Bio-Rad Laboratories Q C d a t a m a n a g e m e n t s o l u t i o n s
Unity™ Interlaboratory ProgramOptimize Your Laboratory Performance as a Member of the World’s Largest Community of QC Users
t a b l e o f C o n t e n t s
Unity™ Interlaboratory Program: An Effective Tool for Evaluating Analytical Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
What are the Advantages of Participating in the Unity™ Interlaboratory Program? . . . . . . . . . . . . . . . . . . 3 - 4
Are Laboratories Required to Participate in an Interlaboratory Program? . . . . . . . . . . . . . . . . . . . . . 5
What are the Basic Comparison Statistics in an Interlaboratory Program and What Do They Indicate About Laboratory Performance? . . . . . . . . . . . . . . . . . . . . 6
Unity™ Interlaboratory Reports Reference Guide . . . . . 7 - 25
Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Unity™ Software & Connectivity Solutions . . . . . . . . . . 27 - 28
2 Unity™ Interlaboratory Program
Unity™ Interlaboratory Program: An Effective Tool for Evaluating Analytical Performance
Clinical laboratories account for a small percentage
of overall healthcare budgets, but have a
tremendous impact on medical decisions (1, 2).
Since every reported test result may impact
a patient prognosis, diagnosis or treatment,
the generation of high-quality results must be
a primary objective.
Cost-effectiveness and quality often conflict, but
with such a tremendous impact on the overall
quality of patient care, laboratories must produce
reliable and accurate test results. Finding affordable
solutions is important, but quality should never be
compromised.
To help ensure the quality of reported patient
test results, a good laboratory quality system is
vital, and more than a simple exercise in good
laboratory practice. This booklet focuses on one
aspect of a good quality system that will not cost
your laboratory a lot of money — participation
in an interlaboratory program. An effective
interlaboratory program provides opportunities to
measure and improve your laboratory’s analytical
performance. An interlaboratory program can also
help your laboratory meet various regulatory and
accreditation requirements.
The Unity™ Interlaboratory Program is the largest
interlaboratory program available to clinical
diagnostic laboratories in the world. Participation
in the program is both practical and cost-effective,
since you already purchase and use Bio-Rad QC
materials. You can simply submit your QC results
to Bio-Rad Laboratories through one of several
QC data management options, and in return
you will receive reports indicating your analytical
performance. We can even help connect your
instrument, LIS or middleware system so that
you don’t need to waste time entering data
manually. The Unity™ peer comparison reports
are made available to you online at QCNet™
(www.QCNet.com) for your convenience.
1 Institute of Medicine Report - Medical Laboratory Payment Policy: Now and in the Future (2000) .
2 Forsman, R .W . “Why is the laboratory an afterthought for managed care organizations?” Clinical Chemistry 1996; 42:5 pgs 813-816 .
Detect and Identify Potential Analytical Errors of Importance
A key reason for participating in the Unity™
Interlaboratory Program is to detect errors in
your test system. Many Unity™ participants have
written letters and emails to Bio-Rad, thanking
us for helping them discover problems with their
test systems that would otherwise have gone
undetected. Often these changes are caused by
events such as reagent or calibrator reformulations,
standardization changes, or instrument software
changes. The Unity™ Interlaboratory Program
can offer you awareness of a trend or shift in your
laboratory, and can also help you verify if other
laboratories are experiencing the same change. In
some instances, you can even be warned
of an upcoming problem before it occurs in
your laboratory.
Benefit from QC Data Generated from Thousands of Other Laboratories
The Unity™ Interlaboratory Program has the largest
peer groups available in the clinical diagnostics
industry, which provides a high degree of
confidence in the statistical comparisons offered.
Meet Accreditation and Regulatory Requirements
The Unity™ Interlaboratory Program can help you
meet ISO 15189 and accreditation requirements.
Although specific requirements and regulations vary
by country, a well-maintained internal QC program
and interlaboratory participation are often required
or encouraged.
3
What are the Advantages of Participating in the Unity™ Interlaboratory Program?
Perhaps this question can be restated another way – Why should your laboratory be a “statistical island”, when information generated from thousands of other laboratories worldwide can benefit your laboratory quality? The reasons for participating in the Unity™ Interlaboratory Program are numerous, but we’ve narrowed it down to ten .
1
3
2
Is your laboratory a “statistical island”?
4 Unity™ Interlaboratory Program
Supplement Proficiency Testing (PT) Programs
The Unity™ Interlaboratory Program complements
PT programs (such as the CAP PT program or
the EQAS program from Bio-Rad). Whereas PT
programs verify your performance periodically as a
snapshot in time (often bi-weekly or monthly), good
daily QC supplemented with interlaboratory reports
challenges test systems every time controls are run.
Acceptable performance on the day of proficiency
testing does not guarantee testing reliability
everyday because errors in a test system can
occur at anytime. Good internal QC supplemented
with an interlaboratory program is the best
way to maintain confidence in your test system
performance every day. Moreover, the Unity™
Interlaboratory Program may give meaningful
comparisons for parameters not available in
PT programs.
Assure Success in Proficiency Testing (PT) Programs
If you compare well to other laboratories in the
Unity™ Interlaboratory Program, you are also likely
to compare well to other laboratories participating
in your PT program.
Act as an Independent Reference
The Unity™ Interlaboratory Program can help
you demonstrate that a test system is faulty and
requires correction. At times, in-kit controls, which
are often manufactured from the same raw material
as kit calibrators or other kit components, may
fail to detect shifts in patient values. Bio-Rad
controls and the Unity™ Interlaboratory Program
can help provide an unbiased assessment of your
test systems.
Receive Reliable Information From a Trusted Source
The Unity™ Interlaboratory Program is a proven
and mature program in the clinical diagnostics
industry that laboratories trust and have come to
rely on. The program has provided laboratories
with valuable statistical information about their test
system performance for over 20 years.
Obtain Immediate On-Demand Analysis for Troubleshooting
In addition to standard reports produced monthly,
you can also receive InstantQC™ reports on-demand
from Bio-Rad. This is particularly useful for
troubleshooting problems with your test system
performance as they occur because of the rapid
report turnaround times and up-to-the-minute peer
group information provided with InstantQC™.
Receive Better Values to Guide You On New Control Lots
If you are using assayed controls, package inserts
are often a good guide to help you determine
whether your QC values in the new lot of control
are appropriate or not. However, the ranges in
package inserts are static and based on data
generated with reagents available at the time
of value assignment. On the other hand, Unity™
Interlaboratory Program values are available for
both assayed and unassayed control materials,
and are updated constantly to represent analyte
recoveries with reagents currently available.
