unity interlaboratory program - qcnet.com · 2 unity ™ terlaboratory rogram unity™...

Unity™ Interlaboratory ProgramOptimize Your Laboratory Performance as a Member of the World’s Largest Community of QC Users

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

www.bio-rad.com/qualitycontrol 11

Table of Contents

Unity™ Interlaboratory Program

An Effective Tool for Evaluating Analytical Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

The Advantages of Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

What are the Basic Comparison Statistics in an Interlaboratory Program

and What Do They Indicate About Laboratory Performance? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Reports Reference Guide

Monthly Evaluation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Laboratory Performance Overview Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Laboratory Comparison Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Laboratory Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Bias and Imprecision Histogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Worldwide Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Statistical Profile Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13

Affiliated Reports

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Laboratory Comparison Report: Abbreviated Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Laboratory Comparison Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Laboratory Data Exception Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Additional Reports

Qualitative Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18-19

Qualitative Worldwide Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

InstantQC™ Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Additional Information

Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Unity™ QC Data Management Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-24

http://www.bio-rad.com/qualitycontrol

Unity™ Interlaboratory Program2

Unity™ Interlaboratory Program: A Powerful Tool for Evaluating Analytical PerformanceJoin over 23,000 of your peers contributing data for over 44,000 instruments in the most robust program for clinical labs.

“To compare our data with a substantial peer group ensures that we are turning out reliable patient data.”

— Laboratory Supervisor, School of Medicine

“The reports are clean and easy to read and understand. For each test, Unity Reports for our lab show a summary of our data, our instrument group, and our method group—reports are simple.”

— Clinical Chemist, Hospital Laboratory

“The documentation of Bio-Rad Controls using the Unity™ QC Program has been well accepted by CAP inspectors. Worry free QC.”

— Laboratory Director, Health Center

“The laboratory shall participate in interlaboratory comparison programme(s) . . .”

— ISO 15189:2012(E), Subclause 5.6.3.1.

“The laboratory shall design internal quality control systems that verify the attainment of the internal quality of results. ”

— ISO 15189:2012(E), Subclause 5.6.2.1.

“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, C24-A3, Vol. 26, No 25.

Quality Control practices have evolved to address patient safety concerns and other laboratory issues – including improvements in the use of statistical analysis for assessment of system performance. An effective interlaboratory program is only as reliable as the data it incorporates, giving laboratories the opportunity to measure and improve their analytical performance. Unity™ Reports are designed with these concerns in mind because so much depends on a lab’s performance.

In addition to daily QC, ISO (International Organization for Standardization), CLSI (Clinical and Laboratory Standards Institute) and other regulatory and accreditation organizations highly recommend participation in an interlaboratory program. Unity™ data comparison provides the context and perspective of performance to your peers allowing for immediate action when potential problems are spotted.


Receive reliable information from a trusted source

• Largest peer groups available in the clinical diagnostics industry.

• Provides a high degree of confidence in the statistical comparisons offered with more than 44,000 instruments participating from over 79 countries.

• Bio-Rad provides over 30 years of experience in managing peer programs.

Detect and identify potential analytical errors of importance

• Detect changes caused by reagent or calibrator reformulations, standardization adjustments or instrument software changes.

• Identify unrecognized trends or shifts that may occur between proficiency tests.

• Unity™ offers values to guide you on NEW control lot performance.

• Improve the reliability of test results for quality patient care.

Get a trusted, unbiased perspective

• Bio-Rad controls and software are not optimized for a specific test system.

• Obtain information from the largest peer group of data users.

• Receive values for both assayed and unassayed control materials.

Supplement Proficiency Testing (PT) Programs

• Complement your PT programs and verify performance on a daily basis by data comparison to your peer groups.

• Increase confidence that your PT outcomes will compare well to those of other laboratories.

• Unity™ may give meaningful comparisons for parameters not available in a PT program.

Meet accreditation and regulatory requirements

• Demonstrates commitment to procedural quality and can help you meet ISO 15189 and accreditation requirements.

• May be used to implement or maintain various LEAN and/or Six Sigma practices.

Access peer data on demand

• Real time data submission allows you to receive on-demand interlaboratory comparison reports with InstantQC™.

• Critical for assessing performance while troubleshooting.

The Advantages of Participating in the Unity™ Interlaboratory Program

Is your laboratory a statistical island?



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


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


Unity™ Interlaboratory ProgramOptimize Laboratory Performance: Become a Member of the World’s Largest Community of QC Users

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 15 Feb-2015 17:28:36

Monthly EvaluationImmunoassay Plus • Lot 12345 • Exp 01-Dec-2018

January 2015 • Lab 12345

The statistics in this report are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package insert 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.

Associated Regional Laboratory 123 Main Street

Anytown, NY 12345-6789Attention: Lab Supervisor

Gentamicin Immunoturbidimetric ug/mLLevel Lab Peer Method

1# Points

Mean

CV SD

# Labs

2.150.146.531

Siemens Dimension RXL

2# Points

Mean

CV SD

# Labs

5.540.171

3.132

5.980.209

3.5

2206588

6.310.469

7.4

65919764

Please review your QC reports for January 2015.

! The tests listed below may require investigation or review !

2.800.170

6.0

2236797

3.000.253

8.4

67020391

Data Exclusion: Lab Mean = 2.15Acceptable values are 2.1841 to 3.5306This data was not used as part of the Unityworldwide statistical database.

!

3# Points

Mean

CV SD

# Labs

7.940.215

2.733

7.870.273

3.5

2236797

8.130.575

7.1

67020391

Level

This level is within established parametersPeer CVR Method CVR

Peer SDI Method SDI

3 0.80.4

0.25-0.33

1

Warning: Acceptable values are above -2.0, below 2.0

Peer CVR Method CVR

Peer SDI Method SDI

2 0.90.4

-2.1-1.6

Alerts you to submission issues, warnings, and data exclusions at a glance.

• Warns you when your SDI or CVR exceed a threshold of 2.0. These limits can be customized upon request.• Alerts you to any data exclusions.• Notifies you if your data was not received on time.

Monthly Evaluation Report

Warns your lab of potential issues that require further investigation.



Laboratory Performance Overview Report

Bias (SDI) and imprecision (CVR) data in a modified Youden chart visually indicate your laboratory performance.

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 15-Feb-2015 17:28:36

Laboratory Performance OverviewImmunoassay Plus • Lot 12345 • Exp 01-Dec-2018





Siemens Dimension EXL

Vancomycin Immunoturbidimetric ug/mLPeer MethodLevel

SDI CVR

# Points # Labs

1 -0.390.1

13448402

-0.850.4

403441206

0

2

-2

2

SDI

CVR

-1

1

Peer MethodLevel

2 -0.280.5

13145398

-0.830.3

394351195

0

2

-2

2

SDI

CVR

-1

1

Peer MethodLevel

3 1.50.5

13448402

2.220.3

403441206

0

2

-2

2

SDI

CVR

-1

1

PeerMethod

PeerMethod

PeerMethod

0

2

-2

2

SDI

CVR

-1

1

No Shading


Light Shading

Acceptable to marginal performance. May need to investigate test system performance.

Dark Shading

Marginal performance. May need to perform corrective action.

Outside of Graph

Unacceptable performance. Requires corrective action.

Performance versus peer (•) and method (□) consensus groups are plotted on a graph for fast comparison to your consensus group statistics.

• SDI (positive or negative) displays on the y-axis, and your CVR on the x-axis in a modified Youden chart.• Print in either color or black and white.• Data displays – up to 3 levels per row – for easy review.• Arrows outside the chart margins indicate the presence of off the chart values.


