SS and IX SS (only).
3.12
1.56
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ACL ELITE/ELITE PRO
FACTOR ASSAYS FOR PARALLELISM TESTS

Introduction Factor Parallelism is a technique used to determine the influence or effect inhibitors have on a samples Factor Assay activity result. The possible presence of an inhibitor and its effect may be determined by assaying the Factor using a series of dilutions. The impact of the dilutions on the factor activity can then be observed. The purpose of the Parallelism function on the ACL ELITE / ELITE PRO is to assist with the identification of an inhibitor in an easy, automated fashion. The Parallelism test mode is a means to create operator definable dilutions. The instrument will execute all dilutions, perform testing on the dilutions, and will provide evaluation data on the results to assist in determining the presence of an inhibitor. The software provides multiple checks of the data generated and provides the operator with valuable information to assist in identifying the presence of an inhibitory pattern. Some of the checks include comparison to the original undiluted result and precision data of the additional dilutions. Performing Factor Parallelism is an optional feature and if executed will provide an operator a definable Flag to alert the operator if a limit has been exceeded. If an inhibitor is suspected, confirmatory testing is suggested.
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Factor Calibration (Dedicated) and Parallelism

Performance Guide Factor Parallelism FVIII SP, FIX SP, FVIII SS or FIX SS (Dedicated Calibration) FVIII SP and FIX SP uses the SP reagent (Synthetic Phospholipids) FVIII SS and FIX SS uses the SS reagent (SynthASil)
Dedicated Calibration means: A separate session is done to perform a calibration. When calibrating Factor Parallelism FVIII SP, FIX SP, FVIII SS or FIX SS place 3 empty cups in the required position and the instrument will make the CAL Low F automatically. Only one calibration can be performed at a time. Step Action Select Setup/Test /View Define enable a Factor test: FVIII SP, FIX SP, FVIII SS, or FIX SS. (The test is dependent on the reagent in use, remember to also enable the factor Parallelism test F8SP-P, F9SP-P, F8SS-P or F9SS-P both tests have to match the reagents) Select Setup / Liquids and enter information for Factor deficient plasma(s) enabled. (FVIII Def or FIX Def) Select Cal Plasma liquid and assign the calibration value from the Cal Plasma insert sheet in the Used By list with the appropriate factor test(s) (FVIII SP or FIX SP or FVIII SS or FIX SS). Select Setup/Multi-Tests/Profiles, Test Groups or Test Group Profiles. Create a multi-test with enabled factor(s), Sort this multi-test. Select Calibration/Calibrate, identify Factor to calibrate. Check materials map to ensure all reagents are available, select run. When calibration is complete, review data and ensure that the r2 value is > 0.980. Note: if the error icon is activated, review error. Select Confirm Setup QC material based on Factor Assay Package insert(s), run QC, then run your patient samples as a Single test or within a crated Multi-Test
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ACL ELITE/ELITE PRO
Factor Calibration (In Session) and Sample Analysis

Factor Assay (In Session Calibration) May be utilized for the following factor assays: (VII, X, V, II, XII, XI, IX and VIII*) *excludes Chromogenic Factor VIII. In Session Calibration means: The calibration is executed the first time with the sample run, and can then be re-used for later sample runs. (If Cal Plasma is present, a new calibration will be performed automatically. If no Cal Plasma is present, the stored calibration is used.) *Multiple calibrations can be performed using In Session calibrations
Performance Guide
Step 1 2 3 4 5 6 7 Action Select Setup/Tests/View Define, enable Factor(s) Select Setup/Liquids enter information for Factor Deficient plasma enabled. Select Cal Plasma liquid and assign the calibration value from the Cal Plasma insert sheet in the Used By list for the enabled factor test(s). Setup the appropriate QC for the Factor assay(s) enabled Select Select Setup/Multi-Tests/Profiles, Test Groups or Test Group Profiles. Create a multi-test with enabled factor(s), Sort this multi-test. Select Analysis from the Main Menu dropdown and select the Multi-test with the Factor assay(s) enabled Verify your materials map and ensure you have prepared the Cal Low F for calibration. Make a 1:16 dilution of Calibration Plasma into a labeled 0.5 mL cup (i.e. 20L Cal Plasma and 300L Factor Diluent). Load controls and/or samples into positions of the sample tray. Load Cal Plasma and Cal Low F in the sample tray if you are calibrating for the first time. If you do not, the system will use the last stored curve-if available (up to five calibration curves can be stored and the last stored calibration will be used if cal plasma is not loaded prior to analysis) Use SA2 module to load QC and sample along with calibrators, select Run
10
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ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the Calibration Report and two patient and applicable parallelism reports.
Sign Off
Instructor
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ACL ELITE/ELITE PRO
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UT
ACL ELITE/ELITE PRO
UTILITY OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, System Training Module you will: Save/Restore all instrument setup Archive Quality Control Archive Patient Data Define Save Last Rotor Data use Identify the use for Save Trace File
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 4 ACL ELITE / ELITE PRO System Training Module Floppy Disks, IBM Formatted Quick Reference Guide
UT 1 of 8
ACL ELITE/ELITE PRO
SOFTWARE OVERVIEW Note: For further information regarding the instruments Utility menu,
please refer to the IL ACL ELITE / ELITE PRO System Operators Manual, Section 4.3.
Utility dropdown menu displays the following selections:

Upgrade IL Library
Upgrades IL test parameter library. Data base files from a diskette are loaded, then displayed on a similar screen below.
After upgrade, modifications and date are listed.
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ACL ELITE/ELITE PRO
Backup/Restore
Backs up or restores the ACL ELITE / ELITE PRO System Configuration Back-up should be created: 1. Before and After any software upgrades 2. Any Setup changes ( ie ..tests, profiles, liquids) 3. Any changes in alignments by your Service Engineer Note: Patient results, Calibration curves, and QC results can not be backed up and restored, see Archive
View the backup date
Restore System Configuration from a diskette
Media storage on your instrument (Floppy or USB)
Archive
Used to copy/transfer various data to a diskette in either excel or txt format. Recommended for QC and patient data on regular basis.
Select this to archive patient data. Type in the date range desired.
Select this to archive Analytical Reference data. Type in date range and select Test desired. (AR not used in USA or Canada)
Select this to archive QC data. Type in date range and select Liquid and Test Select this to delete selected data once archive is complete Select this to archive Calibration data and Select Test desired
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ACL ELITE/ELITE PRO
Software Software Identification:

Displays the level of software the ACL ELITE / ELITE PRO System is currently using.
Software Upgrade-Upload
Allows ACL ELITE / ELITE PRO System operator to upgrade and upload system software when a new software release is available. Follow instructions which are included in the upgrade packet.
Save Rotor Map

Saves the raw data for all testing performed for one of the last 31 days of the last run to a floppy disk (includes QC and Patient results).
Select to save as a DAT file for Windows Research
Select to save as a text file compatible with most text editors
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ACL ELITE/ELITE PRO
Save Trace
Saves all operations performed by the ACL ELITE / ELITE PRO System to a diskette. Used for troubleshooting- software issues
Always save data using the .txt extension
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ACL ELITE/ELITE PRO
UTILITY
Performance Guide Backup/Restore
Step 1 Select Utility Select Backup or Restore
View the backup date Restore System Configuration from a diskette
Action
Media storage on your instrument (Floppy or USB)
3 4 5
A message displays Backup in progress please, wait Another message will appear, Storage media (instrument configured specific After inserting, Select OK (The Backup or Restore will take a few minutes to complete)
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ACL ELITE/ELITE PRO
Archive
Step 1 2 Select Utility / Archive
Select this to archive patient data. Type in the date range desired. Select this to archive Analytical Reference data. Type in date range and select Test desired.
Action
Select this to archive QC data. Type in date range and select Liquid and Test desired.
Select this to delete data from the data base
Select this to archive Calibration data. Select Test desired.
Select from these two options: 3 A. Archive Patient Data B. Archive QC Data (For the class exercise, select both: Archive Patient Data and QC) Select Start, the Archiving will take a few minutes to complete
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ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator the Backup file. 2. Show your facilitator the Archived file. 3. When would a Save Trace File be beneficial? ________________________ 4. When should a back-up of all setup information be created? ______________________________________________________________ ______________________________________________________________ ______________________________________________________________
Sign Off
Instructor
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MS
ACL ELITE/ELITE PRO
MIXING STUDIES OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and System Training Module, you will: Explain why we perform Mixing Studies Define a new liquid called NPlasma Create a new test called PTT 1:1 Demonstrate that the reflex rule has worked Complete a Case Study
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.56 ACL ELITE / ELITE PRO System Training Module
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Mixing Studies
Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Please refer to pages 3-5 of the ELITE / ELITE Pro Training Manual and Operators manual Chapter 4, 4.56. A mixing study is used in the laboratory to discern whether an abnormal APTT or PT is caused by a Factor Deficiency or by an Inhibitor within the sample. When the patients sample is mixed with normal pool plasma and the time is corrected, it is usually a Factor deficiency. If it is not corrected the sample usually contains an Inhibitor.
Performance Guide Create a New Liquid

Step 1 2 3 4 5 6 7 8 9 10 Select Setup / Liquids Select the New Liquid icon Enter NPlasma in both the Liquid ID and Extended Name fields Enter Liquid Code 606 (IL designates available numbers 501-999 for open assays, liquids, test codes. see Operators Manual Appendix A 7.0 ACL Elite/Elite Pro Test Codes). Lot No.: NA Assigned Volume and Warning volume will be vial dependent. Use a 2.0mL cup Accessing Needle: Sample Default Position: A5 Liquid Type: Reagent Fill in Assigned Volume:_______ and Warning Volume:_____________ Select Confirm Action
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Create a Test
Step 1 2 3 4 5 6 7 8 Select Setup/ Test/ View Define Cursor to APTTSYS Select Copy Test icon Enter PTT1:1 in both the New Test ID and Extended Name Fields Enter Test Code for Host: 607 (501-999 used for host communication) Enter Test Code: Same as Host Test Code Select Confirm Enable the PTT1:1 test and select the Details icon Select Analysis Loading Setup in the Test Details screen. 9 All of the changes to the new created test will be performed on the Analysis Loading Setup screen. This is the area of the software where we define the loading sequence for the new test; also we will change the current sample aspiration parameters Scroll down to the index step for the Sample and select Details icon Change Sample Line Loading Type from the drop down menu to In Line Dilution Select Parameters icon for the Sample Line Find the In Line Dilution box, Diluent Liquid ID, Select NPlasma from the drop down menu Enter 26.5 in the Volume box Select the drop down box for the Diluted Liquid ID and select Plasma Enter 26.5 in the Volume box Select Confirm multiple times to exit and answer YES to any message
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Action
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Interference Table
This test must be added to the Interference Table for reagent priming to occur, this improves the system performance and minimizes carryover between tests. Step 1 2 3 Action Select Setup / Tests / Interference Table For PTT1:1, move the R-PT and R-PTe assays from the Enabled Test List to the Interfering Test List Select Confirm
Mixing Studies Analysis

Step 1 2 3 4 Action Define a Reflex rule: If the APTTSYS > 80s perform PTT1:1. (Refer to the RT module performance guide to set up reflex rules) Define a Profile that contains both APTTSYS and PTT 1:1 (Refer to the MLT module performance guide to sort the profile) Sort the Multi-Test profile (Refer to the MLT module performance guide to set up the profile) Analyze a sample from your facilitator to complete an APTTSYS test and initiate the reflex rule created for a PTT1:1 assay
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Skill Check
1. Show your facilitator the setup, and the results obtained from a patient sample. 2. Why do we perform mixing studies in the laboratory? _______________________________________________________________ _______________________________________________________________ 3. Case Study: A 3 year old boy presents with a painful left elbow after mild trauma. Evaluation reveals a hemarthrosis. The child is adopted so no family history is available. The patients mother reports no other problems with the child. The PT is normal, an APTT is prolonged. PT Test 12.3(secs) Patient Laboratory Results APTT Test Mixing Studies (APTT) 95.0 (secs) 33.4 (secs) Normal Pooled used in the study 30.1
Conclusion: What Coagulation Pathway is in question here? Please Check one. a. Extrinsic Pathway?__________ b. Intrinsic Pathway?___________ What additional testing might a physician request for this patient? ______________________________________________________ ______________________________________________________
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Instructor
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SETUP SECURITY ACCESS OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and System Training Module you will: Create new user at Operator access level Create security access for the new user, per laboratory needs
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 4, Section 4.46
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SETUP SECURITY ACCESS

