The European accreditation of Istituto Tumori Giovanni Paolo II of Bari


The National Cancer Institute of Bari (Istituto di Ricovero e Cura a Carattere Scientifico, IRCCS) has been involved since the conception of the project of the Italian Ministry for Health aimed to validate the applicability of the Organisation of European Cancer Institutes (OECI) accreditation and designation (A&D) model to the Network of Italian Cancer Centers, IRCCS, of Alleanza Contro il Cancro. The self-assessment phase of the Institute started in September 2013 and ended in June 2014. All documents and tools were transferred to the OECI A&D Board in June 2014 and a 2-day peer review visit was conducted in October 2014 by an international qualified audit team. The Institute received its final designation and certification in June 2015. The OECI A&D Board, in its final report, came to the conclusion that Istituto Tumori “Giovanni Paolo II” of Bari has a strong research component with some essential elements of comprehensive cancer care still under development; the lack of a system for using outcome data for the strategic management approach to decision-making and missing a regular internal audit system eventually helping further quality improvement were reported as examples of areas with opportunities for improvement. The OECI A&D process represented a great opportunity for the cancer center to benchmark the quality of its performance according to standard parameters in comparison with other international centers and to further develop a participatory group identity. The common goal of accreditation was real and participatory with long-lasting positive effects. We agree with the OECI comments about the next areas of work in which the Institute could produce future further efforts: the use of its powerful IT system as a means for outcome analysis and empowerment projects for its cancer patients.

Tumori 2015; 101(Suppl. 1): 14 - 18

Article Type: REVIEW



Rosanna Lacalamita, Antonio Quaranta, Maria Pia Trisorio Liuzzi, Aldo Nigro, Umberto Simonetti, Massimiliano Schirone, Ferruccio Aloè, Gianluca Capochiani, Genoveffa De Francesco, Cosimo Gadaleta, Domenico Galetta, Luciano Grammatica, Attilio Guarini, Vittorio Mattioli, Piero Milella, Antonio Moschetta, Patrizia Nardulli, Vincenza Nigro, Nico Silvestris, Angelo Paradiso

Article History


Financial support: This work was funded by the Ministry of Health of the Italian government within a Finalized Research Project (coord.: A. Paradiso, F. Belardelli; code: RF-2009-1532731).
Conflict of interest: The authors declare no conflict of interest.

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In recent years, quality management of cancer care services has become a key issue. In particular, the definition of appropriate quality indicators and quality criteria is relevant for the management of cancer centers, well-characterized by a rapid updating of clinical and scientific knowledge, multidisciplinary performance, integration of research into clinical practice, and use of cutting-edge technologies (1).

Certification and accreditation programs are widely implemented for supporting healthcare organizations in demonstrating their compliance to predetermined quality criteria and standards (2) but international models of certification specifically meeting the demands of the complex organization of a Comprehensive Cancer Center are scanty.

Recently, to respond to this need, the Organisation of European Cancer Institutes (OECI) developed an original program for voluntary accreditation of excellence of cancer centers (3). This accreditation and designation program (A&D) is aimed to improve the quality of oncology care, research, and education but also to provide to cancer patients within Europe equal access to high quality of cancer care through a unique vision of oncology built on “an integrated model of the cancer research-to-care process”.

For this reason, in 2010, the Italian Ministry for Health supported the research project “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” with the specific aim to promote the participation of the 11 Italian Comprehensive Cancer Centers (CCCs) to this internationally recognized accreditation program (4, 5) and to further stimulate benchmarking actions and mutual learning in accordance with the distinctive Italian aspects of the National Health System.

The A&D model of OECI is based on several steps, all ­focused to check qualitatively and quantitatively the performance and organization of each cancer center. The 6 chapters in which the OECI standards were grouped are as follows: general standards, strategic plan, and general management; screening and primary prevention and health education; care; research innovation and development; teaching and continuing education; patient-related.

