The Regina Elena National Cancer Institute process of accreditation according to the standards of the Organisation of European Cancer Institutes


The accreditation process is, on the one hand, a tool used to homogenize procedures, rendering comparable and standardized processes of care, and on the other, a methodology employed to develop a culture of quality improvement. Although not yet proven by evidence-based studies that health outcomes improve as a result of an accreditation to excellence, it is undeniable that better control of healthcare processes results in better quality and safety of diagnostic and therapeutic pathways. The Regina Elena National Cancer Institute underwent the accreditation process in accordance with the standards criteria set by the Organisation of European Cancer Institutes (OECI), and it has recently completed the process, acquiring its designation as a Comprehensive Cancer Center (CCC). This was an invaluable opportunity for the Regina Elena Institute to create a more cohesive environment, to widely establish a culture of quality, to implement an institutional information system, and to accelerate the process of patient involvement in strategic decisions. The steps of the process allowed us to evaluate the performance and the organization of the institute and put amendments in place designed to be adopted through 26 improvement actions. These actions regarded several aspects of the institute, including quality culture, information communication technology system, care, clinical trials unit, disease management team, nursing, and patient empowerment and involvement. Each area has a timeline. We chose to present the following 3 improvement actions: clinical trial center, computerized ambulatory medical record, and centrality of patient and humanization of clinical pathway.

Tumori 2015; 101(Suppl. 1): 51 - 54

Article Type: REVIEW



Stefano Canitano, Annunziata Di Turi, Giuseppina Caolo, Adriana C. Pignatelli, Elena Papa, Marta Branca, Marina Cerimele, Ruggero De Maria

Article History


Financial support: This work was financially supported by the Ministry of Health-Italian Government within the Finalized Research Project Code: RF-2009-1532731. (Coord.: A. Paradiso, F. Belardelli).
Conflict of interest: the authors declare no conflict of interest.

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The accreditation process plays a dominating role in all areas of social and economic life in the pursuit of excellence and quality improvement. Accreditations for excellence are based on a logical comparison between homogeneous realities in benchmarking systems.

In the world of healthcare, accreditation processes are adopted as a means to standardize procedures and therefore render processes of care both comparable and homogeneous; at the same time, they are also utilized as a methodology tool to develop a culture of quality improvement. As evidence-based studies have yet to prove that healthcare outcomes improve as a result of accreditation to excellence, it remains unquestionable that a better control of the healthcare processes allow better quality and safety for diagnostic and therapeutic pathways (1).

The ability to be able to provide complex healthcare services inherent to all stages of the disease is a specific and unique characteristic of Comprehensive Cancer Centers (CCC).

In Italy, CCC are recognized by the Ministry of Health as Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS).

Comprehensive Cancer Centers that are recognized as IRCCS must possess specific characteristics mentioned in Decree No. 288/2003 (2), which envisages, among other items, “quality certification of services according to internationally recognized procedures.”

The Ministry of Health in 2009 funded a project aimed at evaluating and verifying the applicability of the Organisation of European Cancer Institutes (OECI) accreditation model to the national network of CCC-IRCCS.

The OECI is a network of cancer institutes that aims to improve the quality of cancer care and translational research in Europe, also from an organizational viewpoint (3). At present, the OECI consists of 70 cancer centers and institutions across Europe. In Italy, there are 10 centers that have already obtained accreditation.

The presentation is financed by funds granted for specific projects by the Ministry of Health for all the IRCCS for accreditation in accordance with the standards of OECI, the only reference model regarding “accreditation for quality specialists,” which made it possible to launch an unprecedented campaign in Italy for the pursuit of quality and safety of research and care.

The Regina Elena National Cancer Institute took part in the accreditation process with determination, commitment, and enthusiasm, successfully obtaining its designation as a CCC. The process consisted of steps toward self-evaluating institutional performance and organization in addition to managing a delicate transition period that consisted of experimenting with a current innovative organizational model, which entailed merging the various clinical areas into a single department together with the surgery and medicine departments and where the diagnostic and radiology departments were brought under one department of experimental research and high technology.

The self-assessment process has allowed us to list the amendments to be implemented in 26 improvement actions, such as quality culture, ICT system, care, clinical trials unit, disease management team, nursing, and patient empowerment and involvement.


The first phase of the accreditation and designation (A&D) process entails submitting an application/designation form, through which the board of A&D proceeds toward undergoing a predesignation screening in order to characterize the type of institute. Subsequently, the institute develops a project foreseeing a steering committee and basic operational team to organize the self-assessment.

The coordinator of the process manages funds granted by the Ministry of Health and informs the entire institute of the steps and the importance of the accreditation process.