This area of the software allows the Laboratory Manager to configure the levels of entry for the other users (as Supervisor and Operator) and define all passwords for all the personnel using the ACL ELITE / ELITE PRO System. Up to 99 users can be defined in the Security area. The first operation to be done by the Laboratory Manager is the definition of the level of entry for the other two user groups.
Delete Details Lab Manager View New User
Confirm
The Laboratory Manager, using his password, will have access to the Lab Manager View button. It is advisable for the Laboratory Manager to define, upon installation of the system, his new password to avoid misuse of the system. Select the Lab Manager View icon, a screen will appear where both Supervisor and Operator access may be defined.
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LAB MANAGER VIEW SCREEN
Lab Manager View Details
In this screen, for each menu/submenu, the Laboratory Manager, according to the specific laboratory needs, can define the level of entry. For each menu/submenu the Laboratory Manager has three basic options: No Access Access, View only Access, Edit No Access means that it will not be possible to enter the menu or submenu; the option will be dimmed. Access-View Only means that the access is possible. The screens can be viewed but no modification can be done. Access-Edit means that the access is possible and Edit capability is available (depending on the type of screen).
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ACCESS DETAILS SCREEN
Access Details
Confirm
By selecting the Details icon after choosing the menu/submenu, the above screen will appear. In the Access Mode box the Laboratory Manager can define the Access/No Access for the specific menu/submenu. If the Access option is chosen the Laboratory Manager can then define either View Only or Editing capability for the selected menu/submenu if available. Select the New User icon from the main Security entry screen to create a new user.
New User
Lab Manager View
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The next screen will appear.
User Details
In this screen the following information needs to be entered: USER NAME: type the user name (it must be unique). It is advisable to keep the name short (minimum of 3 characters) as it will be used to log in to the system. EXTENDED USER NAME: type the extended user name to differentiate between users. LEVEL: the Laboratory Manager defines the entry level for each user: Lab Manager Supervisor Operator PASSWORD: the new user enters his/her password.
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CONFIRM PASSWORD: re-enter the same password for confirmation. Password has to be minimum of 3 characters. When logging into the system User Name and Password will be required.
LOGIN SCREEN:
User Name
Password Confirm
It is recommended that the user log out when the system is not in use (using the key icon) requiring the next user to log-in. When using the Security / Password system, log all important operations into the Logbook.
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SSA SETUP SECURITY ACCESS

Performance Guide
Step 1 Select Setup / Security Select Lab Manager View 2 Action
ACL ELITE/ELITE PRO
Note: Upon installation of the system, it is advisable for the Laboratory Manager to define a new log in using his/her new password to avoid misuse of the system.
3 4 5
Define the level of access. For this class select operator

Operator
Scroll down to each menu and submenu by using the Select the Details icon Define, for each menu/submenu, the level of entry according to the specific laboratory needs. For each menu/submenu, the Laboratory Manager has three basic options: No Access Access, View only Access, Edit No Access: means that it will not be possible to enter the menu or submenu; the option will be dimmed Access-View Only: means that the access is possible. The screens can be viewed but no modification can be done Access-Edit: means that the access is possible and Edit capability is available (depending on the type of screen)
Select Confirm
several times, until you reach the database view
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Create New User

Step 1 Select the New User Icon Complete the user details: USER NAME: type the user name (it must be unique). It is advisable to keep the name short (minimum 3 characters) EXTENDED USER NAME: full user name to differentiate between users 2 LEVEL: the Laboratory Manager defines the entry level for each user. Can designate new user as: Lab Manager, Supervisor, or Operator (Use Operator for this exercise) PASSWORD: the new user enters his/her password CONFIRM PASSWORD: re-enter the same password for confirmation. Password has to be minimum of 3 characters When logging into the system User Name and Password will be required 3 4 Select Confirm x2 Action from the main security screen.
Log Off the system using the log-out key icon Log On to the system using your new created User and Password
User
Confirm
Password
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Skill Check
1. In the Access Details screen give the meaning of the following terms: a. No Access: ____________________________________ ____________________________________ ____________________________________ b. Access, View only: ____________________________________ ____________________________________ ____________________________________ c. Access, Edit: ____________________________________ ____________________________________ ____________________________________ 2. How many users can you define in the ACL ELITE / ELITE PRO? ____________________________________ 3. Name the Icon used to Log-Off from the ACL ELITE / ELITE PRO? ____________________________________
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CLOT CURVE INTERPRETATION OBJECTIVES

Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and Training Module you will: Print a Clot Curve from your instrument Identify and label the four components of the Clot Curve Define representation of the X and Y axis on a clot curve Innumerate the number of optical readings taken per acquisition cycle Define the actions taken when error codes occur
MODULE RESOURCES
ACL ELITE / ELITE PRO Operators Manual, Chapter 3 ACL ELITE / ELITE PRO Training Module, Additional Information
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This is a normal clot curve
In the above diagram we observe a normal Clot Curve. There are other ways in which we observe a Clot Curve, for example: when performing a Tilt Tube Method we visually see the end point of a clot. That is when Fibrinogen has been converted into Fibrin.
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The table below compares the Tilt Tube Method and Instrumentation.
Tilt Tube
Instrumentation
Operator adds reagents and

incubates
Visually determines end point or clot Notes time from addition of last
reagent to clot
Test is automated Instrument takes optical readings Uses formula or algorithm to convert
optical readings to endpoint
Tilt Tube Method
Result A = Result B
Instrument Reading
The Clot Curves can tell us what the instrument sees at any point in time during the acquisition period. The acquisition time is the period when the instrument acquires approximately 1100 data points on each sample being analyzed. The analyzer looks at the clot formation, as we would have done using the Tilt Tube Method. The analyzer draws a picture to show us what the clot formation looks like.
A Clot Curve can show us a picture of the clot
Clot Curves help verify a result or investigate a problem with a sample, reagent or instrument. Lets examine how the ACL ELITE / ELITE PRO detects a clot.
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Optics Detection
When a light ray passes through a substance containing a finely dispersed phase in suspension (fibrin clot),
Light is diffused
Light Scattered
Hi hli h
The scattered light is measured at a 90 angle to the light source (nephelometry). As the clot forms, light scatter increases until the clot formation is complete.
The Clot/Reaction Curve displays the normalized data points recorded during the acquisition phase. The Y axis displays the total reaction change divided into 5 points. The reaction change is rounded to 2 decimal places; therefore samples with a small amount of change may display duplicate points within the 5 that are displayed. Curves for clotting assays typically will be presented in a S pattern. The curve is generally composed of 4 sections: Baseline, Acceleration, Deceleration and Endpoint.
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A Clot Curve Is:
A series of data points that represent individual optical readings
A Normal Clot Curve
Endpoint
Deceleration
Optical Reading Acceleration Baseline
Delta
Time
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Basics
Lets learn the basics of what a Clot Curve is, and its components.
Si Single point: a data reading is taken every 100-300 ms Line: all data readings in series X-Axis : Data Acquisition Time in seconds Y-Axis : optical readings Baseline: Readings taken after the reagent and sample are mixed but before the clot starts forming Acceleration area: Readings taken while the clot is forming Deceleration: Time when the clot formation begins to slow down Endpoint: Readings taken after the clot is complete
Various algorithms are used by the system to select the actual clotting time. Some examples of these include: First Derivative: Time at which the maximum speed of clot formation is noted. Second Derivative: Time at which the maximum change in speed (maximum acceleration) of clot formation is noted. Threshold: Time when a pre-set optical density value is reached. Threshold- 2nd Derivative: If the threshold reading is not met, then the system will use the 2nd Derivative value. When viewing clot curves some items you should make note of include: Shape of the curve (Flat curves may indicate no clotting). Long baselines indicate a prolonged clotting time. Range of the Y axis. A tight range may indicate no clotting or a low fibrinogen value. Compare the questionable samples Y axis with one from a normal sample. A wide range on the Y axis may indicate a high fibrinogen value. Continual rise in the Acceleration phase with no endpoint indicates the sample did not clot within the acquisition time. A drop in the endpoint may indicate an unstable clot formation.
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Abnormal Situations
This sample gave an Error 13. The manual states: Maximum peak of the second derivative is below the selected limit value. Second derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time. Look at the scale of the S/R*100. The units are from about 10 to 19. Compared to a normal curve, that is much too small of a change to indicate clot formation has occurred. The change that we are seeing on this curve is probably just noise. This sample should be repeated in Extended Acquisition Time.
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Clot Curve Interpretation

Performance Guide
Step 1 2 3 4 5 Action Perform a R-PT and APTTSYS on the samples provided to you by the facilitator, or retrieve a sample result from the Database Select Details icon Use the cursor to select a test result, Select Details icon Select Print to print the Clot Curve Label the four components of a Clot Curve and save for skill check
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Skill Check
1. When looking at a Clot Curve what does the following represent? a. X-Axis: ___________________________________________ b. Y-Axis: ___________________________________________ 2. Approximately how many data points does the instrument acquire during acquisition time? ____________________________________________________ 3. What action is required when you receive an error code and no results? ____________________________________________________ 4. What action is required if an error code 14 for a DDimer test occurs? ____________________________________________________ 5. How can Clot Curves benefit the laboratory? ___________________
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Instructor
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AccuTrak
Objective
Given an ACL ELITE / ELITE PRO using Quality Control Data (QC) within the Database Files, the RQC2 Modules in the ACL ELITE / ELITE PRO Training Manual and Quick Reference Guide you will: Understand basic quality control principles Understand the different AccuTrak reporting options Collect data from your instrument for a specific time period Interpret AccuTrak data Maintain QC files in your instrument database
Module Resources
ACL ELITE / ELITE PRO Operators Manual, Chapter 3, Section 3.3.7 ACL ELITE / ELITE PRO System Training Module ACL ELITE / ELITE PRO Quick Reference Guide
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AccuTrak
Introduction
All ACL Coagulation Systems with an on-board quality control program use the Levey-Jennings Chart to plot individual data points. In interpreting the plot made on the chart, it is important to keep in mind the statistical significance of the 2SD lines. Once a method has been evaluated and found to be acceptable, values assayed for a single lot number of control should show normal distribution about the mean with points falling above and below the mean value with relatively even frequency. The 2SD lines delineate the area of the normal distribution in which 95.5% of the points should fall. Approximately once in every 20 tests, the value will fall outside these limits (mainly between 2 and 3 SD). This will occur by chance and thus cannot be said to indicate a definite out of control situation. Points falling outside 2SD must be interpreted in light of the preceding values. Repeating the determination will often result in a value falling within the statistical bounds. Frequently, a single outlier reflects a random error. If the frequency of the points falling outside 2SD limits is greater than 1 in 20, or there are successive points outside the same limiting line, an investigation should be made to determine the cause of the bias. When six successive points fall on the same side of the mean line (even though they are within 2SD), the situation is considered to be out of control. The procedure should be evaluated and the problem corrected.
QC Terminology
Accuracy Precision The degree of closeness of a measurement to its true (accepted) value. AccuTrak reports evaluate accuracy in terms of your individual mean as compared to the peer group mean. The reproducibility of multiple measurements of the same sample. Precision does not necessarily correlate with accuracy. It is possible for a group of measured values to show excellent precision without being accurate. A shift is said to have occurred when 6 successive values have consistently fallen on one side of the mean. These results are not consistent, but rather, successively increase or decrease on either side of the mean. The average of the control values submitted by a laboratory for a particular test (excluding the outlier values). It is used to show central tendency of a group of data. It can be used to evaluate accuracy if a reference to which it can be compared is available.
Shift Trend Mean
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Group = Mean ( X )
The peer group mean. It is used to evaluate inter-laboratory accuracy by serving as the reference to which individual means can be compared. Spread or scatter around the mean. It checks for precision. Standard 68% of all results should fall within 1SD Deviation 95.5% of all results should fall within 2SD 99.7% of all results should fall within 3SD The average standard deviation of the method (group) Pooled irrespective of variations in means between laboratories. It is Standard weighted by the number of results each lab has reported. Deviation Or (PSD) When pertaining to the individual laboratory, the average SD from month to month irrespective of variation in the monthly means An indicator of accuracy by showing how well your lab mean Standard compares to the peer group mean qualitatively (+ or -) and Deviation Index (SDI) quantitatively. The term SDI, as used by CAP-QAS, is also known as Z-Score SDI is used to demonstrate bias. If it is always negative, your method could be recovering low. An SDI of 2 indicates the lab mean is more than 2SD from the group mean and will generate an alert on the report. When the SDI is 2, check the following: Is the lab running within the group 2SD? Are there few labs reporting on this lot? Is the group running very tight? An SDI of 3 indicates a large bias and should be investigated thoroughly. Measures variability around the mean. It is an indication of precision expressing the standard deviation as a percentage around the mean. The CV allows you to compare and measure precision at different levels. However, raw numbers should be examined to establish the CVs significance. Allows you to compare your precision to that of your peers. It is a ratio of your CV to the Group CV and is an estimate of precision.
Coefficient of Variation (CV%) Coefficient of Variation Index (CVI)
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AccuTrak
AccuTrak is Instrumentation Laboratorys inter-laboratory quality control program. This program will assist your QC program by: Statistically comparing your results with other labs using like reagents and instrumentation. Providing users with ongoing peer comparisons for managing laboratory quality. Monitoring laboratory accuracy and precision. Providing users with a selection of reports excellent for reviewing instrument performance and satisfying regulatory requirements.
Enrolling in AccuTrak
There are two choices for enrollment. 1. Call the AccuTrak center at 1-800-678-0710, option 7 and request a new users account. You will be mailed a start-up packet that will include all supplies needed for the first two months including: AccuTrak Laboratory Code Number. AccuTrak Quality Control Program Procedures Manual. 2 sets of data input forms. Pre-addressed mailing envelopes. Calendar with mailing dates indicating when your data should be put in the mail. AccuTrak On-Line Account Access registration information for on-line QC services.
After that, additional supplies can be ordered online at the website below or by calling at the number above. 2. Enroll on-line at www.ilus.com by selecting: Service and Support AccuTrak complete enrollment information then Send Request. An Accutrak Representative will contact you shortly.
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Reviewing AccuTrak Reports

