Discussion 7

The article on IRB this week discusses broad consent under the revised Common Rule. When you are doing any sort of research you are going to need to have your research plan approved by the University’s institutional review board or IRB. If you have never heard of this term before, please take a look online and find a brief summary of what it is about, before you read the article.  

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Please answer the following questions in your main post:

  • What are the main issues that the article addresses?
  • What is the Common Rule?
  • How is this issue related to information systems and digital privacy?

At least one scholarly source should be used in the initial discussion thread. Be sure to use information from your readings and other sources from the UC Library. Use proper citations and references in your post.

RESEARCH ARTICLE Open Access

Development of an enterprise risk
inventory for healthcare
Ana Paula Beck da Silva Etges1,2,3*, Veronique Grenon4,6, Ming Lu4, Ricardo Bertoglio Cardoso3,
Joana Siqueira de Souza3, Francisco José Kliemann Neto3 and Elaine Aparecida Felix5

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  • Abstract
  • Background
  • : The first phase of an enterprise risk management (ERM) program is the identification of risks. Accurate
    identification is essential to a proactive and effective ERM function. The authors identified a lack of such risk
    identification in the literature and in practical cases when interviewing the chief risk officers from healthcare
    organizations. A risk inventory specific to healthcare organizations that includes detailed risk scenarios and risk
    impacts currently does not exist. Thus, the objective of this research is to develop an enterprise risk inventory for
    healthcare organizations to create a common understanding of how each type of risk impacts a healthcare
    organization.

    Method: ERM guidelines and data from 15 interviews with chief risk officers were analyzed to create the risk
    inventory. The identified risks were confirmed through a survey of risk managers from a range of global healthcare
    organizations during the ASHRM conference in 2017. Descriptive statistics were developed and cluster analysis was
    performed using the survey results.

  • Results
  • : The risk inventory includes 28 risks and their specific risk scenarios. Cyberattack was ranked as the principal
    risk by the participants, followed by sentinel events and risks associated with human capital management
    (organizational culture, use of electronic medical records and physician wellness). The data analysis showed that the
    specific characteristics of the survey participants, such as the length of time working in risk management, the size
    of the organization, and the presence of a school of medicine, do not impact an individual’s opinion of the
    importance of the risks identified. A personal background in risk management (clinical or enterprise) was a
    characteristic that showed a small difference in the perceived importance of the risks from the proposed risk
    inventory.

  • Conclusion
  • s: In addition to defining specific risk scenarios, the enterprise risk inventory presented in this research
    can contribute to guiding the risk identification phase of an ERM program and thereby support the development of
    a risk culture. Patient data security in hospitals that operate with high levels of technology is fundamental to
    delivering high quality and safe care to patients. At the top of the risk ranking, the identification of cyberattacks
    reflects the importance that healthcare risk managers place on this risk by allocating time and other resources.
    Exploring opportunities to improve cyber risk management and evaluating the benefits of using the risk inventory
    at the beginning of the risk identification phase in an ERM program are suggestions for future studies.

    Keywords: Enterprise risk management, Healthcare management, Risk inventory, Healthcare, Risk identification, Risk
    analysis

    * Correspondence: anabsetges@gmail.com
    1School of Technology, PUCRS, Avenida Ipiranga, 6681, Porto Alegre
    90619-900, Brazil
    2National Health Technology Assessment Institute, CNPq, Porto Alegre, RS,
    Brazil
    Full list of author information is available at the end of the article

    © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
    International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
    reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
    the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
    (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

    Etges et al. BMC Health Services Research (2018) 18:578
    https://doi.org/10.1186/s12913-018-3400-7

    http://crossmark.crossref.org/dialog/?doi=10.1186/s12913-018-3400-7&domain=pdf

    mailto:anabsetges@gmail.com

    http://creativecommons.org/licenses/by/4.0/

    http://creativecommons.org/publicdomain/zero/1.0/

    Background
    Enterprise risk management (ERM) programs have been
    implemented in organizations across various industries
    with the aim of minimizing the negative effects of uncer-
    tainty in achieving corporate objectives while at the
    same time promoting its potential positive effects [1, 2].
    As stated in the most recent guidelines, ERM programs
    facilitate strategy selection. Choosing a strategy calls for
    a structured decision-making process that analyzes risks
    and aligns an organization’s resources with its mission
    and vision [3]. In the healthcare industry, the ERM
    process has been explored by risk managers to improve
    the organizational value creation process and develop a
    safer environment [4, 5].
    ERM guidelines, including ISO 31000 [6, 7] and COSO

