Point-of-care testing: Implementation and practice of cost-effective total quality management

In the United States of America, point-of-care testing (POCT) generally is defined as laboratory testing performed at or near the patient. The objective is to have results immediately available to clinicians for timely medical intervention. The widespread use of POCT is, in part, a response to advances in technology and increased patient acuity. Theoretically, in the context of the entire health care system, POCT improves "quality" by promoting cost through quicker diagnosis and treatment, which in turn leads to faster recovery, reduced length of stay, more efficient clinicians, and overall better utilization of resources. Total quality management (TQM) generally is associated with improving processes and, therefore in this context, improving patient outcomes. The TQM philosophy focuses on creating products or services, which meet or exceed customer expectations. The successful implementation of POCT in a manner consistent with TQM principles requires assessment of direct, measurable benefits including cost-effectiveness to the health care system.     

Quality and timeliness in medical laboratory testing

In terms of testing, modern laboratory medicine can be divided into centralized testing in central laboratories and point-of-care testing (POCT). Centralized laboratory medicine offers high-quality results, as guaranteed by the use of quality management programs and the excellence of the staff. POCT is performed by clinical staff, and so such testing has moved back closer to the patient. POCT has the advantage of shortening the turnaround time, which potentially benefits the patient. However, the clinical laboratory testing expertise of clinical staff is limited. Consequently, when deciding which components of laboratory testing must be conducted in central laboratories and which components as POCT (in relation to quality and timeliness), it will be medical necessity, medical utility, technological capabilities and costs that will have to be ascertained. Provided adequate quality can be guaranteed, POCT is preferable, considering its timeliness, when testing vital parameters. It is also preferred when the central laboratory cannot guarantee the delivery of results of short turn-around-time (STAT) markers within 60 or (even better) 30 min. POCT should not replace centralized medical laboratory testing in general, but it should be used in cases where positive effects on patient care have been clearly demonstrated.     

A quality systems approach for identifying and controlling sources of error with point of care testing devices

Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error” matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of care. Received: 26 June, 2002 Accepted: 17 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations NCCLS National Committee for Clinical Laboratory Standards (formerly) · POCT point of care testing · QC quality control · HACCP hazard analysis critical control points · CLIA clinical laboratory improvement amendments (of 1988) Correspondence to S. S. Ehrmeyer     

Point-of-care testing (POCT): Current techniques and future perspectives

Point-of-care testing (POCT) is a laboratory-medicine discipline that is evolving rapidly in analytical scope and clinical application. In this review, we first describe the state of the art of medical-laboratory tests that can be performed near the patient. At present, POCT ranges from basic blood-glucose measurement to complex viscoelastic coagulation assays. POCT shortens the time to clinical decision-making about additional testing or therapy, as delays are no longer caused by transport and preparation of clinical samples, and biochemical-test results are rapidly available at the point of care. Improved medical outcome and lower costs may ensue.Recent, evolving technological advances enable the development of novel POCT instruments. We review the underlying analytical techniques. If new instruments are not yet in practical use, it is often hard to decide whether the underlying analytical principle has real advantage over former methods. However, future utilization of POCT also depends on health-care trends and new areas of application. But, even today, it can be assumed that, for certain applications, near-patient testing is a useful complement to conventional laboratory analyses.     

Implementation of an integrated glucose POCT system

In response to a change of the Belgian National Directives whereby hospital laboratories became responsible for all point-of-care testing (POCT) performed within hospital walls a standardized and automated POC glucose-testing system was implemented in our hospital. The system consists of 50 AccuCheck Inform instruments (Roche Diagnostics, Vilvoorde, Belgium), 50 docking stations, a DataCare Server, and connections to the medical laboratory information system (MOLIS, Sysmex, Barchon, Belgium) and to the hospital information system. Implementation involved many parties and extensive preparation and communication. Key issues were bar-coded patient and user identification, training, and responsibilities. One year after the hospital wide implementation of this system the quality of POC glucose testing has significantly increased, thereby improving patient safety. This study describes a stepwise change over involving the medical laboratory and with a focus on hands-on quality.Presented at the ninth conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.     