Laboratory Comparison Report

A comprehensive overview of your monthly and cumulative QC performance compared to peer and method consensus groups.


Laboratory Comparison ReportImmunoassay Plus • Lot 12345 • Exp 01-Dec-2018






Carbamazepine (Tegretol) Immunoturbidimetric ug/mLMon CumLevel Mon Cum Mon Cum Mon Cum

Your Lab Peer Group Method Group

3Peer CVR Method CVR

Peer SDI Method SDI

3 0.70.6

-0.21-0.09

1.41.2

-0.230.11 # Points

Mean

CV SD

# Labs

14.410.391

2.733

14.530.890

6.1294

14.540.588

4.0

2266794

14.680.661

4.5

30853336

14.470.640

4.4

67720382

14.450.730

5.1

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

2 0.90.8

0.05-0.06

0.90.8

-0.55-0.21 # Points

Mean

CV SD

# Labs

8.750.314

3.634

8.660.366

4.2294

8.730.369

4.2

2226412

8.880.402

4.5

30350441

8.770.414

4.7

66619236

8.750.448

5.1

909151K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.90.8

0.100.45

1.81.7

-0.120.4 # Points

Mean

CV SD

# Labs

2.990.170

5.733

2.990.37212.5316

2.970.196

6.6

2266794

3.010.209

7.0

30853336

2.900.201

6.9

67720382

2.900.219

7.6

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

3 1.10.6

0.220.37

1.20.8

-0.020.19 # Points

Mean

CV SD

# Labs

3.200.142

4.432

3.160.170

5.4300

3.170.132

4.2

31010978

3.170.141

4.5

41386299

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.60.4

-0.71-0.58

1.00.7

0.04-0.12 # Points

Mean

CV SD

# Labs

0.7140.038

5.331

0.7670.070

9.1308

0.7660.073

9.5

31010978

0.7640.068

8.9

41386299

0

2

-2

2

SDI

CVR

-1

1


Digoxin EIA ng/mLMon CumLevel Mon Cum Mon Cum

Your Lab Peer Group

SiemensDimension Series

Immunoturbidimetric

Mon CumMethod Group

3.120.219

7.0

62121956

3.120.213

6.8

826173K

0.7720.10113.1

62121956

0.7790.10513.4

826173K

EIASiemensDimension Series











Peer SDI Method SDI

3 0.70.6

-0.21-0.09

1.41.2

-0.230.11 # Points

Mean

CV SD

# Labs

14.410.391

2.733

14.530.890

6.1294

14.540.588

4.0

2266794

14.680.661

4.5

30853336

14.470.640

4.4

67720382

14.450.730

5.1

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

2 0.90.8

0.05-0.06

0.90.8

-0.55-0.21 # Points

Mean

CV SD

# Labs

8.750.314

3.634

8.660.366

4.2294

8.730.369

4.2

2226412

8.880.402

4.5

30350441

8.770.414

4.7

66619236

8.750.448

5.1

909151K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.90.8

0.100.45

1.81.7

-0.120.4 # Points

Mean

CV SD

# Labs

2.990.170

5.733

2.990.37212.5316

2.970.196

6.6

2266794

3.010.209

7.0

30853336

2.900.201

6.9

67720382

2.900.219

7.6

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

3 1.10.6

0.220.37

1.20.8

-0.020.19 # Points

Mean

CV SD

# Labs

3.200.142

4.432

3.160.170

5.4300

3.170.132

4.2

31010978

3.170.141

4.5

41386299

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.60.4

-0.71-0.58

1.00.7

0.04-0.12 # Points

Mean

CV SD

# Labs

0.7140.038

5.331

0.7670.070

9.1308

0.7660.073

9.5

31010978

0.7640.068

8.9

41386299

0

2

-2

2

SDI

CVR

-1

1



Your Lab Peer Group


Immunoturbidimetric

Mon CumMethod Group

3.120.219

7.0

62121956

3.120.213

6.8

826173K

0.7720.10113.1

62121956

0.7790.10513.4

826173K












Peer SDI Method SDI

3 0.70.6

-0.21-0.09

1.41.2

-0.230.11 # Points

Mean

CV SD

# Labs

14.410.391

2.733

14.530.890

6.1294

14.540.588

4.0

2266794

14.680.661

4.5

30853336

14.470.640

4.4

67720382

14.450.730

5.1

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

2 0.90.8

0.05-0.06

0.90.8

-0.55-0.21 # Points

Mean

CV SD

# Labs

8.750.314

3.634

8.660.366

4.2294

8.730.369

4.2

2226412

8.880.402

4.5

30350441

8.770.414

4.7

66619236

8.750.448

5.1

909151K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.90.8

0.100.45

1.81.7

-0.120.4 # Points

Mean

CV SD

# Labs

2.990.170

5.733

2.990.37212.5316

2.970.196

6.6

2266794

3.010.209

7.0

30853336

2.900.201

6.9

67720382

2.900.219

7.6

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

3 1.10.6

0.220.37

1.20.8

-0.020.19 # Points

Mean

CV SD

# Labs

3.200.142

4.432

3.160.170

5.4300

3.170.132

4.2

31010978

3.170.141

4.5

41386299

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.60.4

-0.71-0.58

1.00.7

0.04-0.12 # Points

Mean

CV SD

# Labs

0.7140.038

5.331

0.7670.070

9.1308

0.7660.073

9.5

31010978

0.7640.068

8.9

41386299

0

2

-2

2

SDI

CVR

-1

1



Your Lab Peer Group


Immunoturbidimetric

Mon CumMethod Group

3.120.219

7.0

62121956

3.120.213

6.8

826173K

0.7720.10113.1

62121956

0.7790.10513.4

826173K


Statistics for Each Test Peer and Method Group Statistics

Vital statistics are displayed in an easy-to-read format comparing your results to those of consensus groups.

• Includes the SDI vs. CVR (from individual Laboratory Performance report) in a modified Youden chart.• Provides key statistical measures, your monthly and cumulative Peer and Method CVRs and SDIs.• Control data: Mean, SD, CV, the total number of Labs and Points broken down by your Lab, and Peer, and Method groups

information is condensed by level into rows on a single page.



Laboratory Histogram

Highlights your laboratory’s trending data over the past 12 months against the cumulative peer group range, allowing you to see your lab’s analyte data versus that of your current cumulative peer group.


Laboratory HistogramImmunoassay Plus • Lot 12345 • Exp 01-Dec-2018






Acetaminophen Enzymatic, colorimetric ug/mLLevel CumFeb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan

1 18.65

# Points

Mean

CV SD

14.601.057.240

14.511.137.830

16.21

13.77

16.900.988

5.835

13.70.7005.130

14.130.712

5.034

14.501.127.740

14.591.027.037

16.922.6515.7

32

16.620.833

5.032

16.040.565

3.530

16.150.672

4.233

16.210.531

3.329

15.541.56

10.02467

Your Labvs.

Cum Peer Group

+2 SD

Mean

-2 SD

2 41.85

# Points

Mean

CV SD

38.201.554.140

37.050.8952.42

30

39.01

36.17

36.050.910

2.530

36.570.920

2.531

37.250.897

2.433

38.101.564.136

38.860.612

1.631

38.770.731

1.931

38.50.635

1.630

38.910.796

2.033

39.250.806

2.130

38.071.423.72385

Your Labvs.

