By publishing the abstract of the graduation thesis written by Ms Amelia Sole, we are initiating the work relating the commitment made by our Editor to set aside in our “Palestra Universitaria” [NdT: University Training Ground] column a specials section for university course papers prepared by students in the field of Health-related law and economy. The thesis prepared and discussed by Ms Amelia Sole, former student at the Political Science Faculty of the University of Calabria, who graduated summa cum laude in March 2003, is definitely a worthy thesis, both for the importance of the subject matter and for the high quality of the dissertation itself. We hereby wish to thank Prof. Silvio Gambino, Faculty dean, and Prof. Paolo Jedlowski, chairman of the University Course, for the availability they have granted to us in institutional terms.

The title of the thesis is:
Institutional Accreditation
within the National Health Service

Supervisor: Prof.
Ettore Jorio

Accreditation is a service quality award granted to public or private facilities which are already qualified to carry out their activities, or to professionals who apply for it.

This “institution” was introduced into our legal system with art. no. 8 of the legislative decree no. 502/92, as part of the legal provisions redesigning the organisation of our Healthcare System.

The legislator laid down the minimum standards requested for technological, structural and organisational features, so as to establish the features of the “access organisation” that all those who have an interest in providing services on behalf of the National Health Service (NHS) need to comply with, thus offering guarantees to users so as to obtain the best possible quality from the services supplied.
The new legislation supersedes the old NHS-convention system (save for family doctors or GPs and freely chosen paediatricians, as well as chemist’s shops) and results in a substantial equalization between public and private facilities, through the identification of the quality/quantity requirements which are regarded as necessary in order to ensure effective and efficient services. In itself, this accreditation does not have a contractual nature.
In fact, it is only through the stipulation of specially designed agreements, which are of a contractual nature and which set up an economic understanding between the purchasing and the offering party, that the modes, types and quality of the services are defined, and that the commitments reciprocally undertaken by the parties to the bilateral contract are identified.
Once it has been included in the list of certified institutions, the party is authorised and expected to carry out the activity for which it has applied for accreditation. Once the accreditation has been granted, the Public Administration has in turn no positive duty towards the certified party (any rights and duties will eventually arise from the subsequent contract) save for a general surveillance power over the activity. Based on the general principles of administrative law, Public Administration retains the power to retroactively declare the deed null and void owing to legitimacy errors; to revoke the deed displaying any merits errors for public interest purposes, effective as of the date of revocation; and lastly to declare its withdrawal owing to failure to maintain the prescribed requirements or its lapse in the event of non performance of the activity itself. In the event that the accreditation is denied, since this is a final deed, the applicant is entitled to file an appeal according to the jurisdictional procedure prescribed, or in exceptional cases, directly with the Head of State. With its ruling no. 2940/2002, the Council of State decreed that “neither the preventive authorisation nor the subsequent accreditation fall within typical corporate assets, that may be transferred from one party to another, and hence a change in ownership (either among living parties or as a result of one of the party’s death) results in a situation which is completely different from the previous one”.

