External Quailty Assessment: an Essential Tool for Laboratory Quality

QUALITY CONTROL

Complete QC solutions for results you can trust

Considering that 75% of the information used by physicians to make a diagnosis is derived from laboratory test results, it is vital that laboratories perform regular checks to ensure the results released are accurate and reliable.

The objective of Quality Control is to detect laboratory errors and ultimately, prevent the release of inaccurate test results which could lead to misdiagnosis, inappropriate treatment or treatment delays, all of which could be potentially life threatening for the patient. Quality Control will also decrease the need for repeat tests, directly reducing costs as a result.

A good Quality Control programme should incorporate both Internal Quality Control (IQC) and External Quality Assessment (EQA).

The use of IQC alone is not a sufficient measure of laboratory performance. Participation in an EQA scheme is also required to ensure confidence in patient results.

While IQC will effectively monitor the reproducibility or precision of laboratory testing, it doesn’t enable laboratories to monitor bias or accuracy. Accuracy refers to how close the result generated by the laboratory is to the true value of the sample. In order to effectively monitor accuracy, laboratories must participate in an EQA programme.

Best Laboratory Prctices

‘The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment programmes. Laboratory management shall monitor the results of external quality assessment and participate in the implementation of corrective actions when performance criteria are not fulfilled’ISO 15189:2012 Medical Laboratories: Requirements for quality and competence

Internal Quality Control

External Quality

Assessment Total Quality Assurance

EQA: an Essential Tool for Laboratory Quality

Implementation of an EQA scheme, although appearing to represent additional costs to the laboratory’s budget, will in the long term decrease expenditure, increase productivity and, most importantly, improve performance and minimise patient risk.

Benefits of EQA

EQA – More than just Accreditation

• Provides management with an holistic view of test system performance that IQC alone cannot provide

• Identify potential equipment or reagent faults as well as staff training requirements and issues with staff competency

• Reduce the cost and time associated with expensive repeat tests

• Compare performance with other analytical methods on the market

• Initiate corrective action and evaluate the effectiveness of corrective actions

• Provides an independent assessment of laboratory accuracy for added confidence in patient test results

What Medical Professionals Say About EQA

The following real life testimonials show how EQA has helped laboratories in Africa to improve quality and performance.

“EQA has proved to be of huge benefit to our laboratory. This is mainly because of the narrow SD which ensures that only accurate results are acceptable. EQA has been an eye opener to the shortfalls of our lab. We expect our performance to improve and subsequently our reliability to clinicians.”

Tinei Makurumure, Quality Assurance Manager, Multi-Tech Diagnostics, Harare, Zimbabwe

“EQA has helped me and my team to identify problems associated with the calibration of my analyser. This has been extremely beneficial in running my lab. It gives me confidence in my results and indicates where problems may arise.”

Mrs Anya, Laboratory Manager, Reddington Hospital, Lagos Nigeria

“EQA has improved our laboratory performance and increased our confidence. A good EQA scheme has the potential to offer a wide range of parameters, covering a broad spectrum, rapid turnaround of results and user-friendly reports. It should provide Multi – Instrument reports, allowing a laboratory to compare accuracy between their instruments.”

Dr Veena Vyas, Head of Department (Pathology) The Aga Khan Hospital, Dar es Salaam, Tanzania

“The Nairobi hospital has been using EQA for more than two decades and throughout this period we have been happy partners. EQA provides samples that cover our entire test panel including; blood gas, therapeutic drugs, immunoassay, biochemistry, urinalysis & haematology. Frequent samples are most appropriate for our hospital enabling us to identify non-conforming tests quickly. A good EQA scheme will provide a good reporting format to interpret results and enable us to sustain our ISO 15189 accreditation.”

Dr Peter Kariuki, Deputy Manager of Laboratory Services, The Nairobi Hospital, Nairobi, Kenya

“Our laboratory is a hospital and clinical lab which seeks high technical quality to ensure reliable results. That is why we enrolled for an EQA programme, aware that it provides valuable data and information which will ensure accurate results for our customers, e.g., physicians, patients, health authorities and NGOs alike. EQA provides early warning to problems in laboratory practices, allowing appropriate corrective action and continuous quality improvement.”

