The European Institute of Oncology began the process to reach the accreditation promoted by the Organisation of European Cancer Institutes (OECI) in 2012. This accreditation integrates the quality and safety path started in 2001 with accreditation by the Joint Commission International. Despite the presence of diversified accreditations and certifications and the clear need of time, effort, and commitment, the models are complementary. Each model is not to be considered as an end but as a tool for improvement: e.g., mixing accreditation standards led to an improvement in the quality and safety of processes. The present article details the OECI accreditation experience of the European Institute of Oncology, in particular the following strengths of OECI standards: collaboration among several involved parties (patient, volunteer, patient’s general practitioner) in the clinical and quality/safety processes; a larger involvement of support personnel (psycho-oncologists, dieticians, physical therapists); and the development of clinical/translational research and innovation in prevention, diagnosis, and treatment to guarantee the best available practice in diagnosis and treatment. The OECI accreditation is specific to oncology and therefore its standards are tailored to a cancer center, both in terms of language used in the standards manual and in terms of patient needs. The OECI accreditation system puts an auditor team with a standards manual in charge of verifying quality and confirms the definition of IEO as a Comprehensive Cancer Center.
Tumori 2015; 101(Suppl. 1): 21 - 24
Article Type: REVIEW
AuthorsPietro L. Deriu, Silvia Basso, Fabrizio Mastrilli, Roberto Orecchia
- • Accepted on 02/12/2015
- • Available online on 30/12/2015
- • Published in print on 31/12/2015
This article is available as full text PDF.
The European Institute of Oncology (IEO) project was launched in 1987 by Umberto Veronesi, with the aim of creating a Comprehensive Cancer Center (CCC) with research laboratories as well as clinical and educational services. Clinical activities started in June 1994. Over the years, the IEO, located in Milan, Italy, has become a health group (
European Institute of Oncology (IEO) group and its main components.
The IEO group covers 2 main areas, cancer and cardiovascular diseases, and is composed of 2 research hospitals with the same mission: “To develop and maintain a network of knowledge, skills, and willingness to fight against all forms of cancer and cardiovascular diseases.”
The IEO campus is the research arm of the IEO group dedicated to basic and translational research. There are 450 researchers who work in molecular medicine and drug discovery programs. Clinical research performed at IEO encompasses about 400 ongoing trials with more than 15,000 patients enrolled.
TTFactor is a company with the aim of patenting, managing, and selling IEO intellectual property.
The IEO is not only medicine and research, but also education and training. Since its beginning, IEO has been hosting trainees from all over the world. In 2014, IEO hosted about 300 visiting trainees, more than 75% from foreign countries.
The IEO is fully integrated with the medical school of the University of Milan, as there are 18 university professors among our directors.
The IEO is one of Italy’s 47 research hospitals (Istituti di Ricovero e Cura a Carattere Scientifico) and is accredited by the National Health Service.
The structure of quality and safety management at IEO has not changed since its inception in 2001. We have a quality and safety committee that deals with strategic and management activities and 2 services that coordinate and support all activities: the Quality and Accreditation Service and the Patient Safety and Risk Management Service.
There are also a quality and safety network, a team responsible for ensuring quality and safety in all IEO units, as well as an auditor team, to monitor and control all critical processes. Their aim is to review compliance with laws, regulations, and standards.
The IEO quality and safety path started in 2000, when the regional government began a collaboration with Joint Commission International and some hospitals, IEO among them, accepted the challenge to adopt Joint Commission standards.
The Joint Commission Accreditation award was the first step of our path. Since 2003, 6 surveys have been completed, with an average of 99% of measurable elements met.
Joint Commission International accreditation (3-4-5) was followed by International Organization for Standardization (ISO) 9001 Certification of Laboratories (supply of laboratory medicine services in the hematoncologic fields and supply of laboratory medicine services and of transfusion services concerning the activities of transport, storage and availability of hemocomponents, including management of Point of Care Testing (POCTs)). Since 2003, 14 processes have been certified.
Recently, the IEO has obtained new accreditations or certifications: Occupational Health and Safety Certification (OHSAS 18001); European Society of Breast Cancer Specialists (EUSOMA) certification (6); European Neuroendocrine Tumor Society (ENETS) accreditation as a Center of Excellence for treating neuroendocrine tumor disease (7); and OECI accreditation (8-9-10-11).
With regards to monitoring tools, all systems for accreditation emphasize the importance of audits as a management tool to control and monitor system effectiveness for quality and safety.
“An audit is a systematic, independent, and documented objective process to obtain evidence and assess in order to establish the extent to which audit criteria are met. Audit criteria could be sets of policies, procedures, or requirements used for the audit UNI EN ISO 19011:2012 Guidelines For Auditing Management Systems.”