This will therefore force the “new purchasing party” to newly apply for both provisions (authorisation and accreditation), which will be granted ob rem ac personam, which means that these measures will be subject to the contemporary existence of objective and subjective requirements, the latter being also related to the professional ethics and to the moral standards of the new owner-applicant.
There are two possible types of accreditation: an institutional accreditation and an excellence accreditation The former, which is the one that was introduced into our legal system, represents some sort of audit carried out by a governmental or delegated body, to check on the existence of the minimum facility requirements which are deemed to be indispensable to protect the user for whom the service is designed. It is deemed as compulsory by our Healthcare System, since no public or private facility may, without this accreditation, operate in an integrated manner, within the National Health Service. This civil rights defence tool made its very first appearance in Italy. Its chief feature, which almost provides its unique identifying character, consists in the fact that it delegates to the Regional Authorities the tasks to define the technological, structural and organisational features required both for granting the authorisation and for identifying the standards that “applying candidates” are to comply with to obtain the accreditation. The Regional Authority is to set the manner in which the assessment of facilities, procedures and produced results in terms of quality and treatment adequacy is to be conducted.
The latter, on the other hand, is used in English speaking countries, and in special way in America, Canada and Australia.
The accreditation procedure is deemed as a professional activity aimed at guaranteeing that the quality of service does not drop below certain standards which are rated as minimal, and that it displays in any case a trend towards constant improvement. The accreditation procedures are usually handled by independent agencies. These preliminary remarks already point to the most significant differences in terms of “project” and merits. Institutional accreditation is meant to meet a dichotomic requirement (YES/NO): are there any pre-established standards? Do the facilities meet such standards? Are those which do not fall within such standards eliminated? Excellence accreditation, on the other hand, is based on a comparative type system among homogenous realities: there are no fixed requirements set beforehand, but general ratings are followed which may be adjusted to fit a variety of different realities.
These are ratings that change over time and depending on the country, and are related to the quality of the service provided over the period in question (best practices). Institutional and excellence accreditation are in fact two evaluation systems operating according to different logics and pursue different purposes, which directly represent the cultural expectations arising from the geographical and political features of the countries which adopt them.
It was the general policy law no. 328/2000 that further broadened the field of application of this so innovative tool. It did so by introducing it into the field of social services and of residential and semi-residential facilities. Art. no. 11 of the above-mentioned law explains what the concepts of authorisation and accreditation mean.
The authorisation is required in order to create facilities and carry out assistance activity, whereas the accreditation is the unrenounceable prerequisite for these parties, who have already been granted authorisation, in order to enter the integrated intervention and social service system. Paragraph 1 of this article specifies that the requirements needed in order to qualify for the authorisation, both for public and private facilities, need to be prescribed through regional laws, whose purpose will be to integrated the minimum standards set at a national level, by adjusting them to local needs.
Paragraph 3 of art. no. 11 also prescribes that the accreditation of services and facilities be granted at a regional level, and that certified parties be paid the fees for supplied services within regional and local plans. The meaning of the words “within regional and local plans”, as it relates to the supply of services to be paid to the certified parties, appears to be in keeping with the solution which had already been resorted to with the 1999 NHS reformation, which established an indissoluble link between the possibility of paying the services provided, as well as the contents of the accreditation grants themselves, to the planned demand.
The shortness and concision of the referenced articles seems to inevitably involve that the law is designed to allow the Regional Authorities to enjoy significant discretionary power in this field, since each Region has the possibility to create a accreditation system that meets local requirements as much as possible. If we leave the accreditation subject for a moment, but remain within the field of quality, we should most definitely observe that the ISO (International Organisation for Standardisation) 9000 series standards are ascribed a key role.

The approach to health organisation implemented through this selective system is also based on the acknowledgement of the key role played by the assessment of the final product/service outcome, thus introducing the concept that quality is not only based on individual performances, but on the overall management of the whole system, because it is only thanks to a careful organisational management and to an evaluation of resources, that each “enterprise” can start a steady course of improvement.
Vision 2000 is the name that has been given to the ten-year programme introduced to review and improve the above-mentioned regulations.
The leading concept that has inspired the review can be traced back in the implementation of the quality concept and in the achievement of an ideal condition whereby the requirements of all the parties involved in the process of producing/enjoying goods and services are satisfied.
The certification in question proves to be applicable to the aspects of the healthcare world which relate to its organisation, management and functions, but shows no interest for other aspects which certainly do not play a negligible role within assistance processes involving a high degree of specialisation and professionalism. With the issue of the legislative decree no. 502/92, many Regional Authorities have started to move towards accreditation.
However, there have certainly been different courses and choices involved: some have simply implemented the decree relating to authorisation, whereas others have designed and put into effect their own accreditation system. As of today, the situation applying to the various regional realities can be summarised as follows:

- six Regional Authorities (Trentino Alto Adige, Veneto, Friuli Venezia Giulia, Molise, Calabria and Sicily) have not implemented the 1997 Decree of the President of the Republic;

- seven Regional Authorities (Valle D’Aosta, Trento, Emilia Romagna, Tuscany, Umbria, Marches and Basilicata) have on the other hand implemented the above mentioned Decree of the President of the Republic and have consequently adopted a new reference legislation;

- Lombardy and Apulia have implemented the Decree of the President of the Republic but have not designed a reference legislation.

