Clinical Laboratory Scheme (CLS) External Quality

Clinical Laboratory Scheme (CLS)

External Quality Assessment in Practice

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LGC AXIO Proficiency Testing for Clinical LaboratoriesLGC AXIO Proficiency Testing offers regular clinical EQA programmes as part of the Clinical Laboratory Scheme (CLS), covering a wide range of testing requirements.

Clinical Chemistry

11 clinical chemistry programmes in addition to therapeutic drug monitoring, immunosuppressant, toxicology and drugs of abuse programmes, totalling over 500 analytes.

Thousands of laboratories participating in some of the more popular programmes.

Haematology Basic haematology; 5-part differential; coagulation with extended offerings; urinalysis; sedimentation rate.

Virtual microscopy programmes offering educational challenges.

Blood Bank ABO testing; ABO subtyping; antibody screen/ID; antigen typing; compatibility; DAT testing.

Represent true patient whole blood samples to mimic routine testing.

Immunology Hepatitis, HIV, hsCRP, infectious mononucleosis, immunoproteins, rubella, syphilis, and thyroid antibodies.

Offers a variety of assays compatible with available testing systems.

Microbiology Bacteriology, mycobacteriology, mycology, parasitology, and virology options that are compatible with both culture and molecular methods.

Includes a number of virtual programmes to assist laboratories with education and competency.

Molecular Multiplex

Test materials available for testing of viral respiratory, pneumonia, bloodstream, gastrointestinal infections and meningitis-encephalitis.

Syndromic panel-based testing suitable for multiplex PCR systems.

Clinical Laboratory Scheme (CLS) External Quality Assessment

The primary aim of External Quality Assessment (EQA) participation is to drive improvement in the quality of testing of clinical samples. Every clinical laboratory should regularly participate in EQA programmes across their whole range of diagnostic testing to support their quality assurance system.

Participation in EQA provides laboratories with an assessment of performance, and aids method validation. With personalised feedback reports, participants are able to compare their results to their peers.

Aids MethodValidation

PeerComparison

PersonalizedFeedback

Performance Assessment

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AXIO | Clinical Laboratory Scheme (CLS)

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Why participate in LGC AXIO Proficiency Testing schemes?

GLOBAL PRESENCE

LGC AXIO Proficiency Testing operates in 160+ countries

A high number of peer laboratories sharing data increases the quality and robustness of the data analysis

ISO/IEC 17043 ACCREDITATIONS

Majority of programmes are accredited according to ISO/IEC 17043 by either UKAS or A2LA

Provides laboratories with a high degree of confidence in the EQA scheme since it has been independently assessed against the requirements of the international standard

REPORTING PLATFORM

PORTAL – an online hub for results submissions, report downloads, data export and trend analysis

Provides multiple user/analyst access, user friendly interactive EQA reports and trending tools. Increasing local language options

RANGE OF PROGRAMMES

Over 130 accredited clinical EQA programmes

All EQA needs from one supplier with disciplines such as chemistry, haematology, immunology/serology, blood bank, and microbiology

VIRTUAL PROGRAMMES

Virtual EQA programmes Advanced virtual microscopy technology utilised for interpretative programmes to provide the same slide images to all laboratories

QUALITY OF TEST MATERIALS

EQA test material mimics patient samples

Reflects clinical testing challenges

CERTIFICATES Participation certificate at start & end

Participants can showcase their up-to-date participation with a certificate of participation on commencing programme and upon completion

TECHNICAL SUPPORT & CUSTOMER SERVICE

Global LGC offices and local distributors

Expert teams all over the world are available to help with your order or offer technical assistance



3 AXIO | 2021 Clinical Proficiency Testing schemes


Despatch of test materials and

instructions to participants.

Participants analyse test materials. Scheme allows

participants to change the configuration

of methods and instruments.

Report results through PORTAL*

within the specified deadline. Laboratory enrols instrument(s)

and/or method(s) on PORTAL.

Results analysed and the performance

of laboratories compared using internationally

accepted scoring.

Reports issued and participants

notified once reports are available on

PORTAL. Participants can download a Certificate of Participation.