Cum Peer Group

+2 SD

Mean

-2 SD

3 127.60

# Points

Mean

CV SD

120.51.51.240

120.51.391.230

121.10

114.60

114.51.391.230

118.81.491.331

120.31.441.233

120.32.42.034

120.41.491.231

121.20.841

0.731

120.00.725

0.630

121.21.261.033

122.21.451.231

120.12.281.9384

Your Labvs.

Cum Peer Group

+2 SD

Mean

-2 SD

< -2 SD

< -2 SD

< -2 SD

An excellent tool to meet regulatory and accreditation requirements that oblige laboratories to monitor trends in bias and imprecision over time.

• Bar graph (a bar for each calendar month plus a cumulative bar) exhibits your mean versus your peer group mean.• Data included for each bar: Mean, SD, CV and number of points represented.• Labels and arrows clearly indicate values that fall outside of (above or below) the 2 SD range.• Displaying < or > 2SD, this report is useful for identifying both shifts and trends in monthly analyte results.


Bias & Imprecision Histogram

Indicates performance changes in bias or imprecision over previous 12 months for detection of trends.


Bias & Imprecision HistogramImmunoassay Plus • Lot 123450 • Exp 01-Dec-2018




Associated Regional Laboratory123 Main Street


Acetaminophen Enzymatic, colorimetric ug/mLLevel Feb Mar Apr May Jun July Aug Sep Oct Nov Dec Jan

1 15.70

0

CV Bias

7.8-10.49

-12.835.8

4.265.1

-10.485.0

-12.837.7

-10.557.0

-9.9915.74.38

5.02.53

3.5-1.05

4.2-0.37

3.00.00

Percent

2 4.10

0

CV Bias

2.4-5.02

-6.252.5

-4.592.5

-6.252.4

-4.514.1

-2.331.6

-0.381.9

-0.611.6

-1.072.0

-0.252.1

0.62

Percent

3 5.06

0

CV Bias

1.1-0.50

-3.421.2

-1.451.3

-1.911.2

-0.672.0

-0.671.2

-0.590.7

0.070.6

-0.951.0

0.101.2

0.90

Percent

CV Bias

Chart represents your monthly CV as a bar and your bias as a connected line of dots.

• Displays your lab’s bias compared to the current cumulative peer group mean and your CV.• Easy-to-read, color bars and clearly labeled control levels show changes over time.• Helps identify whether any change is due to imprecision, bias or both.• Can be used to detect aberrant bias or CVs.



Worldwide Report

Summarizing all the peer group data submitted to the Unity™ Interlaboratory Program, this report is available for each lot number of Bio-Rad controls on QCNet.com.

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated15-Feb-2015 17:28:36

Worldwide ReportMultiqual 1, 2, 3 Unassayed • Lot 23456 • Exp 01-Dec-2018

January 2015


Abbott AEROSET/ARCHITECT (c, i, ci models)

Albumin Bromcresol Purple (BCP) g/dLMon CumLevel

1# Points

Mean

CV SD

# Labs

2.400.032

1.32346

2.400.050

2.148958

43 67

3 3.930.169

4.32346

3.880.086

2.248958

43 67

2 3.390.026

0.82270

3.330.057

1.744212

42 66

Mon Cum Mon Cum

Beckman Coulter LX20, LXi725, Chemistry Systems

Conventional Units

Level Level

1# Points

Mean

CV SD

# Labs

2.440.045

1.8436

2.440.054

2.216842

10 58

3 4.020.651.6436

4.030.064

1.616842

10 58

2 3.420.059

1.7416

3.410.071

2.116540

9 54

Beckman Coulter UniCel DxC Series

1# Points

Mean

CV SD

# Labs

2.430.053

2.212556

2.430.069

2.8318K

225 390

3 4.020.084

2.112556

4.020.102

2.5318K

225 390

2 3.410.068

2.012412

3.410.107

3.1307K

222 373

Siemens Dimension Series

Method Group • Bromcresol Purple (BCP)

1# Points

Mean

CV SD

# Labs

2.400.072

3.033572

2.410.073

3.0818K

657 1248

3 3.970.129

3.233594

3.980.108

2.7818K

657 1248

2 3.400.071

2.132648

3.420.105

3.1796K

642 1195


1# Points

Mean

CV SD

# Labs

2.370.080

3.412414

2.390.069

2.9306K

276 552

3 3.950.151

3.812412

3.960.096

2.4306K

276 552

2 3.340.067

2.012080

3.390.076

2.2304K

272 546

Siemens Dimension Vista

1# Points

Mean

CV SD

# Labs

2.440.061

2.55732

2.430.067

2.7121K

99 157

3 3.990.078

2.05732

3.950.093

2.4121K

99 157

2 3.420.072

2.15470

3.390.084

2.5120K

97 156

Beckman Coulter CX Series

1# Points

Mean

CV SD

# Labs

2.440.051

2.188

2.440.056

2.37108

4 24

3 4.060.062

1.5112

4.040.094

2.37356

4 24

2 ----

----

- -

This report, inclusive of all consensus groups, can be useful for starting new control lots before you have submitted data.

• Supplies summary statistics: Means, SDs and CVs, for every peer and method group.• Modified format also available – the Manufacturer’s Report – provides same statistical data but only

for a particular manufacturer’s instruments.


Statistical Profile Report

Compare your laboratory’s statistics to the peer, method, and all labs consensus groups using histograms that summarize where your values fall with respect to those of the indicated consensus groups.

Statistical Profile January 2015 • Lab 12345

1Lab 2s RangeLab 3s Range 1Median

MeanSDCV

|Lab Bias|# Points

# Labs

N/A7.970.08

N/A97 204

N/A7.980.091.181.06N/A

7.977.980.141.710.16356

6

8.058.040.212.660.822096

20

8.018.010.162.030.59

19260216

8.058.050.182.190.88

62940236

8.078.100.212.601.67193K859

8.088.110.222.751.61

718K880

Your Lab

Frequency histogram of laboratory means for this quarter

# Labs

Range of Means

100

200

300

400

500

100

200

300

400

500

All Labs Method Group

Frequency histogram of laboratory CVs for this quarter

Range of CVs0 5.00 10.00 15.0 20.00

Your Lab

PercentileDistribution

10°Qtr Year

20°Qtr Year

30°Qtr Year

40°Qtr Year

Median 50°Qtr Year

60°Qtr Year

70°Qtr Year

80°Qtr Year

90°Qtr Year

95°Qtr Year

Peer

1|Bias|SDCV

0.1600.0700.866

0.1740.0000.000

0.1600.0700.866

0.2470.0490.617

0.1600.0700.866

0.6170.0620.756

0.2500.080

1.00

0.9870.0690.850

0.2670.082

1.02

1.130.094

1.16

0.2670.082

1.02

1.450.100

1.21

1.250.084

1.06

1.550.112

1.37

1.250.084

1.06

2.330.143

1.80

1.630.093

1.16

3.300.148

1.81

1.630.093

1.16

3.540.150

1.94

Method

1|Bias|SDCV

All Labs

1|Bias|SDCV

VITROS 5600 (Dry Slide) mg/dL • Slide generation #19VITROS Microslide

SeriesBromcresol Green (BCG)

-Vitros

Calcium Arsenazo III - VITROS mg/dLLevelLevel YearQtrYearQtrYearQtrYearQtr This Year This Quarter

