Facilitator’s Guide Overview Table of Contents Modules · Facilitator’s Guide Overview Table of...

Global CELL-DYN Hematology Integration

Training Program

Modules

Global Hematology Integration Training Program | Global Service Training | 80000179-101

Facilitator’s Guide

Overview

Table of Contents

Revision History

REVISION STATUS

Document ControlNumber

Revision Date Content or Pages Revised, Added, orDeleted

????????-??? New Release

Any product information in training materials should be used in conjunction with the latest

version of the Operations Manual, Operations Manual addendum, or Product Information

Letter. If discrepancies in information exist within training materials or any other materials, the

latest version of the Operations Manual, Operations Manual addendum, or Product Information

Letter takes precedence.

All samples (printouts, graphics, displays or screens, etc.) are for information and illustration

purposes only and shall not be used for clinical or maintenance evaluations. Data shown in

sample printouts and screens do not reflect actual patient names or test results.

Each person assumes full responsibility and all risks arising from use of the Information. The

Information is presented "AS IS" and may include technical inaccuracies or typographical errors.

Abbott Laboratories reserves the right to make additions, deletions, or modifications to the

Information at any time without any prior notification.

All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott

Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade

dress, or product name may be made without the prior written authorization of Abbott

Laboratories, except to identify the product or services of Abbott Laboratories. All other

trademarks, brands, product names, and trade names are the property of their respective

companies. All rights reserved. Except as permitted above, no license or right, expressed or

implied, is granted to any person under any patent, trademark, or other proprietary right of

Abbott Laboratories.

This guide was developed and produced by Global Service Training, Dallas, TX.

Copyright 2014, Abbott Laboratories, Abbott Park, Illinois.


Training Overview

The Global CELL-DYN Hematology Integration Training Program is designed to provide the knowledge and skills needed to perform effective CELL-DYN Hematology instruments integration.

Goals

Upon completion of the training program you will be able to:

1. Demonstrate proficiency with data collection and analytical systems and tools (especially EP Evaluator)

2. Generate studies/reports for customers abiding by regulatory requirements and discuss results (normal vs. abnormal) to validate instrument performance

3. Complete pre-integration and integration activities by following the CELL-DYN Hematology Integration Checklist

4. Perform troubleshooting during integration activities

5. Complete post-integration activities to transition the customer to post Go-Live support

6. Use My GSS resources to prepare for integration and remain current on instrument updates

7. Deliver training to meet customer needs and contractual entitlements

Prerequisite Activities

In preparation, you must complete the pre-training modules and activities prior to attending class. This material is mandatory. It is designed to provide a baseline level of knowledge and will immediately begin building your understanding of the integration process. This material will not be covered in class. It ensures all participants are at the same level of preparedness for classroom activities and supports maximum hands-on instrument time during the training.

Prerequisite activities that must be completed are:

1. Pre-training Modules· Service Tools (My GSS) CBT· AbbottLink CBT· Basic Statistics CBT· EP Evaluator Hematology Basics Overview CBT· CELL-DYN - Quality Management in Hematology CBT· Test of Records (TOR)CBT

2. Pre-Work Activities· Download, install and activate the EP Evaluator application· Download Fifth Edition lab Statistics Fun and Easy by David G. Rhoads


http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/Ambassadors/EP%20Evaluator/SetupEE11-0(43).zip

http://gssweb.add.abbott.com/hematology/9h_rubyhtml/9101_1.htm#1004867













http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Set%20Up%20Information/EE10%20Users%20Manual%20and%20Lab%20Statistics%20Manual%20Links.docx

http://dalweb6.add.abbott.com/gss/retrieveBiz.asp?Path=GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Set%20Up%20Information&navHistory=Expert%20Information,IACC,US%20TAS%20Organization,EP%20Evaluator,EP%20Set%20Up%20Information

Notes · Verify your laptop has Global Service & Support (GSS) website access (Intranet or Citrix access)

· Install Lexmark Printer Drivers· Add identified Websites to Laptop Favorites· Purchase USB drive and Application Specialist Bag contents

Note: A 2-day AbbottLink Application Training program is available for participants who need additional training in AbbottLink Utilization.

Materials

The Global CELL-DYN Hematology Integration Training Class will be presented by facilitators using the following materials:

· Technical Service Bulletins (TSB)· Instrument Service Advisories (ISA)· CELL-DYN Hematology Operations Manuals· Cell-DYN Hematology Service Manuals· EP Evaluator

NOTE: All example printouts, graphics, displays, screens, etc. are for information and illustration purposes only. Actual printouts, graphics, displays, screens, etc. may vary depending on software revision, hardware revision, and instrument configuration.

Abbott System Operations Manual, Assay-specific Package Inserts, Technical Service Bulletins, and Instrument Service Advisories can be accessed through the Abbott Global Service and Support Intranet site unless otherwise noted. Service Personnel should keep their laptop updated to contain current revision levels of materials.

Safety Hazards

The CELL-DYN Hematology instruments have been designed for optimum operator safety. However, this does not reduce the importance of safety awareness where hazards exist. This section describes the types and locations of potential hazards that could cause physical harm or damage to the laboratory environment or where failure to follow instructions may result in instrument failure or generation of erroneous patient results.

Warnings are inserted throughout the CELL-DYN Hematology Operations Manual to alert Specialists or alert the Application Specialist to potential hazards. You should refer to the following links for safety hazard information prior to beginning this training course.

BiohazardsBiological Hazards

1-4 Global Hematology Integration Training Program | Global Service Training | 80000179-101

http://dalweb6.add.abbott.com/gss/retrieveBiz.asp?Path=GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/Longo%20EP%20Info&navHistory=Expert%20Information,IACC,US%20TAS%20Organization,EP%20Evaluator,Longo%20EP%20Info




http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Operation%20Information%20-%20Operation%20Manual.aspx?View=16B209F6-935C-417C-86DC-32D97F1019FA&FilterField1=Language&FilterValue1=English

http://gssweb.add.abbott.com/hematology/schematics/9H_9055.PDF










http://addlcn10.add.abbott.com/FieldQuality/FQCOMM.nsf/835c3397feac7551862566c2006f4e1c/b558e59b7db9b62986256e2b006842ce?OpenDocument&Highlight=0,1003

http://addlcn10.add.abbott.com/FieldQuality/FQCOMM.nsf/835c3397feac7551862566c2006f4e1c/b558e59b7db9b62986256e2b006842ce?OpenDocument&Highlight=0,1003

http://addlcn10.northamerica.intra.abbott.com/CSCOMM/ISATSBDi.nsf?OpenDatabase&Start=1&Count=30&Expand=1

http://addlcn10.northamerica.intra.abbott.com/CSCOMM/ISATSBDi.nsf?OpenDatabase&Start=1&Count=30&Expand=2

http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Service%20Information%20-%20Service%20Manual.aspx





NotesChemical HazardsElectrical SafetyElectrostatic Discharge (ESD) HazardsHazard Signal WordsLaser SafetyMechanical HazardsPhysical HazardsSafety Icons and Hazard SymbolsStatic Hazard

How to Use This Guide

Black Text

• The black text will appear in both Facilitator Guide and Participant Guide.

Orange Text

• Any text displayed in Orange will only appear in the Facilitator Guide. It will not be visible in the Participant Guide.

Resources

• Resources in black will appear in both the Facilitator and Participant Guides. The resources are hyper links, when clicked, will take you to the location of the specified document or resource.

Additional Training Resources

• Additional Training Resources are available on Global Application SharePoint, which can be access by certified application trainers. The additional training resources are designed to support classroom training when delivering lectures and conducting class activities. Facilitators can make hard copies of materials available during class as needed.

Global Hematology Integration Training Program | Global Service Training | 80000179-101 1-5










Notes


Global CELL-DYN Hematology Integration Training Program

Module 1: Getting Started ............................................................ 1-1

Provide Overview of Integration Training ........................ 1-2Locate and Describe My GSS Resources ........................ 1-5Review Roles and Responsibilities..................................... 1-13Prepare Laptops ................................................................. 1-14Review ................................................................................. 1-15

Module 2: Pre-Integration Activities............................................ 2-1Identify Pre-Integration Activities ...................................... 2-2Prepare for Site Visit............................................................ 2-7Review ................................................................................. 2-10

Module 3: Emerald Integration Activities ................................... 3-1Prepare the Instrument ...................................................... 3-3Running the Instrument ...................................................... 3-8Troubleshooting the Instrument......................................... 3-13Correlation .......................................................................... 3-15Review ................................................................................. 3-18

Module 4: Ruby Integration Activities ......................................... 4-1Prepare the Instrument ...................................................... 4-3Perform Studies ................................................................... 4-5Setup Software.................................................................... 4-9Verify Completion............................................................... 4-13Correlation .......................................................................... 4-15Review ................................................................................. 4-18

Module 5: Sapphire Integration Activities .................................. 5-1Prepare the Instrument ...................................................... 5-2Perform Studies ................................................................... 5-4Setup Software.................................................................... 5-10Correlation .......................................................................... 5-13Review ................................................................................. 5-16


Module 6: EP Evaluator Basics ..................................................... 6-1Complete Basic EP Evaluator Operations ....................... 6-2Review EP Evaluator Basic Statistics ................................. 6-8Run Method Comparison Hematology Studies .............. 6-11Review ................................................................................. 6-14

