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Patient safety in practice: How to manage risks to patient safety and quality in European healthcare

How to manage risks to patient safety and quality in European healthcare were the topics of the 2013 HOPE Agora held in The Netherlands
Pascal Garel 
Chief Executive
HOPE, the European Hospital and Healthcare Federation
Isabella Notarangelo
Health Economist
HOPE, the European Hospital and Healthcare Federation
HOPE held its Agora in The Hague (The Netherlands) 10–12 June 2013, concluding the 32nd HOPE Exchange Programme, a four-week training period intended for hospital and healthcare professionals with managerial responsibilities. “Patient safety in practice: How to manage risks to patient safety and quality in European healthcare” was the topic of the year.
The final evaluation meeting was preceded by a conference on this theme on 11 June, organised by the Dutch Hospitals Association (NVZ) and the Dutch Federation of University Medical Centres (NFU), in collaboration with HOPE – 350 participants attended the conference.
The morning plenary provided an overview of cultural aspects that influence patient safety in hospitals and how managers can deal with this effectively. After an introduction and welcome by Ferry Breedveld (NFU), the session opened with a keynote speech from Leon van Halder (Dutch Ministry of Health, Welfare and Sports), who highlighted several Dutch initiatives and policies to promote patient safety and the cultural aspects that determined them. 
Niek Klazinga (Head of the Health Care Quality Indicators (HCQI) Project at OECD) illustrated the results of the EU-funded research project DUQuE, which assessed the relationship of various quality improvement governance approaches with quality indicators of hospital care. Wim van Harten (NKI-NVL) presented VMS, the Dutch programme for safety management in healthcare, whereas Erik Heineman (Groningen University) focused on the viewpoint of the medical specialist, highlighting cultural differences influencing their work in hospitals. 
Finally, Diana Delnoij (Tilburg University) talked about patient participation in safety management, providing an insight into patients’ experiences and explaining how patients can be involved so to enable their active participation in their safety. 
Concluding this session, Yvonne van Rooy (NVZ) further stressed that improving patient safety represents today an important priority. Stimulating mutual learning and exchanging experiences are fundamental, as safety is the result of the close cooperation among many professionals. 
In the afternoon, several workshops were organised, allowing attendants to share their views and experiences in a more interactive way. During the workshops, experts presented good practices from different European countries on seven themes (medication safety, reporting incidents, communication gaps, patient participation, infection prevention, safety in the operating theatre and working in teams). 
The conference ended with an interview of Jean Bacou (Coordinator of PaSQ Join Action) and Pascal Garel (HOPE Chief Executive), who highlighted the close connection existing between the HOPE Exchange Programme and PaSQ Joint Action, both aiming at promoting and enabling knowledge and good exchange of practices. It was also stressed how flexibility and a bottom-up approach are the way forward in order to take into account the different national contexts and realities existing in Europe.
Sharing practices
During the evaluation meeting in the HOPE Agora, which took place on 12 June, the 141 exchange participants, divided per hosting country, presented the results of their experiences throughout the four weeks they spent in the foreign hospitals. 
The attention was focused on risk management in a broad perspective and the way hospitals are trying to improve safety. Risk management is understood as a continuous and dynamic process, which is connected to the strategy of the organisation in the daily operational activities, involving all human resources – both staff units and healthcare professionals.
The most prominent topics identified by participants were the prevalence of a culture to report incidents and its diffusion within the hospital. Others related to the existence and use of an effective system of data collection and the identification of the “problem owner” of patient safety and of the management and professional responsibility.
Furthermore, HOPE exchange participants covered several issues with an impact on safety/risk management: medication safety, overall hygiene issues, patient involvement before and after the operation, standard operating procedures in each clinical path, patient records and the organisation of archives.
Each presentation explained which measures had been implemented in hospitals to improve patient safety, the most successful action taken and the ones that could be transferred to other European healthcare systems. 
Patient safety initiatives at national level
Patient safety has become a priority issue in the European policy makers’ agenda since the early 2000s. For this reason, many initiatives have been taken at national level. 
In some countries, the instrument used to enhance initiatives was a legislative measure to define rules that healthcare providers must respect when implementing patient safety tools. In Denmark and Finland, patient safety acts outlined the framework for patient safety strategy. In Poland and Sweden, legislation was used to support patient involvement within the national organisations.
In other countries, soft solutions have been considered preferable: local organisations have the possibility to choose the solution that best matches their own features: guidelines, principles, strategy, standards (Finland, France, Greece, Hungary, Portugal, Spain, Sweden and United Kingdom) and programs, plans, projects and campaigns (Belgium, Denmark, Estonia, Finland, France, Hungary, Latvia, Lithuania, Malta, Poland and Spain).
In two of the twenty hosts Member States, additional measures have been adopted: contracts and agreements. The Estonian Healthcare Service has signed a contract in which new indicators and standards have been approved, to achieve better results in the field of quality. In Spain, the Ministry of Health, in order to implement Patient Safety policies, started collaborations with professionals and patients and signed agreements with the seventeen Health Regions and the INGESA (Instituto Nacional de Gestion Sanitaria) and agreements and contracts with public and private organisations. 
In several host countries, dedicated institutions perform an important role in quality management and patient safety initiatives. In some cases, they support the Central Government to develop an effective activity of quality management and control at local level (Hungary, Latvia) and to develop a culture of quality (Andalusia in Spain); in other cases, these institutions strengthen, with their presence at national level, the role of the centrality of patient in the health system (Hungary, Poland).
In some countries, these institutions carry out a very important activity, promoting the implementation of patient safety tools such as satisfaction surveys (Switzerland), checklists in the operating theatre (Switzerland) and complaining system (Latvia). In Lithuania, the National Patient Safety Platform, which includes 20 partners within governmental, non-governmental and educational institutions, ensures a high quality of healthcare services and processes. Some activities promoted by this platform are mandatory for the local organisations. In Andalusia, Spain, the Observatory for Patient Safety and the Observatory for the Quality Training in Healthcare are two specific organisations by which it is possible to be accredited. In Finland, the National Institute for Welfare and Health, a public agency under the responsibility of the Ministry of Social Affairs and Health, is involved in Patient Safety at the national level, assuming a “teaching role”, meaning that it promotes a web-based training programme for professionals working in healthcare institutions. 
In Austria and Portugal, national platforms and databases have been implemented in order to ensure the quality of care through the collection of information and complaints and the mapping of risk events. 
One of the most common initiatives taken at national level is accreditation, the process certified by a third body through which the organisation accepts the requirements and standards needed to be accredited. The accreditation can be either national or international, depending on the nature of the third body. National accreditation has been adopted in the Flemish Region in Belgium, Denmark, France, Germany, Portugal and Andalusia (Spain). Austrian, Hungarian, Lithuanian and Polish organisations have adopted ISO certification system for healthcare services. Accreditation is also seen as the external pressure that pushes towards a cultural change. In countries where patient safety is not strengthened enough, it could be the tool by which new processes are started and initiatives: this happened in Malta and Slovenia.
Indicators and reporting can be included within the initiatives taken into consideration to improve patient safety at national level. In Belgium, a project on quality indicators is carried out by the Flemish Region. In France, the use of national indicators is listed as one of the best practices adopted in the whole country. In Sweden, healthcare organisations must produce an annual report, which allows the comparison between the different realities. The culture of reporting is well developed at all levels: an incident-reporting system exists not only at central level but also in county councils and hospitals. 
Strategies adopted and activities conducted in the healthcare organisations visited vary but there are recurring topics: communication tools for patients; new organisations: risk management.
Communication tools for patients
Communication here means the activity conducted in hospital to involve patients in their care pathway and to sensitise professionals in strategy and concrete actions related to patient safety. During the HOPE Agora Evaluation Conference, it emerged that communication is a critical aspect, in particular the information provided to patients by professionals. The approach of professionals while they communicate with their patients depends on the culture that prevails in the hospitals or in the country. In some cases, a strong hierarchy and a physician-centred culture prevail: professionals do not share with patients any information about their care pathway and patients are unaware of the events related to the treatments. In others, patients are informed about their conditions during their first contact with physicians. Sometimes, they are also involved by the professionals in defining the best treatment to be adopted. 
According to the results identified, the most common tools used to communicate are the hospital intranet system, the internet and the dissemination of flyers. In German hospitals visited, internal communication is based on an intranet shared system through which is possible the collecting of input and information from the staff. Patients are informed about their care pathway through flyers. In Slovenia, the Community Health Centre of Ljubljana introduced on-line reservations on the website. Patients are able to e-book an appointment with the doctor of their choice on the basis of the available time slots. This solution improved the access to care. Furthermore, the website itself provides information about health and lifestyle, putting a focus on prevention.
New organisations 
In parallel with national institutions, specific organisational units have been created in hospitals in order to dedicate resources (both financial and human) to quality and patient safety. In Germany, there are committees in charge of patient safety issues in all hospitals. In the Children’s Hospital of Riga, Latvia, a dedicated team comprised of several professionals belonging to clinical and administrative units has developed the hospital strategy.
The growing importance of the so-called patient safety leadership has attracted the attention of researchers and policy makers. Miller and Bovbjerg (2002) have emphasised that there are two determinants of success in improving patient safety: a demand for safety from external factors (legal, market and professional) and appropriate organisational responses that depend on internal factors such as leadership and governance, professional culture, information-system assets and financial and intellectual capital.(1)
In several European hospitals both professionals and managers have started to work together to create awareness about patient safety concerns in the organisations.
More leadership means better patient involvement in the definition of their care by professionals. In the UK, in particular, the Boards of hospitals are engaged and responsible for the patient safety strategy, rendering necessary a growing commitment of management, staff and carers. In Sweden, in the psychiatric clinic of Borås, patients are actively involved on their own care and they define, together with the healthcare professionals, their own care plan.
As stated by the experiences of the exchange participants, technological solutions have contributed to the development of patient safety strategy, simplifying the information exchange among and within the healthcare organisations. In Andalusia (Spain) and in Sweden, for example, good ICT systems were found to be connecting all the actors involved in the care of the patients. The system facilitated the integration of primary care, hospitals and pharmacies. In Finland, Sweden and Valencia (Spain), ICT solutions were used by the organisations mainly to collect data and to improve the reporting system. In Austria, this tool was used to develop the standards and clinical guidelines at ward level. Technological tools and specific programs are also employed to make e-prescriptions. These instruments support the policy makers to evaluate and to choose. They allow the mapping of the real events and 
the identification of critical issues (incidents, for example) that can be prevented once recognised. ICT improves integration in health systems, allowing the system to offer proper cares to the patients using efficiently and effectively the resources available.
Risk management
Risk management is a systemic process of identification, analysis and evaluation of actual and potential risks to estimate the costs and efforts that they request from the organisations. In hospitals, the risk management activity is done to safeguard the patient, reducing and foreseeing the adverse events and the medical errors through the mapping and the analysis of the root cause.
During the Evaluation Meeting, it emerged that many hospitals in several countries developed different risk management activities. These activities can be clustered as follows: Clinical Audit, Data Collection, Data Protection, Indicators/Benchmarking, Reporting System on Adverse Events/Root analysis and Complaining System. The effective implementation of those activities is related to the patient safety culture that prevails in the hospital. 
Clinical Audit in a modern healthcare system is an activity conducted in the field of clinical governance to improve the standards of clinical practices. According to the results of the conference, the clinical audit is included in the set of solutions implemented in Austria, Estonia and Latvia as a risk 
management instrument.
In particular in Estonia, the aim is to understand the quality level of the care. In the Children’s Hospital of Riga in Latvia, a team dedicated to the development  of a patient safety strategy carries out this kind of activity. 
Data Collection is a tool used to provide information on hospital activity. Through the information produced, it is possible to compare if the measures put in place and the results obtained fit with the standard required by the procedures (Austria). Through this system, it is possible to go back to the causes of an incident (Belgium and Finland) and to improve the clinical activity, and to strengthen the prevention of errors and mistakes or pathologies related to the patient stay at the hospital. 
Patient privacy is safeguarded by a data protection system that, in countries such as Austria and Germany, restricts access to the patient’s documents in order to ensure confidentiality in handling medical record files. Generally, this system is supported by software. 
Policy makers support the use of indicators and the activity of benchmarking, for the purposes of supervising the quality of healthcare services on an empirical basis and encouraging the hospitals to compare with different realities. In Austria, a report containing a set of quality indicators has to be addressed by the hospitals to the Ministry of Health, and the national policy makers can check with reference to the standard defined. Often, it is mandatory to publish quality indicators (France) to make transparent the hospital activity.
Within the solutions adopted at hospital level to recognise the risk and improve practices, the most frequently used instruments were the incidents reporting and the root cause analysis. Of the 20 hosting countries, 14 chose at least one of these two tools to prevent, identify and learn from the errors. Professionals report incidents often use specific web-based systems to provide information (anonymously) used to understand which are the practices or the activities that increase the risk to blunder. Incidents reporting and root cause analysis support both top management and professionals in making strategic decision and in adopting good practices to prevent the errors. In the UK, the system of incident reporting is implemented at national and local levels: every year, thousands of reports are produced and their results are used to train the NHS workforce. In Spain, Hungary and Greece, incidents reporting and root cause analysis need to be developed. In Malta, this topic is a critical issue related to patient safety culture. In this context, it is possible to say that the countries in which a patient safety culture is more developed and effective are the ones where reporting incidents and root cause analysis have produced positive results (Denmark and Finland, for example).
Together with incident reports and root cause analysis, the complaining system contributes to the collection of useful data to analyse the causes related to adverse events. The information provided through the implementation of these elements is used to train the professionals with the intention of making them aware of the risks they could incur while performing their activity and to reduce errors. The complaining system, if effective, allows the professionals to report their own mistakes anonymously, without suffering the consequence of losing their job (Austria).
Patient safety tools
Patient safety tools are the instruments or practices used by professionals to prevent incidents and thus assure high quality of care. They are connected to the risk management activities: if accurately used, these instruments can reduce the risk of making errors carried out in clinical activities. During the Evaluation Meeting, several of them where presented: Checklists; Clinical Report; Control and Prevention of Fall, Infection and Ulcers; Guidelines; Hand Hygiene; Medication Safety; Patient Identification; Prevention; Process Management and Standard Procedures/Processes. The most common solutions implemented at hospital level seem to checklists, the control of falls, infections and ulcers and patient identification. In almost 40% of the host countries, at least one of the three tools was identified. 
Checklists in operating theatres were found in one-half of the countries that hosted HOPE exchange participants. Hospitals usually opt for the WHO Surgical Checklist, which aims at “improving compliance with safety standards and proved to decrease complications from surgery […] where it was evaluated. The checklist was established with a view to simplicity, wide applicability, and measurability.
It divides the operation into three phases, each corresponding to a specific time period in the normal flow of a procedure (the period before induction of anaesthesia – Sign In, the period after induction and before surgical incision – Time Out, and the period during or immediately after wound closure but before removing the patient from the operating room – Sign Out), and a standardised approach to safety management. The success of the Surgical Safety intervention demonstrated by the significant reduction in surgery related morbidity and mortality has triggered a huge response”.(2) The WHO Implementation Manual provides the information the checklist should contain. Additions and modifications to the content are encouraged in order to fit better the hospital/ward practice.
During the Workshop on patient safety in the operating theatre, which took place during the first day Conference on Patient Safety in Practice, it emerged that the SURgical PAtient Safety System (SURPASS) checklist, developed in The Netherlands, has been an effective method to be adopted during a surgery procedure in order to prevent errors and adverse events. A prototype checklist was constructed based on literature on surgical errors and adverse events, and on human-factors literature. The items on the theory-based checklist were validated by comparison with process deviations (safety risk events) during real-time observation of the surgical pathway. Subsequently, the usability of the checklist was evaluated in daily clinical practice. The multidisciplinary SURPASS checklist accompanies the patient during each step of the surgical pathway and is completed by different members of the team. The SURPASS checklist covers the vast majority of process deviations suitable for checklist assessment and can be applied in clinical practice relatively simply. It is the first validated Patient Safety checklist for the entire surgical pathway.(3) Through this specific tool, it has been estimated that it prevented 40% of deaths and 29% of incidents leading to permanent damage.(4)
Along with the use of checklists, the control and prevention of falls, infections and ulcers is one of the most common tools adopted both at hospital (Estonia, Spain and United Kingdom) and national (Portugal) levels, but also in primary care (Finland). In general, the effectiveness of this measure is assessed in terms of improved quality of care (Latvia, Lithuania) and its implementation is supported by an electronic system which collects all the data related to the event (Belgium). Periodically, a report is produced in order to analyse all the circumstances that contribute to falls, infections or ulcers (Austria). In some cases (UK) a holistic approach has been adopted in the prevention of falls, in order to reduce their impact on the NHS. 
Clinical guidelines have been mostly implemented at hospital level and adapted to specific contexts. They can be defined as a set of recommendations to follow in executing the clinical activity in order to reduce the risk of adverse events, incidents or errors on patient identification (Austria, Finland and Portugal). At European level, hospital boards or dedicated staff (Latvia) increasingly focused their attention on clinical guidelines in order to support the staff in following standards and procedures (The Netherlands). This choice allowed an easier control, risk reduction and high quality of care.
Among the guidelines adopted at supranational level, it is important to mention the WHO Guidelines on Health Hygiene in Health Care,  development of which began in the autumn of 2004. They provide a comprehensive review of scientific data on hand hygiene rationale and practices in healthcare. This extensive review includes, in one document, sufficient technical information to support training materials and help plan implementation strategies.(5)
Besides this document, the WHO developed a global campaign called Clean Care is Safer Care in order to improve hand hygiene among healthcare workers and to support the reduction of healthcare-associated infections and their consequences. The WHO Clean Hands Net started as an informal network of national, sub-national and regional hand hygiene campaign in 2007. At this moment, the network is comprised of 48 participants worldwide, involving the following European countries: Belgium, Bulgaria, Croatia, Denmark, France, Germany, Hungary, Ireland, Italy, Luxembourg, Norway, Portugal, Spain, Sweden, Switzerland and the UK.
