SAN MARINO
LAW 25 May 2004 69
REPUBLIC OF SAN MARINO

LEGISLATION ON AUTHORIZATION Realiz TION,
EXERCISE AND INSTITUTIONAL accreditation D ELLE | || HEALTHCARE AND SOCIAL AND PUBLIC HEALTH EP rivate


We the Captains Regent of the Most Serene Republic of San Marino
Promulgate and publish the following law approved by the Great and General Council
its meeting on 25 May 2004
CHAPTER I


General Provisions Art.
1 (Purpose)
The State guarantees citizens and users, through the authorization procedures to
construction, operation and institutional accreditation of public and private structures, effective performance
and safe, continuous improvement of the quality of health centers and health and social
and the systematic development and programmto of health and public health and social services.
Art.
2 (Definitions)
To authorize the establishment and operation means a legal act of the
verify possession, by those who request them, the structural, technological and organizational pre-declared || | objectively and held for realization and ye ar es of medical, social and health and socio-educational
.
For institutional accreditation means the posses or all of the requirements to the realization and
year, with the addition of ascertaining the quality of services provided and results achieved
, in order to provide power performance on behalf of the Public Health Service.

CHAPTER II Authorizations


Art. 3
(Licensing)
They are subject to authorization, the following structures:
a. performance of health facilities that provide specialized care in outpatient regime
;
B. structures that provide high performance of general p tion in outpatient or inpatient
in continuous or diurnal cycle acute;
C. facilities that provide services in hospital ricover regime in continuous cycle or day
acute;
D. health facilities and social health that provide performance in a residential regime and
semi;
E. spas;
F. dentists, doctors and other health professions, where equipped to deliver
ambulatory surgery performance, ie diagnostic and therapeutic procedures
particularly complex or which involve a risk to patient safety;
G. structures as homes characterized by low care intensity, designed to
subjects self-sufficient without a valid family support for children, disabled, elderly and
people with psycho-social problems;
H. with function to protect structures, characterized by medium care intensity, designed to
fragile and subject to risk of loss of autonomy, without valid
family support for children, the disabled, the elderly and people with psycho-social problems;
I. structures with protected function, characterized by a lto level of intensity and complexity of care
, destined to non self-sufficient needing to cycle
daytime or permanent residency and temporary protection of relief to families to function
disabled and elderly;
J. socio-educational facilities for young children;
K) clinics, where you make diagnostic tests, levies and visits
for the exercise of the health surveillance referred to n.31 / 1998 Law are subject to approval
.
They are not subject to permit professional and local studies pertaining to the operation of
health professions that do not fit in the type specified in the first paragraph, where the specialist will be detailed
in the regulation of requirements.
The health care professionals referred to in the second paragraph are nonetheless obliged to
announce the opening of its state Authority study hereafter.
The said authority has made to the studies where they practice health professions
watch for the respect of rules on hygiene and public health.
Art.
4 (Requirements for the authorization and accreditation)

reggenziale by decree, two separate Regulations Within sixty days after the entry into force of this Act are issued, in which we will define the individual types of
health facilities, social and health care of those and those socio-educational, with its general requirements and specific
for authorizing the construction, operation and accreditation.
The requirements will still updated by decree r ggenziale whenever the technological evolution
or regulation so requires.
Art. 5

