QCMD – Molecular External Quality Control
QCMD is a world leading External Quality Assessment (EQA) / Proficiency Testing (PT) scheme, dedicated to improving the quality of molecular diagnostic assays used in the detection of infectious diseases.
With an extensive database of over 15,000 participants in over 100 countries, QCMD is one of the largest providers of molecular EQA in the field of molecular diagnostics.
Blood Borne Viruses
Central Nervous System Diseases
Drug Resistance
Exotic / Emerging Diseases
Gastrointestinal Diseases
Immunocompromised Associated Diseases
Multiple Pathogen / Syndromic Infections
Respiratory Diseases
Serology
Sexually Transmitted Infections
Transplant Associated diseases
Typing
New Pilot Studies
After the close of the results return phase, EQA participants will receive an individual report outlining their performance relative to their method and technology groups. A supplementary report may be commissioned – this includes any additional relevant information regarding the annual EQA distribution, as well as scientific expert commentary and feedback on the overall results within that distribution.
*Randox are authorised by QCMD to provide the QCMD EQA schemes under a strategic global partnership. The EQA design, composition, data analysis & reporting remain the responsibility of QCMD. Please refer to specific geographical regions for further details on availability.
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RIQAS EQA
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The Importance of Meeting ISO 15189 Requirements
Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.
Some key benefits include:
- Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
- Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
- Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.
To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).
In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).
ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.
Meeting ISO Requirements
Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.
Review of QC data
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance”
– ISO 15189:2012
Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.
Calculation of MU
“The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”
– ISO 15189:2012
Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.
More about Measurement Uncertainty and how Acusera 24∙7 can help
Commutability
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”
– ISO 15189:2012
Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.
Medical decision levels
“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”
– ISO 15189:2012
Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.
Comparison of results across instruments
“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
– ISO 15189:2012
Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.
Third Party Control
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”
– ISO 15189:2012
Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.
At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.
Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.
Fig. A
Fig. B
Acusera Third Party Controls
Interlaboratory Data Management
CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf
Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014
Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology, 134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf
Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE, 11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856
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.
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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 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.
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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.
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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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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.
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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.
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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.
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.
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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.
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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.
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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.
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The laboratory’s performance is summarised in various charts including Levey-Jennings, Target Score, % Deviation by sample and % Deviation by Concentration.
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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.
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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.
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