Mrs Maria Santo, Laboratory Manager, ICOR - Instituto do Coração Maputo, Mozambique

Real Life Case Studies Highlighting the Importance of Running Both IQC and EQA in a Laboratory

The following case studies highlight the importance of participating in a reputable EQA scheme in addition to daily IQC to ensure laboratory quality and prevent the release of incorrect patient results, which could be potentially life threatening.

Detecting Concentration Issues

• Upon the review of their EQA report, Laboratory ‘A’ observed poor performance for Procalcitonin. This was evident from the report’s Levey-Jennings chart, which showed erratic dispersal of results. The laboratory’s 1st Party IQC results however, remained within acceptable ranges

• On examining the 1st party IQC kit inserts it was evident that the level 1 and level 3 were not at clinically relevant levels and were not accurately assessing the full range of the assay

Conclusion A good EQA scheme provides samples covering a wider spread of concentrations. Therefore, the EQA highlighted the weaknesses of the range of the Procalcitonin assay which the laboratory’s 1st Party IQC failed to detect.

Detecting Issues Hidden by Inadequate IQC

• Laboratory ‘B’ received EQA reports highlighting poor EQA performance for Amylase but their IQC results were within 2SD limits

• The laboratory contacted their EQA provider who explained that although their IQC results were within 2SD, when the % deviation from the target is calculated 2SD was equal to 20%

• The acceptable limits of performance used by the EQA scheme were much narrower, where 2SD was equal to 10% of the target value

• Therefore EQA proved to be a more stringent assessment of the laboratory’s performance

Conclusion In this example, participation in an EQA scheme highlighted that the acceptable ranges provided by the QC manufacturer were unrealistically wide, thus masking an issue with the test system and ultimately resulting in the laboratory falsely believing that its results were accurate.

Financial and Human Impact of Misdiagnosis

Avoidable repeat tests cost the US $200 million every year

“Globally, best estimates put the incidence of diagnostic error in

assessing patients in the range of 10% to 15%” (1)

Studies put the number of diagnostic errors in Australia at 140,000 cases a

year, with 21,000 cases of serious harm and between 2000 and 4000 deaths.

In 2008, medical errors cost the United States $19.5 billion. About 87% or $17 billion were directly associated with additional

medical cost, including: ancillary services, prescription drug services, and inpatient and outpatient care. (2)

1. http://theconversation.com/the-hidden-problem-of-medical-misdiagnosis-and-how-to-fix-it-146622. J Health Care Finance. 2012 fall; 39(1):39-50. The economics of health care quality and medical errors. Andel C1, Davidow SL, Hollander M, Moreno DA

How does EQA Work?

EQA provides a means of periodically assessing laboratory performance in comparison with other laboratories using the same method and instrument. Unlike IQC, EQA provides an effective method of monitoring a laboratory’s bias or accuracy through the analysis of samples of unknown concentrations, otherwise known as ‘blind samples’. It also enables assessment of the complete testing process including pre-analytical, analytical and post analytical phases.

After analysis, results are submitted to the scheme organiser for statistical evaluation. Laboratories will subsequently receive a report comparing their performance to that of other participants in the programme. The diagram below illustrates how EQA works.

REGISTER

1

36.000 mg/dl

84.800 IU/ml

132.000 ng/ml

Certificate of Participation

Stephen DohertyRIQAS Manager

Randox International Quality Assessment SchemeRandox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, BT29 4QY, United Kingdom PR

-281

APR

15

<Name>

<Laboratory/Hospital>

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Place an order with your local Randox representative. Register by completing enrolment document and submit at least 3 weeks before the cycle starts1

You will receive a set of numbered samples for the

cycle along with a username/password

for RIQAS.Net *

2

Analyse the sample on the recommended date 3

Enter and submit results online

before the final deadline

4 Receive report within 72 hours and

review to assess performance5

Certificates will be awarded at the end of the cycle

providing that more than half of the results are returned

6

QUALITY CONTROL

* Provision can be made for labs without internet access

Levey-Jennings

Levey-Jennings charts are useful for monitoring performance over time, allowing instant identification of any trends or bias. Ideally, results should fall within 1SD (white region) either side of the mean.

