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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.4, #3)
The reference-information model for Dutch hospital pharmacies (RIZA): an aid for implementing a quality system and continuous quality improvement by R. Grouls; Wim van de Laar; Eric Ackerman (pp. B111-B113).
The reference-information model for Dutch hospital pharmacies (RIZA) is an organization-independent, structured description of the function of a hospital pharmacy. By using the process-decomposition diagrams, information flow charts, entity-relationship diagrams and complementary definitions developed for the Dutch system, RIZA can be used as the starting-point in the analysis and description of other organizations. Because of the unambiguous structuring of RIZA, the model can also be used for other applications, i.e. the information laid down is reusable. Therefore, RIZA is extremely flexible and can be used for information and cost management change, human resource and quality management.
Keywords: Key words Information flow; Reference-information model; Organizational layout
Reply to Professor Neidhart's Letter to the Editor
by Hassan y. Aboul-Enein; M. Buzoianu (pp. A111-A111).
Introduction for the special issue on the Antwerp Conferences by J.-C. Libeer; Henk M. J. Goldschmidt (pp. 76-78).
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.
Mapping the road to analytical quality with charts of operating specifications by James O. Westgard (pp. 79-81).
Quality is often described as a journey. In quality management programs, organizational change often gives the illusion of a journey even when it only represents temporary movement without any well-defined destination. Sometimes the change is only to describe where we have been and how we arrived at the present, rather than advancing us to where we need to be in the future. Laboratory programs in quality management need well-defined destinations, maps to guide us to those destinations, and careful planning to assure a smooth journey.
Keywords: Key words Total quality management; Operating specifications; Validator; Dynamic quality control
The attitude of laboratory personnel towards accreditation by Alain G. Verstraete (pp. 82-83).
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.
Keywords: Key words Belgium clinical; laboratory; Medical technologists; Accreditation; EN 45001
The Italian way: Accreditation and continuous quality improvement in clinical laboratories by M. Plebani (pp. 84-86).
The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.
Keywords: Key words Total quality management; Quality control; Peer review; ISO 9000; Clinical Pathology Accreditation
How instrument manufactures help with accreditation and ISO certification by L. Huber (pp. 87-89).
To help users of laboratory instrumentation to obtain laboratory accreditation and International Organization of Standardization certification, instrument manufactures should develop a comprehensive compliance programme for their products that includes product features, documentation and services for equipment validation and qualification.
Keywords: Key words Accreditation; ISO certification; Analytical equipment; Manufactures
Quality management, certification and accreditation in medical laboratories – the view of ECLM by R. Dybkaer (pp. 90-92).
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.
Keywords: Key words Accreditation; Certification; Laboratory medicine; Quality management; Reference examination system
The American (USA) perspective six years after implementation of CLIA'88 (Federal) regulations by S. S. Ehrmeyer; Ronald H. Laessig (pp. 93-98).
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.
Keywords: Key words Clinical laboratory improvement amendments (CLIA'88); United States (Federal) laboratory regulations; Quality mandates; Total quality management; Laboratory accreditation
Practical implementation of a quality system in a hospital clinical chemistry laboratory by T. J. Penders; Ans J. G. Hendriksen-Wissink (pp. 99-101).
In 1995, an audit of laboratory quality systems in hospitals in the Netherlands was started. The audit consisted of the assessment of three levels of the Dutch hospital system: the organization and management as described in a quality manual, the capability and function of professionals and the performance in external quality assessment programmes. Our laboratory was the first to be audited by the Coordinating Committee for the Promotion of Quality Control of Laboratory Investigation in Health Care (CCKLtest) and here we present a description of our quality system, paying particular attention to the quality manual.
Keywords: Key words Quality system; Quality manual; External quality control; Professional requirements; Audit; CCKLtest
The impact of LIMS design and functionality on laboratory quality achievements by T. W. Steele; Alain Laugier; François Falco (pp. 102-106).
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 ".
Keywords: Key words Laboratory information management system; Future information technology; Transparency; Information technology tools
Sense and nonsense of laboratory accreditation by P. C. M. Bartels; Marianne Schoorl (pp. 107-108).
An open mind is essential for the implementation and improvement of total quality management. Leadership, as such, is of no value without a vision concerning corporate culture and human resources. Therefore, constant communication between partners within a corporate body is the cornerstone for empowerment. The evaluation of ideas and complaints is considered to be essential for the identification of strengths and weaknesses of a system, whereas, competition and benchmarking may reveal surprising opportunities for improvement. We discuss the idea that customer-oriented efficiency in a hospital environment may be classified as a critical success factor.
Keywords: Key words Dutch laboratory accreditation; Human aspects; Total quality management
Is accreditation useful for quality improvement? by Robert George Visser (pp. 108-110).
The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.
Keywords: Key words Accreditation; Proficiency test; Quality improvement; Comparability; Laboratory performance