Module 7: On-Site Training........................................................... 7-1Train Additional Operators ................................................ 7-2Demonstrate Proficiency Delivering Operator Training . 7-6Review ................................................................................. 7-9

Module 8: Post-Integration Activities .......................................... 8-1Verify Completion............................................................... 8-2Locate eQC, MSDS and Maintenance Parts List ............ 8-5Follow-Up Off-Site ............................................................... 8-7Follow-Up Off-Site ............................................................... 8-9Review ................................................................................. 8-11

Final Assessment Activities........................................................... 9-1Complete Mock Integration Activities ............................. 9-2Complete the Final Written Assessment........................... 9-4Review ................................................................................. 9-4


Module 1: Getting Started

Estimated Time: [ Hours]

Objectives: • Discuss Overview of Global CELL-DYN Hematology Integration Training Program

• Define the Purpose and Expected Outcomes of Instrument Integration

• Navigate MyGSS and Identify Tools Resources Used for CELL-DYN Hematology Integration Activities

• Review Roles and Responsibilities during CELL-DYN Hematology Integration

• Prepare Laptops for CELL-DYN Hematology Integration

Module Description

Notes

Global Hematology Integration Training Program| Global Service Training | 80000179-101 1-1


This module provides you with an overview of the purpose and expectations of the integration process, the Application Specialist role, where to locate the tools needed to complete an integration, and prepare laptops for CELL-DYN Hematology integration.


Module 1: Getting StartedNotes

Provide Overview of Integration Training • Introduce Integration Training Program

• Define the Purpose and Expected Outcomes of Integration Training

The Application Specialist is in charge of customer integration, providing on-site training and support as well as instrument correlations. Instrument knowledge of one hematology system is a prerequisite to this Cell-DYN Hematology Integration Training Program.

This Global CELL-DYN Hematology Integration Training Program provides an overview of instrument integration process, guiding participants through the steps and procedures necessary to prepare for an integration site visit. Significant time will be spent on the Precision, Calibration and Correlation Studies. A hands-on approach will be used throughout the training program and Application Specialistsare expected to actively participate in all class activities.



NotesTopics ReferencesOutline Integration Training Program

• Housekeeping & ice-breaker activity• Introduce yourself to the class

(Name, Abbott Experience)• Conduct an ice-breaker activity to

have participants introduce themselves

• Review housekeeping items such as breaks, room safety and precautions when working at the instrument

• Review class agenda• Review class agenda (Class agenda

will be available on Global Application Share Point)

• Define class expectations• This training class contains significant

hands-on activities. Participants are expected to perform procedures on instruments and complete troubleshooting activities using Service Tools

• Confirm completion of pre-training requirements by all participants; set completion expectation for individuals who have not finished required pre-learning

• Instructors please contact local area LMS administrator to request pre-training completion status report.

Briefly review Safety Hazards




Notes

Notes

Define Instrument Integration

• Outline the integration process including the purpose and expected outcomes

• List the standard integration steps as outlined in the contractual agreement

• Explain how to handle requests outside of these steps• Use country specific standard

integration documents located on Global Application Share Point

• Summarize major topics on the checklist. Avoid too much detail. Keep the discussion at a very high level, details will come later

• Introduce Integration Checklists ResourcesIntegration Checklists




Notes

Locate and Describe My GSS Resources

Ensure each learner has their laptop open and is able to navigate through the Service Tools Each student must be able to access the Service Tools or have the ability to view with another learner

• Navigate My GSS

• Locate Service Tools for CELL-DYN Hematology Integration

• Identify Different Integration Checklists

Topics ReferencesNavigate My GSS • Review the major links to important

information on My GSS. This was covered in the Service Tools (My GSS) CBT:

• Navigate to the My GSS home page: (http://adcollab.oneabbott.com/add/gss/SitePages/MyGSS.aspx)• Demonstrate navigation to each tool

as listed below; focus on the path and purpose.

• Locate and Describe Package Inserts• Demonstrate how to locate specific

package inserts: <My GSS><Product Family><Hematology><Assay Information>

• Review the importance of checking if insert is worldwide (WW) or US only


http://adcollab.oneabbott.com/add/gss/SitePages/MyGSS.aspx


http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Assay%20Information%20-%20Additional%20Insert.aspx

http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Assay%20Information%20-%20Assay%20Insert.aspx

http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Assay%20Information.aspx



Notes • Locate and Describe the Pulse Library• Demonstrate how to locate the Pulse

Library: <My GSS><Tools & Links><Product Information><Virtual Product Manager - Reagent>

• Locate and Describe Troubleshooting Guides• Demonstrate how to locate iSystem

and cSyetem troubleshooting guides: <My GSS><Product Family><Hematology><Service Information><Troubleshooting>

• Locate the Instrument Order Status Database• TOR Group: Celeste Ellis / Sharla Rich• Navigator?• Shared Drive?

• Locate the Instrument Placement Database• TOR Group: Celeste Ellis / Sharla Rich• Navigator?• Shared Drive?

• Locate the Customer Information Database• http://addcid.abbott.com

• Locate and Describe the Hematology Tech Tools• Shared Drive?

• Locate and Describe the FS Business Database• Shared Drive?



http://addonline.web.abbott.com/pulse_redirect.cfm


http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Assay%20Information%20-%20Troubleshooting%20Guide.aspx



http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Service%20Information%20-%20Troubleshooting.aspx



http://addcid.abbott.com

http://adcollab.oneabbott.com/add/gss/ARCHITECT/SitePages/Assay%20Information%20-%20Application%20Guide.aspx

http://adcollab.oneabbott.com/add/gss/ARCHITECT/SitePages/cSystems%20Assay%20Information.aspx




Notes• Locate and Describe Abbottdiagnostics.com• Abbottdiagnostics.com

• MSDS Sheets• QC Ranges

• Locate and Describe the Hematology Assay Information

• Demonstrate how to locate the cSyetem Assay Application guide: <My GSS><Product Family><Hematology><Assay Information>

• Locate and Describe the Technical Service Bulletins• Demonstrate how to locate the

Technical Service Bulletin: <My GSS><Product Family><Hematology><QDs & TBs>

• Locate and Describe the Product Information Letters• Demonstrate how to locate the

Product Information Letters: <My GSS><Tools & Links><Product Information><Product Information Letters & Field Actions>

• Locate and Describe Expert Information• Demonstrate how to locate Expert

Information: <My GSS><Tools & Links><Intranet Information (Intranet Only)><Expert Information>

• Provide a content overview• Focus on Hematology folder




Abbottdiagnostics.com

Abbottdiagnostics.com










http://addlcn10.add.abbott.com/FieldQuality/FQCOMM.nsf/835c3397feac7551862566c2006f4e1c/4f9a0678c33c2de486257c82004e903f?OpenDocument&Highlight=0,TB1003

http://addlcn10.add.abbott.com/FieldQuality/FQCOMM.nsf/Index?OpenView&CollapseView













http://dalweb6.add.abbott.com/gss/retrievePI-FA.asp



http://dalweb6.add.abbott.com/gss/retrieveBizConfirm.asp









http://dalweb6.add.abbott.com/gss/retrieveBiz.asp?Path=GSSBiz/IACC&navHistory=Expert%20Information,IACC


Notes • Locate and Describe eQc Information• Demonstrate how to register a

customer to eQC: • Peer Review for QC Data• Paid Service• Information on the Shared Drive

• Locate and Describe Knowledge Management (outside GSS)• Demonstrate how to locate

Knowledge Management: <My GSS><Tools & Links><Service and Support Training and Guides><Knowledge Management>

• Locate and Describe the Learning Management System (LMS)/Knowledge Platform LMS (Ultrabot)• Demonstrate how to locate the

Learning Management System: <My GSS><Tools & Links><Service and Support Training and Guides><Knowledge Platform LMS (Ultrabot>

• The Learning Management System distributes course pre-work and assessment/survey and tracks completion

• Locate and Introduce Remote Diagnostic Tools• AbbottLink

• Demonstrate how to locate the AbbottLink Portal: <My GSS><Tools & Links><Tools><AbbottLink Portal Login>

• Log-IC• Demonstrate how to locate the

LogIC Portal: <My GSS><Product Family><AbbottLink><Tools><LOGIC>


https://abbottlinkuser.abbott.com/drm/home/login.jsp


http://adcollab.oneabbott.com/add/gss/km/SitePages/Home.aspx










http://abbottquiz.knowledgeplatform.com/






















http://gssweb.add.abbott.com/AbbottLink/206775-logic.asp




Notes• ASSET

• Demonstrate how to locate the ASSET Portal: <My GSS><Product Family><AbbottLink><Tools><ASSET>

• Locate and Describe e-Solutions Troubleshooting Database• Demonstrate how to locate the

eSolutions Troubleshooting Database: <My GSS><Tools & Links><Prfoduct Information><eSolutuions - Troubleshooting Database>

• Used by all Abbott Service and Support personnel; utilized as a troubleshooting aid to assist with error code or observed problems

• Locate and Describe ISA/TSB Database • ISA/TSB Database - Discuss

differences: <My GSS><Tools & Links><Prfoduct Information><ISA & TSB Database>• Instrument Service Advisory (ISA)

