Institutional accreditation of Health Services in Italy: the long road to quality

Introduction

The term “accreditation” was introduced in Italian health legislation in the early ‘90s, with the adoption of decrees 502/1992 e 517/1993¹. The concept added a new element to the authorisation system defined in Law n. 833, that had established the Italian National Health Service (SSN) in 1978. It has developed over time into an institutional recognition, issued by the Public Authority, that is a statutory requirement for any entity providing services as part of the SSN. It aims to achieve a high level of guarantee of service quality and of the selection of service providers, public and private, that work as part of, or on behalf of, the SSN. Specifically, the National Health Plan 1998–2000 identified the accreditation as one of instruments for ensuring quality of healthcare in that it “responds to the need for a process of provider selection that applies healthcare quality criteria”, thus clearly identifying their essential aims and characteristics. The implementation of this policy was slow and difficult, not only because of the strength of economic interests associated with healthcare activity and the birth of federalism in healthcare provision, but also because of a widespread culture that tends to give more importance to the work of the individual healthcare professional than to achieving a well-integrated and co-ordinated system as a whole, with attention to, and demonstration of, transparency in terms of inputs (resources) and outputs (processes, results and outcomes).

Regulatory development between national and regional level

In order to achieve a smooth transition from the previous contracting system to the new accreditation system, Law 724/1994 introduced the concept of “Temporary Accreditation” for those entities already contracted on January 1^st 1993, subject to the acceptance of the fixed price system for services provided. Unfortunately that transitional period, that was intended to apply only during 1995 and 1996, was prolonged in most Italian regions and was finally revoked only in 2008. During the same period, in response to legal appeals by some regions, the Constitutional Court was deliberating on the subject of accreditation, providing clarifications on the meaning and specifying that “accreditation” was distinct from “authorisation” and that it constituted a second step in the process. As a consequence, it was impossible for the implementation to proceed without the enactment of the government decree establishing the minimal requirements for authorisation (licensure). This was due for adoption in 1993 but was not, in fact, published until 4 years later, in 1997².

No instruction was provided to the regional Authorities regarding the terms “accreditation”, or “control and quality improvement”; their definition remained at the level of technical and academic discussion³. In 1999, the so-called “Third Reform of the National Health Service”⁴ elaborated and defined the entire subject of authorisation and institutional accreditation in the following terms:

• - authorisation for construction is the administrative measure that permits the construction of new health and social health buildings on the basis of real need with regard to regional planning;

• - authorisation for practice is the administrative measure (licensure) that permits the practice of health or social health activities by public or private subjects. This authorisation is released on the basis of the demonstration of compliance with minimal structural, technological and organisational requirements;

• - institutional accreditation is the administrative measure through which a region authorises an entity to provide services in the name and on behalf of the SSN. It is released subject to verification of compliance with a further series of requirements. Through the accreditation process, each regional Authority constructs its own list of service providers, specifically qualified.

In the latter case, contractual agreements can be established in which the regional Authorities and local health service organisations define, together with public and private accredited entities, the type and the quantity of services to be provided to the regional health service, the health objectives and the means of integration, as well as the associated prices to be paid by the public service.

Since 1999, there have not been substantial modifications to the legislative framework established by Law 229/99. However, the basis of the institutional relationships between the State and the regions has changed considerably following the reform of Part V of the Italian Constitution (Constitutional Law n. 3 of 2001), which increased the powers of the regional Authorities, enlarging their competence for the organisation of health services.

As a result, 21 models for regional accreditation developed in the subsequent decade. These had some characteristics in common but there were significant differences too; the models were summarised in a study by the National Agency for Regional Health Care Services (Agenzia Nazionale per i Servizi Sanitari Regionali - Age.Na.S.) published in 2009⁵. The quality criteria most frequently found in the regional provisions are: patient satisfaction, service access, communication, continuous quality improvement, presence of guidelines and protocols, information and data management, technology assessment, appropriateness and continuity of service provision. Age.Na.S. revisited the topic in 2013, updating and exploring it in more depth, summarising the entire picture of regional planning for authorisation - accreditation and focusing on the more recent measures and, in particular, on those adopted to finally overcome temporary accreditation⁶.

In more recent years, there has been a move towards ever greater harmonisation and sharing of approaches between the regional Authorities, a process that has been reinforced by challenges from Europe. Two agreements between the State and the regional Authorities on December 16^th 2010 addressed the quality, safety and appropriateness of the maternity care pathway and blood activities and transfusion medicine⁷. The agreement prioritised the adoption of uniform health and accreditation policies (including a requirement for a minimum of 1,000 births per year). Two important measures were adopted on July 25^th 2012 that promoted national standardisation in a more detailed manner. One was the “Agreement” on guidelines for the accreditation of blood Establishment and blood collection Units and the other was the “Understanding” on standards for the accreditation of hospices and for palliative care and pain therapy units.

Lastly, the Agreement of March 13^th 2013 on the definition of regional or inter-regional care pathways for patients with congenital haemorrhagic disorders defines general instructions and 23 specific “activities” that organisations accredited for the management of these patients must accomplish⁸.

At the end of this long journey, the destination is also a point of departure: the “Understanding” between the State and the regions of December 20^th 2012 defines 8 macro criteria, 28 macro requirements and 123 specific elements of evidence, on the basis of which the regional Authorities are reformulating and updating their own measures for institutional accreditation: operation of a comprehensive management system with identification of roles and responsibilities, description of the range of services provided, suitability of the facilities and equipment, specific competencies of the personnel, communication between professionals and with patients, appropriate clinical practice and risk management, process improvement and innovation and humanisation⁹.

Conclusions

Institutional statutory accreditation is in a phase of renewal in the SSN, with a movement toward ever greater convergence between the regional models, in the interest of greater standardisation, uniformity and quality of the health services delivered to citisens¹⁰. We look forward to a new phase of intense co-operation between the State and the regional Authorities, the professionals and the Health Service organisations.