The process starts with a preliminary designation of the category of the cancer center under scrutiny followed by a 6-month self-assessment and a peer review visit by qualified auditors from different medical disciplines. The auditors assess if the cancer center meets the OECI quality standard (927 requirements spread into qualitative and quantitative questionnaires) and, through a scoring system based on the plan-do-check-act cycle (Deming cycle), validate at which level the quality system is implemented. Once the center is reviewed, the audit team delivers a report that highlights the center’s strengths and opportunities for improvement and the relative level of designation (

We provide a brief description of OECI accreditation process within the Cancer Institute of Bari, drawing attention to the OECI auditors’ findings in terms of strengths and opportunities. Among the opportunities, we focus on 2 pivotal aspects in cancer care: cancer data registration and the role of information and communication technology (ICT) in measuring outcome data; cancer patient empowerment in cancer center activities to better meet patients’ needs and pay more attention to patient-centered care.


The Cancer Institute of Bari moved toward the OECI Accreditation Program with the key objectives of improving adherence to guidelines in each department of the institute; improving multidisciplinary communication, teamwork, and coordination of care; improving the development of clinical pathways.

The self-assessment phase started in September 2013 and ended in June 2014. During those months, the institute was involved in collecting data (quantitative questionnaire), documents and assessing compliance with qualitative OECI standards through a Web-based tool (

The process involved all the professionals of the institute, the definition of a steering committee and project teams for each topic and chapter of the standard areas.

Eight teams of professionals responsible for the coordination and results of the following groups were identified:

Quality system, risk management, education

General standards, strategic plan, and general management

Clinical guidelines and multidisciplinary care

Screening and primary prevention and health education

Palliative and supportive care

Research, innovation, and development

Clinical research


All documents and tools, to which qualitative and quantitative questionnaires were referred, were reviewed by the OECI A&D Board and, in October 2014, a 2-day peer review visit was conducted by a team of 5 auditors from different disciplines and countries. The institute received its final designation and certification in June 2015 in the annual general assembly of OECI.


The peer review report was delivered considering if and at which level the cancer center met the standard and highlighting the center’s strengths and opportunities for improvement.

With regard to the OECI quality standards, the audit team, with the input of the peer review visit, scored the standards of the 6 chapters of the OECI as the cancer center did during the self-assessment period. For each reviewed standard, the team provided a general remark considering to what level the cancer center has met the standard (Fig. 1). With respect to the self-assessment analysis, the audit team found the institute was underestimating its activities in the areas of screening, primary prevention, and health education and overestimating patient-related processes.

Score standards of the 6 chapters of the Organisation of European Cancer Institutes: comparison between self-assessment evaluation and audit team analysis.

Following the OECI accreditation visit, the audit team and the A&D Board of OECI generated a final report with some general remarks and specific description of strengths and opportunities for further improvement of the institute.

Apart from the specific description of some aspects of the institute’s activities, the general comments concerning the climate and organization of the audit visit were positive; the OECI final report noted “an open and friendly atmosphere,” a “highly motivated staff,” and “very approachable for patients.”

Strengths of the cancer center with regard to the OECI quality standards

Research environment

According to peer review report, the Institute of Bari has a strong research environment. All laboratories are well-equipped and the researchers have a high level of expertise in oncology. There is a high level of infrastructure in diagnostic, treatment, and research units and a cutting-edge technology biobank. Cooperation and the exchange of information is effective between the clinicians and the researchers. The dedicated clinical trial unit is active and data about clinical trials are easily available and up-to-date.

Outpatient units

There are well-equipped units, such as the hematology ward with the new transplantation section, endoscopy, and head and neck unit. The radiology department has an interventional radiology section, whose equipment and activity are exceptional. Patient flow is well-organized, including sign-up, communication, and systematically planned postintervention surveillance.

The ICT department

The ICT services are on a high level at the institute. The new electronic patient management system not only has general clinical capabilities, but also has features that can improve the quality management of care.

Pharmacy and chemotherapy preparation unit

The preparation of anticancer drugs and drug administration is centrally organized in the institute. The unit is up-to-date for the preparation of cytostatic drugs carried out by pharmacists. The unit is on a high level both in terms of infrastructure and quality management.

