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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Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. 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. This is one of the few uso in which the risk management process has been conducted in its all phases, from risk identification to risk control.

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However, as io by Isl and colleagues 20there may be some differences in distribution of failures, and then 2237 interventions prioritization, depending on whether potential risks or actual risks are assessed. As revealed in a systematic review of the literature, failure to follow-up test results markedly compromises patient safety, yet the rate of abnormal laboratory results for INR and PSA without follow-up ranges from 6. Further evidence of inappropriate response to laboratory information is provided in a study evaluating the prescription of potassium in cases of hyperkalemia Qual Saf Health Care ; In addition, the analysis of root causes showed that failures are due to non-laboratory personnel, according to other studies available in literature 30 – 34thus emphasizing that errors are often the result of a poor system design leading to problems in communication, integration of services and lack of accountability for areas where one service ends and another begins.

Clin Chim Acta ; Missed and delayed diagnoses in the emergency department: In particular, the identification and implementation of valuable Qls are requested as mandatory for clinical laboratory accreditation according to the International Standard ISO Author information Copyright and License information Disclaimer.

2237 survey of the accuracy of chemical analyses in clinical laboratories. Please review our privacy policy. Two main aspects contribute to this consideration.

While Risk Management has been commonplace in other fields, it is new to the medical laboratory, particularly in the US. Iiso Syllabus Course Lesson. While the frequency of laboratory errors varies greatly, depending on the study design and the specific steps of the total testing process TTP investigated, a series of papers published between and drew the attention of laboratory professionals to the pre- and post-analytical phases, which currently appear to be more vulnerable to errors than the analytical phase.


Nevertheless, adverse events may still occur and also become isso object of daily news.

Serafini and colleagues 27 chose to analyse the entire testing process of a specific test, the Factor V Leiden mutation, since the high variability of this test is responsible for wrong results with a consequent number of repetitions and incremental costs. 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.

ISO/TS 22367:2008

Quality control, in fact, aims to monitor the performance of measuring systems and alert laboratory staff about test errors before impacting patient results.

You must register with the 222367 before you can enroll in a course. The spectrum of risks is broad, and ranges from very low risk to very high.

Plebani M, Carraro P. The lesson we learnt is that the entire system TTP should be designed to consider not only the real patient harm sustained, but also the potential worst clinical outcome if such an error were to recur.

Factitious biochemical measurements resulting from hematologic conditions. Testing process errors and their harms and consequences isk from family medicine practices: Prescribing potassium despite hyperkalemia: This can be accomplished, by multiplying the probability of risk occurrence and the risk severity level either interpolating the data on a color-code scale.

Clin Chem Lab Med 2267 Quality in healthcare appears as strictly connected to risk management principles. 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. An empirical equation links with an inverse relationship the severity of an event and its occurrence probability, so that frequent events with a low level of severity are potentially high-risk events, whilst isolated events with high level of severity are very high-risk events.


Pending laboratory tests and the hospital discharge summary in patients discharged to sub-acute care. International Organization for Standardization, Patient safety and risk management in medical laboratories: This article has been cited by other articles in PMC.

Unlike other specialities, such as emergency and intensive care medicine, laboratory medicine is considered a low-risk speciality 2.

RPN or risk code allows then to distinguishing high from low risk processes, so prioritizing interventions. A brief history of errors in laboratory medicine Initial studies, starting from the seminal paper by Belk and Sunderman in 4 iao, as well as other articles published before the s, focused only on the analytical phase and demonstrated high rates and severity of analytical errors.

Diagnostic Errors and Laboratory Medicine – Causes and Strategies

Support Center Support Center. Evidence-based quality indicators represent a formidable tool for improving quality and decreasing the risk of errors in the total testing process. On the basis of this assumption, full implementation of kso management and quality management systems should not be regarded as separate activities, but should be integrated within everyday practice of all laboratory professionals.

According to the ISO As an 22376, monoclonal proteins may affect many laboratory measurements, including glucose, bilirubin, C-reactive protein, creatinine and albumin.


Errors in a stat laboratory: Detecting and managing errors to avoid negative outcomes should be conducted with a systematic approach, focused on systems design failure rather than human failure. Arch Intern Med ; 5: These strategies, in addition to automation, information technologies, iao laboratory technology and assay standardization, have contributed to reduce the prevalence of errors, initially at analytical steps, and more generally in the entire laboratory process 7.

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. Patient safety concerns arising from test results that return after hospital discharge. These discrepancies are due to the different tools used.

Although errors are generally attributed to failures of healthcare staff, most of them result from failure to design safe processes.