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• W2009581753 abstract "The development of the first portable blood glucose monitors introduced an epoch-making new concept into clinical medicine.1Portable blood glucose monitors.Health Devices. 1992; 21: 41-78PubMed Google Scholar The ability to measure laboratory variables in acute situations near the patient was an appealing way to improve clinical efficiency and patient care. A new trend began, reversing an earlier tendency towards centralization that had begun in hospitals during the 1960s in the course of modernization, rationalization, and the introduction of automation processes.2Kost GJ Guidelines for point-of-care testing: improving patient outcomes.Am J Clin Pathol. 1995; 104: 111-127Crossref PubMed Google Scholar This fundamental shift in diagnostic testing was accompanied by significant advances in technology, with miniaturization of analysers and a remarkable increase in the numbers of different diagnostic and analytic tests available.3Kricka LJ Extra-laboratory immunoassays: technology for rapid analysis of tests ranging from drugs to infectious diseases.Clin Biochem. 1993; 26: 11-13Crossref PubMed Scopus (5) Google Scholar Near-patient testing, ancillary testing, bedside testing, alternative-site testing, decentralized testing, out-of-laboratory testing, and most commonly point-of-care testing, are synonymous terms meaning that analytical testing of patient specimens can be performed at or near the location of patient care.4Kost GJ Ihrmeyer SS Chernow B et al.The laboratory–clinical interface: point-of-care testing.Chest. 1999; 115: 1140-1154Abstract Full Text Full Text PDF PubMed Scopus (112) Google Scholar Near-patient testing does not mean providing a wide variety of laboratory blood tests with small analysers, nor does it mean performing analytic tests in small and decentralized laboratories. It stands for laboratory analysis using an easy-to-operate (point-of-care) device, with rapid availability of the test results, in clinically sensitive areas, carried out by personnel who may or may not have some minimal training and experience in the field of laboratory medicine.5Heinschink A Mueller MM Point-of-care testing.J Lab Med. 2002; 26: 61-67Google Scholar Particularly in critical areas such as intensive care units, operating and recovery rooms, emergency wards, and delivery rooms, near-patient testing has become increasingly important during the past decade, and it is now an indispensable element of everyday clinical routine. However, with the increasing popularity of near-patient testing, there is a risk that such testing may expand in an uncritical and unjustified way. Anaesthetists, intensive care specialists, and emergency ward physicians want rapid results, creating a growing demand for such tests, and the manufacturing industry is steadily increasing the range of analytic tests available.5Heinschink A Mueller MM Point-of-care testing.J Lab Med. 2002; 26: 61-67Google Scholar 6Mueller MM Hackl W Griesmacher A Point-of-care testing in intensive care medicine.Anaesthesist. 1999; 48: 3-8Crossref PubMed Scopus (27) Google Scholar It is therefore not surprising that near-patient testing has become controversial—in addition to differing opinions among clinicians and laboratory staff, there are many questions concerning the advantages, disadvantages, and economic and health-care aspects of near-patient testing that have yet to be resolved. Several professional bodies have evaluated the pros and cons in near-patient testing in order to develop guidelines for implementing and setting up near-patient testing facilities.7Briedigkeit L Müller-Plathe O Schlebusch H Ziems J Patientennahe Laboratoriumsdiagnostik (point-of-care testing), 1: Empfehlungen der Arbeitsgemeinschaft medizinische Laboratoriumsdiagnostik zur Einführung und Qualitätssicherung von Verfahren der patientennahen Laboratoriumsdiagnostik (POCT).DG Klin Chem Mitt. 1998; 29: 129-137Google Scholar, 8Freedman DB Guidelines for implementation of point-of-care testing. International Federation of Clinical Chemistry and Laboratory Medicine, Milan1998Google Scholar, 9Kost GJ Preventing medical error in point of care testing: