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Harmonization in laboratory medicine: the complete picture
Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a three-tier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Quality indicators to detect pre-analytical errors in laboratory testing.
Pre-analytical steps, the major source of mistakes in laboratory diagnostics, arise during patient preparation, sample collection, sample transportation, sample preparation, and sample storage. However, while it has been reported that the pre-analytical phase is error-prone, only recently has it been demonstrated that most errors occur in the 'pre-pre-analytical phase'. This comprises the initial procedures of the testing process performed by healthcare personnel outside the laboratory walls and outside the direct control of the clinical laboratory. Quality indicators (QIs) should therefore cover all steps in the pre-analytical phase, from test requesting to sample storage. In the present paper, the state-of-the-art of QIs in laboratory testing is described. The focus is on the experience of a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in developing a model of QIs, 16 of which concern the pre-analytical phase
The clinical importance of laboratory reasoning.
The radical changes made in the delivery of modern health care have serious implications for laboratory services, because reasoning in laboratory medicine should follow a clinical rather than a technological logic. Appropriate test requesting and interpretation coupled with a patient-oriented vision improve the outcomes for patients, and so ensure the best cost containment strategy. The fact that analytical operations are standardized and quality controlled, may lead to a greater recognition of the importance of pre- and post-analytical issues. Particularly critical aspects are the formulation of the clinical question and the interpretation of laboratory results. Laboratory-clinic communication is fundamental in achieving and maintaining total quality in laboratory services. Effective consultancy stands or falls with the knowledge and experience of laboratorians, as well as continuous education is required to maintain the best utilization of laboratory information in clinical decision-making. As clinical audit is an important tool for reviewing and improving the quality of the service in clinical laboratories, it should make up an important part of programs for accreditation and quality improvement. If a patient-centered vision predominates, the clinical laboratory will be linked to both physicians and patients, making it more tangible to the latter
Pepsinogens in health and disease.
Pepsinogens, precursors of pepsins (potent and abundant digestive enzymes that are the primary products of the gastric chief cells), are members of the family of aspartic proteases. Because of the heterogeneity of pepsinogens, several classifications have appeared in the literature. I describe the recommended classification and nomenclature of the aspartic proteases and discuss their genetics, biochemistry (structure, activation of zymogens, mechanism of proteolytic activity and inhibitors), and physiology. The focus will be on the zymogens of pepsin, the so-called pepsinogens. The measurement of these enzymes in serum is a reliable noninvasive biochemical method for evaluating peptic secretion and obtaining information on the gastric mucosal status. A detailed review of the methods for the measurement of pepsinogens in serum, urine, and gastric mucosa is also provided. Data on pepsinogen levels in healthy subjects are discussed with respect to sex, age, smoking habit, and the presence of a circadian rhythm.
The value of pepsinogen measurements in peptic ulcer to determine ulcer outcome and recurrence, in gastric cancer, and in Helicobacter pylori infection is reviewed. Finally, the effects of drugs on peptic secretion are discussed. In light of these data, the measurement of aspartic proteases, and in particular that of pepsinogen A and C, may be regarded as an effective biochemical approach to the evaluation and monitoring of patients with upper gastrointestinal diseases
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