RIQAS Serology Report
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.
(Click to enlarge)
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.
(Click to enlarge)
RIQAS Urinalysis Report
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.
(Click to enlarge)
Current Sample
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.
(Click to enlarge)
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.
(Click to enlarge)
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
(Click to enlarge)
RIQAS Urine Toxicology Report
A dedicated report is provided for the Urine Toxicology programme. The report is divided into two subsections; the screening (qualitative) and the quantitative section, allowing for visual performance assessment at-a-glance.
RIQAS EQA Reports
Your laboratory’s result is displayed along with the correct response. A visual chart is also provided displaying performance of the last 20 samples. A breakdown of the screening results submitted by other laboratories in your method group and all method groups for the current sample is also provided at a variety of cut-offs. A further breakdown is provided for various methods at your specific cut-off.
(Click to enlarge)
The Quantitative section of the Urine Toxicology report is further broken down into a text section comparing your laboratory’s performance to the mean for comparison, a Histogram chart indicating your laboratory’s performance in relation to the method group and the all method group and a multi-method section highlighting the performance of other methods.
(Click to enlarge)
This Christmas, treat your laboratory to the “gift” of Randox Quality Control
At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.
With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.
Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.
With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!
User-friendly, one page per parameter reports are available within 72 hours of the submission deadline. These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report summarising laboratory performance for each cycle and helping to identify progress over time.
Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.
All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.
Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!
So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.
To find out more on any of our RIQAS programmes visit our website – http://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com
Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!
Meeting ISO 15189:2012 Requirements for Multiple Instruments
Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.
About ISO 15189:2012
ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.
Gaining Accreditation
ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.
A particular requirement of ISO 15189:2012 is:
“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
How Randox can help labs with multiple instruments?
Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.
RIQAS
Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.
Multi-Instrument Reports
All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.
The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.
Acusera 24.7 Live Online
Our stress free QC analysis software is designed to assist in the management of daily QC activities.
Support for multiple instruments
Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.
Helping you get accredited
Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.
To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.
Mythbusting: āUsing IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
Got a question?
RIQAS Instrument Group Report
All RIQAS participants are entitled to register up to five separate instruments per programme at no extra cost.
Individual reports for each instrument are supplied as normal in addition to a complimentary instrument group report allowing the performance of each instrument to be uniquely compared and assessed easily.
RIQAS EQA Reports
The multi-instrument group report displays the %Deviation for the last 10 samples along with the RM%Dev across all registered laboratory instruments. The %Dev for each instrument is plotted on a user-friendly, colour coded chart for instant identification of poor performing instruments.
As an ISO requirement, the Multi-Instrument Report is an extremely useful and beneficial tool for laboratories – “Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers” – ISO 15189:2012.
(Click to enlarge image)
RIQAS Inter-Laboratory Group Report
A unique group reporting facility is available allowing laboratory groups or chains to effectively monitor the performance of satellite sites.
All laboratories within a group will receive their RIQAS sample packs, analyse the samples, return results to RIQAS and receive their individual RIQAS reports as normal. In addition to this a separate group report will be sent to the group manager or supervisor allowing relative performance of all laboratories within the group to be assessed.
RIQAS EQA Reports
For each laboratory in the group, the interlaboratory group report displays the %Dev for the last 10 samples along with the RM%Dev. The %Dev for each laboratory is plotted on a user-friendly, colour coded chart for instant identification of poor performing labs.
(Click to enlarge image)
RIQAS End-of-Cycle Report
RIQAS End-of-Cycle reports are sent to all participants who receive the standard report. Therefore, participants who are enrolled in RIQAS Urinalysis, RIQAS Urine Toxicology and RIQAS Serology programmes will not receive an End-of-Cycle report.
The RIQAS End-of-Cycle report provides laboratories with a complete summary of their External Quality Assessment performance. Performance is also compared to that of the previous cycle providing an indication of progress and improvement over time. Data is presented in both written and graphical format allowing a visual assessment of overall performance.
The RIQAS End-of-Cycle report is split into 3 sub-sections. These sub-sections are designed to allow performance assessment at a glance.
RIQAS EQA Reports
RIQAS End-of-Cycle Report Features
The Parameter Cycle Summary section provides an overview of the results returned for each sample in the cycle. The text section summarises the laboratory’s result compared to the Mean for Comparison. Laboratory performance for the current cycle is also compared to that of the previous cycle. A variety of charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by concentration are also presented allowing a visual assessment of laboratory performance over the cycle.
(Click to enlarge)
The text section provides a summary of the laboratory’s results and statistics including Mean for Comparison, SDPA, %CV, Uncertainty, SDI, Target Score and % Deviation. An additional table comparing performance for the current cycle to the previous cycle is also provided.
(Click to enlarge)
The laboratory’s performance is summarised in various charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by Concentration.
