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 Table of Contents  
Year : 2013  |  Volume : 1  |  Issue : 1  |  Page : 48-53

Organizing and policy-making as a key factor to establish hospital clinical risk management system

1 Health Management and Economic Research Center, Medical Sciences University of Isfahan, Isfahan, Iran
2 Health Services Administration Department, Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
3 Department of Health Service Management, University of Medical Science, Isfahan, Iran

Date of Web Publication30-Nov-2013

Correspondence Address:
Marzieh Javadi
Health Management and Economic Research Center, Isfahan University of Medical Sciences, Isfahan
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Source of Support: Health management and economic researches Centre. Medical University of Isfahan Iran, Conflict of Interest: None

DOI: 10.4103/2347-9019.122459

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Background and Aim: It is impossible to deny the threats and risks endangering the process of health care when offering the services. Confirming this fact does not mean ignorance the risk, or allowance to medical and nursing mistakes to happen; however, it can mean approaching the problem to come up with practical solutions and minimize the risks in the process of providing health care services. The present study was conducted periodically as an applied multi-stage research. Materials and Methods: To do a model of clinical risk management, different authentic texts on risk management in health sector were reviewed focusing on the models available. All such models were tabulated, analyzed and compared together which resulted 62 primary variables. The variables were, then, validated being used in a questionnaire responded by 20 nurses and doctors which, this time, produced a confirmed questionnaire of 40 variables. After that, 215 subjects chosen through a random and a stratified sampling were asked to respond to that questionnaire, making an exploratory factor analysis as well. Results: This study was done ,using principal components analysis as with a rotation of Varimax loadings showed a variety of factors (19 factors) available in the models of clinical risk management were loaded as "organizing and policy-making" factor. This factor illuminated a sum of 25.3% of variances in the model of clinical risk management. The results also showed the loading factor of variables as among 0.5 and 0.7 which indicated a fine correlation among them and the participants' view. Conclusion: It was concluded that "the best care of the patient is accepted as a common perspective in organization" and "the effect of the treatment team's clinical performance on their financial payments" are the most and the least important variables respectively with 0.739 and 0.548 as factor load.

Keywords: Clinical risks management, hospital, immunity, organization, policy-making

How to cite this article:
Javadi M, Yaghoubi M, Sham A, Karimi S, Alavi A. Organizing and policy-making as a key factor to establish hospital clinical risk management system. Int J Health Syst Disaster Manage 2013;1:48-53

How to cite this URL:
Javadi M, Yaghoubi M, Sham A, Karimi S, Alavi A. Organizing and policy-making as a key factor to establish hospital clinical risk management system. Int J Health Syst Disaster Manage [serial online] 2013 [cited 2019 Aug 24];1:48-53. Available from: http://www.ijhsdm.org/text.asp?2013/1/1/48/122459

  Introduction Top

It is a universal challenge, and the temporal end of every health organization, to offer people a really good service. In fact, a specific health organization is valued the most responsible if it consistently seeks the best service delivery. It is also expected that the health service be delivered well while extensively covering such aspects as service effectiveness, optimal consumption of sources, fair delivery of services, risk management for patients, and employees, etc. [1]

In addition, healthcare management is a crucial but easily susceptible task through which some risks will necessarily endanger the patient, doctor, or the health organization as a whole. [2] Inherently having some characteristics deeply distinguish it from other sectors, health sector will face various risks. [3] In other words, the health system is consisted of processes affected by different variables (Peculiarities of individual patient, complexity of health services and activities, various models, and techniques of management, etc.). The functional properties of the health sector make it more necessary to focus primarily on its potential risks: Variety and diversity of operations, measures and apparatus; reproducibility of emergencies; patients' vulnerability to risks in using services; and most importantly, unlike other sectors, few people provide services for a large number of users. [4]

The word "risk" means the possibility of uninvited suffering harm or loss. [2] One of the serious challenges facing the organizations providing healthcare services is creating an atmosphere of safety and security to engage in clinical activities; these organizations must, then, have the potentiality to effectively include the issue of safety in their list of organizational activities. This would be possible if they take a widely held view and go through the risk management process. [5]