Participation in an EQA scheme alone will not automatically improve quality or performance. Perhaps the main value of participating in an EQA scheme lies in the report generated by the scheme provider. Not only should reports be comprehensive, covering a wide range of statistics and charts, it is also important that they are user-friendly and easy to interpret. The ability to understand an EQA report will maximise the benefits of participating in an EQA scheme.

Understanding EQA Reports: the key to improving performance and quality

Histogram

Histograms provide a quick, visual indication of how your laboratory performs in relation to the instrument mean, method mean and all method mean.

% Deviation by concentration chart

Helps to quickly and easily identify any concentration related bias within a test system.

Target score chart

Unique to RIQAS, the Target Score chart provides a visual indication of performance for the last 20 samples. A target score of 50 or more is considered acceptable.

When choosing an EQA scheme to complement your IQC there are several factors to be considered. The below checklist is designed to help you choose, not only the most cost effective, but the highest quality EQA scheme.

Essential Criteria for Choosing an EQA Scheme

• Large number of participants increasing statistical validity and ensuring availability of peer group data for a wide range of analytical methods

• Accreditation to ISO/IEC 17043:2010

• Frequent analysis ensuring system errors are identified as early as possible

• Rapid report turnaround allowing corrective actions to be taken immediately with minimum risk to patients

• Samples that cover the complete clinical range and behave in the same manner as patient samples

• Ability to register multiple instruments

• Multi-analyte programmes allowing effective consolidation

• User-friendly yet comprehensive reports allowing at-a-glance performance assessment

For EQA to be fully effective in improving laboratory performance, we must train laboratory staff on the importance of Quality Management, and more specifically on the application of EQA programmes and the interpretation of the reports that are generated. Training modules available to participating laboratories include:

• Importance of Quality Assurance and Quality Control in the Laboratory Setting

• Eliminating Analytical Error: Identifying Random and Systematic error

• Quality tools to reduce cost and improve the quality of patient results

• ISO15189 & ISO 17043- Quality Accreditation in the Clinical Laboratory

• Troubleshooting laboratory errors - workshop

• EQA report interpretation - workshop

• Pre-analytical, analytical and post analytical error - workshop

Randox continues to bring innovative new products to the IVD market every year, investing up to 16% of revenue in R&D. With around 25% of the company’s personnel focused on research and engineering, Randox is, and will continue to be, at the cutting edge of a fast moving dynamic industry.

Randox: Committed to Training and Education

The only provider to fully meet these requirements is RIQAS; the world’s EQA scheme of choice

Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom +44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com

Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA.

QUALITY CONTROL

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LT64

9 JU

N15

Comprising almost 360 routine and esoteric parameters in 24 comprehensive and flexible EQA programmes, RIQAS is designed to cover all areas of clinical testing. Each programme benefits from a wide range of concentrations, frequent reporting and comprehensive yet user-friendly reports.

The largest global EQA scheme with over 31,000 lab participants

mail@riqas.com riqas.net riqas.com

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RIQAS Programme

Parameter Options

RIQAS Programme

Parameter Options

Ammonia/Etanol 2 Immunoassay Speciality II 5

Blood Gas 10 Lipid 3/7

BNP 1 Liquid Cardiac 9

Cardiac 2/7 Maternal Screening 6

Coagulation 5/17 Serology (EBV) 3

ESR 1 Serology (HIV/Hepatitis) 10

General Clinical Chemistry 10/17/50 Serology (Syphilis) 1

Glycated Haemoglobin 2 Serology (ToRCH) 12

Haematology 11 Specific Proteins 26

Human Urine 25 Therapeutic Drugs 18

Immunoassay 4/13/55 Urinalysis 14

Immunoassay Speciality I 10 Urine Toxicology 20