Unity™ Interlaboratory Program Update Unity Real Time User Group Meeting – Nov 2013

Unity Interlaboratory Program

• Core of Unity… Bio-Rad has over 30 years experience setting the standard for interlaboratory comparisons

• Unity is the diagnostic industry’s largest peer program • 20 000 labs actively participating worldwide

• ~ 10% annual growth rate

• Unity’s peer sizes provide greater statistical integrity and better

information on analytical performance

Worldwide Unity Lab Participation

• Broader strategy than just running controls – Detect errors in analytical performance

– Identify unrecognized trends or shifts that may occur

between proficiency surveys

– Meet regulatory and accreditation requirements

– Supplement proficiency testing programs such as QMPLS/OLA, EQAS

– Improve proficiency testing outcomes

Why Participate (1)?

– Unity is a proven and mature program with over 20,000 participating labs

• More robust, trustworthy statistics

– Obtain better guidance than inserts for new lots – Increase confidence in reported patient test results

and avoid costly medical and laboratory errors

– Help patients worldwide by contributing to peer groups that act as reference set for laboratories to benchmark against.

Why Participate (2)?

Regulatory and Accreditation Requirements

• Laboratory quality management standards and regulations are strengthening worldwide for QC data management and peer programs.

• ISO 15189: 2003(E), sub-clause 5.6.1 “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…”

• CLSI C24-A3, Vol. 26, No. 25 “…. for laboratory self evaluation, peer related bias and relative

imprecision are useful parameters.” • ISO 15189: 2003(E), sub-clause 5.6.4

“The laboratory shall participate in interlaboratory comparisons…”

Unity Interlab Updates

• New Unity Reports – Updated with improved look and feel

– Includes support for master lots with >3 levels

– Maintained the same report types with only a few

modifications to report content to ease transition

• New notification system

• New internal tools to improve statistical integrity

7 |

Monthly Evaluation

• Combined with Data Rejection Report for ease of use

• Provides quick overview of possible issues

• Includes submission status, warnings, and data rejections in one location

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Lab X

Monthly Evaluation

Laboratory Performance Overview

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Laboratory Comparison Report

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Laboratory Histogram

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Bias and Imprecision Histogram

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Statistical Profile Report

• Most sophisticated Unity peer report with unique information not offered anywhere else

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Statistical Profile Report – Summary Stats

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This report is available only in electronic format on QCNet. It is updated every 3 months.

Statistical Profile Report – Frequency Histogram

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Statistical Profile Report- Percentile Distribution

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Affiliated Reports

• Provides ability to compare multiple instruments of a common make and model – Use within a single site if more than one instrument – Use for across site comparison if running the same lots

• Option of three different Affiliated reports

– Full report – Abbreviated Summary – Exception

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Affiliated Report

• Includes more comprehensive comparison of each lab versus Affiliated, Peer and Method for month and cum in new condensed format

• New graphic with SDI and CVR

• List of all labs in their group and participation status

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Affiliated Report (2)

• Includes summary of Affiliate Group versus Peer and Method • New Linear Regression of Means

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Affiliated Report- Abbreviated Summary

• Condensed version of Affiliated Report for quick review

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Affiliated Exception Report

• Provides overview of exceptions for all labs in the group • Includes SDI/CVR warning, data rejections

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Affiliated Exception Report

• Code rejections notification 23 |

Worldwide Report

• Provides summary of all peer groups

• Useful for starting up new lots

• Also available as Manufacturer Reports

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Unity Interlaboratory Program

• In addition to standard monthly reports, InstantQC redesigned in 2009 and is more popular than ever…