Point-of-care testing is a popular means of providing laboratory testing at or near the site of patient care. An extensive literature demonstrates that POCT has the potential to improve patient treatment if undertaken within a comprehensive quality management system. The series of peer-reviewed articles which describe operational aspects of the Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) and the Integrated Cardiovascular Clinical Network (iCCnet) programs attest to this statement.1,2 However, a faster result is not necessarily equivalent to a result obtained from a traditional pathology laboratory and this difference requires a good understanding of the technology involved. In addition, concerns over the quality of POCT have resulted in a hierarchy of laboratory regulations in the USA and other countries, and POCT operational guidelines have been produced by many professional groups in order to maximise patient benefit and minimise testing errors. The International Organisation for Standardisation (ISO) and the Clinical and Laboratory Standards Institute in the USA (CLSI) have produced standards to address many of the perceived operational and technical issues.
Evidence-based medicine has now become the international standard for improving health care. Evaluation of new technologies and clinical procedures should thus be evaluated using an evidence-based medicine approach which includes technical, cost-effective and patient benefit perspectives. At the most elementary level, patients as consumers of health care expect that the quality of care provided be synonymous with freedom from medical error. This includes freedom from errors in laboratory and POC testing. For patient safety to be achieved within the current context (of laboratory and POC testing), quality goals for both analytical and clinical management must be given an appropriate high priority. It has also been stated that the Medical Journal of Australia (MJA) is second only to the British Medical Journal (BMJ) “in publishing the largest number of references indexed under the term evidence-based medicine in English-language journals.” This possibly suggests that Australian medical authors are both knowledgeable and supportive of the concepts of evidence-based medicine.3
The recent (third) edition of the internationally acclaimed text on POCT covers most of the current issues in the POCT debate (Point-of-care testing: Needs, opportunity and innovation Edited by CP Price, A St John and LJ Kricka, AACC Press 2010). Professor Sharon Ehrmeyer in chapter 19 of this text makes an important observation, “Today, most healthcare organisations offer some point-of-care testing (POCT) as a means to improve healthcare delivery. POCT is rather broad in scope and covers any testing that is performed near the patient and outside of the conventional clinical laboratory, whether it is performed in a physician’s office, emergency department, intensive care unit, or an ambulatory care clinic. Although in most countries the highly trained laboratory professionals performing clinical laboratory testing are required to follow extensive government regulations to ensure quality test results, specific testing requirements are not identified for POCT, which is typically performed by individuals without formal laboratory training. In the United States, the federal government mandates minimum standards for all “laboratory” testing, regardless of where it is performed, and exerts control through regulatory policies, public law, and collaboration with professional organisations.” …. “Many countries however, have professional organisations that recommend specific guidelines for POCT that include quality assurance practices and external quality assessment or proficiency testing.”4
The innovation and functionality of POCT brings many challenges for health care funding authorities. In particular, the ability to determine the value which POCT may bring to the patient care process. The penultimate sentence of chapter 1 in Point-of-care testing: Needs, opportunity and innovation, states that: “The four main challenges are, (a) producing the evidence to demonstrate that POCT improves outcomes, (b) changing clinical practice to deliver the benefit, (c) maintaining clinical governance for a more distributed laboratory medicine service, and (d) adjusting the resource allocation to reflect the likely increase in investment in the POCT technology, while recouping the resources from the point in the pathway at which the benefits are made.”5