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ISO/NP 24015 Blood Banks ─ General requirements for the quality and competence of blood bank activities

Scope

This document is applied for all types of blood banks which store or collect blood and loodcomponents for therapeutic purposes.

This document can be used by blood banks in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of blood banks by customers, peer assessment schemes, regulating authorities and accreditation bodies. Note National, International or Regional regulations and requirements could apply.

Purpose

Blood transfusion is an essential part of the modern health care systems. When performed correctly, it saves lives or rapidly improves serious clinical conditions. However, blood transfusion carries a potential risk of immediate or delayed complications and transfusion-transmitted infections. Blood should only be prescribed to treat conditions associated with signicant morbidity or mortality that cannot be prevented or managed by other means. Thus it is always essential to compare the risks of transfusion versus the benets to the patient. The benets should always outweigh the risks. On the other hand, blood is a scarce human resource as it is obtained voluntarily from blood donors. Ensuring safety and clinical effectiveness of blood through accurate, quality-controlled testing and processing requires signicant investments – both human and nancial. It is of utmost importance to formulate and adopt a National Blood Policy covering all aspects of Blood Transfusion Services (BTS), and to create standards for every step in the transfusion process. Also, both BTS and clinical users should combine efforts to establish and implement policies and strategies aimed at reducing the need for transfusions while minimizing unnecessary transfusions and ensuring the safe, rational and appropriate use of blood and blood components.(Please use this field or attach an annex)

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