Rising to the POCT Challenge

POCT has applications in diverse settings, including emergency departments, general practice (physician office laboratories), community testing (pharmacies) and patients’ homes (self-monitoring, e.g. for diabetes and coagulation). Professionally, it is one of my main areas of interest; but it also causes me much concern. Clearly, demand for new POCT devices is being driven by an ever-expanding range of clinically relevant analytes; at the same time, innovative device development is being enabled by rapid advances in technology, informatics, and automation. This is resulting in the design and manufacture of a broader range of better POCT instruments that deliver higher quality performance. From my point of view, however, technology alone is not sufficient to benefit either the individual patient or the healthcare process as a whole.

The first thing to consider is the true reason behind any proposal to introduce POCT. Yes, POCT provides fast results and consequently permits quicker healthcare decisions, but that does not make it the answer to disorganized workflows or inefficient laboratories, which are not uncommon in hospital settings. In fact, turnaround time can be significantly improved, without recourse to POCT, simply by a careful review of all steps within the testing process from the pre-analytical to the post-analytical phase. In many circumstances, then, adoption of POCT is unnecessary, and I would recommend that POCT is introduced only when conventional laboratory solutions prove to be inadequate for meeting specific healthcare demands.

Another consideration is the reception of POCT by the various stakeholders in the clinical testing process. Often, workers outside of the laboratory won’t readily assume additional tasks they don’t consider part of their regular duties. Consequently – at least during the initial implementation of POCT – they may reject the introduction of “laboratory devices” on hospital wards. Clearly, this can be challenging. However, by creating multidisciplinary groups – to include nurses, clinicians, technicians and laboratory staff – at the start of the project, we can give everyone the chance to get involved in selecting the appropriate device and in planning the implementation process. Such stakeholder buy-in significantly facilitates the introduction of 
new technology.

Training the users of new devices is another important aspect of POCT uptake, and is also one of the laboratory’s responsibilities. POCT devices are usually extremely easy to use; nevertheless, people do need training, which also needs documenting, and this may be extremely difficult in environments with high numbers of potential users, such as hospitals. Furthermore, the training must cover not only systematic routine operations and maintenance, but also pre-analytical factors, which can significantly affect sample quality and test results, and which are generally outside the knowledge of POCT users.

An additional and important challenge to effective use of POCT in many countries is inadequate regulation or legislation. Most developed countries do not currently regulate device selection, distribution, maintenance, user training, or results validation. Too often, laboratory professionals have no say in the use of POCT devices in their hospital, and may even be unaware of the number of such devices currently used by their colleagues.

From my experience in the lab, there are many things that we can do to meet the challenges associated with advances in POCT technology and use. First, there is a clear need to proactively identify those specific clinical situations or healthcare issues that only POCT can improve. Selection of the most appropriate technology from the various options available  is a crucial step in this process.

Additionally, not all devices marketed for a given application will have the same technical performance; we should not take their quality for granted. For example, Freckmann et al. report that a significant percentage of blood glucose meter systems, even those carrying a CE label, do not meet the minimum accuracy requirements of the specific standard DIN EN ISO 15197  (1). Consequently, my feeling is that laboratories must be involved in the evaluation and selection of POCT devices that are to be used in local institutions.

Finally, we should be sensitive to the fact that some laboratory colleagues will see POCT as a threat to their jobs and to the status quo of their practice. Evidently, technological advances are enabling the development of new POCT devices and the decentralization of some tests from central laboratories to other settings. At the same time, other innovations are increasing test automation within central laboratories. This seemingly unstoppable process is characterized by small laboratories amalgamating with larger organizations, resulting in fewer overall laboratory jobs.  Both of these trends, POCT and automation, will have a dramatic impact on our profession; under such circumstances, it is critical that we  rise to the challenge and commit to leading the way in these changing times.