An Introduction to P OINT O F C ARE T ESTING

1. An Introduction to POINT OF CARE TESTING Dr Derek McKillop Consultant Clinical Scientist POCT Co-ordinator Revision 1 July 2016

2. POCT Definition • Point Of Care Testing • “… any diagnostic test performed on a person by a competent individual, where a result that can be interpreted is provided before the person leaves” • Alternative names • Near Patient Testing (NPT) • Bedside testing • Extra-laboratory testing Revision 1 July 2016

3. POCT Governance Arrangements • The governance standards for POCT are listed within the Trust POCT Policy. • The policy can be found in policy section of the Trust website or the POCT website • The policy is based on the guidance for the Management ands Use of IVD Point of Care Devices, published by the MHRA and endorsed by the NI Health Estates • The Key principals are summarised in the MHRA Top 10 Tips document. Revision 1 July 2016

4. POCT Governance Arrangements • A question I am frequently asked is “Why do I need to comply with governance arrangements for POCT when it is performed at home by unregulated members of the public ?” • The answer I give is • Health service staff will be using POCT in challenging settings where it could be contra indicated, levels are at the limit of sensitivity, drug interferences are possible, patient are unwell/unstable and critical clinical judgement are made based on results so errors can have tragic consequences. • To comply with the MHRA guidance • To comply with professional codes of conduct. Revision 1 July 2016

5. POCT Governance Arrangements • Governance Objectives • Protect Patients from harm • Protect Staff by helping them to comply with their professional Code • Promote continual improvement. • incident investigation • Audit Revision 1 July 2016

6. POCT Governance Arrangements • POCT limitations • Although you may not be required to perform POCT you will in the course of your duties adjust the clinical management of patients based on results obtained from POCT, therefore: • You MUST be familiar with the limitations listed in the product insert for the POCT devices used to generated these results • Any results which are not in keeping with the clinical presentation MUST be confirmed by the laboratory. • The following slides will list the main limitation of core POCT available within the trust. • Throughout this presentation we will use case studies to highlight how the limitations can adversely impact on patient care. Revision 1 July 2016

7. POCT limitations • Blood Gas • Not using balanced heparinised syringes will cause clots and inaccurate electrolyte results • Air bubbles will result in inaccurate blood gas results • Failure to mix will cause clots and falsely low haemoglobin results • Unlabelled syringes result in patient mix up • Ionised calcium results are different from Total calcium reported by the laboratory • Potassium can be falsely elevated by masked haemolysis in whole blood samples • Dilution from line fluid Revision 1 July 2016

8. POCT limitations • Glucometers/ketone meters • Result may be unreliable if peripheral circulation is impaired. Examples include: • Severe Dehydration due to Diabetic Ketoacidosis • Hypotension • Shock • Hyperosmolar, Hyper glycaemic State (known previously as H.O.N.K ) • Decompensated heart failure NHYA Class IV • If peripheral circulation is impaired send a sample to the laboratory or use a venous sample. • Only heparinised samples can be used - other anticoagulants will result in misleading results • Continued glycolysis will adversely effect results if not analysed immediately • Any sample glucose reading below2.8 mmol/L or above 20 mmol/L, or which is not in keeping with the clinical picture, should be verified by sending a venous specimen of blood to the laboratory. Revision 1 July 2016

9. Management & Organisation Dr P Sharpe Chair POCT Committee (list of members available on POCT website) Ward Managers Clinicians Dr D McKillop POCT Co-ordinator Link Nurses EQA Providers Supplier Users POCT BMS Miss Dorinda O’Neill Pharmacy Laboratory POCT MLA Mr Gareth Prideaux, POCT is managed in partnership between the POCT Committee, the POCT Coordinator and Stake holders The responsibilities of the POCT team and stakeholders are outlined in the trust POCT Policy Revision 1 July 2016