Your Lab Peer Group Method Group All Labs

Unassayed Chemistry • Lot 12345 • Exp 01-Dec-2018 Associated Regional Laboratory


7.80 - 8.14 7.79 - 8.167.71 - 8.22 7.69 - 8.26

9.168.638.107.587.05

0.1840.0610.761

0.2370.0660.818

0.4380.0710.888

0.5100.0740.925

0.6470.0770.969

0.6780.081

1.00

0.8270.082

1.02

0.8920.087

1.08

1.030.087

1.08

1.200.095

1.18

1.180.093

1.16

1.570.103

1.29

1.560.104

1.30

1.870.113

1.41

2.060.121

1.51

2.230.131

1.63

2.370.149

1.85

2.700.163

2.03

2.800.196

2.45

3.290.187

2.32

0.2830.0740.924

0.2420.0780.969

0.6080.085

1.06

0.6200.091

1.12

0.9300.094

1.17

0.9160.104

1.29

1.220.104

1.29

1.200.115

1.42

1.520.115

1.42

1.510.128

1.58

1.830.126

1.5

1.880.140

1.74

2.240.138

1.72

2.280.153

1.89

2.810.156

1.93

2.800.169

2.10

3.480.190

2.36

3.350.201

2.46

4.190.216

2.67

3.910.244

3.05

One of the most sophisticated peer reports offered in the Unity™ Interlaboratory Program, the Statistical Profile Report contains information not offered elsewhere.



Statistical Profile Report: Section 1

Your lab’s ranges for 2 and 3 SDs and summary statistics for quarter and year – Mean and median, CV, and Bias

• A table displays your lab’s 2SD and 3SD range for the current quarter and year as well as summary statistics for your lab and consensus group.



MeanSDCV

|Lab Bias|# Points

# Labs

N/A7.970.08

N/A97 204

N/A7.980.091.181.06N/A

7.977.980.141.710.16356

6

8.058.040.212.660.82

209620

8.018.010.162.030.59

19260216

8.058.050.182.190.88

62940236

8.078.100.212.601.67193K859

8.088.110.222.751.61

718K880

Your Lab


# Labs

Range of Means

100

200

300

400

500

100

200

300

400

500



Range of CVs0 5.00 10.00 15.0 20.00

Your Lab


10°Qtr Year

20°Qtr Year

30°Qtr Year

40°Qtr Year

Median 50°Qtr Year

60°Qtr Year

70°Qtr Year

80°Qtr Year

90°Qtr Year

95°Qtr Year

Peer

1|Bias|SDCV

0.1600.0700.866

0.1740.0000.000

0.1600.0700.866

0.2470.0490.617

0.1600.0700.866

0.6170.0620.756

0.2500.080

1.00

0.9870.0690.850

0.2670.082

1.02

1.130.094

1.16

0.2670.082

1.02

1.450.100

1.21

1.250.084

1.06

1.550.112

1.37

1.250.084

1.06

2.330.143

1.80

1.630.093

1.16

3.300.148

1.81

1.630.093

1.16

3.540.150

1.94

Method

1|Bias|SDCV

All Labs

1|Bias|SDCV



-Vitros





7.80 - 8.14 7.79 - 8.167.71 - 8.22 7.69 - 8.26

9.168.638.107.587.05

0.1840.0610.761

0.2370.0660.818

0.4380.0710.888

0.5100.0740.925

0.6470.0770.969

0.6780.081

1.00

0.8270.082

1.02

0.8920.087

1.08

1.030.087

1.08

1.200.095

1.18

1.180.093

1.16

1.570.103

1.29

1.560.104

1.30

1.870.113

1.41

2.060.121

1.51

2.230.131

1.63

2.370.149

1.85

2.700.163

2.03

2.800.196

2.45

3.290.187

2.32

0.2830.0740.924

0.2420.0780.969

0.6080.085

1.06

0.6200.091

1.12

0.9300.094

1.17

0.9160.104

1.29

1.220.104

1.29

1.200.115

1.42

1.520.115

1.42

1.510.128

1.58

1.830.126

1.5

1.880.140

1.74

2.240.138

1.72

2.280.153

1.89

2.810.156

1.93

2.800.169

2.10

3.480.190

2.36

3.350.201

2.46

4.190.216

2.67

3.910.244

3.05


Frequency histogram of Means and CVs

• Two histograms show: (1) the location of your lab’s mean and (2) your lab’s CV plotted on the range of means / CVs for all labs in the consensus group.



MeanSDCV

|Lab Bias|# Points

# Labs

N/A7.970.08

N/A97 204

N/A7.980.091.181.06N/A

7.977.980.141.710.16356

6

8.058.040.212.660.82

209620

8.018.010.162.030.59

19260216

8.058.050.182.190.88

62940236

8.078.100.212.601.67193K859

8.088.110.222.751.61

718K880

Your Lab


# Labs

Range of Means

100

200

300

400

500

100

200

300

400

500



Range of CVs0 5.00 10.00 15.0 20.00

Your Lab


10°Qtr Year

20°Qtr Year

30°Qtr Year

40°Qtr Year

Median 50°Qtr Year

60°Qtr Year

70°Qtr Year

80°Qtr Year

90°Qtr Year

95°Qtr Year

Peer

1|Bias|SDCV

0.1600.0700.866

0.1740.0000.000

0.1600.0700.866

0.2470.0490.617

0.1600.0700.866

0.6170.0620.756

0.2500.080

1.00

0.9870.0690.850

0.2670.082

1.02

1.130.094

1.16

0.2670.082

1.02

1.450.100

1.21

1.250.084

1.06

1.550.112

1.37

1.250.084

1.06

2.330.143

1.80

1.630.093

1.16

3.300.148

1.81

1.630.093

1.16

3.540.150

1.94

Method

1|Bias|SDCV

All Labs

1|Bias|SDCV



-Vitros





7.80 - 8.14 7.79 - 8.167.71 - 8.22 7.69 - 8.26

9.168.638.107.587.05

0.1840.0610.761

0.2370.0660.818

0.4380.0710.888

0.5100.0740.925

0.6470.0770.969

0.6780.081

1.00

0.8270.082

1.02

0.8920.087

1.08

1.030.087

1.08

1.200.095

1.18

1.180.093

1.16

1.570.103

1.29

1.560.104

1.30

1.870.113

1.41

2.060.121

1.51

2.230.131

1.63

2.370.149

1.85

2.700.163

2.03

2.800.196

2.45

3.290.187

2.32

0.2830.0740.924

0.2420.0780.969

0.6080.085

1.06

0.6200.091

1.12

0.9300.094

1.17

0.9160.104

1.29

1.220.104

1.29

1.200.115

1.42

1.520.115

1.42

1.510.128

1.58

1.830.126

1.5

1.880.140

1.74

2.240.138

1.72

2.280.153

1.89

2.810.156

1.93

2.800.169

2.10

3.480.190

2.36

3.350.201

2.46

4.190.216

2.67

3.910.244

3.05



Percentile distributions: Organized by percentile, then by quarter and by year

• A table includes the consensus group (peer, method and all labs) distributions for absolute bias, SD and CV by quarter and year.