Help Patients Worldwide
Your participation in the Unity™ Interlaboratory
Program can improve the reliability of the test
results you report to clinicians. It will also benefit
other laboratories, clinicians and patients worldwide
by providing information that laboratories can use
to benchmark against.
5
6
9
10
7
8
4
5
Are Laboratories Required to Participate in an Interlaboratory Program?
The requirements for performance, evaluation and documentation of quality control (QC) practices vary by
country. Laboratories in some countries are required to perform and document specific QC practices for
certification and accreditation. For laboratories in many other countries, consensus standard organizations,
such as ISO (International Organization for Standardization) and CLSI (Clinical and Laboratory Standards
Institute) provide guidance for good laboratory practice. Both ISO and CLSI encourage a well maintained
internal QC program and participation in an interlaboratory comparison program.
The following quotes are excerpts from ISO and CLSI documents and demonstrate the importance of quality control and interlaboratory participation .
“The laboratory shall participate in
interlaboratory comparisons…”
ISO 15189:2003(E), Subclause 5.6.4.
“The laboratory shall design internal quality control
systems that verify the attainment of the internal
quality of results. It is important that the control
system provide staff members with clear and easily
understood information on which to base technical
and medical decisions…”
ISO 15189:2003(E), Subclause 5.6.4.
“For laboratory self-evaluation, peer-related bias
and relative imprecision are useful parameters.
Participation in an interlaboratory program provides
an effective mechanism to complement external
quality assessment (proficiency surveys) programs.
Consequently, a laboratory should actively
participate in interlaboratory QC programs when
such programs are available.”
CLSI (formerly NCCLS), C24-A3, Vol. 26, No 25.
6 Unity™ Interlaboratory Program
What are the Basic Comparison Statistics in an Interlaboratory Program and What Do They Indicate About Laboratory Performance?
Two of the most important metrics of an interlaboratory program are the coefficient of variation ratio (CVR) and
standard deviation index (SDI), which are consensus-based metrics of imprecision and bias, respectively.
Coefficient of Variation (CVR)
The CVR allows you to evaluate your imprecision
relative to your consensus group. The CVR is
expressed mathematically by the formula:
Standard Deviation Index (SDI)
The SDI is a useful parameter for evaluating your
bias relative to your consensus group. The SDI is
expressed mathematically by the formula:
If your test imprecision is equal to the imprecision
of your consensus group, your CVR will be 1.0. The
following guidelines are suggested for interpreting
this statistic:
CVR < 1
Acceptable performance
1 < CVR < 1.5
Acceptable to marginal performance; may need to
investigate test system imprecision
CVR > 1.5
Marginal performance; may need to perform
corrective action
The target SDI is 0.0, which indicates that your
mean is identical to the consensus group mean.
A positive or negative deviation from this target
statistic may indicate a bias compared to the
consensus group mean. The following guidelines
are suggested for interpreting this statistic:
-1 < SDI < 1
Acceptable performance
1 < SDI < 1.5 or -1 > SDI > -1.5
Acceptable to marginal performance; may need
to investigate test system bias
SDI > 1.5 or SDI < -1.5
Marginal performance; may need to perform
corrective action
CVR =Your CV
Consensus Group CV SDI =
Your Mean – Consensus Group Mean
Consensus Group SD
7
The following reports are available to your laboratory when you participate in the Unity™ Interlaboratory
Program. With QCNet™, these reports are available through the Internet – saving you time.
Standard Unity™ Interlaboratory Program Reports
Monthly Evaluation Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Laboratory Performance Overview Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Laboratory Comparison Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Laboratory Histogram Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Bias & Imprecision Histogram Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Data Rejection Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Optional Unity™ Interlaboratory Program Reports
Worldwide Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Statistical Profile Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 - 17
Affiliated Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 - 21
Urinalysis Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 - 23
InstantQC™ Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 - 25
Unity™ Interlaboratory Reports Reference Guide
8 Unity™ Interlaboratory Program
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
Monthly EvaluationMultiqual 1, 2, 3 Unassayed
Dear Customer,
Attached are your QC reports for the month of 09-2011. Based on comparisons to the reported peer group, the parameters listed below may require investigation or review.
Monthly: SDI CVR # Labs # PointsAST (ASAT/GOT) UV without P5P Level 1 -0.83 0.88 25 5853 Roche MODULAR Level 2 -0.85 0.58 14 3850 Dedicated Reagent Level 3 -2.03 1.00 25 2300 U/L 37°C
Monthly Evaluation Report
The Monthly Evaluation Report provides a quick overview of laboratory performance for the month .
Standard Unity™ Interlaboratory Program Reports
• Alerts you when your SDI (a peer-based
measure of bias) or CVR (a peer-based measure
of imprecision) exceeds threshold limits. The
default threshold is 2.0 for both CVR and
SDI. These limits can be customized for your
laboratory upon request.
• Notifies you if your data has been rejected and
therefore not compared to the peer group.
• Notifies you if your data was not received on
time. Late reports are available upon request
from your Unity™ QC Program Representative.
9
Laboratory Performance Overview Report
Standard Unity™ Interlaboratory Program Reports
LEVEL
1
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
Alkaline PhospatasePNPP, AMP BufferRoche MODULARDedicated ReagentU/L 37°C
CVR Peer Method SDI: -0.27 -0.24 CVR: 0.7 0.2 # Labs: 15 407 # Points: 4,045 21,250
LEVEL
2
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
CVR Peer Method SDI: 0.48 0.30 CVR: 0.6 0.3 # Labs: 10 112 # Points: 3,763 7,679
LEVEL
1
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
ALT (ALAT/GPT)UV without P5PRoche MODULARDedicated ReagentU/L 37°C
CVR Peer Method SDI: -0.67 -0.81 CVR: 0.8 0.6 # Labs: 23 174 # Points: 4,964 11,755
LEVEL
2
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
CVR Peer Method SDI: -1.04 -0.50 CVR: 0.7 0.4 # Labs: 13 58 # Points: 3,809 5,933
LEVEL
1
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
Alkaline PhospatasePNPP, AMP BufferRoche MODULARDedicated ReagentU/L 37°C
CVR Peer Method SDI: -0.27 -0.24 CVR: 0.7 0.2 # Labs: 15 407 # Points: 4,045 21,250
LEVEL
2
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
CVR Peer Method SDI: 0.48 0.30 CVR: 0.6 0.3 # Labs: 10 112 # Points: 3,763 7,679
LEVEL
1
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
ALT (ALAT/GPT)UV without P5PRoche MODULARDedicated ReagentU/L 37°C
CVR Peer Method SDI: -0.67 -0.81 CVR: 0.8 0.6 # Labs: 23 174 # Points: 4,964 11,755
LEVEL
2
SDI
2.0
1.0
1.0 2.00
-1.0
-2.0
CVR Peer Method SDI: -1.04 -0.50 CVR: 0.7 0.4 # Labs: 13 58 # Points: 3,809 5,933
The Laboratory Performance Overview Report
allows you to visually evaluate both your
bias and imprecision for each of your tests
compared to the peer and method consensus
groups on a modified Youden Chart.
