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Adibi et al. Journal of Diabetes & Metabolic Disorders 2012, 11:15 http://www.jdmdonline.com/content/11/1/15

RESEARCH ARTICLE Open Access

Development of an effective risk management system in a teaching hospital Hossein Adibi1, Nader Khalesi1, Hamid Ravaghi1*, Mahdi Jafari1 and Ali Reza Jeddian2

Abstract

Background: Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context.

Methods: WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches.

Results: The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The “non-punitive responses to error” had lowest positive score with 21.2 percent.

Conclusion: It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

Keywords: Patient safety, Risk management, Adverse event

Background Unsafe and potentially life threatening health care provision is a main cause of death and increased mortality rate amongst hospitalized patients in different countries [1,2]. Results of different studies have shown that a substantial number of patients are affected or even die as a result of defective health care in hospitals [3-18]. Adverse events in hospitals are now widely agreed to be a serious problem,

* Correspondence: [email protected] 1Department of Health Services Management, School of Health Management and Information Sciences, Tehran University of Medical Sciences, Tehran, Iran Full list of author information is available at the end of the article

© 2012 Adibi et al.; licensee BioMed Central L Commons Attribution License (http://creativec reproduction in any medium, provided the or

annually killing more people than breast cancer or AIDS [19]. Studies revealed that 2.9% to 16.6% of patients suffer from at least one of such complications and 5% to 13% of them die as a result. It is estimated that some 50% of this complications can be prevented [3,15,17]. Measuring the indicators and extent of adverse events may create a sense of urgency for Systematic intervention [1,2]. It is generally believed that errors and mismanagements of patients are directly related to defects and insufficiencies of the health care system and in many cases, they are originated from similar defects in the system [18].

td. This is an Open Access article distributed under the terms of the Creative ommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and iginal work is properly cited.

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A system approach to medical error and its reduction is crucial. To meet such important objective, establish- ment of a risk management system is necessary [20]. Risk management in health care is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury to patients, staff, and visitors and the risk of loss to the organization itself [21]. 7 steps in the Risk Management process are estab- lishment the context, identifying, analyzing, evaluating, and treating the risks, continuous monitoring and re- view, and communication and consultation [22]. This study aimed to develop and implement a risk

management system in a large teaching hospital, specif- ically according to World Health Organization guide- lines and patient safety reports. As to our knowledge, it was the first such experience of its type in Iran and we aimed to assess the limitations and insufficiencies of it. Analysis of results and findings of implementation of this system will be presented in separate articles.

Materials and methods Conceptual framework WHO draft guideline that is published in world alliance for patient safety program and patient safety reports from dif- ferent countries were reviewed for defining acceptable framework of risk management system. Also current situ- ation of mentioned hospital which is a large teaching hos- pital with more than 600 beds and expert university faculties, was evaluated in safety matter by direct interview with medical, nursing and management staff, and with focus group discussion in clinical governance committee and visit of wards and divisions. With adjustment of guide- lines and hospital status, the conceptual framework was developed and next, it was validated in expert panel includ- ing senior hospital management and deputy managers of health care, education, supportive affaires; operation rooms and emergency ward managers; clinical governance com- mittee; nursing supervisors; and faculty staff that involved in mortality and morbidity boards and other safety issues. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety areas. For validation of the model and gathering of expert

opinions, a likert questionnaire was used whose content validity approved by experts and its reliability was assessed by Cronbach’s Alpha coefficient. The Cronba- ch's Alpha coefficient equal to 0.76 shows appropriate internal consistency and reliability of the questionnaire for validation of the model. The framework is shown in Figure 1. The policy devel-

opment and executive program in risk management sys- tem consisted of designating a leader and coordinator core and defining its role, and defining communications with hospital boards and committees, describing

processes and preparing the infrastructure for patient safety education and culture-building. Risk management has had reactive and proactive approaches including ad- verse event reporting and learning, root cause investiga- tion and failure mode and effect analysis.

Values and commitments of the System Patient safety enhancement, learning from events and errors, providing feedback to health care workers and confidentiality were four basic principles of the system that have been emphasized. Root cause analysis of reported events and other safety information and dis- semination of results have met such important issues. Providing feedback has been done through safety alerts, presentation of notable cases in safety boards, and offi- cial informing of mentioned solutions to target groups. There were many problems in providing feedback. First, disseminating information in way that didn’t cause sham and blame and lead to disclosure of confidential data, needed to expert staff for providing reports, newsletters or alerts. Besides, high workload of most staff and large amount of documentation tasks have caused that patient safety alerts not to be listened. In order to overcome these problems, safety walkrounds with senior manage- ment was organized to emphasize on patient safety issues and its documents. Priority of safety in hospital, make and maintain of

nonpunitive approach, and provision of substantial resources and efficient staff, were the main hospital mandates. Patient safety information and reports was de-identified and no penal decisions were taken for reporters. Despite of system emphasizing on nonpunitive approach, some members of analysis teams and manage- ment staff have likewise focused on individual errors and necessity of organization encounter with mistakes in early stage of system implementation. With insistence of leadership on system based approach and search for sys- tem defects which underlie individual errors, gradually, this attitude has altered. Fortunately, senior management of hospital through

multiple meetings and discussion about safety data of hospital, had a good deal with system but there was some resistance in middle manager level that presented itself with lack of support of safety programs, resource limitation and punitive directions. Emphasizing on con- fidentiality and prioritizing of system failures, usage of national accreditation rules for safety requirements and reliance to leadership role of respective university were helpful for elimination of resistances.

Patient safety education and culture-building We put especial emphasis on different educational and training methods. Holding conferences, workshops, con- tinuous and short training courses on different aspects

Values & Principles Organization Commitments

Authority, Responsibility and communication

System plan and tasks

Adverse event reporting &

learning

Failure mode &effect analysis

Education and culture building

Root-cause analysis

Information management

system, monitoring patient

safety interventions

Leading

Organizing

Planning

Controlling

Leadership & Guidance Hospital managementClinical governance committee

Figure 1 The Validated model for risk management system.

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of risk management system with the goal of educating all health care providers were the first step to define principles, concepts, and values of the system and culture-building promoting patient safety. Moreover, assisting the patient safety personnel to challengingly visit and auditing different health care delivery sectors and dialogue with the aim of learning from events and analyzing them was used as proactive education and cul- ture building. Furthermore, safety walkrounds in the presence of senior managers of hospital in regular visits were designed and implemented. The main objective of this plan was demonstration of commitment of hospital management in terms of providing patient safety and provision of and monitoring its requirements. It is note- worthy that instructions to use different educational tools such as designing pamphlets and educational ma- terial were demonstrated. Despite of planning for educa- tion, participation of staff was weak and passive. It seems patient safety education should be consisted in work program of staff, or safety learning may be consid- ered as a personal promotion indicator in future plans. High workload and organization culture, that safety doesn’t being prioritized, were the other reasons of weak participation. For evaluation of patient safety culture in mentioned hospital, a cross sectional survey was con- ducted using standard questionnaire of Hospital Survey on Patient Safety Culture from Agency for Healthcare Research and Quality that evaluates 12 patient safety culture dimensions and 2 outcomes. In total, 90

individual responded (overall response rate = 60 per- cent), including 64 nurses, 7 physicians, 19 of other staff.

Reactive approach In our experience, a voluntary adverse event reporting system was implemented in hospital. Reporting was per- formed mainly in two different ways of voluntary report using forms and secondly, documenting the issue and its consequences in patient safety log. Moreover, fatal and serious events should be reported to clinical governance and patient safety department by the head nurse to be followed up. After in receipt of the report and prioritiz- ing of them, primary intervention measures were con- ducted in order to describe the detail of the incident thorough interviews with the responsible personnel, local inspection and reviewing records. Following data compiling, an expert assembly was formed to analyze the incident in depth and suggest strategies to overcome insufficiencies and defects; and ultimately, they super- vised their implementation and outcome. Table 1 shows the aggregated data from all hospital wards. The partici- pation of different wards in reporting process has ex- tremely varied that might be produced by difference of clinical areas and workloads, faculty attitudes and cul- tural factors. In order to overcome low participation in some wards, several walkrounds with senior manage- ment of hospital were considered to promote patient safety and reporting culture. Since underreporting was predictable, internal alternative sources of safety

Table 1 Reported adverse events in 18 months

Type of adverse event Emergency ward Internal med. Wards Surgery wards Intensive care wards Total

