A Comprehensive Guide to External Quality Assessment Programmes
The importance of External Quality Assessment (EQA) programmes in the realm of medical laboratories is beyond dispute. These programmes serve as external control mechanisms, underpinning the accuracy and reliability of diagnostic tests carried out by laboratories across the globe. By participating in EQA programmes, laboratories gain the ability to monitor their proficiency, identify areas for improvement, enhance their analytical performance, and above all, ensure top-tier patient care.
Today, we find ourselves faced with a multitude of EQA programmes, each touting its own, unique features and benefits. Therefore, the question that naturally follows is – how do you choose the right EQA programme for your laboratory?
Understand Your Laboratory’s Requirements
The first step towards selecting an EQA programme is to clearly understand the requirements of your laboratory. These requirements could encompass the range of tests performed, the desired frequency of assessment, and the specific areas where your lab wishes to improve
Examine the EQA Programmes
The next step is to critically examine each EQA programme. Look at the range of tests they cover, the frequency of their assessments, the type of samples they use, and their approach towards feedback and improvement.
One of the most critical aspects of an EQA programme is the results reporting mechanism. This mechanism should provide comprehensive and constructive feedback, highlighting areas of improvement, and offering guidance on how to enhance performance. It is also essential to consider the frequency of reporting. More frequent reporting allows laboratories to identify problems and implement corrective actions swiftly, aiding in the continuous improvement of a laboratory and the confident delivery of accurate patient results.
The accreditation of the EQA programme should also be evaluated. Superior programmes are accredited to ISO17043:2010. Participation in an accredited EQA programme is mandatory under ISO15189:2022 accreditation. Choosing a scheme accredited to ISO17043 ensures that the programme has been rigorously evaluated and meets the necessary criteria of a high-quality EQA programme.
The cost of the EQA programme should be compared to the benefits your laboratory will reap from participating in the scheme. Although cost should not be the sole determining factor, it’s a crucial element to consider. Factors such as consolidation and number of registrations are key areas where many providers differ.
Finally, it’s vital to consider the customer support provided by the EQA programme. Adequate support will ensure that any issues or queries are addressed in a timely and efficient manner
Our latest educational guide Choosing the Right EQA Programme has been constructed to help you with this decision. Providing more detail on the points discussed above and more, this guide displays how the world-renowned RIQAS EQA programmes can help you maximise the accuracy of your laboratory results and achieve ISO15189:2022 accreditation.
In conclusion, selecting the right EQA programme requires a careful and thorough evaluation of several factors. By taking the time to understand your laboratory’s needs, scrutinising each EQA programme, and considering factors such as reporting, accreditation, cost, and customer support, you can make a well-informed decision that will significantly enhance the proficiency of your laboratory and the quality of patient care.
Remember, the primary objective of an EQA programme is to help your laboratory improve. Therefore, the right EQA programme for your laboratory is the one that best assists you in achieving this objective.
The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.
- Lyophilised for enhanced stability
- Monthly reporting
- Human based serum
- Submit results and view reports online via RIQAS.net
- Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output
Not accredited to ISO/IEC 17043
- Direct Bilirubin
- Total Bilirubin
Please note, product availability may vary country to country.
RIQAS is the world’s largest External Quality Assessment scheme with more than 65,000 laboratory participants spanning over 134 countries.
Key Benefits of RIQAS
RIQAS EQA Programmes
Choice & flexibility are guaranteed with our 36 programme portfolio.
Browse the programmes below
RIQAS EQA Reports
User-friendly, one-page per parameter reports allow for at-a-glance performance assessment.
Browse the reports below.
What Does RIQAS Provide?
Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres, RIQAS Point of Care EQA provides independent evidence of the accuracy and reliability of test results. Randox International Quality Assessment Scheme (RIQAS) is the world’s largest EQA scheme with over 55,000 participants in more than 134 countries.
Why RIQAS Point of Care?
