Ministry of Health
Decree — Official Gazette n.305 of
Evaluation in terms of quality, safety and appropriateness of the activities provided for accreditation and for contractual agreements with health facilities
THE MINISTER OF HEALTH
Having regard to Articles 32, 117, paragraph 2, letter r), 117, paragraph 3 and 118
of the Constitution;
Having regard to the Implementing Decision of the Council of the European Union europea
del , concerning the approval of the evaluation del
Italy’s National Recovery and Resilience Plan;
Having regard to art.9 of Regulation (EU) 2016/679 of the European Parliament
and of the Council of 27 April 2016, on alla protection of natural persons with regard to the processing of personal data;
Having regard to the decree legislative 30 December 1992, n. 502, e in
particular its Title II, Articles 8 e following, dedicated
to the regulation of health services;
Having regard to the agreement reached by the Standing Conference for: i relations
between the State, regions and provinces autonomous in data 23 March
2005, which establishes a series of obligations aimed at al monitoring
of the implementation of core levels of assistance from part
regions and autonomous provinces (rep. acts n. 2271/CSR);
Having regard to the Decree of the Minister of Health of 2 April 2015, n.70
containing ‘Standards-Definition Regulation qualitative,
structural, technological e quantities relative assistance
hospital’;
Having regard to the decree of the Minister of Health of the 28 December 1991,
published in the Gazzetta Ufficiale della Repubblica italiana del 17
January 1992, n. 13, e next modifications, relative alla
institution of the hospital discharge card;
Having regard to art. 50 del decree-law 30 September 2003, n. 269,
converted, with amendments, by law no. 326 of 24 November 2003 and
the related implementing decrees, concerning the institution del System
health card;
Having regard to Legislative Decree 7 March 2005, n. 82, bearing ‘Digital Administration code
‘;
Visa the decree legislative 6 May 2011, n. 68, containing
‘Provisions on autonomy di entry of regions a
ordinary and provincial statute, as well as ‘ di determination
costs and standard needs in the health sector’;
Visa art. 12 del decree-law 18 October 2012, n. 179,
converted, with amendments, by the law of 17 December 2012, n. 221
concerning «Electronic health record, surveillance systems
in the health sector and digital health governance» and i relative
implementing decrees;
Having regard to the Decree of the President of the Council of Ministers del 29
September 2015 n.178 laying down the Regulation on the subject di file
health electronic’ and, in particular, the forecasts of which Articles
Articles 18, 19 and 20 concerning the processing of related data for
Purposes of government;
Having regard to the agreement reached by the Standing Conference for: i relations
between the State, regions and autonomous provinces on date 20 December
2012, on the document containing «Discipline for revision of the legislation
of accreditation», in implementation of art. 7, paragraph 1 of the Pact for
health 2010/2012 (rep. acts no. 259/CSR);
Considering that the aforementioned agreement of 20 December 2012 provides,
inter alia, the establishment of the working table per lo development e
the application of the national accreditation system, with the aim
to constitute reference and support to regions and autonomous provinces
for lo development e the application del system di accreditation
institutional;
Having regard to the agreement reached by the Standing Conference for: i relations
between the State, regions and autonomous provinces on date 19 February
2015, on the subject of fulfilments relative accreditation Delle
Health facilities (rep.acts no. 32/CSR);
Visa the decree legislative 14 March 2013, n. 33, containing
‘Reorganisation of the rules concerning the right of civic access and
the obligations of publicity, transparency and dissemination of information
by the public administrations’ e i relative Principles
applicable to institutions and structures that erogano performance for
National Health Service account;
Visa art. 32 del decree-law 24 June 2014, n. 90,
converted, with amendments, by the law of 11 August 2014, n. 114,
as amended by art. 1, paragraph 704 of Law 28 December
2015, n. 208, recante misure straordinarie di management, support e
monitoring of companies involved in criminal proceedings for facts
corrupt i.e. recipients di information antimafia
interdictive, providing in particular, that the measures extraordinary
of corruption prevention of which al recalled art. 32 del
decreto-legge 24 giugno 2014, n. 90, are applied also alle
enterprises carrying out health activities per account del Service
national health service on the basis of the contractual agreements referred to in art.
8-quinquies of Legislative Decree 30 December 1992, n.502;
Having regard to the guidelines of the Authority national anti-corruption For
The application of art. 32, paragraphs 2-bis and 10 del decree-law 24
June 2014, n. 90, to companies that exercise activities health
on behalf of the Service sanitary national in base agli Contractual agreements
pursuant to art. 8-quinquies of the decree legislative 30
December 1992, n. 502, as published in the Gazette Official
n. 197 of 24 August 2016;
Having regard to the decree of the Minister of Health of 21 June 2016 that
has indicated the Programme national outcomes which tool per lo
development of business redevelopment plans ai sensi of art.
