The research hospital Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) of Reggio Emilia has a unique organization that involves a recently recognized IRCCS in oncology within a preexisting general hospital. The IRCCS of Reggio Emilia joined the “Tailored Accreditation Model for Comprehensive Cancer Centers: Validation through the Applicability of the Experimental OECI-based Model to the Network of Cancer IRCCS of the Alliance Against Cancer” and applied the accreditation & designation (A&D) Organisation of European Cancer Institutes (OECI) model in 2013. Before that accreditation, it had never been accredited according to international accreditation systems concerning cancer. By December 2015, the IRCCS of Reggio Emilia completed the first steps of the A&D OECI process (self-assessment period, peer review visit, implementation of the improvement plan). In December 2014, OECI confirmed the accreditation of our IRCCS and its designation as a Clinical Cancer Center and proposed a revisit at 2 years for upgrading the designation to Comprehensive Cancer Center (CCC). On the whole, the results given by adhesion to the A&D-OECI project are numerous and positive, under different points of view, formal (European accreditation and designation as a Clinical Cancer Center with possible upgrade to CCC) and substantial (involvement of professionals, attention to ongoing improvement, work on the sectors mainly of interest). The balance between the advantages and disadvantages linked to this accreditation model was positive. Following our experience, we conclude that the model was useful also for our kind of IRCCS, with its features useful for investigating all the sectors of the patient care pathway and research and necessity to stimulate change.
Tumori 2015; 101(Suppl. 1): 42 - 46
Article Type: REVIEW
AuthorsElisa Mazzini, Loredana Cerullo, Giorgio Mazzi, Massimo Costantini
- • Accepted on 14/12/2015
- • Available online on 30/12/2015
- • Published in print on 31/12/2015
This article is available as full text PDF.
Since 2011, the year of recognition of the Reggio Emilia Hospital as a research hospital for advanced technologies and clinical pathways in oncology (Istituto di Ricovero e Cura a Carattere Scientifico [IRCCS]) by the Health Ministry (1), adhesion to the Organisation of European Cancer Institutes (OECI) network (2, 3) and to its accreditation system (4-5-6-7) has assumed greater importance.
The accreditation and designation project (A&D) of the OECI is among the officially recognized international accreditation systems and has the scope of improving assistance to the cancer patient, according to high-quality standards and levels shared at the European level concerning care, research, and training in the field of oncology. The process makes it possible to designate the cancer centers that have completed the accreditation process as a Comprehensive Cancer Center (CCC), Clinical Cancer Center, or Research Cancer Center.
In Italy, the network of cancer IRCCSs has jointly chosen to adhere to the OECI European accreditation project, using a specific research project for 2011: “Tailored Accreditation Model for Comprehensive Cancer Centers: Validation through the Applicability of the Experimental OECI-Based Model to the Network of Cancer IRCCSs of the Alliance Against Cancer.” By participating in the project, all the Italian cancer IRCCSs had the possibility of starting this accreditation process in the following years. The IRCCS of Reggio Emilia, which was not among the intended institutional beneficiaries of the project, also decided to participate in it by sharing the rationale and objectives (8).
Participation in the A&D OECI project was an important occasion for accreditation for the first time according to an international quality system that, in addition to involving considerable work on standards concerning care, research, and training in cancer, meant fulfilment of the regulatory indications that govern the IRCCS in Italy that call for obligatory international accreditations (9).
The IRCCS of Reggio Emilia is unique in that it is embedded in an preexisting hospital. In addition to the oncologic area for which the IRCCS is recognized, the hospital covers all the care and research sections of a general level II non-university hospital.
The hospital, described briefly in
Details of Santa Maria Nuova Hospital-IRCCS of Reggio Emilia
|Oncology area, %||Non-oncology area, %|
|19,000 Surgical interventions|
|140 New trials/year|
The hospital is accredited according to the institutional accreditation system of the Emilia Romagna region (10), which envisages the general standards applied at the departmental level and specific standards differentiated according to specializations. Moreover, the hospital is accredited according to the Joint Accreditation Committee of the International Society for Cellular Therapy and the European Society for Blood and Marrow Transplantation and European Federation of Immunogenetics system for the hematologic transplant process, which mainly involves the hematology structure and the transfusion service. In the past, the International Organization for Standardization 9001 certification model was also adopted and applied to the nursing direction and to certain transverse hospital services. Before the OECI accreditation, it had never been accredited according to international accreditation systems concerning cancer as a whole and no efforts had ever been made towards improving quality standards in the research sector, the sector covered by the OECI but not envisaged by other international accreditation systems.
