QC Data Management Solutions

QC Data Management Solutions
Introduce your laboratory to a whole new world of Unity data management solutions

Commitment to Quality Control
Using our comprehensive product line of independent controls
is an important step toward helping you improve the reliabilityof your laboratory results. The ability to successfully manage andinterpret your quality control results is also essential to producing
solid, dependable laboratory outcomes.
Bio-Rad Laboratories offers a vision and a commitment to quality control that is unsurpassedin the clinical laboratory industry . Today, your laboratory can be connected to the Unity Interlaboratory
Program, the world’s largest community of quality control users . Improve patient test results
and cost effectiveness with quality control products, quality control data management solutions,industry-leading interlaboratory comparisons and personalized service from Bio-Rad .

Regulatory Requirements“The laboratory shall participate in an interlaboratory comparison programme(s). . .”– ISO 15189:2012(E), Subclause 5 .6 .3 .1

www .bio-rad .com/qc-datamanagement | 1

Unity Interlaboratory Program
Participation in an interlaboratory program is extremely important for laboratories to help ensure the reliability and precision of test
systems . No program in the world is more powerful and effective at providing information and helping to improve laboratory analytical
performance than the Unity Interlaboratory Program .
■Benefit from peer QC data generated from more than
59,000 instruments in 100+ countries■

Recognize analytical process improvement opportunities■

Increase confidence in proficiency survey outcomes■■

Identify unrecognized trends or shifts that may occur between
proficiency surveys■■

Receive monthly reports with regular data submissions
Submit data in real time using one of our Unity software
solutions■

Detect and identify potentially important analytical errors■

Meet accreditation and regulatory requirements

Receive on-demand interlaboratory comparison reports

January 2018
Associated Regional Laboratory
123 Main Street
Anytown, NY 12345-6789
Attention: Lab Supervisor

InstantQC Laboratory Comparison Report
Unassayed Chemistry • Lot 12345 • Exp 01-Dec-2020
Potassium ISE indirect mmol/L
Level Mon

Level

Cum

Your LabMon Cum

Roche cobas 8000
Peer CVR
Method CVRPeer SDI
Method SDI

1

0.2
0.3
0.85
0.99

0.4
0.5
0.34
0.52

2
1
0

CVR
2

-1
SDI -2Peer CVR
Method CVRPeer SDI
Method SDI

2

0.7
0.4
0.6
0.3
0.59 -0.21
0.68 0.10

2
1
0

CVR
2

-1

Peer GroupMon Cum

Method GroupMon Cum

Roche cobas
6000/8000 Series

ISE indirect

Mean
SD
CV
# Points# Labs4.11 4.08
1 0.0200.040

4.04 4.05
0.087 0.107
2.7
2.28671 29935
106
106

4.04 4.04
0.074 0.081
2.0
1.858288 215K
822 890

MeanSD
CV# Points# Labs6.39 6.33
2 0.030
0.067

6.34 6.35
0.085 0.100
1.6
1.38157 27874
103
103

6.31 6.31
0.114 0.119
1.9
1.857653 209K
815 878

0.5
7

0.5
7

1.0
24

1.1
24

SDI -2Chloride ISE indirect mmol/L
Level Mon

Level

Cum

Your LabMon Cum

Peer CVR
Method CVRPeer SDI
Method SDI

1Peer CVR
Method CVRPeer SDI
Method SDI

2

0.5
0.3
0.3
0.2
0.88 0.57-0.98 -0.14

2
1
0

CVR
2

-1
SDI -2

0.7
0.7
0.4
0.3
0.51 0.03-0.64 -0.89

2
1
0

CVR
2

-1

Peer GroupMon Cum

Method GroupMon Cum

Roche cobas
6000/8000 Series

ISE indirect

Mean
SD
CV
# Points# Labs83.09
1 83.500.400 0.674

82.48 82.32
1.16 1.36
1.7
1.48714 29822
107
107

85.59 85.66
2.14 2.26
2.6
2.557618 210K
815 884

Mean
SD
CV# Points# Labs98.06
2 98.600.700 0.845

98.07 98.02
1.03 1.28
1.3
1.08223 27995
104
104

100.0 100.1
2.24 2.31
2.3
2.2
56666 205K
806 875

Roche cobas 8000

0.5
8

0.7
8

0.8
25

0.9
25

SDI -2Cholesterol, HDL DIrect measure–PEG mg/dL
Level Mon Cum
Roche cobas 8000 • 3rd generation
Peer CVR
Method CVRPeer SDI
Method SDI