MeanSDCV

|Lab Bias|# Points

# Labs

N/A7.970.08

N/A97 204

N/A7.980.091.181.06N/A

7.977.980.141.710.16356

6

8.058.040.212.660.82

209620

8.018.010.162.030.59

19260216

8.058.050.182.190.88

62940236

8.078.100.212.601.67193K859

8.088.110.222.751.61

718K880

Your Lab


# Labs

Range of Means

100

200

300

400

500

100

200

300

400

500



Range of CVs0 5.00 10.00 15.0 20.00

Your Lab


10°Qtr Year

20°Qtr Year

30°Qtr Year

40°Qtr Year

Median 50°Qtr Year

60°Qtr Year

70°Qtr Year

80°Qtr Year

90°Qtr Year

95°Qtr Year

Peer

1|Bias|SDCV

0.1600.0700.866

0.1740.0000.000

0.1600.0700.866

0.2470.0490.617

0.1600.0700.866

0.6170.0620.756

0.2500.080

1.00

0.9870.0690.850

0.2670.082

1.02

1.130.094

1.16

0.2670.082

1.02

1.450.100

1.21

1.250.084

1.06

1.550.112

1.37

1.250.084

1.06

2.330.143

1.80

1.630.093

1.16

3.300.148

1.81

1.630.093

1.16

3.540.150

1.94

Method

1|Bias|SDCV

All Labs

1|Bias|SDCV



-Vitros





7.80 - 8.14 7.79 - 8.167.71 - 8.22 7.69 - 8.26

9.168.638.107.587.05

0.1840.0610.761

0.2370.0660.818

0.4380.0710.888

0.5100.0740.925

0.6470.0770.969

0.6780.081

1.00

0.8270.082

1.02

0.8920.087

1.08

1.030.087

1.08

1.200.095

1.18

1.180.093

1.16

1.570.103

1.29

1.560.104

1.30

1.870.113

1.41

2.060.121

1.51

2.230.131

1.63

2.370.149

1.85

2.700.163

2.03

2.800.196

2.45

3.290.187

2.32

0.2830.0740.924

0.2420.0780.969

0.6080.085

1.06

0.6200.091

1.12

0.9300.094

1.17

0.9160.104

1.29

1.220.104

1.29

1.200.115

1.42

1.520.115

1.42

1.510.128

1.58

1.830.126

1.5

1.880.140

1.74

2.240.138

1.72

2.280.153

1.89

2.810.156

1.93

2.800.169

2.10

3.480.190

2.36

3.350.201

2.46

4.190.216

2.67

3.910.244

3.05



Affiliated Reports

The Affiliated Reports allow a group of labs to obtain a simplified, yet detailed, view of their performance and see data warnings and rejections for all affiliate labs. These reports allow a group of labs to become their own consensus group.

Ideal reports for Laboratory Managers or Quality Control Coordinators responsible for multiple sites or multiple instruments of a common make and model.

Types of Affiliated Reports Available:

• Affiliated Laboratory Comparisons Report: Abbreviated Summary• Affiliated Laboratory Comparisons Report• Affiliated Data Exception Report

Contact your Bio-Rad QC Program Representative to request any of the available Affiliated ReportsAdditional charges may apply to configure and maintain Affiliated Reports.

QC Coordinator / Lab Manager

Affiliate Lab 1Affiliate Lab 3

Affiliate Lab 2


Affiliated Laboratory Comparison Report: Abbreviated Summary

This popular summary report provides a simplified view of performance for all your affiliated labs.


Affiliated Laboratory Comparison Report: Abbreviated SummaryUnassayed Chemistry • Lot 12345 • Exp 01-Dec-2018

January 2015




Albumin Bromcresol Green (BCG) g/dL Level

#PointsMean CVSD CVR SDI

AffiliatedCVR SDI

PeerCVR SDI

Method

2.90 0.072 2.5 358123456 Reference Laboratory • Roche MODULAR

10.8 -0.240.7-0.670.90.22

2.88 0.065 2.3 358234567 Western • Roche MODULAR 0.8 -0.420.7-0.900.90.002.88 0.120 4.2 311345678 Central • Roche MODULAR 1.4 -0.471.2-0.971.6-0.062.89 0.072 2.5 297456789 Eastern • Roche MODULAR 0.9 -0.600.7-1.131.0-0.21

2.88 0.085 3.0 1324Affiliated Group2.95 0.078 2.7 6698Peer Group2.93 0.102 3.5 33164Method Group

(4 Labs)(45 Labs)(435 Labs)

-0.420.9-0.911.11

123456135789*

Reference LaboratoryR&D Laboratory

* Lab data was not available for processing for the date listed. Consequently no reports were generated for this lab during the reporting cycle.

234567345678

Western LaboratoryCentral Laboratory

456789999999*

Eastern LaboratorySouthern Laboratory

12.86 0.113 4.0 280123456 Reference Laboratory • Roche cobas 6000 0.92.87 0.128 4.4 281123456 Reference Laboratory • Roche cobas 6000 1.1 -0.571.3-0.671.10.05



-0.701.23-0.781.08

Roche MODULAR (ISE, D, P, E170)

4.60 0.064 1.4 358123456 Reference Laboratory • Roche MODULAR

20.8 -0.130.5-0.470.80.22

4.59 0.056 1.2 357234567 Western • Roche MODULAR 0.7 -0.230.5-0.620.70.074.57 0.119 2.6 312345678 Central • Roche MODULAR 1.4 -0.411.0-0.881.5-0.184.57 0.086 1.9 300456789 Eastern • Roche MODULAR 1.0 -0.390.7-0.851.1-0.16



-0.280.7-0.691.0

Roche cobas 6000/8000 Series

24.65 0.102 2.2 278123456 Reference Laboratory • Roche cobas 6000 0.9 0.320.8-0.250.9-0.074.67 0.121 2.6 279123456 Reference Laboratory • Roche cobas 6000 1.1 0.441.0-0.121.00.7



0.410.92-0.170.96

-0.701.2-0.781.0-0.05

A quick review allows you to focus on key statistics to allow comparison between multiple instruments of a common make and model for statistical comparison of each lab’s results.

• Provides the CVR and SDI for the peer, method, and affiliated groups to allow statistical comparison of each lab’s results.• You can request this report to appear in either SI or Conventional units, rather than both.

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 Peer Method and Affiliated groups

Additional for Peer, Method & Affiliated Groups

• Mean• SD• CV• Number of data points reported• Number of labs reporting



Affiliated Laboratory Comparison Report

Summarizing the performance of each participating affiliated laboratory – provides a detailed look at each lab’s performance.


Affiliated Laboratory Comparison ReportUnassayed Chemistry • Lot 12345 • Exp 01-Dec-2018

