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Application of OECI accreditation program to cancer institutes of the Alleanza Contro il Cancro Italian Network: a special project supported by the Italian Ministry of Health

Abstract

The Ministry of Health of the Italian government requires for Italian Comprehensive Cancer Centers, called Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), to be certified according to international models. In this perspective, considering of particular interest the recent model for accreditation of cancer centers developed by the Organisation of European Cancer Institutes (OECI), the network of Italian IRCCS participating in Alleanza Contro il Cancro activated a project, supported in 2010 by the Ministry of Health, with the primary objective to verify the applicability of the OECI model to the Italian network of IRCCS. All 11 cancer IRCCS took part in the project. We describe in detail the activities performed, the results reached, and the impact of the initiative on the National Health Service. The initiative was concluded in November 2015 with the certification of all the Italian cancer IRCCS. Italy is the only European country that has applied the modern and tailored accreditation model of OECI to all their cancer centers.

Tumori 2015; 101(Suppl. 1): 2 - 5

Article Type: REVIEW

DOI:10.5301/tj.5000455

Authors

Angelo Paradiso, Filippo Belardelli

Article History

Disclosures

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

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Introduction

Cancer is a leading cause of death worldwide, being responsible for about 13% of deaths annually (1). For its frequency and natural history, cancer is configured globally as not only a health issue but also as a social problem that impacts on survival and quality of life. For these reasons, in the last decades European countries produced massive efforts to better coordinate resources, research, and care in oncology (2).

The quality of cancer care is unequally shared across Europe (3), limiting the possibility of harmonization of clinical and scientific activities and improvement of standards of care.

This situation is of significant relevance in the cancer field, which is characterized by multidisciplinary clinical approaches spanning from the prevention phase to diagnosis, treatment and palliation. Moreover the quality of cancer care provided is closely linked to the prompt utilization of emerging clinical and scientific information and new technologies, always with an interdisciplinary and multidisciplinary approach.

In many countries, the complex management of all stages of the disease is performed in Comprehensive Cancer Centers (CCC), where up-to-date knowledge and innovative technologies are continuously applied to patient management and to improve cancer care.

In Italy, the network of CCCs is directly managed by the Ministry of Health of the Italian government, which recognized those centers as able to provide clinical and research activities for cancer disease (Istituti di Ricovero e Cura a Carattere Scientifico [IRCCS]) and supported their translational research with ad hoc funds. These IRCCS are cooperating within the national network of Alliance Against Cancer (ACC) (4).

The IRCCS must be equipped with specific characteristics described by law no. 288/2003, which establishes, among others, timing for the periodic review of standards to confirm the IRCCS designation. A similar process of peer review is used by the National Institutes of Health in the United States for the identification and confirmation of the CCC as national cancer centers that have to be of adequate clinical, scientific, and educational standards (http://www.cancer.gov/research/nci-role/cancer-centers).

Moreover, the Italian law 288/2003 requires that IRCCS be “quality certified according to internationally accepted ­models”. To fulfill this request, Italian IRCCS preliminarily applied different accreditation/certification models (e.g., Joint Commission, ISO 9001: 2008, Accreditation Canada) to their structures, but it was clear from the beginning that a model able to specifically evaluate the performance of IRCCS in terms of capacity for innovation, multidisciplinarity, continuous improvement of health care and performance management, high level of operator training, application of ­guidelines, production of diagnostic and therapeutic pathways, and translational research in the field of primary, secondary, and tertiary prevention was not available (5). This scenario generated an intensive debate in a dedicated Working Group of the Network of Italian IRCCS, whose activities have been supported under program 4 of Art. 3 DM of 21 July 2006 “ISS ACC”.

After several national meetings (ISS, Rome, January 2009; Cancer Institute, Bari, July 2009; IEO, Milan, November 2009; IRE, Rome, March 2010), the need was defined to apply to Italian IRCCS a more specific accreditation system based on external peer review, able to evaluate issues such as quality, efficiency, and monitoring of translational research and care processes, and, interestingly, focused on results and satisfaction of caregivers.

At the European level, the need to establish a model of accreditation for excellence specific for the CCC has been discussed within the Organisation of European Cancer Institutes (OECI) (6), which coordinates 70 CCC across Europe (www.oeci.org). After a pilot study in which the Istituto Tumori, IRCCS, of Bari, contributed directly to the validation of standards and criteria for accreditation, the OECI established the tools and the accreditation/designation model applicable specifically to cancer centers. The model collects information on the following standards:

Standards and criteria for multidisciplinary cancer care (Quality Manual)

Standards and criteria for prevention, treatment, research, training, and follow-up activities

Definition of the process to check for compliance of the cancer center with specific standards

Collection of quantitative data on the infrastructure, resources, and activities of the cancer center

Tools available to collect standardized and quality data measuring treatment plans and outcomes

The process thus conceived was tailored to follow all the processes of care in its interdisciplinary/multidisciplinary characteristics and therefore to assess the quality of care from the organization, management, and preventive/diagnostic/therapeutic/palliative/supportive points of view. The utilization of such a model, providing all-round information on cancer institute activity, becomes a strategic keyboard of data crucial for benchmarking and improving collaboration between CCCs for the development of common translational research (7).