Regulatory compliance vs. NEXUS quality for laboratory tests

In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA) (). The CLIA link test quality and adherence to a body of testing regulations intended to ensure accurate, reliable, and timely patient test results. The goal of the CLIA legislation was to ensure a minimum, fundamental level of quality. In the context of “NEXUS,” quality must “go beyond getting the ‘right’ answer on the ‘right’ patient that can be interpreted against ‘right’ reference values. CLIA regulations with specific minimum, performance requirements, or safeguards, are designed to prevent testing errors. The US Institute of Medicine found that testing processes fail as a result of human error, lack of documentation, and lack of test management. In the latest (2004) interpretations of CLIA regulations, the minimum quality control requirement continues to be analyzing at least two external, liquid quality control materials per test per day. In 1995, we proposed that the responsibility for achieving quality test results shifts from the sole purview of the laboratory director to an “alliance” of laboratory professionals, manufacturers, and regulators. The EQC (equivalent quality control) concept as proposed is a positive step in achieving this alliance. With the obvious lack of scientific and statistical robustness, EQC falls far short of ensuring quality. Achieving the “NEXUS Vision” for quality laboratory testing will not come solely from laboratory professionals. The NEXUS is about how to ensure the full-quality assessment of the testing process – pre-analytical, analytical, and post-analytical.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium.     

Quality targets in dipstick urinalysis

Point of care testing (POCT) of urine has been practiced for many centuries. It has come particularly into its own in the second half of the 20th century with the development of tablet- and later dipstick-testing systems. Unfortunately, it has become embedded in clinical practice outside the laboratory, missing the development of the quality culture that has developed inside the laboratory. Analysis of the results of a Urine Quality Assurance Programme demonstrate the value and the need for this quality culture.     

Quality through the pharmaceutical chain of care

Many medical professionals are involved in patient care processes. For pharmaceutical care this results in many information transfer moments. To provide optimal care, communication and information the transfer should be conducted in a timely manner, fully transparent, complete and relevant. The TRANSFORM project is directed towards the development of a reference information model of the pharmaceutical care chain with the aim to improve the availability (time, place, completeness) and access of pharmaceutical information regarding patients, thereby resulting in continuity and quality of pharmaceutical care, reduction in medical errors and improvement in patient safety through the design of a safer healthcare system. TRANSFORM leads to improved insight into the processes and data transfer points in the pharmaceutical chain of care. Focussed on laboratory medicine and pharmacy, the implementation of the integration of laboratory test and pharmacy information may result in major improvements in drug therapy monitoring and guidance (i.e. drug impact monitoring). Because of the overwhelming amount of data generated by this integration of drugs, drug effects and laboratory test results, an online decision support system is warranted.Presented at the 9th Conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.The following paper may appear at first sight not to be specifically within the realm of ACQUAL. It has been accepted for publication anyway as it is about reliable handling of data, incl. measurement results, which lead to important decisions (in this case related to a patient). The reliability of handling (a large amount of) measurement results towards a basis for important decisions, is a very important feature of the use of such results.Paul De Bièvre, Editor in Chief     

Point-of-care testing of proteins

Point-of-care testing (POCT) is a fast developing area in clinical diagnostics that is considered to be one of the main driving forces for the future in vitro diagnostic market. POCT means decentralized testing at the site of patient care. The most important POCT devices are handheld blood glucose sensors. In some of these sensors, after the application of less than 1 μl whole blood, the results are displayed in less than 10 s. For protein determination, the most commonly used devices are based on lateral flow technology. Although these devices are convenient to use, the results are often only qualitative or semiquantitative. The review will illuminate some of the current methods employed in POCT for proteins and will discuss the outlook for techniques (e.g., electrochemical immunosensors) that could have a great impact on future POCT of proteins.     

Cardiac markers: a clear cause for point-of-care testing

Point-of-care testing (POCT) in patients with ischemic heart disease is driven by the time-critical need for fast, specific, and accurate results to initiate therapy instantly. According to current guidelines, the results of the cardiac marker testing should be available to the physician within 30 min (“vein-to-brain” time) to initiate therapy within 60–90 min (“door-to-needle” time) after the patient has arrived at the emergency room or intensive care unit. This article reviews the current efforts to meet this goal (1) by implementing POCT of established biochemical markers such as cardiac troponins, creatine kinase MB, and myoglobin, in accelerated diagnosis and management workflow schemes, (2) by improving current POCT methods to obtain more accurate, more specific, and even faster tests through the integration of optical and electrochemical sensor technology, and (3) by identifying new markers for the very early and sensitive detection of myocardial ischemia and necrosis. Furthermore, the specific requirements for cardiac POCT in regard to analytical performance, comparability, and diagnostic sensitivity/specificity are discussed. For the future, the integration of new immunooptical and electrochemical chip technology might speed up diagnosis even further. However, every new development will have to meet the stringent method validation criteria set for corresponding central laboratory testing.     