security, validation, safeguards, connectivity.Arch Pathol Lab Med. 2001; 125: 1307-1315PubMed Google Scholar Analytical results are provided more rapidly and effectively with near-patient testing, with a decreased test turnaround time, which can allow a shorter therapeutic response interval or prompt therapy control. Problems with specimen identification and transportation do not arise with near-patient testing. The analysers require only small amounts of whole-blood samples, utilize ready-to-use reagents, and the operator's level of competence is not important, as a trained laboratory technician is not required. The pre-analytic period is shortened and simplified, as there is no need for specialized specimen preparation, such as centrifugation or the addition of extra reagents. This is of special relevance when unstable metabolites are to be measured. An advantage that is certainly minor, although often mentioned, is the substantially improved convenience for the patient and for the staff performing the test. 6Mueller MM Hackl W Griesmacher A Point-of-care testing in intensive care medicine.Anaesthesist. 1999; 48: 3-8Crossref PubMed Scopus (27) Google Scholar, 7Briedigkeit L Müller-Plathe O Schlebusch H Ziems J Patientennahe Laboratoriumsdiagnostik (point-of-care testing), 1: Empfehlungen der Arbeitsgemeinschaft medizinische Laboratoriumsdiagnostik zur Einführung und Qualitätssicherung von Verfahren der patientennahen Laboratoriumsdiagnostik (POCT).DG Klin Chem Mitt. 1998; 29: 129-137Google Scholar, 8Freedman DB Guidelines for implementation of point-of-care testing. International Federation of Clinical Chemistry and Laboratory Medicine, Milan1998Google Scholar, 9Kost GJ Preventing medical error in point of care testing: security, validation, safeguards, connectivity.Arch Pathol Lab Med. 2001; 125: 1307-1315PubMed Google Scholar 10Mizock BA Point-of-care testing of blood lactate.J Lab Med. 2002; 26: 77-81Google Scholar In particular, laboratory physicians and clinical chemists have criticized the lack of analytical performance and quality control of near-patient testing. There are concerns about the reliability of results obtained by non-laboratory personnel, who are often insufficiently or not at all familiar with the analysers they are using. Essential calibration procedures may not be performed, or may only be carried out rarely and/or inadequately. New tests may be adopted uncritically and in an indiscriminate way. As a result of the different methods used, the comparability of the results is limited. Insufficient documentation of the results and of the operating service are criticisms that affect data processing, data transfer, and the data network, particularly with regard to data connections with the central laboratory. In addition, near-patient testing makes additional time demands on physicians and nurses.6Mueller MM Hackl W Griesmacher A Point-of-care testing in intensive care medicine.Anaesthesist. 1999; 48: 3-8Crossref PubMed Scopus (27) Google Scholar, 7Briedigkeit L Müller-Plathe O Schlebusch H Ziems J Patientennahe Laboratoriumsdiagnostik (point-of-care testing), 1: Empfehlungen der Arbeitsgemeinschaft medizinische Laboratoriumsdiagnostik zur Einführung und Qualitätssicherung von Verfahren der patientennahen Laboratoriumsdiagnostik (POCT).DG Klin Chem Mitt. 1998; 29: 129-137Google Scholar, 8Freedman DB Guidelines for implementation of point-of-care testing. International Federation of Clinical Chemistry and Laboratory Medicine, Milan1998Google Scholar 10Mizock BA Point-of-care testing of blood lactate.J Lab Med. 2002; 26: 77-81Google Scholar, 11Erickson KA Wilding P Evaluation of a novel point-of-care system, the I-STAT portable clinical analyser.Clin Chem. 1993; 39: 283-287PubMed Google Scholar, 12Maclin E Mahoney WC Point-of-care testing technology.J Clin Ligand Assay. 