The audit program has been ongoing for 9 years. We performed 346 audits, registering over 1,700 findings. Our audit team is composed of different personnel (physicians, nurses, technicians, biologists, data managers, dieticians, physicists, engineers, physical therapists, administrative personnel). All roles are represented in the team, which numbers more than 100 people, in order to reflect different points of view. The benefit is to analyze a problem from all perspectives and find the best solution for any problems found.
The second tool we use to monitor our performance is a set of indicators, divided into levels:
Required indicators by the regional health system (46 indicators)
General measurements (over 30 indicators), chosen among data from structure, processes, and mostly outcomes
Unit level indicators (from 5 to 10 per unit), presented by the quality manager of each unit in the annual review report
All indicators are presented as charts, analyzed by the owner, in some cases in collaboration with the stakeholders. Improvement actions are decided and implemented based on these results.
We created a dashboard for all units. It is accessible in a specific section of the Intranet.
The indicators monitored can be presented on 3 levels of depth with a synthetic assessment for each topic. The first level is represented by traffic lights, in order to let the reader have an intuitive comprehension of results. The second level is organized with charts: the division data are compared to the IEO average. The third level contains the details of the data presented.
For example, if reviewers see a red light on incident reporting and want to understand the problem better, they look over the chart (second level) and see that their division reports 10% fewer near-misses compared to the IEO average.
The synthetic assessment helps further understanding, while the overall evaluation deals with possible correlations between different indicators. The reports allow an early diagnosis of problems before they can affect patients.
The Italian Ministry of Health identified a panel of experts from different research hospitals representing not only experts in quality but also the clinical and scientific world of cancer research centers. After discussing pros and cons on available certification and accreditation systems when applied to CCCs, they chose the OECI model, a model tailored on oncologic centers.
The IEO was one of the promoters of OECI, whose mission is to bring together the cancer research and care institutions of the European Union in order to create a critical mass of expertise and competence with the view of building and maintaining a consensus on the best models of oncology and solutions to improve the quality of life for patients in the European Union.
The OECI accreditation and designation process starts with an application by the candidate hospital where it reports its quality and quantity data for a preliminary designation. Based on these data, OECI designated the IEO as a CCC. A CCC has to demonstrate the following:
A highly innovative character and multidisciplinary approach using the potential of basic, translational, and clinical research as well as clinical facilities and activities, organized in a sufficiently identifiable entity
Direct provision of an extensive variety of cancer care tailored to the individual patient’s needs and directed towards learning and improving the professional, organizational, and relational quality of care
Broad activities in the areas of prevention, education, and external dissemination of knowledge and innovation; in order to accentuate differences from other cancer centers, a CCC separates itself by the following points: high level of infrastructure, expertise, and innovation in the field of oncology research; maintenance of an extensive network including all aspects of oncology treatment and research; related to an academic/university center or is an academic center
From the designation until the auditing activity, a plan for the adaptation to standards was completed.
The preliminary designation was confirmed during the site visit in 2014.
The main strengths of OECI standards are collaboration among several involved parties (patient, volunteer, patient’s general practitioner) to the clinical and quality/safety processes; larger involvement of support personnel (psycho-oncologists, dieticians, physical therapists); and integration of clinical activities and research.
Patient empowerment allows patients to take an active role in decisions made about their own healthcare, safety, and quality issues (1.5.2.: Quality and risk management and safety requirements: there is a patient committee [or association] for consultative advice about quality of care and risk management).
In order to promote the development of clinical/translational research and innovation in prevention, diagnosis, and treatment, as well as to guarantee the best available practice in diagnosis and treatment, the IEO created multidisciplinary programs (
European Institute of Oncology’s multidisciplinary programs (2015).
A multidisciplinary program has the following characteristics: involvement and integration of all professionals needed for the program: physicians, clinical scientists, translational scientists, and basic research scientists; focus on homogeneous clinical-scientific areas, such as tumor type or treatment modalities; and availability of platforms to support research.
Each multidisciplinary program comprises divisions, units, or professionals from various disciplines dedicated to the program topic. All members of a multidisciplinary program work together to implement and update treatment pathways for patients; to identify any areas lacking adequate ongoing trials to define research opportunities; and to develop a clinical research platform, for global support of clinical research.
This organization guarantees the integration of clinical and research activities and therefore the ability to translate scientific research into new treatments in real time.