Individual Laboratory Report This report is a compilation of statistics for each of your laboratory tests, systems and methods for the last reporting period. It is the basic evaluation of your performance. It also includes your lab history a summary of your laboratory cumulative statistics (past performance). The Individual Laboratory Report is generated immediately after receipt of your monthly data. It is sent to you promptly as documentation of data received in addition to the preprinted forms of your choice. The statistical data is divided into two sections: Statistical Bounds Values for the current data submitted Lab History Year to date historical data for each specific method Each Individual Laboratory Report contains the following information: See Page AT-6 for a Sample of a Report Reporting period covered for this report, your Lab Code Number, Control Code and description of Control submitted Test/System/System #/Method, Level and Lot numbers The temperature of your lab method (T). This applies to methods in which a temperature code is given STATISTICAL BOUNDS N Number of values submitted and acceptable for the specific method Asterisk (*) Indicates exclusion of outlier values from that methods data calculations. A footnote indicating this appears at the bottom of the report. Excluded values are also summarized in the Data Description Report for the corresponding month Mean Average of all values reported for a particular method. Outlier values are not included 1 SD Your labs 1 Standard Deviation. This is a measure of the variance of your method values from their mean. It is a measure of precision -2 SD/+2 SD Statistical Bounds or Confidence Limits. These values are the limits of the range from 2SD below to 2 SD above your labs mean CV Coefficient of Variation refers the reproducibility of your results. It describes the variation around the mean and is expressed as a percent of the mean LAB HISTORY N- Cumulative number of values submitted for the lot/system/method Mean Weighted average of means for the preceding reporting periods PSD Pooled Standard Deviation is the weighted average of Standard Deviations for preceding reporting periods CV Average of Coefficient of Variation for preceding reporting periods
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AccuLert Message/Exception Summary Report This report notifies you systematically of exceptional program considerations in two categories: 1. (This report is standard and received by all participants) General information related to your labs monthly submission report such as: a. Lot expiration - The expiration date for your current lot of control material will appear in the report 3 months prior to expiration. b. Submission by your lab of less than 2 valid data points per test required for processing your data for that test. c. Historical data deleted per your request (generally due to new lot number). 2. (Optional at participants request) ALERT messages calling your attention to possible problems relating to your data, such as: a. Incidence of outlier data values. b. Unusual data variations reflected in your labs mean values in comparison to the group mean values (Standard Deviation Interval or Z-score), or messages about your SD range in relationship to the groups SD range. You will receive the AccuLert Message/Exception Report along with any other optional peer group comparison reports you have requested either online or mailed. If no exceptional considerations of the types described above apply to your program for a given month, you will receive a message stating such. Note: If you have chosen NOT to receive the Alert messages for the Optional report based on statistical data comparisons, you will receive this report based on the Standard messages only. The following information appears on the report: (Messages are grouped by Control, Test/System/Method, Level/Lot) See Page AT-8 for a Sample of a Report Reporting Period to which this report pertains Technical Support telephone numbers for assistance in interpreting AccuLert messages Control Code and description Test/System/Method for which messages are noted Messages pertaining to the specific Test, System, Method, Level and Lot of control Alert Indicates a data exception message related to the statistics derived from your laboratorys data submission. We suggest you review such messages with reference to the statistics for the pertinent Test/System/Method in your various output reports. For help interpreting alert messages, call Technical Support at 1-800-526-7694.
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Laboratory Summary Report
The Laboratory Summary Report provides a month-to-month tabulation (up to 12 months) of summarized results from your lab and the group using your method, together with cumulative individual and group statistics. The report also includes your SDI comparing your lab mean with the group mean.
TIP: This report is useful for detecting shifts and trends and is excellent for satisfying inspectors by verifying instrument performance. See Page AT-10 for a Sample of a Report The Laboratory Summary Report contains the following information:
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Reporting Period, Lab Code Number, Control Code Number, Description of Control Submitted. LAB AND GROUP YEAR TO DATE (YTD) VALUES Mean (Lab YTD) Your labs cumulative mean. Mean (Group YTD) Cumulative mean of all laboratories using the same method for the given test. PSD (Lab YTD) Your labs pooled 1SD. The PSD (Lab YTD) is a weighted average of the monthly SD values. PSD (Group YTD) Cumulative pooled 1SD for all laboratories using the same Lot/System/Method for a given test. The PSD is a weighted average of the monthly PSD. MONTHLY DATA Month Lists each (YTD) monthly reporting period with last month first. N The total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk (N*) indicates outlier data were excluded from your labs calculated statistics. A footnote stating this appears at the bottom of the report on which it appears. Lab Mean The average of all values (excluding outliers) reported by your lab for the specific method during the month indicated. An asterisk next to your lab mean indicates your data was excluded from the group. A footnote stating this will appear on the report on which this occurs. Group Mean The weighted average of the means for all labs using your Lot/System/Method for a given test. SDI (Standard Deviation Interval) Indicates the position of your labs mean in the distribution of all means calculated for that method. An SDI of >2.0 indicates your labs mean is more that 2SD from the group mean. Factors to consider when your SDI is >2SD: Are there a small number of labs reporting to the group? Is the range of values within the group relatively small? Number of Labs The number of labs reporting results determined by you Lot/System/Method for a given test. Lab 1SD One Standard Deviation as determined by the results you lab submitted for the month indicated. Group PSD Weighted average 1SD for all labs using your method for the given test, for the month indicated Lab CV Your labs CV as computed for your data for the month indicated. Group CV Average CV of all labs using your method for the given test. Computed for the month indicated. Test/System/Method for which the data is tabulated on the following lines. Level and Lot of control for which data are shown
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All-Methods Summary Report