All these reasons prompted the Ministry of Health to fund a project aimed at testing the applicability of the OECI model of accreditation to all its cancer institutes participating in the national network of IRCCS in 2009. All 11 Italian IRCCS agreed to join the action, directly involving the general management, quality managers, health and scientific directors of each institute.

Methods

The dedicated Working Group of the ACC applied for funds with 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” to the Call for Special Research Project of the Ministry of Health in 2009. The primary objective of the project was to verify the applicability of the voluntary accreditation model of excellence for cancer institutes developed by OECI to the Italian network of CCC-IRCCS. The project was aimed to verify applicability in terms of time needed, resources needed, availability of trained personnel, and peculiarities with respect to other available accreditation models.

The project, initially 36 months, prolonged to 48 months (December 2011-December 2015), activated a Scientific Committee, composed of Scientific Directors of each of the IRCCS participants, and an Executive Committee with all the Quality referents of each Institute. The IRCCS funded within the project were as follows:

Centro Riferimento Oncologico, IRCCS, Aviano

Istituto Tumori G. Paolo II, IRCCS, Bari

Ospedale San Martino–Istituto Tumori, IRCCS, Genoa

Istituto Europeo Oncologia, IRCCS, Milan

Fondazione Istituto Nazionale Tumori, IRCCS, Milan

Fondazione Pascale, Istituto Nazionale Tumori, IRCCS, Naples

Istituto Oncologico Veneto, IRCCS, Padova

Centro Riferimento Oncologico Basilicata, IRCCS, Rionero in Vulture

Istituto Tumori Regina Elena, IRCCS, Rome

On a voluntary basis and without financial support, 2 new oncologic centers recognized as IRCCS by the Ministry of Health after project approval entered the project:

Istituto Scientifico Romagnolo per Studio e Cura Tumori, IRCCS, Meldola

Istituto Tecnologie Avanzate & Modelli Assistenziali in Oncologia, IRCCS, Reggio Emilia

The project was conducted under the scientific coordination of the Principal Investigator Angelo Paradiso (Istituto Tumori, Bari), supported by the Focal Point International Affairs of ACC, and managed by Filippo Belardelli, Rapporteur for the Istituto Superiore Sanità-Roma.

Actions

The project was organized into multiple tasks with specific deliverables to be achieved according to the following timing:

Action 1: Develop national statements and publish a position paper on the issue of accreditation of CCC with dissemination to scientific and social referents and raise public awareness of the need to monitor quality of care in oncology (1st-6th month).

Action 2: Train on accreditation models internationally available and specifically on the accreditation/designation model of OECI. Develop training program for quality managers of each IRCCS with organization of 2 courses at different IRCCS oriented to all the representatives involved in quality control (6th-9th month).

Action 3: Apply the OECI accreditation model to all IRCCS, including the self-assessment step, undertaken through the use of an IT tool, and the external peer review step. Self-assessment comprised the compilation of a quantitative questionnaire with comprehensive information on resources and activities (care, research, infrastructure, training, and management) to have all audit teams visit with final designation of each cancer center.

Action 4: Provide feedback and report to ACC-ISS and the Ministry of Health. This action is the major endpoint of the project, reporting to national policymakers pro and con comments concerning application of the OECI model to the Italian centers. Key points to report on were costs, applicability, beneficial effects for the IRCCS, and usefulness for Ministry of Health purposes for the Ministry of Health.

Results

The project required coordination of all the groups taking part. Several meetings of the 2 project committees and a series of education/training courses addressed to various health operators were performed in different cancer centers.

The kickoff meeting was held on March 23, 2012, at the Ministry of Health, Rome; the first year meeting for activities monitoring on January 15, 2013, at Istituto Europeo di Oncologia, Milan; the second year meeting for activities monitoring on November 21-22, 2014 at Istituto Superiore Sanità, Rome; the preliminary end meeting of the Project on June 26, 2015 at Istituto Superiore Sanità, Rome; and the final meeting on November 17, 2015 at Istituto Superiore Sanità, Rome.

Moreover, 3 education/training courses for quality referents and health managers were held on March 8-9, 2013; May 8, 2013; and May 22-23, 2013.

Finally, a course for OECI auditors training was held in Bari on July 3-4, 2014.

