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.     

Quality in point-of-care testing: taking POC to the next level

Point-of-care testing (POCT) is a complex system with many opportunities for error. Delivering quality POCT requires multidisciplinary coordination and an understanding of the preanalytic, analytic, and postanalytic processes that are necessary to deliver a test result and take clinical action. Most errors in laboratory testing occur in the pre and postanalytical phases and many mistakes that are referred to as lab error are actually due to poor communication, actions by others involved in the testing process, or poorly designed processes outside the laboratory's control. POCT requires significant operator interaction with analysis and documentation of calibration and quality control, unlike other medical devices. Clinicians often interpret POCT as equivalent to core laboratory testing, only faster, and mistakenly utilize the results interchangeably despite the differences in test methodologies. Taking quality of POCT to the next level involves looking beyond the analytical phase and integration of POCT into the entire pathway of patient care to understand how POCT relates to medical decision-making at specific points during the patient's care. A systematic review of the literature by the National Academy of Clinical Biochemistry is currently being conducted to draft guidelines for best practice that link the use of POCT to improved patient outcomes.Presented at the 10th Conference Quality in the Spotlight, March 2005, Antwerp, Belgium.     

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.     

重组酶聚合酶扩增:扩增原理及性能分析

脱氧核糖核酸(DNA)放大技术对于核酸检测(NAT)至关重要. 聚合酶链式反应(PCR)虽然是核酸检测的基准扩增技术, 但其主要适用于条件较好的中心实验室. 重组酶聚合酶扩增(RPA)是一种非常有潜力的等温扩增技术, 对仪器设备依赖性小, 适用于资源贫乏地区. 因此, 该技术在核酸检测时不受实验场所限制, 非常适合即时检测(POCT). 作为一种正在快速发展的扩增技术, RPA也存在阻碍其进一步发展的缺陷. 本文对RPA的扩增原理和扩增性能进行了总结, 重点讨论了对扩增性能至关重要的引物重组和ATP动态平衡调控过程, 并概述了RPA存在的缺陷和潜在的解决方向.     

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     

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.     

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.     

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.     

Implementation of ISO 9001 in a medical testing laboratory

 The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales, Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services, it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper describes the Quality System that the Department developed and which has been successfully maintained and extended since original certification. Important features of the Quality System are: 1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements. 2. Use of national Quality Award criteria to identify key business processes. 3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective action procedures. 4. Implementation without external resources. Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process. However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible when this process is undertaken at the level of the entire organisation. Received: 9 September 1996 Accepted: 5 October 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.     

Keeping the spotlight on quality from a distance

 Maintaining the quality of testing in remote locations can be demanding of laboratory resources in terms of daily visits to instruments and providing support outside of normal working hours. Recently technology and software solutions have appeared to reduce this burden for laboratory scientists dramatically. The AVL Auto QC unit, in conjunction with OMNILink software, allow laboratory staff to perform many quality control and maintenance procedures on instruments in wards and medical units from a PC in the central laboratory. Assessment of this technology and software in the Special Baby Care Unit at Bradford Royal Infirmary has demonstrated many benefits including reduction in ward visits, better support out of hours, regular quality control checks, and improved analytical quality. Received: 15 April 2000 · Accepted: 15 April 2000     

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 assurance in the view of a commercial analytical laboratory

 The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses. This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation, can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must be demanded of all laboratories. Received: 4 October 1996 Accepted: 15 January 1997     

The European way to go: Virtual Central Laboratory

In clinical pharmaceutical trials often one central laboratory is used for the analysis of routine parameters, the so-called safety parameters. In many countries the heads of laboratory departments question the quality of such analysis in terms of quality of samples after transport, continuity of patient related medical laboratory information before, during and after the trial; turn around time; alerting procedures and consultancy to requesting physicians. On the other hand, the pharmaceutical industry prefers to work with central laboratories since they can claim certification or accreditation. Also the use of one set of reference values is an important issue, as well as electronic data transfer to the trial organizer's database. The concept of a Virtual Central Laboratory (VCL), initiated in the Netherlands, tries to solve this conflicting situation. In the concept, local hospital laboratories receive computer-assisted aid in the identification of patients, trials, visits and requests. The laboratory data are transformed using calibrator sets to produce a homogeneous data set across laboratories, resulting in one set of reference values. The data are electronically transferred to a central computer from which they are send in any desired format to the trial organizer's database. Participating laboratories are obliged to work towards accreditation. The VCL acts as a central counterpart for both the pharmaceutical industry and local laboratories. The concept offers advantages to the pharmaceutical industry, the investigator and local laboratories.     

