The concept of healthcare facility “Accreditation” was introduced in Italy with the amendment decrees covering the law no. 833 of 1978: these were the legislative decrees no. 502/92 and 517/93. These regulatory provisions show the legislator’s willingness to inspire and therefore devote a major part of its legislative project to the achievement of a substantial equalisation of public and private offer within the Healthcare market and, in this way, aim at an improvement in the quality of services. The legislative decree no. 502/92, which has in fact resulted in the Second Amendment of the Healthcare System, has given rise to constitutional legitimacy objections by the Regional Authorities. In particular, objections have been raised as to the constitutional legitimacy of article 3 comma 6, and of article 4 comma 8. As to the former, the Regional Authorities complained about “…the detailed natured of such a provision. As currently worded, this article would both encroach on the primary regional competence in regulating the bodies which report to the Regional Authorities………..., and on the concurring competence as regards public assistance and beneficence, hygiene and healthcare …….”. Regarding the latter, on the other hand, the Regional Authorities lodging the claim, complained about the fact that the regulation in question prescribed that, in the institutional course leading to the establishment and identification of the Local Health Enterprises, the Central Authority reserved the right to exert absolute decision-making power. In this way, it illegally limited the regional administrative authority. The Constitutional Court, with its ruling no. 355/1993, pronounced the constitutional illegitimacy of several articles. Among these was art. 3, with respect to comma 6 and 12, and art. 4, comma 3, concerning the parts identifying the body which was to be in charge of carrying out the tasks therein described. In actual fact, the issue of accreditation and of its meaning was first dealt with in the 1994-96 National Healthcare Plan and in the 1995 Ruling no. 416 by the Constitutional Court: ”…... the term “accreditation” refers to the acknowledgement by an authority or office (in the case in point, the Regional Authorities), that a party or a body possesses specifically prescribed requirements (the so-called Qualifying Standards) and results, in this case, in the registration in a roll, which other individuals (healthcare service beneficiaries-users) may resort to…...” (Constitutional Court, Ruling no. 416/1995 ). The Constitutional Court subsequently established a regular right to accreditation by the facilities that met the requirements covered by art. 8 of the legislative decree 502/92, by linking the right to accreditation to the existence of minimum standards, which were not only requested in defence of quality and efficiency, but also in order to guarantee performance evenness and uniformity throughout the country. Accreditation is therefore viewed as an institutional course and acknowledgement, in that it is granted by a governmental body (the Regional Authorities), with the aim of identifying the parties which are to supply healthcare services, through a quality-related selection. This has introduced a significant change within the organisation of the “Healthcare System”: a market subject to regulated competition, in which a sharp distinction is made among the buyers, the suppliers and last but not least the beneficiaries of the healthcare services. All this has brought about a reversal compared to the previous notion and assessment of performance and management quality: a revised quality assessment and control which require the adoption of new parameters, such as effectiveness, efficiency, cost-control, eligibility and safety. The third amendment of the legislative decree 229/99 finally specifies the course designed for the so-called “three A”s: Authorization – Accreditation - Agreements. Authorization and Accreditation are required for the creation of facilities and for healthcare activity practice; these, together with contractual Agreements, represent the three growing guarantee levels enabling the facilities and a set number of professionals to operate within the NHS. Therefore accreditation only represents a segment (which certainly plays a crucial role) within the whole course leading to the establishment of a relationship between the party supplying a service, and the NHS that purchases this on behalf of the patient/user. Through this mechanism, Public Administration is not only in a position to select products, but also able to guarantee a minimum quality standard. Indeed, any party who has an interest in being granted accreditation is responsible for supplying evidence that it is complying with the prescribed minimum production standards. The logic underlying these legislative measures is, in any case, aimed at reorganising the system so as to attain a public/private equalisation and, in so doing, allow the private and public healthcare facilities to successfully coexist within the NHS. Therefore, this also involves a change in the public-private relationship, and at the same time in the role of Local Health Units (now called Enterprises): these are no longer viewed as the direct suppliers of the services, but as the parties meeting the citizens’ requirements, through their own facilities and other organisations which are linked to them, especially through the accreditation mechanism. The result that this administrative concurrence system is expected to yield is the ability to guarantee quality services to the patients, to the extent that accreditation may be deemed as a quality indicator for the producer who has attained it, almost an acknowledgement for its quality work. Quality within the NHS is not only assessed through performance effectiveness (that is the results achieved), but above all through the ability to meet the various requirements and expectations, such as: equity in service supply; clinical suitability, promptness, confidentiality and many other aspects. In brief, the objective is certainly that of maximising social wellbeing, which as such will never be able to provide for any type of cost minimisation. The value of accreditation consists in the very fact that it is a form of acknowledgement of the competence of the accredited party; this acknowledgement inevitably results in the acknowledgment and utilisation by the market of the services supplied. In fact, the “grant” of this certification ought to represent a stimulus for the accredited party to grow from a professional and competitive point of view; it should also represent a stimulus for constant improvement and for the development of the party’s reliability on the market., as well as for an improvement and quest