(Common/All Product) - Used to communicate information to Abbott Service and Support personnel that may be used for all instruments in a product family, product group or electronic documentation

• Technical Service Bulletin (TSB) – Used to notify Abbott Service and Support personnel how to make a physical change or modification to an instrument that requires implementation by Abbott personnel


http://gssweb.add.abbott.com/wwcs/esolutions/












http://addlcn10.northamerica.intra.abbott.com/CSCOMM/ISATSBDi.nsf






http://gssweb.add.abbott.com/AbbottLink/206776-asset.asp











Notes • Locate and Describe Abbott Customer Pages• Abbott Diagnostics (International):

• https://international.abbottdiagnostics.com/home.cfm

• Review Registration Process• Customer Portal (US):

• https://www.abbottdiagnostics.com/en-us/index.html

• (US):<My GSS><Customer Focus><Customer Experience>

• Review Registration Process

• Locate and Describe Material Safety Data Sheets (MSDS)• Demonstrate how to locate Material

Safety Data Sheets (MSDS): <My GSS><Tools & Links><Tools><Material Safety Data Sheets (MSDS>

• Locate and Describe the Technical Library• Demonstrate how to locate the

Technical Library: <https://www.abbottdiagnostics.com/en-us/index.html><Scroll to the bottom of the page><Support><Technical Library>


https://international.abbottdiagnostics.com/home.cfm



https://www.abbottdiagnostics.com/en-us/index.html




http://portal.oneabbott.com/add/addhome/Organization/Customer%20Experience/Pages/Home.aspx




http://abbott.complyplus.com/default.asp






https://www.abbottdiagnostics.com/registration/login

https://www.abbottdiagnostics.com/registration/login









Notes• Locate and Describe the Online Operators Manual• Demonstrate how to locate the

Online Operations Manual: <My GSS><Product Family><Hematology><Operations Information>• Point out location of Installation

Procedures; highlight importance of performing Installation Procedures

• The Application Specialist is required to review the Installation paperwork to verify the PVT (Performance Verification Testing) and precisions were completed and passed.

Review Service and Support Manual

Review each section of the Service and Support Manual in order

• Demonstrate how to locate the Online Operations Manual: <My GSS><Product Family><ARCHITECT><Hematology><Service Information>• Point out location of Block Diagrams,

Card Cage Board References, FRU, Procedure Locator, PM Checklist, Pre-Site and Installation information

ResourcesMy GSS http://adcollab.oneabbott.com/add/gss/SitePages/MyGSS.aspx


http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Operation%20Information.aspx

http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Operation%20Information%20-%20Operation%20Manual.aspx

http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Operation%20Information%20-%20Operation%20Manual.aspx


http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Operation%20Information.aspx





Notes

Notes

Identify the Integration Checklists

• Locate and Describe the Integration Checklists on My GSS

• Demonstrate how to locate the Integration Checklists on My GSS:

• Differentiate the checklists• Emerald

• Designed for an Emerald instrument

• iSystem• Designed for a Ruby instrument

• Sapphire• Designed for a Sapphire

instrument

ResourcesIntegration Checklists


http://adcollab.oneabbott.com/add/gss/Architect/SitePages/Integration%20Tools.aspx


Notes

Review Roles and Responsibilities• Examine the Roles and Responsibilities of the Integration

Team

Notes


Topics ReferencesReview Roles and Responsibilities

• Provide an overview of the functions of Application Specialists and how they fit into the integration process from both the client and Abbott’s perspective

• Identify country specific Application Specialist contacts

Focus on the role of Application Specialists and how they fit into the implementation process



Notes

Prepare Laptops

• Review Pre-work Related to Laptop Preparation

Participants should have completed pre-work activities including installing software, downloading files and bookmarking recommended websites on their laptops. This should be a brief run through of those items. Provide individual assistance and direction as needed.

Notes


Topics ReferencesReview Laptop Preparation Pre-work

• Verify that EP Evaluator has been downloaded, installed and authorized on all participants’ laptops

ResourcesEP Evaluator.exe

Activity - Pre-work/Laptop Preparation (15 minutes)

Purpose: To validate printer drivers have been installed correctly on learners’ laptops

Action: Participants will locate the latest copy of the Integration Technical Bulletin and then print.

Discussion: Review tips for setting up printer drivers in the field or at customer locations






http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/Longo%20EP%20Info/Quickest%20for%20EP%20Evaluator.xls



http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Evaluator%20International/Longo%20Program%2006-30-2013.xls


Notes

Use this time to answer questions from learners as needed

Review1. What is the main difference between Quality

Bulletins/Technical Bulletins and Product Information Letters?

QB/TBs are normally for Abbott internal use only and Product Information Letters are approved for customer distribution.

2. What is the purpose of the Integration Technical Bulletin?

The Integration Technical Bulletin covers all changes to assay files that have not been updated on the latest version of the assay CD.

3. Where does the following disclaimer appears when you go into a section of My GSS?

"You are entering a section of the GSS Website that includes business information not under review or document control. This information is intended for Abbott personnel for informational use only and is not for customer distribution. It does not provide instruction that can be used to operate, service or support Abbott Instruments. For information to operate, service or support Abbott instruments, refer to the approved operation or service information on the product family pages of the GSS Website. By continuing past this page, you agree to abide by these terms. Do you want to continue?"

a. Product Inserts

b. Expert Information Correct Answer is B

c. MSDS Sheets

d. E-solutions




Notes 4. What is right the sequence you’d follow to locate the CELL-DYN Hematology Online operators Manual on My GSS?

Product Family-Hematology - Operation Information - Operators Manual


Module 2: Pre-Integration Activities

Notes

This module provides you with an overview of the purpose and expectations of the pre-integration activities, verifying account information, creating the integration plan and preparing the information, along with reviewing tools necessary for completing an Cell-DYN Hematology integration.

The Integration Checklist will be used to guide through this training program. The training program will follow the sequence of pre-integration activities, integration activities, and post-integration activities. Distribute appropriate Integration Checklist to participants and check off items as they complete items on the list.



Objectives: • Obtain Instrument and Account Information

• Access the Customer Information Database

• Verify Instrument Installation Date

• Call the Primary Operator at the Account

• Send Cal and QC

• Open Integration Ticket

• Print Documents to take On-Site

Module Description



Notes

Identify Pre-Integration Activities

• Demonstrate how to obtain instrument and account information

• Demonstrate How Locate Customer Information

• Verify Instrument Installation Date and Completion

• List What Should be Discussed During the Pre-Visit Customer Call

• Send Cal and OQC

• Open an Integration Ticket


Topics ReferencesDemonstrate how to obtain instrument and account information

• Aces the Integration Scheduler and the Instrument Placement Database in Lotus Notes to obtain instrument and account information• These instructions will be country

specific; contact your area leads for additional information

Demonstrate How Locate Customer Information

• Access the Customer Information Database to Locate Instrument and Account Information: http://cid.abbott.com• These instructions will be country



http://cid.abbott.com

http://cid.abbott.com


NotesVerify Instrument Installation Date and Completion

• Verify the Instrument Installation Date and Installation Completion Date with Field Services• These instructions will be country

specific; contact your area leads for additional Information

List What Should be Discussed During the Pre-Visit Customer Call

• What are the dates for the Integration?• What is the Time Frame On-site

• Will they be running Retics?• Have the reagents been ordered for

Retics?• Do you have the QC numbers?

• What is the current Instrument?• What will the new instrument be

correlated against?• Is the maintenance on the current

instrument Up to date?

• When will Calibration training be done?• Remind that you will run precisions

first• Initial instrument calibration will be

performed by the primary operator during integration

• You will walk them through the calibration of the instrument from beginning to end

• Plan for 4 hours

• Will you be running Linearity?• Not part of the Integration specialist's

expectations• Have you ordered the Linearity Kit

• Will use commercial kits for everything except Retics



Notes • How much blood will be needed?• Identify what studies will be run -

Recommendation that customer consult regulatory agencies to verify all requirements met

• Identify the number of samples needed

• What is the plan for training?• Primary operator trained in Dallas

during the on-site installation• How many techs are to be trained

(up to 4)• When are sessions?• How long are sessions?

• Has your empty Install Binder arrived• Place it some where it can be found

during integration

• Discuss How to Negotiate with Customer on:• Training time with key operator• Amount of training, training times,

and possible logistics arrangement• Guide discussion on assignment

process from a high level and explain how different functional groups work together to complete integration tasks.

Send Cal and QC • Verify the Calibration and Quality Control Materials Have Been Sent.• These instructions will be country




NotesOpen an Integration Ticket

• Open an Integration Ticket• Verify that the installation ticket has

been closed first

Activity - Integration Timeline(15 minutes)

Purpose: To identify the interdependencies and impact of changes to the integration time line. Explain what happens when changes to deadlines occur or milestones/requirements are not met, or requirements are not met. They will specify who will be impacted, how and what steps need to be taken to minimize that impact.

Action: As a group, discuss interdependencies of integration activities, identify what processes and team members will be impacted by changes and delays to timelines, and what the ultimate impact of delays will have on the Test of Record.

Facilitators will review the Integration Activities Time line with class, highlighting importance of timely delivery of each step.