About RIQAS Point of Care
How it Works
Tests and Analysers
Test Role Matrix Lipids (Total Cholesterol & HDL Cholesterol) • Risk factors for heart disease
• Monitoring lipid lowering therapy
Whole Blood HbA1c (Glycated Haemoglobin) • Diagnosing diabetes mellitus
• Monitoring treatment
• Encouraging self-management
Whole Blood C-Reactive Protein (CRP) • Early detection of infectious disease
• Identifying need for antibiotic treatment
Whole Blood Glucose/Ketones • Diagnose and monitor diabetes
• Monitor for the presence of hypoglycaemia
(low blood glucose) and hyperglycaemia (high blood glucose)
• To determine whether excessive ketones are present in the blood, to detect diabetic ketoacidosis (DKA)
Serum International Normalised Ratio (INR) • Used to measure the effect of anticoagulant
drugs such as warfarin
• Help diagnose a bleeding disorder; to help
estimate the severity of liver disease
Panel Catalogue Number Lipids RQ9181/A Lipids + 1 panel RQ9181/B Lipids + 2 panels RQ9181/C Additional Sample RQ9181/D Glucose and Ketones RQ9188 INR RQ9189 Pipette Tips RQ9182 Bulbous pipette RQ9183
What Participants Say
Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:“All in all a quick and efficient service”
“Good online system”
“Very helpful team”
“They are an experienced team”
“Very satisfied with the service that we receive”
“Very good value for money”
“The website is great”
Key Cycle Dates
RQ9181 Distribution Month Sample Distributed Result Submission Deadline January 2023 9th January 18th January February 2023 6th February 15th February March 2023 6th March 15th March April 2023 3rd April 12th April May 2023 2nd May 10th May June 2023 5th June 14th June July 2023 3rd July 12th July August 2023 7th August 16th August September 2023 4th September 13th September October 2023 2nd October 13th October November 2023 6th November 15th November December 2023 4th December 13th December
Importance of Quality Assurance
Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:Internal Quality Control
Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.External Quality Assessment
External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.
EQA provides assurance to both staff and customers that testing provides accurate and reliable results.
Want to know more?Visit our Importance of EQA page to learn more.
Want to know more?
Contact us or download the RIQAS Point of Care catalogue to learn more.
Frequently Asked Questions
RIQAS (Randox International Quality Assessment Scheme) is the largest global EQA scheme with over 50,000 participants in more than 139 countries. Our range currently comprises 36 programmes and the majority of clinical testing.
• Ammonia/ Ethanol
• Anti-Müllerian Hormone (AMH)
• Anti-TSH Receptor
• Blood Gas
• Cardiac Plus
• Cerebrospinal Fluid (CSF)
• CYFRA 21-1
• General Clinical Chemistry
• Glycated Haemoglobin (HbA1c)
• Human Urine
• Immunoassay Speciality 1
• Immunoassay Speciality 2
• Maternal Screening
• Microbiology (Bacterial Identification)
• Neonatal Bilirubin
• Serology (Anti-SARS-CoV-2)
• Serology (EBV)
• Serology (HIV/ Hepatitis)
• Serology (Syphilis)
• Serology (ToRCH)
• Serum Indices
• Specific Proteins
• Sweat Testing
• Therapeutic Drugs
• Urine Toxicology
*Product availability is dependent on RIQAS stock surplus levels.
Point of Care Testing (POCT) is the delivery of a test at the point in time at which the result will be used to make a decision and taking appropriate action resulting in an improved health outcome. It is also known as near patient, bed-side, extra-laboratory, decentralised, and ancillary testing . It has been shown to reduce hospital stay time, reduce complications, and improve adherence to treatment .
Point of care testing is not a recent practice; many early diagnostic tests were administered at the bedside. However, analytical technology has progressed and multiple tests can be performed within minutes in a laboratory. Recently, this technology has been put into the hands of the staff near the patients . There are two types of technology, benchtop analysers and hand held devices. Bench top systems are just smaller versions of laboratory analysers but some steps are automated. Hand held devices are simple in appearance but complex internally, they can manage several tasks including, adding reagents, separating cells from plasma, and reading colour or other measures.
