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