    [3, 8], outline an ERM process that includes several
    common phases: identification, analysis, assessment,
    monitoring and control. Adequately performing the first
    phase, risk identification, is a requirement to build a
    proactive and effective ERM process [9, 10]. In the same
    way that Cox’s (2008) [11] research explores how risk
    matrices can be used in the ERM process during the risk
    analysis phase, this research takes a deep dive in the risk
    identification phase. The ability to identify and define
    risks correctly is indispensable to subsequently enable
    the effective use of risk analysis tools [10, 12].
    The risk identification process needs to be proactive,

    to involve multiple employees, and to create value for
    and protect the organization [13, 14]. In previous re-
    search that explored how ERM is conducted in health-
    care organizations, it was established that the guidelines
    that currently exist are not practical because they only
    include a list of risk domains [12]. The development of
    an enterprise risk inventory that includes specific risk
    events, details of the risk scenarios and descriptions of
    how each risk impacts the organization was identified as
    a gap for healthcare organizations.
    The guidelines by the Committee of Sponsoring Orga-

    nizations of the Treadway Commission (COSO) were
    the first to define risk factors by industry, but they do
    not explore risk events in detail. In 2014, the American
    Society of Healthcare Risk Management (ASHRM) pro-
    posed risk domains for healthcare organizations, but
    again, risk events and scenarios are not described in de-
    tail [15]. Other institutions, such as Healthcare Insur-
    ance Reciprocal of Canada (HIROC) [16] and the
    National Health Service in England (NHS) [17] have de-
    veloped risk taxonomies that include clinical risks and
    enterprise risks. In 2014, AON Corporation published
    the Healthcare Industry Report [18] based on collabora-
    tive research with various healthcare organizations that
    proposed ten common healthcare risks: regulatory/legis-
    lative changes; failure to attract or retain top talent; eco-
    nomic slowdown/slow recovery; increasing competition;

    damage to reputation/brand; failure to innovate/meet
    customer needs; lack of technology infrastructure to
    support business needs; political risk/uncertainties;
    workforce shortages; and cash flow/liquidity. Unfortu-
    nately, and similar to other existing guidelines, this re-
    port does not define each risk in sufficient detail for
    multiple individuals in an organization to have a com-
    mon understanding of the risks the organization faces.
    This means that every healthcare organization must de-
    velop its own enterprise risk identification process.
    The authors previously interviewed 15 hospital risk of-

    ficers from Brazil and the USA and presented a novel
    model for healthcare risk management, the Economic
    Enterprise Risk Management innovation program for
    healthcare: E2RMhealthcare [19]. This previous research
    identified qualitative differences in individual risk per-
    ception capabilities among risk managers from large and
    small hospitals based on personal background and
    whether the hospitals were associated with a school of
    medicine. To complement the published model, the au-
    thors reviewed the data again and conducted a new sur-
    vey in order to develop an enterprise risk inventory for
    use at the beginning of the risk identification phase.
    Thus, the main objective of this paper is to develop an

    enterprise risk inventory for healthcare organizations in
    order to create a common understanding of how each
    type of risk impacts a healthcare organization. Addition-
    ally, it aims to determine whether the length of time
    working with ERM, the number of employees at the hos-
    pital and the presence of a school of medicine impact
    the perceived importance of the enterprise risks
    identified.

  • Methods
  • This study can be classified as exploratory, as it analyzes
    the literature and data collected from interviews to in-
    crease the knowledge about ERM [20]. Thus, a survey
    was constructed and administered, data from the survey
    responses were collected, and a quantitative analysis was
    performed. Figure 1 illustrates the three phases: survey
    development, survey application and data analysis.

    Survey development
    To construct the survey, two steps were taken. First,
    data from 15 interviews with risk professionals from
    various healthcare organizations in Brazil (7) and the
    United States (8) were analyzed. Hospitals in Brazil were
    identified using a list from the magazine America Econo-
    mia (2014) as “the best hospitals in Latin America”.
    JCI-accredited hospitals and hospitals with risk manage-
    ment teams in their management structure were selected
    and contacted. US hospitals with national quality accred-
    itations as well as established risk management teams
    were also contacted. Data from a ninth US hospital,

    Etges et al. BMC Health Services Research (2018) 18:578 Page 2 of 16

    however, were not included due to incompleteness,
    which prevented comparisons. The resulting sample was
    heterogeneous, as it included data from different types
    of organizations: private and public hospitals, academic
    and non-academic hospitals, and a range of sizes. The
    main characteristics of the healthcare organizations
    interviewed are presented in Additional file 1. Second,
    the content of the guidelines developed by COSO (2007)
    [8], ASHRM (2014) [15], HIROC (2014) [16], NHS
    (2008) [17] and AON (2014) [18] were assessed, as they
    were mentioned by the interviewees as being important
    to the creation of their ERM programs.
    The software NVIVO was used to analyze the com-