(Click to enlarge)
The absolute SDI summary report compares current performance for all parameters to the previous cycle and indicates whether performance is better or worse. Performance is compared to other RIQAS participants in your country and worldwide.
(Click to enlarge)
A certificate of performance is provided listing all parameters, for which the laboratory achieved an acceptable level of performance (Average Absolute SDI <2). Although the End-of-Cycle Report is issued for all registered parameters, the certificate of performance will only be available for parameters where results for at least 50% of samples in the cycle have been returned.
(Click to enlarge)
RIQAS Standard Report
There are a variety of RIQAS reports designed to enable quick and easy identification of any trends or test system issues. The standard quantitative report is provided in a user-friendly, one page per parameter format allowing a visual, at-a-glance assessment of performance. The standard quantitative report is split into several easy to interpret subsections each designed to save valuable laboratory time.
You can explore each of the report sections using the table below. Don’t forget, to enlarge the image, simply click on it.
RIQAS EQA Reports
RIQAS Reports Features
Performance data is presented in a simple one page format for each analyte. Each one page report comprises seven sub-reports providing a statistical and graphical representation of laboratory performance.
(Click to enlarge)
The text section provides a statistical breakdown of results by all methods, your method and instrument group. The Mean, CV% and Uncertainty or Measurement is presented for each comparison group.
Your laboratory’s result is compared to the Mean for Comparison (usually the instrument group Mean). Also included are the RIQAS performance indicators; SDI, Target Score and %Deviation.
Acceptable performance criteria:
- SDI <2
- Target Score >50
- %Deviation
The defined acceptable limits default to the RIQAS TDPA values but may be based on CLIA, biological variation or country specific limits.
Performance goals based on Biological Variation are also stated within the text section for information purposes.
(Click to enlarge)
The histogram chart provides an overview of how your laboratory’s result compares to the all method group, your method group and your instrument group. Your result is represented by a black triangle; the closer to the centre the better.
The chart is intended to provide a quick visualisation of performance compared to other method groups and can be used to identify any potential bias.
(Click to enlarge)
The Levey-Jennings chart plots the last 20 SDI’s and is extremely useful for monitoring EQA performance over time, allowing quick and easy identification of any trends or bias. The chart is colour coded making interpretation simple and easy; results that fall in the white area are excellent and those in the red area unacceptable.
(Click to enlarge)
The Target Score (TS) chart is a unique chart which displays your laboratory’s last 20 target scores delivering an instant, visual indication of performance. The TS chart is conveniently colour coded for even easier performance assessment, a TS >50 is acceptable. The TS is a numerical index relating your %Deviation from the mean to a Target Deviation for Performance Assessment (TDPA).
(Click to enlarge)
The %Deviation by sample chart displays the %Deviation for the last 20 EQA samples enabling identification of trends and shifts in performance. Similar to the other charts on the RIQAS report, the %Deviation by sample chart is shaded to indicate the limit of acceptable performance. A black dot within the white section of the chart will represent results with a %Deviation within your acceptable limits of performance; a black dot within the red section of the chart will represent results with a %Deviation outside your acceptable limits of performance. %Deviations are not influenced by the performance of your peers, as seen with the standard deviation index (SDI) and therefore is a better indicator of individual performance.
(Click to enlarge)
The %Deviation by concentration chart enables easy detection of possible concentration related biases. Unlike the other charts provided on the report, the %Deviation by concentration chart displays the concentration range of the previous 20 samples along the bottom of the chart.
Using this scale along with the percentage deviation, you are provided with a rapid assessment of your %Deviation in relation to the concentration of the:
• Current sample (represented by a square)
• Your 19 previous results (represented by circles)
This chart provides an easy interpretation of potential positive or negative biases at high or low concentrations, or whether a particular sample is a random outlier.
(Click to enlarge)
The Multi Method Stat Section provides you with an easy way of assessing the performance of the other methods used to analyse the parameter. This is useful when your laboratory plans to change the analytical method used for the parameter.
(Click to enlarge)
Located at the back of the standard quantitative report, our quick reference summary page details the performance for each registered parameter in the programme.
Within the performance column, RIQAS provides an effortless method of assessing the performance of each parameter within the sample distribution. When a red triangle appears next to the parameter, this indicates that all performance indicators (SDI, TS and %DEV) have exceeded the performance criteria.
The performance indicator limits for each parameter are exceeded when your result produces:
• An SDI greater than +/- 2 standard deviations.
• A Target Score less than 50 (only when Target Scoring is available)
• A %Deviation greater than your set acceptable limits of performance.
(Click to enlarge)
A summary CSV file is available on request to all participating laboratories. The report provides a summary of all statistics, acceptable limits and performance indicators as a .csv file for each sample in the cycle.
A retrospective statistics summary is also available, four weeks after the final submission date for parameters where a result was not submitted on time.