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.
“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.
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
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.
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.
Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.
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.
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.
Drive for more accurate results in your laboratory
We’ve all been there, you’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. What do you do? In reality, we all know that the problem is unlikely to correct itself, especially if it’s a calibration or analyser issue. Human error is a potential factor, however all possible causes must be eliminated to proceed with patient testing.
What’s the solution?
ISO 15189:2012 recommends that a laboratory should “have a procedure to prevent patient results in the event of a quality control failure”. Implementing an interlaboratory data management program which features peer group reporting can help you meet this requirement and monitor the results you are producing. Such programs can help detect errors in the analytical phase of patient testing, through the automatic application of pre-programmed QC rules, thus alerting staff to failed results.
Why must Peer Groups be a feature?
A peer group is defined as a “Community in which most or all members have roughly the same characteristics…” (Businessdictionary.com, accessed 2017). In this instance the characteristics could refer to the; instrument, test method or QC material in use. As such peer group programmes could help you detect errors in your laboratory by comparing your results to those who are employing a similar method, instrument and QC to what you are using, i.e. comparing apples for apples. Therefore it is essential that the peer group data you require is available in real-time, to ensure you are accessing the most up-to-date data when reviewing your patient test results.
Take the example from the introduction. You’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. As part of your troubleshooting procedures, you are able to compare your results to the results of your peer group and note that this is an isolated incident. Consequently, you have eliminated a widespread problem with the QC, reagent or calibrator and narrowed down the root cause to one of the components in your test system. Thus saving you time in the troubleshooting process.
Benefits of Peer Group Comparison
There are a number of benefits to employing peer group comparison in your laboratory. Peer group data comparisons facilitate faster troubleshooting, helping you identify whether the problem you are seeing is unique to your laboratory, or if other laboratories are reporting the same issue. If other laboratories are reporting the same issue it is possible to conclude that there is a widespread problem with either the QC, reagent or calibrator. On the other hand, if it is not occurring within your peer group you will have to investigate further, reviewing your QC processes. As a result, you could resolve issues much quicker by eliminating either a supplier or laboratory issue. Furthermore, you can also eliminate the need for unnecessary repeat tests or instrument maintenance, saving both valuable time and money.
Other characteristics you should look out for
Whilst peer group comparison is a useful feature there are a number of other features you should consider when selecting the right interlaboratory data management program for you. These include;
- Automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics
- Multiple laboratory management on a single platform
- Accessing data anytime, anywhere via PC, laptop or tablet via a web-based platform
- All data charts you may require to assess whether any bias or imprecision issues are present
- Ability to combine data for multiple QC lots, analytes and instruments on a single Levey-Jennings or Histogram chart
- Automated data import via a direct connection to your LIMS
What can Randox offer?
At Randox we are passionate about quality control and believe in producing high-quality material that can streamline procedures for laboratories of all sizes and budgets through our Randox Quality Control brand. Acusera 24.7 Live Online is just one aspect of our extensive laboratory portfolio that has been designed to help you produce results you can trust. With Acusera 24.7 Live Online you can drive for more accurate results by monitoring and interpreting QC data online, anytime, anywhere. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 will ensure analytical quality.
Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.
There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.
POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;
- Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
- Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
- Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
- Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
- Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
- Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
- Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel
In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.
Our Acusera liquid ready-to-use controls include:
- Blood Gas Control– A liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
- Liquid Cardiac Control– This is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
- Liquid Urinalysis Control– Liquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
- Liquid HbA1c Control– This is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.
Complementary EQA programmes are also available to meet the needs of ISO 22870.
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at email@example.com.
Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
Measuring the Complete Clinical Range
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
|Analyte||Medical Decision Level||Diagnostic Status|
|Glucose (fasting)||<100 mg/dL||Non-Diabetic|
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
|Analyte||Medical Decision Level||Randox Level 1 IA Control||Competitor Level 1 IA Control|
|TSH||0.1 or 0.27 uU/mL||0.15uU/mL||0.37 uU/mL|
|Vitamin B12||190 pmol/L||174 pmol/L||327 pmol/L|
|Ferritin||12 ng/mL||11.1 ng/mL||49.6 ng/mL|
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
“In Vitro Diagnostics (IVD) Quality Controls Market” recently published by Markets and Markets has highlighted an overall significant growth within the Quality Control Market. Further growth is anticipated in the coming years with the Markets and Markets report estimating that the IVD QC market will be worth $979 million.
One area that is currently experiencing growth within this sector is the EQA segment, which Markets and Markets estimates to command a 6.6% share of the overall IVD market. The report is crediting growth within this segment to you, the customer, stating “…various end users or customers of IVD quality control products mostly prefer external support to run their quality control activities. For this, market players are largely focusing on providing external quality assurance (EQA) support”. As such companies such as Randox are being approached to provide EQA for a range of small, independent laboratories and large laboratory chains alike.
What other factors have contributed to this growth?
The adoption of ISO15189 and other similar standards is becoming mandatory in many countries, as discussed in a previous blog post. Accreditation highlights the accuracy and reliability of the patient results being released. ISO15189 states that “The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment or proficiency testing schemes”. Therefore laboratory managers are employing EQA programmes in their laboratory to meet such requirements. EQA also enables laboratories to meet other accreditation requirements such as peer comparison and clinically relevant testing.
Selecting the right EQA for you
When selecting the right EQA scheme for your laboratory there are a number of considerations to be made; sample frequency, peer group numbers, report format, report turnaround and so on. According to a survey conducted by Randox Quality Control 55% of respondents listed sample frequency as the most important feature to be considered when selecting an EQA scheme. Sample frequency is an ongoing debate regarding EQA. However, schemes with frequent reporting will allow you to easily pinpoint when an error occurred and implement corrective actions with minimal disruption. Also making the top three key factors in this survey were; quality samples and peer group numbers.
What can Randox Quality Control offer?
As the largest international EQA scheme available on the market RIQAS offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With more than 40,000 participant in 124 countries and 32 flexible programmes we are certain that the external support we offer for your quality control activities will provide you with the upmost confidence in your laboratory’s performance. Furthermore with our programmes accepted by national and international accreditation bodies worldwide employing RIQAS can help you gain accredited status providing your end users with peace of mind. With other benefits such as programme consolidation, rapid report turnaround, easy to read at-a-glance reporting and the ability to register up to 5 instruments per programme at no extra cost why don’t you contact us today and find out how we can support your quality control activity?
To request a visit from a QC consultant contact us via firstname.lastname@example.org