RISK MANAGEMENT IN CLINICAL LABORATORY

Abstract

In every process of production or distribution of medical devices, there is a risk for its successful commercialization. The glut of new products in all fields of production and everyday life, differing considerably from the natural phenomena and materials, as well as the massive scale of conventional technologies and poorly studied aspects of some new technological processes, runs the risk of being considered to the level of the philosophical categories. The ‘Risk Management’ concept is at the heart of the Laboratory Medicine. The role of the ‘Clinical Laboratory’ specialty is essential in the modern world. The laboratory tests results ensure an objective assessment of the bodily condition. A large percentage of diagnoses are based on laboratory tests. In this context, the Risk Management in the Clinical Laboratory spreads to a much broader content – a set of activities, processes and procedures that track whether the laboratory-diagnostic process guarantees reliable results. Therefore, knowing and managing the risk is absolutely necessary. In response to this in the clinical-laboratory process, a Quality Control Plan (QCP) is established, being a documented strategy that limits and prevents errors and inconsistencies in the laboratory activities. This Plan describes the specific activities related to both the control equipment and the procedures for testing. The development of a QCP requires knowledge of pre-analytical, analytical and post-analytical processes, identification of their weaknesses that may pose a risk to the patient. In the clinical-laboratory process, the Risk Management includes the following stages: Risk Register, Monitoring, QCP, Identification, Analysis and Evaluation, Response. As a result of the stages listed above, it is necessary to reach to solutions leading to the improvement of the organizational framework, the policy and the risk management plan, and consequently to the improvement of the organizational culture for its management in its entirety. At the current stage of development of health systems, great attention is paid to the Risk Management in the clinical-laboratory process in order to achieve the best quality of the clinical and laboratory activities. At all stages of the clinical-laboratory process in the Clinical Laboratory, the quality is a system of activities aimed at achieving the most accurate result, that will help clinicians to diagnose and monitor the effect of the treatment in patients. The ‘Clinical Laboratory’ discipline itself, when used optimally, generates knowledge that guides clinicians and ensures the appropriate treatment of patients, which in turn is the key to quality healthcare and cost effectiveness.