Abstract Laboratory diagnostics, a pivotal part of clinical decision making, is no safer than other areas of healthcare, with most errors occurring in the manually intensive preanalytical process. Patient misidentification errors are potentially associated with the worst clinical outcome due to the potential for misdiagnosis and inappropriate therapy. While it is misleadingly assumed that identification errors occur at a low frequency in clinical laboratories, misidentification of general laboratory specimens is around 1% and can produce serious harm to patients, when not promptly detected. This article focuses on this challenging issue, providing an overview on the prevalence and leading causes of identification errors, analyzing the potential adverse consequences, and providing tentative guidelines for detection and prevention based on direct-positive identification, the use of information technology for data entry, automated systems for patient identification and specimen labeling, two or more identifiers during sample collection and delta check technology to identify significant variance of results from historical values. Once misidentification is detected, rejection and recollection is the most suitable approach to manage the specimen. Clin Chem Lab Med 2009;47:143–53.

Misidentification and Other Preanalytical Errors The largest number of laboratory errors occur in the preanalytical phase and are mainly due to educational and organizational reasons. The experience of our institution, as well as the results of an Italian interlaboratory effort to detect and reduce errors/risk of errors in laboratory medicine will be illustrated.

s: Critical and Point-of-Care Testing: Managing Technology for the Benefit of All Populations: 22nd International Symposium: September 17-20, 2008: Catalonia Barcelona Plaza Hotel|Barcelona, Spain

Prevention of medical errors is a major goal of healthcare, though healthcare workers themselves have not yet fully accepted or implemented reliable models of system error, and neither has the public. While there is widespread perception that most medical errors arise from an inappropriate or delayed clinical management, the issue of laboratory errors is receiving a great deal of attention due to their impact on the quality and efficiency of laboratory performances and patient safety. Haemolytic specimens are a frequent occurrence in clinical laboratories, and prevalence can be as high as 3.3% of all of the routine samples, accounting for up to 40%-70% of all unsuitable specimens identified, nearly five times higher than other causes, such as insufficient, incorrect and clotted samples. This article focuses on this challenging issue, providing an overview on prevalence and leading causes of in vivo and in vitro haemolysis, and tentative guidelines on identification and management of haemolytic samples in clinical laboratories. This strategy includes continuous education of healthcare personnel, systematic detection/quantification of haemolysis in any sample, immediate clinicians warning on the probability of in vivo haemolysis, registration of non-conformity, completing of tests unaffected by haemolysis and request of a second specimen for those potentially affected.

BACKGROUND:An important point in improving laboratory quality is the definition of some indicators to be monitored as measures of a laboratory trend. The continuous observation of these indicators can help to reduce errors and risk of errors, thus enhancing the laboratory outcome. In addition, the standardization of risk evaluation techniques and the definition of a set of indicators can eventually contribute to a benchmarking process in clinical laboratories.METHODS:Five Italian hospital laboratories cooperated in a project in which methodologies for process and risk analysis, usually applied in fields other than healthcare (typically aeronautical and transport industries), were adapted and applied to laboratory medicine. The collaboration of a board of experts played a key role in underlining the limits of the proposed techniques and adapting them to the laboratory situation. A detailed process analysis performed in each center was the starting point, followed by risk analysis to evaluate risks and facilitate benchmarking among the participants.RESULTS AND CONCLUSIONS:The techniques applied allowed the formulation of a list of non-conformities that represented risks of errors. The level of risk related to each was quantified and graphically represented for each laboratory to identify the risk area characteristic for each of the centers involved.

From the beginning of human medicine, urine has been used as a valuable source of diagnostic information. Medieval Uroscopy done with human senses by the uroscopist developed into chemical and microscopic urinalysis programmes more than 100 years ago. These analytes are the basis of most medical laboratories worldwide, the chemical “probes” mostly replaced by dipstick panels. More recently several new developments have challenged the traditional strategy. Thus, so called microalbuminuria, defined by the negative test strip, increased the awareness of insufficient analytical sensitivity of the test strip to screen for early diabetic nephropathy, as pointed out in the contribution of Kutter (1). The increasing frequency of end stage renal disease caused by tubulointerstitial diseases, and the fact that the markers of these tubular proteinurias were not detected by the traditional test strips led to the recommendation of measurement of a low molecular weight protein as a marker of tubular dysfunction (2). Urine microscopy, on the other hand, was challenged by the observation that urine erythrocytes derived from renal sources could be differentiated by their dysmorphic appearance from haematuria caused by postrenal bleeding (3). Immunological assays and the flow cytometric analysis of urine cells and casts challenge the medical experts and laboratory managers to reconsider urine strategy to meet future needs. During an expert meeting sponsored and organized by Menarini Ltd, Florence, Italy, the participants from more than 30 countries discussed the future needs for a test strip panel. Some markers like urobilinogen were said to be of low diagnostic value, whereas others like the protein test strip were said to need higher analytical specificity and sensitivity. Contributions from main speakers of this meeting are included in the present issue. The possibilities of automated test strip as well as morphological urinalysis, covered by the reports of Ceriotti et al. (4) and Fellini and Pirovano (5) as well as good experiences with external quality assurance programmes for urine analytes in various countries, support the view that medical needs have to be redefined with respect to all scientific and technical news available. A European Urinalysis group formed after the meeting and convened by T. Kouri from Tampere, Finland, consisting of colleagues from microbiology, nephrology and clinical chemistry, presented a recommendation on “Best practice in urinalysis”, trying to provide a guideline for basic urinalysis based on present medical knowledge and technical as well as economic factors (6). It is to be hoped that this initiative leads to a new international discussion on the needs in urinalysis based on medical needs of today and tomorrow. Thanks should be given to the sponsors of a meeting, devoted to this part of physicians and laboratories daily work, which may help to bring this field back from the “urine corner” into the centre of our work.

The development of recombinant DNA technology has allowed the study of the molecular pathology of inherited diseases in man. Two main molecular approaches are employed: direct study for detection of molecular defects and indirect detection by linkage analysis. A variety of new technologies and their applications have provided a powerful new tool in the diagnosis of inherited diseases.