Assistance with the accreditation procedure for private healthcare facilities
Institutional accreditation is the procedure through which an already authorised healthcare or health and social care facility is recognised as eligible to operate within the public healthcare system, subject to additional requirements concerning quality, organisation, appropriateness and consistency with regional healthcare planning.
Article 8-quater of Legislative Decree 502/1992 provides that institutional accreditation is granted by the Region to authorised public or private facilities, and to professionals who apply for it. Accreditation is conditional upon verification of additional qualification requirements, consistency with regional planning objectives, and a positive assessment of the activities carried out and the results achieved.
In Sicily, Regional Decree No. 741 of 4 July 2023 contains the consolidated regional provisions governing the authorisation and accreditation of public and private healthcare facilities, updating the framework previously established by Regional Decree No. 724/2022 and subsequent amendments.
Avv. Vecce assists private healthcare facilities, outpatient clinics, laboratories, specialist centres and sector operators in preparing accreditation applications, verifying the applicable requirements, organising the supporting documentation and managing relations with regional offices and the competent technical bodies.
Activities covered
Why it matters
Moving beyond authorisation
Accreditation requires additional requirements beyond the mere entitlement to provide healthcare services.
Organising documentation
Procedures, organisational charts, responsibilities and management documents must be consistent and capable of verification.
Managing the review process
The administrative and technical assessment requires accurate and timely responses to requests, findings and requests for additional documentation.
Preparing for the relationship with the Regional Health Service
Accreditation is a necessary, but not sufficient, step before entering into a contractual relationship with the Regional Health Service.
FAQ
What is institutional accreditation?
Institutional accreditation is the formal recognition by the Region that an authorised healthcare or health and social care facility meets the additional requirements necessary to operate within the public healthcare system. Article 8-quater of Legislative Decree 502/1992 links accreditation to prior authorisation, compliance with additional requirements and consistency with regional healthcare planning.
Is accreditation different from healthcare authorisation?
Yes. Healthcare authorisation allows a facility to provide healthcare services. Accreditation is a separate and subsequent step that determines whether the facility is eligible to operate within the public healthcare system by meeting additional statutory requirements.
Does an authorised facility have an automatic right to accreditation?
No. Authorisation is a prerequisite, but it is not sufficient. The facility must also demonstrate compliance with additional requirements relating to organisational documentation, quality standards, internal processes and consistency with regional healthcare planning.
Does accreditation automatically give the facility the right to enter into a contract with the Regional Health Service?
No. Accreditation does not coincide with contracting. The financial relationship with the Regional Health Service, including service volumes, budget allocations and reimbursable services, is governed by a separate and subsequent procedure.
Which documents are relevant to the accreditation procedure?
Relevant documents include the healthcare authorisation, organisational documentation, internal procedures, organisational charts, professional qualification records, equipment documentation, operational protocols, quality management systems and any additional documents required under the applicable regional legislation.
Who verifies the requirements?
The assessment is carried out by the competent regional authorities and the designated technical bodies in accordance with the applicable regional legislation. In Sicily, Regional Decree No. 741 of 4 July 2023 forms part of the regulatory framework governing the authorisation and accreditation of public and private healthcare facilities.
What happens if deficiencies or issues are identified?
The facility may be required to provide additional documents, clarifications or further supporting material. At this stage, it is important to respond in an organised manner, demonstrating that the applicable requirements are met and that the facility’s internal organisation is consistent with them.
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