(Authority for the authorization, accreditation and quality
health services, social and health and youth)
It 'set up the body for the authorization, accreditation and quality of health services, health and social
and youth, hereinafter referred to as Authority.
The Executive Authority also provides technical support for the exercise of functions relating to health and social services programming
.
Art. 6
(Authority Functions)
The Authority will in particular provide for:
1. coordinate and supervise, as a technical body, the licensing system and
institutional accreditation of health facilities, social care and those socio public and private education
;
2. carry out the analysis of epidemiological data, the population's health needs and the
evaluation of the application on health services, social and health and those socio-educational
; 3
. provide technical support to the health and socio-health programming, n
particular to achieve the objectives set by the health plan;
4. provide the necessary technical support in the development of tools and methodologies for
evaluating the appropriateness of use of technologies, for the definition and management of
care pathways, for the detection of qulità perceived by service users | || health, social, health and educational partner;
5. provide the necessary support, such as technical body, the verification of the quality of services and
of health services, social care and the social and educational, both regarding
public and competent administrative bodies structures, which as to the private
credited;
6. carry out the monitoring of the implementation of continuing education programs;
7. developing methodologies and tools for the definition and evaluation of projects
socio-health integration and clinical innovation programs, organization and management;
8. cooperate and develop relations with WHO technical bodies, with universities and research bodies and
study on strategic issues of innovation;
9. organizing a health and socio-health information system for the collection and processing of government data
and support the programming exercise, the management and
innovation of public and private services.
Art. 7
(Organic and operational areas of the Authority)
The Authority's executive is appointed by the Great and General Council from a list of experts
regarding health care planning and organization, given by the State Congress, in
meet the following requirements:
- university degree
- at least five years experience of factory management and administration in public or private structures
in the health and social health, took place in the ten years prior to serving;
- Training or master's degree in eg health organization concerned with its outcome positive
issued by public or private accredited, operating in the field of education management
.
The leader of the employment relationship is exclusive and is governed by private law contracts of
duration of three years, renewable once.
The staff of the Authority will be defined by ordinary legg.
To carry out the functions referred to in Article 6, the Authority must employ qualified
professional skills.
The Authority may, for particularly complex valuation issues, professionals or private
coming from government.
The State Congress annually submit to the Great and General Council a report on the activities of the Authority
.



Art. 8
(Authorization for the construction of rie healthcare facilities, social and health
and the socio-educational)
Entities wishing to implement, expand, TRASFO sea or transferring health facilities, social and health
and social and educational, without prejudice to the obligations under the Law 28 April 1999 n. 53 and subsequent
implementing decrees, must submit the request to the Authority where is documented:
1. the activities that you intend to deliver, with clear indication of the type, quantity and quality of
performance level.
2. Structural requirements and plant building ture of the instrument and of the premises in which you plan to conduct business
. 3
. professional staff with relevant qualifications of the operators and all personnel
.
4. Compliance building and permissions of the law of building units and installations and
assigned to the business equipment.
The aforementioned documents, details of which will be better defined by the regulations on the requirements