1995; 18: 21-33Google Scholar There are rigorous standards for the quality control of clinical laboratories (mostly based on national standards established by the relevant professional bodies in each country), which have led to improved comparability between analytical results from different laboratories. Comparable standards for whole-blood methods of near-patient testing, limiting the variation in results, have unfortunately not yet been developed in all hospitals.9Kost GJ Preventing medical error in point of care testing: security, validation, safeguards, connectivity.Arch Pathol Lab Med. 2001; 125: 1307-1315PubMed Google Scholar 13Handorf CR Assuring quality in laboratory testing at the point of care.Clin Chim Acta. 1997; 260: 207-216Crossref PubMed Scopus (14) Google Scholar, 14Jansen RTP Blaton V Burnett D et al.Essential criteria for quality systems of medical laboratories.Eur J Clin Chem Clin Biochem. 1997; 35: 121-132PubMed Google Scholar, 15Jansen RTP Blaton V Burnett D et al.Additional essential criteria for quality systems of medical laboratories.Clin Chem Lab Med. 1998; 35: 249-252Google Scholar, 16Plebani M Carraro P Mistakes in a stat laboratory: types and frequency.Clin Chem. 1997; 43: 1348-1351Crossref PubMed Scopus (433) Google Scholar In some countries, it is a legal requirement that the quality control of near-patient testing is performed by skilled personnel from the central laboratory. Consultation with the head of the laboratory department in each hospital is therefore mandatory before introduction of near-patient testing into clinical practice. In this issue of the British Journal of Anaesthesia, Johi, Cross and Hansbro17Johi RR Cross MH Hansbro SD Near-patient testing for coaggulopathy after cardiac surgery.Br J Anaesth. 2003; 90: 499-501Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar present a paper investigating near-patient testing in cardiac surgery. They measured prothrombin time and activated partial thromboplastin time (APTT) in the pre-bypass and post-bypass phase with a near-patient testing device and compared the results with those obtained from a conventional laboratory using established methods. In the post-bypass period, the differences in the results for the measurement of APTT are alarming. Near-patient testing comes with a price tag. The costs of numerous analysers that need to be provided in different critical areas, and the expense of reagents, sample tubes, specimen containers, calibration fluids, and all the materials needed to operate the devices are additional to central laboratory expenses, and they are immense. Implementation of near-patient testing devices for certain laboratory variables often does not entirely replace their measurement in the central laboratory, and therefore does not necessarily reduce central laboratory costs. Several studies, have been published with controversial results, that attempt to compare the costs of near-patient testing with those of conventional laboratory testing with regard to the cost–benefit ratio.18Halpern MT Palmer CS Simpson KN et al.The economic and clinical efficiency of point-of-care testing for critically ill patients: a decision-analysis model.Am J Med Qual. 1998; 13: 3-12Crossref PubMed Scopus (29) Google Scholar, 19Kendall JM Bevan G Clancy MJ Point of care testing in the accident and emergency department: a cost analysis and exploration of financial incentives to use the technology within the hospital.J Health Serv Res Policy. 1999; 4: 33-38Crossref PubMed Scopus (12) Google Scholar, 20Hicks JM Haeckel R Price CP Levandrowski K Wu AH Recommendations and opinions for the use of point-of-care testing for hospitals and primary care: summary of a 1999 symposium.Clin Chim Acta. 2001; 303: 1-17Crossref PubMed Scopus (45) Google Scholar The real costs are difficult to determine, as absolute comparisons are extremely difficult to carry out, and there are wide variations in the costs associated with central laboratories and near-patient testing.21Kilgore ML Steindel SJ Smith JA Estimating costs and turnaround times: presenting a user-friendly tool for analysing costs and performance.Clin Lab Manag Rev. 1999; 13: 179-187PubMed Google Scholar The expenses of training staff, and of obtaining supplies and personnel for near-patient testing in comparison with laboratory testing are only a few of the key aspects involved in assessing costs, and different conditions apply in each hospital. In order to effectively assess the cost–benefit ratio of near-patient testing, each hospital therefore has to evaluate it in its own unique circumstances.22Foster