25 May 2023

Effective use of the right test, in the right place, at the right time, for the right individual is vital to ensure effective, safe patient care.

The role of diagnostic services is to ensure that the right tests are available at the right time to the right patient at the right quality.

Healthcare is changing as technology develops, more virtual and remote models of care are emerging. These models are changing the demands of traditional services, a clear demand is emerging for diagnostics to be delivered at the point of need.

The College in partnership with the Institute of Biomedical Science and the Association for Clinical Biochemistry and Laboratory Medicine have published National Strategic Guidance for at Point of Need Testing.

The paper sets requirements to deliver point of care services to benefit patients within a safe, high quality and accreditable framework.

It sets out a number of objectives:

  • For patient safety, good governance and the effective use of the right equipment, the strategy should be used by those commissioning health care to inform the principles of adoption for point of care testing in all settings. 
  • Laboratory experts should be used as a source of trusted advice to support the design, assessment, implementation, and delivery of diagnostic services outside of the traditional laboratory setting.
  • There is a patient safety imperative that quality standards and good governance are maintained in this complex area of diagnostics, especially as it moves into new and novel domains, with more complex oversight models needing to be developed.
  • Full and properly costed financial resources need to be identified to support high quality, fit for purpose and safe Point of Care Testing (POCT) services.

The report also makes a number of recommendations:

  • When considering and introducing a point of care service there is a requirement to: Identify the unmet need from testing and whether there is a test to meet this need.
  • Involve laboratory professionals to guide best practice in the selection of equipment that ensures adequate safety and quality to optimise cost and minimise risk.
  • Have operational management system applicable to any setting, including community or multi-agency services, that ensures POCT technology is efficiently maintained and competently used by trained operators, risks are effectively addressed, device performance is monitored and optimised, and a high standard of service is delivered. 
  • Establish a model of good clinical governance that satisfies independent regulators and meets applicable quality standards. 
  • Define ‘POCT’ and have a policy directed to support the application within the care setting.
  • Ensure quality standards described are met and the road map to introduction of ISO15189:2022, where applicable, proposed.
  • Understand the needs and demands of the workforce ensuring that it is in place and resourced appropriately with correct training and support to undertake all elements of the service. 
  • Ensure devices are subject to appropriate Internal Quality Control (IQC) and registered for External Quality Assurance (EQA) and performance is monitored by a laboratory professional.
  • Audits of all aspects of POCT services are performed to scrutinise the whole system.
  • Ensure the level of IT connectivity required is equal to that of the main laboratory as far as possible, and not dependent upon care setting.
  • Involve laboratory teams at the earliest stage of any development. Involve laboratory professionals in any research and development of patient pathways using novel or innovating technologies. 
  • Commit to appropriate funding and resources to deliver services that are high quality.  

Point of Care Testing 

  • Point of care testing (POCT) testing can be defined as tests performed with equipment operated outside of a laboratory environment, from patient wearables and lateral flow devices, for example pregnancy tests and covid LFD’s, to ward-based multianalyte devices.
  • The purpose of a POCT service is to enable the delivery of high quality, accessible diagnostics at the point of need for clinical services, improving clinical outcomes and enhancing the patients’ healthcare experience.