engleski

QUALITY MANAGEMENT OF THE PRE-ANALYTICAL PHASE

Quality management in the pre-analytical phase is challenging and complex. It poses substantial demand in terms of human, financial and organizational resources to the laboratory management. It requires contribution by all involved stakeholders: laboratory professionals, medical doctors, nurses and patients, as well as hospital management and regulatory authorities. Nevertheless, ISO 15189 recognizes laboratory as responsible entity for managing the quality of pre-analytical phase, by carefully monitoring and continuous improvement of all respective processes and steps. According to ISO 15198, pre-examination processes include “all steps starting in chronological order from the clinician’s request, including the examination requisition, preparation of the patient, collection of the primary sample, transportation to and within the laboratory and ending when the analytical examination starts”. Several important prerequisites need to be in place in order to establish and maintain an effective pre-analytical quality management system. Those issues shall be discussed and presented in this lecture. In brief, they include carefull risk management by detailed analysis of the processes, by defining the safe practice standards and best practice recommendations and consistently enforcing compliance to those, by establishing systems for error-detection and system performance, by initiating corrective and preventive actions and education and training of staff involved in this processes. The initiatives need to be taken at several levels: by international professional associations in laboratory medicine, by national professional associations and at the level of individual laboratories. International associations should take the lead in defining and providing best-practice recommendations, national professional associations should assist in efficient distribution of those recommendations and individual laboratories should do their best to adhere to the guidance documents.

quality; preanalytical phase; patient safety

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