Nucleic Acid Integrated Technologies for Electrochemical Point-of-Care Diagnostics: A Comprehensive Review

The need for routine and immediate healthcare monitoring has inspired “near-patient testing” or in other words “point-of-care testing (POCT)”. Therefore, POCT can be defined as laboratory tests that are performed at the patient's bedside or in the immediate vicinity of the incident. Among many POCTs, nucleic acid-based testing has attracted enormous attention for the diagnosis of important genetic, inherited and infectious diseases such as cancer and coronavirus. In this review, we outline the integration of nucleic acids into the remarkable electrochemical point-of-care diagnostics including microfluidic, paper and smartphone-based approaches, CRISPR/Cas and liquid biopsy related systems and DNA damage monitoring.     

Post-analytical ’error’ rates in point-of-care testing: use of a quality assurance programme

Laboratory tests are subject to error, pre-analytical, analytical and post-analytical. Post-analytical error includes misinterpretation of results. Point-of-care testing (POCT) can be subject to the same errors This study utilized an external quality assurance programme for capillary blood glucose and ’dipstick’ urinalysis to investigate post-analytical errors of result interpretation by various grades of nurse performing POCT. When the results simulated a hypoglycaemic patient, 84.1% of nurses interpreted the results correctly. In the case of diabetes mellitus, 95.7% of nurses interpreted the results correctly. Whereas in the simulation of a case where the capillary blood glucose was falsely raised due to puncture site contamination only 5.4% of nurses interpreted the POCT results correctly. As the seniority of the nurse made little or no difference to the interpretation given, this study demonstrated the need for improved training within the Taunton and Somerset NHS Trust Hospital.     

The current status and future of medical laboratory quality regulation and accreditation in Ghana

High-quality and reliable laboratory services are important components of effective and well-functioning health systems. Accurate, reliable and timely medical laboratory testing is crucial to patient care and disease surveillance. Unfortunately, in many sub-Saharan African countries, medical laboratory systems are adversely affected by the unavailability of medical laboratories, poor laboratory infrastructure and lack of well-trained personnel [1]. Quality in the laboratory is only achieved in a systematic way through the implementation of a quality management system. The results of the study showed that approximately 60?% of the 78 respondents were unaware of the requirements of ISO 15189:2007. A trial of proficiency testing, termed ??blind proficiency testing??, was carried out in which 19 laboratories determined the concentrations of urea and cholesterol in a proficiency testing material. Of the 19 laboratories that determined the concentration of urea, 63?% produced satisfactory results with scores between ?2 and +2. Similarly, 63?% of the participating laboratories obtained satisfactory z scores for cholesterol determination. Some of the laboratories that obtained satisfactory scores for urea determination had unsatisfactory scores for cholesterol determination and vice versa. It is recommended that the Ghanaian government pass a law and establish a standard to regulate medical laboratories in Ghana in order to improve quality in a significant way.     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998     

Is it safe to have a laboratory test?

A recent US Institute of Medicine report indicated that up to 98,000 deaths and more than 1 million injuries occur each year in the United States due to medical errors. These include diagnostic errors, such as an error or delay in diagnosis, failure to employ indicated tests and the use of outmoded tests. Laboratory tests provide up to 80% of the information used by physicians to make important medical decisions, therefore it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. A review of the literature and a US Quality Institute Conference in 2003 indicates that errors in laboratory medicine occur most often in the pre-analytical and post-analytical steps in the testing process, but most of the quality improvement efforts focus on improving the analytical process. Measures must be developed and employed to reduce the potential for mistakes in laboratory medicine, including better indicators for the quality of laboratory service. Users of laboratory services must be linked with the laboratorys information system to assist them with decisions about test ordering, patient preparation, and test interpretation. Quality assessment efforts need to be expanded beyond external quality assessment programs to encompass the detection of non-analytical mistakes and improving communication between the users of and providers of laboratory services. The actual number of mistakes in laboratory testing is not fully recognized, because no widespread process is in place to either determine how often mistakes occur or to systematically eliminate sources of error. We also tend to focus on mistakes that result in adverse events, not the near misses that cause no observable harm. The users of laboratory services must become aware of where testing mistakes can occur and actively participate in designing processes to prevent mistakes. Most importantly, healthcare institutions need to adopt a culture of safety, which is implemented at all levels of the organization. This includes establishing closer links between providers of laboratory services and others in the healthcare delivery system. This was the theme of a 2003 Quality Institute Conference aimed at making the laboratory a key partner in patient safety. Plans to create a permanent public–private partnership, called the Institute for Quality in Laboratory Medicine, whose mission is to promote improvements in the use of laboratory tests and laboratory services are underway.Presented at the 9th Conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.     