Results can be obtained faster, allowing for more immediate decisions meaning treatment can begin sooner. Patients can live a longer and higher quality life, helped by a reduction in the length of hospital stays.
Some benefits of POCT :
The main objective of Point of Care Testing is to generate results more quickly so that appropriate treatment can be provided, resulting in an improved patient outcome.
Accurate and reliable results can only be obtained if the patient and sample are treated correctly. Point of care testing is likely to be performed by staff with a limited technical background, so training and quality control are vital.
Proper analysis technique alone is not enough to ensure an accurate decision; any test will only be beneficial if the appropriate action is taken based on the result. The effectiveness of POCT is assessed in terms of the overall outcome of the patient.
There are three phases in the POCT cycle: pre-analytical phase, analytical phase, and post-analytical phase. About 90% of quality issues are attributed to the pre-analytical and post-analytical phases . These errors are mainly attributed to user error and can be caused by a number of issues including, selecting the wrong POCT device, not following manufacturer instructions, inadequate training, not adhering to appropriate QC practices, and many more.
The errors can usually be mitigated by implementing an action plan and ensuring it is executed exactly as designed, deviation from the action plan will lead to errors. Errors in POCT diagnostics can lead to misdiagnosis, improper treatment, costly follow-up procedures, and death.
Some strategies for improvement:
Internal Quality Control and External Quality Assessment is conducted to monitor the stability of the analytical measurement system and to alert the operator to a change that may lead to a medically significant error .
A study by Price, Smith and Bruel  was conducted on a number of labs over a period of time of up to 15 years. They discovered that test result performance improved with time and was associated with regular participation in External Quality Assessment (EQA) schemes and with the use of internal quality control (IQC) procedures.
Internal Quality Control
Internal Quality Control (IQC) is used to assess the day-to-day consistency of assay performance, providing quality assurance for patient results. IQC activities are among the ten most common POCT deficiencies. These may include performing and documenting quality control testing and taking the correct action for outliers . This poor performance could be attributed to how IQC is viewed in POCT; users may lack appreciation of the potential for errors and may see the analyser as infallible, they likely see IQC as an additional workload as opposed to part of their testing routine.
CLSI regulations require risk assessment for each stage of patient testing alongside an implementation of a quality control plan. Below are some suggestions for how IQC should be conducted for POCT.
IQC should be conducted when: a new lot of consumable is used; a patient result is queried; after maintenance; the device has been physically insulted. IQC should be conducted by the usual device operator so assurance can be provided for the whole testing process.
ISO 22870 requires POCT users should be trained in the theory and practice of IQC . Staff should be trained in every aspect of POCT including storage, preparation, frequency, documentation and basic troubleshooting.
QC material for POCT should be obtained from a third party provider and not rely on material provided by the device manufacturer, the benefits of which are well documented. It should also contain analytes at clinically relevant concentrations, be provided ready-to-use, and be stable at ambient temperatures.
All IQC results must be recorded with the date, time, user, decision to accept or reject, and any actions taken as appropriate. Locally assigned ranges alongside analyte-specific rules should be used to maximise error detection. An example of how IQC could be recorded and an action flowchart can be seen in Fig. A below.
There should be a protocol for required actions following a failed IQC. Any troubleshooting should be developed with knowledge of the most common errors and user capability.
A monthly review should be conducted to identify persistent failures and trends.
The cost of IQC may also be a factor in resistance to IQC, however, while it is difficult to quantify, the cost of not conducting it may be greater in terms of human harm. A whitepaper is available detailing IQC in POCT (download).
External Quality Assessment
External Quality Assessment (EQA) or Proficiency Testing (PT) involves running blind patient-like samples and comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results. (Learn more about EQA)
Benefits of participation in an EQA programme include assessment of result accuracy, assessment over time, comparisons with instruments, methods and peers, and providing confidence in test results.
