The declination of the wide bed of the concept of safety (of treatments and more) is one of the mainobjectives of the health systems of all developed countries. By way of example, in our legal system, the term“security” in the context of Ministerial Decree 70/2015 is reported twenty-one times in thirty pages. On the operational level, this purpose was also reflected in the progressive structuring normally envisaged by the Clinical Risk Management Units. As is known, these are functions that are actually implemented in various ways in individual regional situations, with proactive or reactive tasks, but still aimed at the prevention / management of errors. The perspective adopted is that of overcoming the binary error / guilt logic and the development of a “no blame” culture, as also confirmed by Article 16 of Law 24/2017 (Amendments to Law28 December 2015, n. 208, regarding the professional liability of health personnel). Judgment no. 180 of 23.3.2021 of the Abruzzo Regional Administrative Court, departing from the previous jurisprudence, recognizes to patients or their families the right of access to the report made by the ASL (LOCAL HEALTHCOMPANY) to SIMES (INFORMATION SYSTEM FOR MONITORING ERRORS IN HEALTHCARE), relating to the qualification of the adverse event, as a corollary of the right of procedural participation, as well as private control over the work of the administration, thus ignoring the regulatory framework of lawno. 24 of 2017 (the so-called Gelli Bianco reform) which instead excludes the possibility to acquire documentation relating to the management of clinical risk can be acquired and then used in legal proceedings.
La declinazione dell’ampio alveo del concetto di sicurezza (delle cure e non solo) è uno degli obiettivi principali dei Sistemi Sanitari di tutti i paesi sviluppati. A mero titolo esemplificativo, nel nostroordinamento, il termine “sicurezza” nell’ambito del Decreto Ministeriale (DM) 70/2015 è riportatoventuno volte in trenta pagine. Sul piano operativo tale proposito ha trovato riscontro anche nella progressiva strutturazione normalmente prevista dalle Unità di Gestione del Rischio Clinico. Come notosi tratta di funzioni, per la verità, variamente implementate nelle singole realtà regionali, con compiti di tipo proattivo o reattivo, ma comunque rivolte alla prevenzione/gestione dell’errore. La prospettiva adottata è quella del superamento della logica binaria errore/colpa e lo sviluppo di una cultura “noblame”, così come confermato anche dall’art.16 della L.24/2017 (Modifiche alla legge 28 dicembre 2015, n. 208, in materia di responsabilità professionale del personale sanitario). La sentenza n. 180 del 23.3.2021 del Tribunale Amministrativo Regionale (TAR) Abruzzo, discostandosi dalla giurisprudenza precedente, riconosce ai pazienti o ai loro familiari il diritto di accesso alla segnalazione effettuata dalla Azienda Sanitaria Locale (ASL) al Sistema Informativo per il Monitoraggiodegli Errori in Sanità (SIMES), relativa alla qualificazione dell’evento avverso, in quanto corollario del diritto di partecipazione procedimentale, nonché del controllo del privato sull’operato dell’amministrazione, così ignorando l’impianto normativo della legge n. 24 del 2017 (cd. riforma Gelli Bianco) che invece esclude la possibilità di acquisizione e quindi utilizzo nei procedimenti giudiziari della documentazione relativa alla attività di gestione del rischio clinico.
Accesso agli atti del sistema informativo per il monitoraggio degli errori in sanità (SIMES): il difficile bilanciamento tra trasparenza e diritto alla sicurezza delle cure nei percorsi di clinical governance
Annamaria Bonomo
;DELL’ERBA A.
2022-01-01
Abstract
The declination of the wide bed of the concept of safety (of treatments and more) is one of the mainobjectives of the health systems of all developed countries. By way of example, in our legal system, the term“security” in the context of Ministerial Decree 70/2015 is reported twenty-one times in thirty pages. On the operational level, this purpose was also reflected in the progressive structuring normally envisaged by the Clinical Risk Management Units. As is known, these are functions that are actually implemented in various ways in individual regional situations, with proactive or reactive tasks, but still aimed at the prevention / management of errors. The perspective adopted is that of overcoming the binary error / guilt logic and the development of a “no blame” culture, as also confirmed by Article 16 of Law 24/2017 (Amendments to Law28 December 2015, n. 208, regarding the professional liability of health personnel). Judgment no. 180 of 23.3.2021 of the Abruzzo Regional Administrative Court, departing from the previous jurisprudence, recognizes to patients or their families the right of access to the report made by the ASL (LOCAL HEALTHCOMPANY) to SIMES (INFORMATION SYSTEM FOR MONITORING ERRORS IN HEALTHCARE), relating to the qualification of the adverse event, as a corollary of the right of procedural participation, as well as private control over the work of the administration, thus ignoring the regulatory framework of lawno. 24 of 2017 (the so-called Gelli Bianco reform) which instead excludes the possibility to acquire documentation relating to the management of clinical risk can be acquired and then used in legal proceedings.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
