Quality Management In Medical Laboratory Research Articles

Significance of Simultaneous Use of Different Methods for Interpretation of Internal Quality Control Data An Experience of a Tertiary Care Hospital

Background: Quality control is an essential part of quality management in medical laboratory. Various methods are available for the analysis of laboratory quality control data, common ones are Levey Jennings chart and Westgard rules. Westgard multi-rules are a set of rules based on combination of criteria to decide whether an analytical run is acceptable or unacceptable. CUSUM uses the cumulative sum of deviations from a target, however, it is rarely used in current medical laboratory practice. We share our experience of using Westgard rules and CUSUM in the analysis of laboratory quality control data. Material and methods: Internal quality control values of 2-year period was included in the present study. Data for platelet count values of normal level control material run on a fully automated haematology analyser (Sysmex XT-2000i) were analysed. A total of 1825 data points were obtained. The data was interpreted by Westgard rules as well as cumulative sum method. The out of control events was analysed. Results: There was 9 incidence of control value outside 3SD (Westgard Rule 13s) which was picked on Levey Jennings chart but missed by CUSUM method. There were 22 instances of shift in mean (bias) which were only picked by CUSUM method. Conclusion: CUSUM was more sensitive for detection of bias whereas random error was picked-up early by Westgard rules. In conclusion we recommend the use of more than one method for analysis of quality control data.

Quality Management in Medical Laboratories for Accreditation

Quality Management in Medical Laboratories for Accreditation

Learning management: intangible motivation as keystone to success in implementing quality management in medical laboratory

Learning management: intangible motivation as keystone to success in implementing quality management in medical laboratory

Useful measures and models for analytical quality management in medical laboratories

Useful measures and models for analytical quality management in medical laboratories

Useful measures and models for analytical quality management in medical laboratories.

The 2014 Milan Conference "Defining analytical performance goals 15 years after the Stockholm Conference" initiated a new discussion of issues concerning goals for precision, trueness or bias, total analytical error (TAE), and measurement uncertainty (MU). Goal-setting models are critical for analytical quality management, along with error models, quality-assessment models, quality-planning models, as well as comprehensive models for quality management systems. There are also critical underlying issues, such as an emphasis on MU to the possible exclusion of TAE and a corresponding preference for separate precision and bias goals instead of a combined total error goal. This opinion recommends careful consideration of the differences in the concepts of accuracy and traceability and the appropriateness of different measures, particularly TAE as a measure of accuracy and MU as a measure of traceability. TAE is essential to manage quality within a medical laboratory and MU and trueness are essential to achieve comparability of results across laboratories. With this perspective, laboratory scientists can better understand the many measures and models needed for analytical quality management and assess their usefulness for practical applications in medical laboratories.

Quality management in medical laboratories

During the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

Managing quality vs. measuring uncertainty in the medical laboratory

ISO 15189's particular requirements for quality management in medical laboratories provide guidance for (a) relating performance specifications to the intended use of a test or examination procedure, (b) designing internal quality control (IQC) procedures to verify the attainment of the intended quality of test results, as well as (c) determining the uncertainty or results, where relevant and possible. This guidance has particular implications for analytical quality management, specifically for validating method performance relative to quality goals or requirements (intended use), designing statistical quality control procedures on the basis of the quality required for a test and the precision and bias observed for a method, and characterizing the quality achieved in practice by calculating measurement uncertainty. There already exists an error framework that provides practical tools and guidance for managing analytical quality, along with an existing concept of total error that can be used to characterize the quality of laboratory tests, thus there is considerable concern and debate on the merits and usefulness of measurement uncertainty. This paper argues that total error provides a practical top-down estimate of measurement uncertainty in the laboratory, and that the ISO/GUM model should be primarily directed to and applied by manufacturers.

Lingo Lesson No. 2, or “Oh No! Here She Comes Again!”

Maybe it’s the blood banker in me; maybe it’s the Virgo in me; maybe it’s because I took some courses in college on the Greek and Latin origins of English words and medical terms. Or maybe it’s because there are fully a dozen phrases that start with the word “quality” in the ISO 9000 Fundamentals and Vocabulary for quality management systems.1 I can’t help but be a fussbudget about using words in their correct context to achieve comprehendible communication—especially about a topic as important as quality management in medical laboratories. Almost 25 years after the term “quality assurance” was introduced into the hospital and medical laboratory environments, there are still pathologists and laboratorians who think that quality control (QC) and quality assurance (QA) are the same thing. It got even more complicated when the phrase “quality system” was introduced in the 1990s and “quality management” was introduced in 2000. Then enter “quality management system.” All these phrases are continually used interchangeably, albeit incorrectly. No wonder everyone’s confused and I feel like Bob Seeger in his classic song, “Runnin’ Against …

