why involve pathology

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- plh-tr.POCTPlymouth@nhs.net

My email- tony.cambridge@nhs.net