January 2015





Bilirubin, Direct/BC (DBIL) Diazotization mg/dLMon CumLevel

123456 Reference Laboratory • Roche MODULAR

234567 Western Laboratory • Roche Hitachi MODULAR E170


Mon Cum Mon Cum Mon CumLab Affiliated Group Peer Group

Affiliated Group: Roche MODULAR

DiazotizationMon Cum

Method Group

Peer CVR Method CVR

Peer SDI Method SDI

1 0.9

0.130.12

0.5

-0.200.13 0

2

-2

2

SDI

CVR

-1

10.2 0.2

Peer CVR Method CVR

Peer SDI Method SDI

2 0.8

0.550.12

1.0

-0.080.14 0

2

-2

2

SDI

CVR

-1

10.3 0.3

123456135789*



234567345678


456789999999*


LinearRegression

of Means

0.52 0.810.23

0.52

0.81

Lab

Affiliate

Peer CVR Method CVR

Peer SDI Method SDI

1 0.70.6

0.060.10

1.30.7

-0.080.13

0

2

-2

2

SDI

CVR

-1

11

# Points

Mean

CV SD

# Labs

0.3010.010

3.3

99

0.3010.015

5.0

821

0.3020.015

4.9

2183

0.3010.012

3.9

31922

0.3000.017

5.7

322459

0.3060.025

8.2

5435520

0.2940.06522.2

81963934

0.2920.06522.4

1404447K

0.2 0.2-0.08 0.06

Affiliated CVR

Affiliated SDI Lab Bias -0.33 0.00 0.33 -1.63 2.38 3.08

Peer CVR Method CVR

Peer SDI Method SDI

2 0.90.7

0.370.06

1.10.9

-0.100.06

0

2

-2

2

SDI

CVR

-1

12

# Points

Mean

CV SD

# Labs

0.8740.044

5.1

99

0.8680.049

5.6

822

0.8840.048

5.4

2184

0.8800.047

5.4

31918

0.8520.058

6.8

292398

0.8840.050

5.6

4733889

0.8630.17219.9

76062348

0.8560.17320.2

1209436K

0.3 0.3-0.22 -0.25

Affiliated CVR

Affiliated SDI Lab Bias 1.36-1.18 2.58 -1.81 1.27 1.40

Peer CVR Method CVR

Peer SDI Method SDI

1 1.31.1

0.210.14

0.70.4

-0.120.12

0

2

-2

2

SDI

CVR

-1

11

# Points

Mean

CV SD

# Labs

0.3040.019

6.2

84

0.3000.008

2.7

739

0.3020.015

4.9

2183

0.3010.012

3.9

31922

0.3000.017

5.7

322459

0.3060.025

8.2

5435520

0.2940.06522.2

81963934

0.2920.06522.4

1404447K

0.3 0.10.09 -0.02

Affiliated CVR

Affiliated SDI Lab Bias 0.66 -0.3 1.33 -1.96 3.40 2.74

Peer CVR Method CVR

Peer SDI Method SDI

2 1.00.8

0.760.19

1.00.9

0.180.15

0

2

-2

2

SDI

CVR

-1

12

# Points

Mean

CV SD

# Labs

0.8960.050

5.6

85

0.8840.048

5.4

738

0.8840.048

5.4

2184

0.8800.047

5.4

31918

0.8520.058

6.8

292398

0.8840.050

5.6

4733889

0.8630.17219.9

76062348

0.8560.17320.2

1209436K

0.3 0.30.25 0.08

Affiliated CVR

Affiliated SDI Lab Bias 1.36 0.46 5.16 0 3.82 3.27

0.52 0.810.23

0.52

0.81

Lab

Peer 0.52 0.810.23

0.52

0.81

Lab

Method

Useful in comparing multiple instruments made by the same manufacturer located within or across sites.

• Designed for managers responsible for overseeing multiple sites / multiple instruments.• Statistics provided for each affiliated laboratory include Mean, SD, CV and number of points.• Condensed format provides comprehensive performance comparisons of each lab versus Affiliated, Peer and Method

for the month and cumulative.• Modified Youden graphs display linear regression plots of means for multiple instrument comparisons.• You can request this report to appear in either SI or Conventional units.


Affiliated Data Exception Report

Indicates data warnings and rejections for affiliate labs and provides an overview of exceptions for all labs in the affiliated group.


Affiliated Data Exception ReportUnassayed Chemistry • Lot 12345 • Exp 01-Jan-2018

January 2015





Lipase Colorimetric (Siemens calibrated) U/L 37°CLevelLevel

123456 City Regional Hospital • Siemens Dimension EXL

Lab Affiliated Peer Method

1# Points

Mean

CV SD

# Labs

165.78.315.033

151.98.095.3

3564

148.17.665.2

1585872

147.88.015.4

26110482

2# Points

Mean

CV SD

# Labs

353.411.99

3.434

325.615.25

4.7

3571

325.615.25

4.7

1585872

320.417.48

5.5

26110482

2# Points

Mean

CV SD

# Labs

28.211.103.934

325.615.25

4.7

3571

322.113.25

4.1

1585872

320.417.48

5.5

26110482

3456789 Reference Lab • Siemens Dimension EXL

Submitted Test Configuration Suggested Test Configuration

123456 City Regional Hospital

Data for 01-2013, 12-2012AmylaseMaltotetraose

Analyte Method

Siemens Dimension EXLInstrument Reagent

U/LUnits Temp

Dedicated Reagent

37° C

CNP-triose/CNP G3

1 0.91.00.9

1.712.302.24

Warning: Acceptable values are above –2 and below 2Warning: Acceptable values are above –2 and below 2

Affiliated CVRPeer CVR

Method CVRAffiliated SDI

Peer SDIMethod SDI

1 0.70.80.6

1.822.371.89

Warning: Acceptable values are above –2 and below 2

Affiliated CVRPeer CVR

Method CVRAffiliated SDI

Peer SDIMethod SDI

Data Exclusion: Lab Mean = 28.21Acceptable values are 282.35 - 361.85This data was not used as part of the Unity worldwide statistical database

2

Coding RejectionsThe following data was not used as part of the Unity worldwide statistical database due to a suspected test configuration error. Please review the "Submitted Test Configuration"and "Suggested Test Configuration" columns below.

In your Bio-Rad software, please correct the test configuration that corresponds with the highlighted area(s) in the "Suggested Test Configuration" column. Upon correction, reports will be generated at your request.

For additional assistance or if you feel your current test configuration is correct, please contact Bio-Rad's Quality Contral Program directly or your local Bio-Rad Office.

123456135789*



234567345678


456789999999*


Includes SDI/CVR warnings, data exclusions, coding rejections.

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 group.• Is rejected by a Unity™ Interlaboratory Program data filter.• Contains a suspected coding error (data rejected due to possible test configuration errors

and suggests potential corrections).



Qualitative Reports

Data submitted for Liquichek™ Urinalysis, qUAntify and qUAntify Plus Controls generates a qualitative report consisting of Chemistry and Microscopic Reports for each method submitted (when appropriate) with a cover page.

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 15-Apr-2015 17:28:36

Qualitative ReportqUAntify Plus • Lot 12345 • Exp 01-Jan-2016


The statistics in this report are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package insert for specific analyte claims and stability information. Qualitative percentage may not add up to 100 due to rounding. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.



Siemens CLINTEK Status# Labs Peer% # Labs Peer%Level 1 Level 2

negtrace

30/1+100/2

300/3+2000/4+

1 2 3 4 5 6

2 2 2 2

2

2

2 2 2

2 2 2 2

2 2 2 2

2 2 2 2

2 2 2 2

2 2 2 2

2

2 2

7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31Day

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 31Day

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 31Day

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 31Day

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 31Day

1 2 3 4 5 6

2 2 2 2

2 2

2 2

2 2

2 2 2 2

2 2 2 2

2 2 2 2

2 2

2

2 2

2 2

7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31Day

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 31Day

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 31Day

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 31Day

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 31Day

45Nitrite

45

100%

16%84%

Urobilinogen

Leukocytes 45

99%1%

neg.trace

small/1+mod/2+large/3+

normal1245

negpos

45

2%50%48%

pH5.06.06.57.07.58.08.5

Leukocytes 45

45

45

45

100%

100%

100%

100%

99%1%

neg.trace


Urobilinogennormal

1245

Protein, Total, Urine/Spinal Fluidneg

trace30/1+100/2

300/3+2000/4+

Nitritenegpos

pH5.06.06.57.07.58.08.5

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 31Day

45100%<1%

<1%

Bloodneg

non-hem trcnon-hemmod

Hem trcsmall/1+mod/2+large/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 31Day

45

100%

Bloodneg

non-hem trcnon-hemmod

Hem trcsmall/1+mod/2+large/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 31Day

45

59%37%3%

Specific Gravity1.0001.0051.0101.0151.0201.0251.030

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 31Day

45

<1%15%81%3%

Specific Gravity1.0001.0051.0101.0151.0201.0251.030

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 31Day

45100%<1%

Ketonesneg

trace/5small/15mod/40large/80

large/160

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 31Day

45100%

Glucoseneg100250500

10002000

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 31Day

45Glucoseneg100250500

10002000

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 31Day

45

91%9%

Ketonesneg

trace/5small/15mod/40large/80

large/160

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 31Day

45100%

Bilirubin, Total/TBILneg


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 31Day

45

4%

96%

4%35%62%

Bilirubin, Total/TBILneg


45

10%90%

Protein, Total, Urine/Spinal Fluid

45

Chemistry Report

Provides a simulation of your laboratory responses versus a representation of group responses using the visual color changes to reagent strips.