1

0.0
0.0
0.0
0.0
-1.33 -1.19-0.33 -0.34

Peer CVR
Method CVRPeer SDI
Method SDI

2

0.0
0.0
0.00
0.34

1
0

CVR
2

-1
SDI -2

0.0
0.0
0.34
0.35

Peer GroupMon Cum

Method GroupMon Cum

Roche cobas
6000/8000 Series

Direct measure–PEG

Mean
SD
CV
# Points# Labs29.00
1 29.00
0.000 0.000

29.95 29.88
0.714 0.735
2.5
2.41013 1815
6
5

29.58 29.59
1.74 1.77
6.0
5.9
14592 50192
304 324

Mean
SD
CV# Points# Labs265.01 64.48
1.48 1.53
2.4
2.3
1019 1816654.18 3.92
6.2
6.613893 47799
297 321

Level

2

2
1
0

CVR
2

-1

Your LabMon Cum

0.0
1

0.0
1

65.00 65.00
0.000 0.000
0.0
0.0
1
1

63.60 63.64

SDI -2Cholesterol, Total Cholesterol oxidase, esterase, peroxidase mg/dL
Level Mon Cum

Level

Your LabMon Cum

Peer CVR
Method CVRPeer SDI
Method SDI

1Peer CVR
Method CVRPeer SDI
Method SDI

2

0.0
0.0
0.0
0.0
-0.74 -0.82
0.19 0.12

2
1

CVR
2

0

-1

SDI -22

1
0-1
SDI -2CVR
2Method GroupMon Cum
ISE indirect

105.0
1 105.0
0.000 0.000

107.8 108.5
3.84 4.34
4.0
3.64930 16777
992104.1 104.4
4.70 5.00
4.8
4.534971 132K
781 885

MeanSD
CV# Points# Labs256.0
2 256.0
0.000 0.000

257.7 3259.2
5.84 6.61
2.6
2.34736 15884
91
90

254.7 254.6
9.25 9.28
3.6
3.634720 130K
778 879

2 | QC Data Management Solutions
0.0
0.0
0.0
0.0
-0.74 -0.48
0.19 0.15

Peer GroupMon Cum
Roche cobas
6000/8000 Series

Mean
SD
CV
# Points# LabsRoche cobas 8000

0.0
1

0.0
1

0.0
1

0.0
1

Receive On-demand InstantQC Reports
Get started at QCNet.com today!
InstantQC Reports allow you to compare your control results to otherlaboratories at any time . These on-demand reports are particularly usefulfor troubleshooting problems with test system performance .

The Advantages of Participating in the Unity Interlaboratory Program
Detecting Errors in Your Test System

Your Proficiency Program is Not EnoughWithout a high quality interlaboratory program, your laboratory
may not be aware of gradual or sudden changes in your test
system that may be caused by events such as reagent orcalibrator reformulations, standardization changes, or instrument
software changes. An interlaboratory program may offer early
awareness of shifts and trends to help avoid costly test repeats
and unnecessary troubleshooting.

 roficiency surveys provide a snapshot in time and shouldP
not be used as a substitute for daily quality control withan interlaboratory program.
■■ cceptable performance on the day of the proficiency testingA
does not guarantee testing reliability every day articipation in an interlaboratory program is the recommendedP
way to improve confidence in test system performance every
day, especially with an interlaboratory program that offers an
option to receive instant interlaboratory feedback on-demandSome advantages for participating in an interlaboratory QC program are:
Verifying that a laboratory is producing QC results that are consistent with other laboratories using the same measurement procedure,
and thus demonstrating that the laboratory is using the measurement procedure correctly■

Detecting and identifying bias in a measurement procedureBias can be caused by events such as reagent or calibrator lot changes or reformulations, changes in calibration traceability to reference
systems, or instrument software changes. Comparison of an individual laboratory’s QC result to a peer group mean value can identify a trendor shift, or ascertain if other laboratories are experiencing the same changes (see Subchapter 3.3.1).”■

Supplementing PT/EQA programs■ 
PT/EQA programs verify performance at a point in time. Acceptable performance on the day of PT/EQA testing does not guarantee testing
reliability every day because errors in a measurement procedure can occur at any time. In addition, the interlaboratory QC data can be used
to investigate a failed or questionable PT/EQA result.
– CLSI, C24, 4th ed. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions.
7.2 Using Interlaboratory Quality Control to Assess a Quality Control Program.

www.bio-rad.com/qc-datamanagement | 3

Choose From Four Unity Solutions
Bio-Rad Laboratories offers several options for participation in the Unity Interlaboratory Program.
Refer to the product comparison grid below to help determine which solution is the most appropriate
for your laboratory.
Desktop software solutions, like Unity Real Time,are appropriate if your internet connection is not sufficient,or if you prefer maintaining local software .

Internet-based solutions such as UnityWeb andUnity Real Time online eliminate the need to install andupdate software locally in your laboratory, and reduce
the amount of support necessary from on-site IT staff .