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The All-Methods Summary Report provides each participating laboratorys statistics for the last month reporting to your Test/System/Method combination. Also included are year-to-date statistics for each lab.
TIP: This report allows you to view each laboratorys data submitted to the group and compare for accuracy and precision. See Page AT-12 for a Sample of a Report The All-Methods Summary Report contains the following information:
Reporting Period, Lab Code Number, Control Code Number, Description of Control submitted. Lab Lab code numbers for each participating laboratory. A T after the lab code indicates the labs own computed statistics submitted on the in-house Computer Data Summary Form or Impact. The identity of each lab remains confidential 3. System The instrument and its designation (instrument #1, 2 etc.) reported. 4. Method for which data is shown 5. Temperature of method Applies only to methods for which a temperature code is given DATA FOR LAST REPORTING PERIOD FOR ALL LABS INCLUDED WITH THE PEER GROUP 6. N The total number of data (excluding outliers) submitted during the last reporting period by that lab for that specific System/Method combination. An asterisk next to a number in the N column indicates outlier data were excluded from the labs calculated statistics. A footnote stating this will appear at the bottom of the page. 7. Mean The average of all reported values for that respective lab. A mean value marked with an asterisk indicates the mean has been excluded from the group as an outlier. A footnote stating this will appear at the bottom of the page. 8. SDI (Standard Deviation Interval or Z Score) Indicator of the position of each individual labs mean in the distribution of all means calculated for that method. An SDI of >2.0 indicates your labs mean is more that 2SD from the group mean. Factors to consider when your SDI is >2SD: Are there a small number of labs reporting to the group? Is the range of values within the group relatively small? 9. 1SD One Standard Deviation is derived from that labs data for the reporting period. 10. -2SD/+2SD Confidence Limits (Stat Bounds) The values in these two adjacent columns are the limits of the range from 2SD below the mean to 2SD above the mean. 11. CV Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean. CUMULATIVE DATA PRIOR TO LAST MONTH IS SUMMARIZED IN THE LAST THREE COLUMNS UNDER LAB HISTORY 12. Mean (in each individual labs data line) The cumulative mean for that lab 13. PSD The Pooled Standard Deviation is the cumulative weighted average YTD of cumulative 1SD values for that lab. 14. CV The Coefficient of Variation is derived from the YTD means and PSD values for that lab. INFORMATION FOR SPECIFIC TESTS, LEVEL AND LOT OF CONTROL 15. Test The test for which the data below are shown. 16. Level and lot number of control for which data are shown 17. Peer Group Data Provides the weighted average group mean 1SD, 2SD range and CV. 18. Standard Deviation of Means 1SD performed on the means submitted to the group for reporting.
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All-Methods Summary Condensed Report
The All-Methods Summary Report is the condensed version of peer group comparisons for All Systems and Methods reporting to you Test/System/Method combination, level and lot number of control(s) reported
TIP: This report is useful in comparing data for other methodologies.
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5. 6. 7.
8 9.
The All-Methods Summary Report contains the following information: See Page AT-14 for a Sample of a Report Reporting Period, Lab Code Number, Control Code Number, and Description of Control submitted. Test/System/Method for which peer comparison data is provided on the following lines. T indicates temperature and applies only to methods for which temperature is required. #Labs The number of labs reporting results to your Test/System/Method, control level and lot number indicated for the reporting period. Group Mean The weighted average of the means for labs of all Systems and Methods reporting to your control levels and lots. PSD Pooled Standard Deviation is the weighted average 1SD from the group. -2SD/+2SD Confidence Limits (Stat Bounds) The values in these two adjacent columns are the limits of the range from 2SD below the mean to 2SD above the mean. CV Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean. Level and lot number of control for which data are shown
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ACL ELITE/ELITE PRO
Condensed Laboratory Summary Report
The Condensed Laboratory Summary Report allows you to view your Current Month, Cumulative and Peer Group Statistics for a specific analyzer in a simple and concise monthly report.
TIP: An excellent report for quick review of an instruments performance and satisfies the requirements of inspectors and other key individuals in your organization. See Page AT-16 for a Sample of a Report The Condensed Laboratory Summary Report contains the following information:
1. 2. 3. 4. 5.
6.
Your Lab Code Number, Facility Name and Contact. Control Code and Description Reporting Period, Business Unit, System Type and Machine (instrument designation 1, 2, 3 etc). Method (reagent), Test, Level and Lot Number of Control. Current Month Statistics: N Total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk indicates outlier data were excluded from your labs calculated statistics. A footnote stating this will appear at the bottom of reports on which this occurs. Lab Mean The average of all values (excluding outliers) reported by you lab for the specific method during the month indicated. An asterisk indicates the mean has been excluded from the group. A footnote stating this will appear at the bottom of the page. Lab 1SD One Standard Deviation as determined by the results your lab submitted for the month indicated. -2SD/+2SD Confidence Limits (Stat Bounds) The value in these two adjacent columns are the limits of the range from 2SD below to 2SD above the mean. CV Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean. SDI (Standard Deviation Interval or Z Score) Indicator of the position of your labs mean in the distribution of all means calculated for that method. It is an estimation of accuracy. An SDI of >2.0 indicates your labs mean is more that 2SD from the group mean. Factors to consider when your SDI is >2SD: Are there a small number of labs reporting to the group? Is the range of values within the group relatively small. CVI (Coefficient of Variation Index An indicator of precision that allows you to compare your precision to that of your peers. Cumulative Statistics: N Total number of data submitted to date for the Lot/System/Method combination. Mean The cumulative mean for your lab. PSD (Pooled Standard Deviation) The cumulative weighted average YTD of cumulative 1SD values for your lab. CV Coefficient of Variation is derived from the YTD means and pooled SD values for your lab.
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ACLELITE/ELITE PRO
Condensed Laboratory Summary Report
The Condensed Laboratory Summary Report allows you to view your Current Month, Cumulative and Peer Group Statistics for a specific analyzer in a simple and concise monthly report. TIP: An excellent report for quick review of an instruments performance and satisfies the requirements of inspectors and other key individuals in your organization. See Page AT-16 for a Sample of a Report The Condensed Laboratory Summary Report contains the following information:
1. 2. 3. 4. 5.
6.
7.
Your Lab Code Number, Facility Name and Contact. Control Code and Description Reporting Period, Business Unit, System Type and Machine (instrument designation 1, 2, 3 etc). Method (reagent), Test, Level and Lot Number of Control. Current Month Statistics: N Total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk indicates outlier data were excluded from your labs calculated statistics. A footnote stating this will appear at the bottom of reports on which this occurs. Lab Mean The average of all values (excluding outliers) reported by you lab for the specific method during the month indicated. An asterisk indicates the mean has been excluded from the group. A footnote stating this will appear at the bottom of the page. Lab 1SD One Standard Deviation as determined by the results your lab submitted for the month indicated. -2SD/+2SD Confidence Limits (Stat Bounds) The value in these two adjacent columns are the limits of the range from 2SD below to 2SD above the mean. CV Coefficient of Variation describes the variation around the mean and is expresses as a percentage of the mean. SDI (Standard Deviation Interval or Z Score) Indicator of the position of your labs mean in the distribution of all means calculated for that method. It is an estimation of accuracy. An SDI of >2.0 indicates your labs mean is more that 2SD from the group mean. Factors to consider when your SDI is >2SD: Are there a small number of labs reporting to the group? Is the range of values within the group relatively small. CVI (Coefficient of Variation Index An indicator of precision that allows you to compare your precision to that of your peers. Cumulative Statistics: N Total number of data submitted to date for the Lot/System/Method combination. Mean The cumulative mean for your lab. PSD (Pooled Standard Deviation) The cumulative weighted average YTD of cumulative 1SD values for your lab. CV Coefficient of Variation is derived from the YTD means and pooled SD values for your lab. Peer Group Statistics: Labs The number of laboratories reporting results determined by you Lot/System/Method for a given test. Mean The weighted average of the means of all labs using your Lot/System/Method for the given test. PSD Weighted average 1SD for all labs using your Lot/System/Method for a given test. CV The average CV of all labs using your Lot/System/Method for the given test. SD of Means 1SD performed on the means submitted to the group for the reporting period. AT 15 of 24
ACL ELITE/ELITE PRO
Instrument Performance Plot
The Instrument Performance Plot Report provides you with an overview of your laboratorys precision and accuracy as compared to the peer group
1. 2. 3. 4.
5. 6.
7. 8.
9.
TIP: The statistical terms used in the explanations that follow are defined in the QC Terminology section starting on page AT-2 of this module. See Page AT-18 for a Sample of a Report The Instrument Performance Plot Report contains the following information: Your Lab Code Number, Facility Name and Contact. Control Code and Description Reporting Period, Business Unit, System Type and Machine (instrument designation 1, 2, 3 etc). Method (reagent), Test, Level and Lot Number of Control. PLOT Level and Lot # of control Lab SDI (Standard Deviation Index) An estimate of accuracy as it compares your mean to the peer group mean CVI (Coefficient of Index) An estimate of precision as it compares your CV to the peer group CV. BASED ON 3SD AND 3CVI X-axis Represents the CVI indicating precision. Y-axis Represents the SDI indicating accuracy. Represents your lab co-ordinates for SDI and CVI INTERPRETATION* 0.0 - 2.0 is Typical Peer Group Performance (95% of peer population) 2.0-3.0 is Borderline Peer Group Performance (5% of peer population)
NOTE: These interpretations are strictly statistical in nature and should be used as guidelines only. It is the responsibility of each laboratory to determine clinical significance and whether corrective action is necessary.
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AccuTrak
Performance Guide
Extracting Data Step 1 2 3 Select QC / Setup/ Review Select Normal Control and the RPT test, then Select Plot and Statistics icon to access the QC Levey-Jennings Charts Select the Interval icon Define date range, input the Start Date, and the End Date, also narrow results from the following choices: Valid Results, Invalid Results, Not Numeric Results, Out of Scale Results, Omitted Results, Transmitted or Not Transmitted and Flagged or Not Flagged. 4 NOTE: In your lab, the start date would be the date you wish to start collecting data from for AccuTrak. For example, if you are preparing data from the 1st of the previous month to the 1st of the current month, enter the 1st of the previous month here. Any data points from QC run after midnight on this date will be found in this report. The end date is when you want to stop collecting data for AccuTrak. Any QC run after midnight on this date will not get placed in this report Select the Confirm icon. Compare your data format to the Self Evaluation on page AT-22 Review the data and make any modifications such as omitting data using OMIT RESULT icon and/or adding comments to a data point using ADD TEXT icon 7 TIP: Typically, any data point outside of 3SD is omitted with supporting documentation. Data points between 2 and 3SD are not omitted as they represent the 5% of results that statistically will fall within this range and represent normal random error. Omitting these data points may eventually create a mean and SD that are too tight. From the QC Plot and Statistics screen as accessed above in steps 1-5, select the Print to print all QC files Repeat the steps above 1-8 to extract and print all Quality Control Folders. One QC test at a time Once data has been reviewed is ready to be sent to AccuTrak Action
5 6
8 9 10
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ACL ELITE/ELITE PRO
Printing the Laboratory Cumulative Reports Step 1 2 3 4 5 6 Select QC / Setup Select Normal Control and Review, select RPT test, then select Cumulative Report icon Select the Extract icon Input the Start Date, and the End Date to select the interval of time to extract the statistical data Press the Extract icon Compare your data format to the Self Evaluation on page AT-23 Review the data and make any modifications such as omitting data using OMIT RESULT icon and/or adding comments to a data point using ADD TEXT icon 7 TIP: Typically, any data point outside of 3SD is omitted with supporting documentation. Data points between 2 and 3SD are not omitted as they represent the 5% of results that statistically will fall within this range and represent normal random error. Omitting these data points may eventually create a mean and SD that are too tight Select Cumulative Report as accessed above in steps 1-5, select the Print to print all QC files. (One QC test at a time) Identify by highlighting the following information to be sent to AccuTrak for peer review: Actual Mean found in the middle left of the Levey-Jennings Report. Target Mean found on the middle left of the Levey-Jennings Report. Actual SD found in the middle left of the Levey-Jennings Report. Target SD found in the middle left of the Levey-Jennings Report. Actual CV found in the middle left of the Levey-Jennings Report. No. of Results in Statistics found on the middle left of the Levey-Jennings Report.
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Action
Selecting the Data from Printouts to Be Sent to AccuTrak
ACL ELITE/ELITE PRO
Sending in Your Data Decide which method you wish for submission of your data then follow the guidelines for either as outlined by AccuTrak for proper submission
SKILL CHECK
1. Show facilitator printouts of the Levey-Jennings chart and Cumulative Report with the highlighted data to be sent to AccuTrak 2. Define the following: Accuracy _________________________________________ Mean ____________________________________________ Precision _________________________________________ Shift _____________________________________________ Standard Deviation _________________________________ Trend ____________________________________________ 3. Define four things the AccuTrak program provides for QC assistance. ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ 4. How many different types of reports does AccuTrak have available? ______ Name them. ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ ______________________________________________________________ ______________________________________________________________
Sign Off
Instructor
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SKILL CHECK
QC ran after 12:00 on this date will automatically go into this Report
QC ran before 12:00 on this date will automatically go into this Report Mean & 1SD and No of results in Statistics to be submitted to AccuTrak
Levey Report
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SELF-EVALUATION SKILL CHECK
Only QC data points range between these dates will be in this Report
Data point has been omitted and a note attached
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TRAINING OBJECTIVES
Given an ACL ELITE / ELITE PRO workstation, Operators Manual, and Training Module you will:
Produce an outline as a Training Plan for your lab Document at least one module completion
MODULE RESOURCES
ACL ELITE / ELITE PRO System Training Modules
T 1 of 12
ACL ELITE/ELITE PRO
MENTOR/TRAINER
Introduction
Youve just completed training on the ACL ELITE / ELITE PRO Coagulation System and you are about to return to work. Once the mail has been gone through and you have put out all of the fires that were started while you were gone, how will you apply the skills youve learned in class? How will you move yourself and your department in the direction of reporting patient results from your new instrument? Your new skills wont do you or anyone else any good if you dont get a chance to apply them and they wont last unless you use them before they wither away. Use it or lose it! Unless you do some planning, you may find yourself overwhelmed by the pressure of work. Here is your opportunity to get a game plan together to help make the training a little more streamline. Remember the saying see one, do one, teach one and remember that by training, you are practicing your skills.
Attitude
While it is nearly impossible to control all of the factors that influence attitude toward learning or change, we as instructors can set the tone. In other words, if we are positive and excited about what we are teaching and embrace change, we can be quite contagious and in most cases, a positive attitude will rub off. Your approach will make or break the transition of your new instrument into your lab.
Training Plan
Before you startHAVE A PLAN! Refer to the example on page T-6. The plan should be specific as to what you want to accomplish, what resources and which people, will be involved to complete this plan. Your plan should also contain a timeline and how success will be measured. An example of a Training Plan might be as follows: List all personnel to be trained including the following: o What shift do they work and when you expect them to train (does a 3rd shift person stay late to meet your schedule or do you come in early to meet theirs) o What Security Level will they have (how in depth is their training)
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ACL ELITE/ELITE PRO
Devise a Training Outline (see example on pages T-8 thru T-12): o Include specific objectives, let them know what you expect o Include procedural guides and other aids (flowcharts, etc)
TIP: Job Aids are a quick, handy tool to act as a reminder on how to perform a specific task(s) after the official training has been completed. o Include skill checks or other methods of measuring proficiency o Include a place for the trainee and trainer to document that the trainee has demonstrated proficiency for each objective Propose a detailed timeline: o When training will start o Who will train when o When all training will be completed, including practice time o The Go Live date and time How proficiency will be documented and continuously monitored What festivities there will be to celebrate the completion of training! (good to include with the Go Live date)
Training Tips
KISS Keep It Super Simple, Teach only what they need to know Have supplies ready: copies of Training Outlines, Modules, Skill Checks, Job Aids, etc Provide practice, practice, and more practice for trainees! Watch trainees, but let them do the hands-on stuff! Its OK for trainees to make a mistake! Dont jump in too quickly, unless there is a real danger involved. Offer encouragement and positive reinforcement! Have trainees tell you what they learned about the topics. Training is an ongoing process, not a one-time event! Encourage pride in a job well done.
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ACL ELITE/ELITE PRO
Performance Guide
Choose one of the following to be completed in class: 1. Using the Training Plan outline provided on page T-6, T-7, devise a basic training plan for your lab. Or 2. Select one topic from the Training Outline on page T-8 and teach it to your lab partner and have them give you feedback to include the following:
Presentation:___________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ Content (were all objectives covered?):_______________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ Additional Notes:________________________________________________ ________________________________________________________________ ________________________________________________________________ ________________________________________________________________
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ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Plan

1. Trainees (list all to be trained on this instrument): Shift Security Level Training Start Date Training End Date Training Complete
Name
2. Training Materials to be used:
3. How will proficiency be documented?
4. How will proficiency be continuously monitored?
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ACL ELITE/ELITE PRO
5. Training timeline:
Task
Start Date
End Date
Task
Start Date
End Date
6. Go Live date and festivities: __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
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ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Outline

Department of Laboratory and Pathology Services Training Documentation
SUBJECT: ACL ELITE / ELITE PRO Trainee Name: ______________________________________ Training Date:_____________ Trainer Name: ______________________________________ Topic 1. Instrument overview (Module IB) 2. Instrument Maintenance (Module M) 3. Reagent Reconstitution/Stability (Product Inserts) 4. Specimen Handling 5. Running QC (Modules RQC2) 6. Running Patients/Barcode (Module SA2b) 7. Running Patients/No Barcode (Module SA2c) 8. Viewing Results/Errors (Module SA2) 9. Clot Curve Interpretation (Module CCI) 10.Verifying Results Trainee Initials Date Trainer Initials
I have received all of the information relating to the above topics. I understand that I am responsible for making sure all competencies are acceptable and current. Trainee Signature:______________________________________________ Trainer Signature: ______________________________________________
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ACL ELITE/ELITE PRO
ACL ELITE/ELITE PRO Training Outline