Prior to Testing

Testing Results Submission

After Reporting Deadline

Reports Issued

The LGC AXIO Proficiency Testing EQA Process

*(portal.lgcstandards.com)

Simple Ordering and EnrolmentOrders will be placed either with your LGC sales office or via the authorized distributor in your country. Laboratories can commence their participation at any time during the calendar year and renewals for the following year are processed from October. Invoices are charged per shipment.

Distribution and ShippingSamples are shipped according to the shipping schedule which is given on the application form. Shipments are consolidated where possible to reduce costs. Sample integrity is retained by shipping between 2 °C and 8 °C. There are no requirements for frozen or dry ice shipments.



http://portal.lgcstandards.com


FAST. SIMPLE. INTERACTIVE.

LGC AXIO proficiency testing date available 24/7. A User Guide is available to PORTAL

users at https://portal.lgcstandards.com/

What does PORTAL offer LGC AXIO Proficiency Testing users?

USER MANAGEMENT & PERMISSIONS

PORTAL provides multi-user, permission-controlled access to your EQA programmes.

EQA reporting responsibilities can be shared across the laboratory team and competency assessed.

EVENT CALENDAR

Overview of EQA activity in the current month and quick access to results entry and reports.

Calendar shown after login. User friendly reminder system.

LABORATORY EQA CONFIGURATION

Simple results entry. Email confirmation. Multiple results per round permitted, up to 5 results per programme.

INTERACTIVE REPORTS

Click through your EQA report to view your performance against peers and assess the competency of your laboratory, methods/instruments, and analysts.

Various reports available.

Summary Report. Analyte Report. Main Report.

PERFORMANCE MONITORING

Statistical performance indicators, histograms and performance trends for the past 9 rounds.

Summary of assessments by analyst also available.

DASHBOARD ALERT SYSTEM

Colour coded control panel showing Satisfactory, Questionable and Unsatisfactory results per round.

Quickly identify areas that require attention.

CERTIFICATES A Certificate of Participation is available once the laboratory commences reporting EQA results.

A Certificate of Completion is awarded at the end of the cycle if the results submission criteria is met.

Reporting with PORTAL



https://portal.lgcstandards.com/


Simple & Comprehensive Reports AvailableAt the conclusion of each round, the following reports are issued via PORTAL:

1. Individual Report (Summary Report)2. Analyte Report3. Main Report

1. The Individual Report (Summary Report) summarizes the assessment of the laboratory results and provides peer data statistics.

A summary table presents an overview of assessments received for each sample, and the number of satisfactory, questionable and unsatisfactory assessments.

Fig. 1

If unsatisfactory or questionable performance scores were received, the applicable analytes will be indicated as in the following table:

Fig. 2

The report ends with an overview of each result reported in table form with colour-coded performance assessment and peer group statistics. These colour-coded performance scores provide a quick visualization of lab performance by parameter.

Fig. 3




Scheme: Clinical Laboratory Scheme (CLS)Round: CL21CHM006 Issued: 15/09/2021

Analyte: PSA, totalMethod: Roche Cobas e411 / RocheInstrument Group: Roche

Sample CHM, Quantitative Methodology Summary

MethodResults

Unit Median Robust SD Range Sat % Questionable % Unsat %Number Excluded % of Total

Roche 26 0 43 ng/ml 5.73 0.39 4.75 to 6.58 92.3 7.7 0.0

Abbott Instruments 15 0 25 ng/ml 4.49 0.19 3.81 to 5.30 80.0 20.0 0.0

Beckman 13 0 22 ng/ml 5.23 0.55 4.64 to 6.37 92.3 7.7 0.0

Other Instruments 3 0 5 ng/ml 4.98 0.40 4.68 to 5.25 100.0 0.0 0.0

Biomerieux miniVidas 2 0 3 ng/ml 5.46 0.15 5.36 to 5.56 100.0 0.0 0.0

Ortho Vitros Eci 1 0 2 ng/ml 5.00 0.00 5.00 to 5.00 100.0 0.0 0.0

Sample Comments

Sample CHM

The target value for PSA, total obtained by a reference method was 5.95 ng/mL. Assessment could not be performed for methods that have less than five participants.

Laboratories may compare their results to the target value and the assigned value for the various methods in the quantitative statistics table.

