A five-channel grating spectrometer for millimeter-waves

A five-channel grating spectrometer for use in millimeter wave band (25100GHz) is described with its design theory of optical path, and measured results of insertion loss and resolving power.     

Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius

Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation.     

Controlling the quality of testing

 This article mainly focuses on the testing of products, materials, etc., but the general principles are applicable in a broader perspective. Quality of testing should be judged based on fitness for purpose. This judgement includes both objective and subjective elements. The possibility to make decisions and other professional judgements based on test results alone is discussed and compared with the decisions and judgements being made through the certification and inspection process. Quality, including the uncertainty of the test results, depends on many factors, and in order to make necessary improvements in the testing procedures based on the customers' needs, the right issues should be addressed. The question arises as to whether, in laboratories' quality systems and in the accreditation and certification process, attention is really paid to those factors that are crucial to obtaining reliable results.     

Approach to Quality System in Research and Development

 There is growing interest in developing a general strategy and quality standards for possible accreditation or certification of R&D laboratories. This article discusses the scope and limitations of Quality Systems in R&D activities. The extension of QA to R&D centres in general requires emphasis on project management and scientific competence in addition to quality management and technical competence. Received: 11 September 1996 Accepted: 13 November 1996     

An overview of laboratory performance studies conducted by the IAEA for marine pollution studies of metals and organic contaminants

Aspects of the International Atomic Energy Agency (IAEA) Analytical Quality Control Services (AQCS) for marine environmental studies are discussed, focusing on recent laboratory performance studies (LPS) and the production of reference materials for trace metals and organic compounds in various marine matrices. The IAEA has organized seventeen global interlaboratory studies for a range of organic contaminants. Of note has been the inclusion of numerous polychlorinated biphenyl congeners (PCBs) and some sterols of anthropogenic origin. Concurrently, there have been eleven worldwide intercomparison exercises for trace metals in the marine environment, most of which included methylmercury. Although such interlaboratory studies can help improve performance in individual laboratories and regional laboratory networks, the results reveal that problems remain in the determination of some metals and many organic contaminants.     

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.     

The quality of leadership (QL): the EFQM leadership criterion in relation to the 360° feedback evaluation method

The European Foundation for Quality Management (EFQM) integral quality management model covers nine issues: five so-called enabler criteria and four so-called result-oriented criteria. The first enabler criterion concerns leadership and covers all kind of strategic management aspects. However, directly or indirectly, the leadership of the board of directors or its individual members is characterized and scored. An even more explicate technique, originated in a totally different way, is the 360° feedback evaluation method. In this paper both methods are compared and practiced on various individuals. A checklist was developed to facilitate scoring in the EFQM leadership submodel. Both methods, although from a different origin, could be linked easily, covered very similar aspects and gave results that were in excellent agreement with each other. The scoring showed almost identical results, supporting in large the use of the integral EFQM model. Received: 25 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 H. M. J. Goldschmidt     

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     

Measurement uncertainty and the use of reference materials

The use of (certified) reference materials and quality control materials can form a suitable basis for evaluating measurement uncertainty of routine measurements. In particular when these materials are used for quality control purposes, it is not always evident how the quality control data can be used in the uncertainty budget of a routine measurement. Current guidance documents on the evaluation of measurement uncertainty and the use of reference materials treat this subject only in part, or in very generic terms. ISO/REMCO has established a new working group that will provide practical guidance and examples on how to use quality control data in the evaluation of measurement uncertainty. A short introduction to the subject is given.

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