DiscussionDiscuss different scenarios that might be encountered:

Guide class discussion and challenge learners to think about how to handle challenging What if... situations:

Instrument not installed or breaks down?Primary operator resigns? Reagents do not arrive? Catastrophic event occurs?

Additional Training ResourcesIntegration Activities Time lines



Notes Notes



Notes

Prepare for Site Visit

• Print Necessary Documentation

• Prepare the Application Specialist Tool Kit

• Make Travel Arrangements


Topics ReferencesPrepare the Application Specialist Tool Kit

• List and Describe What Should be printed to take on-site• Integration Checklist

• MyGSS?• Training Checklists

• Demonstrate how to locate Training Checklists: <MyGSS><Product Family><Hematology><Training Tools><Checklist>

• Pre-Calibration Checklist:• Demonstrate how to locate the

Pre-Calibration Checklist: <MyGSS><Product Family><Hematology><Operation Information><Operation Manual>

• CID page with Abbott Contacts• Demonstrate how to use the CID

Page: http://addcid.abbott.com/


http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Training%20Tools%20-%20Checklist.aspx

http://adcollab.oneabbott.com/add/gss/Hematology/SitePages/Operation%20Information.aspx


Notes • Extraction Procedure• Demonstrate how to locate the

Extraction Procedures: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/Forms/Field%20Service.aspx

• <ADD Home><Our Organization><Service><US Service><Libraries><All Documents><Field Support><Document Type: EP Evaluator><EP Evaluator CELL-DYN Extract Procedures>

Go through the list of documents, explaining functions of each item and when to use.

ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx

Prepare the Application Specialist Tool Kit

• List and Describe What Should be Included in the Application Specialist’s Tool Kit• Floppy Disks (Older Instruments)• USB Thumb Drive• CDs• Laptop• External Keypad• External Floppy Drive (Older

Instruments)


http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx

http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/Forms/Field%20Service.aspx




Notes

Notes

• 10ft Printer Cable• Go through Application Specialist

tool kit with participants, explaining functions of each item and when to use.

• Older instruments ONLY have a floppy drive

ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx

Make Travel Arrangements

• Define the Process for Making Travel Arrangements• This will be country specific. Contact

your area lead for additional information

• Focus on the basics• Where to make arrangements• Who to contact/where to go for

help

ResourcesCorporate Travel


http://travel.web.abbott.com/

http://travel.web.abbott.com/




Notes


Review1.

a.

b.

c.

d.

Correct answers is

2.

a.

b.

c.

Correct answer is

3. What are some options you can use to gather contact information for a customer you are going to integrate?

CID page with Abbott Contacts: http://addcid.abbott.com/

Instrument Order Status Database: TOR Group: Celeste Ellis / Sharla Rich

Instrument Placement Database: TOR Group: Celeste Ellis / Sharla Rich




Notes4. Which of these activities are part of the Pre-Integration Activities? (Choose all that apply)

a. Verify the installation date

b. Determine how many secondary operators will need to be trained

c. Discussion about who completes studies that cannot be finished during the integration process

d. Determine if the initial order is correct and has been placed

Correct answers are a, b, c, and d

5. Who is responsible for making travel arrangements?

Each individual is responsible for making their own travel arrangements.



Notes


Module 3: Emerald Integration Activities

Notes



Objectives: • Perform Advanced Set-Up Configuration

• Perform Other Settings Configuration

• Perform Quality Control File Set-Up

• Check Bar Code Reader Demographic Field Choice (NAME, PID and SID)

• Perform START UP

• Run a patient sample to check for Temperature or Clog errors

• Perform Carryover

• Perform Precision

• Perform Auto Calibration Procedure

• Run Commercial Controls

• Print Setup Configuration

• Shut Down

• Troubleshooting

• Correlation



Notes

This module will discuss and demonstrate the Emerald integration process which includes system configuration and instrument correlation at the customer site. It will review preparing the instrument, identifying studies and their purpose, and how to correlate instruments. In addition, it will cover common integration challenges/issues troubleshooting.

The focus of this module is to review integration and system configuration procedures. Hands on activities are to prepare participants to reinforce knowledge and be ready for instrument integration activities.

Module Description



Notes

Prepare the Instrument

• Perform Setup Menu Configuration

• Perform Advanced Setup Configuration

• Perform Other Settings Configuration

• Perform Quality Control File Setup

• Check Bar Code Reader Demographic Field Choice (NAME, PID and SID)


Topics ReferencesPerform Setup Menu Configuration

• Point Out Best Practices for Setting Up the Menu Configuration• Date and Time• Language• Printer• Paper Size• Auto SID• Printer 3 Update• Remind Application Specialists they

work with the site lead when setting up the menu configuration

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 2, Installation procedures an Special Requirements





Notes Perform Advanced Setup Configuration

• Point Out Best Practices for the Advanced Setup Configuration• Printer• Communication• Reporting options

• Options• Units• Barcode Reader• Bold Display

• Lab Preferences• Type• Limits• Thresholds (Factory Use Only)• Alarms (Factory Use Only)• Specimen Cal Adjustments• Rename Specimens• Storage• FIFO Mode• Real Time Runs Save

• Remind Application Specialists they work with the site lead when completing the Advanced Setup Configuration





NotesPerform Other Settings Configuration

• Point Out Best Practices for Configuring Other Settings• Shut Down• Probe Up• Set Auto clean• Wake Up• Pressure Checking• Lab Tech Password• Date Format

• DD/MM/YY• MM/DD/YY• YY/MM/DD• YY/DD/MM

• QWERTY• Remind Application Specialists they

work with the site lead when configuring other settings





Notes Perform Quality Control File Setup

• Point Out Best Practices for Setting Up the Quality Control File• Lot Number• Expiration• Level of Control• WBC

• Assays (Target Values)• Limits

• Remind Application Specialists they work with the site lead when setting up the Quality Control File

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 11, Quality Control

Check Bar Code Reader Demographic Field Choice (NAME, PID and SID)

• Point Out Best Practices for Configuring Other Settings

• Scan S/N Barcode on label on the rear of the instrument

• Verify PID, Name or SID• Remind Application Specialists they

work with the site lead when configuring other settings






Notes

Notes

Activity - Instrument Setup( Minutes)

Purpose: To be proficient in completing Configuration Activities

Action: Participants will follow the steps as listed in the Integration Checklist to perform Instrument Configuration

Discussion: Discuss

Participants should be able to perform this activity without guidance. Walk around classroom and provide guidance as needed

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 2, Installation procedures an Special RequirementsCELL-DYN Emerald Operator'sManual, Section 11, Quality Control





Notes

Running the Instrument

• Perform START UP

• Run a patient sample to check for Temperature or Clog errors

• Perform Carryover


• Perform Auto Calibration Procedure

• Run Commercial Controls

• Print Setup Configuration

• Shut Down


Topics ReferencesPerform START UP • Point Out Best Practices for performing

START UP• Print Start Up Background Count• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 4, SystemSpecifications





NotesRun a patient sample to check for Temperature or Clog errors

• Point Out Best Practices for performing START UP• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 10, TroubleshootingSpecifications

Perform Carryover

• Point Out Best Practices for performing Carryover• For an alternate method to perform

a Carryover, refer to CELL-DYN Emerald Operator's Manual, Section 4, System Specifications

• Document "Passed" in Verification on Install Ticket

• Print and retain a copy of the carryover results

• Sign, date, and label as "Carryover test"

• Remind Application Specialists...







Notes Perform Precision • Point Out Best Practices for performing Precision• Document "Passed" in Verification on

Install Ticket• Print and retain a copy of the

replicate file• Sign, date, and label as "Precision"• Remind Application Specialists...


Perform Auto Calibration Procedure

• Point Out Best Practices for performing Auto Calibration Procedures• Print and retain a copy of the

completed Calibration screen• Sign, date, and label as "Calibration"• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 6, Calibration, Calibration Procedure





NotesRun Commercial Controls

• Point Out Best Practices for Running Commercial Controls• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 11, Quality Control, Quality Control Guide

Print Setup Configuration

• Point Out Best Practices for Setting up the Print Configuration• Remind Application Specialists...


Shut Down • Point Out Best Practices for performing Shut Down• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 5, Operating Instructions






Notes

Notes

Activity - Run the Instrument( minutes)

Purpose: To run the instrument from start up to shut down

Action

• Participants will use the Emerald Integration checklist to run the instrument from start up to shut down

Discussion: Review key steps in running the instrument

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 4, System Specifications




Notes

Troubleshooting the Instrument

• Troubleshoot Errors on the Instrument


Topics ReferencesTroubleshoot Errors on the Instrument

• Point Out Best Practices for Troubleshooting• Temperature Error (INS_T)• Clog Error (W_CL and/or R_CL or ----

in results field)• Background Failure• Imprecision• Control Assay Values not in Range• Remind Application Specialists...

