why involve pathology
TRANSCRIPT
Plymouth Hospitals NHS Trust Point of Care Testing Team (Plymouth POCT)
Serving the Acute Trust and The Community
Point of Care Testing
Why Involve Pathology and What Can We Offer?
Tony CambridgeChief Biomedical Scientist
POCT Co-ordinatorDerriford Hospital
Why Perform POCT in the Community?
It has long been established that POCT offers the following advantages-
Convenience Rapid Good accuracy/precision Allows rule in/rule out Immediate action taken Can save money Engages and empowers patients Improves patient care
What does the MHRA say?
The MHRA are clear that where point of care testing is made available there is a responsibility for clinical governance, along with an understanding of the medico-legal implications of an erroneous result.
It is vital that an appropriate senior professional is identified and given the authority and overall responsibility for the service at the beginning of the process.
What does the MHRA say?
This individual will have responsibility for both the results generated and the correct use of the devices that generate those results.
Just because an instrument/test has a CE mark it does not mean that it will be suitable for the purpose intended.
The Point of Care becomes the Laboratory
When using point of care tests, essentially you are using it in place of the laboratory test.
What governance is adopted in the laboratory?
- Method selection and evaluation- Internal quality control- External quality assurance- Full training and competency for staff- Only trained staff perform the test
The Point of Care becomes the Laboratory
- Reagents stored correctly- Result validation- Fully auditable system- Standard Operating Procedures- Accreditation- Clinical Support
What can happen at the point of care?
Often a test performed at the point of care will have little or no clinical governance
Potential for untrained operators to perform the test Infrequent quality control performed or recorded No quality assurance Equipment not standardised No test evaluation prior to use
Can you show why you adopted a test?Can you prove up to date training and competency?What was the quality control result on any particular day of use?Which lot/batch number of test was in use?
What can happen at the point of care?
No standardised protocol No audit of the system Consumables inappropriately stored or used beyond ‘use by’
date Little guidance or support
If the POC test is being used in place of the laboratory then why aren’t the same principles of clinical governance applied?
The Current Picture
Hopefully this paints a picture……
Fragmented service Potential for misleading results Potential impact on decisions Missed opportunities for intervention Poorer patient outcomes Increased burden on health services
We can reduce these risks with good governance
Potential to Decrease the Burden?
After examination of the patient-
-Symptoms indicate a test is required to rule in/out a condition-Sample taken and sent to lab-Results are negative, positive or non conclusive-Patient returns for follow up appointment-If negative another test might be indicated. If positive, treatment is started or a referral made
• Potential for a step to be removed if test performed at the point of care
• Benefits for the patient and the busy clinician
The POCT Team at Derriford
The POCT team with CPA certificates of accreditation
So what can the team offer?
• Full governance of POCT activities
We have accreditation
We are accredited by Clinical Pathology Accreditation (CPA) - the only POCT team with accreditation for external sites in the UK
The team is based in the Combined Laboratory at Derriford which is also fully accredited by CPA
It does not matter how simple or complex the test is, the service offered is the same in principle
The POCT service
Service Framework-Controlled documentation POCT Policy
POCT Training Policy POCT Audit Policy
Standard Operating Procedures (SOPs)
Patient Result Logbooks Quick-guides Quality Control Logbooks
The service is covered by a Service Level Agreement (SLA).
Test Selection
The most appropriate test will be introduced The test will be validated against the laboratory method Tests, where possible, are standardised within the Peninsula Peninsula Purchase and Supply Alliance (PPSA)- Tenders Increased buying power, cheaper tests
The main suppliers of POCT are known to us and we have good relationships with them
Equipment, such as glucose meters or urine test strip readers can often be supplied for free
Training and Competency
Full face-to-face training provided by the POCT team, manufacturer or link trainers on site
We have a Pathology pool car Training records and certificates issued Full competency assessments for staff
-Q&A sessions Up to date supporting information provided
Audit
Quality management system (QMS) in use QPulse software Management of non-conformance and poor performance The team can provide regular audit of all POCT processes Regular feedback Corrective and Preventive action taken/suggested
Assuring Quality
Regular Internal Quality Control Monthly External Quality Assurance All data analysis handled for you Regular feedback on performance Maintenance and troubleshooting provided by POCT team Free replacement of faulty equipment
Support
Access to the team 09.00-17.30 Monday to Friday except BH Support from the clinical and management leads for POCT Advice from Pathology consultants Manufacturers and suppliers Procurement IT if connectivity required (the success of ICE- order comms)
Commissioning services
Any new service can be set up through consultation with CCGs Decide whether you want to introduce more governance of
current tests Do you want to introduce more POC tests?
-GP Leaflet
What do I need to know?Which investigations qualify for payments from central funds? (such as the NHS Health Check)Would POCT help you achieve certain clinical goals?Are there conditions more prevalent among your patients that you would like to manage at your practice?
Tests that we can support
We can currently support:
Glucose monitoringPregnancy Testing
INRCholesterol
HbA1c UrinalysisDrugs of Abuse/Misuse Sexual Health TestsESR D-dimerCardiac Markers HaemoglobinCRPMore to follow based on clinical need
Conclusion
Manage and reduce the risk associated with performing POC tests by introducing an appropriate level of governance
Optimise patient care
Avoid medico-legal action
Contact Details
POCT Team at Derriford-Tel- 01752 792299email- [email protected]
My email- [email protected]