1. Instrument Overview Discuss all major components of the instrument and consumables: o Objective: Identify major components of the analyzer Consumables when used and when you can replace including Rotors, sample cups, reagents, Cleaning Solution 0.1N HCL (PN 9831700), Cleaning Agent Sodium Hypochlorite solution (PN 9832700), Wash R Emulsion Software Overview: Complete Module IB o Objectives: Navigate different sections of the Main Screen Identify functions of the F keys Access the Main Menu o Skill Check: Navigate correctly as directed in the Performance Guide. Correctly answer the questions in the Skill Check 2. Instrument Maintenance: Daily Maintenance: Complete Module M o Objectives: Perform Cleaning Cycle (Routine) Perform additional daily maintenance task per module o Skill Check: Correctly perform and document maintenance per the ACL Elite/Elite Pro Maintenance Log. Correctly answer the questions in the skill Check Scheduled Maintenance: Complete Module M o Objectives: View Maintenance Demonstration Perform Weekly maintenance Understand how to perform As Needed maintenance o Skill Check: View Maintenance Demonstration Correctly perform and document maintenance per the ACL Elite/Elite Pro Maintenance Log
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ACL ELITE/ELITE PRO
Correctly answer the questions in the skill Check 3. Reagent Reconstitution: Review: Pipettes Water Procedure When to Make New o Objective: Demonstrate proper reconstitution procedures o Skill Check: Controls pass using reagents prepared by trainee 4. Specimen Handling Review: To Ice or Not to Ice Spin Time Platelet Poor Specimens Freezing Specimens CLSI Recommendations o Objective: Demonstrate proper processing of a specimen o Skill Check: Specimen has been properly processed 5. Running QC: Review: When to Run QC Using INSERT to Select the QC Material What QC to Run Handling QC Troubleshooting Out of Range QC o Objectives: Run QC Identify failed QC from the QC Determination screen
Complete Module RQC1
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o Skill Check: Produce correct screen comparisons and printouts as directed in the Performance Guide Correctly answer the questions in the Skill Check Complete Module RQC2 o Objectives: Run QC Review QC from the Levey-Jennings Chart Omit and Restore results using the OMIT/RESTORE key Add a Note using the ADD NOTE button o Skill Check: Produce correct screen comparisons and printouts as directed in the Performance Guide Correctly answer the questions in the Skill Check 6. Running Patients/Barcode and no Barcode: Complete Module SA1 o Objectives: Run samples with and without barcode labels o Skill Check: Produce correct screen comparisons and printouts as directed in the Performance Guide Correctly answer the questions in the Skill Check 7. Running Patients/Barcodes/No Barcode/No Host: Complete Module SA2 up to Reviewing Results o Objectives: Run samples without barcodes or Host Computer Run Samples with barcodes and a Standard Profile Review Status Symbols on the Main Screen o Skill Check: The Skill Check for this section will be completed at the end of section 8, Viewing Results/Errors
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ACL ELITE/ELITE PRO
8.
Viewing Results: Complete Module SA2 starting at Reviewing Results o Objectives: Identify results with Flags View More Detail for sample results o Skill Check: Produce correct screen comparisons and printouts as directed in the Performance Guide Correctly answer the questions in the Skill Check
9.
Clot Curve Interpretation: Complete Module CCI o Objectives: Understand Nephelometry Describe how a Clot Curve is formed Identify the components of a Clot Curve Understand the significance of the Error/Warning Flags Use the Error/Warning Flag and Clot Curve to troubleshoot abnormal results o Skill Check: Correctly answer the questions in the Performance Guide
10.
Verifying Results: Review the rules for verifying results in the LIS Does the result satisfy delta rules? Is the result physiologically possible? Does the result make sense? Is the specimen of good quality? Garbage InGarbage Out o Objectives: Understand the rules for verifying the results in the LIS o Skill Check: Correct results were verified in the LIS as demonstrated by Quality Assurance review
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ACL ELITE/ELITE PRO
Skill Check
When you have completed the module, Show your Facilitator or Application Specialist the completion of pages T 5, T 6, and T 7 of the ACL ELITE / ELITE PRO Training Plan.
Facilitator(s) or Applications Specialist onsite
Facilitator Applications sign off

____________________
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NL OBJECTIVE
ACL ELITE/ELITE PRO
NEW LOT SETUP
Given an ACL ELITE / ELITE PRO workstation, the Operators Manual, Training
Manual, Quick Reference Guide and an installed printer you will: Create/Copy and Edit a Test to Perform New Lot Testing Create a new liquid called NLPT Fib Create a new test called PTNL Create a new test called NLFIB_ Create a new liquid called NLPTTSP Create a new test called NLAPTTSP Create a new liquid called NLCaCl2SP Create a new test called NLAPTTSP Create a new liquid called NLPTHS+ Create a new test called NLPTHS+ Transfer the profile to the Sorted List Interference Table Create/Setup a new QC files Test/Material Backup and Upload
MODULE RESOURCES
ACL ELITE /ELITE PRO Training Manual ACL ELITE /ELITE PRO Operators Manual, Chapter 4, Section 4.1.12 ACL ELITE /ELITE PRO Quick Reference Guide, Reagent Loading, Lot Change and New Test Setup HemosIL Reagent/Calibration Package Inserts
Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Please refer to Chapter 4, page 4.55 of the ELITE / ELITE PRO Operators Manual.
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ACL ELITE/ELITE PRO
New Lot PT (PT FIB) Reagent

Performance Guide
Copy Tests/New Lots are used to run two different lot numbers of the same reagents (PT Fibrinogen) prior to use for analysis and result reporting. Create a New PT Liquid Step 1 2 3 4 5 Action Select Setup / Liquids from the main menu Select the New Liquid icon Enter NLPT Fib in the Liquid ID field Enter New Lot PT FIB in the Extended Name field Start the new Liquid Code above 501. Enter 602 for Liquid Code (IL uses many of the codes below this number for their own test liquids see Operators Manual). Enter the new Lot No.: ________ Expiration Date ________On board Stability________ Assigned Volume and Warning volume will be vial dependent. Use a 10 mL vial. (See LD Module, page LD 3) Accessing Needle: Reagent Default Position: R2 Liquid Type: Reagent Check the Refrigerated box and Stirred box Select Confirm x 2
6 7 8 9 10 11 12
Note: If a message appears A valid and unique liquid code is required This indicates that the liquid code number is used by another liquid; the system will not allow you to save this liquid. You must use a code that has not been previously defined; use a number greater than 501.
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Create/Copy a New PT Test (using PT Fib reagent) Step 1 2 3 4 5 6 7 8 9 10 11 12 Action Select Setup / Tests / View Define from the main menu Select the PT Test / Copy Test Enter PTNL in the New Test ID field Enter New Lot PTFIB in the Extended Name field Enter Test Code for Host: 601 (501-999 used for host communication) Enter Test Code: Same as Host Test Code (601) Select Confirm Enable the test you defined PTNL Select Test Details. Use the to highlight the unit to be removed in the database view Select Ranges. Deselect the show in sample list icon. Do this for % and ratio Modify any ranges established by your laboratory in the Normal Ranges: min/max values for s and INR Select Confirm Proceed to Analysis Loading Setup
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All changes to the new Copied Test parameters will be performed in the Analysis Loading Setup parameters. Step 1 2 3 4 5 Select Analysis Loading Setup Select Index Step 1, AR Select Details icon Select Parameters icon for the Reagent Line In the No Dilution Liquid ID box use the drop down arrow and change PT FIB to the new liquid ID NLPT Fib Select Confirm At message appears: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles, Select Yes Select Index Step 2, Sample Select Details icon Select Parameters icon for the Reagent Line In the No Dilution Liquid ID box use the drop down arrow and change PT FIB to the new liquid ID NLPT Fib Select Confirm X 2 Action
6 7 8 9 10 11
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Calibration Loading Setup

Change the Reagent Aspiration and Calibration Loading Setup to define the loading sequence of reagents and samples. Step 1 2 3 4 5 Action Select Calibration Loading Setup icon Highlight and select Index Step 1 for the Std 1 Select Details icon Select the Parameters icon for the Reagent Line In the No Dilution Liquid ID box using the drop down menu and change PT FIB to the new liquid NLPT Fib Select Confirm A message appears: A New Liquid has been selected. If you save the new test setup, the Test will be removed from all profiles Select YES Select Confirm Highlight and select Index Step 2 for the Std 2 and repeat steps 3-7 above Highlight and select Index Step 3 for the Std 3 and repeat steps 3-7 above Select Confirm multiple times to exit, and select YES to any questions If only performing PT Test, no PT calibration is necessary If performing Fibrinogen test in your laboratory, continue with the procedure to create the new PT based fibrinogen FIB_ NL test procedure (pages NL 6-12)
6 7 8 9 10 11 12
Note: Verify the INR for the new PT test, you must input the MNR (Mean of the Number Range) under the Setup/Test area, and the new ISI from the package insert under the Setup / Liquids area. The ACL ELITE / ELITE PRO and the ACL 8, 9 and 10000 use identical analytical systems. Reagents, Calibrators, Controls and their assigned values are interchangeable between the two systems. All responsibility for parameter development and validation of a new or copied test belongs to the user alone.
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Create/Copy a New PT FIB Fibrinogen Assay Step 1 2 3 4 5 6 7 8 9 10 11 Select Setup / Test / View/Define Select Fib_ Select Print icon to print the test parameters, Select YES to prompt: Do you want to print the test report? Set printed report aside for later use Select Copy Test icon to make an exact copy of FIB_ Name the New Test ID FIB_NL and the Extended name New lot PT FIB Enter Test Code 630 for Host and Test Code 630 Select Confirm Enable FIB_NL test Select Details Use the drop down and Change Import Raw Data From to PTNL, and Imports Calibration from None A message appears: The use of imported raw data has been modified. Current parameters for the loadingwill be lost proceed? Select YES Action
Note: ALL parameters will be erased for this test and requires re-entry by editing parameters.
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Editing the Parameters when Raw Data is imported Step 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Select Calculation Setup Change Algorithm Type to Delta Algorithm Change Scope to Sample Ratio: use the drop down menu and select R=S/Std1 A message appears: Selecting a change will be erased resultsconfirm? Select Yes Select Define Parameters icon Enable the 1st Smooth and enter value of 15 for Degree, and press (Enter) Enable the 2nd Smooth and enter value of 9 for Degree, and press (Enter) For the First Part of the Reaction Curve, enable Offset and enter 10 for Points For the Final Part of the Reaction Curve, enable Final and enter 10 for Points Select Curve Check Parameters icon Enable Saturation (x) Enable Final Slope and enter the following numbers: a. Points = 101 b. Value = 5 Enable 1st Threshold Select Threshold Parameters icon Enter the Value of 3 under the 1st Threshold Verify Threshold Search Direction is selected to Forward Verify Threshold Mode is selected to Absolute
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Action
ACL ELITE/ELITE PRO
Step 19 20 21 22
Action Confirm A message appears: Selecting a new Parameter for the current list.. Do you confirm this new selection? Select YES Enable 2nd Threshold and enter the number 6 Confirm A message appears: Selecting a new Parameter for the current list.. Do you confirm this new selection? Select YES Enable the box Delta Correction (x) Select Correction Parameters icon A message appears: A new Correction can cause inconsistency of results already stored in Patient QC, AR.. Do you confirm this new selection? Select Yes
23
Enter the following parameters: Min st 1 Interval 100.00 200.00 2nd Interval rd 400.00 3 Interval Confirm x 2 Change Scope to AR
Max 200.00 400.00 leave
M(coeff) 0.0023 0.0014 these
q(coeff) 0.7701 0.9479 blank
24 25 26 27
Repeat Step 6 through 24 for AR Scope Select Calibration Setup icon Select All Std on the left side of the screen and enter the values displayed in green, in the table below: Note: A message appears for every Dilution Ratio% : As a consequence store calibration will be erased confirm? Select Yes
28 Standards Std 1 Std 2 Std 3

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Dilution Ratio % 100.00 50.00 25.00
CV 8.0 12.0 12.0

ACL ELITE/ELITE PRO
Step 29 30 31
Action Response Type: use the drop down arrow menu and select Delta Select Check CV (X) to enable Select Outlier (X) to enable Final Unit use the drop down arrow and selects mg/dL. A message appears Selecting a result unit for the current test all results already stored in patient QC, AR and calibration databases will be erased. Do you confirm the new selection? Select YES Select Calibration Curve Setup icon, and enter the following information. X= r = x/Std1 Y= y In Calibration Curve Setup table, enter the following information using the drop down arrow:
32
33
34 Start Point Std 1 End Point Std 3 F(x) x G(y) y q (x) to enable Translation Point Std 1
1st 35
In Calibration Curve Checks table, enter the following information: Slope Range 0.0000 to 1000.0 r > = 0.980
1 Curve 36 37 38 39 40 41 42
st
Select the Define as Mandatory icon Select Std 2 and the Define as Mandatory icon Select Std 3 and the Define as Mandatory icon A check mark () in each of the standards (Std 1, Std 2 and Std 3) Confirm x 2 Select Std 1 and press Define Parameters icon Enable the 1st Smooth and enter value of 15 and press Enter
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Step 43 44 45 46 47 48 49 50 51 52 53 54 55
Action Enable 2nd Smooth and enter value of 9 and press Enter First Part of the Reaction Curve, Select Offset and enter 10 for Points Final Part of the Reaction Curve, press on Final and enter 10 for Points Select Curve Check Parameters icon Enable Saturation (X) Enable Final Slope and enter the following numbers: a. Points = 101 b. Value = 5 Enable 1st Threshold Select the Threshold Parameter icon Enter the Value of 3 under the 1st Threshold Verify the Threshold Search Direction is selected to Forward Verify the Threshold Mode is selected to Absolute Select Confirm A message appears: Selecting a new Parameter for the current list. Do you confirm this new selection? Select YES Enable 2nd Threshold and enter the number 4 Select Confirm A message appears: Selecting a result unit for the current test all results already stored in patient QC, AR and calibration databases will be erased. Do you confirm the new selection? Select Yes Select Confirm Select Std 2 and Define Parameters icon, Repeat steps 42-57 Select Std 3 and Define Parameters icon, Repeat steps 42-57
56
57 58 59
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Step
Action Select Confirm until back at the Test Details screen for FIB_NL
Units Showing
60
Ranges
61 62
Use the to select the units that will be showing in the database Highlight the unit and select the Ranges icon Check the Show in Sample List box (X) if you want this unit to appear in the Database Screen. Uncheck the box if you do not want the unit to appear (FIB_NL only show unit mg/dL) Input the Test Range and Scale Range for Delta / Ratio / mg/dL Select the unit and press the Ranges icon to input the following ranges:
63
64 Delta R mg/dL
Min. Value Test Range 0.000-400.000 70.000-900.000
Max. Value Scale Range 0.000-999.000 0.000-10.000 0.000-3000.00
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ACL ELITE/ELITE PRO
Step 65 Select Confirm
Action
66
A message appears: Selecting a result unit for the current test all results already stored in patient QC, AR and calibration databases will be erased. Do you confirm the new selection? Select YES A message appears: Database Update in Progress Print the new FIB_NL test definition and compare it to the original test definition FIB_, previously printed. (Note: You will have more printed pages than original test since you set up each Std level, Sample and AR Scope separately.) Do not forget to enter the calibrator value for the new Fibrinogen Assay FIB_NL under Setup/ Liquids/ Cal Plasma. The value is found within the Calibration Plasma package insert. Calibrate the new tests: the PTNL and FIB_NL Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone.
67
68 69
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ACL ELITE/ELITE PRO
New Lot (APTT-SP) Reagent

