ABSTRACT
The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.
Subject(s)
Cancer Care Facilities/legislation & jurisprudence , Certification/legislation & jurisprudence , Quality Assurance, Health Care/legislation & jurisprudence , Radiation Oncology/legislation & jurisprudence , Risk Management/legislation & jurisprudence , Cancer Care Facilities/organization & administration , Clinical Audit/legislation & jurisprudence , Clinical Audit/methods , France , Humans , Patient Participation/legislation & jurisprudence , Quality Improvement/legislation & jurisprudence , Radiation Oncology/standards , Radiotherapy , Risk Management/methods , Societies, MedicalABSTRACT
Quality and safety management have been implemented for many years in healthcare structures (hospitals treating cancer, private radiotherapy centres). Their structure and formalization have improved progressively over time. These recommendations aim at describing the link between quality and safety management through its organization scheme based on quality-safety policy, process approach, document management and quality measurement. Dedicated tools, such as experience feedback, a priori risk mapping, to-do-lists and check-lists are shown as examples and recommended as routine practice.
Subject(s)
Quality Control , Radiotherapy/standards , Safety Management , Checklist , Forms and Records Control , Healthcare Failure Mode and Effect Analysis , Humans , Medical Errors , Medical Records/standards , Neoplasms/radiotherapy , Quality Improvement , Radiation Injuries/prevention & control , Radiotherapy/adverse effects , Risk Management/organization & administration , Risk Management/standardsABSTRACT
PURPOSE: Failure modes and effects analysis (FMEA), is a risk analysis method used at the Radiotherapy Department of Institute Sainte-Catherine as part of a strategy seeking to continuously improve the quality and security of treatments. PATIENTS AND METHODS: The method comprises several steps: definition of main processes; for each of them, description for every step of prescription, treatment preparation, treatment application; identification of the possible risks, their consequences, their origins; research of existing safety elements which may avoid these risks; grading of risks to assign a criticality score resulting in a numerical organisation of the risks. Finally, the impact of proposed corrective actions was then estimated by a new grading round. RESULTS: For each process studied, a detailed map of the risks was obtained, facilitating the identification of priority actions to be undertaken. For example, we obtain five steps in patient treatment planning with an unacceptable level of risk, 62 a level of moderate risk and 31 an acceptable level of risk. CONCLUSION: The FMEA method, used in the industrial domain and applied here to health care, is an effective tool for the management of risks in patient care. However, the time and training requirements necessary to implement this method should not be underestimated.
