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Event reporting in laboratory medicine. Is there something we are missing?
... Some of these sentinel events have already been identified, including inappropriate test requests and patient misidentification (pre-analytical phase), use of wrong assays for critical diseases (eg Myocardial infarction) severe analytical errors, critical test like electrolytes performed on unsuitable samples. (eg haemolysed sample), the release of laboratory results in spite of poor quality control results, the failure to alert critical values and the wrong report destination (Lippi et al., 2009). This tragic event cause by a human error, once again demonstrated weakness in the system and holes in the defensive layers. ...
Interest in laboratory error was heightened with the publication of the Institute of medicine (IOM) report in 2000: To Err is human; however, there is still a neglect on the problem of error. Beside causing serious harm to patients, medical errors translate into huge costs for the national economy. This article demonstrates that pre and post analytical steps of the total testing process (TTP) are prone to error than the analytical phase. In the interest of patient any direct or indirect negative consequence related to the clinical laboratories must be considered. International ideas should identify areas of quality improvement. Redesigning the system will help prevent error.
... The automatic detection and subsequent rule-based algorithm for the actions to be undertaken can also remarkably increase the rate and effectiveness of detection for both serum interferences and in vivo hemolysis, so that routine reporting of the HI along with the results of single analytes should be considered. In the developing process toward implementation of sentinel events and quality indicators (i.e., to assess and monitor the quality systems of clinical laboratories) [170,171], objective measures of sample quality such as the HI offer the benefit of quality management, providing a suitable background for the development of notable and intolerable interference-induced bias. Finally, for instruments providing quantitative or semiquantitative results, serum indices can obviously be employed as a reliable measure of the degree of such interference and for the potential (mathematical) correction of test results, although we generally advise against this solution. ...
Hemolysis is an important phenomenon in laboratory medicine because it may derive from two different sources, which deserve different approaches: (a) in vivo hemolysis, which may be caused by a variety of conditions and disorders, can lead to various degrees of anemia (up to life-threatening anemia, when the concentration of hemoglobin declines very rapidly and/or falls below 6 mg/dL), and (b) in vitro hemolysis, which is caused by inappropriate procedures for collection and/or handling of the biological specimen, and can seriously impact patient care and a laboratory’s reputation through a wide range of adverse affects on test results. Hemolytic specimens are a frequent event in laboratory practice, with an average prevalence described as about 3% of all of routine samples referred to a clinical laboratory, and accounting also for 39–69% of all the unsuitable specimens received in clinical laboratories (i.e., nearly five times higher than the second major cause). Hemolysis, therefore, still represents the most prevalent preanalytical error across countries, health care facilities, and types of clinical laboratories. Several causes have been traditionally associated with an increased burden of in vitro hemolysis, including difficult venipunctures, use of inappropriate devices, underfilling of blood tubes, exposure to extreme temperatures and physical forces during sample transportation via pneumatic systems, and centrifugation at a too high speed of partially coagulated specimens. In addition, even an excessive shaking or mixing of blood after collection (i.e., for times longer than recommended or with great force) is also usually acknowledged as a leading source of RBC injury. The prevalence of hemolytic specimens is increasingly considered a reliable index for assessing preanalytical quality and, more interestingly, for introducing new tools and guidelines for the safe management of hemolytic samples. Therefore, this volume represents a fundamental source for updating knowledge on hemolysis and on a valuable approach to hemolytic samples in clinical practice.
... Physicians responsible for making clinical decisions seldom do not perceive laboratory errors as a harmful source of patient adverse events, nor do they understand that most laboratory defects may arise from the pre-and post-analytic steps. Some of these ""laboratory sentinel events" have already been identified, including inappropriate test requests and patient misidentification (pre-analytical phase), use of wrong assays, severe analytical errors, tests performed on unsuitable samples, release of lab results in spite of poor quality controls (analytical phase), and failure to alert critical values and wrong report destination (post-analytical phase) (3,4). Modern robotic technologies and information systems can also help reduce pre-analytical errors. ...
Abstract:
Objective: Errors in laboratory can occur at all levels; with the advent of technology errors in analytical stage
were decreased compared to pre & post analytical stages. Advances in software technology and its integration
in healthcare industry as HIS and LIS is a step forward to minimize pre and post analytical errors in the
laboratory. In this study the effectiveness of online software in reporting results is compared with older manual
reporting.
Methods: Our one year old Health 4all (YouSee) online software with non interfaced instrumentation at
Biochemistry laboratory was reviewed for its efficacy. We took feedback by Laboratory staff, clinical staff and
patient attenders by interviews and opinions noted for drawing conclusions.