EQA for POCT is, in theory, similar to EQA in a large laboratory. There is a significant difference however, the POCT participants are usually health care professionals with little knowledge of laboratory medicine. A lack of understanding of the importance of EQA had led to a smaller percentage of sites participating than large laboratories.
A Good EQA Scheme
A good EQA scheme should offer:
Conducting EQA in POCT
Below are some suggestions for how EQA should be conducted for POCT.
EQA samples should be commutable, meaning they have the same numeric relationship between measurements procedures as is observed for a panel of patient samples (reacts the same as a real patient sample).
A fast turnaround time allows test system errors to be identified sooner and necessary corrective actions to be taken immediately with minimum disruption to the lab.
A regular review of past EQA results should be part of the cycle of quality.
A POCT EQA provider should be able to provide assistance when the user is having difficulties.
Individuals carrying out testing should have the correct knowledge to interpret results, choosing a scheme with easy to interpret results can help.
Internal Quality Control
Randox offer a number of controls suitable for Point of Care Testing applications:
Acusera Blood Gas Control
The Randox Acusera Blood Gas Quality Controls contain assayed target values for ten parameters, covering pH, pCO2, pO2, electrolytes, glucose and lactate. The material is provided in easy to open ampoules for added convenience and ease-of-use. The liquid ready-to-use nature of the control makes it ideal for use in point-of-care testing and on a wide range of blood gas instruments.
Acusera Liquid Cardiac Control
The Randox Acusera Liquid Cardiac control is designed to be both convenient and easy to use. The liquid ready-to-use format makes it ideal for both clinical laboratories and point-of-care testing. Assayed, instrument specific values are provided for an impressive 8 cardiac markers including, NT-ProBNP, D-dimer and Troponin ensuring consolidation and flexibility. Furthermore, an open vial stability of 30 days for all analytes helps to keep waste and costs to a minimum.
Acusera Liquid HbA1c Control
Liquid Urine Control
The Randox Acusera Liquid Urine quality control is designed to be both convenient and easy to use. The liquid ready-to-use format eliminates issues with pipetting and allows convenient storage at 2℃ – 8℃. Assayed instrument and method specific target values and ranges are provided for 18 commonly tested urine chemistry parameters.
External Quality Assessment
Randox offers RIQAS Point of Care, a simple EQA scheme designed for use in point of care settings. It is a single sample, single scheme programme featuring whole blood samples for authentic patient sample assessment.
RIQAS Point of Care
 C. Price, A. St john and J. Hicks, “Point-of-care testing”, 2004. [Online]. Available: http://mldt.hu/upload/labor/document/PRICEP.pdf. [Accessed: 23- Jul- 2018].
 C. Price, “Point of care testing”, BMJ, vol. 322, pp. 1285-1288, 2001.
 A. Okorodudu, “Optimizing accuracy and precision for point-of-care tests”, Acutecaretesting.org, 2011. [Online]. Available: https://acutecaretesting.org/en/articles/optimizing-accuracy-and-precision-for-point-of-care-tests. [Accessed: 24- Jul- 2018].
 H. Holt and D. Freedman, “Internal quality control in point-of-care testing: where’s the evidence?”, Annals of Clinical Biochemistry, vol. 53, no. 2, pp. 233-239, 2016.
 “ISO 22870:2016 – Point-of-care testing (POCT) — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/71119.html. [Accessed: 25- Jul- 2018].
 J. Gill and M. Shephard, “The Conduct of Quality Control and Quality Assurance Testing for PoCT Outside the Laboratory”, Clin Biochem Rev., vol. 31, no. 3, pp. 85-88, 2010.
 A. Stavelin and S. Sandberg, “Essential aspects of external quality assurance for point-of-care testing”, Biochemia Medica, pp. 81-85, 2017.