Stop smoking program for the employees (and public awareness)

The Institute has a positive open stop smoking program for the employees of the institute. The stop smoking working group has a health educational activity especially for children. The auditors were impressed by the training aid prepared for students.

Opportunities for the cancer center with regard to the OECI quality standards strategy

Implementing strategy and vision in integrated cancer, research, collaboration, and innovation is essential to the further development and optimal use of the available high-quality resources.

Multidisciplinary environment

The auditors experienced good cooperation among physicians of different disciplines on a personal level. The institute just started formalized multidisciplinary harmonization. At a later stage, evaluation and experience is needed to optimize multidisciplinary groups and to further increase the quality of their activity.

Role of the nurses

The Institute has motivated nurses. Tasks and responsibilities of nurses are different in different units and wards. Although formal training for nurses in oncology in Italy is missing, the tasks and responsibilities beyond the general job description and specific to oncology care could be performed. In general, nurses could be more involved in the management of patient pathways and the role of the nurses should be increased in the multidisciplinary team approach.

Integrated palliative and supportive care (inclusive psychosocial support)

The supportive team has a strong intent to improve the supportive/palliative care in the institute. In order to achieve this goal, besides employing appropriate and experienced employees, it is necessary to improve and formalize the communication, screening, referral, and procedures between the clinical and supportive services. Increase in the number of supportive care employees is necessary to ensure continuity of care.

Strategic use of (outcome) data

The current and advanced ICT system and a good statistics department gives the opportunity to extract high-quality data. The institute should develop a system to use outcome data for strategic management. A comprehensive database, instead of single data in several files, is essential as a good basis for strategic (management) decisions.

Internal audit system

A visible quality management is active in the Institute, but a regular internal audit system is missing. Implementation of an internal audit system could help further quality improvement and improve the results of external audits.

Patient empowerment

The patients are not directly and actively involved in the development of the institute’s services. The link to patients is mostly organized with volunteer organizations instead of patient organizations. In order to better tailor the center’s activity to the patients’ needs, a higher level of patient empowerment would be beneficial.


The process of OECI A&D represented for the Istituto Tumori of Bari an exciting and positive experience because it was a great opportunity for the cancer center to make benchmarking according to standard parameters with respect to other international centers; the entire institute was involved in the process, viewing accreditation as a first-class endpoint. All the institute’s professionals worked towards the common goal, resulting in long-lasting positive effects including:

Real engagement by all disciplines and all levels of staff in the process, with dozens of people at all levels, and increased awareness

Strong positive team-building and network building effect

The challenge to gather data and examine quality systems was a benefit in itself

Elaboration of high-quality improvement plans with clear identification of opportunities and timing

Incentive towards a better formal organization of the multidisciplinary teams and cancer care pathways

The OECI A&D process was not only an exciting and positive experience for the institute of Bari , but it was conducted also overcoming some important delicate points: the process resulted in a considerable workload for the institute; the IT operators were stressed to collect and analyze data according to nonstandard queries. Moreover, several important difficulties were encountered when trying a) to demonstrate the adherence of the institute's management policies, dictated by the Italian National Health Service, to OECI standards; b) to relate the budget management modalities of the institute, which are strictly controlled by the regional government, to the long-term strategies requested by the OECI program. Those delicate points were difficult to address within the short visit by the international audit team.

However, in spite of some limitations, the audit team was able to identify the essential elements of the institute, describing the Istituto Tumori Giovanni Paolo II as characterized by “a strong research component. Some essential elements of comprehensive cancer care are still under development. Examples are the early phase in multidisciplinary harmonization, the lack of a system to use outcome data for strategic management, and the missing of a regular internal audit programme as a ‘managing tool’ for determining that the effectiveness of the quality management system is implemented and maintained, to help further quality improvements and recommendations of external audit.”

Two comments of the OECI about our institute deserve particular attention. One of the main comments concerned the performance of the internal ICT system. Interestingly, the audit team described ICT services as of “high level with the new electronic patient management system with not only general clinical capabilities, but also features that can improve the quality management of care”. Among the good examples of the potentialities of the institute's ICT system, the audit mentioned its capability to have access to and periodically monitor the waiting times of several index clinical procedures, the workload of all units, and the drug consumption.