The following results were achieved:

Action 1: production of a position paper. The first endpoint of the project was to draw up a position paper on specific issues regarding the accreditation to excellence of CCC. After discussion, a position paper was published in 2013 (8), in which current knowledge, legal rules, and guidelines concerning the accreditation of cancer centers was reported. In particular, based on participants’ experience and recent international guidelines/recommendations (http://www.jointcommissioninternational.org/about-jci/jci-accredited-organizations/; http://www.internationalaccreditation.ca/; http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm; www.oeci.eu/Documents/OECI_ACCREDITATION.pdf), a document defining the most relevant elements of the models most commonly used in accreditation to excellence was elaborated. This document underlined the definitive and global acceptance of the model of accreditation for excellence by Italian cancer centers. In that paper, the representative of the Italian CCC reported awareness of the need to adopt common basic principles and agree on the conduction of a specific, coordinated nationwide action. The definition of common general principles was considered the basis for the adoption and implementation of a model of accreditation based on the OECI model. The paper outlined the characteristics of an ideal model for peer-reviewed CCC accreditation in which all the clinical and technological standards of a modern cancer facility but also the capability to perform experimental translational research need to be included. The position paper also considered the possibility that the application of the accreditation model of OECI to a country-wide reality should require modifications to meet the specific needs of a national reality.

Action 2: training/education on accreditation models. Three editions of education/training courses for quality referents and health managers were held on March 8-9, 2013; May 8, 2013; and May 22-23, 2013. The training course for OECI auditors held in Bari on July 3-4, 2014, by the Belgian company Kerteza included 12 operators from the IRCCS involved in the project and 4 from foreign European cancer centers.

Action 3: accreditation according to the OECI model of all Italian IRCCS. The activities concerning this point are summarized in Table I, where dates of different steps of the process (start and end of self-assessment, peer review, certification) are specified for each institute. All the IRCCS reached the certification within the planned timing. The only exception is represented by the IRST-IRCCS of Meldola, for which OECI noted a major limitation of the OECI model when applied to a cancer institute organized as a territorial network rather than as a comprehensive concentrated cancer center like the Cancer Institute of Meldola. A debate internal to OECI on the peculiarity of the IRST Meldola organization model was activated in order to set up an accreditation model fitting this modern way to provide cancer care and research. An ad hoc Working Group of OECI is working on this topic.

Action 4: final report to ACC and Ministry of Health. A final report on the project experience for each IRCCS has been produced by OECI while the point of view of different IRCCS on the process performed for accreditation is summarized by each IRCCS in this issue. The articles published in this issue by OECI representatives (9) and by the president of the ACC (10), provide an analysis of the strengths of the Italian program, distinctive Italian aspects, and opportunities for further initiatives.

Actions and timing of OECI accreditation process of 11 Italian cancer centers

Cancer center Self-assessment starting date Self-assessment closing date Peer review date Certificate acquisition date
IRCCS = Istituti di Ricovero e Cura a Carattere Scientifico; OECI = Organization of European Cancer Institutes.
IEO Milano March 2013 October 2013 December 2013 June 2014
IRST Meldola March 2013 October 2013 January 2014 See text
CRO Aviano March 2013 October 2013 February 2014 October 2014
IRCCS Reggio Emilia March 2013 October 2013 February 2014 December 2014
INT Milano June 2013 March 2014 June 2014 February 2015
IOV Padova June 2013 April 2014 September 2014 June 2015
IRCCS Bari June 2013 June 2104 October 2014 June 2015
IRCCS Genova June 2013 March 2014 December 2014 June 2015
IRCCS Napoli June 2013 October 2014 January 2015 July 2015
IRCCS Roma June 2013 January 2014 April 2015 September 2015

Conclusion

The results have several implications for the Italian National Health System. The project permitted definition of specific indicators of quality and set up minimum quality performance standards important for care of cancer patients. It is clear from this analysis that IRCCS should routinely check the quality and efficacy of their performance, identify areas of weakness and excellence, and compare their performance with that of other centers through benchmarking analysis.

The OECI model was demonstrated to be useful for Ministry of Health monitoring IRCCS activities and permitting a simple qualitative/quantitative performance check.

The OECI model of accreditation of excellence emerged as specifically permitting tailored evaluation of a complex structure such as a cancer IRCCS.

Italy is the only European country that has applied the modern and CCC-tailored accreditation model of OECI to all its cancer centers. The network of ACC is thus able to take an important leading role in collaborative research projects for cancer care in Europe.

Disclosures

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

Affiliations

  • Experimental Medical Oncology, Istituto Tumori G. Paolo II, IRCCS, National Cancer Institute, Bari - Italy
  • Ematology, Oncology and Molecular Medicine Department, Istituto Superiore Sanità, Rome - Italy

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