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 9, Service and MaintenanceCELL-DYN Emerald Operator'sManual, Section 9, Service and Maintenance





Notes

Notes

Activity - Troubleshooting the Instrument( minutes)

Purpose: To troubleshoot the instrument

Action

• Participants will use the Emerald Operator’s Manual to troubleshoot error manufactured by the facilitator

Discussion: Review key steps in troubleshooting the instrument

Potential Errors:Clog Error (W_CL and/or R_CL or ---- in results field)Background FailureImprecisionControl Assay Values not in Range

Resources9159968J CELL-DYN Emerald System Installation_Integration Instructions.pdfCELL-DYN Emerald Operator'sManual, Section 4, System Specifications




Notes

Correlation

• Identify Instruments to Correlate

• Identify Data to Correlate

• Perform Studies on the Instrument

• Extract Data


Topics References

Identify Instruments to Correlate

• Point Out Best Practices for idetifying the instruments to be correlated•

Resources9157105C CELL-DYN Emerald Integration Checklist.pdfCELL-DYN Emerald System Operator'sManual, Section 2, Installation Procedures and Special Requirements

Identify Data to Correlate

• Point Out Best Practices for identifying the data to correlate• Identify what studies will be run -


Resources9157105C CELL-DYN Emerald Integration Checklist.pdfCELL-DYN Emerald System Operator'sManual, Section 2, Installation Procedures and Special Requirements







Notes Perform Studies on the Instrument

• Point Out Best Practices for performing the studies discussed earlier•

Resources9157105C CELL-DYN Emerald Integration Checklist.pdfCELL-DYN Emerald System Operator'sManual, Section 4, Performance Characteristics and SpecificationsCELL-DYN Emerald System Operator'sManual, Section 5, Operating InstructionsCELL-DYN Emerald System Operator'sManual, Section 6, Calibration ProceduresCELL-DYN Emerald System Operator'sManual, Section 11, Quality Control CELL-DYN Emerald System Operator'sManual, Section 12, CELL-DYN Immuno T-Cell (CD3/4/8) AssayCELL-DYN Emerald System Operator'sManual, Section 13, CELL-DYN ImmunoPit (CD61) Assay

Extract Data • Point Out Best Practices for Extracting Data From the Instrument•

ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxCELL-DYN Emerald System Operator's Manual, Section 5, Operating Instructions




http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Evaluator%20International/QRG%20Longo%20Result%20Log%20file%20instructions.doc









Notes

Notes

Activity - Correlation (Minutes)

Purpose: To be proficient in Completing the tasks on the instrument necessary to complete the studies in EP Evaluator.

Action: Participants will follow the steps to prepare for the Correlation studies in EP Evaluator

• Identify instruments to correlate

• Identify data to correlate

• Perform studies on the instrument

• Print Reports

• Extract Data

Discussion: Discuss

Resources9157105C CELL-DYN Emerald Integration Checklist.pdfCELL-DYN Emerald System Operator'sManual, Section 2, Installation Procedures and Special RequirementsCELL-DYN Emerald System Operator'sManual, Section 6, Calibration ProceduresExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx









Notes


Review1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer




Notes



Notes


Module 4: Ruby Integration Activities

Notes

This module will discuss and demonstrate the Ruby integration process which includes system configuration and instrument correlation at the customer site. It will review preparing the instrument, identifying studies and their purpose, and how to correlate instruments. In addition, it will cover common integration challenges/issues troubleshooting.


Estimated Time: [8.2 Hours]

Objectives: • Perform Maintenance

• Perform Background Counts

• Perform Open Mode Precision

• Perform Closed Mode Precision

• Perform Pre-Calibration

• Perform Auto Calibration

• Perform Open/Closed Mode Bias Check

• Print Auto-Calibration Summary

• Customize Software

• Retics QCID File Setup

• Backup Setup

• Verify Completion

Module Description



Notes The focus of this module is to review integration and system configuration procedures. Hands on activities are to prepare participants to reinforce knowledge and be ready for instrument integration activities.



Notes

Prepare the Instrument

• Perform Maintenance


Topics References

Perform Maintenance

• Point Out Best Practices for Performing Maintenance

Resources9157087B CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 9, Service and Maintenance





Notes

Notes

Activity - Perform Instrument Maintenance( minutes)

Purpose: To perform instrument Maintenance

Action: Participants will perform the instrument maintenance on the Ruby InstrumentDiscussion: Review key steps in performing maintenance




http://adcollab.oneabbott.com/add/gss/ARCHITECT/Product%20Family%20Documents/201837-111.pdf

http://adcollab.oneabbott.com/add/gss/ARCHITECT/Product%20Family%20Documents/201837-111.pdf




Notes

Perform Studies









Topics References

Perform Background Counts

• Point Out Best Practices for performing Background Checks• Print and retain a copy of the

Background count• Refer to Table A in Integration

Checklist for Background Specifications






Notes Perform Open Mode Precision

• Point Out Best Practices for performing Open Mode Precision• Print and retain a copy of the Open

Mode Precision check• Refer to the CELL-DYN Ruby

Operator's Manual, Section 4, for the whole blood ranges used for imprecision testing

Resources9157087B CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 4, Performance Characteristics and Specifications

Perform Closed Mode Precision

• Point Out Best Practices for performing Closed Mode Precision• Print and retain a copy of the Closed

Mode Precision check


Perform Pre-Calibration

• Point Out Best Practices for performing Pre-Calibration• Print and retain a copy and label as

"Pre-Calibration"










NotesPerform Auto Calibration

• Point Out Best Practices for performing Auto Calibration• Refer to the CELL-DYN Ruby System

Operator's Manual, Section 6: Calibration Procedures and perform an Auto Calibration in the Open Mode using calibrator

Resources9157087B CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 6, Calibration Procedures

Perform Open/Closed Mode Bias Check

• Point Out Best Practices for performing an Open/Closed Bias Check


Print Auto-Calibration Summary

• Point Out Best Practices for printing an Auto-Calibration Summary










Notes

Notes

Activity - Perform Studies( Minutes)

Purpose: To be proficient in running the calibration and Precision Studies

Action: Participants will follow the steps as listed in the Integration Checklist to perform the following studies:








Discussion: Discuss







Notes

Setup Software

• Customize Software

• QCID File Setup for each level (Low, Normal and High) of commercial control

• Setup Retics QCID File


Topics References

Customize Software • Point Out Best Practices for customize the Ruby software• Customize Run View:

• Chartable Page (Parameter Sets)• Units Selection• Data Log View• QC View• Customize Printed Report

• Header• Patient Sample Setup

• Limits• Default Patient Test Selection

• Orders Setup (Automatic Orders Cleanup)

• QC Download ID File Setup



Notes • Moving Averages• Moving Average View• Moving Average Acceptance

Setup• Monitor Off/On

• User Interface Preferences (QCID Daily Cleanup)

• LIS setup (Auto and Manual transmission)

• Operators Setup• Operator Account setup• Laboratory I/ II customization

Resources9157087B CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 2, Installation Procedures and Special Requirements

QCID File Setup for each level (Low, Normal and High) of commercial control

• Point Out Best Practices for setting up the QCID File• Refer to the CELL-DYN Ruby System

Operator's Manual for instructions on the automated upload of assay values from a QC Disk








NotesSetup Retics QCID File

• Point Out Best Practices for setting up the Retics QCID File• Refer to the CELL-DYN Ruby System

Operator's Manual for instructions on running the Reticulocyte Assay.


Setup backup • Point Out Best Practices for setting up the Backup• Refer to the CELL-DYN Ruby System

Operator's Manual, Section 6: Calibration Procedures, Subsection: Post-Calibration Procedure.








Notes

Notes

Activity - Software customization( Minutes)

Purpose: To be proficient in customizing the Ruby software

Action: Participants will follow the steps as listed in the Integration Checklist to:

• Customize the Ruby software

• Setup QCID File

• Setup Retics QCIS File

• Setup Backup

Discussion: Discuss


Resources9157087B CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 2, Installation Procedures and Special RequirementsCELL-DYN Ruby System Operator'sManual, Section 6, Calibration Procedures





Notes

Verify Completion

• Verify Control Levels

Module 4: Assay Verification/Validation

Topics References

Verify Control Levels • Point Out Best Practices for Verifying Control Levels

• Run each level of control daily for a minimum of five (5) to ten (10) runs each, and verify that each level's mean falls within expected assay ranges. If results are not within expected ranges, troubleshoot as necessary.Chartable Page (Parameter Sets)




Notes

Notes

Activity - Verify Control Levels ( Minutes)

Purpose: To be proficient in verifying control levels


•Discussion: Discuss




Notes

Correlation




• Extract Data


Topics References



Resources9157105C CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 2, Installation Procedures and Special Requirements




Resources9157105C CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 2, Installation Procedures and Special Requirements









Resources9157105C CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 4, Performance Characteristics and SpecificationsCELL-DYN Ruby System Operator'sManual, Section 5, Operating InstructionsCELL-DYN Ruby System Operator'sManual, Section 6, Calibration ProceduresCELL-DYN Ruby System Operator'sManual, Section 11, Quality Control CELL-DYN Ruby System Operator'sManual, Section 12, CELL-DYN Immuno T-Cell (CD3/4/8) AssayCELL-DYN Ruby System Operator'sManual, Section 13, CELL-DYN ImmunoPit (CD61) Assay


ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxCELL-DYN Ruby System Operator's Manual, Section 5, Operating Instructions













Notes

Notes







• Print Reports

• Extract Data

Discussion: Discuss

Resources9157105C CELL-DYN Ruby Integration Checklist.pdfCELL-DYN Ruby System Operator'sManual, Section 2, Installation Procedures and Special RequirementsCELL-DYN Ruby System Operator'sManual, Section 6, Calibration ProceduresExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx









Notes


Review 1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer




Notes



Notes


Module 5: Sapphire Integration Activities

Notes

This module will discuss and demonstrate the Sapphire integration process which includes system configuration and instrument correlation at the customer site. It will review preparing the instrument, identifying studies and their purpose, and how to correlate instruments. In addition, it will cover common integration challenges/issues troubleshooting.