structural, technological and organizational, will be the basic reference for the inquiry and the opinion that the
Authority will send to the Congress of State by tren to days of receiving the request.
The Congress of State, in the case of certain conflicting assessments of new elements not
emerged during the investigation, returns with adequate reasons a second inquiry.
The Authority, for the tasks set out in this article, you can make use of specific professional skills and administrative
present in Public Administration.
Art.
9 (Authorisation to the medical, social and health
and the socio-educational)
Those authorized the construction of health facilities, social and health and the socio-educational
on completion of the construction work and in any case before using the same should apply to the Authority
authorize the pursuit of.
The Authority shall conduct verification of effective compliance with the requirements, within thirty days, using
staff specially accredited.
If check is OK, within fifteen days is granted final authorization
exercise.
Art. 10
(Provisions common to authorization)
The issued permit shall state:
- the personal details of the applicant in the event that the latter is a natural person;
- The seat and the name in case the applicant is a company;
- The seat and the name in case the applicant is a public entity;
- The type of authorized services;
- Any requirements to ensure the effective fulfillment of requirements;
- The name and the qualification of healthcare rio Director or the responsible manager.
Art. 11
(in opposition appeals)
In the event of refusal of authorization or in the case that contains the same requirements deemed incorrect
or unacceptable, the applicant may appeal, objection under Article 12
Law of 28 June 1989 68.
Espresso another refusal, the applicant concerned may ere the administrative justice with
procedures provided by law.
Art. 12
(Transmission and lapse)
The authorization is transmitted, in the opinion of the Authority, only in the case of transfer to a
party other than authorized, provided they meet the legal requirements .
In the case of an authorized person dies, the heirs can pursue activities
for a period not exceeding one hundred and eighty days from death.
The authorization also lapses in the event of termination of the legal person authorized and renunciation of the authorized
.
Art. 13
(Maintenance of authorization and supervision requirements)
The entities authorized to sanit ria activities, social and health and socio-educational,
send to the Authority, every two years, on the self-declaration permanence of possession of
requirements.
The Authority shall exercise controls and inspections with use being made of personnel with technical skills
of evaluator of quality systems according to current regulations.
The staff, though not directly dependent on the Authority, must, however, be included in a special list
held by the said Authority.
Each control and inspection must be subject to special reasoned report, countersigned by
evaluators, registered and preserved for any legal use.
The outcome of the checks and verifications shall be communicated to the structure t mpestivamente interested
.
The Authority, although they can conduct supervision at a pace determined by its independent responsibility
, it is always bound to at least one annual inspection.
Art.
14 (Suspension and revocation)
In case of violation of the rules of this Act or of the conditions attached in the
order permitting or welfare dysfunction that can be eliminated through appropriate and suitable
interventions, the Authority distrusts the person authorized to provide for the regularization
or submit any justification or counterclaims within a reasonable
term.
The Authority, if it is not satisfied with the justifications put forward, or if the time has elapsed
unnecessarily period granted or have been provided in full or in part in the
regularization requests, order the closure of the structure until they are not removed
causes that led to the measure.
The reopening must be specifically authorized by the Authority.
In the case of serious or repeated infringements of the provisions of this Act or the conditions attached to the

Order permitting or serious dysfunction repeated assistance, the Authority asks, with
reasoned decision, the State Congress the withdrawal itself.



Art.
15 (Sanctions)
The exercise of health or social health without the required authorizations
activity involves the subjection to an administrative penalty in the amount of between a minimum of € 5,000.00
and a maximum of EUR 20,000.00 and the prevention of operation of the same activity for
a year.
In the case of construction, extension, transformation and transfer of structures without
authorization, the Authority proposes to the State Congress for the immediate closure.
CHAPTER III Institutional accreditation


Art.
16 (Requirements and procedures for institutional accreditation)
The determination of the additional requirements for accreditation under the second paragraph of Article 2
, uniforms for public and private structures, is established by the State Congress, on a proposal
Authority, in relation to the functions identified by the state planning to ensure
levels of health care, social and health and the socio-educational, under the plan, and health
national social health.
Those requirements can also be established with distinct measures in relation to different types of structures
.
The Congress of State verifies that they meet the requirements for accreditation using
Authority.
The Authority shall ensure the examination of the documentation and performs the verification visits,
directly or through qualified entities, based on the already established procedures for the authorization
exercise.
Once you have checked, the Authority shall provide a report reasoned all'accreditabilità
order or less of the structure.
The Congress of State, on the basis of the documentation provided, grants or denies accreditation with
precisely measure within six months of submission of the application.
Accreditation may also be granted with prescriptions.
In this case, the measure establishes the maximum term for the adaptation and
within which the Authority provides for a reassessment.
The accreditation is valid for three years and demand for renewal must be submitted at least six
months before the expiry date of the previous ext institutional accredited ranges.
No creditable the Anonymous Society, and legal persons whose members are not
individuals.
Art. 17
(in opposition appeals)
In the case of accreditation refusal or if the release contains requirements deemed incorrect
or unacceptable, the applicant may appeal, objection under Article 12 | || Law of 28 June 1989 68.
Espresso a further denial the applicant may appeal to the administrative courts with
procedures provided by law.
Art. 18
(Temporary Accreditation)
All health facilities, social and health and socio-educational accredited, for the activation of new
structures or for starting new activities in existing facilities, must apply,
together with the authorization to the exercise, the temporary accreditation for the time necessary to verify the
volume of activity carried out and the quality of its results, and in any case for a period not exceeding six months
.
The temporary accreditation should be issued after positive verification of
functionality than the programming addresses and possession of authorization requirements and those
further specified in Article 16.