The aim of this article is to describe the OECI accreditation process conducted at the IRCCS of Reggio Emilia, highlighting the strong and weak points, and analyzing the impact on the quality of care and research in cancer.
The A&D model of the OECI
The accreditation process consists of the following standardized steps carried out over a period of 5 years:
A period of self-assessment
A peer review visit
Formulation of an improvement plan and confirmation of accreditation according to one of the types of institutes envisaged by the OECI
Implementation of the improvement plan
A follow-up of the state of progress of the improvement plan and results achieved at 1 year following confirmation of the accreditation
The next visit after 5 years
By December 2015, the IRCCS di Reggio Emilia completed the first 3 steps of the process.
Self-assessment period (2012-2013)
During 2012, meetings were held with the Health Ministry and with the other IRCCSs for preparation and programming of the project, and in 2013 the IRCCS of Reggio Emilia, which was one of the 4 IRCCSs that were the first to have joined the project, carried out the application procedure in February and completed the self-assessment step in November 2013, collecting all the required information and documents and sending these to the OECI.
Throughout 2013, the IRCCS worked on implementing the following actions:
Setting up a hospital board for coordination of the project that defined specific responsibilities, methods, and implementation timelines and steps.
Disseminating detailed information to all professionals of the departments and services involved in the accreditation by means of ad hoc meetings and during scheduled institutional meetings for sharing among professionals and medical and scientific directions the improvement plans to be started up within the institute. In order to make the information as extensive, prompt, and effective as possible, a computerized space was created on the hospital intranet for the collection and diffusion of all the material concerning the OECI in all the steps of the accreditation process. It was a demanding task from the point of view of organization and time investment, but also a fundamental step to facilitate knowledge and sharing of the project by all professionals.
Analyzing and realizing actions/projects for upgrading to the quality standards by setting up several teams with reference to the fields to which the OECI gave extensive emphasis and in which the IRCCS had to invest to a greater extent: multidisciplinary groups and cancer care pathways, information and communication with the patient, pain management, palliative care, and psycho-oncological care.
Compiling the qualitative and quantitative questionnaire in the e-tools, which involved the self-assessment and the preparation of documents to be sent as evidence of adhesion to the standards. As regards document analysis, it is specified that all the documentation has been translated into English so as to be legible by external auditors.
Organizing internal audits in every department and service subject to external audit according to a predefined calendar and with mini-reports of visits by the medical direction and the quality systems office.
Planning the peer review visit: sharing and disseminating the visit agenda, preparing the material to be projected and/or submitted to the auditors, preparing professionals.
In December 2013, confirmation of acquisition and completeness of the documentation was received from the OECI (go decision of the OECI) and preparation of the peer review visit was started.
Peer review visit (February 2014)
On February 10 and 11, 2014, the accreditation visit was conducted, which involved verification of implementation of the quality of the clinical activities, care, and research by external and independent reviewers. The team of auditors consisted of 4 professionals from Holland, Sweden, Belgium, and Italy. These were doctors and nurses working in different European cancer centers, and they were trained to evaluate the quality requirements of other cancer centers in peer mode. The auditors visited our hospital according to a predefined busy visit agenda, which saw them pass through several departments and services and involved direct contact with the staff by means of interviews.
Numerous professionals were involved: the hospital management, directors and head nurses of departments, medical staff and healthcare professions of the various departments, services, and laboratories, supportive care staff (psychologists, social assistants), researchers, and many trusts services (training service, quality systems office, tumors register, ICT department, risk management), and also certain representatives of volunteer associations working in the oncology sector. Field tests allowed the auditors to check the level of compliance with the quality standards and the degree of knowledge and application by all the professionals who work with cancer patients in our hospital.
At the end of the 2 days, the auditors returned the preliminary results, the result of the visit and analysis of the documents. These aspects were then more fully described in the final visit report received in June 2014 in which, in addition to the strengths and salient features already explained during the visit, areas requiring improvement were detailed more thoroughly. The auditors returned their judgements on every standard with their comments regarding our level of compliance and possible improvements for each subject. Results are summarized in a target plot (
Target plot of results of the Organisation of European Cancer Institutes report.
The improvement plan and OECI recognition (2014)
During 2014, our IRCCS formulated an improvement plan, prepared and shared with the hospital management and with all the professionals involved, which contained all the improvement actions required by the visit report. By December 2014, the improvement plan was approved by the OECI, which gave our IRCCS accreditation according to the OECI model and assigned us the designation as a Clinical Cancer Center. This designation reflects the picture of the IRCCS but, as mentioned in the visit report, the auditors, seeing the considerable investment made by our institute in the field of cancer and the trend of our activity, proposed a revisit at 2 years instead of according to the scheduled period (4 years), to request upgrade of the designation from Clinical Cancer Center to CCC.
