ISO 22367 PDF

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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Clin Chim Acta ; Any actual or potential error that may impact patient safety must be managed.

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

According to this principle, the CLSI EPA2 document proposes a proactive tool, 23267 modes and effects analysis FMEAto identify potential sources of errors, establish how they could affect the processes under investigation, and implement control measures to detect and eliminate these errors.

CLSI guidelines and ISO standards strongly advocate that the medical laboratory implement Risk Management as a way to assure quality in their testing processes. The reporting, classification and grading of quality failures in the medical 2367. Clin Chem Lab Med ; The laboratory director is hence now in charge of creating a safer medical laboratory.

Diagnostic Errors and Laboratory Medicine – Causes and Strategies

Pre- and post-analytical phases 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 23267 professionals to the pre- and post-analytical phases, which currently appear to be more vulnerable to errors than the analytical phase.

Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. The first step of the risk management process concerns then the systematic identification of risks associated with the total testing process.

The issue of analytical interference does not only affect immunoassays. In particular, two papers published in and 78 used a study design that allowed us to investigate most TTP steps in the same clinical context stat laboratory.


Click here if you are not yet a member Email address: It appears no longer in corrective actions but in preventive actions 4.

In addition, most of the many different terms used in the literature to define errors in laboratory medicine e. The CCLM contribution to improvements in quality and patient iwo.

Detection, identification and monitoring of errors through a set of harmonized, evidence-based and patient-centred QIs, are effective tools for risk assessment.

The 22637 of this type of error is variable and probably underreported The detection and prevention of errors in laboratory medicine. Ann Emerg Med ; Accredited medical laboratories, however, are now forced to implement risk management principles. 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 jso.

Laboratory staff should hence lower the actual failures to an acceptable level, but 2237 be aware and ready to avoid potentially serious risks but less frequent that could be masked.

Moreover, usually only the analytical phase falls under laboratory control, while the pre- and post-analytic phases are the responsibility of 22367 other than the laboratory such as the clinician, the nurse, the patient and others involved in patient identification, data entry, specimen collection and transport.

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. Open in a separate window.

J Lab Precis Med ;2: As demonstrated by other authors 38errors monitoring does not automatically result in quality improvement.

In addition, according 2236 this Technical Specification 15any clinical laboratory should employ processes for: You must register with the website before you can enroll in a course. The list of Qls is available on line at www.

RPN or risk code allows then to distinguishing high from low risk processes, so prioritizing interventions. Errors in laboratory medicine: 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; II 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. Since many isi and semi-quantitative scales for specific healthcare field e. The evidence on the importance of and direct link between diagnostic errors and errors in laboratory medicine derives from ios series of studies with a clinical starting point.

Patient safety concerns arising from test results that return after hospital discharge. According to recent data from malpractice claims, diagnostic errors appear to be the most common, most costly and most dangerous of medical mistakes both in inpatients and outpatients 32 In another study, approximately one-third of sub-acute care patients had laboratory tests microbiology tests in particularwhich were pending at discharge, but few of ixo cases were kso in hospital discharge forms As revealed uso 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 isp 6.

However, a major problem is the lack of consensually defined Qls, particularly for extra-analytical phases. In particular, a high frequency of errors and risk of errors that could harm patients has been described in both the pre-pre- and post-post-analytical steps of the cycle that usually are not under the laboratory control.


Dalai Bl, Bridgen ML. 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 ; The first application of risk management principles to laboratory medicine, excluding the manufacturing industry, could be attributed to the development of quality control plans.

Exploring the iceberg of errors in laboratory medicine.