Copy Tests/New Lots are used to run two different lot numbers of the same reagents (APTT SP) prior to use for analysis and result reporting. Create a New Liquid Step 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Action Select Setup / Liquids from the main menu Select the New Liquid icon Press space bar and enter NLAPTTSP in the Liquid ID Enter NEW LOT APTT-SP in the Extended Name field Start the new Liquid Code above 501. You may enter Liquid Code 618 (IL uses many of the codes below this number for their own test liquids see Operators Manual) Lot No: _______________ and Expiration Date: _________________ Assigned Volume and Warning Volume, vial dependent. Use a 10 mL vial Accessing Needle: Reagent Default Position: R3 Liquid Type: Reagent Check the Refrigerated box Select Confirm Select Setup / Liquids from the main menu Select the New Liquid icon Press space bar and enter NL CACL2 in the Liquid ID
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ACL ELITE/ELITE PRO
Step 16 17 18 19 20 21 22 23
Action Enter NEW LOT CACL2 in the Extended Name field Start the new Liquid Code above 501. You may enter Liquid Code 619 (IL uses many of the codes below this number for their own test liquids see Operators Manual) Lot No: _______________ and Expiration Date: __________________ Assigned Volume and Warning Volume will be vial dependent. Use a 10 mL Accessing Needle: Sample Default Position: R7 Liquid Type: Reagent Select Confirm x 2
Create a Test Step 1 2 3 4 5 6 7 Select Setup/ Test/ View/Define Select APTT SP Select Copy Test icon New Test ID: APTTSPNL for the Extended name: NEW LOT APTT SP Enter Test Code for Host: 620 (501-999 used for host communication) Enter Test Code: Same as Host Test Code Select Confirm Action
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ACL ELITE/ELITE PRO
Editing Test Definition

All of the changes to the new Test parameters will be performed to the Analysis Loading Setup parameters. This is the area of the test parameters where we define the loading sequence for the test. We will change the current Reagent Aspiration, Reagent Priming parameters. Step 1 2 3 4 5 Action Enable APTTSPNL test, and select Details icon Select Analysis Loading Setup icon within the Test Details screen Select Index 1 for the AR and select Details icon Select the Parameters icon to the right of the Reagent Line In the No Dilution Liquid ID box, using the drop down menu, change APTTSP to the liquid you have defined as your new liquid i.e. NLAPTTSP Select Confirm 6 A message appears: A New liquid was selected. Saving the new setup the test will be removed from profiles. Select YES Select Index 2 for the Sample and select Details icon Select Parameters icon to the right of the Reagent Line In the No Dilution Liquid ID box, using the drop down menu, change APTTSP to the liquid you have defined as your new liquid i.e. NLAPTTSP Select Confirm x 2 Select Index 4 for the Sample AR and press the Details icon Select Parameters icon to the right of the Sample Line
In the No Dilution Liquid ID box, using the drop down menu, change APTT CaCL2 to the liquid you have defined as your new liquid: NL CACL2
7 8 9 10 11 12 13 14 15
A message appears: A New liquid was selected. Saving the new setup the test will be removed from profiles. Select YES Select Confirm multiple times to exit, answering YES to any message
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ACL ELITE/ELITE PRO
Interference Table
To minimize reagent carryover between the PT and APTT tests, it was found experimentally that performing an operation called needle conditioning or reagent priming may improve the system performance. The Interference Table option is used to activate this feature between test pairs. Step 1 2 Action Select Setup / Tests / Interference Table This screen contains three windows: Test with reagent priming, Interfering Tests and Enabled Tests. Select the new APTT test: APTTSPNL From the Enabled Tests column, select the PTNL. Use the arrow icon to add and the scissor icon to remove test (s) that interfere (s) with APTTSPNL test in the Interfering test column Select Confirm Repeat steps 2-3 choosing APTT SP, and APTT SPe individually A message appears: Do you want to save the Interference Table Select YES
4 5 6
Define a Profile
Step 1 2 3 4 5 6 Action Select Setup / Multi-Tests / Profiles Select New Profile icon Select Confirm Define a profile called NEW LOT with the following tests: PTNL, FIB_NL, APTTSPNL Select Setup / Multi Test / Sort Multi Test, Sort New Lot using icon Proceed to analyzing samples using this Profile
Note: All responsibility for parameter development and validation of a new or copied test belongs to the user alone. Please refer to ELITE / ELITE PRO Operators Manual.
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ACL ELITE/ELITE PRO
Create New QC Liquids

Step 1 2 Select Setup/Liquids Select the New Liquid icon. Enter the name of your control liquids. Begin each Liquid ID with a single space as this will bring the liquid name to the top of the liquid list. Set up the following control liquids: Liquid ID 3 Normal 2 High 2 Low Fib 2 4 5 6 7 Extended Name Normal Control 2 High Abn Control 2 Low Fib Control 2 Liquid Code 620 622 623 Action
Assign: Lot no., Expiration Date and On Board Stability for each new liquid Select Liquid Type, use dropdown to select Control Review and select Confirm Repeat steps 3-6 with all liquids displayed in step 3 table
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ACL ELITE/ELITE PRO
Create New QC Files

Step 1 2 Select QC / Setup / Review Deselect the check box for Show Enable Cursor () to the new QC liquids (defined on previous page), and Setup the following Quality Controls Files (refer to SQC Module):
Control Material
Normal 2
Action
Test Stored
RPT-2 NEWFIB_ SYS2 RPT-2 SYS2 RPT-2 SYS2 NEWFIB_
Unit
Sec mg/dL Sec Sec Sec Sec Sec mg/dL
Target Mean
Use Your Target Range Use Your Target Range Use Your Target Range Use Your Target Range
Target SD
Use Your SD Range
SD Range
2 2 2 2 2 2 2 2
3
Low 2
Use Your SD Range Use Your SD Range Use Your SD Range
High 2
Low Fib 2
For each test that you configure, input:

Units used for each test Target Mean Target SD SD Range
Note: Removing a test from this list will also delete all the results saved for this test. 5 6 7 Select QC Range Check icon (the control will be checked and flagged if out of range) Select Flag Patient Results icon (flags any patient results after an out-ofrange control is detected) Select Confirm Select Show Enabled (X) to narrow the quality control liquid list on the QC Review screen to those setup with configured tests and values assigned
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ACL ELITE/ELITE PRO
Create Test Profile

Step 1 2 3 4 5 6 7 Action Select Setup / Multi-test / Profiles / New Profile Select Profile ID(provide a name) Profile Code (0-99) Select the New Lot Tests in the Enable Test column and to the Test in Profile column Select Confirm Select Setup / Multi-test / Sort Multi-Tests Use to Sort new Profile from steps 1-4 Select Confirm
QC LoadList
Step 1 2 3 4 5 6 Action Select Analysis /Multi-Test Session / New Profile from above Select Add QC Add QC levels from list Select Store Loadlist icon, select a loadlist number Select Confirm Proceed to run QC
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ACL ELITE/ELITE PRO
Test/Material Backup and Upload

