Legal basis
In France, healthcare safety and quality are mainly guaranteed by:
- A set of regulatory measures that apply to operations and activities in various areas: authorizations to practice or set up equipment, organization of public and private healthcare facilities, technical operating conditions in high-risk sectors, monitoring of the use of healthcare products, etc;
- Several sector-specific monitoring programs that are used to detect adverse effects linked to the use of healthcare products as well as treatment-related adverse incidents and events;
- Regulatory authorities organized region-by-region so that compliance verifications and inspections can be conducted on-site;
- A certification system for healthcare facilities;
- Best-practice recommendations for healthcare professionals, drawn up by national authorities (Haute Autorité de Santé, Haut Conseil de Santé Publique) and approved by the health authorities;
- State-sanctioned degree programs that grant authorization to exercise health professions.
Established programs that guarantee compliance with healthcare quality and safety standards and prerogatives:
- A region-by-region healthcare plan with an array of healthcare networks in the various medical and surgical disciplines;
- A prior-authorization system that is activated when setting up high-risk care and specialties, as well as major medical equipment;
- Compliance verification before opening new facilities, beginning new activities, or rolling out major equipment or new treatment locations;
- Prevention systems that include regulatory reporting requirements for health products, blood transfusions, transplants and biological therapies, hospital-acquired infections, the medical use of ionizing radiation and research activities;
- Obligatory certification for healthcare facilities in order to assess the implementation of the facility's specific standards and recommendations;
- Optional accreditation for high-risk specialties;
- Quality assurance systems have been rolled out in areas that are considered to be high-risk: treatment-related infections, the medication circuit within the facility, radiotherapy, cancer detection programs;
- Regional expertise and support systems that assist healthcare facilities in preventing and combating care-related infections;
- Unannounced or planned on-site verifications (inspections) to measure any departures from the established standards and recommendations;
- Databases on healthcare facilities' activities, which allow government authorities to oversee the billing of the care provided;
- Databases on the activities (and where applicable, prescriptions written by) independent health professionals, including dispensary pharmacists, so that the French healthcare authorities can conduct targeted verifications.
Mechanisms used to identify non-compliances with the established quality and safety of care standards
- France's Regional Health Agencies (Agences Régionales de Santé/ ARS) register any complaints and grievances that are submitted by patients and their families, professionals, and members of the public, and investigate on-site when necessary.
- Specific risks (health products, medical use of ionizing radiation, care-related infections, and medically-assisted reproduction) are dealt with by specialized agencies. Many of these prevention systems accept reports from third parties in addition to patients.
- A system that can be used to identify healthcare facilities and authenticate healthcare professionals and their authorization to practice currently exists and is in the process of being rolled out. The competent authorities (professional associations, ARS, etc.) are closely involved in implementing the approval and updating mechanism and publish a list of healthcare professionals who are authorized to practice.
Healthcare quality and safety indicators
In order to promote the improvement of quality and safety of care and to satisfy the requirements of patients and users, the Ministry of Health implements a policy of transparent results of the actions carried out in public and private health care facilities. These actions are monitored using specific quality and safety indicators in health care facilities.
The provision of quality and safety indicators is intended to supply tools to:
- Inform patients about the quality of hospital care,
- Help health care facilities to monitor the quality and safety of care and ensure continuous improvement,
- Steer public authority decisions at regional and national level.
All health care facilities are required to disclose their indicators to the public; the list of these indicators is established annually by the Ministry of Health.
Quality and safety indicators are used in particular for the certification of health care facilities by the French National Authority for Health (Haute Autorité de Santé), in long-term contracts on goals and means, and on financial incentives for quality improvement. QualiScope (HAS) provides access to each healthcare facility's individual results.