K Despotis G Scott MG Point-of-care testing: cost issues and impact on hospital operations.Clin Lab Med. 2001; 21: 269-284Abstract Full Text PDF PubMed Google Scholar There is universal agreement that near-patient testing can be a prerequisite for early recognition of life-threatening conditions, and for early therapeutic intervention and effective short-term therapy control. If this genuinely results in a significant improvement in patient care, reduced length of stay in an intensive care unit and/or hospital, decreased blood product usage, and reduced morbidity and/or mortality, then the benefits of near-patient testing will far outweigh the costs and will justify its use.18Halpern MT Palmer CS Simpson KN et al.The economic and clinical efficiency of point-of-care testing for critically ill patients: a decision-analysis model.Am J Med Qual. 1998; 13: 3-12Crossref PubMed Scopus (29) Google Scholar 19Kendall JM Bevan G Clancy MJ Point of care testing in the accident and emergency department: a cost analysis and exploration of financial incentives to use the technology within the hospital.J Health Serv Res Policy. 1999; 4: 33-38Crossref PubMed Scopus (12) Google Scholar 22Foster K Despotis G Scott MG Point-of-care testing: cost issues and impact on hospital operations.Clin Lab Med. 2001; 21: 269-284Abstract Full Text PDF PubMed Google Scholar 23Tsai WW Nash DB Seamonds B Weir GJ Point-of-care versus central laboratory testing: an economic analysis in an academic medical centre.Jt Comm J Qual Improv. 1997; 23: 362-380PubMed Google Scholar In a study of patients who underwent coronary revascularization, near-patient testing was beneficial in the early detection of bleeding and anaemia. This clinical benefit was clearly associated with positive economic effects.18Halpern MT Palmer CS Simpson KN et al.The economic and clinical efficiency of point-of-care testing for critically ill patients: a decision-analysis model.Am J Med Qual. 1998; 13: 3-12Crossref PubMed Scopus (29) Google Scholar However, in a controlled and randomized investigation of 1728 patients in an emergency department, Kendall and co-workers found that, although near-patient testing resulted in reduced turnaround times and earlier therapeutic interventions, it did not lead either to differences in the length of stay in the emergency department and hospital, or to a reduced mortality rate. The authors concluded that the often-cited advantages of the reduced turnaround time provided by near-patient testing did not significantly affect the relevant variables.24Kendall J Reeves B Clancy M Point-of-care testing: randomised controlled trial of clinical outcome.Br Med J. 1998; 316: 1052-1057Crossref PubMed Scopus (160) Google Scholar Similar results were obtained by Parvin and co-workers.25Parvin CA Lo SF Deuser SM Weaver LG Lewis LM Scott MG Impact of point-of-care testing on patients length of stay in a large emergency department.Clin Chem. 1996; 42: 711-717PubMed Google Scholar Another investigation by Kilgore and colleagues, provided evidence that near-patient testing may result in reduced acceptance and satisfaction among employees. Small satellite laboratories were found to be preferable, but employee satisfaction with near-patient testing was still greater than satisfaction with the central laboratory.26Kilgore ML Steindel SJ Smith JA Evaluating stat testing options in an academic health centre: therapeutic turnaround time and staff satisfaction.Clin Chem. 1998; 44: 1597-1603PubMed Google Scholar There is no doubt that near-patient testing may in many respects be an advantageous tool in modern medicine. It is essential that clinicians and laboratory staff work closely together and establish arrangements that can bring the accuracy of near-patient devices close to that of laboratory methods, as has been demonstrated for the measurement of blood glucose.6Mueller MM Hackl W Griesmacher A Point-of-care testing in intensive care medicine.Anaesthesist. 1999; 48: 3-8Crossref PubMed Scopus (27) Google Scholar 1. At present, near-patient testing is not a replacement for conventional laboratory services, but rather a supplement to it." @default.
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