for perfectibility of the services directly supplied to the users. Professionals will have to do their best to attain the highest possible results, to increase their expertise and competence and to keep constantly up to date. Failing this, they would be facing a gradual professional decline, with negative effects involving not only the individual in question, but also the related facility and hence the patients. A further quality assessment method, derived from the industrial world, is the ISO 9000 certification. ISO standards are international, and are broken down into 20 categories, which take into account every aspect of corporate management and, above all, the evaluation of the final product in terms of quality. The strength of this regulation consists in the fact that every 4-5 years the system provides for an upgrade of the art of management, thus guaranteeing constant evolution. On the other hand, the weakness consists in the absence of a well-established expertise in the healthcare sector and in the fact that often even the mere interpretation of the standards and their implementation in the field in question proves a difficult task. The focal point of such standards is the awareness that quality should not simply be assessed on the basis of the individual service rendered, but on the final outcome of the management as a whole. In actual fact, one of the emerging problems in the application of such principles in the Healthcare sector is caused by the fact that these lack specifically technical aspects. These standards only offer simple organisational rules, which require interpretation. They describe the procedures relating to the individual activities and the procedures facilitating fast, clear and easily verifiable internal communication. The ISO standards applied to Healthcare could therefore offer the opportunity to modernise a system which still continues to prove too poor and old-fashioned, and is often unable to adapt to the new requirements of the patients, whilst controlling costs and reducing squandering. On the other hand, the possible employment of this quality certification system within the healthcare sector may be faced with the limitations involved by its direct application to certain aspects of the Local Health Enterprises, especially the ones related to their management and functionality. The principles of the ISO 9000 standards are those underlying the Decree of the President of the Republic (DPR) dated 14 Jan. 1997: this lists the minimum facility, technological and organisational requirements that public and private facilities are to meet in order to qualify for the certification. In referring to this DPR, the Regional Authorities are to autonomously decide about any further requirements for accreditation. Therefore, being based on the above-mentioned DPR, all regional choices have an ISO 9000 origin, shaped to meet specific local requirements. Both accreditation and the ISO 9000 standards represent but an attempt to create a quality system for healthcare services and for the facilities providing such. Accreditation can be of two types: institutional accreditation and excellence accreditation. The former, which was introduced in Italy with the legislative decrees 502/92 and 517/93, represents a system aimed at verifying compliance with the requirements prescribed by a governmental body. Such requirements are indispensable for the attainment of the accreditation status and hence for qualifying for the stipulation of agreements with the Local Health Enterprises. Only in this way will the public and private facilities be entitled to supply services within the NHS. The positive aspect displayed by this establishment is that it gives the Regional Authorities the task of identifying and specifically detailing any further requirements for accreditation in addition to those prescribe by the Minister of Health. The latter – whose chief implementation results may be seen in America, Canada and Australia – is represented by a voluntary professional activity aimed at guaranteeing a set quality threshold, which is meant to lead to constant improvement. The procedures involved by this type of accreditation are managed by independent agencies, which have laid down standard criteria. Unlike institutional accreditation, in excellence accreditation the committee appointed by the agency to verify the existence of the requested criteria continues to cooperate with the facility in its improvement activities. In our country, it was a group of doctors who, in 1992, decided to test the accreditation procedure. First of all, they laid down their objectives, they identified specific results to be attained in terms of quality improvement, and they checked on the degree of agreement and interest shown by healthcare operators for the project. This working team was organised by the Friuli Venezia Giulia regional section of the Italian Society for Quality Control and Review. The object of the test was the First Aid Department, since this exists in all hospitals and it is characterised by a great variety of services. A list of criteria was drafted: these included reference to structural aspects, drug supplies, staff, internal organisation, procedures and results. The following year patients were examined and evaluated by the same team of doctors. The results displayed an extremely varied overall situation, with experiences showing a greater or smaller degree of positivity and satisfaction. The in-depth and detailed analysis of all the services supplied allowed the gathering of such a detailed amount of information, that it was possible to outline a complete picture of the First Aid healthcare situation for the whole region. But the accreditation was only subject to a really in-depth review with the legislative decree 229/99. Greater detail was applied in the description of the three consequential levels of guarantee: Authorisation - Accreditation - contractual Agreements. Authorisation must be requested for the creation of new healthcare facilities and in order to practice healthcare and socio-medical activities, and it assumes compliance with the minimum requirements set. The Municipal Authority is to check the compatibility of the project by submitting it to the Regional Authority, which will have to evaluate the overall requirements and the geographical location of the facilities that already exist. Authorisation to practice applies to: general practitioners’ surgeries, complex health centres, healthcare facilities and socio-medical facilities. Accreditation involves the possession of further qualification requirements and their preservation in time, since the system provides for constant inspections on the activity carried out and on the results achieved. The inspections will involve the