Medication is an area where adverse events regularly happen and, for this reason, medication safety has become a priority on the agenda (Denmark). During the Evaluation conference, it emerged that, at hospital level, common measures have been adopted in order to guarantee a safe method of pharmaceuticals administration. Medication safety is not only about the administration: it also involves storage and transport (Estonia). One of the solutions broadly implemented is the presence of a dedicated pharmacist on the ward who ensures the risk reduction through pharmaceuticals dispensation and control the drug omission (Belgium, UK). Other initiatives to guarantee  safe medication are the use of single-dose packages (Belgium) or the identification through different labels of syringes and pharmaceuticals (Lithuania). In Finland, for example, hospitals have adopted the Evidence-Based Medicine electronic Decision Support, a system that receives structured patient data from electronic health records and returns reminders, therapeutic suggestions and diagnosis-specific links to guidelines.
Patient identification is one of the most-used measures, implemented in almost one-half of the host countries of the Exchange Programme. The tools adopted to identify patients with a specific pathology and address them to the correct clinical-path are bracelets and the implementation of a triage system. Each bracelet corresponds to a process for that patient (Austria, Estonia, Latvia and Portugal). Triage is the process of determining the priority of patients’ treatments based on the severity of their condition.(6) It is necessary to ensure that patients are treated in the order of their clinical urgency and that the treatment is timely. It also directs the patient to the proper treatment area and provides information that helps to describe the departmental case-mix. Urgency refers to the need for time-critical intervention(7) (Latvia, Lithuania and Slovenia). In the Lucus Augusti Hospital, Galicia (Spain), a system of patient identification has been implemented to distinguish patients affected by several pathologies but also to track blood transfusion. In the UK, slipper socks are used for patients who risk falling.
Prevention campaigns have been introduced at both national (Portugal) and hospital (France) level, in order to sensitise professionals to respect Patient Safety measures, such as hand hygiene standards (Estonia). These programmes concern mainly the prevention of infections (Lithuania) but also diseases such as breast cancer (Malta).
Healthcare practices are characterised by complex clinical processes in which high-risk activities take place. A clinical process can be seen as a particular work flow where medical (for example, treatments, drugs administration, guidelines execution and medical examinations) and non-medical (for example, patient enrolment and medical record) activities and events occur. A successful approach for reducing cost and risk and enhancing patient safety is a process-oriented vision of healthcare services and practices. Systems providing clinical processes design, execution and analysis functionalities can change clinical practices and can help the diffusion of a process and quality awareness in healthcare organisations.(8) During the HOPE Evaluation Conference, it emerged that, in some European hospitals, process management has became a strategic activity in which all professionals are involved, not only top management (Belgium). Many resources have been invested in order to update the processes (UK) and their management is a future challenge to be developed at NHS level (Spain), since it obtained further relevance in the policy makers’ agenda. 
The use of standard procedures and protocols is a measure implemented in order to give professionals clear indications to follow in conducting the clinical activity. The purpose is to reduce the risk of adverse events through the application of strengthened suggestions in treating the patient. According to HOPE exchange participants’ experience, this tool has been adopted in host hospitals situated in Austria, Belgium, Finland, Spain and The Netherlands. Standard procedures and protocols could refer to the activities carried out in the operating theatre (for example, checklists) or in providing care to patients with specific diseases.
It has been argued for a long time that patients have the right to be involved in the care they receive. Vincent and Coulter (2002) asserted that this necessity increased by the recent emergence of concern on patient safety. HOPE exchange participants identified several instruments used in European hospitals (Estonia, Finland, France, Poland, Portugal, Spain, Sweden, Switzerland and The Netherlands) to involve the patients: surveys (mainly about satisfaction related to the care received) and the implementation of a system of complaint.
Surveys are generally collected at the moment of the discharge, with the aim of investigating whether or not the patients are satisfied with the quality of the care they received while hospitalised. In some countries, the submission of surveys at least every one or two years is compulsory (Switzerland and Finland). The results obtained are collected in a report and used by the professionals with learning purposes. In the Psychiatric clinic of Borås (Sweden), patients participate actively with professionals in the definition of their care-plan as well as surveys and root cause analysis. Another initiative (Portugal and The Netherlands) through which patients give their feedback is the introduction of a complaint system: committed staff take charge of the complaints of the patients, giving them a reply within a few days. 
The necessity of involving professionals in Patient Safety issues makes policy makers at all levels aware of the importance of education, traini