Implementation of the improvement plan (2015–underway)
Starting in January 2015, the IRCCS of Reggio Emilia started working on the implementation of the improvement plan. These actions and the state of progress of the plan will then have to be reported to the OECI with a follow-up planned for January 2016. About a year after follow-up, a new external peer review visit will be rescheduled.
Although the process is still underway, certain points regarding the accreditation received can be described and analyzed. The specific nature of the cancer center model of Reggio Emilia, embedded in a general hospital, could have been a problem for the IRCCS as well as for the accreditation model. The positive result is an indicator of the work done by the IRCCS of Reggio Emilia as well as the flexibility of the OECI accreditation model.
First, the project brought to our recently set up IRCCS the first quality certification according to an international accreditation system. The OECI accreditation was not only the success of the efforts towards improving quality according to the European quality requirements, but also, as mentioned in the Introduction, upgrading to the Italian standards that govern the IRCCSs. In the final report, the availability and willingness for exchange of views, the major investments made in recent years in the field of care and research (opening of new departments, services, and laboratories, as well as technological and structural investments, like the new onco-hematologic building that will open in 2016), the range of services dedicated to the care of cancer patients, from screening to follow-up, with a large number of cases and wide range of illnesses treated, were highlighted as the salient features of our IRCCS. Among the opportunities noted, the need for investing more in care pathways, in the role of nurses, in the role of patients, and in the computerization of medical documentation were highlighted. The designation as Clinical Cancer Center with the possibility of reapplying, in a short time, for an upgrade to CCC and then as a center of maximum complexity was a positive result. Considering the recent recognition by the Ministry as an IRCCS, the fact that the institute was able to obtain designation as a Clinical Cancer Center just a few years after its creation confirms the successful outcome of the work done and considerable investments made by the research institute in technologies, care, and organizational models and research.
The accreditation experience probably produced overall quality improvement. As for the results related to the entire procedure, the IRCCS of Reggio Emilia recorded the following results, linked on the one hand to the characteristics of the OECI model and on the other hand to the methods of adhesion to the project:
Multidisciplinary work: efforts were made to improve the quality of care on standards focused on the patient pathway, from prevention to follow-up, and not focused on individual sections or departments but transverse to the hospital organization. This allowed efforts shared among professionals, of different disciplines and fields and professions, who analyzed and developed shared actions for improvement. Already in 2013, but in the experimental stage, 2 care pathways were accredited during the regional accreditation visits. The positive results already obtained in this first trial were strengthened, implemented, and consolidated by the application of a quality management system concerning the cancer patient pathway and not the patient of a specific organizational-management setting. This led to a more systematic structuring of the interface reports and interconnections among the different settings the patient passes through during the course of diagnosis and care.
Extensive involvement and commitment by all professionals, at both the managerial and operational level, maintaining pressure for improvement for all stages of the pathway (beyond the visit and receipt of certification). The rationale of the A&D OECI model, which involves a peer review evaluation method, called for a great degree of involvement of professionals at all levels in our organization, from formulation of standards concerning all the work areas, both managerial and operational, to the method of implementation of the site visit, which involves peer reviewers and interviews of all departments, services, and managements concerned. In all the internal meetings, it was pointed out that the scope of the process was improvement of internal quality. Pressure for quality improvement, to be desired in every quality system, emerged as concrete, owing to the formulation of an improvement plan tested at midterm and to scheduling of a new visit after 2 years. This made it possible to maintain the attention of all those involved in the improvement plan and actions it entails. The presence of quality standards focused on research, alongside those focused on care, made it possible to work also in this field in an integrated transverse manner between the healthcare and scientific component of the IRCCS.
Work in fields of cancer care in which our hospital has not invested with priority over the years: multidisciplinary work and clinical pathways; supportive, psychological, and palliative care; and the role of the patient and of information and communication.
Certain aspects in which our IRCCS has not invested or had not paid priority attention in the past were common to other IRCCSs and, in any case, to the Italian situation in general. These include the patient’s role, the nurse’s role, multidisciplinary approach, computerization of clinical documentation, and supportive care. The OECI model envisages numerous standards regarding all these sectors; in certain cases, entire chapters or dedicated paragraphs. In the IRCCS of Reggio Emilia, the stimuli for development of the 3 aforementioned sectors were taken into particular consideration. Also owing to the influence of this model, our IRCCS worked towards the development and structuring of multidisciplinary groups of pathology and new care pathways. Specific operating procedures were identified and adopted for the multidisciplinary groups, and software was implemented for collection of data of the clinical pathway and analysis of indicators, and we progressed, during the 3 years, from a small number of groups and pathways to 14 pathology groups with 6 pathways constructed and another 5 under construction.
