ISO 22367 PDF

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

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. This article has been cited by other articles in PMC.

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.

Author information Copyright and License information Disclaimer. Two main aspects contribute to this consideration. Types and origins of diagnostic errors in primary care settings.

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

Since there is no ido activity, the ultimate goal of this process is to reduce the risk to an acceptable level for both patients and clinicians. As demonstrated by other authors 38errors monitoring does not automatically result in quality improvement.

This inspired a patient-centred evaluation of errors in laboratory testing and an increased concern to identify weaknesses and vulnerability in procedures and processes, so that corrective and preventive actions can be activated before any adverse event or patient harm may occur.

Evidence-based quality indicators represent a formidable tool for improving quality and decreasing the risk of errors in the total testing process. Frequency of failure to inform patient of clinically significant outpatient test results.

These discrepancies are due to the different tools used. 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. The concept of risk management, regularly used in aerospace and automotive industries since the 222367 10has been initially applied to medical laboratories by the in vitro diagnostic manufacturers, in which products and components are subjected to stringent risk assessments before being marketed.


The frequency of missed test results and associated treatment delays in a highly computerized health system. In particular, a relatively high frequency of analytical errors has been documented for immunoassays with associated adverse clinical outcomes, sometimes resulting in grossly erroneous results 2.

A brief history of errors in laboratory medicine Initial studies, starting from the seminal lso by Belk and Sunderman in 4 io, as well as other articles published before the s, focused only on the analytical phase and demonstrated high rates and severity of analytical errors. These strategies, in addition to automation, information technologies, improved laboratory technology and assay lso, have contributed to reduce the prevalence of errors, initially at analytical steps, and more generally in the entire laboratory process 7.

Open in a separate window. For each failure that can be identified it is possible to obtain a risk priority number RPN or a risk code respectively, on uso semi-quantitative or qualitative scale is ido. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis: The use of a consensually-defined list of evidence-based Qls to be applied in the accreditation programs of clinical laboratories according to the current International Standard ISO Clin Chem Lab Med ; Missed and delayed diagnoses in the emergency department: However, although the state-of-the-art highlights that pre- and post-analytical phases are more vulnerable to errors, there is still evidence indicating that analytical quality remains a major issue.

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 Prescribing potassium despite hyperkalemia: The organization within which the laboratory operates and the available resources are other factors to be considered when choosing approaches.


Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. The reduction of RPN after three months from implementation of corrective actions showed their effectiveness summed to that of the entire risk management process, although FMEA remains a technique especially useful for evaluating a new process prior to its implementation and not for process monitoring.

It is hence described as a global process, which should anticipate what may go wrong non-conformities, errors and accidentsthus assessing plausibility of errors occurrence along with consequences they cause and implementing strategies to reduce the risk of potential harm. Errors in laboratory medicine: The overall rate of failure to inform the patient or to record communication of information was 7.


Missed and delayed diagnoses in the ambulatory setting: Medical laboratories – reduction of error through risk management and continual improvement. I an error has a negative impact on patient as shortest is the time between one process and another, due to the limited number of barriers useful to intercept and eliminate errors; Jso more the completion of a process entails human physical and intellectual intervention, more likely the increase of the harm. As an example, monoclonal proteins may affect many laboratory measurements, including glucose, bilirubin, C-reactive protein, creatinine and albumin.

CLSI guidelines and ISO standards strongly advocate that the medical laboratory implement Risk Management as a way to assure quality in their testing processes. Since many qualitative and semi-quantitative scales for specific healthcare field e. 222367 the opportunities for applying risk management to pre-analytic and post-analytic processes.

Quality control, in fact, aims to monitor the performance of measuring systems and alert laboratory staff about test errors before impacting patient results. Many models have been developed over the past decades to help medical laboratories improving quality certification and accreditation models, six sigma tool and enhancing safety FMEA, hazard and operability studies, probabilistic risk assessment 6since complex and mature organizations are now asked to continuously monitor their processes for preventing that actual observed failures can be repeated.

QIs incorporated in laboratory quality management system can minimize the possibility of errors occurrence and, consequently, enhance patient safety. Table 1 The journey towards a patient-centered view of errors in laboratory medicine. In addition, different approaches are used to defining goals and identifying risks. Lab Advice on Risk Analysis – includes final exam. The reporting, classification and grading of quality failures in the medical laboratory.

Participants laboratories, in addition to other statistics, receive the RPN calculation.

The CCLM contribution to improvements in quality and patient safety. Qual Saf Health Care ;