Laboratory quality regulations and accreditation standards in Canada

Objectives To review the current status of laboratory quality regulations and accreditation standards in Canada. Design and methods The review is written based on information collected by survey questionnaires, a comprehensive review of available websites, and personal communications. Results Accreditation of medical laboratories in Canada is regulated by provincial health authorities. Out of the ten provinces of Canada, five have provincial accreditation bodies, while in the other five provinces, medical laboratories are accredited by Canadian Counsel on Health Service Accreditation (CCHSA). Each of these accreditation bodies has developed their own standards, implementing the International Organization for Standardization (ISO) documents to variable extent. Canadian Coalition for Quality in Laboratory Medicine (CCQLM) has recently been incorporated to provide a national structure for harmonizing quality management in medical laboratories across Canada. Conclusions Although provincially regulated, implementation of ISO in accreditation standards and coalition of accreditation bodies have been promoting the harmonization of quality regulations in Canada.

Die Situation des Qualitätsmanagements in Österreich / Quality Management in Austria

Abstract This article deals with the situation of quality management in Austrian medical laboratories. Starting in 1994 after several rounds of discussion, the Society for Good Analytical und Laboratory Practise (GALP) was founded by the two major societies for laboratory medicine und clinical chemistry. This society had the purpose to work out strategies for quality management for Austrian medical laboratories. The major outcome of the activities was the adoption of ISO 9002:1994 as the model for quality management in medical laboratories and the publication of a guideline for the implementation of ISO 9002:1994 in the medical laboratories. This guideline was the basis for many medical laboratories in Austria to seek ISO 9001/2:1994 certification. Currently most medical laboratories (except those in hospitals, where certification is not so prevalent) are ISO 9000 certified. The next major development in quality management was the adoption of the third medical device guideline of the European Union (IVD-Guideline) and its national implementation in the Austrian Law on Medical Devices. This law includes several clauses, which can be used by the ministry of health to require quality management systems in medical laboratories and to establish rules for certification agencies in this field. However, the implementation of these clauses in the law is weak due to the lack of resources on side of the ministry. Nevertheless, European Union demands will lead to more effective measures as they did in the field of clinical studies. The development of EN ISO 15189:2003, which will be published in German language in December 2003, will lead to a change from certification to accreditation, at least in the high quality segment of medical laboratories. This will bring Austria in line with the international situation. Currently, quality does not have any impact on reimbursement of medical laboratories in Austria, so quality matters only in terms of cost but not in terms of higher earnings. Therefore quality is motivated by idealistic factors which tend to lose when economic pressures rise. In the future, changes in this field will be necessary too.

The German perspective of using the EFQM model in medical laboratories

The financial resources of health care services are only nominally growing in Germany. Therefore, the politicians have been forced to act. Up to now, a fixed limit of remuneration should not affect the quality of patient management. However, these primary economic issues have initiated positive and negative reactions from the laboratory medicine community. In hospital laboratories the challenge is to realise continuous improvement of service quality but at the same time reduce costs. This can only be achieved by introducing total quality management (TQM) and measuring the quality obtained by the European Foundation for Quality Management (EFQM) model. Predominantly formal attempts to improve quality at the level of ”enablers” such as certification (ISO 9000) or accreditation (EN 45000, ISO 15189) will not solve these problems. Two groups in Germany work on TQM and EFQM: the Working Group ”Laboratory Management” of the German, Austrian and Swiss Societies for Laboratory Medicine and for Clinical Chemistry, and the Institute for Quality Management in Medical Laboratories (INQUAM). Their work has resulted in several books on the subject, successful propagation of application of the EFQM model and a proposal for a formalized ”certification” procedure according to the model.

IVD industry role for quality and accreditation in medical laboratories

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

Medical Laboratory Accreditation - The Road Ahead

Medical Laboratory Accreditation - The Road Ahead

Effect of accreditation schemes on the setting of quality specifications by laboratories

In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory-clinic interface are the most difficult to assess and evaluate in an adequate quality management system.

Total Quality Management for Clinical Laboratories: A Need or a New Fashion?

SummaryIn most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general standards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implementation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical competence must be examined, but also if there is a real contact between pathologists and clinicians and if laboratory results are clinically validated (clinical audit).This new vision on quality in medical laboratories will ask a reconsideration of the tasks, duties and knowledge of clinical pathologists.