 C. Price, I. Smith and A. Van den Bruel, “Improving the quality of point-of-care testing”, Family Practice, vol. 35, no. 4, pp. 358-364, 2017.
 “ISO 15189:2012 – Medical laboratories — Requirements for quality and competence”, Iso.org, 2018. [Online]. Available: https://www.iso.org/standard/56115.html. [Accessed: 31- Jul- 2018].
 J. Crilly, “Mythbusting: Frequency of EQA Reports”, Randox Laboratories, 2017.
 G. Kristensen and P. Meijer, “Interpretation of EQA results and EQA-based trouble shooting”, Biochemia Medica, pp. 49-62, 2017.
External Quality Assessment (EQA) / Proficiency Testing (PT) allows for a comparison of a laboratory’s testing procedures to other laboratories across the world. Comparisons can be made to a peer group of laboratories or to a reference laboratory.
EQA involves running blind patient-like samples, comparing your results to peer results, in order to retrospectively monitor the accuracy of reporting. EQA samples should be treated as if they were a patient sample and therefore must be run by personnel who would normally use the device. This provides confidence in the reliability of patient test results.
EQA provides assurance to both staff and customers that testing taking place at your laboratory provides accurate and reliable results. Problems can be identified early on and corrective action can be untaken. The reliability of methods, materials, and equipment can be evaluated and training can be developed and its impact monitored.
Large laboratory groups can compare their performance with sites across their group, ensuring accuracy and consistency no matter where testing takes place.
EQA participation is often a requirement for accreditation, gaining accreditation alone has a host of benefits, not least an increased confidence in results from customers, current and potential.
Read more about accreditation: ‘The Importance of Meeting ISO 15189 Requirements’.
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand for POCT has recently seen rapid growth, this comes from the advantages including the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.
EQA is strongly recommended for all point of care devices and is recommended by ISO 22870, which providesspecific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.
There are many External Quality Control schemes that come in different varieties. EQA schemes can be mandatory, required either by accreditation or law. Others are voluntary and carried out by laboratories who want to ensure that they are carrying out accurate testing and improve the quality of the lab’s performance .
A good EQA scheme should offer:
EQA is a great tool for comparing against a peer group and maintaining an effective QC strategy, however, it has its limitations.
EQA / PT alone cannot provide a complete evaluation alone; it is important to also run third party controls regularly. You can find out about the importance of third party controls here.
EQA results can also be affected by variables not relating to patient samples, including preparation, clerical functions, matrix effects, and selection of method. The errors can appear to be a downside to EQA but it can be used as a way to evaluate staff performance as well as assay performance.
If possible, every laboratory should participate in an EQA scheme that covers all testing procedures. Laboratories need to develop a management process with the objective to assure that EQA samples are treated appropriately and in the same manner. This includes, sample handling, sample analysis, record keeping, investigating deficiencies, taking corrective actions, and communicating results with laboratory staff and management.
Problems at any stage of sample analysis can cause errors, when an error does happen, all elements of the process need to be checked. Some examples of errors:
• Incorrect sample handling during preparation, shipping or storage
• Improper storage
• The material has expired
• An error in manufacturing
• Instrument, calibration or reagent defects
• Staff competency
• Matrix effects
• Incorrect analysis method
• Report misinterpretation
• Clerical or transcription errors
• Failure to take corrective action
• Where possible, all laboratories should participate in an EQA scheme for all tests that they perform.
• EQA samples should be treated in the same way as a patient sample, using the same procedures, instruments, methods, and staff who normally perform the testing.
• EQA provides valuable resources and data to effectively maintain accurate and reliable results and should be seen as educational.
Randox offers RIQAS, the largest EQA scheme in the world with over 45,000 participants across 133 countries, offering 33 consolidated programmes. Randox also offers a range of over 90 molecular programmes for infectious disease testing with Quality Control for Molecular Diseases (QCMD).
Features and Benefits
RIQAS Point of Care
 WHO, Overview of External Quality Assessment (EQA). World Health Organisation, 2009.
