NEWS
Management and use of IVD point of care devices. DB 2010 (02)
Executive summary
The key issues addressed in this guidance include:
· A clinical need must be identified before the implementation of a POCT service
· Consider involving the local hospital laboratory in the management of POCT services
coming under a growing amount of scrutiny.
“There is an organisation called Clinical Pathology Accreditation (CPA) UK Ltd, which has been around since the early 1990’s and assesses both NHS and private laboratories in the UK against a set of well established criteria of standards and part of those look at point-of-care testing taking place in each establishment. In April, CPA published new standards specific for point of care (Additional Standards for Point of Care Testing (POCT) facilities. CPA (UK) Limited. April 2010).”
POCT opens up a whole range of different clinical governance issues.
“The clinical governance issues around point-of-care testing are huge. For example, if my laboratory gets a result wrong and it has affected the patient, as head of department the buck stops with me and the trust. Similarly, if an error is made by someone using point-of-care testing in our trust, because the laboratory is responsible for it, the buck will again stop with me and the trust.
“However, if something goes wrong with POCT in a primary care setting, then it is the GPs responsibility. Also, there are issues about how to ensure results get into the patient’s notes as well as indicating that they are results using POCT.
“With regards to the cost, there is a diversity of views around whether there is evidence that POCT is cost effective. There are the protagonists and antagonists with it all depending on what you are actually measuring to establish cost effectiveness.
“For example, if you compare a point of care test carried out at a GP’s surgery for glucose levels with a patient having a blood test which is then processed by a laboratory, then it will work out far more expensive, because POCT is not cheap.
“But if you consider in a holistic sense that a point-of-care test will allow you to get a result straight away without the need for the patient to take time off work to go to a walk-in centre, e.g. to be bled, then the benefits become clear because ultimately these other resources are not being used. You need to look at the whole picture when
Jul/Aug 10 considering the value of POCT.”
In addition to the overall cost benefits, there is growing evidence that point-of-care testing also has clinical benefits when compared to laboratory testing due to the nature of the test.
“There is growing evidence that POCT can positively affect clinical outcomes mainly because of the speed at which you get the result back. This has been shown in a Department of Health funded trial which looked at HbA1C testing on diabetics. This found that when HbA1C tests were conducted in an outpatient clinic, as opposed to sending the tests to a laboratory, the overall diabetic controlled improved.
“This means that there is now evidence that POCT can improve clinical effectiveness.”
Clearly, if POCT is used appropriately, both from a clinically and cost perspective and ensuring patient safety by following MHRA guidance, it can benefit both the patient and clinician.
· Lines of accountability for POCT management must be clear
· Managers of POCT services must be aware of their responsibilities under clinical governance
· Arrangements for training, management, quality assurance (QA) and quality control (QC), health and safety policy and the use of standard operating procedures (SOPs) must be made and reviewed at frequent specified intervals
· Assessment of the service by an external accreditation body is recommended
· You should consider the available evidence for the performance of the test
· Adverse incidents must be reported to the MHRA
· Clear, comprehensive record keeping and documentation is vital
· Everyone involved in POCT should know what to do in the event of any abnormal result or unsatisfactory QC result
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