Scribd
Upload
322 views33 pages

Quality Control With Bio Rad Unity Real Time

Uploaded by

Ahmed Maaouia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
322 views33 pages

Quality Control With Bio Rad Unity Real Time

Uploaded by

Ahmed Maaouia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 33

Bio-Rad Unity Real Time (URT)

Clément Arès
Bio-Rad Laboratories (Canada) Ltd
Senior Product Manager
What is Unity Real Time?

______________
• Unity Real Time . . .
– QC data management program that provides statistical review, documentation and
analysis across all controls used in the laboratory
– Is a networkable QC program to cover every area in the lab
– Analyzes all quality control data to assist the laboratory staff in completing their QC tasks
per lab policy and regulations
– Allows for external peer group analysis so you are not caught standing alone
Data Innovations Connectivity

•Unidirectional = Run time decision making, Peer participation


•Bidirectional = Unity™ powered Autoverification, and everything else!
3 |
Different connectivity options

Data Other
LIS Analyzer
Innovations Middleware
Additional Hardware No No Yes Yes/No

Real Time Yes No Yes Yes

Integrate w/ AutoVerification Yes No No No

Partnership with Bio-Rad Yes No Siemens No

4 |
Auto-verification Workflow

a
1 b
LIS
1) QC Sent by Instrument a) If Pass: DI “automatically
2) DI sends QC to URT 2 3 verifies” and releases
3) URT validates result & result to LIS
returns Pass/Fail and b) If Fail: DI holds results
rules if failed until manually released
by Technician (after
troubleshooting)
How is this implemented?

• You drive the schedule


• 100% Remote

1. Introduction Conference Call


2. IT focused Conference Call
3. Unity Real Time installation
4. Connectivity Configuration
5. Unity™ Training
6. Follow up Training

6 |
What do I need for Instrument Manager?

• For Instrument Manager:


Bi-directional QC Integration license *
Specimen Management license *
Unity Real Time “client” installed

• To determine if licensed
From the Instrument Manager menu,
Reports → License Information

7 |
What do you need to have in URT?

• Unity Real Time


– URT database on SQL Server on same LAN
– URT configuration:
o Unity Lab Number(s)
o Instrument(s)
o Control(s)
o Test(s)

8 |
Instrument Manager Connection to URT

• Quality Control Setup


– Point IM to URT server

9 |
Instrument Manager Mapping

– Configure or “Map” codes


o Instruments to Unity Lab Numbers
o Specimen IDs to Unity Lot Numbers
o Test Codes to Unity Analytes

10 |
So Many Regulations!
Unity Real Time and Regulations-
Ensure Minimum of Two Levels of QC

The Joint Commission Histogram Chart


CAP
COLA
QMP-LS/OLA
Accreditation Canada

Levey-Jennings Chart
Data Set Analysis Grid
It’s not only about Chemistry!

o Hematology
– Coagulation
• Microbiology
– Virology
o Blood Bank
• Serology

13 |
Regulations -
Record of Qualitative Control Events

Qualitative data input screen


Regulations - Validity of QC Ranges

_______________
Levey Jennings Graphed against
peer data

Full line of Unity


Reports
Regulations-
QC analysis occurring when scheduled

_______________
Unity Alert
Regulations-
QC analysis occurring when scheduled

_______________
Manage Expected QC Results
Regulations-
Statistical tools for analysis and display

_______________
Levey-Jennings
Supervisor Report Data Set Analysis Grid

Histogram Chart
Regulations-
Monitoring Accuracy and Precision

And Unity Reports-


Performance
Yundt Chart in URT Overview
Regulation - Monitoring Lab Performance

Unity Real Time offers Six Sigma and Total Allowable


Error in the data set analysis grid and SDI and CVR
with the peer group

Unity peer group


Reports offers SDI
and CVR
Data Analysis Grid
Regulation:
Proper handling of QC results if outside set limits

Bench and Supervisor Review


Bench Review
Regulations:
Proper QC documentation

Automatic documentation required on out of control events.


Audit trail keeps track of changes that can affect result interpretation

30 day Expired lot notification


Regulations - Instrument Correlations

Multi Levey-Jennings
Data Set Analysis Grid
Will also help

Unity Affiliate Report


Multi Levey-Jennings Chart
Regulations - Retaining QC Records

Archive QC data
Regulations - QC Competency or Training
Integrating Bio-Rad Unity Real Time®
Rule Examples for Instrument Manager

30 |
IM Use Case Examples

QC Failure Notification *
IF: {( {Specimen Type} = "Q“ ) {AND} ( {QC Rule Violated} {On Any
Test} {Contains} {Value List:QCFlag} )

THEN: {Trigger Notifier Event} "QC Failure" {AND} {Add} {Notifier Event
Text of} "QC Failure" = “Any text you want to include in message“

Value List:

• Notifier Function in Instrument Manager


Event time and day of week determines whom to notify
Notices sent via email, text, network notice, and/or light pole
31 | * Note: Instrument Manager rules provided as an example. Customer is responsible for testing and validation of any rules in their system.
IM Use Case Examples

QC Rule Violation (Autoverification) *


IF: {( {Specimen Type} = "Q“ ) {AND} ( {QC Rule Violated} {On Any
Test} {Contains} {Value List:QCFlag} )

THEN: {Trigger Notifier Event} "QC Failure" {AND} {Add} {Notifier Event
Text of} "QC Failure" = “Any text you want to include in message“
{AND} {Start Holding That Test with That Instrument ID for
Verification}
Value List:

32 | * Note: Instrument Manager rules provided as an example. Customer is responsible for testing and validation of any rules in their system.
Questions?

Thank you for your time!

Sales
Data Innovations 802.658. 2850
northamerica‐[email protected]

Bio-Rad 1.800.854.6737 – US
1.800.361.1808 – Canada
Support
Data Innovations 802.658.1955
northamerica‐[email protected]

Bio-Rad 1.800.854.6737 - US
1.800.361.1808 option 1 - Canada

You might also like