1, paragraph 528, of Law no. 208 of 28 December 2015, with particular
reference to the identification degli scopes welfare e dei
parameters for continuous monitoring assistance sanitary e
to the development of clinical-organizational auditing activities;
Having regard to the Decree of the President of the Council of Ministers del 12
January 2017, which defined and updated i levels essential di
assistance (LEA), pursuant to art.1, paragraph 7, of Legislative Decree
30 December 1992, n. 502;
Having regard to the law of 8 March 2017, n. 24 containing «Provisions on the subject
di sicurezza delle care e della persona assistita, as well as in materia
di Responsibilities professional degli merchants le professions
health’;
Having regard to the decree of the Minister della health del 12 March 2019
concerning the new system di warranty per the monitoring
of healthcare, published in the Official Journal della
Italian Republic of 14 June 2019, n. 138;
Having regard to the Agreement of the Standing Conference for the relations
between the State, regions and autonomous provinces on date 17 December
2020, on the document containing «National indications per the provision of telemedicine services
(rep.acts no. 215/CSR);
Having regard to art. 1, paragraphs 491, 491-bis, 492-496 of the law of 30 December
2020, n. 178, regarding the safeguard appropriateness of
care, of the right to proximity of services, e del law di
free choice of the citizen, and in particular the provision referred to in
aforesaid art. 1, paragraph 492 according to which the Committee permanent
for the verification of the disbursement of the LEA pursuant to art. 9 of the agreement
between the State, the regions and le Provinces autonomous di Trento e di
Bolzano sanctioned on 23 March 2005, «adopts guidelines e set di
objective indicators e measurable, also through i data del
Health card system, al end di harmonize i systems di
control di appropriateness degli dispensers accredited with
the goal of improving efficiency e appropriateness in the use
of the factors of production and the orderly programming of the appeal agli
accredited public and private providers, orienting to maintenance
of high standards in the activity rendered by the dispensers public e
private accredited, also recognized, as hospitalization institutes and
scientific care»;
Having regard to art.1, paragraph 493 of Law No 178, which
provides that the Standing Committee for la verification of the disbursement
of the LEA referred to in art. 9 of the agreement between the State, the regions e le
Autonomous provinces of Trento and Bolzano sanctioned in data 23 March
2005, adopts guidelines and sets of objective indicators and measurable,
also through card system data sanitary, al end di
harmonize the appropriateness control systems of dispensers
accredited with the objective di improve efficiency e
the appropriateness in use dei factors productive e the ordinate
programming del appeal agli dispensers public e private
accredited, orienting al maintenance di elevated standard
in the activity rendered by public providers e private individuals accredited,
also recognized, as hospitalization institutions e care a character
scientific;
Visa art. 9 del decree-law 8 October 2021, n. 139,
converted, with amendments, by law , n. 205,
on entities and methods for processing dei data personal
related to health, without direct identifiers;
Having regard to the decree of the Minister of Health of 23 May 2022, n.
77, on ‘Regulation laying down the definition of models and standards
for the development of territorial assistance in Service health
national’;
Considering that art.15, paragraph 1 letter a), of the law 5 August
2022, n. 118, replaced art. 8-quarter, comma 7, del Legislative Decree
Legislative No 502 of 30 December 1992, providing that accreditation
may be granted on the basis of quality and volumes dei services
da dispense, as well as ‘ sulla base dei results of the activity
possibly already carried out, also taking into account the objectives di
safety of health care and outcomes of activities
of control, supervision e monitoring per la evaluation of
activities dispensed in terms di quality, safety ed
appropriateness, le which modalities are definite with decree of
Minister for Health, after agreement within the Standing Conference
for relations between the State, the regions and le Provinces autonomous di
Trento and Bolzano, pursuant to art.8, comma 6, della law 5
June 2003, n. 131;
Considering that art. 15, paragraph 1 letter b), n. 1) of the law 5
August 2022, n. 118 introduced paragraph 1-bis to art. 8-quinquies
of Legislative Decree no. 502 of 30 December 1992, pursuant to the which
private entities interested parties alla subscription degli agreements
contractual, for the provision of care benefits on behalf of
e a load del Service sanitary national, are identified
by transparent, fair procedures and not discriminatory, previous
publication by the regions of a notice containing criteria
objective selection, which prioritize the quality
of the specific health services to be provided. La selection di
such subjects must be carried out periodically, held account
of regional health planning and on base di verifications
of if any needs di rationalization della network in
convention e, per i subjects already holders di agreements
contractual, of the activity carried out; a such Ends si keeps account
also’ of the effective power supply in manner continuous e
prompt del dossier sanitary electronic (ESF) ai Senses
of art.12 of Decree-Law no.  of 18 October 2012; 179, converted,
with amendments, by law no. 221 of 17 December 2012, second Le
