Unity Interlaboratory Reports

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1 Bio-Rad Laboratories QC Data Management Solutions Unity Interlaboratory Reports There has never been a better time to be a member of the world s largest QC peer group program. Bio-Rad drives innovation in the development of Quality Control for the clinical laboratory and we re raising the bar again. It s time to take a fresh look at your Unity peer reports. Redesigned formats make them easier than ever to read. The addition of color, graphics and statistical information allows you to interpret your data with ease, enabling prompt action to potential problems. Condensed report formats require fewer pages and view equally well printed in color or black and white. NEW Unity Interlaboratory Program Reports Feature: Logical arrangement of data provides a quick and more intuitive read Data consolidation and imagery simplifies interpretation of lab data Condensed report formats conserve paper and printing costs Please review the following pages for more information about individual reports, the redesigned format, and more importantly, their new look and content. Visit QCNet.com for more information and status updates on Unity Interlaboratory Reports.

2 Monthly Evaluation This report provides a summary of your lab s performance. A glance will alert you regarding issues such as submission status, warnings, and data exclusions all in one report. January 4 Lab 45 Monthly Evaluation Immunoassay Plus Lot 45 Exp -Jan-6 Please review your QC reports for January 4. Main Street Anytown, NY ! The tests listed below may require investigation or review! Gentamicin Immunoturbidimetric ug/ml Siemens Dimension RXL Data Exclusion: Lab =.5 Acceptable values are.84 to.56 This data was not used as part of the Unity worldwide statistical database.! Peer R.9 R.4 Peer I -. Warning: Acceptable values are above -., below. I -.6 Peer R.8 R.4 Peer I.5 I -. This level is within established parameters Lab Peer Key statistical measures for your Peer and Rs and Is.. The Data Rejection report information, with data exclusions and warnings, is now combined.. Detail:,, and total number of Labs and Points arranged by your Lab, Peer, and groups. Laboratory Performance Overview Providing a visual indication of your laboratory performance in terms of bias (I) and imprecision (R), the Performance Overview offers new color graphics to display your I and your R in a modified Youden chart. January 4 Lab 45 Laboratory Performance Overview Immunoassay Plus Lot 45 Exp -Jan-6 y Main Street Anytown, NY Vancomycin Siemens Dimension EXL I R Immunoturbidimetric ug/ml Peer Peer - I - R Peer Peer - I - R Peer Peer - I - R. Data now displays in rows with up to levels per row; allowing more data to fit on a single page.. Arrows outside the chart margins indicate the presence of off the chart values.

3 Laboratory Comparison Report Offering a comprehensive overview of your monthly and cumulative QC performance, the Comparison report displays vital statistics that can be examined in an easy-to-read format comparing results to those of your peer and method consensus groups. January 4 Lab 45 Laboratory Comparison Report Immunoassay Plus Lot 45 Exp -Jan-6 Main Street Anytown, NY Carbamazepine (Tegretol) Immunoturbidimetric ug/ml Your Lab Peer Group Group Mon Cum Mon Cum Mon Cum Mon Cum Siemens Immunoturbidimetric Siemens Dimension EXL Dimension Series Peer R R Peer I. -. R I K I - Peer R R Peer I R I K Peer R R Peer I I I R. - I K 95. This report now includes the I vs. R (from the individual Laboratory Performance report) in a modified Youden chart.. Control data is condensed by level into rows allowing more data to fit on a single page. Unity Interlaboratory Reports

4 Laboratory Histogram Many regulatory and accreditation requirements oblige laboratories to monitor trends in bias and imprecision over time. This report is an excellent tool to complete this objective, highlighting your lab s trending data against the cumulative peer group range. January 4 Lab 45 Laboratory Histogram Immunoassay Plus Lot 45 Exp -Jan-6 Main Street Anytown, NY Acetaminophen Enzymatic, colorimetric ug/ml Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Siemens Dimension EXL Your Lab 8.65 vs. 6. Cum Peer Group.77 < - Your Lab 4.85 vs. 9. Cum Peer Group < Cum Your Lab 7.6 vs.. Cum Peer Group < Better labeling and arrows clearly indicate values that fall outside of (either above or below) the range.

