This international standard characterizes the application of ISO as a system for reducing laboratory error and improving patient safety by applying the . ISO Argentina Australia. Austria Belgium Brazil Canada Chile implementation of ISO ; ISO/TS Medical laboratories–. ISO/TS Medical laboratories – Reduction of error through risk management and continual improvement. • CLSI EPA. Laboratory QC Based on.

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Lao and colleagues 20for example, mapped the total testing process by using a Visio Standard Microsoft Office program in order to obtain a global perspective of laboratory.

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23267 According to ISO FMEA and FTA should be alternately or jointly applied to evaluate complex system, before implementing a new test, installing new equipment or introducing any changes to an existing process Identification errors were noted too, although the appropriateness of test request was not considered in the study design.

I an error has a negative impact on patient as shortest uso the time between one process and another, due to the limited number of barriers useful to intercept and eliminate errors; II more the completion of a process entails human physical and intellectual intervention, more likely the increase of the harm. Testing process errors and their harms and consequences reported from family medicine practices: Further evidence of inappropriate response to sio information is provided in a study evaluating the prescription of potassium in cases of hyperkalemia Risk Analysis Guidelines Risk Management is coming to the medical laboratory.

The risk estimation, also defined risk assessment, is an essential step of risk management process. This is one of the few studies in which the risk management process has been conducted in its all phases, iwo risk identification to risk control.


QIs incorporated izo laboratory quality management system can minimize the possibility of errors occurrence and, consequently, enhance patient safety. Patient safety is defined as the absence of avoidable patient harm due to adverse events occurring in any process of medical attention. When iao testing leads to harm: Laboratory errors and risk management From a risk management viewpoint, the great majority of laboratory errors have little direct impact on patient care but provide important learning opportunities.

These strategies have certainly led to errors reduction in analytical steps so that this phase is now reasonably considered the most well-managed throughout the total testing process.

Patient safety and risk management in medical laboratories: theory and practical application

Incorrect interpretation of diagnostic or laboratory tests in the end stages of the TTP loop was found to underlie a large percentage of errors in the ambulatory setting and in emergency departments. Uso to follow-up test results for ambulatory patients: Although the introduction of risk management as a requirement places a new focus on medical laboratories, the Standard does not specify the methodology to apply.

Quality Indicators in Laboratory Medicine: The CCLM contribution to improvements in quality and patient safety. Author information Copyright and License information Disclaimer.

Partners in reducing diagnostic error related to laboratory testing. Consider the opportunities for applying risk management to pre-analytic and post-analytic processes. According to the ISO Laboratory staff should hence lower the actual failures to an acceptable level, but should be aware and ready to avoid potentially serious risks but less frequent that could be masked. Course Syllabus Course Lesson.

The last step of risk management process, the risk control, involves evaluating the effectiveness of the entire process. National Academies Press US ; However, despite the limited study design, they provided a wide range of opportunities to improve analytical performance, including the development of external quality assurance programs EQA and improved rules for internal quality control IQC.


Pending laboratory tests and the hospital discharge summary in patients discharged to sub-acute care. The system also requires reporting the area inside or outside laboratorysource and detection system compliant, laboratory quality system, unknown of errors, in order to encourage participants to analyse the causes and responsibility of these errors Two considerations may be brought to explain this data: The isi step of the risk management process concerns then the systematic identification of risks associated with the total testing process.

Any actual or potential error that may impact patient safety must be managed. Clin Chem ; In addition, sio of the many different terms used in the literature to define errors in laboratory medicine e. Arch Pathol Lab Med ; A survey of the accuracy of chemical analyses in clinical laboratories.

ISO/DIS – Medical laboratories — Application of risk management to medical laboratories

Accredited medical laboratories, however, are now forced to implement risk management principles. The risks estimation has shown that strategic and support processes, due to their lower estimated frequency and gravity, respectively, contribute to patient risk rate much lower than the operational processes.

J Gen Intern Med ;