As regards supportive care, owing also to the OECI accreditation, we worked towards the structuring of palliative and psycho-oncological care for which specific internal resources of the hospital were identified (institution of a hospital palliative care unit in 2013, and setting up of an experimental psycho-oncology unit) and whereby there exists a project for standardization of the procedures and working methods and methods for covering all cancer cases.
Finally, as regards the patient’s role and communication with patients, their representatives, and family members, we worked to provide patients with a qualified information point, a library for entertainment, and the preparation and provision of dedicated informative material, and are still working on a project for active involvement of patients in programming care, including planning and implementation of care pathways, and in research projects. The work done and yet to be done is intended to include the patient as an active member of the care pathway.
On the whole, the results given by adhesion to the A&D-OECI project are numerous and positive. The balance between the advantages and disadvantages linked to this accreditation model was positive, since the disadvantages are limited to aspects of interpretation of certain standards or those difficult to apply to the Italian National Healthcare System. The disadvantages, in addition to being limited, have been overcome with upgrading of the standards by the OECI itself, which took into account, in addition to the numerous other variables, feedback from and applicability by the Italian IRCCSs.
Our cancer center, as described in the Introduction, has a unique organization as a recently established IRCCS within an existing general hospital. The recent history as an IRCCS and longer as a general hospital was an essential starting point in our course of accreditation, which could have been critical in the approach to the A&D OECI model designed for unique dedicated cancer centers. The model was useful for our situation, with its features useful for investigating all the sectors of the patient care pathway and research and necessity to stimulate change.
The quality management system according to the A&D OECI not only fits perfectly with that of the regional accreditation model adopted, as evidenced by the overlap of many quality standards, but enriches it by focusing all the specific elements of an oncologic pathway addressed not only to health care but also to research. The results of this project for our IRCCS can be highlighted according to the following 2 different points of view:
The formal results, which concern achievement of European accreditation and designation as a Clinical Cancer Center: for our IRCCS, the OECI model was the first international accreditation and therefore the first possibility of dealing with the highest European quality standards. It was also the first possibility of focusing the work on quality improvement in oncology and with a transverse pathway approach and attention aimed not only on the quality of care but also on research in the cancer field.
The substantial results, which concern the entire accreditation process and the involvement of professionals, the attention to ongoing improvement rather than achievement of immediate but temporary results, and the work on the sectors mainly of interest.
Overall, the A&D OECI model was an important and difficult testing ground for our IRCCS. The results of the work carried out were satisfactory and repaid the efforts and investments made.
The authors thank Giovanni Apolone, Past Scientific Director of the IRCCS of Reggio Emilia; Ivan Trenti, Past General Director of the IRCCS of Reggio Emilia; Antonella Messori, General Director of the IRCCS of Reggio Emilia; Executive Board of the LHA of the IRCCS of Reggio Emilia; and all professionals of the IRCCS of Reggio Emilia involved in the process.
Emilia Romagna Regional Council. Emilia Romagna Regional Council Resolution 327/2004 “Application of Regional Law 34/98 for the authorization and institutional accreditation of health care facilities and professionals. Revoking previous measures” and Regional Law n.34/1998. Available at: http://assr.regione.emilia-romagna.it/it/servizi/pubblicazioni/legislazione-e-atti-amministrativi/requisiti-accreditamento/requisiti-specifici.accessed December 23, 2015.
- Mazzini, Elisa [PubMed] [Google Scholar] 1, * Corresponding Author (Elisa.email@example.com)
- Cerullo, Loredana [PubMed] [Google Scholar] 2
- Mazzi, Giorgio [PubMed] [Google Scholar] 1
- Costantini, Massimo [PubMed] [Google Scholar] 3
Medical Directorate, Arcispedale S. Maria Nuova - IRCCS di Reggio Emilia, Reggio Emilia Research Hospital, Reggio Emilia - Italy
Quality Systems Office, Arcispedale S. Maria Nuova - IRCCS di Reggio Emilia, Reggio Emilia Research Hospital, Reggio Emilia - Italy
Scientific Directorate, Arcispedale S. Maria Nuova - IRCCS di Reggio Emilia, Reggio Emilia Research Hospital, Reggio Emilia - Italy