Your SDI is a peer-based measure of bias,
and your CVR is a peer-based measure of
imprecision.
No ShadingAcceptable performance.
Light ShadingAcceptable to marginal performance. May need to investigate test system performance.
Dark ShadingMarginal performance. May need to perform corrective action.
Outside of GraphUnacceptable performance. Requires corrective action.
The Laboratory Performance Overview Report displays your SDI (positive or negative) on the y-axis, and your CVR on the x-axis . Your performance versus the peer group (•) and method group ( ) are plotted on the graph . You can easily interpret the graph by observing where in the shaded regions your point falls .
The origin of the graph (SDI and CVR both equal to zero) represents perfect agreement between your
laboratory’s values and your consensus group (peer or method) statistics. Your bias and imprecision increase
as your values move further away from the origin of the graph.
The reverse side of this report has a comment section where you can record any observations or changes in
your test system in response to the results of this report.
10 Unity™ Interlaboratory Program
Laboratory Comparison Report
Standard Unity™ Interlaboratory Program Reports
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Laboratory Comparison ReportMultiqual 1, 2, 3 Unassayed Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
Analyte Methods Units TempInstrument / Kit Reagent
Alkaline Phosphatase
PNPP, AMP Buffer U/L 37° C
Roche MODULAR Dedicated Reagent
Your Lab Mean SD CV (Peer) CVR (Method) CVR (Peer) SDI (Method) SDI # Points
Peer Group Mean Roche MODULAR SD CV # Points # Labs
36.010.870
2.40.70.2
-0.27-0.24
534
36.351.283.5
404535
37.074.3611.8
21250407
36.971.333.60.80.3
0.00-0.212501
36.971.584.3
2164340
38.024.9012.9
298501612
141.11.991.40.60.3
0.480.30534
139.53.322.4
376322
138.87.565.4
7679112
141.42.261.60.60.3
0.370.272503
139.94.022.9
1725434
138.89.817.1
86655196
289.53.821.30.40.1
0.960.24
24
280.89.103.250431
283.624.98
8.816468
383
290.24.521.60.40.2
1.130.20136
278.510.31
3.75602
37
285.025.56
9.0267886
588
Mean SD CV # Points # Labs
Group Values by Method
Level 1
Mon Cum
Level 2
Mon Cum
Level 3
Mon Cum
The Laboratory Comparison Report allows you to compare your results to those of your peer and method
consensus groups. This report includes many vital statistics and is often the first report reviewed by
Unity™ participants.
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Laboratory Comparison ReportMultiqual 1, 2, 3 Unassayed Lot 10000
Data For: 05-2007Lot Exp: 08-31-2009
Printed: 05-31-07Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Labortories.
Analyte Methods Units TempIntrument / Kit Reagent
Alkaline Phosphatase
PNPP, AMP Buffer U/L 37° C
Roche MODULAR Dedicated Reagent
Your Lab Mean SD CV (Peer) CVR (Method) CVR (Peer) SDI (Method) SDI # Points
Peer Group Mean Roche MODULAR SD CV # Points # Labs
36.010.870
2.40.70.2
-0.27-0.24
534
36.351.28
3.54045
35
37.074.3611.8
21250407
36.971.33
3.60.80.3
0.00-0.212501
36.971.58
4.321643
40
38.024.9012.9
298501612
141.11.99
1.40.60.3
0.480.30534
139.53.32
2.43763
22
138.87.56
5.47679
112
141.42.26
1.60.60.3
0.370.272503
139.94.02
2.917254
34
138.89.81
7.186655
196
289.53.82
1.30.40.1
0.960.24
24
280.89.10
3.2504
31
283.624.98
8.816468
383
290.24.52
1.60.40.2
1.130.20136
278.510.31
3.75602
37
285.025.56
9.0267886
588
Mean SD CV # Points # Labs
Group Values by Method
Level 1
Mon Cum
Level 2
Mon Cum
Level 3
Mon CumStatistics for Each Test
Each test will contain
Your Lab
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Laboratory Comparison ReportMultiqual 1, 2, 3 Unassayed Lot 10000
Data For: 05-2007Lot Exp: 08-31-2009
Printed: 05-31-07Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Labortories.
Analyte Methods Units TempIntrument / Kit Reagent
Alkaline Phosphatase
PNPP, AMP Buffer U/L 37° C
Roche MODULAR Dedicated Reagent
Your Lab Mean SD CV (Peer) CVR (Method) CVR (Peer) SDI (Method) SDI # Points
Peer Group Mean Roche MODULAR SD CV # Points # Labs
36.010.870
2.40.70.2
-0.27-0.24
534
36.351.28
3.54045
35
37.074.3611.8
21250407
36.971.33
3.60.80.3
0.00-0.212501
36.971.58
4.321643
40
38.024.9012.9
298501612
141.11.99
1.40.60.3
0.480.30534
139.53.32
2.43763
22
138.87.56
5.47679
112
141.42.26
1.60.60.3
0.370.27
2503
139.94.02
2.917254
34
138.89.81
7.186655
196
289.53.82
1.30.40.1
0.960.24
24
280.89.10
3.2504
31
283.624.98
8.816468
383
290.24.52
1.60.40.2
1.130.20136
278.510.31
3.75602
37
285.025.56
9.0267886
588
Mean SD CV # Points # Labs
Group Values by Method
Level 1
Mon Cum
Level 2
Mon Cum
Level 3
Mon Cum
Peer and Method Group Statistics
Each test will contain
Monthly Cumulative Monthly Cumulative
Peer GroupRoche MODULAR
Group Values by Method
11
Laboratory Histogram Report
Standard Unity™ Interlaboratory Program Reports
The Laboratory Histogram Report contains information that you report for each analyte over a 12-month
period. It has a bar for each calendar month plus a cumulative bar. The Laboratory Histogram plots your
monthly means against the current cumulative peer group mean ± 2 SD range. For each bar, the report lists
your mean, SD, CV and number of points.