5 Bias & Imprecision Histogram The information in this report shows trending over the previous months for easy detection of performance changes in your bias or imprecision. This report is also an excellent tool to meet regulatory and accreditation requirements to monitor trends in bias and imprecision over time. January 4 Lab 45 Bias & Imprecision Histogram Immunoassay Plus Lot 45 Exp -Jan-6 Main Street Anytown, NY Acetaminophen Enzymatic, colorimetric ug/ml Feb Mar Apr May Jun July Aug Sep Oct Nov Dec Jan Siemens Dimension EXL Bias 5.7 Percent Bias Percent Bias Percent Bias Your monthly is still represented as a bar chart and your bias as a connected line of diamonds, but the addition of color, wider bars and clearly labeled control levels gives a modern look and feel to this report. 4 Unity Interlaboratory Reports

6 Worldwide Report Providing a summary of all peer groups representing all the data submitted to the Unity Interlaboratory Program, the Worldwide report is available for each lot number of Bio-Rad controls on QCNet.com. Inclusive of all consensus groups, this report can be useful for starting up new control lots before you have submitted any data. January 4 Worldwide Report Multiqual,, Unassayed Lot 456 Exp -Jan-6 Conventional Units Albumin Bromcresol Purple (BCP) g/dl Mon Cum Abbott AEROSET/ARCHITECT (c, i, ci models) Mon Cum Mon Cum Beckman Coulter CX Series Beckman Coulter LX, LXi75, Chemistry Systems Beckman Coulter UniCel DxC Series Siemens Dimension Series Siemens Dimension Vista K K K K K K K K K Containing familiar information, the addition of shaded color bars and clearly labeled control levels make this report much easier to read. 5

7 Statistical Profile Compare your laboratory s statistics to the peer, method, and all labs consensus groups. Two histograms summarize where your lab s and values fall with respect to the range of values calculated for the indicated consensus groups. Section : Your lab s ranges for and s and summary statistics for quarter and year and median,, and Bias Section : Frequency histogram of s and s Section : Percentile distributions: Now organized by percentile, then quarter and by year Our most sophisticated peer report, with information not offered elsewhere, contains the same unique data in a user friendly format that includes histogram color, shading across lines of data and consolidated information. Section Statistical Profile January 4 Lab 45 Unassayed Chemistry Lot 45 Exp -Jan-6 Calcium Arsenazo III - VITROS mg/dl This Quarter This Year VITROS 56 (Dry Slide) mg/dl Slide generation #9 Lab s Range Median Lab s Range Lab Bias N/A N/A N/A N/A 97 4 VITROS Microslide Series Your Lab Peer Group Group All Labs Bromcresol Green (BCG) -Vitros K K 88 Section 5 Frequency histogram of laboratory means for this quarter 5 Frequency histogram of laboratory s for this quarter Your Lab Range of s Range of s Your Lab All Labs Group Section Percentile Distribution Peer Bias Bias Median All Labs Bias Unity Interlaboratory Reports

8 Affiliated Laboratory Comparisons Report: Abbreviated Summary This popular summary report provides a simplified view of performance for all your affiliated labs. A quick review enables 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. January 4 Affiliated Laboratory Comparison Report: Abbreviated Summary Unassayed Chemistry Lot 45 Exp -Jan-6 Main Street Anytown, NY Reference Laboratory 5789* R&D Laboratory Western Laboratory Central Laboratory Eastern Laboratory * Southern Laboratory * Lab data was not available for processing for the date listed. Consequently no reports were generated for this lab during the reporting cycle. Albumin Bromcresol Green (BCG) g/dl # Points Affiliated R I Peer R I R I Roche MODULAR (ISE, D, P, E7) Affiliated Group (4 Labs) Peer Group (45 Labs) Group (45 Labs) 456 Reference Laboratory Roche MODULAR Western Roche MODULAR Central Roche MODULAR Eastern Roche MODULAR Affiliated Group (4 Labs) Peer Group (45 Labs) Group (49 Labs) 456 Reference Laboratory Roche MODULAR Western Roche MODULAR Central Roche MODULAR Eastern Roche MODULAR Roche cobas 6/8 Series Affiliated Group ( Labs) Peer Group (5 Labs) Group (45 Labs) 456 Reference Laboratory Roche cobas Reference Laboratory Roche cobas Affiliated Group ( Labs) Peer Group (5 Labs) Group (49 Labs) 456 Reference Laboratory Roche cobas Reference Laboratory Roche cobas

