Confidence in testing services – new expectations, new rules, new challenges. 5th Eurolab Symposium offered important information and stimulating discussions

The 5th Eurolab Symposium on 4th and 5th October in Edinburgh was the highlight event of Eurolab in 2000, Eurolab’s 10th anniversary year. Under the title: ”Confidence in Testing Services – new expectations, new rules, new challenges” it reflected recent changes and developments in the laboratory scene and focussed on new tasks and challenges. The most essential changes for laboratories are connected with the new standard ISO/IEC 17025 ”General requirements for the competence of testing and calibration laboratories”. Keywords in this respect are uncertainty of measurement and traceability to SI units, requirements on personnel, proficiency testing, customer orientation, and management systems.     

Proficiency testing as tool for ISO 17025 implementation in National Public Health Laboratory: a mean for improving efficiency

Public Health Laboratories (PHL) as part of Public Health Services are involved in law enforcement and ensuring food and water quality. The laboratories had to go through an organizational and monetary change imposed by the growing and changing needs of the state of Israel. The laboratories had to become more modern and to implement new and more sophisticated testing methods. Another requirement was to perform a steadily increasing number of tests and to be more flexible towards customers’ demands. Yet, the budget was not changed accordingly, as the Public Service to which the laboratories belong to do not respond to changing needs. Management realization was that the accreditation process could be used as a tool to achieve organizational and cultural change. Understanding and transformation were required throughout the organization, including management. Proficiency testing is performed for all testing methods in all areas even for non-accredited tests such as clinical tests. Proficiency testing was used as a tool for organizational culture change. It is a great index with game elements, that gives employees and managers the possibility for comparison, fixing problems and corrective action. The demands of ISO 17025 made it necessary to change peoples’ attitudes and views on both professional and communication levels. Laboratory quality consists now on the four main principles, described in the 5M&E model which is typical to small organizations and which ensures a constantly improving system: ”Policy statement”, ”Machine”, ”Material”, ”Measurement”, ”Method”, ”Manpower”, and ”Environment” targeted to achieve ”Quality upgrade”. Slowly we succeeded in providing better and more reliable services and have increased our income on what would hopefully become our way to financial independence. We hope this process would provide the Ministry of Health with a better chance to public health using the same financial sources. Received: 25 October 2000 Accepted: 12 December 2000     

Different approaches to legal requirements on validation of test methods for official control of foodstuffs and of veterinary drug residues and element contaminants in the EC

 In order to ensure food consumer protection as well as to avoid barriers to trade and unnecessary duplications of laboratory tests and to gain mutual recognition of results of analyses, the quality of laboratories and test results has to be guaranteed. For this purpose, the EC Council and the Commission have introducedprovisions – on measures for quality assurance for official laboratories concerning the analyses of foodstuffs on the one hand and animals and fresh meat on the other, – on the validation of test methods to obtain results of sufficient accuracy. This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions and requirements have to be revised and further additions have to be made.     

Proficiency testing schemes for therapeutics and toxicology

 This report addresses the proposition: current proficiency testing (PT) schemes for therapeutics and toxicology can easily engender complacency. The proposition was based on the premise that there are substantial between-laboratory differences and objectives in the supply of services for the measurement of drugs, as a result of which it is difficult to design PT schemes which adequately cover the requirements of all laboratories. Thus, acceptable performance in a PT scheme may lead participants to consider that they have tested their procedures more rigorously than is the case. Four areas, validity of the PT scheme, PT material, frequency of testing and acceptance criteria are examined. Received: 15 April 2000 · Accepted: 15 April 2000     

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     

Improvements in performance in medical diagnostics tests documented by interlaboratory comparison programs

There is evidence to support the notion that interlaboratory comparisons (ILCs) are an effective tool for laboratory improvement. However, despite widespread experience and anecdotal evidence of improvements there are few published studies demonstrating any benefits from ILCs– in any field of testing. Published demonstrations of benefits can help justify the growing use of ILCs. ILCs and proficiency testing have been common for many years in medical laboratories; there has been open information on the results of ILCs, and there has been standardization of results from thousands of laboratories. These studies show general improvement over time in several areas of testing in different countries. Many articles cite specific reasons for the improvements, either proven or supposed. An early version of this paper was presented at the International Laboratory Accreditation Cooperation Conference ”ILAC 2000” in Washington D.C., on 31October, 2000. Received: 10 February 2001 Accepted: 21 January 2002     

Hematological health-related intervals estimated using an indirect method in order to satisfy the accreditation standards