modalities defined pursuant to paragraph 7 of the same art. 12, as well as
of the results of the control activities, vigilance e monitoring
for the evaluation of the activities provided, le which modalities are
defined by the decree referred to in art. 8-quarter, paragraph 7;
Detected, because of the above, the need di define a
homogeneous methodological framework at national level, in compliance with
programming prerogatives regional, in merit alla definition
of activities di monitoring, control e supervision
on disbursement of performance sanitary quali conditions di
access by disbursed private individuals al system di Assistance
Healthcare dispensed da part del Service sanitary national,
through a specific implementation of the activities of fitting
between le discipline regional in matter di accreditation
institutional carried out from table di work per lo development e
the application of the national accreditation system;
Tenuto account that shall be identified dei relative
indicators for analysis and monitoring of performance, homogeneous
at national level ed eligible a represent effectively le
actual operating conditions of miscellaneous systems health
regional, in compliance with the prerogatives of health planning
that sorting recognizes e guarantees a each region e
autonomous province;
Acquired the agreement sanctioned from Conference permanent per i
relations between the State, the regions and the autonomous provinces of Trento e
of Bolzano at the meeting of (rep.acts no. 258/CSR);
Decree:
Art. 1
Scope
1.This decree defines, in implementation of provisions
of articles 8-quarter, paragraph 7 and 8-quinquies, paragraph 1-bis del
Legislative Decree 30 December 1992, n. 502 so how modified
by art. 15, paragraph 1, letters a) and b) of the law, n.
118, the evaluation methods in terms of quality, safety and
appropriateness of the activities provided, to be applied:
(a) in case of request di accreditation da part di new
public and private or start-up facilities di new activities in
pre-existing structures, on the basis of the elements set out in Annex
A of this decree, for quantum compatible in relationship alla
type of structure considered;
b) for the selection of private subjects ai Ends della stipulation
degli agreements contractual, sulla base degli elements di cui
to Annex B del present decree, per quantum compatible in
relation to the type of structure considered.
2.Annexes A and B are an integral part and substantive
of this decree.
3. The evaluation activities are developed in accordance with what
is expected from system di monitoring e verification dei Levels
essential assistance.
4. The high vigilance of the __-nbsp remains unchanged; Ministry della health such as
required by current legislation.
Art.2
Release evaluations
new institutional accreditations
1. Institutional accreditation shall confer on the _- Facilities, already’
in possession of health authorization, la qualification di subject
suitable ad dispense performance per account del Service health
national, has a limited duration in time and is aimed at ensuring
conditions di quality, security, equity e transparency
in the provision of benefits, ensuring consistency respect ai
health needs of the community.
2.The issuance of institutional accreditation di which art.
8-quarter, paragraph 7, of Legislative Decree 30 December 1992, n. 502,
in favour of new structures that ne facciano request, o For
the start of new activities in existing structures is allowed in
based on assessment, from part di each region e province
autonomous:
a) functionality and consistency respect agli addresses
current regional programming, in relation to typology e
to the volumes of services to be provided;
(b) the fulfilment of the accreditation requirements laid down in the requirements laid down; from
region o province autonomous in consistency with le indications
of the agreement between the State, the regions and the provinces autonomous del 20
December 2012 on the document containing «Specification per la revision
della legislation accreditation’ (rep. acts n. 259/CSR),
through verification documental e in loco pipelines using
of the technically accrediting body;
(c) results of the activity possibly already turning point da
part of the requesting structure;
(d) the commitment to pursuit degli objectives di security
of performance, defined from region o province autonomous
taking into account the legislation on the management of the risk clinical e
of the safety-related items listed in Annex A del
present decree;
e) degli outcomes of activities di control, vigilance e
monitoring for evaluation in terms of quality, safety ed
appropriateness of activities dispensed, second quantum listed
in Annex A.
3.The regions and autonomous provinces shall carry out, within _- a term
anyway not top a six months from data di release
of accreditation, verification of what is established in points c) ed
e) of paragraph 2, for structures that not abbiano carried out ACTIVITIES
Healthcare o socio-health formerly al Release
of accreditation.
4. The structures referred to in paragraph 2, in possession of the authorisation
to exercise, which submit the application again accreditation, the
accompany a self-assessment, regarding the possession of the requirements
further di accreditation e alla conformity agli elements
listed in the Annex A del present decree, as well as ‘ di a
activity report possibly already turning point in regime di
permission.
5.It is the responsibility of each region and autonomous province to supervise the
maintenance of requirements minimum authorizations e dei Additional accreditation requirements
.
