Biological variation: back to basics

Biological variation: back to basics

PRE-ANALYTICAL ERRORS AND PATIENT SAFETY PREANALITI^KE GRE[KE I BEZBEDNOST PACIJENATA

Summary: Laboratory medicine, as a specialty that had prioritised quality contr ol, has always been at the for efront of error reduction. In the last decades, a dramatic decr ease of analytical errors has been experienced, while a relatively high frequency of errors has been documented in the pr e-analytical phase. Most pr e-analytical errors, which account for up to 70% of all mistakes made in laborator y diagnostics, arise during patient pr eparation, and sample collection, transportation, preparation for analysis and storage. However , while it has been r eported that the pr e-analytical phase is error-prone, only r ecently has it been demonstrated that most of these errors occur in the »pre-pre-analytical phase«, which comprises the initial procedures of the testing process performed outside the laboratory walls by healthcare personnel outside the dir ect control of the clinical laborator y. Developments in automation and infor mation technologies have played a major r ole in decreasing some pre-analytical errors and, in particular, the automation of r epetitive, errorprone and bio-hazardous pre-analytical processes performed within the laboratory walls has effectively decreased errors in specimen preparation, centrifugation, aliquot pr eparation, pipetting and sorting. However, more efforts should be made to improve the appr opriateness of test r equest, patient and sample identification pr ocedures and other pr e-analytical steps performed outside the laborator y walls. Keywords: quality indicators, er rors in laborator y medicine, pre-analytical phase, pr e-pre-analytical phase, total testing process, quality specifications Kratak sadr`aj: Laboratorijska medicina, kao specijalnost u ko joj je prioritet kontr ola kvaliteta, uvek je pr ednja~ila u redukciji gre{aka. U pro{loj deceniji do{lo je do dramati~nog smanjenja broja analiti~kih gr e{aka, dok je r elativno visoka u~estalost gre{aka zabele`ena u pr eanaliti~koj fazi. Pre analiti~ke gre{ke, koje ~ine i do 70% ukupnog br oja gre{aka u laboratorijskoj dijagnostici, ve}inom nastaju tokom pripr eme pacijenta i sakupljanja uzoraka, njihovog transporta, pri preme za analizu i skladi{tenja. Me|utim, mada je ustanovljeno da je preanaliti~ka faza podlo`na gr e{kama, tek nedavno je pokazano da ve}ina tih gre{aka nastaje u »pre-preanaliti~koj fazi«, koja obuhvata po~etne postupke u pr ocesu testiranja koje izvan zidova laboratorije izvode zdravstveni radnici koji nisu pod dir ektnom kontrolom klini~ke laboratorije. R azvoj automatizacije i infor macionih tehnologija pr esudno je uticao na smanjenje br oja nekih pr eanaliti~kih gre{aka, a naro~ito je automatizacija pr eanaliti~kih postupaka podlo`nih gre{kama koji se izvode u okvir u laboratorije efikasno snizila broj gre{aka u pripr emi uzora ka, centrifugiranju, pripr emi alikvo ta, pipetiranju i sortiranju. Ipak, potr ebni su dodatni napori kako bi se postiglo da zah tevi za testovima budu potpuno odgovaraju}i i da bi se una predili postupci identifikacije pacijenta i uzorka kao i ostali pr eanaliti~ki koraci koji se izvode izvan laboratorije. Klju~ne re~i: indikatori kvaliteta, gr e{ke u laboratorijskoj me dicini, preanaliti~ka faza, pr e-preanaliti~ka faza, ukupni proces testiranja, specifikacije kvalitet

Current Issues, Challenges, and Future Perspectives in Clinical Laboratory Medicine

none2no: Laboratory medicine has undergone a profound evolution in organizational, methodological, and cultural terms in recent decades [...].openMannello, Ferdinando; Plebani, MarioMannello, Ferdinando; Plebani, Mari