This allows single material and test definitions created by user, to be copied onto disks and uploaded from disk to the ACL ELITE or ELITE PRO (copied from same instrument type is recommended; for example copy can go from an ACL Elite to an ACL Elite Pro but not the reverse. If attempt to copy from ACL ELITE PRO to ACL ELITE the Error message appears: cannot save data into database if attempt to go from an ACL ELITE PRO to an ACL ELITE. Step 1 2 3 4 Action Select Utilities/ Test/Materials/ Backup Select Test or Materials Locate Materials or Test in the list Provide a file name (type in exactly as original) and select Confirm to backup to disk To upload to another like instrument, select Utilities/ Test/Materials/ Upload (Upload Materials first, then repeat process for Test) Note: If you are uploading a PT and PT based Fib test, upload PT test first to avoid an error Select Confirm, Upload will commence Tests and Materials can be located in Setup Tests/Liquids, and enabled Copied tests may need to be calibrated
5 6 7 8
Remember: All responsibility for parameter development and validation of a new or copied test (s) belongs to the user alone.
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ACL ELITE/ELITE PRO
Skill Check
1. Show your facilitator or your application specialist the setup files and the results obtained from a New Lot Setup.
Sign Off
Instructor
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ACL ELITE/ELITE PRO
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Jan.2008 - Rev. 0
ACL ELITE/ELITE PRO - Application Chart
Page 1 of 8
PT and PT-Based Fibrinogen PT-Fib P/N 0009756710, PT-Fib HS P/N 0008468210, PT-Fib HS Plus P/N 0008469810, PT- Fib Recombinant P/N 0020005000, PT-Fib RecombiPlasTin P/N 0020002900, PT-Fib RecombiPlasTin 2G P/N 0020002950 Location Preparation Notes (**) Dedicated Calibration Material Analysis Calibration PT Reagent R1+ Stirbar X X Dilute with 8 mL water (RecombiPlasTin/(2G) and HS+ dilute with enclosed diluent) Factor Diluent (*) A2 X Ready to use Cal Plasma (*) A1 X X Dilute with 1 mL water (Optional for AR - Analysis) APTT APTT Synthasil P/N 0020006800, APTT-SP P/N 0020006300, APTT SynthAFax P/N 0020007400 Material Location Analysis Calibration Preparation Notes (**) APTT Reagent R2 X Ready to use; Invert to mix (For SP Reagent shake for 15 seconds) R8 X Ready to use CaCl2 Cal Plasma (*) A1 X Dilute with 1 mL water (Optional for AR with APTT SP, others not required) Clean A(*) R6 X Ready to use APTT-Lyo Lyophilized Silica P/N 0008468710 Material Location APTT Lyo Reagent R2 R8 CaCl2 Cal Plasma (*) A1 Clean A(*) R6 Fibrinogen Clauss Fibrinogen-C P/N 0008469110 Material Location Fib - C Thrombin R5 Factor Diluent (*) A2 Clean A(*) R6 Cal Plasma (*) A1
Analysis X X X X
Calibration
Preparation Notes (**) Dilute with 9 mL water Ready to use Dilute with 1 mL water Ready to use
Analysis X X X
Calibration X X X X
Preparation Notes (**) Dilute with 2 mL water; Invert to mix Ready to use Ready to use Dilute with 1 mL water
Dedicated Calibration
(*) Material not included in kit. (**) Refer to insert sheet for complete instructions. () Refer to Material Map on analyzer for reagent postions during analysis
Jan.2008 - Rev. 0
Page 2 of 8
Antithrombin Liquid Antithrombin P/N 0020002500 Material Location Analysis AT FXa- Liquid R3 X AT Substrate R7 X Factor Diluent (*) A2 X Clean A(*) R6 X Cal Plasma (*) A1 APCR+V APCR+V P/N 0020008700 Material Location APC V APTT R2 Factor V Reagent Plasma A8 R7 APCR V CaCl2 w/APC APC V CaCl2 R8 Cal Plasma (*) A1 D-Dimer D-Dimer P/N 0020008500 Material Location DD Buffer A4 DD Latex R4 Factor Diluent (*) A2 DD Calibrator A3
Calibration X X X X X
Preparation Notes (**) Ready to use; Invert to mix Ready to use; Invert to mix Ready to use Ready to use Dilute with 1 mL water
Analysis X X X X X
Calibration
Preparation Notes (**) Ready to use, Mix thoroughly Dilute with 4 mL water Dilute with 2 mL water Ready to use Dilute with 1 mL water (Optional for AR - Analysis)
Analysis X X X
Calibration X X X X
Preparation Notes (**) Ready to use; Invert to mix Dilute with 3 mL water; Avoid foaming Ready to use Dilute with 1 mL water; Avoid foaming
Jan.2008 - Rev. 0 Factor II Factor II Deficient Plasma P/N 0008466050 Material Location Analysis FII Deficient Plasma A8 X PT-Reagent(*) R1 X Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A (*) R6 X Factor V Factor V Deficient Plasma P/N 0008466150 Material Location Analysis FV Deficient Plasma A8 X PT-Reagent(*) R1 X Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A (*) R6 X Factor VII Factor VII Deficient Plasma P/N 0008466250 Material Location Analysis FVII Deficient Plasma A8 X PT-Reagent(*) R1 X Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A (*) R6 X Factor X Factor X Deficient Plasma P/N 0008466350 Material Location Analysis FX Deficient Plasma A8 X PT-Reagent(*) R1 X Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A (*) R6 X
Page 3 of 8
Calibration X X X X X X
Preparation Notes (**) In-Session Calibration Dilute with 1 mL water Dilute with 8 mL water (RecombiPlasTin/(2G) and HS+ dilute with enclosed diluent) Ready to use Dilute with 1 mL water 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve Clean A -Ready to use: RecombiPlasTin Factors only
Jan.2008 - Rev. 0 Factor VIII VIII Deficient Plasma P/N 0008466450 Material Location Analysis FVIII Deficient Plasma A8 X APTT(*) R2 X R8 X APTT CaCl2(*) Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A(*) R6 X Factor IX Factor IX Deficient Plasma P/N 0008466550 Material Location Analysis FIX Deficient Plasma A8 X APTT(*) R2 X R8 X APTT CaCl2(*) Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A(*) R6 X Factor XI Factor XI Deficient Plasma P/N 0008466650 Material Location Analysis FXI Deficient Plasma A8 X APTT(*) R2 X R8 X APTT CaCl2(*) Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A(*) R6 X
Page 4 of 8
Calibration X X X X X X X
Preparation Notes (**) Dedicated Cal except Lyo & SynthAFax Dilute with 1 mL water Ready to use, mix per insert requirement (APTT-Lyo Dilute with 9mL water) Ready to use Ready to use Dilute with 1 mL water 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve Ready to use
Preparation Notes (**) Dedicated Cal except Lyo & SynthAFax Dilute with 1 mL water Ready to use, mix per insert requirement (APTT-Lyo Dilute with 9mL water) Ready to use Ready to use Dilute with 1 mL water 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve Ready to use
Preparation Notes (**) In-Session Calibration Dilute with 1 mL water Ready to use, mix per insert requirement (APTT-Lyo Dilute with 9mL water) Ready to use Ready to use Dilute with 1 mL water 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve Ready to use
Jan.2008 - Rev. 0 Factor XII Factor XII Deficient Plasma P/N 0020201200 Material Location Analysis FXII Deficient Plasma A8 X APTT(*) R2 X R8 X APTT CaCl2(*) Factor Diluent (*) A2 X Cal Plasma (*) A1 X Cal Low F (*) A3 X Clean A(*) R6 X Free Protein S Free Protein S P/N 0020002700 Material Location FPS C4BP Latex FPS MAb Latex Factor Diluent (*) Cal Plasma (*) Heparin Heparin P/N 20009400 Material Factor Xa reagent Chromogenic Substrate Antithrombin Buffer Working Diluent Clean A(*) Cal 0.0(*) Cal 0.8(*) R5 R7 A2 A1
Page 5 of 8
Preparation Notes (**) In-Session Calibration Dilute with 1 mL water Ready to use, mix per insert requirement (APTT-Lyo Dilute with 9mL water) Ready to use Ready to use Dilute with 1 mL water 300ul Factor Dil + 20ul Cal Plasma - Optional for low calibration curve Ready to use
Analysis X X X
Calibration X X X X
Preparation Notes (**) Reconstitute with C4BP Buffer, sit for 30 min at 15-250C Invert to mix Ready to use Dilute with 1 mL water
Location R5 R8 N/A N/A A7 R6 A6 A5
Analysis X X X X X X
Calibration X X X X X X X X
Preparation Notes (**) Dedicated Calibration Dilute with 5 mL water Dilute with 4 mL water Dilute with 3 mL water Dilute concentrated buffer 1:10 (1ml buffer + 9ml water To 24 mL of dilute buffer; add 1ml of reconstituted antithrombin reagent Dilute Clean A 1:8 (1mL of Clean A solution + 7mL of water) NPP without heparin NPP spiked with 0.8 heparin
Hepatocomplex (HCX) not available in all countries Hepatocomplex P/N 0009758710 Material Location Analysis Calibration Bovine Plasma A5 X X Thrombin R3 X X Factor Diluent(*) A2 X Cal Plasma (*) A1 X
Preparation Notes (**) Dilute with 3 mL water Dilute with 7 mL PCX/HPX diluent(*) Ready to use Dilute with 1 mL water
Jan.2008 - Rev. 0 Homocysteine Homocysteine P/N 0020007800 Material Location HCY Buffer A1 HCY Calibrator A2 HCY Conjugate A3 HCY Enzyme R2 HCY Latex A4 R1 HCY Reductant LAC Screen / LAC Confirm LAC Screen P/N 0020008000 Material Location LAC Screen R5 Cal Plasma (*) A1 LAC Confirm P/N 0020008200 Material Location LAC Confirm R6 Cal Plasma (*) A1 Plasmin Inhibitor Plasmin Inhibitor P/N 0020009200 Material Location Plasmin R6 Substrate R7 Buffer A7 Cal Plasma (*) A1 Plasminogen Plasminogen P/N 0020009000 Material Location Streptokinase R6 Substrate A6 Cal Plasma (*) A1
Page 6 of 8
Analysis X X X X X
Preparation Notes (**) Invert to mix prior to use Invert to mix prior to use Invert to mix prior to use Invert to mix prior to use Dilute with 2 mL water Invert to mix prior to use
Analysis X X Analysis X X
Calibration
Preparation Notes (**) Dilute with 2 mL water Dilute with 1 mL water (Optional for AR - Analysis) Preparation Notes (**) Dilute with 2 mL water Dilute with 1 mL water (Optional for AR - Analysis)
Calibration
Analysis X X X X
Calibration X X X X
Preparation Notes (**) Dilute with 2.5 mL Diluted Buffer Dilute with 4 mL water Dilute as needed 1:10 (1 part Buffer + 9 parts water) Dilute with 1 mL water
In-Session Calibration
Analysis X X X
Calibration X X X
Preparation Notes (**) Dilute with 2.5 mL water Dilute with 2 mL water Dilute with 1 mL water
Jan.2008 - Rev. 0 Pro-IL Complex (PCX) not available in all countries Pro-IL Complex P/N 0009758810 Material Location Analysis Bovine Plasma A5 X Thrombin R3 X Factor Diluent (*) A2 Cal Plasma (*) A1 Protein C (Chromogenic) Protein C P/N 0020009100 Material Location PC Activator R6 PC Substrate A6 PChrom Diluent (*) A7 Cal Plasma (*) A1 ProClot: APTT-SP or APTT Lyo Protein C P/N 0008468310 Material Location P-Clot Def A8 P-Clot Working Dil A3 APTT SP(*) R2 CaCl2(*) R8 Cal Plasma (*) A1 Pro-S Pro-S P/N 0020002800 Material Prot S Reagent PS Deficient Plasma Factor Diluent (*) ProS 50% Cal Cal Plasma (*)
Page 7 of 8
Calibration X X X X
Preparation Notes (**) Dilute with 3 mL water Dilute with 7 mL PCX/HPX Diluent(*) Ready to use Dilute with 1 mL water
Analysis X X X X
Calibration X X X X
Preparation Notes (**) In-Session Calibration Dilute with 2.5 mL water Dilute with 2 mL water Dilute PC Diluent (*) 1:10 with water (1 mL of PC Diluent to 9mL of water) Dilute with 1 mL water
Analysis X X X X
Preparation Notes (**) Dedicated Calibration Dilute with 1 mL water Dilute PC Diluent (*) 1:10 with water (1 mL of PC Diluent to 9mL of water) Refer to instructions for APTT Refer to instructions for APTT Dilute with 1 mL water
Location R3 A8 A2 A3 A1
Analysis X X X X X
Preparation Notes (**) Dilute with 3 mL water Dilute with 1 mL water Ready to use Cal Plasma diluted 1:1 with Protein S Deficient Plasma Dilute with 1 mL water
Jan.2008 - Rev. 0 Silica Clotting Time Screen/Confirm Silica Clotting Time P/N 0020004800 Material Location SCT Screen R2 SCT Confirm R3 SCT CaCl2 R7 Thrombin Time 2/5/8 Thrombin Time P/N 0009758515 Material Location Buffer N/A Bovine Thrombin R5
Page 8 of 8
Analysis X X X
Calibration
Preparation Notes (**) Add 50ul Confirm, gently mix Ready to use Ready to use
Analysis X
Calibration
Cal Plasma (*) Clean A(*)
A1 R6
X X
Preparation Notes (**) Dilute buffer at a 1:5 (1ml + 4ml) ratio with water Dissolve the contents of each vial with: Diluted buffer 2.0 mL to 7.5 UNIH/mL Thrombin concentration Diluted buffer 5.0 mL to 3.0 UNIH/mL Thrombin concentration Diluted buffer 8.0 mL to 1.9 UNIH/mL Thrombin concentration Dilute with 1 mL water (Optional for AR - Analysis) Ready to use
VW Factor Activity VW Factor Activity P/N 002004700 Material Location VWF:Act Latex R1 Factor Diluent (*) A2 Cal Plasma (*) A1 VW Factor Antigen VW Factor Antigen P/N 0020002300 Material Location VWF:Ag Buffer A6 VWF:Ag Latex R1 Factor Diluent (*) A2 Cal Plasma (*) A1
Analysis X X
Calibration X X X
Preparation Notes (**) Pour vial of buffer into latex bottle; avoid foaming Ready to use Dilute with 1 mL water
Analysis X X X
Calibration X X X X
Preparation Notes (**) Invert to mix Invert to mix Ready to use Dilute with 1 mL water
R. Gagnon
August 2009
Contents
1. Introduction- What is a clot signature curve.. 3 2. Parts of the clot signature curve.. 3 3. What to examine in the curve segments 4 4. What can affect the curve appearance?................................. 5 5. Curve shape characteristics and possible causes.... 6 6. Comparison of good and bad curves... 7 7. How to display a curve on the ACL ELITE / ELITE PRO..9 8. Examples of clot curves .. 11 9. Data Reduction flow chart for PT/APTT/TT ..19 9. Analytical Error and Warning Codes... 20
The Clot Signature Curve; many of you have heard of it but what do you really know about it? This document is intended to provide answers to the following questions about clot signature curves: What is a Clot Signature Curve? How is a Clot Signature Curve created? What things will impact the formation of the Clot Signature Curve? How can I use the Clot Signature Curve in my laboratory?
What is a Clot Signature Curve?

A clot signature curve is a visual representation of the coagulometric or absorbance reaction taking place in a cuvette on the analyzer. A clot signature curve can easily be displayed for all results on the ACL ELITE / ELITE PRO analyzers. The clot signature curve can be a valuable tool for investigating abnormal or questionable results. In addition, it can also be used to investigate warnings or errors during sample analysis.
Y- Axis
X- Axis
Parts of the Clot Signature Curve

Y Axis: Representation of nephelometric (light scatter) reading. As fibrin forms it increases the amount of light scattered. On the ELITE this is represented as a ratio between the sample and reference (Wash-R) times 100. X Axis: Increase in Time going from left to right Delay: Sample monitoring begins at time zero. During the Delay time the sample and reagent are initially mixed. Data acquired during this period is not used in the data reduction calculations.
Baseline: Commences the start of the data acquisition. This segment begins after the delay time; after the sample and reagent are mixed. During this segment little change in the optical reading will occur until the fibrin clot begins to form. The baseline is generally short for normal clotting reactions, and will be longer for abnormal samples. Acceleration: This segment represents the fibrin formation period. During this segment the optical change will be rapid resulting in the steep slope rise. Slow clot formation will be displayed as a curve with a shallow slope. Deceleration: Immediately follows the Acceleration segment and represents the decrease in the rate of clot formation. During this segment the available fibrinogen will have been converted to fibrin and thus the optical change and reaction slope plateaus off. Weak clots from samples with low fibrinogen may exhibit a slight decrease during this segment as the clot formed is fragile. Endpoint: The point at which the data acquisition stops. Delta: Change in absorbance between the baseline and endpoint phase
What to examine in the curve segments

The clot curve above has the characteristic Sigmoidal, or slanted S shape. The S shape results from the baseline, acceleration and deceleration segments. The areas to investigate within each of these segments include the following: 1. Baseline - Starting point reading on the Y axis - End point reading on the Y and X axis - Stability: Is the baseline segment smooth or bumpy? - Slope: Is the baseline rising rapidly? 2. Acceleration segment - Starting point reading on the Y and X axis - End point reading on the Y and X axis - Slope: Is it a steep rise or low, gradual rise? - Is the Acceleration segment line smooth or bumpy? 3. Deceleration and Plateau segment - Starting point reading on the Y and X axis - End point reading on the Y axis - Stability: Is this segment smooth or bumpy? - Slope: Is the plateau flat, rising or falling?
What can affect the Curve appearance?

