Evaluation of the quality of the total testing process of a laboratory is very important to assure that the results supplied by the laboratory are correct and can be used for decisions by the personnel ordering the tests. In this paper Proficiency Testing (PT) or External Quality Assessment (EQA) is described. PT is...

Like many hospitals throughout the world, the Princess Royal Hospital in Sussex, England has set up a quality assurance (QA) scheme to verify the competency of glucose-meter operators. Their scoring system, however is anything but typical. Instead of relying solely on individual results, the system also uses...

Preanalytical errors are said to be the reason for up to 75 % [1] of all errors in laboratory medicine. The diagnostic consequences depend on the magnitude of the preanalytical error.  In worst case, these errors may lead to mistreatment of patients; in all cases, these errors are an extra workload for the hospital...

The Directive is a complex and detailed document and in the following the author focuses on some of the items that are particularly important for the user to be aware of.  Most of the rules will apply to the manufacturers and the public and the users will take advantage of the rulings if they become aware of their...

Accreditation of medical laboratory examinations in the widest sense is becoming important as a management tool and a means to create confidence in results. The International Standard ISO/IEC 17025:1999 provides the general requirements for quality management system and technical competence, but the medical...

With the increasing number of blood tests performed at the point of care (POC), it has become more and more important to perform method comparison studies, comparing new methods to the existing methods used in the laboratory (LAB). This is done primarily to ensure that uniform results are reported throughout the...

In our laboratory, we have used a combination of assay capability and the Westgard multirules as the basis of our quality control procedures. We have also used the concept of six sigma as the criterion for performance acceptability, which has allowed the identification of problem analytes and instituted improvements...

When performing method comparisons, it is important to address a number of preparatory and preanalytical issues to ensure that comparisons solely reflect the analytical differences between the two methods in question. This article provides preparatory and preanalytical checklists that can be used when comparing two...

"Six Sigma" is the latest trend in quality management and is being widely implemented in business and industry today. Six Sigma represents an evolution of Total Quality Management (TQM), providing a more quantitative framework for evaluating process performance and clearer goals for process improvement. The...

In the U.S. all testing, including decentralized testing, is regulated according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). Congress passed CLIA'88 to ensure accurate, reliable, and timely test results regardless of test site. These quality control, quality assurance, and proficiency tesing...