Notification of critical values

Although it is widely agreed that clinicians must be informed of abnormal laboratory results that constitute a life-threatening condition for the patient, as well as for any values for which delays in reporting can result in adverse outcomes for patients, the criteria for considering tests results critical are controversial. Moreover large variability exists in defining low and high critical values cut-offs and in notifying them to caregivers. In Italy, basically the critical values were communicated to physicians ordering the tests (37.3%), nurses (29.4%) and at a lower extent to any physician on call (17.9%), any people working in the ward (11.9%), and clerks (3%). Again some differences with the US have been demonstrated, being the notification directed also to patients (12.2%), and even to the general practitioner\u27s relatives. Some interesting differences were observed when comparing the Italian and US policies in critical values notification. In Italy the notification is made principally by laboratory managers, i.e., pathologists, biologists, doctors on call, rather than by laboratory technologists, who provide the notification in only 11.1% of institutions. In turn, the professionals involved in communicating critical values in US institutions are usually laboratory technicians or technologists who performed the tests. The reporting of critical values from the laboratory to caregivers is still made mainly by telephone (81.1% in the Italian survey). Less commonly used means of communication included computer (10%), fax (1.1%) or all tools indicated. In the US, laboratories have created call centers in order to centralize critical value reporting

Lot-to-lot variation: no longer a neglected issue

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Notification of critical values

Although it is widely agreed that clinicians must be informed of abnormal laboratory results that constitute a life-threatening condition for the patient, as well as for any values for which delays in reporting can result in adverse outcomes for patients, the criteria for considering tests results critical are controversial. Moreover large variability exists in defining low and high critical values cut-offs and in notifying them to caregivers. In Italy, basically the critical values were communicated to physicians ordering the tests (37.3%), nurses (29.4%) and at a lower extent to any physician on call (17.9%), any people working in the ward (11.9%), and clerks (3%). Again some differences with the US have been demonstrated, being the notification directed also to patients (12.2%), and even to the general practitioner\u27s relatives. Some interesting differences were observed when comparing the Italian and US policies in critical values notification. In Italy the notification is made principally by laboratory managers, i.e., pathologists, biologists, doctors on call, rather than by laboratory technologists, who provide the notification in only 11.1% of institutions. In turn, the professionals involved in communicating critical values in US institutions are usually laboratory technicians or technologists who performed the tests. The reporting of critical values from the laboratory to caregivers is still made mainly by telephone (81.1% in the Italian survey). Less commonly used means of communication included computer (10%), fax (1.1%) or all tools indicated. In the US, laboratories have created call centers in order to centralize critical value reporting

An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU)

Diabetes Mellitus and Reprogrammed Glucose Metabolism in Pancreatic Cancer: Features for Clinical Translation

The reprogrammed metabolism of cancer cells underlies the shift of glucose energetics from the highly efficient oxidative phosphorylation to the less efficient aerobic glycolysis, the Warburg effect. This phenomenon, with the activation of the glutamine pathway, advantage survival and proliferation of pancreatic ductal adenocarcinoma (PDAC) cells, which live in an adverse hypoxic and nutrient restricted microenvironment. In PDAC, glucose metabolic alterations occur also at the whole organism, diabetes mellitus (DM) being diagnosed in approximately 60% to 80% of patients. The association beteen PDAC and DM is a dual face phenomenon, DM being both a risk factor for and a consequence of this tumor type. Data from epidemiology indicate that longstanding DM increases PDAC risk 1.5 to 2.0 fold, probably because of the pro-proliferative effects of hyperinsulinemia. By contrast early onset DM, i.e. diabetes diagnosed no more than two years prior to cancer diagnosis, is considered a consequence of PDAC. Secondary DM is due to complex interactions between tumor cells, tumor microenvironment and pancreatic endocrine cells. In this scenario the role of the inflammatory S100A8 calcium binding protein, matrix metalloproteinases, Vanin1 or amylin has been experimentally demonstrated. However, the efforts made to translate in the clinical practice any individual new poteantial biomarker failed, because none reached enough sensitivity and specificity to be considered a reliable biomarker to diagnose PDAC even in high risk subjects as those with new onset DM. Therefore the identification and clinical validation of new biomarkers remains a challenge for future studies