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.     

Evaluation of the quality of clinical laboratories in the Slovak Republic: conceptual and contextual remarks

The paper demonstrates conceptual parallels and relationships between intellectual capital measurement methods and the evaluation of quality in clinical laboratories in the Slovak Republic. It explores further the contextual links of those parallels with the tangibility (or intangibility) of quality indicators of laboratory diagnostics. It also highlights the problems which laboratory staff in Slovakia are confronted with. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

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     

Joint Commission International accreditation: a laboratory perspective

Joint Commission International accreditation (JCIA) offers the international community a standards-based, objective process for evaluating healthcare organizations. The eleven JCIA standards are functionally organized. The standards are grouped by functions related to the provision of patient care and functions covering the provision of a safe, effective, and well-managed organization. The focus of the JCIA survey process is on the whole organization rather than on individual departments/services. The survey is carried out by trained and experienced healthcare peers. Healthcare organizations worldwide should be encouraged to seek accreditation such as that offered by JCIA. Where affordable, laboratories that are part of larger healthcare organizations should strive to achieve independent laboratory accreditation. The perspective of a laboratory undergoing a JCIA survey is briefly presented. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

The American (USA) perspective six years after implementation of CLIA'88 (Federal) regulations

 On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement (CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process. Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992. Received: 5 October 1998 · Accepted: 20 October 1998     

The attitude of laboratory personnel towards accreditation

 A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload had been increased by the accreditation process but they did not think that the process had improved the quality of their results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather than in a non-accredited one. Received: 5 October 1998 · Accepted: 20 October 1998     

Benchmarking and quality management indicators in three medical laboratories

The aim of this study was to calculate various annual quality management indicators and implement them as a management tool in laboratories. The study was performed in three laboratories over five years, from 2000 to 2004. These laboratories are part of the XHUP (Public Hospital Network in Catalonia). We collected 20 annual items over five years and calculated 20 annual indicators. The Laboratory Manual Index Program from the College of American Pathologists was used as a reference. We also compared an analytical quality indicator versus productivity and calculated annual budget laboratory deviation. The information obtained from these indicators provides laboratories with a useful benchmarking tool to determine the results of management change and understand the real situation in laboratories. We found a lack of standardisation in management data. A future area of work could involve unifying some of the different characteristics. Presented at the Conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

Practical experience of simultaneous accreditation and certification acquired in RIVM's official medicines control laboratories

 This article presents an overview of the practical experience acquired in two governmental medicines control laboratories in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer requirements. Received: 1 October 1998 · Accepted: 21 December 1998     

The process of management review

Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000 standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness, and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources, etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are taken that improve the effectiveness of the quality-management system. As output from the management review process, there should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements; corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the processes involved and using the process approach in the management review ensures the continual improvement of the quality system. Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium.     

Symposium overview the Shell Conference on computer-aided molecular modelling

The Shell Conference on ... series began in 1985 and meetings are held approximately twice a year. The idea behind the conferences is to bring together invited scientists from both universities and industry, and representatives from different Shell Research laboratories, to create a forum to discuss the future directions of the chosen research area. These meetings have embraced a wide range of topics of interest to Shell Research as a whole.This particular conference, organised by the Analytical Department of the Koninklijke/ShellLaboratorium, Amsterdam (KSLA), was held on 4–6 October, 1987 at Hoenderloo in the Netherlands. The aim was to review the state-of-the-art and to discuss the future of molecular modelling and design. The programme itself consisted of a series of presentations on prescribed topics, panel discussions, and software and hardware demonstrations. Many of the presentations given consisted of overviews, experiences, advice and predictions for the future. The panel sessions, which involved the speakers within that session and a discussion leader who summarised some of the points made in an introduction, encouraged even further discussion and speculation. This overview attempts to catch the flavour of the meeting and convey some personal views that were expressed and conclusions drawn.     

Using a learning curve approach to reduce laboratory errors

Hospital laboratories have error rates that are too high and in some cases may be responsible for adverse patient treatment. This paper introduces reliability growth management (RGM), which is based on learning curve theory, as a method to improve laboratory error rates. RGM is widely used in the defense and automotive industry to solve problems when resources are limited and knowledge about the product and/or process is incomplete. An example of RGM, which was used to improve the reliability of instrument assay systems in the medical diagnostics industry is presented. RGM is a closed-loop process that entails creating a goal and event model, classifying events with failure review and corrective action system (FRACAS), tracking progress and predicting completion with Duane analysis. Results achieved by RGM were far better than those obtained by previously used methods. RGM techniques can be transferred to hospital laboratories to reduce laboratory error rates. The advantages of RGM compared to other quality initiatives such as ISO 9000 and Six Sigma are discussed. Received: 3 February 2002 Accepted: 17 July 2002 Acknowledgements The majority of the work of transferring reliability growth management from the defense industry to the medical device industry was performed by Keith K. McLain, while he was at Ciba Corning Diagnostics. Keith is now at Ortho-Clinical Diagnostics (email: KMcLain@ocdus.jnj.com). Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations  RGM Reliability growth management · FRACAS failure review and corrective action system · CAP College of American Pathologists · LIS laboratory information system · HIS hospital information system Correspondence to Jan Krouwer     