As Joint Commission on Accreditation of Healthcare Organization (JCAHO) defines, "risk management" in health sector as a process which includes any activity, clinical or offcial; to identify, assess, and reduce the risks threatening patients, employees, and visitors. The available sources suggest that in about 4,000 years ago, it was included in the law code of Hammurabi-the king of Babylon-that one's fingers should have been cut if he harmed a patient's eye. Then, risk management, for healthcare organizations, is nothing new to be taken into consideration. [6]

Risk management have a broad background in industry and public sector organization; moreover, key measures have been implemented in such sectors as military aviation industry as well as in academic fields like occupational health, and any other sectors. However, despite the variety of risks threatening the issue, it is no more than a decade that the available risks in health sector have been systematically focused on, and the issue of its risk management has been arisen. [5] In the process of healthcare services, potential risks and problems are incurred regarding patient safety, some of which are inevitable because of the particular nature of the process. In other words, some risks or dangers threatening the healthcare system and health professions are inherent. [7] It should be noted that "error" is an inseparable part of human nature and activity; however, these risks should be managed and minimized as much as possible. In some countries and reputable health organizations, several programs are developed and implemented to manage the risks in health system.

Various measures should be taken regarding risk management in health sector in order to improve its quality and ensure patients' safety. [8] Briefly considering the risk management models implemented in a number of organizations reveals the fact that it is impossible to manage the risks available in the process of healthcare unless there exists a comprehensive program coordinately run. In fact, to begin controlling and minimizing clinical risks in this process, it is necessary to design a coherent model in line with organizing and setting up their own administration; furthermore, a controlled program should be outlined to prevent harm and guarantee the patients the safety in healthcare process. There also need be a specific, systematic, and coherent process defined to track and indemnify for the loss, and to demand plaintiffs and possible victims' need. The last point is that all these measures and activities are supported and implemented via a specific financial and budget planning. [9],[10],[11] Thus, "organization", "organizational framework", "organization operation framework", or any other terms which may substitute the word imply that in many models of risk management, organization and organizational rules are among the key elements in the issue of clinical risk management. This concept constitutes a part in all such activities necessary to manage a unit in risk management as policy and statement development, training and staff development, coordination and managing risk management committees in hospital, assessments of risk management programs, target development and updating, etc. [9] Cassirer, defines "risk management organization" as an organizational structure supporting the process of clinical risk management. He believes supporting governance team of hospital, appointing risk manager, and involving employees forms three key elements in risk management organization. [10] Moreover, in addition to organizational structure, mobilizing and ensuring clinical risk management activities necessitate policy-making and applying organizational policies in the field, so that this issue is emphasized in different under-study models of clinical risk management. Policy-making and the concept of organizational culture are all together in some of these models. For instance, Alan's model refers to developing safety culture and auditing activities based on standards, among the other factors affecting the risk management in pediatric department of a hospital in Sheffield. [12] Furthermore, in some others, organizational policies are referred to as "legal dimension" affecting clinical risk management. [13] Still, in some other models, they are referred to as "having framework and applying clinical governance to medical services". [14] The model of clinical risk management available in American Society for Healthcare Risk Management (ASHRM) also focuses on organizing as the "functional activities of risk management" and policy making as "regarding accreditation rules and regulations". In another models available in ASHRM these two issues form a concept called "organizational framework of operational risk management". [10]

Certainly, there is no specific coherent system in the health sector of our country to focus on risks and errors. Moreover, the studies available in the issue of "risk" are mostly descriptive and aiming at describing the current. In addition, there is no systematic approach presented in the available studies. When reviewing health database and searching the risks in health system, we face different examples as; the effect of environmental risks on health, [15] the risk assessment of compost prepared from municipal waste, [16] environmental risk, [17] the assessment of possible risks in various working place [18] which mainly relate to different risks in working place and in society but there is no model or structure available to control risk taking in the centers providing healthcare. Usually, developing countries and specially our country have not implemented systematic activities to manage the risks except in some operating instructions to perform safe surgical operation, perform safe injection, wash hands while taking therapeutic actions, and impose measures to control infection. Ministry of health has run some programs to initiate executing clinical governance in hospitals and to propose various components of clinical governance, like risk management; therefore, some research is currently needed to be done to complete administrative actions and form the academic and scientific basis of this issue. Then, the present study can result in identifying and establishing an effective and coherent system of clinical risk management in Iran which finally leads to improving performance in the health system. This is, therefore, to explain and verify the components of clinical risk management model while emphasizing the organization and policy-making factor.