Basic User Options
UnityWeb

Advanced User Options
Unity Real Time LT

Unity Real Time online

Unity Real TimeType of Solution

X

Web Service (Web-based)

X
X

Desktop Software

X

Unity Interlaboratory Reports

Monthly Reports

X

X

X

X

InstantQC Reports

X

X

X

X

Westgard Rules

X

X

X

X

Various Charts and Reports

X

X

X

X

X

X

Basic Intralaboratory Charts & Reports

Additional Features

Westgard Advisor (Subscription sold separately)X

Bench Review with Data Review Report

X

X

X

X

Supervisor Data Review with Data Review Report

X

X

Analytical Goals

X

X

Dynamic Data Set Comparisons

X

X

Database Platform

X

Bio-Rad Hosted

X
X

Installed on Local Laboratory PC

X

Connectivity (Sold separately)

WebConnect

X

UnityConnect

X

Basic

Advanced

X
X

Desktop based

X

Web based

X

MobileWant to know more? Discover the power of Unity Solutions at www.bio-rad.com/qc-datamanagement

4 | QC Data Management Solutions

Basic User Options

Unity Real Time LT
Entry-Level Desktop QC Data Management Solution■■■■

Basic QC rules, charts and reports
Configurable Levey-Jennings charts
Upgrade easily to Unity Real Time for more advanced tools and features
Upload QC data points from an LIS, middleware or instrument (optional)

UnityWeb
Entry-Level Online QC Data Management Solution■■■■

No software to install and maintainUse basic QC rules, charts and reports
Upgrade easily to Unity Real Time online for more advanced tools and features
Upload QC data points from an LIS, middleware or instrument (optional)

Connectivity

Basic

Advanced

WebConnect

UnityConnect

Automated Uploads to Unity Software

A connectivity solution that allows QC data from
LIS systems, middleware and/or instruments to be quickly
and easily imported into Unity software and web services

A web-based connectivity solution that allows laboratories to easily
upload QC data from LIS systems, middleware and/or instruments
directly into Unity Real Time online or UnityWeb■■■

Eliminate manual keying of data
Standard LIS QC reports can be used
No software to install

■
■
■
■
■

■
■

Eliminate manual keying of QC data
Standard LIS QC reports can be used
Automatic data import and real-time connection
Transparent to the flow of data to the LIS
Capture and analyze QC data economically from laboratory
instruments not connected to the LIS
Easy-to-install optional interface hardware
Choose from soft, serial and ethernet connections

www .bio-rad .com/qc-datamanagement | 5

Advanced User Options

Unity Real Time
Expert QC Data Management Solution for Desktop Users
■
■
■
■
■
■
■
■

Facilitate regulatory compliance under CLIA and ISO 15189
Improve real-time bench and supervisor QC data review
Implement best QC rules when used with Westgard Advisor
Run validation with comprehensive audit trails
Advanced charts and reports for data analysis
Reduce non-essential retests with Analytical Goal options
Upload QC data points from an LIS, middleware or instrument (optional)
RiLiBÄK Advisor module available to comply with German regulations

Unity Real Time online
Expert QC Data Management Solution for Online Users
■
■
■
■
■
■
■

Facilitate regulatory compliance under CLIA and ISO 15189
Improve real-time bench and supervisor QC data review
Implement best QC rules when used with Westgard Advisor
Run validation with comprehensive audit trails
Advanced charts and reports for data analysis
Reduce non-essential retests with Analytical Goal options
Upload QC data points from an LIS, middleware or instrument (optional)

Westgard Advisor

Unity Alert

Automatic QC Rules Selection Engine

Continuously Monitor QC Status

■

■
■
■

■
■

Recommend and automatically apply best QC rules withpatented technology
Easy step-by-step automatic rule selection capabilities
Reduce false rejections and desensitization to false error flags
Save time and money by reducing unnecessary repeats andtroubleshooting
Improve laboratory test quality with optimally selected QC rules
Available as an optional module with Unity QC data
management solutions

■

■

■

■

■

■
■

6 | QC Data Management Solutions

Notifications of missing QC runs can help to ensure propermonitoring of instrument performance
Notifications of new violations can be useful for troubleshooting
and monitoring problem analytes
Alert rules are easy to set up and customize for specificinstruments or tests
Receive emails remotely to stay informed of QC issues
in your laboratory
Color-coded displays help draw attention to the most urgent
QC issues
Notifications are provided even when Unity Real Time is not in use
Available as an optional module with Unity Real TimeAdvanced User Options

Bio-Rad Mission: Control
Take the guesswork out of your QC strategy
Employing a robust quality control system is an essential
step for any laboratory hoping to provide reliable results forappropriate patient care . Unfortunately for clinical laboratories,
selecting the right QC rules and frequency can be challenging,and questions often arise .
■■How often should controls be run for specific assays–
is there an optimal frequency?
How can QC be managed to minimize the riskof releasing incorrect patient results?

