White Paper ISO 15189 Accreditation to an International Standard Medical laboratory services and the many pathology laboratories are essential in the smooth running of our health systems. Through their testing, result validation, interpretation, and reporting, they are vital in the diagnosis and assessment of the health of patients. Although it is all too easy to take for granted the systems and protocols behind this relentless production of test results, the recent publication of EN ISO 15189 gives medical laboratories a new opportunity to reassess their training procedures and working practices in the process of demonstrating the quality of their services through accreditation. At the same time, the new standard is a chance to re-evaluate the servicing and maintenance requirements of all the laboratory instrumentation – both hand-held and benchtop - that can have a significant impact upon these test results. An evolving process towards enduring quality Laboratories must take account of an increased focus on a number of areas, including internal verification and validation, measurement uncertainty, traceability, and test assurance. Above all, in the ISO 15189 standard, it is made clear that laboratories should commit to regular reflection, evaluating the impact of their routine working practices and assessing potential failure points in order to reduce overall risk. In essence, ISO 15189 makes it clear that laboratory managers cannot presume the enduring quality of their processes or the accuracy and precision of their instruments. Demonstrating your competence and becoming ISO 15189 compliant is but the first step along an evolutionary path. The vital component for all laboratories is ensuring an ongoing process is in place to maintain competence between assessments and into the future.
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Whi
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aper ISO 15189
Accreditation to an International Standard
Medical laboratory services and the many pathology laboratories are essential in the smooth running of our health systems. Through their testing, result validation, interpretation, and reporting, they are vital in the diagnosis and assessment of the health of patients. Although it is all too easy to take for granted the systems and protocols behind this relentless production of test results, the recent publication of EN ISO 15189 gives medical laboratories a new opportunity to reassess their training procedures and working practices in the process of demonstrating the quality of their services through accreditation. At the same time, the new standard is a chance to re-evaluate the servicing and maintenance requirements of all the laboratory instrumentation – both hand-held and benchtop - that can have a significant impact upon these test results.
An evolving process towards enduring quality Laboratories must take account of an increased focus on a number of areas, including internal verification and validation, measurement uncertainty, traceability, and test assurance. Above all, in the ISO 15189 standard, it is made clear that laboratories should commit to regular reflection, evaluating the impact of their routine working practices and assessing potential failure points in order to reduce overall risk.
In essence, ISO 15189 makes it clear that laboratory managers cannot presume the enduring quality of their processes or the accuracy and precision of their instruments. Demonstrating your competence and becoming ISO 15189 compliant is but the first step along an evolutionary path. The vital component for all laboratories is ensuring an ongoing process is in place to maintain competence between assessments and into the future.
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Effective quality systems
The new standard demands effective and compliant quality managements systems involving the laboratory environment itself, your personnel, and the laboratory equipment, reagents, and consumables in use. Assessment of competence is central to accreditation and Section 5 of ISO 15189 includes requirements for staff qualifications, training, competence, and continuing professional development (CPD).
Laboratories must also measure the uncertainty of results if the examination procedure is quantitative and the mechanisms by which this uncertainty is quantified must include all aspects of the pre-examination, examination, and post-examination processes. Even if the end result of a test procedure is not numeric, all aspects of the process will need to be reviewed to determine whether or not there is a measurement step and, if so, the level of accuracy and precision that can be attached to it. For instance, has a limit of detection been established in order to issue a ‘not detected’ result? Or, is it necessary to determine the temperature, weight, or volume of anything in order to produce a result?
Traceable calibration of laboratory equipment
At the heart of ISO 15189 is the mandate that all pieces of laboratory equipment that have a significant influence on the results must be traceably calibrated. This means that you must appreciate the impact that each and every individual instrument has in every test protocol. If even a large error will not significantly impact the validity of the result, then no action is needed. But, if just a tiny error will influence the results, then calibration and testing regimes conforming to ISO 17025 is an absolute.
Remember though, this is on an instrument-by-instrument basis. For example, you may have a large number of pipettes in your laboratory with a mixture of fixed volume and variable volume types or, possibly, a mix of manual and electronic models. Although ISO 15189 does not state that every single pipette should be calibrated to ISO 17025, does say that every pipette that may significantly influence the test result must be calibrated to ISO 17025. If only a subset of the pipettes is currently used in procedures where a small error will significantly influence the result, then it is just this subset that will need to be regularly and traceably calibrated to ISO 17025. Alternatively, you could isolate a cohort of pipettes and mandate that only these will be used in procedures where the pipette influences the result. Then, only this cohort will need to be calibrated to ISO 17025.
The importance of maintenance for all instruments
This is not to say that those instruments not in your ‘special cohort’ do not need maintenance! It is common sense to look after all your laboratory instruments and keep them in good working condition, and good practice to test and calibrate them regularly – pipettes, pH meters, thermometers, balances, pH meters, PCR machines, photometers – ALL instruments need maintaining and you should proscribe and record an in-house preventative maintenance regime for all your instruments.
At the same time, laboratories should put in place a training regime in best practice techniques for every person who is expected to use those instruments in the course of their work. This training should also encourage every user to examine their work to see if their technique is influencing the results they achieve and how this may be corrected. As an example, the table below shows how to recognise possible sources of pipetting error and ways of correcting them.
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Observed effect % Error CorrectionDripping tip or maximum permitted errors are exceeded
Up to 50%Use original or recommended pipette tips for proper seal
Uneven tips on multichannel pipette Up to 10% Use original or recommended pipette tips
Maximum permitted errors are exceeded Up to 4% Do not re-use pipette tips
Maximum permitted errors are exceeded Up to 3%Wipe off the pipette tip on the vessel wall (wiping distance 8 mm to 10 mm), observing ISO 8655-6
Maximum permitted errors are exceeded Up to 2% Pre-wet pipette tip
Maximum permitted errors are exceeded Up to 1.5%Smooth rhythmic pipetting technique
Plunge depth too deep and at an angle Up to 1% Hold pipette vertically and observe ISO 8655-6
At METTLER TOLEDO Rainin, we firmly believe that a pipetting system is only as good as the people who use it. Good technique, and knowing which techniques to use for various liquids, affects precision, accuracy and the reproducibility of your results. Our Good Pipetting Practice programme offers a systematic approach to maximising pipetting accuracy and precision through a package of risk analyses, educational materials, seminars and training. It may help you appreciate the commonplace pipette and see it in a new light.
Make full use of ISO 17025 compliant service centres
To maintain compliance with ISO 15189, laboratories must demonstrate that they adhere to defined quality assurance levels and retain traceable records of consistent testing, competently performed. Only service companies accredited to ISO 17025 can guarantee the quality and traceability of the work being performed on your equipment. Companies like METTLER TOLEDO Rainin, with ISO 17025 compliant service centres, are also a huge source of help and experience that you should not hesitate in accessing. After all, we’ve been trusted by laboratories for more than 30 years and have experienced and expert staff who can be relied on to keep on top of developments and offer impartial advice.
The introduction of the new ISO 15189 standards will mean that laboratories have to change. In assessing the full scope of a laboratory’s activities, there will be an increase in assessment activity over the accreditation cycle involving extra preparation and additional documentation. But, we believe that positive support for ISO 15189 will only increase confidence in the results accredited laboratories produce by eliminating, wherever possible, the causes of variability in their protocols and urge all EU labs to embrace this change.
www.mt.com/rainin-serviceFor more information
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