RIQAS – Randox International Quality Assessment Scheme

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RIQAS – Randox International Quality Assessment Scheme

RIQSA External Quality Assessment - Connecting Your Laboratory

The World’s Largest External Quality Assessment Scheme

Uniquely connecting you with 45,000 laboratory participants across 32 flexible yet comprehensive programmes, RIQAS is the world’s largest external quality assessment (EQA) scheme. Access to maximised peer groups ensures availability of comparison data for a wide range of instruments and methods, ultimately increasing confidence in test system reliability. The added benefit of frequent analysis, user-friendly reports, multi-instrument reports and consolidated programmes makes a cost-effective, high quality EQA solution for any laboratory.

Benefits of RIQAS

Consolidation

Comprised of over 360 parameters in 32 comprehensive programmes, RIQAS streamlines EQA by significantly reducing the number of individual programmes required.

User-friendly reports

RIQAS presents reports in a simple one page per parameter format for at-a-glance performance assessment, including Levey-Jennings charts, Histograms, % Deviation charts, and more; providing a visual representation of laboratory performance, all within 24-72 hours of the submission deadline.

Frequency

Frequent analysis coupled with our rapid report turnaround will allow labs to pinpoint when an error occurred and implement any corrective actions necessary.

Flexibility

With 32 flexible EQA programmes available, RIQAS has something to suit every lab. Reduced parameter and report options ensures suitability for laboratories of every size and budget.

The ability to register up to 5 instruments per programme at no extra cost will ultimately save money facilitating comparative performance assessment.

Accreditation

Being part of a reputable External Quality Assessment scheme like RIQAS is highly encouraged by international and national regulatory bodies and will help your laboratory meet ISO 15189:2012 accreditation requirements:

“the laboratory shall participate in inter-laboratory comparisons such as those organised by external quality assessment schemes…”, “EQA should, as far as possible, cover the entire range of tests, and the entire examination process, from sample reception, preparation and analysis to interpretation and reporting.”

RIQAS systems and procedures are accredited to ISO 17043:2010 ‘Conformity Assessment – General Requirements for Proficiency Testing’ ensuring a high quality programme that is fit for purpose and will assist laboratories in meeting and maintaining ISO 15189:2012 standards.

In addition to ISO 17043:2010, RIQAS is recognised by the UK National Quality Assurance Advisory Panel (NQAAP) for Clinical Pathology and the Joint Working Group on Quality Assurance (JWG QA).

Learn More

To learn more or to get signed up, fill in the contact form below.

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Product Spotlight: PTH Control

Liquid CSF Control Image

PTH Control

PTH is a notoriously unstable analyte and many competitors make reduced stability claims in their Immunoassay controls. Randox’s Liquid PTH Control provides laboratories with a dedicated product with an extended, 30-day, open vial stability to reduce waste and costs.

Parathyroid Hormone, better known as PTH, is produced by the Parathyroid glands to help the body maintain steady
volumes of calcium in the blood stream. PTH is part of a ‘feedback loop’ which also includes; calcium, vitamin
D, phosphate and magnesium. Interruptions to this loop can result in higher or lower levels of calcium or
PTH, leading to Hypercalcaemia or Hypocalcaemia. The Parathyroid Glands are responsible for the secretion of PTH in response to low calcium concentrations in the blood.

Product Overview

Released in 2016, Randox’s Liquid PTH Control provides a true third party solution for the measurement of Intact PTH, delivering an unbiased, independent assessment of analytical performance.

Key Features & Benefits

  • Liquid for ease-of-use
  • Human based serum
  • Assayed target values available for many immunoassay platforms
  • Stable to expiry date at -20°C to 70°C
  • Open vial stability of 30 days at 2°C to 8°C
Unrivalled Stability

Our Liquid PTH Control boasts a remarkable 30-day open vial stability! Many competitors fail to make stability claims in their immunoassay controls. Our PTH control includes target values and ranges, eliminating the need for extra validation work.

A True Third Party Control

The Acusera PTH Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

Liquid Frozen

Available in three levels Acusera PTH Control is supplied in liquid frozen format, ensuring ease-of-use with no need to reconstitute. Coupled with it’shuman based matrix, it’s perfect for any laboratories conducting PTH testing.

Analytes

Intact PTH (Parathyroid Hormone)

Download some of our related brochures below and broaden your understanding.

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The Benefits of Peer Group Data to your Troubleshooting Process

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.

Scenario

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.


ISO 22870- Are you meeting expectations?

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:

  1. Blood Gas ControlA 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.
  2. Liquid Cardiac ControlThis 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.
  3. Liquid Urinalysis ControlLiquid 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.
  4. Liquid HbA1c ControlThis 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: Where Are We Now?

What is IQCP?

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.

Where are we now?

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:

Positive Opinions 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

Negative Opinions of IQCP

  • 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.

ISO 15189:2012 requirements

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 acusera@randox.com.

References:
  1. Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.

Liquid HbA1c Quality Control

Therapeutic Drug Quality Control

Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.

Features & Benefits

  • Liquid ready-to-use
  • Human based whole blood
  • Assayed target values
  • Convenient bi-level pack covering clinically relevant decision levels
  • Stable to expiry date at  2°C – 8°C
  • Open vial stability of 30 days at  2°C – 8°C

DescriptionSizeAnalytesCat No 
Liquid HbA1c Control2 x 2 x 0.5 ml1HA10155
Liquid HbA1c Control Level 16 x 1 ml1HA10224
Liquid HbA1c Control Level 26 x 1 ml1HA10225

Analytes

HbA1c (Haemoglobin A1c)


Does Your QC Cover Clinically Relevant Ranges?

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:

AnalyteMedical Decision LevelDiagnostic Status
Glucose (fasting)<100 mg/dLNon-Diabetic
100–125 mg/dLPre-Diabetic
>125 mg/dLDiabetic

Competitor QC

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).

Randox QC

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:

AnalyteMedical Decision LevelRandox Level 1 IA ControlCompetitor Level 1 IA Control
TSH0.1 or 0.27 uU/mL0.15uU/mL0.37 uU/mL
Vitamin B12190 pmol/L174 pmol/L327 pmol/L
Ferritin12 ng/mL11.1 ng/mL49.6 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.


Demand for external support driving growth of EQA

“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 acusera@randox.com


Adiponectin Quality Control

Therapeutic Drug Quality Control

Dedicated Adiponectin control designed for use in routine monitoring of the Randox Adiponectin assay.

Features & Benefits

  • Liquid ready-to-use
  • Human based serum
  • Stable to expiry date at 2°C – 8°C
  • Once opened stable to expiry date at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Adiponectin Control Level 23 x 1ml1AO2815
Adiponectin Control Level 33 x 1ml1AO2816

Analyte

  • Adiponectin

Microalbumin Control Calibrator

Therapeutic Drug Quality Control

Dedicated Microalbumin calibrator designed for use with Microalbumin assays on a wide range of clinical analysers. 6 levels are provided in a liquid ready-to-use format making it both easy and convenient to use.

Features & Benefits

  • Liquid ready-to-use
  • 100% human serum
  • Stable to expiry date at 2oC – 8oC
  • Once opened stable to expiry date at 2oC – 8oC
DescriptionSizeAnalytesCat No 
Microalbumin Calibrator Series6 x 2ml1MA1567

Analytes

  • Microalbumin

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