 The estimation of reference limits represents quite a taxing task for laboratories which frequently adopt the limits suggested by manufacturers or those reported in the literature. This practice does not meet the requirements of accreditation programs (i.e. Essential Criteria, Clinical Pathology Accreditation) that require laboratories to produce or check all their reference intervals. We collected 15 244 hematological results from females aged 0–99 years obtained by the Rovereto Hospital Laboratory and calculated the reference intervals, or to be more precise the health-related intervals, using an indirect method (based on all the inpatient and outpatient results). All the measurements were carried out using an automatic Coulter STK S analyzer, and the results were transferred to Verona by e-mail. The results for hemoglobin were: <1 year (n=154)=90–171 g/l; 2–8 years (n=619)=104–136 g/l; 9–14 years (n=322)=118–143 g/l; 15–44 years (n=6329)=106–144 g/l; 45–75 years (n=4893)=107–148 g/l; 75–99 years (n=2927)=90–153 g/l. The results appear different from the results currently used by Rovereto Hospital (120–160 g/l) but comparable to those reported in the literature with the exception of the subjects under 1 year and over 75 years, probably due to the excess of "diseased" subjects in these classes. The indirect method allows even small laboratories to produce or check their reference intervals for all age groups, increasing the clinical effectiveness of laboratory results and satisfying the accreditation standards. Received: 15 April 2000 · Accepted: 20 April 2000     

Quality (r)evolution – guidelines and practical implementation of quality management: the U.S. perspective

 All clinical laboratories in the United States were required for the first time in 1992 to comply with universal minimum regulations: the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). The CLIA'88 regulations precipitated revolutionary and evolutionary changes based in both total quality management and continuous quality improvement principles. The regulations specify minimum requirements for personnel, quality control, and proficiency testing. Under quality assurance, the requirements are more individualized and allow laboratories to meet the needs of their customers while being in compliance with the regulations. Biannual inspection is integral to CLIA'88. However, laboratories can choose other federally approved, "deemed" professional organizations, with regulations equivalent to CLIA'88. Selection of one of these organizations allows for some flexibility in the application of the requirements, and eliminates having federal CLIA'88 inspectors perform the inspection. Since CLIA's inception in 1992, inspectors have noted a decline in the number of deficiencies cited. An improved level of proficiency testing performance also indicates that better quality test results are being provided to clinicians. The quality evolution and revolution will continue in the United States, and a major impetus will be health care reform's mandate to reduce cost. Received: 13 December 1995 Accepted: January 1996     

Quality improvement through verbal and written interviews of laboratory employees

 There is a growing awareness of the importance of the human factors involved in total quality management. Tools to monitor and improve the knowledge and skills of all those involved in production processes in medical laboratories are recognized and applied. The effect of providing written information and verbal presentations concerning specific items (such as documentation, standard operating procedures, etc.) was monitored through an external questionnaire. Not only the level of information but also the employees' perception of their own work gained in depth and positivity. Received: 10 July 2000 / Accepted: 10 July 2000     

Laboratory accreditation – where next?

 Laboratory accreditation is now well established and can justly claim to have had a beneficial impact on the quality of the services provided by accredited laboratories. However, the needs of laboratories and their customers are continually evolving. It is necessary for accreditation practices to keep abreast of these changing requirements if they are to continue to be of benefit to laboratories and their customers. This paper gives a brief review of current accreditation practice and suggests some changes that should be made to help laboratories meet the demands made on them by their customers. Received: 2 July 1998 · Accepted: 3 August 1998     

External quality assessment schemes for clinical analysis in Russia

 The history and the present condition of external quality assessment (EQA) schemes for clinical laboratories in Russia are described briefly. The creation of EQA programmes started in Russia in the 1980s. Now almost 20 years later these schemes have been transformed. The National External Quality Assessment Scheme ensures quality control in the clinical chemistry sector (more than 2000 laboratories) and is the most powerful scheme in Russia. The (Sistema Vneshnego Kontrola Katchestva, *) (BKK) system, covering about 120 Russian laboratories, and a lot of local regional programmes (mainly in Siberia), is also very active. The purposes and design of the operating programs, reference materials used, algorithms of estimation, modes of result representation and development prospects are considered. The basic obstacle to the development of EQA schemes in Russia is financial restriction.     

Accreditation of proficiency-testing schemes in The Netherlands

Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.     

Basic steps towards a self-sustainable quality system and laboratory accreditation

 Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories. Received: 5 June 1997 · Accepted: 7 December 1997     

Accreditation for United States environmental laboratories

 There is currently no national program for recognition of United States environmental laboratories. This situation should change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency test samples, and meet specified quality assurance standards.     