The focus of this module is to review integration and system configuration procedures. Hands on activities are to prepare participants to reinforce knowledge and be ready for instrument integration activities.



Objectives: • Perform Maintenance



• Perform Calibration


• Perform Optical Verification, Standardization and Signature

• Perform CD61 Setup

• Perform CD3/4/8 Auto Gain Adjustment

Module Description

Global Hematology Integration Training Program | Global Service Training | 80000179-101 6-#


Notes

Prepare the Instrument• Perform Maintenance


Topics References

Perform Maintenance

• Point Out Best Practices for Performing Maintenance

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 9, Service and Maintenance





Notes

Notes

Activity - Perform Instrument Maintenance( minutes)

Purpose: To perform instrument Maintenance

Action: Participants will perform the instrument maintenance on the Sapphire InstrumentDiscussion: Review key steps in performing maintenance

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 9, Service and Maintenance





Notes

Perform Studies






Topics References

Perform Background Counts

• Point Out Best Practices for performing Background Checks• Print and retain a copy of the

Background count• Refer to Table Background Count

Specifications in the Integration Checklist for Background Specifications

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 5, Operating Instructions





NotesPerform Precision • Point Out Best Practices for performing Precision• Print and retain a copy of the

completed Precision • Sign, date and label as "Precision"• Refer to the CELL-DYN Sapphire

Operator's Manual, Section 4, for the whole blood ranges used for imprecision testing

• Refer to Table CV Specifications in the Integration Checklist for Background Specifications

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 4, Performance Characteristics and Specifications

Perform Calibration • Point Out Best Practices for performing Calibration• Print and retain a copy of the

completed Calibration• Sign, date and label as "Calibration"

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 6, Calibration Procedures







Notes Perform OpticalVerification,Standardizationand Signature

• Point Out Best Practices for performing Auto Calibration• Optical WBC SRP

• Print and retain a copy of the completed Optical WBC SRP

• Sign, date, and label as "Optical WBC SRP"

• WBC Moving Average• Refer to VP-54, WBC/ Optical

Platelet/Reticulocyte Whole Blood Standardization Procedure for complete instructions. (Sample age: minimum 30 minutes to a maximum of four hours post draw.)

• Print and retain a copy of the completed WBC Moving Average

• Sign, date, and label as "WBC Moving Average" and compare them to the specifications labeled WBC Fresh Blood Channel Specifications in the installation Checklist

• Refer to the CELL-DYN Sapphire System Operator's Manual, Section 11: Quality Control

• If the customer will be using the CELL-DYN ImmunoPLT (CD61) assay, perform the following verification. A minimum of six (6) CD61 reagent tubes will be required.

• Confirm that PLTo is calibrated properly and controls recover in range before proceeding with the setup of CD61.

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 11, Quality Control





NotesPerform CD61 Setup • Point Out Best Practices for performing the CD61 Setup• Perform VP-55 CD 3/4/8 Whole Blood

Standardization Procedure• Print and retain a copy of the

completed CD61 Setup• Sign, date, and label as "CD61 Setup"

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 13, CELL-DYN ImmunoPit (CD61) Assay





Notes Perform CD3/4/8 AutoGainAdjustment

• Point Out Best Practices for performing the CD61 Setup• Parameter Sets• Laboratory Worksheet• Patient Limit Sets• Demographics Headings• Data Log• Delta Check• Work List• Moving Average Programs• Paired Difference Program• Halt Behavior• Print Settings• Groups

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 12, CELL-DYN Immuno T-Cell (CD3/4/8) Assay





Notes

Notes

Activity - Perform Studies( Minutes)

Purpose: To be proficient in running the calibration and Precision Studies

Action: Participants will follow the steps as listed in the Integration Checklist to perform the following studies:





• Perform CD61 Setup

• Perform CD3/4/8 Auto Gain Adjustment

Discussion: Discuss

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 4, Performance Characteristics and SpecificationsCELL-DYN Sapphire System Operator'sManual, Section 5, Operating InstructionsCELL-DYN Sapphire System Operator'sManual, Section 6, Calibration ProceduresCELL-DYN Sapphire System Operator'sManual, Section 11, Quality Control CELL-DYN Sapphire System Operator'sManual, Section 12, CELL-DYN Immuno T-Cell (CD3/4/8) AssayCELL-DYN Sapphire System Operator'sManual, Section 13, CELL-DYN ImmunoPit (CD61) Assay





Notes

Setup Software

• Perform Software Configuration

• Perform System Configuration


Topics References

Perform Software Configuration

• Point Out Best Practices for performing the Software Configuration• Parameter• Laboratory Worksheet• Patient Limit Sets• Demographics Headings• Data Log• Delta Check• Work List• Moving Average Programs• Paired Difference Program• Halt Behavior• Print Settings• Groups

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 2, Installation Procedures and Special Requirements





NotesPerform System Configuration

• Point Out Best Practices for performing the System Configuration• Date/Time Format to local values• Units Format• Language Selection• Alarm Settings• Bar code type• Backup Setup Data to the Setup Disk• Refer to Operator's Manual

• Refer to the CELL-DYN Sapphire System Operator's Manual for instructions on the Backup Procedures






Notes

Notes

Activity - Software customization( Minutes)

Purpose: To be proficient in customizing the Sapphire software


• Configure the Sapphire Software

• Configure the Sapphire System

Discussion: Discuss

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 2, Installation Procedures and Special RequirementsCELL-DYN Sapphire System Operator'sManual, Section 6, Calibration Procedures





Notes

Correlation




• Extract Data


Topics References
















Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 4, Performance Characteristics and SpecificationsCELL-DYN Sapphire System Operator'sManual, Section 5, Operating InstructionsCELL-DYN Sapphire System Operator'sManual, Section 6, Calibration ProceduresCELL-DYN Sapphire System Operator'sManual, Section 11, Quality Control CELL-DYN Sapphire System Operator'sManual, Section 12, CELL-DYN Immuno T-Cell (CD3/4/8) AssayCELL-DYN Sapphire System Operator'sManual, Section 13, CELL-DYN ImmunoPit (CD61) Assay


ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxCELL-DYN Sapphire System Operator's Manual, Section 5, Operating Instructions













Notes

Notes







• Print Reports

• Extract Data

Discussion: Discuss

Resources9157105C CELL-DYN Sapphire Integration Checklist.pdfCELL-DYN Sapphire System Operator'sManual, Section 2, Installation Procedures and Special RequirementsCELL-DYN Sapphire System Operator'sManual, Section 6, Calibration ProceduresExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx









Notes


Review1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer



Module 6: EP Evaluator Basics

Notes

This module provides an overview of EP Evaluator, from install to data interpretation. You should have gained an overview of EP Evaluator from pre-training modules. The focus of this module will be putting the learning from the pre-training module into practice, running studies and interpreting the data.

This module will use data participants had from previous module and focuses on statistical analysis and data interpretation in EP Evaluator.



Objectives: • Complete Basic EP Evaluator Operations

• Review EP Evaluator Basic Statistics

• Run a Method Comparison: Hematology Study

Module Description



Notes

Complete Basic EP Evaluator Operations

• Review EP Evaluator Pre-Training Materials

• Manually Enter Data and Basic Studies in EP Evaluator

• Import EP Evaluator Data using the Direct Cable Download Data Import Method

• Import EP Evaluator Data Using Results Log Method


Topics ReferencesReview EP Evaluator Pre-training Materials

• Review the Basic Operations of EP Evaluator Introduced in the Pre-training CBT

• Clarify Learning Points in Pre-training Materials Related to Basic EP Evaluator Operations

ResourcesEP Evaluator Downloads: <My GSS><Tools& Links><Intranet Information (Intranet Only)><Expert Information><I Agree><IACC><US TAS Organization><Ambassadors><EP Evaluator><SetupEE11-0(43).zip>

Use EP Evaluator Basics CBT as a resource of reviewing software navigation, basic functions, and steps of generating EP Evaluator Studies.


http://dalweb6.add.abbott.com/gss/retrieveBiz.asp?Path=GSSBiz/IACC/US%20TAS%20Organization/Ambassadors/EP%20Evaluator&navHistory=Expert%20Information,IACC,US%20TAS%20Organization,Ambassadors,EP%20Evaluator





NotesManually Enter Data and Basic Studies( minutes)

• EP Evaluator is a Part of the Correlation Activities

• Identify, Demonstrate and Discuss the Steps Necessary to Manually Enter Data From Studies Run in the Previous Module into EP Evaluator:• Precision Studies• Calibration Studies • Method Comparison Studies• Carryover Studies

• Guided Practice: Have the participants work through the steps to enter data and run a basic study as you demonstrate