The situation certainly appears more varied if we take into account the definition of those that are described as further requirements.
Only nine Regional Authorities have issued specific deeds aimed at regulating such; out of these nine Regional Authorities, only Valle D’Aosta, Lombardy, Friuli, Emilia Romagna, Tuscany, Basilicata and Calabria have also arranged for the approval deed in connection with the above mentioned requirements. At an international level the different formats given to the accreditation models in the various industrialised countries worldwide represent an interesting example of a different way of viewing quality in the healthcare field. In its embryonic stage, accreditation was first devised in the United States in 1910, thanks to the efforts of Dr. Ernest Codman. In any event, it was only in 1951 that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) was established; this created and published the first Standards for Hospitals’ Accreditation, providing for the minimal requirements of healthcare service suppliers.
The United Kingdom has not devised a national accreditation system.
The National Health Service (NHS) is indeed against any form of surveillance. Only toward the end of the 1980s was an accreditation agency created, in line with the experience of other English-speaking countries. But despite the various attempts made to propose national bodies for standard definition and surveillance, there have not been any notable national developments.
The accreditation system that has developed without a national political-institutional support has in itself been inconsistent and particularly complex. Among the best organised and serious ones is the King’s Fund Organisational Audit, designed for hospitals, first aid and community hospitals. Also France, following the example of many European Countries, started in the nineties its progress towards accreditation, as part of an overall Healthcare renewal and reorganisation plan. It was the law issued on 24 April 1996 that introduced and disciplined the accreditation procedure, based on a range of previous reformations aimed at solving the problems relating to healthcare management.
The realisation of an accreditation system for healthcare facilities, under the surveillance of ANAES (Agence Nationale d’Accreditation et d’Evaluation en Santé), represents a guarantee of service quality.
In Canada, on the initiative of the medical associations and of the Hospital Association, the Canadian Council on Accreditation of Healthcare Organizations (CCAHO), was established in 1958 and it continues to be the only accreditation agency acknowledged by the Canadian Secretary of State. The objective was to offer increasing quality services through a multidisciplinary approach involving all patients, physicians, staff members and volunteers.
The Australian accreditation system, on the other hand, is optional and it is managed by the Australian Council on Healthcare Standards (ACHS), a body established in 1974. ACHS provides for different levels of accreditation: full three-yearly accreditation; partial yearly accreditation; no accreditation. The surveys are conducted by nurses, physicians and administrators, who are duly qualified to carry out their tasks. The purpose is to ensure constant improvement based on full self-assessment of the facility. Despite the differences arising from the various national experiences, accreditation increasingly appears a tool capable of regulating the healthcare service supply.
The most difficult goal the various operators will have to attain will be to consolidate into a single tool the strictness of an objective method, aimed at protecting citizens’ health and the desirable flexibility typical of human resources, to guarantee the quality of interpersonal relations required for the “humanisation” of the whole System.
There are many concerns regarding the actual impact of accreditation activity.
The risk we face is that great part of the activities and actions grouped under this heading may end up being a range of bureaucratic accomplishments rather than a real tool capable of protecting citizens.
The right approach at this stage, in view of the failures and negligence-related delays displayed so far, would be to cherish the common hope that experience may teach us the best way to proceed and hence implement a quality healthcare service, worthy of an advanced and modern European country.

Translated by interpres sas