Discussion: This study highlighted the importance of selection of proper and suitable software for a particular
hospital, need of appropriate staff training and how it adds benefit in improving the quality of results and safety
of patient data.
Conclusion: Importance of integration of administration and laboratories in understanding the challenges; and
acting in right direction by retrospection, can deliver quicker and better performance thus improving the quality
of services and patient care.
Keywords: HIS hospital information system, LIS laboratory information system, COMPUTERS, Online
Reporting, Pre analytical & Post Analytical Errors.
... Es necesario alcanzar un consenso para establecer un conjunto de eventos centinela en el laboratorio 128 . Se han identificado algunos eventos centinela, como la solicitudes de pruebas inadecuadas para patologías críti cas, errores de identificación del paciente (fase preanalítica), elección erró nea del procedimiento analítico, errores graves en la realización del análisis, pruebas realizadas a partir de muestras inadecuadas y distribución de los resultados a pesar de resultados deficientes de los controles (fase analítica), falta de alerta de los valores críticos y envío del informe a un destino equi vocado (fase post-analítica) 129,130 . ...
Estándares y recomendaciones del laboratorio clínico central.
... haemolysed, clotted), the release of laboratory results in spite of poor quality control results, the failure to alert critical values and the wrong report destination. 74 Finally, the lesson we have learnt from the worst laboratory error in Italy (a report transcription error resulting in HIV transmission to three transplanted patients) is the need to avoid manual transcription of data. 75 This tragic event caused by a human error, once again, demonstrated weaknesses in the system and holes in the defensive layers. ...
... Some of these sentinel events have already been identified, including inappropriate test requests and patient misidentification (pre-analytical phase), use of wrong assays, severe analytical errors, tests performed on unsuitable samples, release of lab results in spite of poor quality controls (analytical phase), and failure to alert critical values and wrong report destination (post-analytical phase). 26,27 The Drafting Group of WHO's International Classification for Patient Safety (ICPS) has also developed a conceptual framework that might also be suitable for diagnostics errors. 28 Development and widespread implementation of a Total Quality Management (TQM) system is the most effective strategy to minimize uncertainty in laboratory diagnostics. ...
While many areas of health care are still struggling with the issue of patient safety, laboratory diagnostics has always been a forerunner in pursuing this issue. Significant progress has been made since the release of "To Err is Human."1 This article briefly reviews laboratory quality assessment and looks at recent statistics concerning laboratory errors.
The Healthcare context is characterized by a high degree of complexity. Despite eager efforts of the healthcare per sonnel, sometimes things go wrong and produce unintentional harm to the patients. As such, patient safety must be considered as one of leading healthcare challenges. Some foremoststu dies have highlighted that serious medical errors might occur rather frequently, jeo par dizing patient's health and costing a hu ge amount of money to the healthcare system. A medical error is traditional ly defined as an unintended act, the failure of a planned action to be completed as intended, the use of a wrong plan to achieve an aim when the failure can not be attributed to chance. Medical errors can be classified according to several models, such as the clinical pathway (i.e., diagnostic, treatment, prevention and others), or the resulting harm to the patient (i.e., near misses, no harm or harmful incident). Medical errors can also be classified in skill-based slips and lapses (i.e., errors of action), or rule and knowledge-based mistakes (i.e., errors of intention). According to the source, most errors result from the combination of active failures and latent conditions. It is no teworthy, however, that diagnostic errors have been frequently underestimated in the clinical practice. A laboratory error is any defect occurring at any part of the laboratory cycle, from ordering tests to reporting, interpreting, and reacting to results. Although they have been traditional ly identified with analytical problems and uncertainty of measurements, an extensive scientific literature now atte ts that the vast majority of the se arise from the extra-analytical activities of the totaltesting process. Data from representative studies also show that preanalytical errors are the first cause of variability in laboratory testing. The aim of this article is to provide an overview on the current knowledge about patient safety in healthcare and laboratory diagnostics.
Background: Although the contribution of laboratory diagnostics is integral to the clinical decision making, quality and safety in diagnostic testing are essential to furthering the goal of high-quality and safe healthcare. Despite remarkable advances in the quality of the total testing process, the preanalytical variability is the leading source of errors and uncertainty. As such, the implementation of a systematic policy for recording preanalytical errors would grant major benefits for identifying critical activities of this process, planning and monitoring effective actions for improvement. The aim of this article is to describe the software developed for the recording of preanalytical errors in our laboratory.