• Refer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78

ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxIACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78







Notes Import EP Evaluator Data Using the Direct Cable

• Identify, Demonstrate and Discuss the Steps Necessary to Import Instrument Data Using the Direct Cable Download Data Import Method• Guided Practice: Have the

participants work through the steps to import data using the Direct Cable Download Data Import Method


Resources Extraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docx

Refer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78


http://dalweb6.add.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Evaluator%20International/EP%20download%20QRG%2010.25.11.pdf










NotesActivity - Import EEP Data Using Direct Cable ( minutes)

Purpose: To import data using the EP Evaluator Direct Cable Download Data Import Method

Action: Participants will import data using the EP Evaluator Direct Cable Download Data Import Method

• Use data created in the previous module

• Study data selection will be country specific

Discussion: Review key steps in data importing using the Direct Cable Download Data Import Method

Refer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78

Resources Extraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxRefer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78







Notes Import EP Evaluator Data Using Results Logs

• Identify, Demonstrate and Discuss the Steps Necessary to Import Instrument Data Using:• Results Log

• Identify, demonstrate and discuss the steps necessary to retrieve Result Logs• CD• USB Drive• AbbottLink


ResourcesExtraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxRefer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78







Notes

Notes

Activity - Import EP Evaluator Data Using The Results Log ( minutes)

Purpose: To import data using the Results Logs Data Import Method

Action: Participants will import data using the Results Log

• Use data created in the previous module

• Study data selection will be country specific

• Highlight data will not import correctly through the download cable if samples were not named correctly in previous activities


Discussion: Highlight key steps in data importing

Resources Extraction Procedure: http://portal.oneabbott.com/add/addhome/Organization/Service/US%20Service/All%20Documents%20Library/EP%20Evaluator%20CELL-DYN%20Extract%20Procedures.docxcRefer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual, Page 31-78


abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Evaluator%20International/Longo%20Program%2006-30-2013.xls





Notes

Review EP Evaluator Basic Statistics

• Review Basic Lab Statistical Terms and Concepts as Related to EP Evaluator

• Review Lab Basic Statistical Analysis as Related to EP Evaluator

• Discuss How to Interpret Statistical Data Using EP Evaluator

• Explain How to Communicate Statistical Data Analysis (Tools and Templates)

• Discuss Method Verification/Validation and Acceptance Normal vs. Abnormal Data


Topics ReferencesReview Basic Statistical Terms

• Review the Basic Statistics Terms and Concepts Presented in the Pre-training Material• CELL-DYN - Quality Management in

Hematology - CBT• http://gssweb.add.abbott.com/he

matology_cd/205138-101.swf

Resources

CELL-DYN - Quality Management in Hematology - CBThttp://gssweb.add.abbott.com/hematology_cd/205138-101.swf



http://gssweb.add.abbott.com/hematology_cd/205138-101.swf

http://gssweb.add.abbott.com/hematology_cd/205138-101.swf




NotesReview Basic Statistical Analysis

• Review Basic Statistical Analysis Related to EP Evaluator • Refer to the EP Evaluator

Interpretation Guide for explanations of the statistical analysis

ResourcesOperations Manual Appendix B: Verification of iSystem Assay ClaimsLab Statistics Fun and Easy Fifth Edition, Chapter 4 Statistics 101

Discuss Interpretation and Use of Statistical Data

• Explain How to Interpret Statistical Data Using EP Evaluator• Refer to the EP Evaluator

Interpretation Guide for explanations of the statistical analysis

ResourcesOperations Manual Appendix B: Verification of iSystem Assay Claims

Explain Communication of Statistical Analysis

• Demonstrate and Explain How to Communicate Statistical Data Analysis

• Identify Available Tools and Templates to be Used to Present the Analysis to the Customer

• Refer to the EP Evaluator Interpretation Guidelines for explanations of the statistical analysis

• Review the tools available through the EP Evaluator software Tools menu option

• Identify Web casts available though Data Innovations website: http://www.datainnovations.com/services/training/ep-evaluator-training-programs


bbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Set%20Up%20Information/EE10%20Users%20Manual%20and%20Lab%20Statistics%20Manual%20Links.docx


















http://www.datainnovations.com/services/training/ep-evaluator-training-programs


Notes

Notes

ResourcesOperations Manual Appendix B: Verification of iSystem Assay ClaimsLab Statistics Fun and Easy Fifth Edition, Chapter 4 Statistics 101

Define Normal vs. Abnormal Data

• Define and Compare Normal vs. Abnormal Data• Present and discuss normal case

studies• What makes the case study

normal?• What makes the data normal?• Is the data accurate; can it be

used?• Show and discuss abnormal case

studies• What makes the case study

abnormal?• What makes the data abnormal?• Is the data accurate; can it be

used?



d.abbott.com/gss/GSSBiz/IACC/US%20TAS%20Organization/EP%20Evaluator/EP%20Set%20Up%20Information/EE10%20Users%20Manual%20and%20Lab%20Statistics%20Manual%20Links.docx







Notes

Run Method Comparison Hematology Studies

• Run Method Comparison Hematology Studies in EP Evaluator

• Print Hematology Method Comparison Report

• Ensure that correlations have been started and are acceptable to the Hematology Supervisor or Primary Operator


Topics ReferencesActivity-Method Comparison Hematology Study(45 minutes)

Purpose: To run a Method Comparison Hematology Study in EP Evaluator and interpret data

Action: Complete the EP Evaluator Supplemental Activities as directed by instructor; refer to the EP Evaluator Supplemental Activities on page 79 to 110 in the IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual



Notes • Instructors will print and hand out these studies to the class prior to discussion so learners do not see the answer key provided in the EP Evaluator Training Guide

Discussion: Discuss how to interpret and communicate results to the customer as well as how to troubleshoot abnormal data

• Refer to IACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual Pages 79-110; Appendix

ResourcesIACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual Pages 79-110; Appendix

Print Hematology Method Comparison Report ( minutes)

Demonstrate how to Print Hematology Method Comparison Report

ResourcesIACC EP Evaluator Training Hematology Evaluating Clinical Laboratory Methods Manual

Activity-Print Hematology Method Comparison Report ( minutes)

Purpose: Demonstrate how to Print Hematology Method Comparison Report

Action:

Discussion: Discuss









Notes

Notes

Ensure that correlations have been started and are acceptable to the Hematology Supervisor or Primary Operator Method Comparison Report ( minutes)

Demonstrate how to ensure that correlations have been started and are acceptable to the Hematology Supervisor or Primary Operator





Notes


Review1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer



Module 7: On-Site Training

Notes

This module focuses on activities following the completion of the integration. These activities will provide closure for the customer and prepare them to move on to the GoLive and Test of Record.



Objectives: • Train Additional Operators

• Demonstrate Proficiency Delivering Operator Training

Module Description



Notes8

Train Additional Operators• Review the Training Checklists• Discuss Training Logistics• Perform Secondary Operator Training


Topics References

Review the Training Checklists

• Identify and distinguish the Training Checklists• Identify the different checklists• Discuss the training items to be

covered for operators

• On-Site Training is a part of the activities on the Integration Checklist; participants will check off each activity on the Integration Checklist as it is discussed

• Consult with lab management to understand needs, arrange training schedule, identify any special lab considerations to be addressed

• Use Training Checklist to guide through items in this section

ResourcesInstrument Training ChecklistsInstrument Training Checklists


http://adcollab.oneabbott.com/add/gss/ARCHITECT/SitePages/Training%20Tools%20-%20Checklist.aspx



NotesDiscuss Training Logistics

• Examine Basic Operations Training• Discuss the basic session duration• Discuss how to determine the

number of sessions• Discuss how to identify the number of

operators to be trained• Operators will need dedicated time

for training• Discuss how to determine if

additional training may be required to complete all items on the checklist• The primary operator will

complete any additional training of secondary operators

• Identify what should be covered in Basic Operations Training• Basic Operation• Calibration and QC Runs• Daily and Weekly Maintenance

• All of these details will be country specific

ResourcesInstrument Training Checklists ARCHITECT c16000 Training Checklist, Basic Training Checklist (c8000 Global),Basic Training Checklist (i1000SR Global), Basic Training Checklist (i2000SR-Global), Training Checklist (c4000) Basic Checklist Trainer’s Notes.doc

Additional Training ResourcesStandard Integration.doc (US)




http://adcollab.oneabbott.com/add/gss/ARCHITECT/Product Family Documents/204127-104.pdf






Notes Perform Secondary Operator Training

• Demonstrate and explain how to complete an integration ticket• It is VERY important to make sure that

the installation ticket has been closed BEFORE closing the integration ticket

• Demonstrate and explain the process of opening/closing a Test of Record (TOR) ticket• Stress the impact and importance of

timely, accurate documentation • Highlight Ticket Codes

• These processes will be country specific

Resources TOR Phase II Training Final (Full).pptxTOR Guide for Navigator.pdf

Additional Training ResourcesTOR Ticket Business Rules.docxTOR Slide.pptx

Review Follow-up Training Documentation

• Discuss the process of providing training documentation upon the completion of training • This will be country specific. Trainer

will share your country/area process• (US Only) PACE Certificate is an

example from US area

Additional Training ResourcesInteractive PACE Certificate.pdf (US)


http://dalweb6.add.abbott.com/gss/TOR-Best-Practices/TOR%20Education%20and%20Guides/TOR%20Phase%20II%20training%20Final%20(Full).pdf

http://dalweb6.add.abbott.com/gss/TOR-Best-Practices/TOR%20Education%20and%20Guides/TOR%20Guide%20for%20Navigator.pdf





Notes

Notes

• Validate that any open issues have been communicated to the appropriate Abbott personnel

• Review the folder of integration data given to customers, including EP Evaluator Studies report, etc.

