This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The te...

The Ad hoc Group of experts on antimicrobial resistance of the Office International des Epizooties has developed a guideline on the standardisation and harmonisation of laboratory methodologies used for the detection and quantification of antimicrobial resistance. The existing methods (disk diffusion [including concentration gradient strips], agar dilution and broth dilution) are reviewed, incl...

The Lebanese External Quality Assessment Scheme (LEQAS) was established in 2000 with the aim of helping medical laboratories to improve the quality and comparability of their results. Participation in the scheme for hospital and private laboratories, from all over the country, was voluntary. Between the years 2000 and 2003, the participants took part in three series of surveys and were asked to...

BACKGROUND Following the 2013 USA release of the Influenza Virologic Surveillance Right Size Roadmap, the New York State Department of Health (NYSDOH) embarked on an evaluation of data sources for influenza virologic surveillance. OBJECTIVE To assess NYS data sources, additional to data generated by the state public health laboratory (PHL), which could enhance influenza surveillance at the st...

According to many questions arising in clinical laboratories community on quality assessment and performance of In Vitro Diagnosis (IVDs) process in Iran, we are publishing a descriptive detailed process of Ministry of Health & Medical Education (MHME) role in achieving a permit for importing or local production of IVDs, supervi-sions on distribution, consumption, post marketing monitoring, lim...

The ERNDIM Urine Mucopolysaccharide scheme is aiming at (1) provision of urine samples obtained from confirmed MPS patients to enable laboratories to gain or maintain experience to identify MPS patients and (2) proficiency testing of laboratories providing urine screening of mucopolysaccharidosis. The scheme is organised by Erasmus Medical Centre (Rotterdam, NL) in conjunction with SKML, the Du...

PURPOSE To address the shortage of laboratory scientists in Botswana, an innovative, one-year academic bridging program was initiated at the University of Botswana, to advance diploma-holding laboratory technicians towards becoming laboratory scientists holding Bachelor's degrees. An evaluation was conducted, which described the outcomes of the program and the lessons learned from this novel ap...

After a long-standing tradition of analytical quality and analytical quality control programs, most medical laboratories that are aware of the need for total quality management, are experiencing new systems designed to assure quality throughout the entire total testing process, from the pre-analytical to the post-analytical steps. The availability of a new International Standard, ISO 15189:2003...

The objective of this article is to show the results of a research study conducted to evaluate the need for a quality standard specific for medical research laboratories based on the shortfalls of ISO 15189 when used for this purpose. A qualitative research methodology was used, which comprised of collecting data from 20 well-qualified and experienced medical laboratory personnel by means of in...

BACKGROUND Automated urine sediment analyzers have proven their feasibility in medical laboratories. However, editing manual microscopic review of some specimens severely limits the usefulness of such systems. This study aims to give feedback on the practical experience on »Yeast«, which is one of the parameters that compel frequent manual reviews. METHODS 5448 freshly collected urine specime...