This is followed by the process of self-assessment according to the standards of qualitative and quantitative questionnaires. The basic operating team verifies adherence to the standards described in the questionnaires in all departments and offices of the institute. The process takes about 6 months.

At the end of the 6-month self-assessment period, a peer review visit takes place, which lasts 2 days. During the site visit, a group of auditors visits the institute, verifies data provided by the institute during the self-assessment period, and interviews the staff of the institute. After the peer review visit, the audit team prepares a report of the visit, listing the strengths and opportunities for the institute along with an improvement action plan.

After preparing the improvement action plan by the working group managed by the coordinator of the process and approving the improvement action plan by the audit team, the board of the A&D designates the institute as a CCC.

From this moment onwards, the institute must intervene on the critical points highlighted by the audit team following the preparation of the improvement action plan. After 1 year, the institute then receives a second site visit in order to evaluate any improvements. If accreditation is confirmed, a subsequent self-assessment begins after 4 years (4).


Following the OECI accreditation, the Regina Elena Institute developed an improvement action plan based on the opportunities identified by the audit team during the peer review visit.

The improvement action plan (26 actions) sets out manageable steps to implement a quality culture throughout the cancer center that will push the Regina Elena National Cancer Institute into gaining greater international impact through its research program. This will then lead the audit team and A&D board to assess whether OECI criteria for a CCC have been met.

We chose to describe the following 3 actions:

Clinical trial center

Computerized ambulatory medical record

Centrality of the patient and humanization of the clinical pathway

The clinical trial center aims to comprehensively manage clinical trials and establish a center where investigators may be supported and facilitated to conduct nonprofit and profit trials and where the information regarding ongoing clinical trials is constantly updated and available for patients and researchers. This center will also have the responsibility to coordinate research nurses and assure quality control of clinical trial, paying particular attention to research promoted by the Regina Elena National Cancer Institute. On the other hand, the research project center will ensure fundraising and technology transfer. Each unit will work according to the standard operating procedures.

The clinical trial center is structured in 3 sections:

Site management organization

Clinical trial management

Technical-scientific ethics committee secretariat will then set up the translational research unit

The site management organization comprises the following:

Grant office: will help and facilitate researchers to participate in national and international grants

Site management unit: will carry out all administrative tasks related to clinical trials

Technology transfer office: will facilitate the process of economic exploitation of knowledge through transferring research results, products, technology, and innovation into the commercial industry

The clinical trial center comprises the following:

Biostatistical unit: will support investigators in designing clinical trials and research projects, developing case report form Web-based and translation databases, and performing statistical analysis

Quality assurance and data management unit: will ensure quality control of clinical trials through data managers and control good clinical practice adherence

Research nurse unit: will promote research among nurses and will act as a trait de union between PI and nurses; for early phase studies, a limited number of nurses will be trained to support the PI

Epidemiology and hospital cancer registries: will be responsible for the hospital cancer registry and provide study feasibility in terms of patients

Pharmacovigilance and adverse events management: will deal with the administrative aspects of pharmacovigilance

Research projects and clinical trials registry unit: will keep available registries of clinical trials and research projects updated, publish annual report on clinical trials, and support investigators in promoting and conducting clinical trials

Technical-scientific ethic committee secretariat: is strictly related to the ethics committee activities

The clinical trial center has its own operating regulations and standard operating procedures that will be systematically monitored through internal audits from a continuous quality improvement perspective.

The computerized ambulatory medical record project aims to integrate the technology platform already present with the business and healthcare information system.

One of the first and most important issues to achieve in an integrated healthcare information system is to define a unique mode for identifying patients within the institute.

Over the last few years, an anagraphic registry of patients has been set up at the Istituti Fisioterapici Ospitalieri (IFO), connecting all diagnostic departments (laboratory analysis, radiology, pathology) with the admission discharge transfers unit and in turn interfacing with the Anagraphical Registry of the Regional Service provided by the Lazio region.

This allows identification of a patient only once within the IFO and sharing of medical examinations and data relating to the patient among all systems, with considerable advantages for both the clinical and research components.

On this basis, over time, a computerized system has been built allowing the computer coverage over various environments.

All components interface with one another in Middleware based on Picasso Noemalife technology, which allows the management of information relating to patients, examinations, and various aspects through exchanging HL7 messages.

Some components should be implemented. In particular, perhaps the most important of these is a computerized ambulatory medical record.

A patient coming to the institute for the first time often presents through ambulatory visits. This approach is used in order to appoint first-time patients to an appropriate medical ward or day hospital for cancer treatment. The paperwork for managing outpatient access involves a break with the remaining health area, already computerized.

Therefore, the introduction of a computerized ambulatory medical record for IFO represents a fundamental step towards better patient care and better management of the cancer registry and research.

