Julie Russell, Head of Culture Collections at Public Health England, explains the recent changes to UKAS accreditation.
Most medical laboratories in the UK are in a period of transition and working towards the attainment of UKAS accreditation to the internationally recognised standard ISO 15189:2012 – Medical laboratories – Requirements for quality and competence (1).
Accreditation is not a new concept – Clinical Pathology Accreditation (CPA), was described initially in 1991 (2), introduced in 1992, and by 2012 had been awarded to nearly 1,000 medical laboratories.
Several factors prompted the recent change of approach to accreditation.
In 2009, UKAS acquired CPA (3) as part of a strategy to modernise the UK’s pathology services, and the UKAS role was reinforced by 2012’s Barnes Review (4), commissioned following an incident in which serious negative outcomes for patient care were attributed to problems with quality assurance of laboratory results and inadequate governance processes.
Adoption and scrutiny
ISO 15189 is not a new standard; the first version took seven years to develop and was published in 2003. It was revised and republished in 2007 and 2012. By 2013, it had been adopted by accreditation bodies in over 60 countries. Widespread adoption has helped a uniform approach to determining laboratory competence and has encouraged internationally accepted testing and measurement practices.
Scrutiny of the quality of medical laboratory results is due in part to the extensive recognition of their importance in diagnosing causes of ill health and their essential role in improving healthcare outcomes for patients. Laboratory results are crucial for medical decision-making and more sophisticated technology and processes also add to the need for a strengthened quality assurance framework.
The key principles of ISO 15189:2012 are that the laboratory management must have a clear remit and responsibility to manage all aspects of the work of the laboratory, they must know who the users (customers) are and what they need, and they must provide a physical environment that is appropriate for the laboratory workers and the tests they undertake.
The laboratory must be able to demonstrate a clear understanding of what the service should be achieving (specification, standards); clear evidence of how assurance is being achieved (key indicators, measurements), and there must be clear consequences if assurance is not provided (corrective actions).
Where to focus
A laboratory must appoint an advisory panel of users (including external clinicians) and have a mechanism to capture customer complaints. Most laboratories applying for accreditation would probably start with a gap analysis to identify what needs to be done to comply with each clause of the standard. Laboratories transitioning from CPA accreditation would benefit from focusing on the requirements relating to organisation and management, resource management, examination procedures and the evaluation and quality improvement processes.
Contacting the accreditation body can be helpful to discuss the best way forward. Perhaps one of the more challenging aspects of meeting the requirements is the assessment of method uncertainty and traceability. There will need to be readily available estimates of uncertainty of measurement and a clear documented understanding of the impact of uncertainty on the patient pathway.
In addition, UKAS assessment focuses on the laboratory’s production and evaluation of validation and verification data for all laboratory procedures. External quality assessment (EQA) is an essential component of accreditation and most medical laboratories in the UK will already participate in one or more EQA schemes.
Independent third party control materials should be considered wherever possible, in addition to those provided as part of a diagnostic kit or by the manufacturers of diagnostic instruments. It should be noted that relevant paperwork for all controls including proof of provenance, certificates of analysis and material data sheets should be accessible.
A reliable indicator
There is no doubt that working towards accreditation can be a costly and time consuming process. However, it is generally agreed there has been too much variation between pathology services in the past and a continued lack of harmonisation is unacceptable.
Multistep processes used for diagnostic testing are subject to many sources of error and this applies to both manual and automated procedures. Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. It provides a ready means for customers to identify and select reliable services that are demonstrably committed to improving operational effectiveness and health outcomes for patients.
It should also be noted that minimising errors and increasing scrutiny of external suppliers may result in operational cost-savings – an essential consideration in the current financially challenging era. As the UKAS assessments are being rolled out, it is heartening to see that laboratories are starting to report their positive experiences regarding accreditation to ISO 15189:2012 (5).
Q&A
Q: What is most important when preparing for accreditation?
A: Attitude is a little thing that makes a big difference – positive leadership is key to ensuring that staff are engaged in the process which must embed in the day-to-day work of the laboratory.
Q: My laboratory isn’t yet accredited to ISO 15189:2012 – is this a problem?
A: The plan is that all UK laboratories will have gone through the transition from CPA accreditation by the end of 2017 and during the course of 2018 the CPA Standards will be withdrawn altogether – so you still have time.
Q: What about accreditation of POC testing?
A: UKAS accredits organisations which provide point of care testing against a different standard: ISO 22870:2006, which is applied in conjunction with ISO 15189:2012. Further information can be found at ukas.com
REFERENCES
1. ISO 15189:2012 - Medical laboratories - Requirements for quality and competence Available from http://www.iso.org/iso/catalogue_detail?csnumber=56115
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC496660/pdf/jclinpath00412-0...
3. https://www.ukas.com/services/accreditation-services/clinical-pathology-...
4. https://www.england.nhs.uk/wp-content/uploads/2014/01/path-qa-review.pdf
5. https://www.ukas.com/services/accreditation-services/medical-laboratory-...