The clot/reaction curve results from the interaction of the sample and reagent in conjunction with the analyzer (temperature, mixing, incubation time, etc). Anything that can affect these items could impact the clot curve. Sample quality o Improper collection o Clotted sample o Improper sample storage o Inadequate centrifugation o Over anti-coagulated (elevated hematocrit) o Under anti-coagulated (low hematocrit) o Frozen sample thawed incorrectly o Sample Age Reagents o Improper reconstitution o Expired reagents (onboard stability and / or lot expiration) o Incorrect placement on analyzer o Lack of stir bar usage when required o Reagent contamination Instrument Issues o Sample and Reagent Probe condition o Sample and Reagent Aspiration component condition o Spills / Dust in the reading area o Environmental surroundings electrical interference o Contamination o Dirty cuvettes o Damaged optical components Clinical Condition of the Patient o Factor level deficiency o Disseminated Intravascular Coagulation (DIC) o Sepsis o Excessive lipemia o Liver Disease o Anticoagulant therapy o Drug interference
Curve Characteristics (shape) and possible causes

Curve Characteristics - Flat Curve (Indicative of no clot formation) Possible Cause - Lipemia or other interfering substance masking clotting activity - Low Fibrinogen - Excessive Anticoagulant - Reagent Quality - Sample Quality - Instrument fluidic handling issue - Slow clot formation due to slow conversion of fibrinogen to fibrin (similar to a flat curve) - If extremely small Optical change and very short clot time, noisy baseline causing false result - Low Fibrinogen concentration - High Fibrinogen concentration - Unstable clot - Clot formation is still progressing
Shallow Acceleration Segment Small changes in Raw Counts from Baseline to Endpoint Large Change in Raw Counts from Baseline to endpoint. Endpoint drops towards Baseline Endpoint rises
Acceleration segment seen but no Endpoint - Clot formation did not occur within the Acquisition time Long Baseline - Prolonged/impaired clotting mechanism
Comparison of good and bad curves

800 700 600 500 400 300 200 100 Note Smooth Baseline Starting around 220 on the Y Axis 10 15 20 25 30 35 40 45 50 Note the Bumpy Baseline Starting around 300 on the Y Axis
800 700 600 500 400 300 200 100 10 15 20 This curve has an acceleration segment with a shallow slope and increasing plateau segment. This curve has an acceleration segment with a good slope
25
30
35
40
45
50
800 700 600 500 400 300 200 100 10 15
This curve has a nice stable plateau
This curve has a decreasing baseline and a plateau segment that decreases over time and ends up lower than the starting point.
20
25
30
35
40
45
50
How to Display a Curve on the ACL ELITE / ELITE PRO:

Select the desired sample from the main results (database) screen and press the Detail icon
Select the desired result for which you wish to view the clot curve and press the Detail icon
The clot curve will then be displayed
Example of a printed Clot Curve from the ELITE / ELITE PRO Analyzers
Important Summary Notes:

When you look at a clot curve always remember to observe the following: 1. The scale of the Y axis on the graph, see if it is a narrow or wide optical reading band. The system always maximizes the curve to fit the entire window. Observation of the Y axis readings is the only way to determine the delta between the baseline and endpoint. 2. The shape of the curve, it should generally have the 3 segments: baseline, acceleration, and plateau. 3. What are the initial and endpoint readings? 4. Note the vertical line which denotes the clot point.
10
Example Clot Curves for PT and APTT
This section of the document will present PT and APTT clot curves from the ELITE / ELITE PRO systems. The examples will include discussion information on the shape of the curve along with any flagging that occurred
1. Normal PT Curve
This PT curve illustrates what a normal sample for PT should look like. This curve has a classic baseline, acceleration and plateau phase. Also note the Y axis scale illustrates a good delta between the baseline and endpoint. The Clot time was 12 seconds for this sample.
11
2. Extended PT Curve
This sample illustrates a typical clot curve for a sample with an extended PT clotting time. On this sample you will note: - Long baseline phase - Standard acceleration phase - Standard deceleration/plateau phase - Acceptable delta between baseline and endpoint based upon the Y axis readings The reading for this sample is taken at 75.2 seconds.
12
3. PT Delta Error
This sample illustrates a PT clot curve with an unstable decreasing plateau phase - The reaction starts out as a normal S shaped curve, however after the maximum reading is achieved the reaction begins to decrease. - Note the Y axis delta ranges from 43 to 89 which is good - This is indicative of a clot that is not stable. This sample resulted in a Failed reading with an error 11 (curve dropping after reaching its maximum) This sample should be repeated.
13
4. PT Error due to Reagent Issue
This sample illustrates what appears to be a standard clot curve. When viewing the curve note: Y axis scale ranges from 14 to 26.6 resulting in a low delta for the curve Y axis reading is starting off very low compared to a normal PT Low reactivity resulting from reagent issue (contamination, degradation)
This sample resulted in a Failed reading, error 12 (coag error), for the PT. Sample should be repeated. If failure occurs a second time then controls should be run. If the controls are not within the specifications, new reagent should be prepared. If the controls are acceptable, then the sample should be investigated for possible low fibrinogen concentration.
14
5. Normal APTT Sample
This sample illustrates a typical clot curve for a sample with a normal APTT clotting time. On this sample you will note: - Standard baseline phase for APTT - Standard acceleration phase - Standard deceleration/plateau phase - Acceptable delta between baseline and endpoint based upon the Y axis readings The reading for this sample was 29.8 seconds.
15
6. Extended APTT Sample
This sample illustrates a clot curve for a sample with an extended APPT clotting time. On this sample you will note: - Extended baseline phase for APTT - Standard acceleration phase - Commencement of the deceleration/plateau phase - Acceptable delta between baseline and endpoint. This sample resulted in a reading of 118.2 seconds for the APTT.
16
7. APTT Error
This sample illustrates a clot curve for an APTT sample run in the standard mode. On this sample you will note: - Lack of the standard S shape to the reaction curve - Readings on the Y axis range from 45 to 50 reflecting a lack or reactivity and therefore a low delta - A rising baseline appears to be present followed by what appears to be the start of the acceleration phase. - This sample should be rerun using the extended mode The reading for this sample resulted in a Failed result from error 31 (minimum delta not met). This clot curve was obtained from a patient on heparin
17
8. Lipemic Sample APTT
This sample illustrates a APTT clot curve for an extremely lipemic sample - Note the Y Axis reading. The reading starts around 340. For a normal sample this is generally in the range around 40. - The curve does not present the classic S form. This sample resulted in a Failed reading with an error 31 (minimum delta not met)
18
Data Reduction for PT and APTT
Note: The first derivative is defined as the maximum velocity of the curve. The second derivative is defined as the maximum change in velocity (acceleration) of the curve or the fastest rate of fibrin formation.
19
Analytical Error and Warning Codes The tables below include codes and flags that may be associated with curves/ results Error code - 5 Meaning Cause Flags Results Remedial Action Error code 6 Meaning Cause Flags Results Remedial Action Error code 7 Meaning Cause Flags Results Remedial Action Coag error Second threshold not passed. R Error 7 instead of the result.
Sample clot curve is noisy and does not give a normal clot signal within the acquisition time. Repeat the test in extended acquisition time.
Optical failure
ADC saturation (signal above 9.5 V at the end of the clotting curve).
R Error 5 instead of the result.

Possible high Fibrinogen concentration. Dilute the sample 1:1 with factor Diluent and repeat the test.
Not coag First threshold not passed. R Error 6 instead of the result. Sample does not clot within the acquisition time. Repeat the test in extended acquisition time.
Error code - 8 Meaning Cause Flags Results Remedial Action Coag error
Delta time between the two thresholds is higher than the selected value.
R Error 8 instead of the result.

Possible non-phasic clotting curve. Review the clot curve. Possible sample interference with the clotting reaction.
20
Error code - 9 Meaning Cause Flags Results Remedial Action Coag error Initial slope of the reaction curve is higher than the selected value. R Error 9 instead of the result. Possible bi-phasic clotting curve. Review the clot curve. Possible sample interference with the clotting reaction.
Error code - 10 Meaning Cause Flags Results Remedial Action Coag error Final slope of the reaction curve is higher than the selected value. R Error 10 instead of the result. Unstable endpoint of the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in extended acquisition time.
Error code - 11 Meaning Cause Flags Results Remedial Action Final delta error is a check that the curve is not dropping too much after reaching its maximum reading Final delta of the reaction curve (maximum abs reading final abs. reading) is higher than the selected value. R Error 11 instead of the result. If this is a nephelometric reaction, it may be an indication of an unstable endpoint in the clotting curve. Review the clot curve. Possible sample interference with the clotting reaction. Repeat the test in extended acquisition time. If this is an absorbance test, it may be an indication of an absorbance value outside the specified limit.
21
Error code - 12 Meaning Cause Flags Results Remedial Action Coag error Maximum peak of the first derivative is below the selected limit value. R Error 12 instead of the result. First derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.
Error code 13 Meaning Cause Flags Results Remedial Action Coag error Maximum peak of the second derivative is below the selected limit value. R Error 13 instead of the result. Second derivative peak is not significant enough to indicate a real clotting reaction point. Review the clot curve. Repeat the test in extended acquisition time.
Error code - 14 Meaning Cause Offset error (delta algorithm) Offset value is greater than First part value defined in calculation setup section of test definition or below scale range low limit. R Error 14 instead of the result. Review the clot reaction curve Y axis scale to determine if value is low or high (turbid). Rerun Sample.
Flags Results Remedial Action
Error code - 30 Meaning Cause Flags Results Remedial Action Offset error (delta algorithm) Offset of the initial part of the curve is below the selected limit value. R Error 30 instead of the result. Initial reaction turbidity is relatively low. Review the clot reaction curve. Check integrity of reagents, and make sure no bubbles are present
22
Error code - 31 Meaning Cause Minimum Curve Delta not met The total delta of the reaction curve is less than the limit specified in the test setup. (Reaction curve is flat, and clot formation may not have occurred) R Error 31 instead of the result. Review the curve and rerun the sample. Sample may have an extended clotting time.
Flags Results Remedial Action
Noisy Baseline/Reaction Curve (Error 32/33) Meaning Cause Flags Results Remedial Action Reaction curve baseline readings are erratic Interference in reaction readings Q - Noisy Baseline/Reaction Curve displayed in Warning List box when clot curve is displayed Error 32/33 instead of the result Review Curve and repeat sample
23

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INSTRUMENTATION LABORATORY ACL ELITE* / ELITE PRO System

WARNINGS AND PRECAUTIONS

PN 722277BB (December 2010)

PN 722277BB (December 2010)

IL ACL ELITE/ELITE PRO

ACL ELITE / ELITE PRO Course Map3

How Course Works.6-7 Course Modules Additional Information

PN 722277BB (December 2010)

Miami Education Center

PN 722277BB (December 2010) Miami Education Center

IL ACL ELITE/ELITE PRO

ADVANCED TOPICS ELECTIVE TOPICS FA

IL ACL ELITE/ELITE PRO

PERSONAL PROGRESS SUMMARY

___________ ___________ ___________ ___________ ___________ ___________ ___________ ___________ ___________

_______ _______ _______ _______ _______ _______ _______ _______ _______

_____ _____ _____ _____ _____ _____ _____ _____ _____

PN 722277BB (November 2010) Miami Education Center

IL ACL ELITE/ELITE PRO

PN 722277BB (December 2010) Miami Education Center

IL ACL ELITE/ELITE PRO

HOW COURSE WORKS

Lets look at the makeup of this course

PN 722277BB (December 2010) Miami Education Center

IL ACL ELITE/ELITE PRO

Personal Progress Summary

Master Progress Chart

PN 722277BB (December 2010) Miami Education Center

IL ACL ELITE/ELITE PRO

PN 722277BB (December 2010) Miami Education Center

ACL ELITE/ELITE PRO

REAGENT / CALIBRATOR INSERT REVIEW

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ACL ELITE/ELITE PRO

Reagent Insert Review

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ACL ELITE/ELITE PRO

Sample of a Reagent Insert

NOTE: Linearity (14) is not applicable to the Thrombin Time Test

P/N 722277BB (December 2010) Miami Education Center

ACL ELITE/ELITE PRO

P/N 722277BB (December 2010) Miami Education Center

ACL ELITE/ELITE PRO

Obtain HemosIL reagent package inserts, from your facilitator.

Complete the Skill Check.

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ACL ELITE/ELITE PRO

P/N 722277BB (December 2010) Miami Education Center

IB INSTRUMENT BASICS OBJECTIVES

IL ACL ELITE/ELITE PRO

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IL ACL ELITE/ELITE PRO

Calibrate Review Calibration Analytical Reference

Software Upgrade SW Master SW Slave SW REM Backup Upload Upload Upgrade

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IL ACL ELITE/ELITE PRO

POWER ON AND LOG ON TO THE SYSTEM

How To Use the Touchscreen

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IL ACL ELITE/ELITE PRO

How To Use the Keyboard

How To Use the Mouse

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