• Arrows identify the majority group response.• Displays multiple responses per day.


Microscopic Report

Graphics simulate your average response and the group’s average response.

• Your lab’s daily responses appear above the graphics; an arrow indicates the majority group response.

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 15-Apr-2015 17:28:36

Qualitative ReportqUAntify Plus • Lot 12345 • Exp 01-Jan-2016


The statistics in this report are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package insert for specific analyte claims and stability information. Qualitative percentage may not add up to 100 due to rounding. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.



Microscope# Labs Peer% # Labs Peer%Level 1 Level 2

Your Lab Average ResponseAbsent/Rare per hpf

Peer Average ResponseAbsent/Rare per hpf

Your Lab Average ResponseAbsent/Rare per hpf

Peer Average ResponseAbsent/Rare per hpf

Your Lab Average Response0–3 per hpf

Peer Average Response0–3 per hpf

Your Lab Average Response26 or more per hpf

Peer Average Response26 or more per hpf





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

Crystals per hpf 35100%Absent/Rare

12–56–9

10 or moreDay 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

Crystals per hpf 35

63%

37%Absent/Rare1

2–56–9

10 or moreDay

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

RBC per hpf 35100%0–3

4–1011–1516–2021–25

26 or moreDay 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

RBC per hpf 35

6%39%55%

0–34–10

11–1516–2021–25

26 or moreDay

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

WBC per hpf 35100%0–5

6–1011–1516–2021–2526–3031–35

36 or moreDay 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

WBC per hpf 35

6%45%39%10%

0–56–10

11–1516–2021–2526–3031–35

36 or moreDay

Qualitative Worldwide Report

Summarizing all the peer group data submitted to the Unity™ Interlaboratory Program, this report is available for each lot number of Bio-Rad controls on QCNet.com.

• Supplies monthly and cumulative response distributions• Modified format also available –The Manufacturer’s Report – provides the same response distribution

for a single manufacturer’s instruments

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 26-May-2015 17:28:36

Worldwide ReportUrinalysis • Lot 12345 • Exp 30-Nov-2016

April 2015


Siemens Atlas

Conventional Units

Glucose DipstickMon CumLevel

neg100/trace

250/1+500/2+

>=1000/3+# Points

# Labs

100%0%0%0%0%321

18

100%0%0%0%0%

212730

1

Mon CumLevel

0%0%1%

91%9%322

18

0%<1%<1%89%10%2114

30

2

Roche URISYS 2400

normal50

100300

1000# Points

# Labs

93%0%2%5%0%700

29

96%<1%

1%2%0%

456938

1 <1%0%6%

45%49%678

26

<1%<1%12%42%45%4196

36

2

Siemens CLINITEK Series

neg100250500

10002000

# Points# Labs

100%0%0%

<1%0%0%852

30

100%<1%<1%<1%

0%0%

648344

1 <1%<1%

2%48%44%

5%846

30

<1%<1%

2%51%44%

3%6127

43

2

URIT MEDICAL Urinalysis Models

-(0)-/=(2.8)+95.6)++(14)

+++(28)++++(>=55)

# Points# Labs

100%0%0%0%0%0%

32

99%<1%<1%

0%0%0%315

5

1 0%0%0%0%0%

100%32

1%0%5%

48%6%

40%312

3

2

YD Uriscan

neg100/trace

250/1+500/2+

1000/3+2000/4+# Points

# Labs

100%0%0%0%0%0%451

19

100%0%0%0%0%0%

250926

1 <1%0%

<1%2%

16%81%504

21

<1%0%

<1%2%

17%82%2795

27

2



Instant QC™ Reports

The Unity Interlaboratory Program offers all program participants the ability to receive on-demand InstantQC™ Reports.

© 2015 Bio-Rad Laboratories, Inc. Page 1Generated 15-Jan-2015 17:28:36

InstantQC Laboratory Comparison ReportUnassayed Chemistry • Lot 12345 • Exp 01-Dec-2018

January 2015


Roche cobas 8000



Potassium ISE indirect mmol/LMon CumLevel Level Mon Cum

Your Lab


Mon CumPeer Group

ISE indirectMon Cum

Method Group

Peer CVR Method CVR

Peer SDI Method SDI

1 0.20.3

0.40.5

Peer CVR Method CVR

Peer SDI Method SDI

1# Points

Mean

CV SD

# Labs

4.110.020

0.5

7

4.080.040

1.0

24

4.040.087

2.2

1068671

4.050.107

2.7

10629935

4.040.074

1.8

82258288

4.040.081

2.0

890215K

2# Points

Mean

CV SD

# Labs

6.390.030

0.5

7

6.330.067

1.1

24

6.340.085

1.3

1038157

6.350.100

1.6

10327874

6.310.114

1.8

81557653

6.310.119

1.9

878209K

0.85 0.340.99 0.52

2 0.40.3

0.70.6

0.59 -0.210.68 0.10

0

2

-2

2

SDI

CVR

-1

1

0

2

-2

2

SDI

CVR

-1

1

Roche cobas 8000

Chloride ISE indirect mmol/LMon CumLevel Level Mon Cum

Your Lab


Mon CumPeer Group

ISE indirectMon Cum

Method Group

Peer CVR Method CVR

Peer SDI Method SDI

1 0.30.2

0.50.3

Peer CVR Method CVR

Peer SDI Method SDI

1# Points

Mean

CV SD

# Labs

83.500.400

0.5

8

83.090.674

0.8

25

82.481.161.4

1078714

82.321.361.7

10729822

85.592.142.5

81557618

85.662.262.6

884210K

2# Points

Mean

CV SD

# Labs

98.600.700

0.7

8

98.060.845

0.9

25

98.071.031.0

1048223

98.021.281.3

10427995

100.02.242.2

80656666

100.12.312.3

875205K

0.88 0.57-0.98 -0.14

2 0.70.3

0.70.4

0.51 0.03-0.64 -0.89

0

2

-2

2

SDI

CVR

-1

1

0

2

-2

2

SDI

CVR

-1

1

Roche cobas 8000 • 3rd generation

Cholesterol, HDL DIrect measure–PEG mg/dLMon CumLevel Level Mon Cum

Your Lab


Mon CumPeer Group

Direct measure–PEGMon Cum

Method Group

Peer CVR Method CVR

Peer SDI Method SDI

1 0.00.0

0.00.0

Peer CVR Method CVR

Peer SDI Method SDI

1# Points

Mean

CV SD

# Labs

29.000.000

0.0

1

29.000.000

0.0

1

29.950.714

2.4

51013

29.880.735

2.5

61815

29.581.745.9

30414592

29.591.776.0

32450192

2# Points

Mean

CV SD

# Labs

65.000.000

0.0

1

65.000.000

0.0

1

65.011.482.3

51019

64.481.532.4

61816

63.604.186.6

29713893

63.643.926.2

32147799

-1.33 -1.19-0.33 -0.34

2 0.00.0

0.00.0

0.00 0.340.34 0.35

0

2

-2

2

SDI

CVR

-1

1

0

2

-2

2

SDI

CVR

-1

1

Roche cobas 8000

Cholesterol, Total Cholesterol oxidase, esterase, peroxidase mg/dLMon CumLevel Level Mon Cum