10. Procurement &Laboratory Support • Procurement stages • Stage 1- prepare for approval a business case to secure funding for the new POCT service and support services • Stage 2- Discuss with the POCT coordinator who will advise on the completion and submission of the POCT application form for approval by the POCT committee. • Stage 3- approved equipment should NEVER be purchased as a non stock item. The trust is the legal entity in relation to procurement. To ensure compliance with procurement rules the advice of the POCT coordinator and the procurement department should be sought. The following must be taken into consideration • Is there a Regional contract? • Is there a Local contract? • Is NHS supply chain a viable option? • Any tender must allow for future growth for the service from other departments. Revision 1 July 2016

11. Training & Competency Assessment • Training • Only staff whose training and competence has been established and documented can perform POCT. • The training program is designed to ensure staff have the knowledge to use the device safely and avoid patient harm. • POCT training is provided by either: • The supplier • Online training package with observational competency assessment • At formal training sessions organised by the laboratory • Local cascade training by a Link Nurse • All link nurse trainers MUST have completed the company's train the trainer training and signed up to the Cascade trainer model of good practise Revision 1 July 2016

12. Training & Competency Assessment • On going competency assessment • The competency of all trained POCT users MUST be evaluated at least every 3 years. • This should be noted as part of the KSF exercise and added to the PDP at least 6 months before competency is due to expire. • Line manager should inform their designated POCT link nurse of staff that requires competency assessment within the next 6 months. • Or • If the member of staff has not been rotated or routinely worked in a section for a period of at least 6 months. • Following return from maternity leave. • Following return from extensive sick leave. • Secondment to a new role. Revision 1 July 2016

13. Document Management • All POCT related documents are controlled and regularly reviewed within the Q-Pulse document management system • All controlled documents are hosted on the POCT website: http://vsrintranet/SHSCT/Labs/webhb/poct/home.htm • Printing documents is discouraged as they are only controlled on the day of printing. • As a regularly used site we would recommend placing a link on your desktop by opening the page, right click, create short cut/ select yes. Revision 1 July 2016

14. Record keeping • It is imperative to keep accurate records which must include: • testing info- date; device type; batch numbers; result; operator identity; patient identity. • Stock control • Temperature monitoring (if required) • Ensure records are stored so as to protect patient confidentiality Revision 1 July 2016

15. Maintenance • Maintenance and appropriate storage of consumables is essential for the safe and effective use of POCT devices • Planned preventative maintenance should follow the manufacturer’s guidance, • A maintenance contract should be in place to cover • Preventative maintenance • Out of hours call out • Follow the weekly and monthly maintenance checks as stated in the SOP and manual • All devices must be decontaminated as per the SOP prior to maintenance Revision 1 July 2016

16. Adverse Incident Reporting • An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users including patients or other persons. • All incidents should be reported using the IR1 procedure. • To ensure thorough investigation it is essential that where possible the reporter: • Contacts the POCT coordinator at the time of the incident • Retains the sample and quarantines implicated test strips. • Retest using alternative device/strip lot and confirm with lab result Revision 1 July 2016

17. Adverse Incident Reporting • An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users including patients or other persons. • If the root cause identifies an issue with the device then the incident must be escalated to NIAC • Please complete the NIAIC form available on the trust share point and return to the risk manager Nigel.McClelland@southerntrust.hscni.net (http://sharepoint/pr/ess/grm/Policies%20and%20Procedures/Forms/AllItems.aspx) Revision 1 July 2016

18. Conclusion • POCT is a risky aspect of your role • Working with the POCT team we can minimise those risks, both for the patient and for you • You must now complete a short test based on the information you have been given • To access the e-learning platform to complete your test email elearning.support@southerntrust.hscni.netor Tel: 028 37412655 • When you have completed the introduction module and passed the test, you must now complete the POCT device specific training modules as per your job role requirements. POCT online courses can be located at http://www3.hscni.net/stlabs/webhb/poct/training.htm • Doctors must complete the e-declaration on southern Docs to verify completion of the introductory module. • Thank you for completing this module • . Revision 1 July 2016