Can the progress in quality management tools for POC tame the fiends from Pandora's box?

POCT provides the opportunity to significantly improve the overall quality of blood testing in an organization. The design of the product, the redesign of the testing process and the tools used to manage a completely distributed testing process, are key to the quality implementation of POCT. Both theoretical considerations and practical outcomes are discussed in this paper, using the i-STAT^® System as an example of a POCT system.     

A review of autovalidation software in laboratory medicine

Although autovalidation procedures have been around for many years, through the use of computers and the application of (medical) protocols, they are now becoming part of the production environment of medical laboratories. The introduction of high volume instruments within routine medical laboratory testing certainly speeded up their application as well. After defining autovalidation, autoverification and autoconfirmation, this paper provides a framework for the different ways and places where these tools can be applied within laboratory medicine. Technology as well as organization are essential building blocks to reach well-defined, transparent and assured quality. A laboratory automation system (LAS) brings both areas together in a logical, future-oriented way. Strengthening the information loop, reaching guaranteed quality (analytical, turnaround times and efficiency), leads towards strict management of the laboratory processes. This includes all laboratory processes and here autovalidation and autoreporting become essential. A survey of currently available software routines and their appraisal from a managerial viewpoint are given. It can be concluded that autovalidation software in laboratory medicine is maturing and is rapidly becoming a critical success factor in any medical laboratory. Quality can be automated for sure and autovalidation software will prove to be a valuable aid to do so. Received: 23 August 2002 Accepted: 26 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium     

Why do food analysts need quality assurance?

 Most sophisticated products require testing for compliance with specifications and safety regulations before release into many markets, and trade in many simpler commodities and products also requires supporting technical information. Test documentation has become an essential element in this trade. Food intended for human consumption certainly falls into the "sophisticated products" category. Lack of acceptance of laboratory test data across national borders may be a significant barrier to trade. In order to avoid such barriers and unnecessary duplication of laboratory tests, mutual recognition of laboratory results should be regarded as an important means of facilitating international trade in food products. It is difficult to envisage recognition of test data across borders without internationally agreed criteria for assessing the competence of testing. These criteria should, as a minimum, require that a laboratory involved in the analysis of foods operates a suitable quality system. The laboratory must create a quality system appropriate to the type, range and volume of work performed. It is necessary for the elements of this system to be documented in a quality manual which is available for use by the laboratory personnel. The quality manual must be kept up-to-date by a person or persons having responsibility for quality assurance within the laboratory. This paper describes and discusses the elements of a quality system in a food laboratory, including suitable quality assurance measures, the use of validated analytical methods and participation in proficiency testing schemes. Received: 24 February 1996 Accepted: 13 March 1996     

Electrochemical Biosensors Based on Micro-fabricated Devices for Point-of-Care Testing: A Review

Point-of-care testing (POCT) is becoming a hot research topic that allows rapid, on-site, and non-professional measurements outside the central laboratory. The micro-fabricated devices prepared by various micro-machining technologies have shown the advantages of low reagent consumption, high-throughput samples, and wearability. This review presents the recent progress of electrochemical biosensors based on various micro-fabricated devices for POCT and the corresponding electrochemical techniques. Signal amplification strategies based on enzyme and nanotechnology are also illustrated for the more sensitive POCT applications of these micro-fabricated devices. Consequently, the trends and challenges of electrochemical biosensors based on micro-fabricated devices in POCT diagnosis are discussed.     

A new quality control method for lateral flow assay

We proposed a lateral flow assay (LFA) based on internal quality control microspheres to realize the accurate diagnosis of HbA1c in human body. This method can improve the precision and accuracy of HbA1c detection.