The Swiss External Quality Assessment Scheme in Bacteriology and Mycology 1992–1996

 The Swiss External Quality Assessment Scheme in Bacteriology and Mycology was created in 1980 and has been organised since 1983 by the Department of Medical Microbiology in Zurich. The number of Swiss participants has steadily risen from 66 in 1989 to 92 in 1996. Twelve bacterial and fungal strains are sent to the participants in four despatches, each containing three specimens, per year. Scores are allocated per specimen and range between 0 and 1. Participants with mean scores of ≤0.75 are considered poor performers. The mean scores increased from 0.85 in 1992 to 0.91 in 1996. This improvement can be attributed to the educational effect of the external quality control scheme, since all participants receive a detailed discussion for each specimen together with their individual results. On average, both large University and Cantonal (state) laboratories as well as private laboratories show satisfactory performance. In particular, laboratories officially recognised by the Swiss Federal Office of Public Health (SFOPH) rate better than non-recognised participants. Many small regional hospital laboratories, most of them not SFOPH-recognised, are often among the poor performers. They are often managed by technical staff and lack a trained microbiologist. The recently introduced legislation in Switzerland renders participation in external quality assessment schemes compulsory, and all clinical microbiology laboratories are required to employ qualified microbiologists. This will certainly help to improve the quality standards of all laboratories performing microbiological tests. Received: 13 November 1997 · Accepted: 28 December 1997     

Quality management systems in radiochemistry and radiopharmacy — applications in academy and industry

Except the nuclear fuel reprocessing and nuclear materials safeguards, at present there are two areas of an increased responsibility of nuclear scientists for their results: radioecology and human medicaments. At both of them, quality and trustfulness of results is of great importance for their end-users and may have serious economical and legal consequences. The trends of implementation of good laboratory and manufacturing practices under umbrella of international quality management standards like ISO 17025:2005 and ISO 9001:2000 in radiochemical and radiopharmaceutical laboratories are discussed as expanding to “good scientific practice”. The case studies of the Comenius University laboratory LARCHA authorized for radiochemical analysis, and the company BIONT producing medical radionuclides and PET radiopharmaceuticals are used as the examples.     

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     

Clinical reference materials for the validation of the performance of photometric systems used for clinical analyses

 There are a wide variety of spectrophotometric devices nowadays used in health services with various qualities of manufacture methods of measurement and metrological characteristics for performing the necessary measurements. Therefore, to meet the accuracy and repeatability requirements needed in medical diagnosis and treatment, the validation of the performance of such systems by clinical chemistry laboratories is essential. However, the validation of a spectrophotometric system for clinical analyses requires several reference materials, according to the end use of the measurement results. This paper discusses some characteristics required of the clinical reference materials needed and used by Romanian Institute of Metrology for validation work. Types of clinical reference materials developed in the national area for this purpose are also presented. Received: 23 April 1997 · Accepted: 7 July 1997     

Measurement uncertainty—Surveys about customers' knowledge, reactions and needs

During discussions early in 2000, representatives of accredited analytical laboratories expressed concern about what the customers' reactions might be when the new requirements for evaluating and reporting uncertainty are implemented. In collaboration with accreditation bodies, authorities, laboratories and interest organisations, a two-page leaflet was produced. It was intended to be used by testing laboratories as information, e.g. together with the test report. To gain further insight into customers' views on measurement uncertainty, two surveys were conducted among some 1,200 Swedish customers. The result shows that the majority of them need and value uncertainty statements in the test report.     

Integration of metrological principles and performance evaluation in a proficiency testing scheme in support of the Council Directive 98/83/EC

Proficiency testing as a means of external quality assessment plays the role of independent evidence of laboratories’ performance. To enable laboratories to fulfil the requirements stated in legislation, methodology for evaluation of laboratories’ performance in proficiency testing schemes should incorporate principles of measurement results which are fit for intended use and incorporate evaluation of laboratories’ performances based on independent reference value. A proficiency testing scheme was designed to support Drinking Water Directive (98/83/EC) specifically. The methodology for performance evaluation, which takes into account a “fitness for purpose”-based standard deviation for proficiency assessment, is proposed and discussed in terms of requirements of the Drinking Water Directive. A ζ′-score, modified by application of target uncertainty was developed in a way that fulfils requirements defined in the legislation. As an illustration, results are reported for nitrate concentration in water. The approach presented can also be applied to other fields of measurements.