The Path(ology) to Quality Improvement
What labs need to know about the importance of ISO 15189 accreditation
Pathology service accreditation has come a long way in the last 25 years. Although the principles of accreditation haven’t changed since its roots were established back in the 1960s, the process is constantly evolving as a source of confidence to regulators, commissioners, laboratories and – most importantly – patients. The catalyst for the most recent changes was the Report of the Review of NHS Pathology Services in England, chaired by Lord Carter of Coles (1). Aside from criticizing the low number of fully accredited laboratories, the report had two key recommendations: first, that “objective and measurable quality standards should be developed,” and second, that “pathology service providers… should be subject to mandatory accreditation by an [independent] organization.”
At a Glance
- Accreditation gives laboratories, regulators and service users confidence in pathology
- National accrediting bodies like UKAS are responsible for ensuring that service providers uphold the internationally recognized ISO 15189 standard
- In the UK, the previous CPA standard will be withdrawn in 2018, so ISO 15189 accreditation is a priority for NHS England
- Accredited labs are able to reduce risks, control costs and stimulate innovation, providing patients with high-quality services
Why is accreditation so important? It addresses the primary concerns of everyone involved in medical laboratory services: accuracy, reliability and safety. It means that medical laboratory services have been assessed against internationally recognized standards to demonstrate their competence, impartiality and performance capability. The Pathology Quality Assurance Review, chaired by Dr Ian Barnes in 2014 (2), explains that “the main purpose of pathology laboratory accreditation is to assure the quality of the service being provided.” Further, it is “a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results.”
The United Kingdom Accreditation Service (UKAS) is the UK’s national accreditation body. Appointed by, but independent of, government, its role is to assess the competence of organizations that provide conformity assessment services (like certification, inspection, testing and calibration) against international standards. One such organization, Clinical Pathology Accreditation (CPA), has provided pathology accreditation to over 1,250 laboratories since its formation in 1992 – and after the emergence of the Carter of Coles report, the Department of Health supported any merger between CPA and UKAS to provide the necessary independence and transparency to adhere to European accreditation laws. As a result, in 2009, CPA became a wholly-owned subsidiary of UKAS.
But creating an independent accreditation body was only the first step. Next, we had to ask the question: what’s the most appropriate accreditation standard to use for pathology labs?
Implementing ISO 15189
A key part of modernizing UK pathology services is transitioning all CPA-accredited laboratories to UKAS accreditation against the internationally recognized ISO 15189 standard. We chose this standard because it was specifically created to help medical laboratories develop their quality management systems and assess their competence. It’s concerned with improving patient safety, mitigating risks and increasing operational efficiency in areas where medical laboratory practices directly impact the continuum of care. It can even be used as the basis for accrediting point-of-care testing (POCT) providers when applied in conjunction with ISO 22870 (which gives specific requirements for POCT).
As noted in the Barnes review, “the new ISO 15189 standard has increased emphasis on continuous improvement” and differs from the CPA standard in a number of important ways. Broadly speaking, new requirements regarding information management, evaluation and risk assessment, equipment records, staff suggestions and service agreements have been introduced. In addition, the criteria for meeting staff competence, EQA/IQC, purchasing, verification/validation, uncertainty, traceability have been modified from CPA standards.
Overall competence is no longer restricted to the technical competence of staff. It also now includes the environment, handling and sampling systems, as well as the validity and appropriateness of methods. Similarly, management competence encompasses the qualifying of external services and suppliers and the management of patient feedback, in addition to internal audits of quality management systems and methods of controlling documents and records.
ISO 15189 looks at end-to-end processes in laboratories, both pre- and post-examination. The investigations are underpinned by UKAS-accredited external quality assessments, which themselves involve a more rigorous assessment of data and statistical evaluation, leading to greater confidence in the ultimate outcome. The ISO 15189 standard is also more patient-focused; it’s not just about “following the process,” but about ensuring the methods used are suitable for the diagnosis in question. During assessments, assessors will seek to determine how the laboratory has established that the examination procedures used are clinically suitable for the patient demographic. The clinical suitability of examinations offered by the medical laboratory must also be regularly reviewed.
Despite the differences between the standards, the basic principles of accreditation remain unchanged; namely it is an assessment (rather than an audit) that looks for multiple ways to establish conformity. The assessment team adopt a holistic approach to their work, where individual components of the standard are assessed together (where appropriate) instead of
Fast Facts About ISO 15189
- A comprehensive laboratory quality standard
- One of the fastest-growing international quality standards in the world
- National standards bodies can and should participate in ISO 15189 development
- Based on ISO 9001 and ISO 17025
Quality and CLSI QSEs include:
- Structure (organization, management responsibility, personnel/human resources)
- Oversight and improvement (assessment, occurrence management, process improvement, customer satisfaction)
- Operations (purchasing and inventory, equipment, documents and records, process control/management, safety and facilities, information management)
- Awareness of users (clinicians) and ability to meet their requirements
- Laboratory advisory panel consisting of users
- Mechanism for user complaints
- Personnel competency, procedure processes and documentation, reagents and materials, equipment, environment and conditions
- Thoughtful lab design to avoid interference with workers or samples
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Making the standard switch
In October of 2013, the approximately 900 CPA-accredited laboratories in the UK began transitioning to UKAS accreditation. Nearly two years later, about 250 of those labs had been assessed against the ISO 15189 standard, with 60 awarded accredited status and a further 90 close to achieving it (3). And it’s spurred pathology service providers to get organized, too. At UKAS, we’ve observed that many service providers are now “joining up” individual laboratories into a single UKAS accreditation covering each lab’s individual scope. This consolidation will lead to the accreditation of as many as 350 laboratory units by 2018, when the CPA standard will be withdrawn.
The accreditation of all diagnostic services is a business plan priority for the National Health Service (NHS) in England and is strongly supported by the National Clinical Directors for both Pathology and Diagnostics. The Barnes review also recommends UKAS accreditation to ISO 15189. On an operational level, accreditation encourages the sharing of best practices and prevents unnecessary duplication of performance information gathering for Care Quality Commission registration. It’s not just about being organized, though; through embracing targets like fitness for purpose, value for money, and reliability, the goal is to improve outcomes for patients. Through providing independent assurance of quality and safety and providing a mechanism for measuring improvements, accreditation can enhance both the quality and value of patient care. Accreditation brings all quality assessments together in a single package – reducing risks, controlling costs and stimulating innovation. It enables cultural change and gives organizations a competitive edge – which is why Sue Hill, Chief Scientific Officer for NHS England, said, “… the standards, approach and protocols of the accreditation process itself do an enormous amount to embed a quality culture within each individual
- Department of Health, “Report of the Second Phase of the Review of NHS Pathology Services in England”, (2008). Available at: bit.ly/1mwn8nh. Accessed January 5, 2016.
- NHS England, “Pathology Quality Assurance Review”, (2014). Available at: bit.ly/1VEVpil. Accessed January 5, 2016.
- J Martin, “The benefits that ISO 15189 accreditation is bringing to pathology”, Presentation to IBMS Congress delegates, September 28, 2015.
- NHS England, “Chief Scientific Officer bulletin: June 2015”, (2015). Available at: bit.ly/1S1Y5aI. Accessed January 5, 2016.
Paul Stennett is Chief Executive of UKAS and its wholly owned subsidiary, CPA. He is also an Honorary Fellow of the Royal College of Pathologists, a member of the BIS Measurement Strategy Board, and was appointed MBE in 2008 for services to business and pathology.