Other important benefits of introducing a computerized ambulatory medical record are as follows:


Using a single, flexible, and ergonomic instrument for reporting medical examinations

Standardizing the layout of the ambulatory patient medical report

Ability to make the order entry, directly from the ambulatory unit, using the forms used in the hospital wards

Improving healthcare processes

Controlling the repository of patients’ clinical history

Possibility of accessing patients’ medical history in order to verify their whole medical history

The solution to reporting outpatients will include the following features:

A work list for ambulatory units and/or dispenser

Outpatient medical report forms for compiling and printing (and eventually signing) medical examinations and patient files

Within the project of a computerized ambulatory medical record, we propose a timeline that foresees the definition of tendering over 2 months, with a 1- to 3-month time for delivery. The fourth month foresees a technician who will oversee the implementation process over an 8-month period from the tendering process.

In order to check the project’s progress, some direct indicators (number of computerized patient medical reports produced) and indirect indicators (average number of outpatient visits made, average waiting lists for outpatients) can be identified that can measure the impact and results in terms of improving healthcare services for patients.

Besides these advantages, one of the most important aspects for the patient is the reduction of clinical risks within the clinical pathway. In fact, the use of IT tools that allow us to capture the clinical parameters in real time, complemented by the possibility of implementing safety procedures, allow greater control and management of the patient.

Another important aspect is reduction in waiting time, both for delivering medical records and in terms of waiting for outpatient services.

The proposed project aims to complete a computerized healthcare system of the institute. Completing and achieving a computerized healthcare system of the institute meets the criteria for excellence of OECI European accreditation, representing considerable advantages for better care of patients, the cancer registry, and research.

Centrality of the patient and humanization of the clinical pathway aims to do the following:

Establish a permanent working group on patient empowerment, including at least one member for each area involved, creating a multidisciplinary team including patient representatives. A protocol fully describing the actions planned for empowering and educating ­patients and their families was provided by the group in September 2015.

Identify ongoing services, processes, and resources, both institutional and carried out by patient associations, aiming to support, educate, and empower cancer patients and their families. The procedures and the resources will be reviewed and checked for quality according to the national and international standard criteria (Honcode, eEurope 2002: Quality Criteria for Health-related Websites).

Organize a Patient Empowerment Network. The actions will include collecting documentation produced for patients and their relatives inside the institution, creating a repository in the patient library for printing, and online documents. Information for patients, aggregated on the institutional Web site, will be visible, easily accessible (unique point of access), directly from the home page (only trusted documentation), and integrated (booklets, state-of-the-art information, directories of services and institutions, database of clinical trials) from the Italian and international trusted Web sites and portals for patients.

Promote the application of narrative-based medicine in order to strengthen the therapeutic alliance.

Promote training courses on information, communication, humanistic and narrative medicine, and therapeutic patient education for health professionals, patients, and family members, to be integrated with the educational initiatives already undertaken.

The whole process will be regularly updated, monitored, and assessed for quality, focusing mainly on user satisfaction.


Through a project funded by the Ministry of Health, the Regina Elena National Cancer Institute participated in the accreditation process according to OECI standards, and on ­September 10, 2015, was designated a CCC.

The process highlighted the strengths and opportunities of the institute.

The OECI accreditation provided an opportunity to strengthen and consolidate the institute for better quality and safety of treatment. It allowed the institute to ensure a culture of quality, implement an institutional ICT system, and accelerate the process of patient involvement in strategic ­decisions.

The accreditation has increased our awareness, involved leadership at all levels, helped accelerate the integration of research and clinical practice, allowed us to improve at both a strategic and operational level, and enhanced organization of the disease management team and clinical pathways.

The accreditation has made us part of a cancer network on a European level, contributing to the production and dissemination of knowledge in order to reduce fragmentation and ­increase competitiveness, find new and better treatments, provide more comprehensive care, and improve patients’ quality of life through evidence-based medicine.


The authors thank Tania Merlino for linguistic revision of the manuscript.


Financial support: This work was financially supported by the Ministry of Health-Italian Government within the Finalized Research Project Code: RF-2009-1532731. (Coord.: A. Paradiso, F. Belardelli).
Conflict of interest: the authors declare no conflict of interest.
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  • Radiology Department, Regina Elena National Cancer Institute, Rome - Italy
  • Scientific Directorate, Regina Elena National Cancer Institute, Rome - Italy
  • Quality committee,Regina Elena National Cancer Institute, Rome - Italy
  • Exem Consulting SA, Melide - Switzerland
  • Directorate-General, Regina Elena National Cancer Institute, Rome - Italy
  • Medical Directorate, Regina Elena National Cancer Institute, Rome - Italy

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