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Laboratory Histogram ReportMultiqual 1, 2, 3 Unassayed Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
PeerGroupRange
Level 1
Bromcresol green
Roche Hitachi Systems (USA) Dedicated Reagent g/dL
4.37
4.24
4.10
3.97
3.84
Mean 3.99 4.02 0 4.07 4.03 4.05 4.03 4.02 4.05 3.99 3.99 4.07 4.02 SD 0.040 0.07 0 0.080 0.090 0.070 0.070 0.070 0.080 0.080 0.080 0.090 0.081 CV 1.0 1.7 0.0 2.0 2.2 1.7 1.7 1.7 2.0 2.0 2.0 2.2 2.0 # Points 20 31 0 13 31 27 29 31 2 31 31 31 246
+2 SD
Mean
-2 SD
Albumin
Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Cumulative
PeerGroupRange
Level 2
2.99
2.89
2.79
2.69
2.58
Mean 2.72 2.73 0 2.82 2.77 2.77 2.76 2.73 2.72 2.71 2.72 2.74 2.74 SD 0.050 0.07 0 0.070 0.080 0.070 0.070 0.070 0.060 0.070 0.070 0.070 0.073 CV 1.8 2.6 0.0 2.5 2.9 2.5 2.5 2.6 2.2 2.6 2.6 2.6 2.7 # Points 21 31 0 13 31 27 27 31 21 31 31 31 264
+2 SD
Mean
-2 SD
Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Cumulative
The report provides a means to visually compare
your performance to your peer group over time.
This report is useful for identifying both shifts
(abrupt changes in values) and trends (gradual
changes in values) in your monthly results.
If a month contains no data points, it indicates that
either no values were submitted by your laboratory
for the month, late values were submitted for the
month, or all submitted values for the month were
outside of the statistical acceptance window and
were rejected by the Unity™ Interlaboratory Program
data filters.
12 Unity™ Interlaboratory Program
Bias & Imprecision Histogram Report
Standard Unity™ Interlaboratory Program Reports
The Bias & Imprecision Histogram Report was developed based on the work of Dr. Carmen Ricos, et al. in
Clinica Chimica Acta in 2004. This report provides a graphic representation of your lab’s bias, compared to the
current cumulative peer group mean and your CV. On the chart, your monthly CV is represented as a bar, and
your bias is represented as a diamond with lines connecting each diamond.
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Bias & Imprecision HistogramUnassayed Chemistry Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
(%)
Level 1Enzymatic, colorimetric CV BiasSiemens ADVIA 1650 DCL µg/mL
9.45
7.20
4.95
2.70
0.45
-1.80
-4.05
-6.30
-8.55
CV 4.35 9.48 7.89 6.90 5.13 4.39 4.35 5.08 5.13 4.35 9.48 7.89 Bias -7.75 -6.94 -8.55 -6.94 -6.14 -8.55 -7.75 -5.34 -6.14 -7.75 -6.94 -8.55
Acetaminophen
Oct07 Nov08 Dec07 Jan08 Feb08 Mar08 Apr08 May08 Jun08 Jul08 Aug08 Sep08
(%)
Level 2 CV Bias
6.35
5.24
4.13
3.02
1.91
0.80
-0.31
-1.42
-2.53
CV 1.95 5.90 6.35 4.32 5.33 2.69 3.88 3.61 3.75 1.95 5.90 6.35 Bias -1.74 -0.84 -2.53 -1.06 -0.73 -2.53 -1.40 -0.27 -0.84 -1.74 -0.84 -2.53
Oct07 Nov07 Dec07 Jan08 Feb08 Mar08 Apr08 May08 Jun08 Jul08 Aug08 Sep08
The Bias & Imprecision Histogram Report is
intended for you to detect changes in performance
over time, and to identify whether these
performance changes are due to imprecision, bias,
or both. The Bias & Imprecision Histogram Report
can be used to detect aberrant bias or CVs, but
does not contain specific thresholds for allowable
bias or allowable imprecision.
The primary use of this report is to detect changes
in performance over time. The determination
of whether a shift in performance is meaningful
or problematic can be made from other metrics,
including the SDI or CVR provided on the
Laboratory Comparison Report or by using
biological variation values for allowable
bias and imprecision.
13
Data Rejection Report
Standard Unity™ Interlaboratory Program Reports
The Data Rejection Report identifies data that
has been excluded from the Unity™ Interlaboratory
Program. Rejected data points are not included
in cumulative statistics or statistical comparisons.
If a rejection is due to data entered in error, you
can correct the error and Unity™ reports can be
regenerated upon your request by your Unity™ QC
Program Representative.
Data points may be rejected for two reasons:
• They fall outside the acceptable statistical
windows, based on the cumulative consensus
group mean or SD range, or based on the CV.
• They were reported using an incorrect test
definition (i.e., invalid units, invalid method, etc.).Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Data Rejection ReportUrine Chemistry Lot 10000
Data For: 05-2007Lot Exp: 08-31-2009
Printed: 05-31-06Page 1
Dear Customer,
The following data was not used as a part of the Unity™ worldwide statistical database. Please refer to your manual for a detailed explanation of rejection criteria.
Analyte / Date Level Mean SD CV # Points
Potassium ISE indirect Roche Hitachi Systems (USA) Dedicated Reagent mEq/L 05-2011 Level 2 5.22 0.07 ---- 16 Acceptable values are between 3.688 – 4.262
Statistical Threshold for CVs
For many analytes, if your CV is ≥ 40%, data will be
rejected. If your CV is < 40%, data will be accepted.
The CV limit may be tightened or widened for
selected tests. The acceptable CV threshold is
printed on the Data Rejection Report.
Statistical Window for Means
Mean ≤ 5.0 The allowable statistical window
is ±4 standard deviations from last month’s
consensus group cumulative mean.
Mean > 5.0 The allowable statistical window
is ±3 standard deviations from last month’s
consensus group cumulative mean.
14 Unity™ Interlaboratory Program
Worldwide Report
Optional Unity™ Interlaboratory Program Reports
Worldwide ReportUnassayed Chemistry
Conventional Units
Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
Analyte Methods Units TempInstrument / Kit Reagent
Hexokinase mg/dL
Abbott AEROSET / ARCHITECT (c8000, ci8200, i2000) Dedicated Reagent Mean SD CV # Points # LabsSiemens Dimension Series Dedicated Reagent Mean SD CV # Points # LabsOlympus AU 400 / 600 / 640 / 2700 / 5400 Dedicated Reagent Mean SD CV # Points # LabsRoche MODULAR (ISE, D, P, E170) Dedicated Reagent Mean SD CV # Points # Labs
87.482.052.3
133139
86.232.112.4
8679220
87.471.832.1
572631
87.231.912.2
201426
87.152.192.5
921450
86.712.072.4
71244273
87.692.002.3
4982736
87.652.022.3
1362326
288.64.811.7
127838
281.46.042.1
514429
283.75.892.1
5144229
286.25.902.1
200526
287.65.591.9
914750
283.76.262.2
72111274
284.45.992.1
4908136
287.26.062.1
1362726
Level 1
Mon Cum
Level 2
Mon Cum
Level 3
Mon Cum
Glucose
The Worldwide Report summarizes all the data submitted to the Unity™ Interlaboratory Program and
demonstrates both the tremendous breadth of the program and the size of the consensus groups. These
reports are available for each lot number of Bio-Rad control on QCNet.com or by special request.
