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Getting straight to the point

Point-of-care testing offers clinicians a fast and convenient way to carry out a variety of tests and is set to increase in the future, reports Richard Mackillican

There are many situations in the day to day running of the NHS where clinicians are forced to act quickly in order to deliver the best patient care. This is where point-of-care testing becomes an extremely useful tool.

POCT is used in a variety of settings and according to Dr Danielle Freedman, vice president of the Royal College of Pathologists, its real utility comes when clinicians need to make a quick decision.

“For example, in an acute setting we would use it to check a patient’s blood gas levels, if they are using a ventilator in the intensive care unit.

“Using POCT means that you get a response immediately, as opposed to sending samples down to the laboratory, which could take anything up to a few hours, depending on what tests are being carried out.”

The speed and convenience which POCT offers means that it used in many areas of acute care such as the accident and emergency department, intensive therapy unit and neo-natal intensive care units.

However, despite its diagnostic speed making it perfect for an acute setting, GPs are also using POCT in primary care settings as well.

“GPs use it for anticoagulant monitoring and test patients to assess adequacy of warfarin dosage, along with checking the glucose levels in diabetic patients and also cholesterol checks. Given its success so far, I believe that its use in primary care will continue to grow.”

High street chemists are already offering point-of-care testing for certain conditions, with some also considering entering into agreements with primary care trusts to offer point-of-care testing more widely to patients.

Despite the good work being carried out by many high street chemists with POCT, there are some who look to exploit it to make money out of a wary public.

“There is also a problem with some outlets which are offering supposed tests to the public. For example, there is what looks like a converted burger van set up in one town centre which offers ‘a test’ for prostate cancer, for a fee of course. These are not run by any NHS organisation.”

The growth of the internet has also fuelled the amount of ‘tests’ which are available online, some of which are rather questionable.

“There are even some companies which offer ‘allergy tests’ on the internet, which involve you sending them a capsule of your blood through the post. They will even send you a little kit to bleed yourself with, again, for a large fee.

“This is why I think that POCT needs proper clinical governance arrangements.”

Dr Freedman is one of a team of professionals who recently contributed to guidance on the use of POCT (‘Management and use of IVD point of care devices: DB 2010 (02)) published by the Medicines & Healthcare Products Regulatory Agency.

“One message which must get to anybody considering the use of point-of-care-testing is that they must follow this MHRA guidance, as it is applicable to both primary and secondary care, along with the private sector as well as the NHS.”

This guidance covers many areas, one being the role and importance of the hospital laboratory, which Dr Freedman explained using her own trust as an example of best practice.

“We have a POCT committee which assess the need for any kind of point-of-care testing equipment and is accountable to the risk management committee. A recent example was that of our respiratory physicians who wanted a gas machine to measure gas levels in patients with chronic obstructive pulmonary disease.

“To do this they had to put together a proper business case for the procurement of the equipment which was then put before the committee. This business case had to cover the clinical need for it together with a recognition of the cost involved and reassurances on how they would maintain quality assurance.

“The laboratory plays a big role in this quality assurance, including the training of the user or testing their competency. This means that I know that anyone using POCT in the hospital has the right experience to do so properly so that clinicians can be sure that the results they are given are correct and, more importantly, ensuring patient safety.”

Due to the advance of technology, it is also possible for the laboratory team to monitor POCT remotely.

“Through the use of information technology it is possible for me to monitor, for example, someone’s blood glucose levels measured by POCT, in a ward at the other side of the building.”

Dr Freedman and her team also maintain good links with their colleagues working in primary care to ensure that they also work to a good governance model.

“We work very closely with them to make sure that they are complying with the guidance set out by the MHRA. This should also be the case in private laboratories from the independent sector.”

Due to its increasing significance in modern healthcare, POCT is 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 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.

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
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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