151019 Membership_format_EPSO_def_Italy.doc
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Information about THE SUPERVISORY ORGANISATION(s) in
1. COUNTRY/REGION: ITALY
Website of the supervisory organisation:
www.agenas.it
Is this website in English or partly in English?
Yes, partly
Contact person(s)
Name and function
Giovanni Caracci- Head of Quality and Accreditation Department
Address
Via Piemonte 60- 00187 Rome (Italy)
Email
caracci@agenas.it
Telephone number
+39 06 55122 250
Mobile phone
Name and function
Vanda Raho- research consultant, Quality and Accreditation Department
Address
Via Piemonte, 60- 00187 Rome (Italy)
Email
raho@agenas.it
Telephone number
+39 06 55122 224
Mobile phone
Name and function
Mario Braga- Coordinating Director
Address
Via Piemonte, 60- 00187 Rome (Italy)
Email
braga@agenas.it
Telephone number
+39 06 42749334
Mobile phone
2. THE STRUCTURE OF THE SUPERVISORY ORGANISATION(s)
The Head of the Supervisory Organisation (name and function).
Prof. Francesco Bevere - Director General
Prof. Giuseppe Zuccatelli- Acting President
Size of the Supervisory Organisation:
Number of inspections/supervisions or number of inspectors or number of full time equivalents of people working in the organisation; number of hospitals or health institutions under supervision
Number of people working in the organisations
46 full time employees + about 200 consultants- experts in various areas (quality improvement, health expenditure, HTA, Continuous Medical Education)
Other relevant information about the Supervisory Organisation in your country or region
The National Agency for Regional Health Services (Agenas) acts as a scientific and technical body of the Italian National Health Services in charge of supporting national and regional health planning. It promotes quality in health care by: monitoring outcome measures to support clinical and organizational audit programs aimed at improving both effectiveness and equity in the national health system; comparing costs and efficiency of health care services; detecting malfunctions in managing health resources (human resources, materials and provision); spreading health innovation and experimentation of new models care. Its involvement is based on guidelines approved by the Standing Conference on the Relations between the State, the Regions and the Autonomous Provinces. Agenas’ main areas of activity are:
- Evaluation and monitoring of Quality, efficiency and equity of healthcare services;
- Analysis of health expenditure;
- Support to Regions in health planning and evaluation and managing health innovation (Health Technology Assessment);
- Support to Regions in defining uniform criteria for service accreditation;
- Support to Ministry of Health for defining the National Monitoring System for the Essential Levels of Care;
- Support the Regions in defining and evaluating healthcare models and integrated care models;
- Support to the National Anticorruption Agency for defining anticorruption policies in the healthcare sector;
- Support to Regions with financial troubles complying with recovery plans;
- Managing continuing medical education providing administrative support to the National Commission for Continuing Medical Education and to other activities, as requested by the Italian Regions or by other public institutions.
It was founded in 1993 by Legal Decree n. 266, and its role has been increasingly developed over the years. Recently the Patto per la Salute 2014-2016 (Pact for health- a three-year plan that is agreed jointly between central and regional governments), has assigned to Agenas a stronger role in monitoring, analysing and controlling performance of the Regional healthcare systems.
The role of Agenas is justified by the features of the Italian Servizio Sanitario Nazionale (National Health Service), that was established in 1978 to grant universal access to a uniform level of care throughout Italy, free at the point of use, financed by general taxation. The Ministry of Health fulfils the function of the overall steward of the health system and defines the livelli essenziali di assistenza (or essential levels of care, LEA) to be delivered across the country. Beyond this, Italy’s 21 Regions and Autonomous Provinces (R&AP) are responsible for the actual planning and delivery of services. Articulation between central government’s steering role and regional government’s delivery role is expressed in the Patto per la salute.
Web address
3. THE SCOPE OF THE SUPERVISORY ORGANISATION(s)
Is there supervision on health care in general?
Supervision on health care is carried out through different monitoring activities carried out by Agenas.
According to the provision of the Patto per la Salute 2014-2016, Agenas is in charge of setting up a system that allows monitoring, analysis and control of the Regional healthcare systems. This system also allows detection of possible differences in performance among healthcare organizations and Regional healthcare systems related to quality of care, efficiency, efficacy, safety, appropriateness and equity of the services provided.
Furthermore, since 2008 Agenas has been giving technical and scientific support to the annual monitoring of the level of implementation of intra moenia activity. In this fields, Agenas manages and coordinates the National monitoring of waiting times for outpatient services provided by intra moenia and extended intra moenia professional activity. Agenas deals with data processing and draws up a half-year technical report, forwarded to the National Observatory on Liberal Profession, which is part of the “Report on the implementation status of the exercise of intra moenia professional activity in accordance with L.n. 120/2007”, that is annually forwarded to the Parliament. An ad hoc web-portal has been set up on Agenas website for online gathering of data, from Regions and Autonomous Provinces, concerning waiting times and services provided by intra moenia professional activity.
Among the monitoring activities assigned to Agenas, there are the monitoring of the good practices for patient safety and monitoring of malpractice claims, both in place since 2008.
Agenas is responsible of the National Outcome Evaluation Program (PNE) aims to measure the outcome variability among providers and/or health professionals and among Local Health Units (ASL) in Italy, with possible applications in terms of accreditation, remuneration as well as patient information.
Is there supervision on hospitals?
Direct supervision falls under the responsibility of the Regional Governments.
