Download Blazing New Paths with SoftBank Quality Control

Blazing New Paths with
SoftBank Quality Control
Linda Connelly, MBA, BSMT(ASCP)BB
SoftBank Implementation Specialist
Objectives
• Identify the Quality Control options available
in SoftBank currently
• Maximize the set up of traditional Quality
Control in SoftBank
• Explore TQC options for equipment records
(temperature or centrifuge checks)
• See new QC features in v25.3.0.5
QC Overview
Allows you to:
• Maintain an inventory of reagent lot numbers (not
stock levels), with received, opened and end-of-use
dates
• Document reagent quality control results
• Perform on-line review and sign-off of QC results
• Access computerized QC results for inspections
Key Terms
• Template – ‘skeleton’ of QC protocol
• Reagents – both kits with component vials and
individual reagents
• Rack – combines the templates and reagents into a
working tool to run daily QC and record results
2 or 3 Test Phases?
• Set by parameter
• 2 Phases
– Result
– Appearance/Performance (A/P)
• 3 Phases
– Result
– Appearance
– Performance
QC Setup – Step 1
• Build in the Setup Files:
– Manufacturers/ Sources
– Reagents – kits, component vials and individual reagents
– Tests
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Phases and Phase Groups
Interpretations
Group Test (Basic and Complex)
Logic Tables for Basic Tests
– Exception Codes
Manufacturers/ Reagent Sources
• 6-Setup>Blood>Source
• Add all manufacturers or sources
Reagent Codes
• 6-Setup>Tests>Reagents
• Add all required reagents
– Kits (by kit name)
– Kit component vials
– Individual reagents
Test Phases and Phase Groups
• Add Test Phases
• Use Phase Groups to interpret reactions
Test Interpretations
• Add the QC Interpretation
Basic Tests
• Add all QC tests
– Positive, Negative, Documentary
– Include all appropriate phases
Logic Tables
• 2nd page of Basic Test setup
• Include all possibilities, pass, fail, problem and
abnormal (new field).
Exception Codes
• Add Exceptions for invalid results
QC Setup – Step 2
• Under 4-Results>Quality Control
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Build a QC Template
Register reagents
Open ‘known’ reagents
Build QC Rack
QC Template
• Build QC template using a worksheet as a guide
• Include reagent, control, and type of test
Register Reagents
• Individual reagents
• Reagent kits, including component vials
Open Reagents
• Individual reagents
• Kits – remember to open the component vials
QC Rack
• Build all required racks, placing ‘sited’ reagents on
each.
• The act of placing an unknown reagent on the rack
will open it.
Using the QC module
• Entering results – Daily Rack
No more paper?
• QC phases within Antigen tests
– Expandable rack
• Which one to choose - Daily, Day-of-Use, Antigen
• Entering results – QC as a phase in a Basic Test
No more paper?
• QC Doc to record reagent lot numbers
– Unknown vs. known (benign) reagent
Review/ Sign-off of Results
• Access 5-Management>Blood Bank Log
• All results on the rack must be completed
• Sign off (release) with Reviewer and D/T
Using TQC for BB equipment
TQC Setups for BB Equipment
• Same as for Lab equipment
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Location
Department
Workstation
Add each piece of equipment and date put into use, creating
maintenance records
• BB refrigerators
• Heat blocks
• Centrifuges
QC Enhancements
• Developmental tasks included:
• PCC-56310
– 25.3.0.5.17
25.5.2.0.9
• PCC-56388
– 25.3.0.5.16
25.5.2.0.5
• PCC-57307
– 25.3.0.5.16
25.5.2.0.9
QC Enhancements
• Renamed Field
– QC Warn (formerly QC Flag)
QC Enhancements
• New Fields
– QC Interval
– Grace Period
– Start Time
QC Warn (QC Flag)
• Renamed to reflect enhanced functionality
• If checked (field is active), the system can
accommodate a range of acceptable values for the QC
Interval field.
New QC Fields
• QC Interval
– Allows the builder to define how often within a 24 hour
period, the QC rack should be tested.
New QC Fields
• Grace Period
– Set in minutes or hours
– Allows for a specified time that QC can be performed prior
to the start of the shift (new Start Time field).
New QC Fields
• Start Time
– Defines when the QC clock should start
– No longer automatic midnight start!
– Uses military time (HH:MM)
Special Thanks
• Tracy Dorgan – SCC Education Department
• Shawn Johnson – SoftBank Post-Live Support
Team Lead
• Laurie Sapp – SoftBank Product Analyst
Blazing New QC Paths