The Worldwide Report supplies summary statistics,
including the means, SDs and CVs, for every peer
and method group in the Unity™ Interlaboratory
Program. This report is particularly useful when you
are starting a new lot of control and you want to
benchmark your first few data points against your
peers that have already started using the particular
lot of control.
Worldwide Reports are also available in a
modified format called the Manufacturer’s Report.
The Manufacturer’s Report is identical to the
Worldwide Report, except it lists only the statistics
for a particular manufacturer’s instruments.
15
Statistical Profile Report
Optional Unity™ Interlaboratory Program Reports
The Statistical Profile Report is one of the most advanced reports offered in the Unity™ Interlaboratory Program for analyzing your lab’s performance .
The Statistical Profile Report allows you to compare
your laboratory’s statistics to the peer, method,
and all labs consensus groups. The Statistical
Profile Report also provides two histograms that
summarize where your lab’s Mean and CV values
fall with respect to the Range of Mean and Range
of CV values calculated for each consensus group.
Major Sectionsof the StatisticalProfile Report4
Your Lab’s 2SD & 3SD Ranges A table displaying your lab’s 2SD and 3SD range for this quarter and this year.
1
Summary Statistics A table displaying summary statistics for your lab and your consensus group (peer, method and all labs) for this quarter and this year.
2
Histograms Histograms showing the location of your lab’s mean plotted on the range of means for all labs in the consensus group and your lab’s CV plotted on the range of CVs for all labs in the consensus group.
3
Percentile Distribution Table A Percentile Distribution table that includes the consensus group (peer, method and all labs) distributions for absolute bias, SD and CV for this quarter and this year. The Unity™ Interlaboratory Program excludes labs that report fewer than 6 data points during the quarter from the percentile distribution.
4
16 Unity™ Interlaboratory Program
Continued: Statistical Profile Report
Optional Unity™ Interlaboratory Program Reports
Your Lab’s 2 SD and 3 SD Ranges
The following figure shows the Statistical Profile Report header, and your lab’s 2SD and 3SD range for this
quarter and this year.
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Statistical ProfileUnassayed Chemistry Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
AlbuminRoche MODULARBromcresol greeng/dLDedicated Reagent
Your Lab 2s Range Your Lab 3s Range
3.93 – 4.21 3.86 – 4.27
3.86 – 4.29 3.76 – 4.40
This Quarter
This Year
Summary Statistics
The following figure shows the Statistical Profile Report summary statistics table for your laboratory and the
three consensus groups (peer, method, and all labs).
Your Lab Peer GroupMethodGroup All Labs Your Lab Peer Group
MethodGroup All Labs
Summary Statistics (This Quarter) Summary Statistics (This Year)
N/A 4.10 4.07 3.83 N/A 4.10 4.08 3.83
4.07 4.10 4.07 3.84 4.08 4.10 4.08 3.84
0.07 0.09 0.09 0.09 0.11 0.08 0.09 0.08
1.68 2.28 2.37 2.34 2.62 2.02 2.15 2.22
N/A 0.77 0.04 5.92 N/A 0.64 0.12 6.20
1 35 219 960 1 33 223 988
227 3468 28248 103592 238 3009 33254 113082
Median
Mean
SD
CV
/ Lab Bias /
# Labs
# Points
1
2
17
Continued: Statistical Profile Report
Optional Unity™ Interlaboratory Program Reports
Histograms
The frequency histogram section of the Statistical Profile Report contains two frequency histograms:
• Lab Means for this quarter
• Lab CVs for this quarter
LEVEL 1
3.39 3.51 3.83 4.05 4.26
250
225
200
175
150
125
100
75
50
25
FREQUENCY HISTOGRAM OF LABORATORY MEANS FOR THIS QUARTER
Num
ber o
f Lab
orat
orie
s
Range of Means8 Labs 28 Labs
LEVEL 1
0 5.0 10.0 15.0 20.0
500
450
400
350
300
250
200
150
100
50
FREQUENCY HISTOGRAM OF LABORATORY CVs FOR THIS QUARTER
Num
ber o
f Lab
orat
orie
s
Range of CV 1 Lab
All Labs Method Group Your Lab’s Mean or CV
Percentile Distribution Table
The Percentile Distribution Table shows the lab distribution in percentiles for absolute bias, SD and CV for each consensus group (peer, method, and all labs). You can compare your absolute bias, SD or CV to the table to discover your approximate position in the percentile distribution and find out how many labs have better or worse performance than your laboratory.
This Quarter
Percentile Distribution
This Year
0.31 0.68 1.14 1.30 1.52 1.86 2.13 2.59 2.86 3.21 0.25 0.47 0.54 0.83 1.10 1.64 2.13 2.75 3.74 1.97
0.07 0.06 0.09 0.09 0.10 0.10 0.10 0.11 0.14 0.14 0.06 0.06 0.07 0.08 0.08 0.08 0.10 0.11 0.13 0.07
1.51 1.91 2.14 2.26 2.30 2.33 2.41 2.62 3.29 3.51 1.41 1.53 1.70 1.87 1.90 1.94 2.56 2.68 3.03 1.60
0.37 0.58 0.98 1.35 1.74 2.17 2.65 4.35 7.38 11.85 0.38 0.63 1.00 1.55 1.90 2.30 3.31 4.55 7.37 12.27
0.05 0.06 0.07 0.07 0.08 0.09 0.10 0.11 0.13 0.18 0.05 0.06 0.06 0.07 0.08 0.08 0.09 0.10 0.11 0.15
1.23 1.45 1.65 1.84 1.99 2.19 2.41 2.63 3.13 4.62 1.14 1.34 1.52 1.70 1.85 1.96 2.23 2.51 2.83 3.83
1.47 3.14 4.79 5.51 6.31 7.10 8.15 9.99 12.83 14.98 1.58 3.62 5.39 6.14 6.70 7.35 8.46 10.58 13.12 15.01
0.05 0.06 0.07 0.07 0.08 0.08 0.09 0.10 0.13 0.15 0.05 0.06 0.07 0.07 0.07 0.08 0.09 0.10 0.12 0.15
1.33 1.53 1.71 1.86 2.01 2.19 2.45 2.75 3.34 4.06 1.27 1.45 1.59 1.78 1.93 2.14 2.39 2.73 3.15 3.86
/Bias/
SD
CV
/Bias/
SD
CV
/Bias/
SD
CV
Median 10° 20° 30° 40° 50° 60° 70° 80° 90° 95°
Median 10° 20° 30° 40° 50° 60° 70° 80° 90° 95°
Peer
Met
hod
All L
abs
3
4
The arrow represents your lab’s performance so you can visually determine where your lab fits in the distribution of consensus group means and CVs.