Agenas, through the National Outcome Evaluation Program (PNE), monitor and evaluate the outcome variability among providers and/or health professionals and among Local Health Units (ASL) in Italy. This system is mainly focused on Hospital activity and performances.
Is there supervision on other health care institutions like nursing homes / convalescent homes?
Is there supervision on the production and the use of medicines?
Is there a supervisory relation with health care professionals? If yes, what kind of relation
Supervision on the activity of healthcare professionals is carried out through the National Program on Continuing Education in Medicine (NPCEM) aimed at ensuring that physician knowledge is constantly updated and that medical doctors possess the adequate skills to meet the growing demand for health care. The NPCEM requires health care professionals to obtain 50 CME credits per year. In 2008, Agenas took over the administration and organisation of the CME programme and it collaborates with the NPCEM to achieve a system capable of verifying and promoting high quality of continuous medical education. Agenas also supports Regions that have signed agreements for the accreditation of regional providers.
Other relevant information about the scope of the supervisory organisation.
Ageans provides assessment and evaluation of system and service organizations at regional level.
Ageans collaborate with the Ministry of Health for building Inspection teams in case of relevant, critical healthcare events.
4. METHODS OF INSPECTION OR SUPERVISION
What methods of inspection or supervision are used in your country/region?
Regions have the direct responsibility to monitor and inspect health care services (both hospital and community services, public and private). The range of inspection fields include: respect of accreditation criteria(structural, technological and organizational); safety and prevention in the workplace; Quality assurance; Good practice delivery; Respect of contractual agreements for private services (Volume, range of activities and quality).
Controls are performed both through automated monitoring and on-site visits by public officials.
Other information about the methods of inspection in your country / region
Other regulators commission other organisations to monitor against standards
In Italy accreditation for healthcare facilities is mandatory and is responsibility of the Regions, who define their own accreditation models. This has led to 21 accreditation models with varying minimum standards across the country. A stronger steering and supervision role from the central authorities is being developed thanks to the recent agreement on new rules for accreditation, that has led to the identification, by a commission composed of representatives of the Ministry of health, AGENAS and Regions, of quality standards to be uniformly implemented within regional accreditation systems so as to achieve a more uniform approach. It is the Regions who monitor compliance of healthcare facilities against these standards.
5. WHAT IS THE COMPETENCE OF THE SUPERVISORY ORGANISATION IN YOUR COUNTRY?
Is the supervisory organisation entitled to use compulsory measures (sanction/repression/enforcement)
Agenas is not entitled to use compulsory measures. Its tasks are mainly focused on monitoring performance in order to promote quality improvement. This is done for example by the National Outcomes Program, that is a professionally-led initiative that monitors health care outcomes across hospitals and municipalities in Italy. The programme began in the 1980’s looking at outcomes in cardiac care and has since expanded to cover over 129 indicators across a range of clinical areas.
Is the supervisory organisation entitled to take precautions and implement measures to prevent accidents or incidents?
Agenas is entitled to promote implementation of quality and safety measures. For example, as a result of a project carried out by Agenas and aimed at promoting implementation of the WHO surgical checklist, all the healthcare organizations of two Regions have successfully implemented it.
Does the supervisory organisation have the authority to close institutions or stop non proper healthcare
Agenas has no authority power to sanction Institutions or to close them. It can inform Regional Authorities and the Ministry of critical situations.
Is the supervisory organisation allowed to interfere in other ways? Can remove licence, enforce recommendations for social care centres . If yes, in what way?
Other relevant information about the competence of the supervisory organisation
Agenas is instrumental in co-ordinating activity across levels of government. Its responsibilities include supporting national and regional health planning with analyses of need and supply, assessing the costs and effectiveness of health care nationally and across R&AP, supporting innovation, evaluation and disseminating good practices and, finally, supporting R&AP subject to Piani di Rientro(Recovery plans) to comply with fiscal consolidation requirements whilst maintaining the accessibility and quality of services.
6. INTERESTING ONGOING DEVELOPMENTS IN YOUR COUNTRY/REGION
The Patto per la Salute 2014-2016 provides for the re-organization and re-qualification of the Regional healthcare systems to guarantee realization of a monitoring system that allows to intervene before the conditions to impose the Piani di rientro (Recovery plans) on the regional health systems occur.
To do so, the Central Government and the Regional governments agree that the new programs for reorganization, re-qualification and strengthening of the Regional Healthcare systems should include:
- Objective and actions aimed at a clear definition of the processes of regional governance, in accordance with the principles stated in the legislation aimed at ensuring provision of the Essential Levels of Care, verification and monitoring of healthcare.
- Actions of re-organization and re-qualification of the Regional healthcare systems that can guarantee achievement of both the essential levels of care and financial balance.
Among the new responsibilities assigned to Agenas, there is the setting up of a National system for monitoring, analyzing and controlling the trend in the performance of the regional healthcare systems to allow detection, through a specific early warning mechanism, of the discrepancies in performance of healthcare organizations and Regional healthcare systems as per quality, safety, efficacy, efficiency, appropriateness and equity of the services provided.
The Patto per la Salute also provides for the Agency to coordinate the setting up of the National HTA program for medical devices, on the basis of a national collaborative network among Regions aimed at defining and using tools for medical devices’ governance and HTA.
A further provision of the Patto per la Salute is the setting up of a Technical Group whose main function will be the monitoring and verification of the implementation of what is provided for in the Patto itself and of possible measures of health spending review.
Agenas will be responsible for the Safety Observatory at National Level.
