Accreditation of Point of Care Services: Forming Good Habits

Key points:

• Accreditation standards available
• The importance of accreditation
• Why isn’t accreditation mandatory for clinical services
• Mandatory private service requirements

Attaining accreditation for point of care testing (POCT) and decentralised diagnostics services is seen by some as the pinnacle of recognition and peer assessment. For others, achieving accreditation is not a goal, or at least it doesn’t seem in reaching distance. For a process which is not mandatory, to not try may seem like a reasonable choice.

However, using these standards to improve your service, form good habits and develop quality processes over time, is essential for anyone involved in POCT and rapid testing. Starting with one test or device in your service might be the best approach, a blueprint developed, then applied to the rest of the service sequentially.

Others may choose to take a ‘big bang’ approach, design the full scope of the service to meet accreditation standards

Accreditation Standards

The most widely adopted standards are those developed by ISO – International Organisation for Standardization https://www.iso.org/standard/71119.html and CAP – College of American Pathologists https://www.cap.org/laboratory-improvement/accreditation

Compliance with the appropriate standards is assessed by an accreditation body based in the territory, or appointed on behalf of the country where the organisation undertaking the assessment is based. For example the United Kingdom Accreditation Service (UKAS) will assess compliance through scheduled assessments where the scope of the accreditation is defined by the applicant https://www.ukas.com/accreditation/standards/poct/ and may do so in territories outside of the United Kingdom.

The standard for POCT is ISO 22870:2016 (currently under systematic review as standards are reviewed every 5 years) and is used in conjunction with ISO 15189:2012. Details of the CAP process can be found on their website link above.

Why is Accreditation important?

The UKAS website states the following is true of the accreditation process:

• Provides independent assurance of quality and safety that supports objectives to deliver better care and value for patients
• Provides a mechanism for measuring quality improvement and encouraging innovation through continuous service improvements
• Supports consistency in the quality of care with reliable outcomes

Why isn’t it mandatory for clinical services?

Although recommended, applying for, attaining and maintaining accreditation is not mandatory. There is no clear reason why neither medical laboratory accreditation or POCT accreditation is a mandatory requirement. The most likely explanation across the point of care landscape is the lack of standardisation in service provision, historical clinical resistance and concern over the performance of the technology.

The repertoire of tests and size of service differs greatly across organisations and healthcare locations. The size of the workforce and the investment can be polar opposites. This leads to variation that makes imposing a mandatory assessment difficult.

Clinical, managerial and executive support for POCT has steadily changed over the last decade, and the SARS-CoV-2 pandemic has in effect, been an enabler for the decentralised diagnostics approach. As more organisations appear on the list of accredited POCT services, confidence will grow so that more service providers start their preparations, and some take the step to apply.

Accreditation of private services

Accreditation for private providers of COVID lateral flow testing, services such as those required to support individual’s being able to travel, are in contrast mandatory. The process is overseen by UKAS in the UK and a list of approved providers of accredited testing can be found here along with more details around the requirements.

https://www.gov.uk/government/news/government-publishes-list-of-approved-covid-19-test-providers.

‘The new UKAS accreditation scheme is a 3-stage process that has been developed in partnership between DHSC and UKAS. This accreditation scheme simplifies the regulatory landscape for private COVID-19 testing, allowing providers of testing services to start providing services more quickly while demonstrating that their services are of a high quality.’

More detail on the accreditation process and what is excluded can be found here

https://www.ukas.com/resources/latest-news/covid-19-lateral-flow-tests/

Meeting the standards provides assurance to service users that testing and results processes are of an appropriate quality, provided by individuals and organisations who are competent to do so. The requirement to gain accreditation in the commercial landscape stems from the impact that providing erroneous COVID-19 results to the general public would have on society in terms of spread of infection or inappropriate assurance for:

• Workplaces
• Travel
• Events and Hospitality
• Other areas of society which may have large gatherings, multiple interactions

Quality and competence – what does this mean?

• One interpretation is that the POC service is delivered within a robust well designed Quality System and that service users are competent to deliver a safe clinical or private service
• The challenge is therefore to set up an effective quality system and ensure users of the service are competent to apply the principles
• Accreditation goes beyond producing accurate results for patient care by developing confidence in the service as a whole
• Compliance is more about effective control processes and standardisation of service provision

Effective Quality Management is Key

The implementation of an effective quality management system, demonstrating sustainability through evidence, will form the basis of an application for accreditation. Starting off with stable foundations built on the principles of quality and safety is a must. Building on that foundation will then become easier as more and more measures are implemented within the service to meet the requirements of the standard and promote excellence.

More guidance on effective governance and quality of POCT services can be found in the first part of this artcle The governance challenge the essential elements of a well governed service part 1