We Must Guide POCT

Point-of-care testing (POCT) should not be a new topic for laboratory medicine discussions but in some institutions, it is. And, those who are unaware of the potential problems of poor global quality management of POCT need reminding about it regularly, particularly as people who are not laboratory medicine specialists may perform the measurements!

Clearly, there are very good reasons for using POCT. For example, it reduces turnaround time (TAT) or “vein to brain time” (time from result availability to action taken), and it is advantageous in reducing unnecessary blood drawing (in intensive care and neonatal intensive care units). It also minimizes handling or transporting samples to the laboratory, improves patient care by reducing hospital visits and, therefore, unnecessary journeys.

I would say that, above all, any decision to implement POCT should be guided by a desire to improve patient care, eliminate problems caused because the laboratory cannot improve TAT, and overcome problems experienced with laboratory processes that prove difficult or impossible to improve. But, it is important to ensure that the quality of POCT is of the same high standard as those tests performed in the laboratory.

In my view, laboratory professionals should see POCT as an extension to lab work and subject it to the same quality standards. Consequently, there is no need to reinvent the wheel, just use your established standards. Here are some of the basic items we have implemented within our POCT quality standards in Barcelona:

• take care of the patient
• create and lead a team
• analyze, simplify and document all processes
• select and evaluate POCT analyzers
• assure global POCT quality
• learn from errors allowing continuous quality improvement.

All of the above are simply what we’ve been doing for a long time!

Undoubtedly, every new POCT scenario should be developed with the aim of improving healthcare and patient benefits while maintaining outstanding reliability of every point-of-care measurement. Far from facing these tasks as individuals, it needs a strong team led by an experienced laboratory professional as POCT coordinator. I suggest that the POCT coordinator has very important responsibilities, including:

• selecting and leading a team of trained and strategic professionals
• deciding which global quality assurance protocols will be applied. He or she will monitor internal quality control, external quality assurance, process performance indicators, quality system assessments, and implement further improvements as necessary
• assuring access to important information allowing efficient and effective use of systems. He or she will demonstrate a deep knowledge of every test procedure (identification and preparation of patient, how to obtain and manage samples, analytical process, validation, etc.)
• establishing training plans for personnel (subjects, timing, assessment of acquired knowledge, etc.)
• assuring that all testing conforms to legal requirements.

Hopefully, your team will be multiskilled, comprising a variety of professionals from both healthcare (nurses, physicians, clinical laboratorians) and from other disciplines too (such as information technology, administration, and others). This will provide a unique opportunity to approach POCT subjects from several inspiring points of view.

In that context, clinical laboratory professionals will have a vital role in POCT team education and training by providing well-structured and easily understandable documentation and instructions for using POCT devices. This kind of education is necessary because there is a general lack of laboratory specific education for healthcare professionals, as well as a false assumption of “simplicity” of POCT devices, and an incorrect, general belief that whatever value obtained from a measuring system is true. So, laboratory professionals must publish clear, visual, and easy to read operating instructions. These must be available at the POCT site, allowing others to use POCT devices safely, with the highest quality throughout the measuring process, which will ensure reliable results, avoid errors and help protect patient safety.

Clearly, the participation of laboratory professionals in selecting and evaluating POCT devices will help to ensure that hardware is fit for purpose. Importantly, device evaluation must be to Clinical and Laboratory Standards Institute (CLSI) guidelines – this is mandatory, and so is observing global quality assurance regulations such as ISO9001, ISO15189, ISO22870 or any others (CAP, Joint Commission, etc). Finally, a well-structured quality assessment system is essential to enable continuous improvement and to contribute to patient safety.

By following the above and applying global quality standards here in Barcelona, we’re achieving great things with POCT – and those are the same standards we’ve always used as laboratory medicine professionals.