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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Medical laboratories – reduction of error through risk management and continual improvement.

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Although there are relatively few reports on active use of risk management tools applied to medical laboratories, the latest ones to be published not only focus on analytical steps 25but relate to the entire testing process 26 – According to this principle, the CLSI EPA2 document proposes a proactive tool, failure modes and lso analysis FMEAto identify potential sources of oso, establish iwo they could affect the processes under investigation, and implement control measures to detect and eliminate these errors.

International Organization for Standardization, In particular, a high frequency of errors and risk of errors that could 222367 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. Am J Clin Pathol ; Suppl 1: Understand the risk analysis approach that is recommended for implementation in laboratories.


National Academies Press US ; Further evidence of inappropriate response to laboratory information is provided in a study evaluating the prescription of potassium in cases of hyperkalemia Testing process errors and their harms and consequences reported from family medicine practices: Clin Chim Acta ; BMC Fam Pract ; 8: Consider the opportunities for applying risk management to pre-analytic and post-analytic processes.

National Center for Biotechnology InformationU. The organization within which the laboratory operates and the available resources are other factors to be considered when choosing approaches.

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. Am J Clin Pathol ; Errors in a stat laboratory: 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.

The spectrum of risks is broad, and ranges from very low risk to very high. As an example, monoclonal proteins may affect many laboratory measurements, including glucose, bilirubin, C-reactive protein, creatinine and albumin.

In particular, the identification and implementation of valuable Qls are requested as mandatory for clinical laboratory accreditation according to the International Standard ISO Open in a separate window. FMEA and FTA should be alternately or jointly applied 2237 evaluate complex system, before implementing a new test, installing new equipment or introducing any changes to an existing process Plebani M, Carraro P.


CEN ISO/TS 22367

In addition, most of the many different terms used in the literature to define errors in laboratory medicine e. Periodic participation in external quality assurance EQA programs is another example of risk management principles applied to medical laboratories 22367 Course Syllabus Course Lesson.

The ISO standards, and will also be introduced. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis: The CCLM contribution to improvements in quality and patient safety.

In the patient-centered laboratory, it is no longer enough to identify, analyse 2237 monitor errors, but it is now compelling to understand and manage the potential risks error associated with errors.

Missed and delayed diagnoses in the ambulatory setting: Quality control, in fact, aims to monitor the performance ixo measuring systems and alert laboratory staff about test errors before impacting patient results.

In fact, any error, regardless of its apparently trivial nature, might indicate weaknesses in policies and procedures that 223677 not lead to adverse events in their particular context, but might cause the patient harm in slightly different circumstances According to the ISO Click here if you are not yet a member Email address: