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Achievement of European standards by CROB-IRCCS

Abstract

The Organisation of European Cancer Institutes (OECI) has recently endorsed a program for the accreditation of Italian cancer institutes. Any cancer center that aims to provide research, education, and care services to cancer patients should undergo an evaluation process in order to become OECI accredited. On a center basis, the task turned out to be challenging, and required commitment and increased workload. The timing is an adjunctive constraint, especially when dealing with bureaucracy. Once undertaken, the accreditation process goes through preparation and completion of the self-evaluation, peer review, report, and final designation. This process constitutes an unrepeatable opportunity for improvement. It is required to implement the necessary changes in order to improve policies, procedures, and employee training. Sharing the highlighted general remarks, strengths, and opportunities provided by the different audit teams (on a cancer center basis) will constitute a significant instrument to enhance cancer care.

Tumori 2015; 101(Suppl. 1): 47 - 50

Article Type: REVIEW

DOI:10.5301/tj.5000460

Authors

Rosj Gallicchio, Daniele Scapicchio, Pellegrino Musto, Giovanni Storto

Article History

Disclosures

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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Introduction

The Organization of European Cancer Institutes (OECI) accreditation program (1) is an assessment process that can be implemented to establish whether health care providers hold or might embrace quality standards. The accrediting organization’s survey takes into account evaluation of the whole system, in all its aspects, including administration, personnel, and information management, and research and education facilities, evaluating even areas unknown to the stakeholders. Accordingly, the task of endorsement is challenging, requiring a large commitment. Any cancer center that provides research, education, and care services to cancer patients and that is willing to become a recognized member of the OECI cancer community must undergo a strenuous evaluation ­process in order to become OECI accredited. This process constitutes an unrepeatable opportunity for improvement. Nevertheless, one should consider that resources, both human and technological, are limited, and an increased workload is to be expected. In addition, the OECI accreditation and designation (A&D) teams establish a timeline for each cancer center applying for the program, in order to allocate the ­necessary time for the preparation and completion of the self-evaluation, peer review, report, and final designation. The timing is an adjunctive constraint, especially when dealing with bureaucracy. Once visited, the cancer center must generate a plan as soon as possible, including a detailed timeline, for implementing the necessary changes, developing ­appropriate policies and procedures, and training the employees (as per ­improvement plan).

This article aims to convey the CROB-IRCCS experience with the OECI accreditation process, describing trial findings and highlighting general remarks, strengths, and opportunities provided by the audit team following the OECI accreditation visit (2, 3).

General remarks by the audit team following the visit

First, the audit team was impressed by our new and clean hospital building. The auditors noted a motivated staff who participated in an open and friendly way during the audit visit; in particular, they appreciated the fact that most of the required documents had already been anticipated in view of the visit. Besides the prepared documents, further necessary documents were needed. Finally, the auditor team recognized a well-prepared audit and organized visit.

Strengths of CROB-IRCCS according to OECI quality standards

The OECI A&D Board identified several strengths in our center. A total of 68% of the total number of substandards (n = 263), as provided by the self-assessment procedure, were scored as “yes” or “mostly” by the audit team: this means that for those indicators, the standard had been implemented in the cancer center and that the plan-do-check-act cycle (Deming cycle) was completed at least twice. The Deming cycle, or PDCA cycle (also known as PDSA cycle), is a continuous quality improvement model consisting of a logical sequence of 4 repetitive steps for continuous improvement and learning: plan (plan ahead for change), do (execute the plan), study (check the results), and act (take action to standardize or improve the process). The strengths described below represent only a part of the highest scored standards (4).

Small institute with a variety of services

The CROB-IRCCS is a young research hospital conceived as a territorial hospital that later became a scientific institute committed to oncology. The institute is located at the crossroads of 3 regions of southern Italy (Basilicata, Campania, and Puglie) with a strong relationship with another region (Calabria). The neighboring area contains almost 7.5 million inhabitants. The center offers a complete list of services in the oncologic field belonging to a transregional network with 2 other research oncologic centers (Bari and Naples). Accordingly, we register a high quota of incoming patients from the neighboring regions (5). On the other hand, as the population of the Basilicata region is demographically scattered, the institute represents the hub of the oncologic network coordinating and providing cancer cures on a territorial basis. The CROB-IRCCS provides a nearly complete coverage of cancer diagnostics and care including the full range of molecular diagnostics (research laboratories, advanced imaging, nuclear medicine, radiotherapy). In addition, the audit team highlighted the implementation of several internal guidelines on a cancer-type basis, the so-called percorsi diagnostici terapeutici assistenziali (PDTAs), already adopted (for breast cancer, lymphomas, colon-rectal cancer, prostate and lung cancer) and being realized (for melanoma and kidney cancer). They aim to represent the quintessence of the multidisciplinary approach to cancer that the institute would pursue. In particular, the audit team identified the clear definition of roles (medical staff, nurses) reported within, and that the PDTAs were compiled taking into account the current national and international guidelines as well as most recent recommendations.

Research

Our center has been recognized as a research institute by the Ministry of Health since March 2008. The auditors noticed the emphasis given to the research matter, with special regard to the translational orientation. Moreover, CROB-IRCCS has a biobank and well-equipped laboratories for basic and clinical research (except for consulting oncogenetics) and demonstrates consideration for young researchers.

The audit team also identified a well-functioning clinical trial unit with a prepared staff. Despite the small size of the institute, a large number of clinical phase I-IV trials are being continuously implemented, including spontaneous, sponsored, and registration studies. The auditors only advised improving the research program by establishing an external scientific advisory board, which will be appointed. However, the organization of this structure needs to be endorsed by the Regional Health System (RHS).

Hospice

The CROB-IRCCS has its own hospice unit. This feature was appreciated by the auditors, considering that our hospice is readily available for all end-of-life patients, including those from other territorial structures. In addition, the hospice unit works as a team according to a multidisciplinary approach. A brochure containing requirements for hospitalization in the hospice is available for patients and relatives and was well-received by the audit team.

Supportive services

Among the several high-tech services committed to oncology, the auditors highlighted the nuclear medicine department. As stated by them, this department is equipped with the most advanced technologies in terms of both diagnostics and treatment facilities. Moreover, it has an exemplary quality and organization system, participating in various quality assurance programs, also having a strong research focus.

The information communication technology (ICT) system

The auditors noted a user-friendly ICT system that provides a good clinical platform for both inpatient and outpatient use. This system includes easily accessible guidelines as well as a direct communication channel from the management to the employees. A strong emphasis is given to waiting times for all the services, since data supporting surveillance and the decision-making process of the management can be easily extracted. The auditors only advised the full implementation of the electronic patient dossier.

Opportunities for the CROB-IRCCS according to the OECI quality standards

The OECI A&D Board identified some opportunities for the center. In fact, 27% of the total number of substandards (n = 263), as provided from the self-assessment procedure, were scored as “partially” or “no” by the audit team: this means that for those indicators the standard was not yet implemented or implemented on a modest scale, and consequently the Deming cycle had not been completed. The opportunities described below, as requested by the auditors, have been addressed in the improvement plan and most of the required improvements have been put into action.

Quality management

The audit team required us to extend on a large scale the quality management of the institute in order to embrace every activity of the center, from diagnostics, to care, to rehabilitation/supportive cares, to research. With the development of the quality system, more human resources could be allocated to strengthen the quality management team and to appear stronger at management level. An important part of the quality assurance system that has to be improved is starting a registry procedure concerning deviations from guidelines. In recent years, the management of CROB-IRCCS changed frequently, according to RHS policy; nevertheless, the new General Director intends to strengthen the newly appointed quality team, in terms of both professionals and structures, involving most of the internal employees’ categories (nurses), partnerships (supportive care), and patients and relatives associations (patient empowerment; we are also entering into a multicenter project on patient endorsement, supported by the Ministry of Health). In particular, a newly appointed taskforce (the clinical governance department) is going to work for a powerful audit system able to realize specific action strategies and interventional programs passing from government (the logic of bans and rules) to governance (to build consent for making health policy through accountability and learning culture, at every level). It will also deal with health technology assessment and intellectual property. We intend to construct a ductile (sharable) assessment model to evaluate the quality of care and how it is delivered at any level in the center. As a referral cancer center and once validated, we aim to share the abovementioned model with other regional hospitals. The entire process (revision and adoption of fitting guidelines) has been started and will take approximately 1 year.

Multidisciplinary environment

Although a number of multidisciplinary teams (MDTs) are in operation, not all tumor types are discussed in an MDT. In this context, OECI A&D Board recommended to structure the organization of the MDTs at the institutional level. From the beginning, the new General Director aimed to confer a strong multidisciplinary mold to the institute. Our purpose is to give to the patients and their relatives the impression of an all-inclusive approach once they seek treatment at the hospital. Resources and instrumentation (devices and rooms for meetings) will be dedicated to this objective, building an environment with the aura of learning culture and self-improvement. The accomplishment of this objective, toward which we are working, will be scored by annual indicators for each department, but not with the purpose of an awarding mechanism. Concerning the treatment of bone metastases from castration-resistant prostate cancer, a specific MDT exists, encompassing the urology department, oncology department, nuclear medicine department, and radiation therapy department.

Drug preparation system/central pharmacy

According to the OECI quality standards (2, 4), preparation and administration of medical oncology drugs has an outstanding importance in a cancer institute. Therefore, the establishment of a central pharmacy where a pharmacist (or someone under the direct supervision of a pharmacist) prepares the drugs will improve not only quality and patient safety, but also the carrying out of clinical trials. At the time of the audit visit, this structure was lacking, as were related processes. As a result, after the audit visit the strategic direction has dedicated funds for a centralized unit for drug preparation. Presently, a committed pharmacist takes care of procedures, guidelines, and pathways. A location has been dedicated for a new comprehensive pharmacy. Structural jobs have been outsourced. In addition, the organizational, hierarchical model is being implemented by selecting committed professionals. A training course on clinical risk management in oncology and hematology for preventing drug preparation and administration error has been carried out. Significant support has been also provided by the ICT department for digital matter and informatics. The abovementioned weakness and the promptly adopted contrameasures show how feedback represents an opportunity for improvement.

Coordination/integration of supportive and palliative care

The auditors recognized that most of the necessary means for supportive/palliative care are available at CROB-IRCCS. However, some services are provided by external institutions based on contract, and, in some cases, the resources are modest. Consequently, with these resources, continuity of care cannot be guaranteed. Although the institute has hospice facilities, the basic palliative care support should be more integrated. The new multidisciplinary approach will include issues related to better coordination/integration of supportive and palliative care (the satisfactory model implemented in the hospice department will be shared in the institute and on a territorial basis). However, the strategic direction endorses the need of centralized coordination of both supportive and nursing care, knowing that this lack may have crucial repercussions on continuity of care. As a result, a plan to institute coordination is being evaluated, even if centralized coordination (at the institutional level) needs to be formalized with the RHS. Since the topic contains intrinsic logistic problems (strengthening agreement with external institutions and fulfilling RHS rules), we consider that it could be implemented within 1 year. The health direction, which has been restructured recently, is now supported by several staff services. Moreover, a model for sharing and advertising the multitude of tools and services related to supportive and palliative care in the institute will be implemented. Concerning the integration of care, it is intended to reinforce the staff of dedicated professionals (psycho-oncologist, rehabilitation operators, specialized nurses) according to both needs of patients and rules dictated by RHS. The strategic direction is determined to warrant the continuity of care using a new all-inclusive, active approach, involving the general practitioners (who may have active free access to the hospital and its services), the territorial structures (for continuous support at home, as well as social and psychological), and patients’ associations.

Nurse and patient empowerment

The audit team highlighted that our institute has motivated nurses. However, they advised implementing nurse representation at management level; in particular, a person with responsibilities able to coordinate all aspects of nursing (nurse director). By means of an internal competition, the strategic direction has appointed a nurse director and a technologist director.

Concerning patient empowerment, examples of patient-centered activities, like the smile program or art and dance therapy, are present. Nevertheless, some criticisms have been made of the fact that patient feedback is rarely used for improvement, although a well-functioning customer satisfaction system exists. Education materials for patients and their relatives should be developed and should include information about, for example, tumor types, diagnostics, treatments, symptoms, supportive care, patient associations, and self-help groups. Our Web site provides a great deal of information for patients. In the tribunale del malato (TDM) office, patients and families can find volunteers committed to accomplish their needs.

Conclusion

The audit team appreciated CROB-IRCCS’s efficient and effective organization, including the documentation provided and visit schedule. According to the OECI quality standards (2, 3), our hospital had features of a comprehensive cancer center with good clinical service and an excellent research orientation. Nevertheless, complete implementation of the multidisciplinary approach as well as a comprehensive quality management system should be done. Considering the data provided by CROB-IRCCS, it was clear that the institute exhibited the standards of a Clinical Cancer Center and some standards of a Comprehensive Cancer Centre. Thus, the final recommendation was to designate CROB-IRCCS as a Clinical Cancer Center. After the draft report, our institute has prepared and sent the improvement plan, which, among others, includes a description on how the center intends to meet the standards listed as opportunities.

At present, before the deadline, we have implemented most of the contrameasures. Yet, as stated above and according to our process, we consider that the type of designation, appointment, and accreditation should be more contextualized in the social, demographic, and political environment of the centers.

In conclusion, the assessment process was challenging and partially overloaded by issues related to resources availability; even so, the actual project plan of CROB-IRCCS is ­focused on further achieving standards of excellence in health care, including the development of biomedical research, the fulfillment of the healthcare demand in oncology, the acquisition of up-to-date health technology, as well as clustering with other institutes.

Disclosures

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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Authors

Affiliations

  • Referral Cancer Center of Basilicata, Scientific Institute for Hospitalization and Care, Rionero in Vulture (Potenza) - Italy

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