Point of Care Testing (POCT) (BSH 2019)


Read original guideline for details, this is just a summary of the issues to consider.

Be aware of the multiple national and international agencies involved in laboratory management.


Advantages of POCT

Reduces Turn Around Times (TATS) for tests —> prompt and effective patient management plans, facilitates patient flow, meets waiting time targets.


Range of POCT Tests available:

  • FBC + Automated differential

  • Blood Gas Analysers

  • Prothrombin Time (PT)

  • Viscoelastic Assays (e.g. TEG, ROTEM)

  • Standalone Haemoglobin

  • Activated Clotting Time (ACT)

  • Activated Partial Thromboplastin Time (APTT)

  • D-Dimer

  • DOAC Measurements (e.g. CoaguChek, Hemochron)


Quality Assurance Programme, led by a Quality Manager, to include:

  • Training & Development

  • Personnel

  • Equipment

  • Appropriateness of testing

  • Pre-analytical, Analytical and Post-analytical aspects of the POCT

  • Internal Quality Control (IQC)

  • External Quality Assessment (EQA)

  • Internal Audit Schedule

  • Document control including Standard Operating Procedures (SOPs)

  • Accreditation to the ISO 15189 / 22870 standards

  • Quality Manual for delivery of the service

  • Annual management review


Internal Quality Control

  • Aims to control accuracy, within and between-day variability, and drift

  • Controls should include clinically relevant normal and abnormal results

  • Perform minimum of every 24 hours if POCT in daily use


External Quality Assessment

  • Complements, but does not replace, the real time results of IQC

  • Provides peer reviewed assessment, with performance score of your device relative to other users

  • If EQA not available, other methods available (see full guideline)


Standard Operating Procedures, expected minimum content:

  • Training & competency requirements for POCT users

  • Roles & responsibilities of POCT users

  • Interpretation & troubleshooting of errors/problems

  • Contingency plans for device failure

  • Reporting, documenting & transmission of results

  • Handling & communication of critical results


Training & Development Programme, to include:

  • Ability to demonstrate an understanding of how to use the device

  • Theory of the measurement system

  • Appreciate the pre-analytical aspects of analysis

    • Sample collection

    • Clinical utility and limitations

    • Expertise in the analytical procedure

    • Reagent storage and stability

    • Quality control and quality assurance

    • Technical limitations of the device

    • Response to results that fall outside pre-defined limits

    • Correct documentation and maintenance of devices/results

  • Retraining, annual audit of training, and user feedback should all be done


Management & Governance

  • Clear accountability for the clinical and operational management of a POCT service

  • POCT services usually a sub-section of an accredited pathology laboratory

  • A MDT POCT committee should provide governance


Finance & Cost Benefit

Costs and financial impact of POCT services must be considered, as they are often resource intensive


Equipment Selection & Verification

  • Medicines and Healthcare products Regulatory Agency (MHRA) regulate POCT devices

  • Procurement decisions made by individual NHS Trusts

  • Centre for Evidence-based Purchasing (CEP) at the DoH have already provided evaluations for many POCT devices.

  • Devices should be Conformite Europeenne (CE) marked, indicating the manufacturer has validated the performance claims of the device

  • Correlation & Precision studies run as part of device set up (see guideline for detail)


Health & Safety

Hospital Health and Safety, ISO 15189 and ISO 22870 standards should all be met

Some considerations

  • Risk assessment of device

  • Policy for high risk samples

  • Personal Protective Equipment (PPE)

  • Control of Substances Hazardous to Health (COSHH) assessment/registration of reagents


Reflex Testing

  • Establish a cut-off value for retesting sample in a central laboratory

  • Take into account limitations of the assay and the threshold for management decisions (e.g. transfusion trigger on a haemoglobin result)


Adverse Event Reporting

  • Definition: Any event that has the potential to cause an unexpected or unwanted effect on patients and/or service providers.

  • Events should be raised locally —> root cause analysis, immediate remedial action, corrective and preventative action

  • In addition, events should also be reported to the clinical risk department

  • In England, manufacturers are legally responsible for reporting events to the MHRA but device users may also do so


Documenting and Recording Results

Storage and retrieval of data should conform to the General Data Protection Regulation (GDPR)

Key result data includes:

  • Initial request and requestor

  • Operator ID

  • Patient ID

  • Final result in patient notes

  • Reference ranges

  • Clear indication that the result comes from a POCT device