  Materials and Methods Top

This study is an applied multistage research conducted cross-sectionally. The components of clinical risk management organization are here explained through reviewing different authentic texts on risk management in health sector. Due to the fact that the issue of risk management in health sector, particularly clinical risks, is in its early stages; and just a limited number of countries provide an operating and theoretical model in the field, five coherent and valid models form the basis of analysis in this study. These are Cassirer's model, New Zealand/western Australia model of health department, ASHRM, the model of common commission on change in healthcare services (Rosan and Carrol), the researchers' model in Harvard University, and the model of management educating center in America.

In the first stage, these models were precisely examined while each one's factors were separately reviewed. As the researcher perceived, 62 variables were derived as the primary research tools. These were, then, validated by a group of 40 nurses, doctors, and the faculty members of management of health services and management of health information departments. In the second stage, taking the mean and Cronbach's alpha into account, the researcher designed a questionnaire of 40 variables accepted finally as the tool (α = 0.89). The respondents' view are determined by a scale of 5 points in the alternatives of this questionnaire from 0 (strongly disagree) to 5 (strongly agree). The participants in this stage of study were nurses, doctors, and experts in the departments of management of health services and management of health information. Two hundred and fifteen (215) subjects were chosen from three hospitals in three provinces in the center, north, and west of Iran (Isfahan, Gilan and Kermanshah) through a random and a stratified sampling. In the third stage, an exploratory factor analysis was used to explain organization and policy-making factor, and its subvariables. In this analysis, principal components analyses as well as an orthogonal rotation of Varimax loadings were used. The factors are determined based upon the Scree slope and the value being more than one. Finally, based on the significant results (P < 0.001), Kaise-Meye-Olkin measure of sampling adequacy (KMO = 0.94) as well as Bartlett's test (4591) verified that the organizing and policy-making factor were loaded in 19 factors/items.


Demographically, the data analysis throughout this study proves the existence of 191 questionnaire responded (response rate 89%) by the subjects, from among which 19.2% were academic members, 22.4% doctors, and 58.3% nurses.

Other findings are illustrated in [Table 1] below:

The findings also suggest that the three mentioned groups' ideas are not homogenous, but are different in some aspects. To distinguish, an analysis of variance (ANOVA) statistical test was used showing a significant difference between the groups' ideas: The academic experts enjoyed the highest mean. [Table 2] shows the results.
Table 1: Mean of three different group of subjects' idea on the model of clinical risk management

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Table 2: Comparison of three groups of respondents on the model of clinical risk management

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To analyze the factors in the questionnaire of the clinical risk management, an exploratory factor analysis using principal components analysis as well as an orthogonal rotation of Varimax loadings were used. The results showed a variety of factors (19 factors) were loaded as just one factor. Analyzing them in one hand, and considering the theoretical base of the study, or any other models of clinical risk management, on the other, these 19 factors were called "organizing and policy-making factor". Moreover, based on the significant results (P < 0.001), Kaiser-Meyer-Olkin measure of sampling adequacy (KMO = 0.94) as well as Bartlett Test (4591) verified the organizing and policy-making factor with 19 factors/items. The results also showed the mount of variance for the organizational structure, and the policy-making before (55.9) and after (25.3) the rotation, explaining the sum of 25.3 of the total variance in clinical risk management.