However, the audit team stressed that, besides mandatory reports for the authorities, the institute should develop a system also recording outcome data needed for a strategic management based on a comprehensive analysis of positive and negative impact of several factors on disease outcomes.

The point observed by the team is relevant and is based on the view that the ICT system has to be more widely integrated in the institute’s life, guaranteeing the recording, monitoring, and analysis of what is the important endpoint in oncology: clinical outcome (6). Conversely, the ICT system of our institute seems only utilized to provide a quantitative analysis of standard clinical practices (as defined by Laws 502/92 and 229/99), information needed to go ahead with the reimbursement by the National Health Service for each provided procedure rather than focused on the clinical outcomes achieved – in spite of the modern vision of cancer care in which several structures, actors and disciplines contribute to reach better results in terms of clinical, economic and humanistic outcomes (7).

Another issue contributes to the need to increase the performance of the IT system of a cancer center like ours. Clinical cancer research is even more difficult to perform for several reasons: the competition for funds is difficult as only large cancer centers can invest the amount of money needed for organization of omic platforms and management of specific competences (8); in addiction, present clinical trials are essentially based on specific and small subgroups of patients with similar clinical, molecular, and genetic features on which to test drugs selectively targeting molecular characteristics (9). Such trials require a large number of patients to be selected and have complicated enrollment procedures that can only be conducted in a high-quality multi-institutional scenario in which good clinical practices can be managed and guaranteed.

The basis for such modern effort is necessarily represented by an interinstitutional IT platform giving the possibility to a network of institutes for crosstalking and contributing to a common endpoint. An example of such cooperation is already represented by the WIN Consortium, clustering several European cancer centers in pan-European trials (10). Italy, through the Network of Cancer Institutes of Alleanza Contro il Cancro (5), represents the ideal model to go ahead with such a policy and to explore a pivotal common IT ­platform focused on needs of cancer research and looking for application of the new concept of outcomes for cost reimbursement.

Another area of critical activity for our institute, according to the OECI A&D report, is the need for further patient empowerment. The audit team observed that “patients are not directly and actively involved in the development of the institute’s services…The link to patients is mostly organized with volunteer organizations, instead of patients’ organizations.” The comment is opportune considering the characteristics needed by a modern P4 platform (predictive, preventive, personalized, and participatory) in oncology, in which participation of patients in increasingly taking control of their own health is mandatory (11). Bringing these actors into direct health government is needed but this implies a change in education not only of health professionals but also of patients and stakeholders.

Europe is aware of this need, thus urging projects in which patient perspective is central in determining priorities for clinical research, drug development, and benefit-risk assessment. The last call of the Innovative Medicines Initiative of the European Union is one example of the direction the European Union is moving toward (, in which the patient is considered important to determine the benefits/risks of medical actions and establish patient preferences, also according to the expectations and perspectives of each individual patient.

We are fully convinced that the constant presence of patient representatives is needed in a modern cancer institute in order to comply with their current priorities. The patient representative must play a key role in assessment panels in research committees and perform periodic measurement and monitoring of quality performance and patient satisfaction; this is to ensure that care and empowerment of patients and their families are effectively fulfilled and maintained (12).

Future programs of the institute should be focused on patient participation and empowerment with a greater representation in clinical and research committees and by activating specific educational programs tailored to patient needs.

The primary goal of the institute of Bari is thus defined: patient-centered care.


The authors thank the staff of “Istituto Tumori Giovanni Paolo II” of Bari for their contributions to the accreditation project.


Financial support: This work was funded by the Ministry of Health of the Italian government within a Finalized Research Project (coord.: A. Paradiso, F. Belardelli; code: RF-2009-1532731).
Conflict of interest: The authors declare no conflict of interest.
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  • Istituto Tumori Giovanni Paolo II, IRCCS, National Cancer Institute, Bari - Italy
  • TQM Management, Bari - Italy
  • Azienda Sanitaria Locale, Local Health Authority, Bari - Italy

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