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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.13, #3)


Benchmarking and quality management indicators in three medical laboratories by A. Salas García; C. Vilaplana Perez; A. Calderón Ruiz; C. Gimeno Bosch; J. Perez Jove; C. Sevillano Herrada; M. A. Bosch Llobet; X. Boquet Miquel (pp. 123-132).
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.

Keywords: Quality indicators; Clinical laboratory management indicators; Benchmarking; Budget


Tumour markers workload of an university hospital laboratory two years after the redesign of the optical reading request forms by Romolo M. Dorizzi; Anna Ferrari; Annalisa Rossini; Umberta Mozzo; Sandra Meneghelli; Nicoletta Melloni; Paolo Rizzotti (pp. 133-137).
Tumour markers are traditionally requested in fixed panels more than on the basis of specific conditions or professional guidelines, wasting a large amount of resources with little or no benefit to the patients. In the summer 2004 the optical-reading requests form used by our laboratory was redesigned; the section “Apparatus” was added and since then tumour markers have been measured only if the specifically related organ has been simultaneously and coherently marked (e.g. liver when AFP is requested). The hospital clinical staff has been involved in the project and has been extensively informed through meetings and paper and electronic newsletters and messages. Thereafter, when the request form has not been correctly completed, a reminder has been electronically forwarded to the requesting physician asking for more information. In the first trimester of 2006, 30.9% fewer tumour markers were measured in inpatients than in the first trimester 2004 (e.g. AFP: −37.6%; CEA: −30.6%; CA 19-9: −43%; TPA: −36.6%); the decrease of outpatients requests in the same period was about 9.2%. Inpatients workload further decreased in 2006 versus 2005 while the outpatients workload increased. In conclusion, small administrative changes and an intensive information effort about appropriate requesting of tumour markers induced a relevant workload reduction in a short time.

Keywords: Tumour markers; Optical-reading card; Optical reading form; Request form; Appropriateness


Can auditing save us from a quality disaster? by Sharon S. Ehrmeyer; Ronald H. Laessig (pp. 139-144).
Auditing of clinical laboratories is a recognized component of quality assurance practice. National regulatory standards, such as the U.S. Clinical Laboratory Improvement Amendments (CLIA), and international voluntary standards, such as those promulgated by the International Organization for Standardization (ISO), are used in the auditing. Professional organizations have long recognized the benefit of on-site, peer review. However, recent events in the U.S. question the validity of current auditing practices. To be effective, auditing must be part of a continuous quality improvement system and a key component of laboratory leadership.

Keywords: Auditing; External laboratory inspections; Quality; Quality practices; Quality assurance; Quality assessment


Comparison of evaluation procedures used by European external quality assessment scheme organizers for haemoglobin concentration and leukocyte concentration by Marjan Van Blerk; Stéphanie Albarède; André Deom; Gabriela Gutiérrez; Silke Heller; Aida Nazor; Anja Pakkanen; Robert Rej; Kathleen M. Curran; Erika Sarkany; Milan Skitek; Joan-Lluis Vives-Corrons; Evgeny Zaikin; Jean-Claude Libeer (pp. 145-148).
This study aimed to assess currently used evaluation procedures for haemoglobin concentration and leukocyte concentration in European external quality assessment schemes (EQAS). Participating EQAS organizers were asked to complete a questionnaire gathering information on the statistical procedures used to assess the performance of participants, and to analyse an Excel file with 262 results for haemoglobin concentration and leukocyte concentration. Responses were received from the New York State Proficiency Testing programme in the US and from 11 European EQAS: Belgium, Croatia, Finland, France, Germany, Hungary, Russia, Slovenia, Spain (two organizers), and Switzerland. Five of the 11 European EQAS use fixed limits based upon experience, biological variation, state of the art, or professional consensus. The other EQAS use variable limits based upon statistical analysis of the performance attained. With the exception of the German, Hungarian, and Slovenian schemes, all European EQAS use consensus target values. The percentage of unsatisfactory results obtained by the European EQAS organizers for the given set of data varied between 0.4 and 15.6% for haemoglobin concentration and between 0 and 19.8% for leukocyte concentration.

Keywords: Acceptability criteria; External quality assessment scheme; Haemoglobin concentration; Leukocyte concentration


Statistical analysis of serum protein electrophoresis results in External Quality Assessment schemes by Lixin Zhang; Christel Van Campenhout; Nicole Devleeschouwer; Jean-Claude Libeer; Adelin Albert (pp. 149-155).
The goal of External Quality Assessment (EQA) schemes is to ensure that results obtained on a particular specimen in a given clinical laboratory are compatible with those obtained by other laboratories on the same specimen. Serum protein electrophoresis is a laboratory test consisting of five fractions (albumin, α1, α2, β and γ globulins), which sum up to 100% of total proteins. So far, in EQA schemes the five fractions have been analyzed separately as for ordinary tests like glucose or cholesterol. This approach does not consider the fractions as a whole and the linear relationship between them. A statistical approach has been developed to analyze EQA electrophoresis results from a global standpoint by using robust multivariate method to eliminate the effect of outlying profiles. As illustrated on electrophoretic data from the Belgian EQA scheme, the novel approach improves the detection of poor performing laboratories. The method will be implemented in the Belgian EQA scheme on a routine basis.

Keywords: Electrophoresis; EQA schemes; Outliers; Robust statistics


The process of management review by Henrik Islin; Torben Andersen (pp. 157-160).
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.

Keywords: Process approach; ISO standards; Input; Output; Follow-up


Joint Commission International accreditation: a laboratory perspective by Gurdeep S. Dhatt; Ahlam Al Sheiban (pp. 161-164).
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.

Keywords: Accreditation; Hospital; Laboratory medicine; Peer review


Evaluation of the quality of clinical laboratories in the Slovak Republic: conceptual and contextual remarks by Gustáv Kováč; Anna Porubenová (pp. 165-171).
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.

Keywords: Quality; Clinical laboratories; Evaluation; Concepts; Context; Intellectual capital; Balanced scorecard; Scandia navigator; Intangible assets monitor; Intellectual capital index; External quality assurance; ISO 9000:2000; ISO 17 125-120 15189:2007; European quality foundation model
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