Your Lab


Mon CumPeer Group

ISE indirectMon Cum

Method Group

Peer CVR Method CVR

Peer SDI Method SDI

1 0.00.0

0.00.0

Peer CVR Method CVR

Peer SDI Method SDI

1# Points

Mean

CV SD

# Labs

105.00.000

0.0

1

105.00.000

0.0

1

107.83.843.6

924930

108.54.344.0

916777

104.14.704.5

78134971

104.45.004.8

885132K

2# Points

Mean

CV SD

# Labs

256.00.000

0.0

1

256.00.000

0.0

1

257.75.842.3

904736

3259.26.612.6

9115884

254.79.253.6

77834720

254.69.283.6

879130K

-0.74 -0.820.19 0.12

2 0.00.0

0.00.0

-0.74 -0.480.19 0.15

0

2

-2

2

SDI

CVR

-1

1

0

2

-2

2

SDI

CVR

-1

1

With up-to-the-minute peer group performance data, these immediate reports are particularly useful for troubleshooting issues with test system performance.

• InstantQC™ Reports are available to all Unity™ participants with access to the QCNet™ website (www.qcnet.com). • Reports are generated with all the peer group data available at the moment the report is requested – whether you have

submitted your data for the selected month or not.• All Unity™ report participants can generate InstantQC™ Reports for open tests at any time.• InstantQC™ Reports are generated in the same language you request for your monthly Unity Interlaboratory Reports.• InstantQC™ Reports are available as Adobe Acrobat® PDF files.

The InstantQC™ Reports are intended primarily for troubleshooting test system performance when a malfunction is suspected. For the 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.


Glossary of Terms

Affiliated Group

A 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 Group

The 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.

Bias

The 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.

CVR

Coefficient of variation ratio — a statistic that compares your lab’s precision to that of other labs in a consensus group.

Imprecision

Imprecision 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).

Mean

The arithmetic average of a set of data points.

Method Group

The 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 Group

The “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

• ∑ (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.

CV =Standard Deviation

Mean• 100

CVR =Your CV

Consensus Group CV

SD = (xn – x– )2

n – 1

SDI =


Consensus Group SD

Bias% =


Consensus Group Mean• 100



Compare Your Unity™ Options: Choose Web-based or Desktop SoftwareBio-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.

Want to know more? Discover the power of Unity™ Solutions at www.bio-rad.com/unity

Basic Advanced Desktop based Web based Mobile

Web-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.

Basic User Options Advanced User Options

UnityWeb® Unity Real Time® LT

Unity Real Time®

onlineUnity Real Time®

Type of Solution

Web Service (Web-based) X X

Desktop Software X X

Unity™ Interlaboratory Reports

Monthly Reports X X X X

InstantQC™ Reports X X X X

Basic Intralaboratory Charts & Reports

Westgard Rules X X X X

Various Charts and Reports X X X X

Additional Features

Westgard Advisor™ (Subscription sold separately) X X 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

Bio-Rad Hosted X X

Installed on Local Laboratory PC X X

Connectivity (Sold separately)

WebConnect™ X X

UnityConnect™ X X X X

http://www.bio-rad.com/unity


Unity Real Time®

Expert QC Data Management Solution for Desktop or 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)• RiLiBÄK Advisor™ module available to comply with German regulations

UnityWeb®

Entry-Level Online QC Data Management Solution

• No software to install and maintain• Use 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)• Access UnityWeb® via mobile device

Unity Real Time® LTEntry-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)

Westgard Advisor™

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



Connectivity Solutions for Automated Uploads to Unity™ Software

Simple automated uploading of your data from your instruments, middleware and LIS to Unity™ Software solutions.

Personalized, Step-by-step Deployment

• Bio-Rad connectivity experts work directly with your IT team

• Our Training Department provides a wealth of curriculum and personalized training sessions for your lab personnel

• You set the pace; we work to your timetable

Reliability Based on Experience

• We connect more than a thousand customers per year to Unity™

• Pre-existing solutions for hundreds of devices to get you up and running quickly

• Enterprise solutions can connect multiple sites across continents

Unlock powerful functionality in Unity™ with real-time connectivity. We adapt to your environment with online and locally installed solutions to capture data directly from instruments, middleware or LIS. Auto-verification support available with popular middleware solutions.

Unity™ AlertContinuosly Monitor QC Status

• Notifications of missing QC runs can help to ensure proper monitoring 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 specific instruments 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®

Unity™

Instrument

Connectivity

Middleware

LIS

UnityConnect™

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

• 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, 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®

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

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

For further information, please contact the Bio-Rad office nearest you or visit our website at www.bio-rad.com/qualitycontrol

Clinical Diagnostics Group

Website www.bio-rad.com/qualitycontrol Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium +32 (3)710-53-00 Brazil +55 (31)3689-6600 Canada 1-514-334-4372 China 86-21-61698500 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 1800-180-1224 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 Korea 82-2-3473-4460 Mexico +52 (55)5488-7670 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 +7-495-721-1404 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden +46-8-555-127-00 Switzerland +41 (0)26-674-55-05/06 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44 (0)20-8328-2000

© 2015 Bio-Rad Laboratories, Inc. Printed in USA QSD15-122 Q-1144 Rev. 09/2015 Printed on recycled paper with soy-based inks

Quality Controls

Broad portfolio of independent controls provides an unbiased assessment of methods and system performance.

QC Data Management Solutions

Manage and interpret your QC results using the industry-leading Unity™ Interlaboratory Program and benefit from data generated by users worldwide.

Customer Support

Receive the backing of full-service technical and customer support trained to handle your inquiries in a prompt, knowledgeable manner.

Education

We offer the educational tools and resources to help improve your ability to produce reliable test results.

Bio-Rad is Dedicated to Advancing QC Solutions Worldwide

Ordering InformationCat # Configuration

Unity Real Time®

804 Installation Package . . . . . . . . . . . . . . . . . . . Single use 804-1 Unity Real Time® . . . . . . . . . . . . . . Annual subscription 825i Unity™ Remote Installation & Training . . . . . . Single use

UnityWeb®

870-1 UnityWeb® . . . . . . . . . . . . . . . . . . . Annual subscription

Unity Real Time® LT

804 Installation Package . . . . . . . . . . . . . . . . . . . Single use 805-1 Unity Real Time® LT . . . . . . . . . . . Annual subscriptione

Westgard Advisor™

811-1 Westgard Advisor™ . . . . . . . . . . . . . Annual subscription

Cat # Configuration

Unity™ Alert

806-1 Unity™ Alert . . . . . . . . . . . . . . . . . Annual subscription

WebConnect™

858i Connectivity Remote Installation & Training . Single Use 870-W1 WebConnect™ 2.0 . . . . . . . . . . . . . Annual subscription

UnityConnect™

820-1 UnityConnect™ Software . . . . . . . . Annual subscription 858i Connectivity Remote Installation & Training . Single Use

Contact your Bio-Rad sales representative for region-specific information. Hardware solutions available for serial and network devices. Contact your Bio-Rad sales representative for recommendation.


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