Metrology in laboratory medicine – Reference measurement systems

 The medical laboratory must provide results of measurements that are comparable over space and time in order to aid medical diagnosis and therapy. Thus, metrological traceability, preferably to the SI, is necessary. The task is formidable due to the many disciplines involved, the high production rate, short request-to-report time, small sample volumes, microheterogeneity of many analytes, and complex matrices. The prerequisite reference measurement systems include definition of measurand, unit of measurement (when applicable), consecutive levels of measurement procedures and calibrators in a calibration hierarchy, international organizations, reference measurement laboratories, dedicated manufacturers, written standards and guides for the medical laboratory, production of reference materials, internal and external quality control schemes, and increasingly accreditation. The present availability of reference measurement procedures and primary calibrators is shown to be insufficient to obtain international comparability of all types of quantity in laboratory medicine. Received: 19 April 2000 / Accepted: 3 July 2000     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Biological variation data are necessary prerequisites for objective autoverification of clinical laboratory data

The wealth of quantitative data on random biological variation has been used for setting quality specifications, assessing the utility of conventional reference values, and deciding of the significance of changes in serial laboratory results. Most analytes have marked individuality and this makes conventional population-based reference values of low utility. In consequence, reference limits are not ideal for autoverification strategies. Clinical decision limits may be better criteria for holding results for verification by laboratory professionals. Changes in serial results are significant only when the reference change value is exceeded. Such values can be generated by all laboratories and can be implemented, not only to flag reports, but also in delta checking and autoverification since these are objective rather than empirical. We have put these considerations into operation into our laboratory. Apart from special cases, our general approach is that results flagged as having changed 0.05<P<0.01, flagged as just outside the reference limits, or not flagged in any way, are autoverified and reported to the user without intervention. Only results outside pre-set clinical limits and those that have changed highly significantly P<0.01 are held for verification by clinical scientists and medical staff. This strategy allows autoverification of ca. 60% of reports. Received: 15 May 2002 Accepted: 17 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to C. G. Fraser     

Getting the most from your laboratory information system in the hematology laboratory

As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS). Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s dynamic health care must continue to implement new and innovative approaches with their LISs. Received: 26 July 2002 Accepted: 6 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium     

From a single analyzer to multiple instruments—The GUM approach

Assessment and expression of analytical quality have become novel spotlights in medical laboratories since accreditation began in the early 1990s, in Europe. Evaluation of uncertainty of measurement by definition was launched in Finland when the Finnish Accreditation Service (FINAS) accredited the first medical laboratories in the mid 1990s. In spite of all the analytical and statistical knowledge which has been available in medical laboratories for years, evaluation of total uncertainty of measurement has not yet caught on. The concept is still unfamiliar to experts and, indeed, little guidance has been available. National and international activities, with good results, can be shown when the educational aspect is considered. The Guide to the Expression of Uncertainty in Measurement (GUM) remains the main document for uncertainty evaluation. Uncertainty of measurement together with target value of uncertainty can be used as a good measure for analytical quality in large or smaller laboratories over time, because it is a quantitative indication and the evaluation is easy to repeat as running practical tools are available.Presented at the 8th Conference on Quality in the Spotlight, 17–18 March 2003, Antwerp, Belgium     

The College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves. Received: 8 August 2002 Accepted: 10 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to A. Rabinovitch     

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     

The impact of LIMS design and functionality on laboratory quality achievements

 A laboratory information management system (LIMS) can make a major contribution to the quality and therefore to the efficiency and competitiveness of a laboratory. Since it can impact all aspects of a laboratory's organization it must be the key if not the principal player of the laboratory's quality system. It should support the laboratory in establishing, maintaining and applying quality procedures thereby enabling the laboratory to achieve its quality goals. As a tool, LIMS permits the laboratory to input and use its own know-how and experience to optimize the total organization (internal and external) and workflow of generated information. However, perceived "quality" in the context of an LIMS, can be viewed as being made up of different facets such as the security, reliability and accessibility of information as well as its turn around time and production cost. This paper reviews the role of a LIMS in the laboratory and the contribution that both system design and functionality can have on "building quality ". Received: 5 October 1998 · Accepted: 20 October 1998