18 Unity™ Interlaboratory Program
Affiliated Reports
Optional Unity™ Interlaboratory Program Reports
The Affiliated Reports allow a group of labs to compare their results — essentially becoming their own
consensus group. These reports are ideal for a Laboratory Manager or Quality Control Coordinator who is
responsible for multiple sites or multiple instruments of a common make and model.
Contact your Bio-Rad QC Program Representative
to request any of the available Affiliated Reports.*
Types of Affiliated Reports Available
• Affiliated Laboratory Comparison Report: Abbreviated Summary
• Affiliated Laboratory Comparison Report
• Affiliated Data Exception Report
Comparing Results Across Affiliated Laboratories
* Additional charges may apply to configure and maintain Affiliated Reports .
19
Optional Unity™ Interlaboratory Program Reports
Affiliated Laboratory Comparison Report: Abbreviated Summary
The Affiliated Laboratory Comparison Report: Abbreviated Summary is a simplified version of the original
Affiliated Laboratory Comparison Report (the first affiliated-level report developed by Bio-Rad). The abbreviated
version quickly became the most popular affiliated report when it was introduced. This report is designed for
quick review and focuses on key statistics to provide a performance summary.
Bilirubin, Direct/BC (DBIL) mg/dL cont.
LabInstrument
DiazotizationDedicated Reagent Peer
MethodAffiliate
Mean SD CV # Points # Labs 0.294 0.043 14.63 1690 25
0.332 0.080 24.10 12121 317
0.289 0.022 7.61 77 4
Mean
SD
0.30
0.00
0.00 0.00 0.00 0.00 0.14 -0.40 0.50
31
CVR
(Peer)
CVR
(Method)
CVR
(Affiliate)
SDI
(Peer)
SDI
(Method)
SDI
(Affiliate)
CV
# Points
Mean SD CV # Points # Labs 1.20 0.091 7.58 1619 24
1.37 0.317 23.14 11676 303
1.15 0.058 5.04 77 4
Mean
SD
1.17
0.04
3.42 0.45 0.15 0.68 -0.33 -0.63 0.34
31
CVR
(Peer)
CVR
(Method)
CVR
(Affiliate)
SDI
(Peer)
SDI
(Method)
SDI
(Affiliate)
CV
# Points
170278 Associated Regional Lab 1
Roche Hitachi Systems (USA)
Level 1 Level 2
0.30
0
0.00 0.00 0.00 0.00 0.14 -0.40 -0.50
1
1.20
0
0.00 0.00 0.00 0.00 0.00 -0.54 0.86
1
170293 Associated Regional Lab 5
Roche Hitachi Systems (USA)
0.26
0.02
7.69 0.53 0.32 1.01 -0.79 -0.90 -1.32
22
1.14
0.08
7.02 0.92 0.30 1.40 -0.66 -0.73 -0.17
22
194633 Associated Regional Lab 8
Roche Hitachi Systems (USA)
0.30
0.10
3.33 0.23 0.14 0.43 0.14 -0.40 0.50
23
1.12
0.04
3.57 0.47 0.16 0.72 -0.88 -0.79 -0.52
23
227703 Associated Regional Lab 2
Roche Hitachi Systems (USA)
Standard For Each Test
• Lab Mean
• Lab SD
• Lab CV
• Number of data points reported
• CVR compared to the Peer Method and Affiliated groups
• SDI compared to the Peer Method and Affiliated groups
Additional For Peer, Method & Affiliated Groups
• Mean
• SD
• CV
• Number of data points reported
• Number of labs reporting
You can request that this report appear in either SI
or Conventional units, rather than both.
This report provides
the CVR and SDI for
the peer, method, and
affiliated groups, which
allows you to statistically
compare each lab’s
results to these groups.
This report summarizes the performance of each participating affiliated laboratory in a single report and is designed for the Quality Control Coordinator or the Laboratory Manager responsible for multiple sites .
20 Unity™ Interlaboratory Program
Optional Unity™ Interlaboratory Program Reports
Affiliated Laboratory Comparison Report
The Affiliated Laboratory Comparison Report
summarizes the performance of each participating
affiliated laboratory in a single report and is
designed for the Quality Control Coordinator or the
Laboratory Manager responsible for multiple sites.
This report is also useful for comparing multiple
instruments made by the same manufacturer,
whether the instruments are within or across sites.
Statistics provided for each of your affiliated
laboratories include the Mean, SD, CV and the
number of points. The statistics from each affiliated
laboratory are compared to both the peer group
and lab group (affiliated group). This report also
includes a comparison of your affiliated group
as a whole to the peer group.
If you are a laboratory that reports results in both Conventional and SI units, you can request that this report appear in one or the other units, rather than both .
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Lot 00000
Data For: 09-2011Lot Exp: 09-30-2013Printed: 09-30-2011
Page 1
Affiliated Laboratory Comparison ReportUnassayed Chemistry
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Labortoraies.