Bio-Rad Mission: Control is the first objective risk
management solution for quality control in laboratories .
The intuitive interface allows users to focus on patient safety
by assessing the risk of reporting incorrect patient resultsin their laboratory .

Bio-Rad Mission: Control allows you to:
■

■

■

■

■

Determine your laboratory’s Risk Management Index (RMI)
Evaluate your test method performance based on your
QC results
Quantify the likelihood and severity of reporting
incorrect patient results
Assess how much you can lower your risk, basedon instrument performance
Create a QC Plan by confidently selecting rules andfrequency that fit your risk tolerance

Minimize your risk of reporting unreliable patientresults
A patient risk approach to Quality Control is a progressive step
toward improving quality assurance and patient care . Bio-Rad
can help you understand what this means for your laboratory andhow to take steps to implement an effective approach for Quality
Control within your analytical test phase .

For more information,
visit www.qcnet.com/missioncontrol

Regulatory Requirements“The laboratory shall design quality control procedures that verify the attainment of theintended quality of results.”– ISO 15189:2012(E), Subclause 5 .6 .2 .1

www .bio-rad .com/qc-datamanagement | 7

QCNet is the Leading QC Portal on the Internet
Learn more about the many QC tools and resources from Bio-Rad at www.QCNet.com

Quick Links to the most-used features
Unity Reports■

Get your Unity Reports in just a few clicks .

My eInserts■

Access product inserts

EQAS
■
■
■
■

View Reports
Access EQAS Online
Training/Tutorials
View Product Information

Access country-specific information
At the bottom of the QCNet home page, click on
the country name shown to access the pop-up
menu, then select the desired country* .
*Not all countries are available.

Explore the drop-down menus to find more online QC tools on QCNet

Quality Controls

QC Data Management

Resources

Support

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Infectious Disease
Immunoassasy
Chemistry
Diabetes & Hemoglobin
Immunology
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Tumor Markers
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Hematology
Coagulation
Urinalysis

UnityWeb
Unity Real Time online
Unity Software Solutions
Peer Reporting Program
Mission: Control
EQAS
Linearity Web
Data Submission Calendar

Training & Education
Technical Documents
Frequently Asked Questions
Barcode Label Generator
Value Assignment Program

My Account - Log in
Lab Admin
Contact us

8 | QC Data Management Solutions

Ordering Information
Cat #Description

Cat #Description

Unity Real Time LT
Unity Real Time online
804
Installation Package .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Single use 804-W1 Unity Real Time online .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
805-1
Unity Real Time LT .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
825i
Unity Remote Installation & Training .  .  .  .  .  .  .  .  .  .  . Single use Westgard Advisor
811-1
Westgard Advisor.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
UnityWeb
870-1
UnityWeb .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription Unity Alert
806-1
Unity Alert.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
WebConnect
825i
Unity Remote Installation & Training .  .  .  .  .  .  .  .  .  .  . Single use
870-W1 WebConnect 2.0. .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
825i
Unity Remote Installation & Training .  .  .  .  .  .  .  .  .  .  . Single use Cat #Description
Bio-Rad Mission: Control
UnityConnect
1100002 Mission: Control .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual Subscription
820-1
UnityConnect Software. .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
1100005 Mission: Control .  .  .  .  .  .  .  . Subscription and Service Bundle
825i
Unity Remote Installation & Training .  .  .  .  .  .  .  .  .  .  . Single use
Unity Real Time804
Installation Package .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Single use
804-1
Unity Real Time. .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . Annual subscription
825i
Unity Remote Installation & Training .  .  .  .  .  .  .  .  .  .  . Single use

EQAS

Independent QC

Unity

An independent, external assessment of laboratory
performance in comparison to your peers.

Ongoing, proactive, unbiased daily QC thathelps identify errors as they occur or begin to trend.

QC Data Management tools that help you createa strategy to reduce risk and streamline QC workflow.

QCNet.com/eqas

QCNet.com/independentqc

QCNet.com/datamanagement

Bio-RadLaboratories, Inc.
ClinicalDiagnostics Group

Website www.bio-rad.com/diagnostics U.S. 1 800 224 6723 Australia +61 (2) 9914 2800 Austria +43 (0) 1 877 89 01 9 Belgium +32 (0) 3 710 53 00
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Finland +358 9 804 22 00 France +33 (0) 1 47 95 60 00 Germany +49 (0) 89 31884 393 Greece +30 210 7774396 Hong Kong +85 2 2789 3300
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Q-1181

BIO-RAD, MISSION:CONTROL, UNITY REAL TIME and UNITYWEB are trademark of Bio-Rad Laboratories, Inc.
in certain jurisdictions.

© 2024 Bio-Rad Laboratories, Inc. QSD24-2013 Rev. 2024/02