condition of the staff, the instrumental and technological endowment and internal organisation. A regional estimate of the healthcare assistance demand which cannot be covered by the existing accredited parties/bodies is also required. The detailed documentation resulting from the inspectors’ work, combined with the overall degree of compliance to the requirements set forth by the regional plan, may lead to three different types of judgement: - Accredited, that is full and complete compliance with the most significant requirements. - Accredited with reservation, that is, substantial compliance with the chief requirements, but with some need for further integration, from a documentation, instrumental, organisational or structural point of view. - Non-accredited, that is total absence of any possible (even minimum) requirement. The granting of this title is of a temporary nature; indeed, as a rule it does not exceed a three-year validity, after which the whole procedure has to be repeated. This procedure is subsequently completed through specific contractual agreements setting forth the quality-quantity range of the services that may be supplied – with special reference to clinical suitability, waiting times and accessibility, which must be compatible with the resources available and with the scheduled assitance levels. On the other hand, the administrative procedure required to reach such agreements, as well as any competition stages involving the accredited parties, has not yet been determined. The authorised parties who wish to operate within the NHS must submit an accreditation application to the Regional Authority they belong to. Once the latter has ascertained the compliance with the prescribed qualification requirements and the functionality of the facility with respect to the regional plan, it issues to the applicant the certificate attesting accreditation for practice on behalf of the NHS. However, this accreditation certificate is not sufficient on its own in order to operate on behalf of the NHS, which is why a specific contractual agreement is required. This is how the quality of healthcare services and the selection of the supplying parties is guaranteed. Since Local Health Units (or Enterprises) only stipulate such agreements with accredited parties, a minimum quality guarantee exists both for the NHS in purchasing services on the patients’ behalf and for the patients themselves. However we should not forget that the legislative logic underlying this establishment is not only and exclusively the guaranteed of a minimum quality threshold, but it is above all the maximisation of social wellbeing and performance excellence! The 1998-2000 Healthcare Plan describes accreditation as one of the tools aimed at guaranteeing assistance levels, in that it “meets the requirement to carry out the suppliers’ selection process through assitance quality criteria” and “represents a prerequisite for the identification of the parties which, in compliance with specially designed contractual agreements, contribute to the supply of the services provided for by the annual and long-term activity plans drawn up by the Local Health Units (or Enterprises)”. This form of accreditation is therefore part of a course providing for progressive levels of guarantee, both for the parties (Regional Authorities and Local Health Enterprises) offering the assistance activity, and for the beneficiaries thereof. This is a process which changes the status of the party authorised to practice the healthcare activity into that of a party qualified to practice such activities on behalf of the NHS, thus becoming a potential supplier; only at a later stage is the party enabled, through the stipulation of specific contractual agreements, to supply such healthcare services on behalf of the NHS. Besides representing a guarantee tool for the public bodies that purchase services on behalf of the patient/user (to whom they therefore offer a quality guarantee), accreditation is, also for the producer itself, a means for certifying the quality/quantity level of the services it suppliers, which should be matched of course by fair contractual conditions; it therefore combines the purchaser’s ethical purposes (supplying healthcare assistance), with that of the producer (producing an income). Major changes have recently been introduced within the Healthcare System by the Constitutional Law no. 3/2001. If we specifically analyse the Health aspect, we shall find that art. no. 117 and 118. are particularly interesting, in that their contents is so incisive that it may possibly result into a new reorganisation of the Healthcare sector at a national level, but above all at a regional level. The former of the above-mentioned articles provides for an exclusive legislation by the State with regards to the determination of the essential level of services concerning civil and social rights, and for a concurring legislation as regards “health safeguard”, thus drawing a distinction between the fundamental principles set forth by the State through its “framework-laws” and the detailed regulations entrusted to the Regional Authorities. On the other hand, article no. 118 introduces the subsidiarity principle. The novelty introduced in our legislation by this constitutional amendment is not related to the vertical subsidiarity principle, which had already been introduced by the Bassanini Amendment: the majority of the administrative competences and functions must be first of all entrusted to the Municipal Authorities, then to the Provinces and to the Mountain Area Consortia of Municipalities, hence to the Regional Authorities and finally to the State. The real change provided for by comma 4 of art. 118 lies within the concept of horizontal subsidiarity: “State, Regional Authorities, Metropolitan Municipal Authorities, Provinces and Municipal Authorities foster citizens’ autonomous enterprise …...., for the accomplishment of activities of public interest.…”. The innovatory significance of this comma can be detected in the possibility that private parties may supply services, which so far have always been offered by the public system. This article causes the arousal of several doubts: should the word “foster” be interpreted as a mere faculty that the public authority may exert towards private parties, individuals or partnerships, or should it on the contrary be interpreted as an actual obligation to promote private enterprise? Finally, one last doubt emerges as I read the new article: has the higher rank legislator possibly decided to introduce in this way the accreditation tool to regulate the relations between the public and private sectors? Translated by interpres sas.

Amelia Sole
studentessa del 4° anno
del Corso di Laurea in Scienze Politiche
dell’UNICAL