Analyte Methods Units TempIntrument / KitReagent Lab
Glucose oxidase, hydrogen peroxide (Trinder) mg/dL
VITROS 250 / 500 / 700 Slide Generation #32
254890 Associated Regional Laboratory Mean SD CV # Points
Lab to Peer Group CVR SDI
Lab to Lab Group CVR SDI
252458 Memorial Medical Center Laboratory Mean SD CV # Points
Lab to Peer Group CVR SDI
Lab to Lab Group CVR SDI
92.11 88.24 283.9 278.0 1.95 2.39 5.52 5.45 2.1 2.7 1.9 2.0 24 270 24 270
0.8 0.9 1.0 0.9 2.52 0.20 1.69 0.27
0.5 1.0 0.8 1.0 0.93 0.52 0.79 0.67
88.54 88.16 277.2 276.1 2.87 2.93 5.01 6.19 3.2 3.3 1.8 2.2 34 408 36 432
1.2 1.1 0.9 1.0 0.88 0.17 0.41 -0.03
0.7 0.9 0.7 0.9 -0.14 -0.02 -0.30 -0.07
Level 1
Mon Cum
Level 2
Mon Cum
Glucose
21
Affiliated Data Exception Report
Optional Unity™ Interlaboratory Program Reports
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Lot 00000
Data For: 09-2011Lot Exp: 09-30-2013Printed: 09-30-2011
Page 1
Affiliated Data Exception ReportMultiqual 1, 2, 3 Unassayed
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
131876 Associated Regional Lab
Chloride ISE indirect Beckman Coulter CX Series Dedicated Reagent mEq/L
09-2011 Level 1 Lab Mean = 81.00 Lab SD = 0.900 Lab CV = 1.11% Lab # Points = 32 Lab # Labs = N/A Peer Mean = 80.14 Peer SD = 1.76 Peer CV = 2.20% Peer # Points = 2257 Peer # Labs = 46 Method Mean = 75.85 Method SD = 2.55 Method CV = 3.15% Method # Points = 22027 Method # Labs = 387 Affiliate Mean = 81.00 Affiliate SD = 0.900 Affiliate CV = 1.11% Affiliate # Points = 32 Affiliate # Labs = 1
Method SDI = 2.02 Acceptable values are between 0 – 2.00
987654 Associated Regional Lab 1
Albumin Bromcresol purple Beckman Coulter CX Series Dedicated Reagent g/L No Temperature
09-2011 Level 1 Lab Mean = 2.5 Lab SD = 0.05 Lab CV = 2.0% Lab # Points = 29
Acceptable Mean values are between 20.9979 – 26.2313
480921 Associated Regional Lab 2
Albumin Bromcresol purple Beckman Coulter CX Series Dedicated Reagent g/L No Temperature
08-2011 Level 3 Lab Mean = 4.2999 Lab SD = 0.06 Lab CV = 1.39% Lab # Points = 24
Acceptable Mean values are between 38.5843 – 44.7415
SDI AND CVR WARNINGThe following data exceeded prescribed SD or CVR warning limits when compared to the consensus group.
DATA REJECTIONThe following data was not used as a part of the Unity™ worlwide statistical database.
The Affiliated Data Exception Report, in combination with the other Affiliated Reports, is ideal for Quality Control
Coordinators or Laboratory Managers who either manage multiple lab sites or multiple instruments of the same
make or model.
For all laboratories within the affiliated lab group, this report lists any analyte that:
• Exceeds specified SDI or CVR warning limits compared to the consensus groups
• Is rejected by a Unity™ Interlaboratory Program data filter
• Contains a suspected coding error
22 Unity™ Interlaboratory Program
Urinalysis Reports
Optional Unity™ Interlaboratory Program Reports
If you submit data for any Bio-Rad Urinalysis control product to the Unity™ Interlaboratory Program, you will
receive a qualitative report that consists of the following:
• Cover page
• Chemistry Report for each method submitted (when appropriate)
• Microscopics Report for each method submitted (when appropriate)
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Peer Group Quality Control ReportqUAntify Plus Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
qUAntify Plus Level I Lot #: N3025 – 22 labs reporting
Leukocytes
Day of Month 1
Group
50.0%
50.0%
0.0%
0.0%
0.0%
neg.trace
+/small++/mod.
+++/large2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Urobilinogen
Day of Month 1
Group
50.0%
0.0%
50.0%
0.0%
0.0%
normal1245
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Protein
Day of Month
Group
50.0%
50.0%
0.0%
0.0%
0.0%
0.0%
neg.trace+/30
++/100+++/300
++++/20001 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Nitrite
Day of Month
Group
51.1%
48.9%
neg.trace
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
pH
Day of Month
Group
25.0%
22.7%
2.3%
0.0%
50.0%
0.0%
0.0%
5.06.06.57.07.58.08.5
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
qUAntify Plus Level II Lot #: A3025 – 22 labs reporting
Protein
Day of Month
Group
0.0%
0.0%
0.0%
0.0%
50.0%
50.0%
neg.trace+/30
++/100+++/300
++++/20001 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Urobilinogen
Day of Month 1
Group
50.0%
0.0%
50.0%
0.0%
0.0%
normal1245
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Leukocytes
Day of Month 1
Group
50.0%
0.0%
50.0%
0.0%
0.0%
neg.trace
+/small++/mod.
+++/large2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Nitrite
Day of Month
Group
50.0%50.0%
neg.trace
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
pH
Day of Month
Group
50.0%
0.0%
0.0%
0.0%
50.0%
0.0%
0.0%
5.06.06.57.07.58.08.5
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Chemistry Report
The chemistry section of the Urinalysis Report
provides a simulation of your laboratory responses
vs. a representation of the group responses using
the visual color changes of reagent strips.
On this report, arrows identify the majority group
response. The complete report includes leukocytes,
nitrite, urobilinogen, protein, pH, blood, specific
gravity, ketones, bilirubin, glucose and hCG.
23
Continued: Urinalysis Reports
Optional Unity™ Interlaboratory Program Reports
Microscopics Report
Graphics on the Microscopics Report simulate your average response and the group’s average response. Your
daily responses appear above the graphics with an arrow to indicate the majority group response.
Lab 001234
QC CoordinatorAssociated Regional Laboratory123 Main StreetAnytown, NY, 12345-6789
Peer Group Quality Control ReportqUAntify Plus Lot 10000
Data For: 09-2011Lot Exp: 09-30-2013
Printed: 09-30-11Page 1
The following statistics are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to customers. Such action does not imply support of reported analytes and test methods for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.
qUAntify Plus Level I Lot #: 78811 – 31 labs reporting
RBC per hpf
Your Average Response0 – 3 per hpf
Group Average Response0 – 3 per hpf
Day of Month
Group
0.0%
0.0%
0.1%
0.2%
5.5%
94.2%
26 or more21 – 2516 – 2011 – 154 – 100 – 3
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
qUAntify Plus Level II Lot #: 78812 – 31 labs reporting
RBC per hpf
Your Average Response4 – 10 per hpf
Group Average Response11 – 15 per hpf
Day of Month
Group
0.0%
0.0%
0.2%
94.2%
5.5%
0.1%
26 or more21 – 2516 – 2011 – 154 – 100 – 3
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
The complete report includes RBC, WBC and crystals .
24 Unity™ Interlaboratory Program
InstantQC™ Reports
Optional Unity™ Interlaboratory Program Reports
The Unity™ Interlaboratory Program offers all
program participants the ability to receive
on-demand InstantQC™ Reports. These reports are
particularly useful for troubleshooting issues with
test system performance at the time they occur
because of the immediate report availability with
up-to-the minute peer group data.
