unity interlaboratory program - bio-rad

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”?


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.


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


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 .


• 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


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


LEVEL

2

SDI

2.0

1.0

1.0 2.00

-1.0

-2.0


LEVEL

1

SDI

2.0

1.0

1.0 2.00

-1.0

-2.0

Alkaline PhospatasePNPP, AMP BufferRoche MODULARDedicated ReagentU/L 37°C


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


LEVEL

2

SDI

2.0

1.0

1.0 2.00

-1.0

-2.0


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.


Laboratory Comparison Report


Lab 001234


Laboratory Comparison ReportMultiqual 1, 2, 3 Unassayed Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013


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



Data For: 05-2007Lot Exp: 08-31-2009


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






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



Level 1

Mon Cum

Level 2

Mon Cum

Level 3

Mon CumStatistics for Each Test

Each test will contain

Your Lab

Lab 001234



Data For: 05-2007Lot Exp: 08-31-2009


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






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



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


11

Laboratory Histogram Report


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


Laboratory Histogram ReportMultiqual 1, 2, 3 Unassayed Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013



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.


Bias & Imprecision Histogram Report


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


Bias & Imprecision HistogramUnassayed Chemistry Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013



(%)

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


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


Data Rejection ReportUrine Chemistry Lot 10000

Data For: 05-2007Lot Exp: 08-31-2009


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.


Worldwide Report


Worldwide ReportUnassayed Chemistry

Conventional Units

Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013


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


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


Continued: Statistical Profile Report


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


Statistical ProfileUnassayed Chemistry Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013



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


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.


Affiliated 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


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



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



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



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 .



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


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


Lab 001234


Lot 00000

Data For: 09-2011Lot Exp: 09-30-2013Printed: 09-30-2011

Page 1

Affiliated Data Exception ReportMultiqual 1, 2, 3 Unassayed


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


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


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


Urinalysis 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


Peer Group Quality Control ReportqUAntify Plus Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013



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


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


Peer Group Quality Control ReportqUAntify Plus Lot 10000

Data For: 09-2011Lot Exp: 09-30-2013



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 .


InstantQC™ 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


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.


Glossary of Terms

CV =Standard Deviation

Mean100

CVR =Your CV

Consensus Group CV

SD = (xn – x)2

n – 1

SDI =


Consensus Group SD

Bias% =


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™


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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unity interlaboratory program - bio-rad

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