Number of wrong infusion 3 21 9 37 70

Number of unsafe patient transport 4 10 1 6 21

Number of wrong sampling 14 5 2 17 38

Number of Unsuccessful urinary catheterization 8 9 0 4 21

Number of Unsuccessful IV- line catheterization 17 87 32 20 156

Number of urinary tract rupture during catheterization 1 3 0 0 4

Number of Bed sore occurred in hospital 131 503 245 66 945

Number of burning induced cautery 0 2 2 39 43

Number of adverse event from intubation 0 2 2 6 10

Number of falling 4 24 8 0 36

Number of kardex mistakes 113 0 0 31 144

Number of transfusion errors 1 1 0 1 3

Number of other reported events 0 190 33 228 451

Total 296 857 334 455 1942

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information were also used for achieving event informa- tion. The mortality and morbidity board that inspect all expired patients, in previous 6 mounts, referred 33 sus- picious cases to patient safety office for complementary investigation and root cause analysis. Besides, The com- mittee of complains referred cases which correlated with medical errors and complains or self consent for dis- charge. Malpractice claims from external authorities were also started as a patient file and promptly con- ducted an investigation, interviewing all personnel involved to understand and correctly document exactly what happened. Although reporting was voluntary, providing root

cause analysis of catastrophic events which accompanied by an action plan was required. Expert group of RCA consisted of patient safety staff, clinical care provision teams, nursing staff, and managers of the hospital. Root cause analysis of most reported sentinel events was regu- larly conducted to identify human, organizational, and technical factors and to uncover the underlying systems failures, with the goal of redesigning system to reduce the likelihood of patient injury, and finally the results were fed back to caregivers and external authority in case of health care deputy of university. Inadequate participation of staff in reporting and ana-

lyzing, because of fear of being blame and expectation that reports are ineffective, and limitation of resources and resistance of hospital management for solutions were the main executive problems. Also high turnover of medical staff, residents and interns, was considered as a reason of low participation of medical group in risk management processes. It seems that patient safety issues should be included in educational curriculum of medical students.

Proactive approach Using the technique of Failure Mode and Effect Analysis can be considered as a step-by-step approach to recognize different modes of the potential errors and failures in clinical service delivery. In this study, different interactions and functions of health care delivery in hos- pital are prioritized based on their importance and are systematically analyzed to define potential errors and malfunctions leading to the events, assess probable their consequences and distinguish contributory factors. Con- sequently, FMEA team, which was comprised of expert staff who were familiar with considered procedure, was committed for finding strategies to deal with predictable errors and control of their consequences. Therefore, this was highlighted for quality improvement as an ongoing process of risk management system. Organizing FMEA teams in each ward with faculty supervision was the final recommendation that could prevent coordination and orientation problems.

Results The findings of reporting activities in defined framework of risk management are shown in Table 1. According to number of patients, the incidence rate of

adverse events was calculated to 3.6% of hospitalized patients that is much less than expected rates. A root cause analysis was conducted for some cases

which referred from mortality board of hospital (33 cases). Although due to underreporting, the referred and reported events could not provide a representative data- base for patient safety accidents in hospital, however, this can be concluded that at least 5.3 percent of deaths in hospital related with adverse events. On the other hand, in

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at least 0.2 percent of hospitalized patients, adverse events played a role in patients death in past 6 mounts. The results of survey on patient safety culture in hos-

pital indicate that the patient safety culture scores were considerably low (average score of 12 dimensions of pa- tient safety culture was 46.2 percent). The lowest scores were “non-punitive responses to error” (21.2 percent), “staff and related subjects” (26.1 percent), “teamwork across hospital units (29.1 percent) and “management support for patient safety” (29.7 percent). The dimension “teamwork within hospital units” generated the highest score (69.9 percent). In addition, 44.3 percent of the staff of hospital graded the safety performance of hospital as very good. Moreover, no events were reported by 57 per- cent of respondents during past 12 month (Table 2).

Discussion Health and clinical service delivery organizations are obliged to provide a safe environment for patients as well as staff [23]. Several different studies revealed that risk management is the basis for minimization of med- ical errors and enhancement of patient safety in hospi- tals which needs to be implemented as strategies and practical plans; and, simultaneously, clinical staff should be trained and well oriented of different risk manage- ment guidelines and scheme [24-26]. The results of a study in Iran indicated that no minimum risk reduction requirements are complied with in different wards of hospitals. Therefore, different risk assessment plans and also method for staff training and supervision was sug- gested [27]. Furthermore, Verbano et al., having assessed human errors and validity of risk management in health care provision institutes in Italy, concluded that attitudes