InstantQC™ Reports are available to all Unity™
participants with access to the QCNet™ website
(www.qcnet.com). From QCNet™, InstantQC™
Reports are generated at the moment you request
a report with all the peer data that is available at
the moment the report is requested. Even if you
have not yet submitted data for the selected
month, you will still receive the very latest peer
group information for all your tests open in Unity™.
The InstantQC™ Report provides up-to-the minute peer group information for troubleshooting issues with your setting systems .
Advantages of InstantQC™ Reports
• InstantQC™ Reports are generated at the moment you request them with the peer data available at the moment the report is requested.
• All Unity™ Interlaboratory participants can
generate InstantQC™ Reports for all open tests at any time, even if you have not yet submitted data for the selected period.
• InstantQC™ Reports are generated in the same language you request for your
monthly Unity™ Interlaboratory Reports.
• InstantQC™ Reports are now available as Adobe®
Acrobat® PDF files, in a format similar to the
monthly Unity™ Interlaboratory Reports.
25
Continued: InstantQC™ Reports
Optional Unity™ Interlaboratory Program Reports
The InstantQC™ Reports are intended primarily for troubleshooting test system performance when
a malfunction is suspected. For this reason, the reports are only provided for time periods up to the release
of the standard monthly Unity™ Interlaboratory Program reports. You should always refer to your standard
monthly reports as they become available. The monthly reports are more comprehensive, and the
application of a deadline ensures that peer group sizes are maximized for regular, documented review
of your test systems.
26 Unity™ Interlaboratory Program
Glossary of Terms
CV =Standard Deviation
Mean100
CVR =Your CV
Consensus Group CV
SD = (xn – x)2
n – 1
SDI =
Your Mean – Consensus Group Mean
Consensus Group SD
Bias% =
Your Mean – Consensus Group Mean
Consensus Group Mean100
Affiliated GroupA group of labs that the Unity™ Interlaboratory Program groups together to form an ad hoc consensus group and for which it generates specific Affiliated Reports. You must contact your Bio-Rad Software Support Representative to request inclusion in an affiliated group.
All Labs GroupThe Unity™ Interlaboratory Program consensus group that encompasses all labs reporting values for an analyte/matrix combination irrespective of the methodology, instrument or reagents. Of peer, method and all labs, this is the least specific consensus group.
BiasThe difference between the expected test results and an accepted reference value. In Unity™, the consensus groups are used for the comparator.
NOTE: Bias is the total systematic error as contrasted to random error. There may be one or more systematic error components contributing to the bias. A larger systematic difference from the accepted reference value is reflected by a larger bias value. [ISO 3534-I]
Coefficient of Variation (CV)The relative standard deviation (i.e., the standard deviation expressed as a percentage of the mean). The CV is useful because it is concentration independent.
CVRCoefficient of variation ratio — a statistic that compares your lab’s precision to that of other labs in a consensus group.
ImprecisionImprecision is a term to describe the dispersion or spread of a set of values about the mean value of a normal or gaussian distribution. It is usually expressed as a standard deviation (SD) or coefficient of variation (CV).
MeanThe arithmetic average of a set of data points.
Method GroupThe Unity™ Interlaboratory consensus group that encompasses all labs reporting an analyte using the same methodology code (e.g., all customers reporting glucose by hexokinase).
Peer GroupThe “ideal” consensus group that encompasses all labs using the exact same methodology, instrument and reagents.
Standard Deviation (SD)Abbreviated as SD or s. The SD quantifies the degree of dispersion of data points around the mean and is defined by the formula:
Where:
• SD = standard deviation • x = mean (average) of the QC values•• •Σ•(xn – x)2•= the sum of the squares
of differences between individual QC values and the mean
• n = the number of QC values in the data set
Standard Deviation Index (SDI)A statistic that measures your lab’s bias relative to your consensus group.
27
UnityWeb® Unity Real Time® LT
Unity Real Time®
onlineUnity Real Time®
Basic User Options Advanced User Options
Internet-based solutions such as UnityWeb® and Unity Real Time® online eliminate the need to install and update software locally in your laboratory, and reduce the amount of support necessary from on-site IT staff.
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 or Desktop Software?
Compare Your Unity™ OptionsBio-Rad offers several options for participation in the Unity™ Interlaboratory Program.
Type of Solution
Web Service (Internet-Based)
Desktop Software
Unity™ Interlaboratory Reports
Monthly Reports
InstantQC™ Reports
Basic Intralaboratory Charts & Reports
Westgard Rules
Various Charts and Reports
Additional Features
Westgard Advisor™ (Subscription sold separately)
Bench Review
Bench & Supervisor Data Review
Analytical Goals
Dynamic Data Set Comparisons
Database Platform
Bio-Rad Hosted
Installed on Local Laboratory PC
Connectivity (Sold separately)
WebConnect™
UnityConnect™
28 Unity™ Interlaboratory Program
Want to know more? Discover the power of Unity™ Solutions at www.QCNet.com/Unity
Unity Real Time®
• 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
• RiLiBÄK module to comply with German regulations
• Upload QC data points from an LIS, middleware or instrument (optional)
Expert QC Data Management Solution for Desktop or Online Users
Automatic QC Rules Selection Engine
• Recommend and automatically apply best QC rules with patented 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 and troubleshooting
• Improve laboratory test quality with optimally selected QC rules
• Available as an optional module with Unity™ QC data management solutions
Westgard Advisor™
Entry-level QC Data Management Solutions
• Basic QC rules, charts and reports
• Easily upgradable to Unity Real Time® for more advanced tools and features
• Upload QC data points from an LIS, middleware or instrument (optional)
• No software to install with UnityWeb®
UnityWeb® & Unity Real Time® LT
Automated Uploads to Unity™ SoftwareUnityConnect™
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.
• Eliminates manual keying of QC data • Enables standard LIS QC reports to be used • Provides automatic data import • Provides real-time connection • Transparent to the flow of data to the LIS • Captures and analyzes QC data economically from
laboratory instruments not connected to the LIS • Easy-to-install optional interface hardware • Choose from soft, serial, ethernet and wireless connections
WebConnect™ 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®.
• Eliminates manual keying of data • Enables standard LIS QC reports to be used • No software to install
Clinical Diagnostics Group
Website www.bio-rad.com/qualitycontrol U.S. 1-800-2BIO-RAD Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-64260808 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary +36-1-459-6100 India 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 Korea 82-2-3473-4460 Mexico 52(55)5200-0520 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000
© 2011 Bio-Rad Laboratories, Inc. Printed in the USA 11/11 QSD11-428 Q-1144
For further information, please contact your local Bio-Rad office or learn more online at www.QCNet.com.
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