9 Affiliated Laboratory Comparison Report This report provides a detailed look at each affiliated lab s performance by summarizing the performance of each participating affiliated laboratory. Designed for the manager responsible for overseeing multiple sites, it is also useful for comparing multiple instruments made by the same manufacturer located either within or across sites. January 4 Affiliated Laboratory Comparison Report Unassayed Chemistry Lot 45 Exp -Jan-6 Main Street Anytown, NY Reference Laboratory 5789* R&D Laboratory Western Laboratory Central Laboratory Eastern Laboratory * Southern Laboratory * Lab data was not available for processing for the date listed. Consequently no reports were generated for this lab during the reporting cycle. Bilirubin, Direct/BC (DBIL) Diazotization mg/dl Lab Affiliated Group Peer Group Group Mon Cum Mon Cum Mon Cum Mon Cum Mon Cum Roche MODULAR (ISE, D, P, E7) Roche MODULAR Diazotization (ISE, D, P, E7) 456 Reference Laboratory Roche MODULAR.7. Affiliated R Peer R R.. R Affiliated I Lab Bias Peer I K I.. I Affiliated R Peer R R.. R Affiliated I Lab Bias Peer I K I.6.6 I Western Laboratory Roche Hitachi MODULAR E7..7 Affiliated R Peer R R.. R Affiliated I.9 -. Lab Bias Peer I K I.4. I Affiliated R Peer R R.. R Affiliated I.5.8 Lab Bias Peer I K I.9.5 I Affiliated Group: Roche MODULAR Peer R.9.5 R.. Peer I. -. I.. Peer R.8. R.. Peer I I I - - I - R R Linear Regression of s Lab.8.5 Lab.8.5 Lab Affiliate..5.8 Peer A condensed format provides more comprehensive performace comparisons of each lab versus Affiliated, Peer and for the month and cumulative.. Modified Youden graphs.. Linear regression plots of means for multiple instrument comparisons. 8 Unity Interlaboratory Reports

10 QC Data Management Solutions Affiliated Data Exception Report This report shows data warnings and rejections for affiliate labs and provides an overview of exceptions for all labs in the affiliated group. It includes I/R warning, data exclusions, coding rejections (data rejected due to possible test configuration errors and suggests potential corrections). Layout consolidation of data exclusion information, the rearrangement of detailed data in linear rows, and the addition of shaded bars for alignment of data make this report easier to interpret and use. January 4 Affiliated Data Exception Report Unassayed Chemistry Lot 45 Exp -Jan-6 Main Street Anytown, NY Reference Laboratory 5789* R&D Laboratory Western Laboratory Central Laboratory Eastern Laboratory * Southern Laboratory * Lab data was not available for processing for the date listed. Consequently no reports were generated for this lab during the reporting cycle. Lipase Colorimetric (Siemens calibrated) U/L 7 C Siemens Dimension Series 456 City Regional Hospital Siemens Dimension EXL Affiliated R.9 Peer R. R.9 Affiliated I.7 Peer I. Warning: Acceptable values are above and below I.4 Warning: Acceptable values are above and below Affiliated R Peer R R Affiliated I Peer I I Warning: Acceptable values are above and below Lab Affiliated Peer Reference Lab Siemens Dimension EXL Data Exclusion: Lab = 8. Acceptable values are This data was not used as part of the Unity worldwide statistical database Coding Rejections The 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. Submitted Test Configuration 456 City Regional Hospital Data for -, - Analyte Amylase Maltotetraose Instrument Siemens Dimension EXL Reagent Dedicated Reagent Units U/L Temp 7 C Suggested Test Configuration CNP-triose/CNP G For further information, please contact the Bio-Rad office nearest you or visit our website at Clinical Diagnostics Group Website Australia Austria Belgium Brazil +55 () Canada China Czech Republic Denmark Finland France Germany +49 () Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +5 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland +4 () /6 Taiwan Thailand United Kingdom +44 ()-88- Bio-Rad Laboratories, Inc. Printed in USA Q-56 Q-96 Rev. / Printed on recycled paper with soy-based inks