Art. 19
(Surveillance, suspension and revocation institutional accreditation)
The Authority can verify the permanence of the requirements for
anytime accreditation and implementation of requirements that may be adopted by the measure
same accreditation.
If the Authority finds the loss of r requirements for accreditation, issues warning to
provide for the regularization or submit any justification or counterclaims
within a reasonable period.
The Authority, if it is not satisfied with the justifications put forward or if it is unnecessarily spent
the term of regularization, send pro preclude the State Congress:
- revocation, in case of loss essential requirements or in the event of a breach of the agreements
performance;
- Suspension, until they are not removed the causes that determined the
measure.
The accreditation can not be suspended for more than three years, he spent unnecessarily
which is revoked.
The accreditation is suspended or revoked, respectively, in case of suspension or revocation of

Order permitting.
Art.
20 (Charges for the authorization and accreditation)
All costs, direct and indirect, for approving and accreditation, checks and inspections
are borne by the requesting parties.
With Regency Decree will be issued a special tariff that will be periodically updated
according to the costs incurred by the Public.
Art. 21
(contractual agreements)
accredited Subjects for health, social care and private socio-educational activities can access
contractual agreements with the public body for the provision of performance.
The Congress of State, making use of the Authority, is required to determine the scope
of contractual agreements by defining:
- guidelines for the formulation of the work programs of the facilities concerned, with
indication of functions and activities to strengthen and weaken, along the lines of
national planning and in meeting the priorities of the health and social-health plan;
- Plan of activities related to high cuisine and the network of emergency services;
- Criteria for determining the remuneration of the structures;
- Health goals and the integration of services programs;
- Maximum volume of services that these structures are committed to ensuring,
distinguished by type and mode of assistance;
- Service requirements to make, especially with regard to accessibility, appropriateness
clinical and organizational, waiting times and continuity of care.

CHAPTER IV Adaptation of existing structures and final provisions
Art. 22
(Provisional authorization)
The subjects, the date of entry into force of this Law, the performance of medical, social and health
and socio-educational, provided for in Article 3, may continue their activities until
authorization provided respect the laws in force in health and hygiene, the
job security and protecting the natural environment and built.
The same must adapt the structures to the requirements within the time allowed by a specific
measure of the State Congress, felt the Authori y.
The adjustment must still be made within three years after entry into force of this
measure.
Art. 23
(Provisional Accreditation)
The public health facilities, social and health and qu us a socio-educational in service on
entry into force of this Act, shall be provisionally accredited.
The same will be subject to institutional accreditation within the timeframe set by the State Congress, felt
the Authority.
The adjustment must still be made within three years after entry into force of this
measure.
The Budget Law will allocate annually in an own budget adequate resources to
accreditation of public facilities within the ermini provided by this Act.
Art.
24 (Transitional Provisions)
Institutional accreditation for rie healthcare activities, social and health and socio-educational
can not be activated and released before the processing and approval of the health plan and socio | || many years of health.
Art.
25 (Special provisions for socio-educational facilities for young children)
The operating authorization and accreditation, and forward tasks, inspection and control
of socio-educational services for early childhood, at the state or private management,
occur in the manner prescribed by this Act.
To fulfill these functions the Authority, in addition to skills already present within it,
will use an educational psychology expert appointed by the Congress of State and a
expert in the field of social and educational services, indicated by the Manager the Minors' Service, identifiable
even among those employed in the same service.
Art.
26 (Repeals)
are repealed all provisions contrary to this law and, especially, are repealed
Read 1 December 1982 and all 106 articles of the Law January 28, 1987 # 10 for
exception of articles 8, 9, 10 and 11.
Art.
27 (Entry into force)
This Law shall enter into force on the 30th day following that of its legal publication.



Our Residence, this day of 31 May 2004/1703 dFR






The Captains Regent Paolo Bollini - Marino Riccardi