• Share general Integration report writing template with class; country specific information will be adjusted in the report as needed; highlight good practice as Application Specialists when wrapping up integration activities

Additional Training ResourcesDHM Commissioning Summary report.pdf NCI Evaluation Report.pdf



Notes

Demonstrate Proficiency Delivering Operator Training

• Demonstrate and Discuss How to Train Operators on:

• System Overview

• Inventory Management

• Daily and Weekly Maintenance

• Running Calibration

• Running QC

• Running Patients

• Perform Basic Troubleshooting

• Contact Customer Support

• Complete the Training Checklist


Topics ReferencesActivity - Deliver Operator Training(180 Minutes)

Purpose: To deliver operator training on instrument operations

Action: Facilitator will group participants into teams for the role playing activity. Have them alternate playing the role of trainer, operator and/or observer. They should focus their training on the identified areas of Training proficiency:

• System Overview

• Inventory Management

• Discuss Daily and Weekly Maintenance

• Running Calibration



Notes• Running Patients

• Basic Troubleshooting Techniques

• Contacting Customer Support

• Completing the Training Checklist

• How to Negotiate with Customer:• For training time with key operator• On amount of training and training

times possible/logistics

Discussion: Discuss training tips and how to handle challenging training scenarios

Highlight general facilitation skills with class.

The facilitator can add levels of difficulty to this activity such as operators not engaged, operators not receptive to training, and others as relevant.

These challenges are basic train the trainer issues; use this role play activity to reinforce tips/knowledge of conducting training. Participants should have completed basic presentation/training skills class before taking integration class.

ResourcesTraining Checklists ARCHITECT c16000 Training Checklist, Basic Training Checklist (c8000 Global),Basic Training Checklist (i1000SR Global), Basic Training Checklist (i2000SR-Global), Training Checklist (c4000)










Notes

Notes

Additional Training Resourcesci41k Daily Start Up Checklist.docStandard Integration.doc (US)



Notes


Review1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer




Notes


Module 8: Post-Integration Activities

Notes

This module focuses on activities following the completion of the integration. These activities will provide closure for the customer and prepare them to move on to the GoLive and Test of Record.


Estimated Time: [1.5 Hours]

Objectives: • Verify Completion

• Locate eQC, MSDS, maintenance parts list and share with customer

• Follow-up On-Site

• Follow-up Off-Site

Module Description



Notes8

Verify Completion• Ensure correlations have begun and results are

acceptable.• Assure performance of instrument meets customer's

expectations after the installation is complete.• Refer to Local Area Service and Support Organization

procedures to discuss follow-up schedule with customer as needed


Topics ReferencesIdentify Post-Integration Activities

• Identify and discuss the Post-Integration Activities from ARCHITECT Integration Checklist

• Post-Integration Activities are a part of the Integration Checklist; participants will check off each activity on the Integration Checklist as it is discussed

Ask participants to check off post-integration activities from Integration Checklist as class goes.

ResourcesIntegration Checklists





NotesIllustrate the Go-Live Process

• Identify the general expectations of Go-Live support

• This will be country specific. Share with class process/contact in your country/area.

Complete Integration and TOR Tickets

• Demonstrate and explain how to complete an integration ticket• It is VERY important to make sure that

the installation ticket has been closed BEFORE closing the integration ticket

• Demonstrate and explain the process of opening/closing a Test of Record (TOR) ticket• Stress the impact and importance of

timely, accurate documentation • Highlight Ticket Codes

• These processes will be country specific

Resources TOR Phase II Training Final (Full).pptxTOR Guide for Navigator.pdf

Additional Training ResourcesTOR Ticket Business Rules.docxTOR Slide.pptx


http://dalweb6.add.abbott.com/gss/TOR-Best-Practices/TOR%20Education%20and%20Guides/TOR%20Phase%20II%20training%20Final%20(Full).pdf

http://dalweb6.add.abbott.com/gss/TOR-Best-Practices/TOR%20Education%20and%20Guides/TOR%20Guide%20for%20Navigator.pdf


Notes

Notes

Conduct Exit Interview(30 Minutes)

• Explain how to review completed studies and results with the appropriate laboratory personnel• Provide copies of completed studies

to customers• Leave documentation with the

customer

• Identify, for the customer, the Follow-up Support process• Discuss support for any studies that

were not completed during the integration process

• Validate that any open issues have been communicated to the appropriate Abbott personnel

• Review the folder of integration data given to customers, including EP Evaluator Studies report, etc.

• Share general Integration report writing template with class; country specific information will be adjusted in the report as needed; highlight good practice as Application Specialists when wrapping up integration activities

Additional Training ResourcesDHM Commissioning Summary report.pdf NCI Evaluation Report.pdf



Notes

Locate eQC, MSDS and Maintenance Parts List

• Register to eQC• Document the Installation• Review Install Binder with Customer• Sign and date all documents


Topics ReferencesDiscuss Performance Metrics for Integration

• Briefly introduce the Performance Metrics for Application Specialists• These will be country specific.

Highlight importance of performance metrics for Application Specialist.

• Review an example of a NPS Hot Sheet• Go over items included in the NPS

Hot Sheet

Additional Training ResourcesExample of an NPS Hot Sheet.doc



Notes

Notes

Summarize ARCHITECT Integration Training

• Review the Integration Checklist

• Review the Assay Verification/Validation Process

• Review EP Evaluator

• Review On-Site Training

• Review the Exit Interview Topics



Notes

Follow-Up Off-Site

• Follow-up until on-line• Get estimated TOR date/Online Date• Review Go-Live Support






Hot Sheet










Notes Notes



Notes

Follow-Up Off-Site

• Close Integration Ticket• Send email to Team• Update Instrument Placement Database•






Hot Sheet




Notes

Notes









Notes


Review1. Question

Answer

2. Question

a. ?

b. ?

c. ?

d. ?

Answer

3. Question

Answer

4. Question

Answer

5. Question

Answer




Notes


Final Assessment Activities

Notes

This module focuses on Final Assessment Activities. There are two parts of assessments: Mock Integration and Final Exam. Mock Integration activity will be completed at the instrument. Final exam will be completed on the LMS.


Estimated Time: [8 Hours]

Objectives: • Assess ARCHITECT Integration Skills via the Mock Integration Activities and Final Written Test

Module Description



Notes

Complete Mock Integration Activities• Demonstrate proficiency in all of the major areas of the

Integration Process by successfully completing the Mock Integration Activities


Topics References

Mock Integration Assessment(8 Hours)

Purpose: To demonstrate competency in performing integration tasks

Actions: Complete the Assay Verification/Validation process for the selected assays from start to finish. The Learner will present their results to the facilitator who will role play the customer.

• Activity Preparation: Before the Mock Integration activity, the facilitator will instruct participants to perform the pre-integration steps by following the Integration Checklist.

• Step 1: Participants will compose an email to the customer to arrange integration activities.

• Step 2: The facilitator will distribute the Mock Integration handout. Direct participants to perform integration activities by following Integration Checklist.

• Step 3: The facilitator will choose one CC and/or one IA assay as appropriate for available platforms.



Notes

Notes

• Step 4: The facilitator will choose country specific studies based on the experience of the group.

• Step 5: Participants will prepare EP Evaluator reports and complete exit interview with facilitator acting as the customer.

• Step 6: Facilitators will use the Assessment Matrix to evaluate the Mock Integration Activity/Hands on Assessment. Distribute the Assessment Matrix to the class ahead of Mock Integration activity. The example of assessment matrix will be available from Global Application SharePoint for download.

Additional Training Resources Mock Integration Activity.doc




Notes

Complete the Final Written Assessment• Demonstrate Competency in Performing Instrument

Integration Scoring of 80% or Higher on the Final Assessment

Notes


Topics ReferencesReview(60 Minutes)

LMS - Final Assessment – learners should login to the Knowledge Platform System (LMS) and complete the IACC Integration Global Training Program Exit Exam and Course Survey.

Final exam with answer keys will be available from Global Application SharePoint.

The Final Exam is made up of 25 multiple choices questions pulling from question pool, assessing knowledge in EP Evaluator, Pre-Integration activities, Post-integration activities, Verification/Validation Studies, troubleshooting, assay installation, My GSS resources, and AbbottLink.




NotesKey Points to Wrap Up Training

• Highlight importance of using My GSS resources when performing integration tasks

• Highlight importance of using AbbottLink to check instrument activity before field visit

• Highlight importance of following Integration Checklist for consistency

• Highlight importance of using ASE skills when interacting with customers

• Ask participants to wrap up the training:• Ensure instrument is ready for next

class use• Complete Integration Checklist;

clean up classroom tools, waste, etc.• Thank learners for participating in the

training



Notes


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