Art. 3
Evaluation of activities with reference ai subjects private
accredited persons interested in entering into contractual agreements
1. In the identification of private subjects for the purposes of stipulation
of contractual agreements, each region e province autonomous
takes into account the provisions of which art. 8-d, comma
1-bis, of Legislative Decree no.502 del 1992, that require The
publication of a notice containing objective selection criteria,
that prioritize the quality and minimum volumes of
specific services to be provided. The selection of such subjects e’
made periodically, held account of specifications
organizational and consistent with programming regional, delle
eventual needs di rationalization della network in
convention, of the activity carried out for the subjects already holders
of chords contractual, of the effective power supply in manner
continuative e timely del dossier sanitary electronic,
as well as ‘ degli outcomes of activities di control, vigilance e
monitoring for the evaluation of activities dispensed, carried out
based on the elements reported in the Annex B del present
decree.
Art.4
National monitoring activities
1. The working table for the development and application of the system
di accreditation national, through la own activities,
ensures that the institutional accreditation system develops
in accordance with the provisions of the present decree, monitoring its application
at national level and lending if any support
to the regions and autonomous provinces in the implementation of the modalities
of verification of the elements indicated in Annexes A and B of present
decree.
2. In the selection of providers, the regions and provinces
autonomous, in relationship al own context territorial, alla
type of structures present e ai data a they disposition,
can take into account dei results of the activity di monitoring
conducted by the National Agency per i services sanitary regional
(AGENAS), relative to aspects di competence indicated agli
Annexes A and B of the present decree, using, in particular,
of the National Observatory of good practices sulla safety
in health as well as in the findings of the National Programme outcomes
(PNE).
3.AGENAS shall draw up and publish a report
with the indication of the results of the monitoring activities of
referred to in paragraph 2, on an annual basis for the structures hospital e
triennale per le other types di dispensers subjects
to accreditation. The first report is made available by the 30
November 2023.
4. AGENAS, within the framework of the activities del Program national
outcomes (PNE), promotes, in collaboration with the regions e provinces
autonomous, integrated audit paths at facilities dispensers
that present values critics per determined indicators. Such
paths are aimed at verify le anomalies through the
control of quality of encodings e, where necessary,
favor it the exceedance through specific audit
clinical-organizational coordinated from AGENAS, functional alla
identification of actions of improvement. In the fulfillment di
tali paths, AGENAS can’ avail yourself della collaboration di
professionals di proven experience in evaluation della
quality.
5.The regions e le provinces autonomous communicate, with cadence
semi-annually, by 30 June and 31 December di each year, ad
AGENAS, accreditation measures and agreements contractual
stipulated with accredited private structures, useful for monitoring
referred to in paragraph 2.
Art. 5
Final provisions
1. Le regions e le provinces autonomous adapt the own
sorting to the provisions of art. 8-quarter, comma 7 e
art.8-quinquies, paragraph 1-bis of Legislative Decree no. 502 del
1992 within nine months of the date di publication del
this decree in the Official Gazette of the Italian Republic.
2. Within the period referred to in paragraph 1 le regions e le provinces
autonomous adapt to the provisions of this decree the own
system di control, vigilance e monitoring of activities
provided, defining, in relation to the evaluation elements of which
to Annexes A and B, indicators taking into account del context del
own territory and the types of structures present, equipping itself
di specific regulation.
3. Pending the implementation of the provisions of this article
, continue ad apply i previous criteria ai purposes
of accreditation and for the conclusion of agreements contractual with
accredited private facilities.Contractual agreements stipulated
before the adaptation of the regional regulations pursuant to paragraph
1 remain effective until the contractually established expiry.
4. The verification of implementation of this measure constitutes
fulfillment for access purposes al financing integrative del
National Health Service for purposes and effects art. 2,
paragraph 68, letter c), of Law no. 191 of 23 December 2009, extended
starting from 2013 by art. 15, comma 24, del decree-law 6
July 2012, n. 95, converted, with modifications, from law 7
August 2012, n. 135, ed e’ carried out in the field del Committee
permanent for the verification of the disbursement of the LEA referred to in art. 9
of the agreement between the State, the regions and the autonomous provinces of Trento
and Bolzano sanctioned on 23 March 2005.
5.The provisions of the __- present decree are applicable in
regions with special statute and in Provinces autonomous di Trento e
Bolzano compatible with the statute of autonomy special e Le
related implementing rules.
Art. 6
Financial invariance
1.The regions and autonomous provinces shall implement the present decree,
without new or major charges a load della finance publish e
within the financial framework programmed per the Service
national health service.
This decree is published in the Gazzetta Ufficiale della
Italian Republic.
Rome,
The Minister: Schillaci
Registered at the Court of Auditors on
Office for the Control of the Acts of the Ministry del work e of
policies social, del Ministry education, del Ministry
of University and Research, Ministry della culture, del
Ministry of Health, reg.n. 3275
;—— &_ — Annex A
&_ — Annex B
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