Issue Number: Page 43 of 43 Issue Date:

Lab ID: Lab X SampleScheme: Clinical Laboratory Scheme (CLS)Round: CL21CHM006 Issued: 15/09/2021

Analyte: PSA, totalMethod: Roche Cobas e411 / RocheInstrument Group: RocheResults

Sample Instrument Ref Result Unit Perf Score Score Type % Diff

CHM 5.71 ng/ml -0.07 zScore 0.44

Assessment Statistics

Sample CHM

Assigned Value 5.73

Assigned Value Derived By instruments

Uncertainty of Assigned Value 0.096

SDPA 0.383

Satisfactory Range 4.97 to 6.5

Satisfactory z/z score 92.3%

Questionable z/z score 7.7%

Unsatisfactory z/z score 0.0%

Result Statistics

Sample CHM

Number of Results 26

Number of Excluded Results 0

Mean 5.68

Median 5.73

Standard Deviation 0.402

Robust SD 0.393

Last 9 Performance Scores

Sample CHM - Round Instrument Ref 21_001 21_002 21_003 21_004 21_005 21_006

Roche Cobas e411 / Roche 2.09 -0.17 0.11 -0.28 -0.07

< or > = Less/Greater than result returned, no assessment given. ZS = Zero Spiked Sample, no assessment given. Blank = No result submitted

Issue Number: Page 42 of 43 Issue Date:

Lab ID: Lab X Sample

1 Header section shows the following information:

• Lab ID number • Laboratory name• Report name • Scheme name/programme• Specific Round • Date issued

2 Your results are shown for your method and instrument peer group. Colour coded performance scores indicate:

Satisfactory Questionable Unsatisfactory

3 Summary of performance assessment data, showing:

• Calculated assessment statistics for the current sample/analyte• The assigned value for comparison• Your comparison peer group • Summary of comparison group statistics

4 Histogram displays two data sets:

All results Your peer group results

‘V’ Indicates your result(s)

The Y-axis shows the number of labs reporting results and the X-axis shows the range of reported values.

5 A table tracks your last 9 performance scores for up to 5 instruments, colour coded to match performance.

6 Two charts plot your performance scores:

• Across the past 9 samples, to visualise trends over time

• By concentration levels to visualise performance across a range of concentrations

• Chart colours match performance assessment. Multiple instruments included

7 Method group statistical summary:

• Peer group statistics for the most common instrument / method combinations reported

• Provides a helpful way of comparing your method with other methods used

8 Method group box and whisker plots:

• Box-and-whiskers plot the minimum and maximum values and middle 50% of the data in each peer group

• Allows comparison of method means and spread of results for different methods.

9 Technical comments

• When appropriate technical comments will be provided by LGC AXIO Proficiency Testing Technical Managers to assist with report interpretation.

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2. The Analyte Report presents more detail on the performance data in a two page format. Statistical analysis for each analyte is provided. Performance indicators and graphical analysis help identify any quality issues and important trends.




Monitoring Good EQA Performance in the Laboratory Even when EQA performance is satisfactory, reviewing an EQA report is more than just checking for “green” or satisfactory performance scores. Reviewing good performance can help identify emerging trends and any potential bias in your results. On the Individual Report, the brief summary format allows you to scan the column of performance scores to ensure you are not receiving consistently positive or negative z-scores, which would indicate potential bias in your method or instrument results.

The Analyte Report enables you to monitor specific analytes, looking at trends over time, or across a range of concentrations.

To get the most value from EQA participation, laboratories should use the reports provided as an independent source of information, together with internal QC and review of patient reports, to monitor their overall laboratory quality.

Troubleshooting Poor EQA Performance in the LaboratoryAs part of a root cause analysis for a non-compliant EQA result, a laboratory should examine their EQA report carefully and review any technical commentary provided.

The following flowchart will help to identify potential causes of non-compliant results.

The main report for each round of a scheme is the same for all laboratories. It contains more detailed statistics on all samples and analytes in that round. Both assessment statistics and descriptive statistics are provided for every comparison group, with the number of results in each group. Histograms of

participant results by z-score are also provided. These statistics are most often used for troubleshooting poor performance or trends noticed in your analyte report. They can also be useful for non-EQA activities like researching a possible method change in your laboratory.

No

YesObservation Comment/Corrective Action

Error in reportingtest results from

instrument to PORTAL

1Review how test result is recorded

from instrument and reported on PORTAL.