Table 2 Positive scores of patient safety culture dimensions

Teamwork within units 69.86

Supervisor/manager expectations & actions promoting patient safety

51.91

Organizational learning and continuous improvement

67.90

Management support for patient safety

29.69

Overall perceptions of patient safety

44.63

Feedback & communication about error

65.93

Communication openness 50.91

Frequency of events reported 50.33

Teamwork across units 29.09

Staffing 26.05

Handoffs & transitions 46.39

Nonpunitive response to errors 21.19

and cultures towards risks and its management mea- sures can differ vastly from one to another. Therefore, patient safety culture should be developed based on clin- ical governance policy and programs, comprehensive and short courses for risk management training, and im- plementation of clinical risk management [28]. Results of different research studies have demonstrated that educating staff regarding safety measures can lead to pa- tient safety improvement [29]. The findings of another study indicated that a 4 weeks training program on safety significantly improved judgment and understand- ing of nurses, and as a result, they adhered more strictly to safety measures [30]. The leader and the manager of the organization or hospital play a key role in implemen- tation of different safety measures through high priority of safety [31]. The results of risk management study in Baghiatollah hospital in 2007 demonstrated that patient safety improvement in hospitals requires a systematic approach and involvement of senior managers of hos- pital in safety management systems and their strict com- mitment [32]. In report of Surveillance Systems for Adverse Events and Medical Errors in the Unites States, there were many possible explanations for underreport- ing. The most commonly mentioned ones included: the fear of being blamed, the possibility of legal liability, and an expectation that reports will be futile. Moreover, the necessity of establishment of a confidential environment without “blame and shame” culture was highlighted [33]. Study on 700 hospital beds in 2007, revealed that achievement to an acceptable safety level in hospitals needs a close working relationship between clinical staff and support teams of hospitals [34]. In a different study in 44 hospitals of Pennsylvania in 2005; it was also con- cluded that for enhancement of patient safety, structural and organizational reforms and such as improvements in staff training programs, management information sys- tem and improvement of workplace situations is neces- sary, and this can only be successfully achieved when it is fully supported by the hospital management and well funded [35]. In all hospitals, a safety guideline needs to be designed and supported by high ranking officials and the ultimate goals and objectives need to be clearly defined [36]. A study on patient safety culture at the similar hospi-

tals in Iran revealed that safety culture score in 10 dimensions is low to moderate, and lowest score was in nonpunitive response to errors and teamwork between hospital wards [37]. This subject was noticeable in our hospital which was presented in inappropriate time ap- portion and weak participation in reporting and analyz- ing patient safety information by all staff. This has been usually correlated with useless of data gathering. Frankel and et al. indicate that safety walkrounds

appears to be an effective tool for identifying safety

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issues, engaging leadership, and supporting a culture of safety [38]. His study has revealed that safety climate scale scores in hospitals have been increased 18 months post-walkrounds implementation. Walkround imple- mentation requires significant organizational will [39]. Safety walkrounds helps educate leadership and frontline staff in patient safety issues and results in cultural changes, as manifested in more open discussion of ad- verse events and an improved rate of safety-based changes [40]. Weakness of patient safety culture and low knowledge

resulted in weak participation in reporting and analysis. Uselessness of aggregated data and dominance of blame and penalty culture in hospital brought about under reporting and hiding events. Unremarkable commitment of hospital management on patient safety measures and monitoring of activities in this field led to ineffectiveness of safety improvement. Thus hospital risk management system should be focused on education and culture build- ing in hospital. Furthermore, according to dominance of blame culture and existing tendency for hiding of informa- tion by all caregivers and also weakness of hospital infor- mation infrastructure, the voluntary reporting system was considered as the basis of data collection process. Because of predictable underreporting, other sources of informa- tion such as mortality and morbidity board, committee of complains and Malpractice claims were perceived. Be- cause of cultural issues and expected loss of information, exploit of a proactive approach was considered necessary which applied by establishment of FMEA teams. However, the model introduced in this article can provide a practical framework in risk management system at the national level and for developing countries, especially at the initial steps of their system development.

Competing interests The authors declare that they have no competing interests.

Authors’ contribution HA: had the main role in design, implementation of this project, performance analysis of data and writing of manuscript. NK: supervisor of this project and deliver advantage guidance to progress this idea. HR: the corresponding author of this paper and had a benefit guidance in selecting methods and approved this idea. MJ and ARJ: had a good cooperation in this project and data gathering. All authors read and approved the final manuscript.

Acknowledgment This study was part of a PhD thesis supported by Tehran University of Medical Sciences (Grant No: TUMS/SHMIS-1390/543). The assistance of Dr. Ali Tootee in preparation and editing of manuscript and contribution of clinical governance office of Shariaty hospital in project, respectively, is gratefully acknowledged.

Author details 1Department of Health Services Management, School of Health Management and Information Sciences, Tehran University of Medical Sciences, Tehran, Iran. 2Shariaty Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Received: 22 August 2012 Accepted: 6 September 2012 Published: 21 September 2012

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doi:10.1186/2251-6581-11-15 Cite this article as: Adibi et al.: Development of an effective risk management system in a teaching hospital. Journal of Diabetes & Metabolic Disorders 2012 11:15.

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