The findings illustrate 19 variables including questions 29, 24, 36, 28, 23, 35, 27, 25, 38, 39, 30, 32, 21, 34, 20, 26, 22, 31, and 33 are loaded in the factors of organization and organizational structures in risk management. The highest factor loading (0.739) is related to "the best care of the patient is accepted as a common perspective in organization" and the lowest one in regards to "the effect of the treatment team's clinical performance on their financial payments" [Table 3].
Table 3: Rotational factor loading of variables in organization and policy-making discussion

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As reported in the present study, the academic experts' view is valued significantly higher in research variables, compared to the other two groups. In fact, the academic members are more in line with the concepts introduced in organization and policy-making regarding clinical risk management. This may be the result of their more comprehensive theoretical background in clinical risk management.

The results also showed that organization and policy-making are crucial and effective factors in hospital risk management in Iran, covering a vast number of variables or structures. The factor loadings of variables are also 0.5-0.7 indicating a fine correlation between these variables and the academic views.

The organization and organizational structure are also emphasized in other models of risk management considered in health sector, e.g. Cassirer's model of clinical risk management [10] called "risk management organizational program" and Sedwick's model named "operational or functional activities of risk management." [9]

This factor is, in fact, covering all activities necessary for managing management unit. According to ASHRM, a hospital risk management program must have a defined organizational structure to support the risk management functions. Moreover, here some special aspects should take into consideration leading to increasing commitment of governance team, defined duties of hospital risk manager, and participation of medical team in the programs. [19]

Organization and policy-making of risk management includes different items in this study [Table 3]. The results indicate the most important item in organization and policy-making of risk management is "the best care of the patient is accepted as a common perspective in organization" showing 0.739 as loading factor.

This concept is regarded as a cultural phenomenon in the organization closely related to such items as "patient and personnel's safety being the most important concern of organization" and "discussing and negotiating freely on the errors, and learning from committed errors (not to repeat them)". Several other studies have focused their attention to the issue of culture, too. The organizational policy and its cultural infrastructure can serve a leading role in instituting safety culture in organization. Then, the quality improvement committee of National Health Service (NHS) regards clinical risk management as:

  • Risk identification and the necessary measure implementation
  • Continuous risk reduction in organizations and their personnel
  • Cultural, structural, and procedural infrastructure to realize potential opportunities which lead to managing unintended errors. [20]

The second important item in organization and policy-making is the variable titled "appointing specific person with particular duties for risk management activities of the organization including ensuring care quality, managing safety, resolving complaints, financing, providing safety, and establishing relations with patients" showing 0.687 as loading factor.

Regarding this issue, ASHRM emphasized that a hospital risk management program must have a defined organizational structure to support the risk management functions. Moreover, here some special aspects should take into consideration leading to increasing commitment of governance team, defined duties of hospital risk manager, and participation of medical team in the programs. [19]

The third important one is "a system available for recognizing unintended accidents for risky clinical points" having 0.685 load of factor. This item is, in fact, concerned with such concept emphasized in several texts on risk management as learning from the errors, and the system designed to record incidents.

Kohn and his colleague suggest, here, that it is necessary for all healthcare organization to have a system designed to record incidents and that such a system has two advantages: 1) making the healers responsible for their work; 2) providing information which leads to ensuring safety. [5]

Furthermore, it is suggested, in another study which examines clinical risk management in out-of-hours services, that to manage risks threatening the out-of-hours services, it is necessary to consider such things as strengthening team relationship, following and using protocols, assessing risk, reporting incidents, and developing staff. [14] Harding suggests in his paper that having a system designed to record incidents is, in fact, a proactive, opposed to reactive, approach to risk management. Proactive approach makes it feasible not to repeat the errors having the incidents recorded and learning from the errors. [21]

Other concepts are also identified, in this study, as the items of organization and risk management policy-making which are regarded as principal concepts of risk management, from among which is training that plays a vital role in performing management activities. This item is also confirmed in Wilson and Taylor's model as "staff training and development." [14] Another variable confirmed in this factor is item# 9 [cf. [Table 3]] "adopting preventive measures and activities depending on the results of risk identification programs" which necessitate planning and implementing organizational measures to control and prevent risks in hospitals. This is confirmed by Golfieri's results, too. Golfieri has suggested the following principles as the main principles to prevent risks posed in clinical areas:

  1. Do not make duty and working process dependent upon the users' attention, care, or short-term memory
  2. Revising the work process, the amount of time and work given to each personnel, reduce work stress
  3. Simplify the work process and duty
  4. Pay attention to user's ability when using the equipments; maintain the equipment seriously, too
  5. Standardize working processes and minimize the complexity of non-standard processes
  6. Routinely use the protocols and checklists. [22]

The results also indicates that one of the other items conformed in the model of organization and policy-making of clinical risk management is "treatment team's clinical operation affecting their payment" having the least factor loading (0.548). The planners in health sector should take into account this item as well as "hospital rankings, quality of care, reducing medical errors, and improving the clinical performance being the crucial factors in allocation of funds" item. The former belongs to the domain of validation while the latter belongs to the domain of medical auditing. Organizationally, the accreditation, and individually, auditing are from among the items which help the risk management programs work effectively. In this regards, Kohn et al., claim that taking a brief look at several safety programs run in American healthcare centers shows that these programs is based on issuing the license, accrediting voluntarily or by organizations such as JCAHO. To accredit the hospitals, this commission has such standards as organizational programs aiming at ensuring patient's physical safety and keeping him against harm, risks, incidents, and injury; patient's life safety; controlling infectious diseases; prevention; controlling the use of blood and blood products; any other approaches focusing on learning from the errors; and how it can prevent death. [5]

Other items confirmed in this study relate to employee's participation and noticing the processes, adopting organizational policy and statement, and the commitment of the organization manager to the program which are all in the focus of most quality models and clinical governance program in the countries. [23],[24]

  Conclusion Top

The factor analysis of variables in the present study shows that 19 variables can be summarized in just one factor as "organization and policy-making" factor. This concept is regarded as one of the key factors of clinical risk management in health sector necessary to be considered in order to begin and go through the challenging process of risk management. The "organization and policy-making" factor includes items or variables each of which are emphasized in many quality and management models and are particularly important when considered individually. The most important variable is the vital and fundamental issue named "the best care of the patient accepted as a common perspective in organization". Its more value as compared to the other variables makes it necessary for the organizations to pay more attention to people's perspective and beliefs about safety. This means that the organizations should at first adopt a positive perspective on safety before doing anything else. In addition, as this verified model shows itself, other items should support and reinforce it simultaneously. At last, "treatment team's clinical operation affecting their payment" is accepted as an item with the least factor loading which, considering the fact that the issues of safety and risk management are in their early stage in health sectors in Iran, implies that planners not only should seriously conduct their operation and handle the organizational and structural affairs, but also should cautiously have the healers pay the taxes.

  Acknowledgement Top

I would like to acknowledge the people who assisted me in doing this research: Firstly nurses and phisycians for their cooperation in this work, then managers and executives of hospitals for facilitating data gathering.