Check the units indicated with results on PORTAL. Modify and report correct unit, or contact EQA provider to add your

correct unit.

Review the laboratory processof results entry and checking.

Modify and report the correct peer(method/equipment) group.

Mixed up test results

Reporting units error

Registered in incorrectpeer group

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3

4

Tran

scri

ptio

n

No.

No

YesObservation Comment/Corrective Action

Error in reportingtest results from

instrument to PORTAL

1Review how test result is recorded

from instrument and reported on PORTAL.

Check the units indicated with results on PORTAL. Modify and report correct unit, or contact EQA provider to add your

correct unit.

Review the laboratory processof results entry and checking.

Modify and report the correct peer(method/equipment) group.

Mixed up test results

Reporting units error

Registered in incorrectpeer group

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3

4

Tran

scri

ptio

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No.

(Continued on next page)

3. A Main Report is the definitive version of the EQA report.




5Inappropriatestorage of thetest material

Reconstitutionproblem

Was there a problemwith the reagent/

instrument?

Problems with internal

quality control

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9Deviation similar to

previous EQA resultsat similar levels

Large variation inEQA results for the

method used

Check re-run valueagainst initial value

Check results ofother Internal QC

measures

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Participate in nextEQA round and review results

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Poor test material storage may lead to poor EQA results. Evaluate storage procedures.

Poor reconstitution due to a pipetting/volumeissue or test material mixing. Follow reconstitution

instructions provided.

Are reagents stored correctly and within theperiod of open vial stability? Review operation

log of instrument at time of EQA. Look formaintenance issues. Is instrument within calibration?

Look for trends (% deviation) in the internal quality control at the time of the EQA.

Discuss possible causes with EQA and assay providersto help determine whether deviation is more

likely to be internal or external to the laboratory.

Discuss with EQA and assay providers whetherthe deviation could be due to inappropriate

EQA material for the method, or whether there would be a more suitable peer group for your method.

Repeat analysis of retained test material. If repeated results show agreement with assigned value, the

corrective action has been effective.

Ensure that both internal quality control andpatient results were correct during the same

EQA reporting period.

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Further Resources

Clinical Profi ciency Testing Schemes


ISO/IEC 17043

LGC AXIO Proficiency Testing Clinical EQA Brochure

Profi ciency Testing Schemes


Food & FeedBeverageWater & EnvironmentPetroleum

Consumer SafetyClinicalForensic

ISO/IEC 17043

LGC AXIO Proficiency Testing Catalogue

LGC AXIO Proficiency Testing Clinical EQA Video

Further technical documentation including Scheme Description and Accreditation documents are available on our website.

Please contact your local LGC Sales Office or authorized distributor for further information.

FAQsFurther useful information is available in our Frequently Asked Questions section on our website, found here: https://www.lgcstandards.com/GB/en/support/faq#proficiency-testing




Order your LGC AXIO Proficiency Testing schemes online

Identify and order clinical proficiency testing programmes to fit your requirements online now at lgcstandards.com/AXIO

Key features include:

Whilst every effort has been made to ensure the accuracy of the information in this catalogue, customers are directed to their local sales office or the LGC Standards website for further details and to verify product information. Specifications, terms and pricing are subject to change. LGC does not guarantee availability and reserves the right to discontinue any product. LGC does not accept liability for any loss that is caused by inaccurate product information, customer selection or inappropriate use of a product. Unless otherwise stated all trademarks are the property of LGC or its affiliated group companies. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or any retrieval system, without the written permission of the copyright holder. © LGC Limited, 2021. All rights reserved.

You can also browse, search and order the wide range of LGC reference materials at lgcstandards.com

1 Simple Enrolment

Laboratories can enrol simply and quickly. Configuration is flexible, meaning changes can be made at any time to reflect changes in the laboratory.

2 State of the Art Reports

Laboratory staff can visualize instrument performance with state of the art reporting tools and current peer group performance data.

3 Comprehensive and Consolidated Schemes

A full range of both unique and consolidated programmes for all laboratory types, designed to ensure that the needs of all laboratories are met and fully assessed to the highest standard.


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Documents

Clinical Laboratory Scheme (CLS) External Quality