 ISO 15189:2012 Medical laboratories — Requirements for quality and competence, 3rd ed. ISO, 2014.
 ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence, 2nd ed. ISO, 2016.
RIQAS Point of Care
The Serology report is available within ten days of the final submission date. The results for each parameter are displayed on a single page report. There are two types of Serology report – one for qualitative reporting and one for quantitative reporting. Each of these report ensure quick and easy performance assessment.
RIQAS EQA Reports
The Qualitative report comprises three subsections including a text section, Histogram and method summary. The text section conveniently displays your laboratory’s result to the correct result for your method. The Histogram visually displays your laboratory’s result in relation to all of the results submitted for your method group and the all method group. Finally, the method summary provides a breakdown of the results for all methods registered with RIQAS.
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The Quantitative report comprises four subsections including a text section, Histogram, Levey-Jennings chart and method summary. The text section conveniently displays your laboratory’s result to the mean for comparison, the histogram visually displays your laboratory’s result to the mean for comparison, the Levey-Jennings chart displays the SD for the last 20 samples ensuring instant identification of performance over time and finally the method summary provides a breakdown of the results submitted for all methods registered with RIQAS.
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RIQAS Urinalysis reports have been designed specifically for participants of the RIQAS Urinalysis programme (RQ9138). Report features include;
- Scoring system
- Ability to rate performance and visualise historical performance data
- Visual representation of performance
- Peer group comparison levels
To find out more on the range of features available with the report, see the table below.
RIQAS EQA Reports
The Urinalysis Report scoring system, scores participants based on a spread of results over each category and how far a participant is away from the consensus, which is referred to as the Target Category.
The score calculated is based on how close to the target category a participant’s result falls. A score of 0 refers to a result which falls within the target category and therefore, the comment “acceptable” will be given. A laboratory’s performance is described as being acceptable or unacceptable based on this calculated score.
A laboratory must achieve a score of between -6 and +6 for their performance to be deemed acceptable. Scores can fall between the values of -10 and +8.
- If a participant’s result matches the target category then they will receive the score of 0 and the comment “acceptable” given.
- Where a participant returns a negative result and the target category is positive (category 9), the participant score will be -10. The comment “unacceptable” will be given.
- Where a participant returns a positive result (category 9) and the target category is negative, the participant score will be +8 and the comment “unacceptable” given.
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The score achieved for the current reported sample together with the associated comment of acceptable, unacceptable or borderline will be listed in the comments box located towards the top of the results page for each registered parameter. The percentage (%) of results from the selected peer group which fall within the target category are also stated.
Potential Historical Information
The number of correct scores (i.e. scores of 0) that have been submitted in the last “n” samples, up to a maximum of 6 previous samples. The number of acceptable assessments that have been submitted in the last “n” samples, up to a maximum of 6 previous samples.
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Charting of Current & Historical Information
Results of scoring for each sample are displayed on a Levey-Jennings style chart with “0” score in the middle and scoring categories positioned on either side for 2, 4, 6, 8 and 10. The chart is shaded into bands depending on the scores.
Acceptable scores (0-6) have no shading, Borderline scores (6-8) have light red shading and unacceptable scores (8-10) are shaded a darker red.
Scores for each of the last 12 samples are plotted against the appropriate sample number and the chart also indicates whether the participant’s reported result category is higher or lower than the target category.
The target categories are stated along the top of the chart and if there are no target categories due to a lack of numbers then an “X” is plotted to show that a result has been submitted but could not be scored.
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Reporting – Summary Page
The summary page at the end of the report lists all of the parameters that a participant has registered for.
For each parameter the following information is stated:
- Target Category, which is dependent on the unit registered
- The result which has returned by the participant
- The score achieved for the current sample
- The comment of Acceptable / Unacceptable / Borderline
- Where the comment is “Unacceptable” it is highlighted in bold italics and underlined
- The number of “Acceptable” assessments that have been achieved over the previous 6 samples
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