  References Top

1.Khaleghinezhad N, Ataee M, Hadizadeh F. Window to the Clinical Governance and Clinical Excellence Service. Isfahan: Isfahan University of Medical Science pub; 2008.  Back to cited text no. 1
2.Joint Standards Australia/Standards New Zealand Committee OB-007, Risk Management, revision of AS/NZS 4360:1999, Risk management. S/NZS 4360:2004, Risk management. Available from: www.ucop.edu/riskmgt/erm/documents/as_stdrds4360_2004.pdf [last accessed date 2013].  Back to cited text no. 2
3.Reason J. Human Error. Cambridge: Cambridge University Press; 1990.  Back to cited text no. 3
4.Bellandi T, Albolinoy SC, Omassini R. How to create a safety culture in the healthcare system: The experience of the Tuscany Region. Theoretical Issues Ergonomics Sci 2007;8:495-507.  Back to cited text no. 4
5.Kohn LT, Corrigan JM, Donaldson MS. To err is human: Building a safer health system. Committee on Quality of Health Care in America. IOM (Institute of Medicine) Washington: National Academy Press; 2000.  Back to cited text no. 5
6.Sadaghiani , Ebrahim M. Health Care Evaluation and Hospital Standards. Tehran: Moeen Elm o Honar Publications; 2006  Back to cited text no. 6
7.Treanor HL. Health risks and the health care professional. Med Health Care Philos 2000;3:251-5.  Back to cited text no. 7
8.Chiara V, Federica T. A human factors and reliability approach to clinical risk management: Evidence from Italian cases. Safety Sci 2010;48:625-39.  Back to cited text no. 8
9.Sedwick J. The health care risk managent professional. In: Carrol R, editor. Risk Management Handbook for Health Care Organizations. 4 th ed. California: Jossey-Bass Publisher; 2003. p. 119-56..  Back to cited text no. 9
10.Cassirer C. Risk program evaluation. In: Carrol R, editor. Risk Management Handbook for Health Care Organizations. 4 th ed. California: Jossey-Bass Publisher; 2003. p. 1295-320.  Back to cited text no. 10
11.Toolkit for Managing Risk in Health Care, Office of Safety and Quality in Health Care, Department of Western Australia. Available from: www.safetyandquality.health.wa.gov.au [last accessed date 2013].  Back to cited text no. 11
12.O′Rourke A. Minimizing clinical risk. Curr Pediatr 2005;15:466-72.  Back to cited text no. 12
13.Clinical Risk Management Guidelines for the Western Australian Health System Information, 2005; Series No. 8.Office of Safety and Quality in Health Care Western Australian Department of Health. Available from: http://www.health.wa.gov.au/safetyandquality/[last accessed date 2013].  Back to cited text no. 13
14.Wilson J, Taylor K. Clinical risk management in out-of-hours services. Nurs Manag (Harrow) 2011;17:26-30.  Back to cited text no. 14
15.Ravanipour M, Masoomeh R, Soltanian A, Hamidreza R, Darush R. The effect of education on the knowledge of environmental threats on health in students of elementary schools in Bushehr port. Iran South Med J 2004;8:178-86.  Back to cited text no. 15
16.Bidhendi GH, Daryabeigi ZA. Risk assessment of compost prepared from municipal waste (MSW) in comparison with other parts of the world. J Environ Study 2004;31:31-50.  Back to cited text no. 16
17.Abbaspour M, Motlagh MS, Mansouri N. A comprehensive program to control the environmental risk caused by chemical incidents. Environ Sci Technol 2004;6:1-10.  Back to cited text no. 17
18.Yarmohammadian MH, Tofighi S, Sekineh SE, Naseribooriabadi T. Risks involved in medical records processes of Al-Zahra Hospital. Health Inf Manage 2007;4:51-9.  Back to cited text no. 18
19.Carrol R(Editor). Risk Management Handbook for Health Care Organizations. Ching WR, Author of Chapter1. 4 edition. California: Jossey-Bass Publisher; 2003.  Back to cited text no. 19
20.NHS quality improvement Scotland. Clinical governance & risk management: Achieving safe, effective, patient-focused care and services clinical governance & risk management, 2007. Local report. Available from: http://library.nhsggc.org.uk/mediaAssets/library/qis_CGRM_LREP_GRGL_APR07.pdf[last accessed on 2013].  Back to cited text no. 20
21.Harding K. Risk management in obstetrics. Obstet Gynaecol Reprod Med 2012;22:1-6.  Back to cited text no. 21
22.Golfieri R, Pescarini L, Fileni A, Silverio R, Saccavini C, Visconti D, et al. Clinical Risk Management in radiology. Part I: General background and types of error and their prevention. Radiol Med 2010;115:1121-46.  Back to cited text no. 22
23.Singh RK. Clinical governance in operation - Everybody′s business: A proposed framework. Clinical Governance: An International Journal 2009;14:189-97.  Back to cited text no. 23
24.Halligan A, Donaldson L. Clinical governance: Turning vision into reality. BMJ 2001;322:1413-7.  Back to cited text no. 24


  [Table 1], [Table 2], [Table 3]


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