The main objectives of the use of research results in clinical practice are building clinical pathways for prevention, diagnosis, treatment, and follow-up; guaranteeing the best available practice for diagnosis and treatment; giving each patient the most advanced experimental treatments available; guaranteeing each patient respect for his or her personal anxieties and expectations as well as support in comprehending his or her disease; increasing educational activities; and promoting the development of clinical/translational research and innovation in prevention, diagnosis, and treatment.
Each program identifies research priorities, according to the Scientific Directorate’s strategic plan. The Scientific Directorate, in collaboration with the Health Directorate, is in charge of institutional monitoring. In order to control the progress of activities, a quarterly update meeting is convened by the Scientific Director with all Program Directors to evaluate the trend of research activities applied to clinical practice.
On the subject of research, OECI stresses the importance of a procedure for dealing with scientific misconduct (18.104.22.168.1.: There is a procedure for dealing with scientific misconduct). The IEO took this opportunity and implemented a procedure, “Verification of scientific misconduct,” describing what to do in case of suspected scientific misconduct (coded event, e.g., unjustified interruption of a trial, failure to publish results, missing voluntary consent of the participant, the trial is carried out in a way that does not avoid discomfort and pain to the patient, the trial is not carried out by highly qualified personnel or in adequate facilities, the participant is not allowed to interrupt his or her involvement freely and at any moment, the researcher is not willing to interrupt the trial in case of damages, disabilities, or deaths of any participants, inadequate participant selection or distribution for trials requiring randomization, attempted adjustment of results through a more accurate selection of the participating population, unclear informed consent, conflict of interest in the staff involved with the trial, protocol amendments “in itinere” [without notifying competent authorities], inadequate monitoring and reporting of adverse events, failure to report adverse events, misuse of blind or double-blind definitions, priority randomization according to the patient’s or involved personnel’s choice).
The IEO created a Committee Against Scientific Misconduct composed of members with expertise in both the health and scientific fields, such as forensic scientists, scientific director’s representatives, data managers, and research nurses.
An advantage of the OECI accreditation process is that the auditing team comprises only clinical personnel from other cancer centers, which ensures the effectiveness of the peer review process.
On the other hand, the agenda defined for a site visit to a CCC is too packed (e.g., 10-20 minutes per meeting) to achieve the in-depth analysis of standards necessary, at least during the first site visit.
The OECI, as did Joint Commission International before them, gave IEO a good system to verify and encourage international standards of excellence.
The OECI accreditation is specific to oncology and therefore its standards are tailored on a cancer center, both in terms of language used in the standards manual and in terms of patient needs. The multidisciplinary approach is clear even in the table of contents of the manual, e.g., a number of requirements deal with roles and tasks of the members of the supportive care staff and communication between the members of the supportive care staff. In addition, there are specific standards that point out the importance of palliative/supportive and terminal care, psycho-oncology service, social counseling, and rehabilitation. The understandable language and the multidisciplinary approach to care guarantee involvement of all clinical staff.
The OECI also stresses the importance of research, innovation, and development. First, the OECI standard requires structural cooperation between researchers and clinicians, in agreement with the organization of multidisciplinary programs organized as a tumor board with continuous meetings among clinicians and researchers. The involvement of research scientists is fundamental in the perspective of guaranteeing the best available practice in diagnosis and treatment.
Finally, the Italian Ministry of Health project gave us the opportunity to create a network of oncologic research hospitals to share the process of quality improvement. We have the choice to organize meetings and analyze together the OECI requirements in order to determine the best solution for each improvement opportunity.
This could be the starting point for benchmarking among Italian (or European) institutions treating cancer patients, e.g., it might be possible to benchmark indicators or the use of guidelines.
The IEO has many and diversified accreditations and certifications. Although all accreditation systems require time, effort, and constant commitment to be maintained, they complement each other. Mixing accreditation standards led to an improvement in the quality and safety of processes. Each model is not to be considered as an end but as a tool for improvement.
The OECI accreditation system puts an auditor team with a standards manual in charge of verifying quality and confirms the definition of IEO as a CCC.
Funded through a Finalized Research Project of the Italian Ministry of Health (code: RF-2009-1532731).
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- Deriu, Pietro L. [PubMed] [Google Scholar] 1, * Corresponding Author (firstname.lastname@example.org)
- Basso, Silvia [PubMed] [Google Scholar] 1
- Mastrilli, Fabrizio [PubMed] [Google Scholar] 2
- Orecchia, Roberto [PubMed] [Google Scholar] 3
Quality and Accreditation Unit, Istituto Europeo di Oncologia, European Institute of Oncology, Milan - Italy
Medical Administration, Istituto Europeo di Oncologia, European Institute of Oncology, Milan - Italy
Scientific Directorate, Istituto Europeo di Oncologia, European Institute of Oncology, Milan - Italy