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.     

The Virtual Central Laboratory approach for the retrieval and management of clinical laboratory data for clinical studies

In 1996, the Virtual Central Laboratory (VCL) concept was presented at the 2nd Conference on Quality [R]evolution in Clinical Laboratories: participating laboratories measure calibrators. The outcome of these measurements is used to calculate conversion factors. The obtained factors are subsequently applied to standardize the results of a number of routine chemistry parameters. This conversion method is now part of a quality system to collect clinical laboratory data in accordance with the Good Clinical Practice guidelines on patients participating in clinical trials organized by the pharmaceutical industry. This approach eliminates the need for centralized laboratory services. Presently over 300 laboratories participate in a number of pan-European clinical trials where the VCL is applied. In this paper our experiences over the last 2?years will be discussed.     

QUASIMEME results of laboratories involved in the German Marine Monitoring Programme for the North and Baltic Seas

This case study is written for laboratories in the German Marine Monitoring Program (GMMP) for the North and Baltic Seas in order to give support to the assessment of proficiency testing results for their external quality assurance. A second issue is to provide a practical, understandable and common way for the calculation of laboratory performance parameters, so-called combination scores. In this paper, the GMMP laboratory proficiency testing results of QUASIMEME (Quality Assurance of Information for Marine Environmental Monitoring in Europe) Laboratory Performance Studies for the last 5 years were reviewed. Combination scores for organochlorine pesticides and chlorinated biphenyls in marine sediment are presented and explained. However, the assessment approach is very general and should be applicable to most testing laboratories in the chemical field.Presented at the Eurachem PT Workshop September 2005, Portorož, Slovenia     

Proficiency testing and external quality assurance: crossing borders and disciplines

Proficiency testing and external quality assurance of medical laboratories is now entering its sixth decade. These activities comprise a broad range of applications including: providing participants and public health authorities with estimates of measurement uncertainty and national infrastructure; providing education; provision of a practical basis for accreditation and regulatory compliance. All branches of medical laboratory science have employed external quality assurance as a basis for improvement and comparability. The opportunities and challenges reviewed here include: the proper establishment of multiple target values in comparison to a system of traceability to reference or definitive methods; the problems of matrix effects and commutability of patient and proficiency test samples; generating information on laboratory infrastructure and trends in analytical technique and performance; providing education and setting goals for laboratory improvement; problems of specimen distribution; application of Internet technology; the role of programs in legal mandates and accreditation. Received: 24 April 2002 Accepted: 11 July 2002     

Introduction for the special issue on the Antwerp Conferences

Quality management of laboratory medicine has become a hot topic at many conferences. Also, many national and international organizations have created working groups and committees with the task of working out standards, guidelines or recommendations for quality management of medical laboratories. We have observed that there is a great deal of interest not only from professional and scientific organizations directly involved in medical laboratory tests, but also from accreditation and certification bodies, from test laboratories in general, from in vitro diagnostic devices (IVD) manufacturers and their associations, and from other medical laboratory suppliers. However, we found that all these parties were discussing from their own point of view, without taking into account the position of other involved partners and that there was a need for creating a discussion forum for quality management in clinical laboratories. So in 1995, we started the Antwerp conferences on quality (r)evolution in clinical laboratories. The aim was to bring together all concerned partners and to establish a forum for brainstorming, independently of any pressure group. The leitmotif for the Antwerp conferences (Fig. 1) is a chain model showing the interfaces and relationships between all the partners involved in laboratory tests. During the conferences, this chain model has been examined from different angles and a summary of the concepts evolving from the discussions can be found in the conference abstracts and conference review reports in this journal. A Selection of ideas emerging from these conferences are presented below. Received: 5 October 1998 · Accepted: 20 October 1998