Summary of the POCT Policy
The purpose of the POCT policy is to ensure that POCT is used in a safe and effective way in accordance with best practice.
The aim is to ensure that POCT results used in patient management are as near as possible in quality to those issued by an accredited hospital laboratory.
The following principles must be followed:
- Only Trained members of staff may use POCT devices
- For every type of POCT operators should know
- What to do in the event of abnormal results, breakdown of device, or unsatisfactory quality control.
- How to report POCT adverse incidents in accordance with the Trust Policy and Procedures for Reporting Adverse Incidents, and the Trust Medical Devices Policy. Incidents must also be reported to the Clinical lead for POCT within the Pathology Directorate who will notify the Medical and Healthcare Products Agency (MHRA).
- Before a decision is made to introduce a POCT, the need must be identified and justified both clinically and economically to the Trust POCT group by completion of the form in Appendix C.
- For every type of POCT device there will be
- Clinical benefit
- Cost Benefit analysis
- Analytical evaluation
- Arrangements for training, management, Quality Assurance (QA), Internal Quality Control (IQC), External Quality Control (EQA). The Pathology Department will monitor IQC and EQC results.
- Risk assessments and Standard Operating Procedures (SOPs) which must be reviewed at frequent specified intervals
- A maintenance schedule agreed.
- Clear, comprehensive record keeping and documentation
- The Pathology directorate / Clinical lead for POCT will audit the above points. Significant issues such as persistent unsatisfactory performance, including non-return of results will be reported to the Site Manager/Clinical Service Lead and appropriate action agreed which can include withdrawal of a device. If no action is taken and agreement is not reached, then the issue will be escalated to the Clinical Service Unit Management Team.
- Advice can be sought from the Clinical lead for POCT within the Pathology Directorate.
The POCT policy applies to all employees of Leeds Teaching Hospitals NHS Trust (LTHT) including those on permanent, temporary and bank contracts
A full copy of the POCT policy can be found here