TRAINING CHECKLIST FOR MINI_VIDAS_MU_EN_99188_E
This part should be completed by the TRAINEE
TRAINEE NAME :
DATE OF TRAINING STARTED:
SECTION :
Yes
No
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Training Method
Explanation Lectures
Demonstration
Practice
Computer based
Self study
Training Materials
SOP
Manuals
Package Inserts
Lecture Hand outs
Computer Program Handouts
Videotape (s)
Practice materials
Yes
No
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Read the following sections of the operator’s manual before starting training.
Operator’s Manual Section/ Topic
Date Completed
Trainee Initials
Minividas Procedures Manual
Safety Symbols ….. Preface P. 2- 3
Safety Precautions ……. Preface P. 4- 6
Precautions on Use ……. Preface P. 7- 10
Analytical Methods Principles ……. Section 7.1
QC rules ……. Section 7.2.5
Calibration Methods ……7.2.3
Calculating the concentration of sample/control …..7.2.4
System Description …… Chapter 1
Basic Operations…… Chapter 3
Technical Specifications…. Appendix A.1
Environmental Requirements….. Appendix A.4
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 1 of 7
Training Checklist
Please Tick the appropriate box to the right
Read &
Understood
Training Element
Explained/
Discussed
Observed
1. Intended use
2.
1.
2.
1.
2.
3.
Analytical Methods Principles (Resource: operating Manual 7- 1 to 7-3)
Qualitative mini VIDAS assays
Analysis methods used for single reagent strip (P/S method and the
P-S method)
Analysis methods used for dual reagent strip (P/N method and the
P-N method)
Quantitative mini VIDAS assays
Patient to standard ----- (Resource: Minividas Procedures Manual,
Chapter 5)
Patient to reference ----- (Resource: Minividas Procedures Manual,
Chapter 5)
Curve fitting equations - (Resource: Minividas Procedures Manual,
Chapter 5)
1. QC rules
 Westgard Multi-rule
 Cumulative Sum Check
2.
 Twin-plot
Calculation Method of ISE Unit
3. Specifications
 Technical
 Power Requirements
 EMC
 Environmental Requirements
4. System Description
Hardware
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Reagent strip tray
S PR® block
Operating status light
Microprocessor
Incubators
Strip preparation tray
Detection system
Central processing unit
Keypad and screen
Internal / External printer
Rear panel components
Bar code readers
Software
mini VIDAS menus
Memory cards
Contents of the assay kit
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single or dual reagent strips
SPRs (Solid Phase Receptacle)
control(s)
standard(s)
diluent
package insert
MLE card
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 2 of 7
Performed
Proficiently
Read &
Understood
Training Element
Explained/
Discussed
Observed
5. Basic Operations
 Starting up the analyzer
 Shutting down the analyzer
 Configuring the analyzer
dose units
 Set up
user ID
the
report header
date and time
display contrast
Selecting the printer
Defining the sample ID character sets
Changing the key click volume
Changing the beep volume
Setting initial and final error beep volume
Enabling display blinking
Expired Standard warnings (Onscreen & Printed)
Checks for expired calibrations (Any & Current
Standard at Assay Startup)
Check for master lot at assay startup
LIS user options
Creating normal ranges for assays
Installing paper in the printer
Routine Procedure
Precautions for use of reagents
Basic mini VIDAS work flow
Type of run required
Planning a run
Assay compatibility
Standards and controls
Master lot data
Assay requests
Running Assays
Starting a defined run
Starting a load and go run
Assigning a dilution factor
Calibration and
recalibration
quantitative or qualitative
Principles of calibration using the mini VIDAS
Principles of recalibration using mini VIDAS
Establishing the master curve
Master Lot data
How to calibrate
Automatic and manual master lot data entry
How to see the stored standards for a particular assay
lot
How to display the master lots for a particular assay
procedure to stop the processing of one or both sections
procedure to print a list of the mini VIDAS assays that have Master
Lot Data loaded on your mini VIDAS.
The assay report
Printing and reprinting assay report
assay report for qualitative assay
assay report for quantitative assay
Assay report errors messages
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 3 of 7
Performed
Proficiently
Training Element
Read &
Understood
Explained/
Discussed
Observed
Validating LIS results
Environmental requirements (Resource: Minividas Procedures Manual,
Chapter 8, Appendix A)
Temperature Control (Resource: Minividas Procedures Manual, Chapter 8, ,
Appendix A)
 Preparing for Analysis
 Starting Analysis
 Processing Results
 Finishing Analysis
6. Advanced Operations (the operating software of analyzer)
 Sample
 Sample Information dialog box
Request
 Delete dialog box
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Change Sample Position dialog
box
Requesting Samples or
Modifying Information
Scan Sample Barcode
Download Sample Information
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Probe
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Analysis
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Current Results
(Rerun sample tests)
Historical Results
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QC Request
Start
Stop
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Results
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Replace the cuvettes
Relog the operating software
Exit the operating software
Reagent Setup screen
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Calibration
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Calibration
Screen
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Calibrator
screen
ISE screen
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Calibration Request screen
 Request Calibration
 Reset Position of a Calibrator
Calibration Results
 Calibration Curve
 Calibration Reaction Curve
 Reagent Blank Trend Curve
 Calibration Data
 To Recalculate or Modify
Calibration Parameters
parameters on the screen.