Materials and methods: We have developed error recording software based on Microsoft Access. The main fields included in the software comprehend a numerator for progressive enumeration of the samples, the date of receipt of the specimen, the Sample ID, the patient’s name, the type of request, the referring ward, sample matrix, the type of non-conformity, the action undertaken to solve the problem, a second field for possible additional actions undertaken, and the operator ID. The database is stored on a common repository in our laboratory information system, so that it can be accessed by any computer in the laboratory, allowing continuous and standardized input of the data.
Results and discussion: The implementation of a software for systematical recording of preanalytical errors grants major benefits, including harmonization of incident reporting practices, simplicity of digital recording, elimination of handwritten reports, inclusion of validated measures of laboratory performance, handily customization, exportation on worksheets for comprehensive statistical analyses, improved data searching and processing, as well as production of improved statistical reports.
Failure to adequately communicate a critical laboratory value is a potential cause of adverse events. Accreditation requirements specify that clinical laboratories must undertake assessments and appropriate measures to improve the timeliness of critical value reporting and prompt receipt by the responsible caregiver. Documentation and communication processes must be regularly monitored and implemented under ongoing systems for quality monitoring. Critical value reporting is an important phase of the clinical laboratory testing process, and notifications of results outside the target time can indicate ineffectiveness of the process. In the present study, we report data obtained in a 12-month period of critical values analysis and describe a computerized communication system conducive to improving the quality of critical value reporting at a university hospital. Automated communication improves the timeliness of notification and avoids the potential errors for which accreditation programs require read-back of the result. The communication also improves the likelihood of reaching the physician on call and may provide important decision support.
The clinical laboratory is no longer its own limited ecosystem, as it is increasingly integrated with patient care, assisting diagnosis, monitoring therapies and predicting clinical outcomes. Although efforts and resources are continuously focused to achieve a satisfactory degree of analytical quality, there is clear evidence that the preanalytical phase is much more vulnerable to uncertainties and accidents, which can substantially influence patient care. Most errors within the preanalytical phase result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to in vitro hemolysis, clotting, insufficient volume, wrong container, contamination and misidentification. A reliable approach to overcome this problem entails prediction of accidental events (exhaustive process analysis, reassessment and rearrangement of quality requirements, dissemination of operating guidelines and best-practice recommendations, reduction of complexity and error-prone activities, introduction of error-tracking systems and continuous monitoring of performances), an increase in and diversification of defenses (application of multiple and heterogeneous systems to identify non-conformities), and a decrease in vulnerability (implementation of reliable and objective detection systems and causal relation charts, education and training). This policy, which requires integration between requirements and design, full commitment and interdepartmental cooperation, should make laboratory activity more compliant to the inalienable paradigm of total quality in the testing process.
Clin Chem Lab Med 2007;45:720–7.
Abstract,Objective: To evaluate the effect of an automatic,alerting system on the time
Critical results demand rapid patient evaluation, possibly followed by life-saving intervention. A national survey of children's hospitals determined the critical limits used for emergency notification of critical laboratory results. Mean low and high critical limits for children for the tests listed most frequently were as follows (millimoles per liter): glucose, 2.6 and 24.7; potassium, 2.8 and 6.4; calcium, 1.62 and 3.17; and sodium 121 and 156. For newborns, significantly different (P less than .01) critical limits were glucose, 1.8 and 18.2; and potassium, 7.8. Hematology mean critical limits for children included hemoglobin, 69 and 208 g/L; platelets, 53 and 916 x 10(9)/L; hematocrit, 0.20 and 0.62 L/L; and white blood cell counts, 2.1 and 42.9 x 10(9)/L. Critical limits for pH were 7.21 and 7.59; for PCO2, 21 and 66 mm Hg; and for PO2, 45 and 124 mm Hg. Important qualitative critical results included blasts on the blood smear and abnormal cerebrospinal fluid findings. In comparison with other medical centers, children's hospitals maintained tighter critical limits for surveillance of renal function, hemostasis dysfunction, and newborn hypokalemia. Use of these results to eliminate outliers can help reduce unnecessary statim notification and improve resource utilization for the acute diagnosis and treatment of critically ill newborns and children.
Reporting of laboratory critical values has become an issue of national attention as illustrated by recent guidelines described in the National Patient Safety Goals of the Joint Commission on Accreditation of Healthcare Organizations. Herein, we report the results of an analysis of 37,503 consecutive laboratory critical values at our institution, a large urban academic medical center. We evaluated critical value reporting by test, laboratory specialty, patient type, clinical care area, time of day, and critical value limits. Factors leading to delays in critical value reporting are identified, and we describe approaches to improving this important operational and patient safety issue.