IRCCS confirmation procedure

The recognition of the scientific nature of public and private structures takes place with reference to one or more thematic areas, referred to in Annex 1 of Legislative Decree no. 200/2022 and is subject to the possession, based on a valid title, of the following requirements:

• legal personality under public or private law
• health authorisation and accreditation holders
• cost-effectiveness and efficiency of the organization, quality of structures and technological level of equipment, adequacy of the organizational structure with respect to research purposes and economic, financial and patrimonial balance, as well as at least 35 percent of researchers with a subordinate employment contract according to the national collective labour contract of public and/or private health. For the purposes of calculating this percentage, personnel dedicated to health care as well as personnel posted exclusively on the basis of agreements with Universities are not calculated 
• characteristics of excellence of the level of hospitalization and high specialty care activity directly carried out in the last three years, namely of the technical-scientific contribution provided, within the framework of a nationally and internationally recognized biomedical research activity, in order to ensure a higher quality of care activity, attested by public structures of the National Health Service, the complexity of the services provided, the structural characteristics, the volume and type of activities and the care path, as well as the qualification of clinical – care reference center at the regional or supra-regional level for the thematic area to which it belongs
• characteristics of excellence of the research activity carried out in the last three years in relation to the specific discipline assigned according to internationally recognized bibliometric systems
• demonstrated ability to network with research institutes in the same area of reference, to collaborate with other public and private bodies, as well as to prove the number of multicentre clinical trials and the number of participations in Community call for bids
• quality certification of services according to internationally recognized procedures. (art. 13 of Legislative Decree no. 288 of 16 October 2003 and subsequent amendments and additions)
• pursuant to Article 13, Legislative Decree no. 288/2003 and subsequent amendments, the status of reference centre at regional or supra-regional level for the thematic area for which recognition is requested, as better specified in Annex 3 of Legislative Decree 200/2022, as well as the existence of the minimum catchment area on a territorial basis by thematic area of recognition, as identified in Annex 2 of the aforementioned legislative decree.

The procedure for confirming the scientific nature is regulated pursuant to art. 15, paragraph 1, according to which every four years the IRCCS Foundations, the unprocessed Institutes and the IRCCS under private law send to the Ministry of Health their updated data certifying the permanence of the legal requirements, in accordance with the provisions of Annex B to the Ministerial Decree of 5 February 2015.

(Ref. https://www.salute.gov.it/portale/ricercaSanitaria/dettaglioContenutiRicercaSanitaria.jsp?language=italian&id=1487&area=Research%20sanitary&menu=ssn)

The Foundation/IRCCS has carried out its care activities in agreement with the Regional Health Service since 2005, first at the S. Pietro Fatebenefratelli Hospital, managing the accredited beds made available by the latter, then from 2008 to 2012, by virtue of specific conventional acts, at the San Giovanni Addolorata British Hospital. Subsequently, the IRCCS G.B. Bietti Foundation with a specific agreement between the Lazio Region and the aforementioned Company, since 2017 has undertaken a specific path that involved the restructuring and leasing of a wing of the British Hospital (block B, plan T, 1, 2, 3) in addition to Block C (plan –1) dedicated to research. Upon completion of the work in 2021, all the documentation for obtaining the authorization to operate and institutional accreditation was prepared and sent, and, after the verification and inspections phase, the authorization and institutional accreditation title was issued on April 5, 2022, with the resolution of the Regional Council of Lazio no. 164. From December 1, 2022, the new Ophthalmological Centre for care activities was activated under the ordinary and daytime continuous cycle of hospital admission for acute as well as outpatient care, becoming a full member of the national and regional health service. 

The new configuration of the Ophthalmological Center, with an area of approximately 1600 square meters divided over four floors for care and translational research activities, therefore includes over 18 visiting and diagnostic environments, spaces for ordinary hospitalization and day hospital/day surgery, 1 operating room, 1 PC1 and 1 PC2 and more than 530 square meters dedicated to the basic research laboratory. 

Scientific research, welfare activities and attention to socially sensitive issues constitute the activities of general interest carried out by the Foundation for the pursuit of the statutory purpose. In this sense, the Entity’s mission is expressed synergistically through the integration and development of all three of its components, aiming to increasingly tighten the link between care and research activities, guaranteeing quality, originality, innovation and transferability to clinical practice of laboratory results.