Modify Calibrator Information
parameters on the screen
Search ISE Calibration Results
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 4 of 7
Performed
Proficiently
Training Element
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QC screen
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Status screen
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Statistics
screen
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Parameters
screen
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Setup
System
screen
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Hospital Screen
User screen
Print screen
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Read &
Understood
Explained/
Discussed
Observed
Real-time QC screen
Daily QC screen
(QC Reaction Curve)
Day to Day QC screen
QC Summary screen
Control screen
Modification of Control
Information
Sample Disk screen
Reagent Disk screen
Reaction Disk screen
Worklist screen
Results screen
(Search dialog box)
Workload screen
Charges screen
 Conditions dialog box
 Set Cost and Price
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Test Screen
 parameters screen
 Reference ranges screen
 Calibration screen
 QC Rules screen
QC Screen
ISE screen
Profile screen
Calculation screen
Off-system screen
Carryover screen
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Basic
ISE
Bar Code
LIS
Dictionary
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General
Template
 Maintenance screen
 Daily Maintenance screen
 ISE maintenance
 Daily maintenance screen
screen
 Maintenance Record screen
 Log screen
 Import/Export screen
System Screen
 Alignment
Motion screen
screen
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 5 of 7
Performed
Proficiently
Training Element
Read &
Understood
Explained/
Discussed
Observed
7. Maintenance
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 Daily
Maintenance 
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 ISE Unit 
Maintenance
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 Weekly
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Maintenance 
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 Monthly
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Maintenance 
 Maintenance 
Every Six Months
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 Irregular
Maintenance
Checking Remaining Deionized Water
Emptying Waste Tank
Checking Connection of Deionized
Water
Checking Connection of Wastewater
Checking Syringe
Checking Probe
Checking Mixing Bar
Daily Cleaning
Pump Calibration
Cleaning Probe
Cleaning Mixing Bar
Washing Deionized Water Tank
Washing Waste Tank
Cleaning Sample/Reagent
Compartment and Barcode Reader
Cleaning Panel of Analyzing Unit
Cleaning Wash Well of Probe
Cleaning Wash Well of Mixing Bar
Washing Dust Screens
Replacing Filter Assembly
Unclogging Probe
 Replacing Probe
 Replacing Mixing Bar
 Replacing Plunger Assembly of
Syringe
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8.
Removing Air Bubbles
Replacing Lamp
Replacing ISE Components
 Replacing Reagent Pack
 Replacing Electrodes
ISE Unit Storage (optional)
Maintenance Log
Troubleshooting
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process to determine alarm
status
help system
9. Safety
 Safety Symbols
 Safety Precautions
 Precautions on Use
12. Running the Following Assays
1. Troponin
2. Estradiol
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 6 of 7
Performed
Proficiently
3.
4.
5.
LH
FSH
Progesterone
6.
7.
8.
CK- mb
H. pylori
HCG
Level of achievement Date/ Trainer Initials:
Level of achievement defined:
Discussed- Process/ procedure has been discussed; principles, procedures, processes, have been explained and
demonstrated by the trainer. The trainee has observed demonstration and asked questions
Observed- Trainee has practiced the procedure/ process under the direction of the trainer with guided instruction.
Performed Proficiently- Trainee can accurately complete the task with minimal supervision and evaluates results
or troubleshoots problems when indicated. Completes the procedure entirely according to written SOP
Trainee Performance Evaluation
This part should be completed by the TRAINER
Please Tick the appropriate box to the right
Yes
Evaluation Method
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Result Of Evaluation
Un
Satisfactory
Satisfactory
Oral evaluation
Direct observation competency (If yes, complete the form)
Written competency
Unknown samples (If yes, include a copy of the result)
Other
Corrective Action If Needed
DATE OF TRAINING COMPLETED
TRAINEE SIGNATURE
TRAINER SIGNATURE
SUPERVISOR SIGNATURE
DATE
: ……………………………
: ……………………………..
: ……………………………..
: ……………………………..
: ……………………………..
Training and Competency Assessment Program/ Training
Effective Date: 21 August, 2011
Version 1
ULC/TCP/11F
Page 7 of 7
No