    bined content of the interviews and guidelines. The re-
    searchers used the software to identify the risks listed by
    the interviewees to develop a first enterprise risk inven-
    tory list based on repetition of the risks by the inter-
    viewees and the literature. In sequence, two external risk
    management consultants, one Brazilian and the other
    from USA, both of whom had more than 10 years of ex-
    perience in healthcare risk management, discussed the
    risk inventory with the two first authors of this study.
    The inventory was agreed upon by the authors,

    including the name of the risk, the concept that it de-
    scribed, and a detailed risk scenario. The risk scenarios
    considered real examples that occurred in recent years
    in hospitals throughout the world that were shared on
    global media.
    Subsequently, the survey was built using the Qualtrics

    platform. The survey was made available online, and the
    participants were asked to choose if they strongly agree,
    somewhat agree, neither disagree nor agree, somewhat
    disagree or strongly disagree when asked about the im-
    portance of each risk identified. The complete question-
    naire can be found in Additional file 2 through an
    online link.

    Survey application
    A stratified approach was used to calculate the mini-
    mum number of surveys that needed to be completed.
    Two variables for stratification were defined: length of
    time working in risk management and type of risk man-
    agement (clinical or enterprise). These variables were se-
    lected based on the results presented by Etges et al. in
    previous research [19]. The 15 interviews were analyzed
    to develop an ERM model oriented toward healthcare

    Fig. 1 Research methods

    Etges et al. BMC Health Services Research (2018) 18:578 Page 3 of 16

    organizations. The model also presented the differences
    between clinical and enterprise managers and those re-
    lated to length of working time in risk management. For
    each stratum variable, two classes were identified:
    (stratum 1) number of years working in risk manage-
    ment – less than 7 years and more than 7 years; and
    (stratum 2) type – clinical risk management and enter-
    prise risk management. The total number of strata is
    therefore four. To calculate the minimum number of
    questionnaires per group, a normal distribution was
    used. The formula to calculate the number of question-
    naires per group is defined in eq. 1:

    n ¼ Z2α
    2

    CV 2

    ER2
    ð1Þ

    Z2α
    2
    = significance level to be applied in the estimation;

    CV2 = coefficient of variation;
    ER2 = the permissible relative error, that is, the per-

    centage error in the estimate that we were willing to
    accept.
    Assuming a significance level of 5%, Z2α

    2
    ¼ 1:96, with a

    moderate CV and a low ER, we calculated 16 completed
    surveys per group and a total of 64 completed surveys
    for the four groups combined.
    In October 2017, the American Society of Healthcare

    Risk Management’s annual conference took place in Se-
    attle. The survey was distributed at the conference dur-
    ing ERM workshops and at the exhibit hall, where only
    people participating in the conference had access. In
    parallel, emails were sent to various healthcare risk pro-
    fessionals in Brazil and United States who worked at ter-
    tiary hospitals and occupied a risk management position.
    The survey was open from October 10, 2017 to January
    5, 2018.

    Data analysis
    The survey data were extracted from Qualtrics and ana-
    lyzed using SPSS and Microsoft Excel software. The de-
    scriptive statistical analysis was used to create a risk
    ranking and analyze differences between the strata. The
    risk ranking was first analyzed based on the Likert scale.
    The second, third and fourth analyses utilized a binary

    reference. The answers “strongly agree” and “somewhat
    agree” were classified as agreeing that the risk is an im-
    portant enterprise risk in the healthcare industry. The
    answers “strongly disagree”, “somewhat disagree” and
    “neither agree nor disagree” were classified as not agree-
    ing that the risk is an important enterprise risk in the
    healthcare industry. The second analysis combined dif-
    ferent sample strata (time working in risk management
    and type of risk management background, clinical or en-
    terprise). The third analysis compared the survey results
    between participants who worked in organizations with

    more than 1000 employees to those who worked in or-
    ganizations with fewer than 1000 employees. The fourth
    analysis compared the participants’ opinions from orga-
    nizations with and without a school of medicine.
    Cluster analysis was performed to allocate the risk

    professionals to groups based on their answers regarding
    the perceived importance of each risk. The cluster classi-
    fication was performed in the software SPSS in two steps
    following Favero et al. (2009) [21]. First, the hierarchical
    algorithm nearest neighbor was applied to the data,
    which enabled the number of clusters to be defined
    through an analysis of the resulting dendrogram. Sec-
    ond, based on the number of clusters previously defined,
    the non-hierarchical algorithm K-means was used to es-
    tablish the members of each cluster. The nearest neigh-
    bor algorithm used the Euclidian distance as the
    distance measure, while the K-means algorithm used the
    square of the Euclidean distance. Additionally, the
    K-means algorithm was configured to (i) use random
    seeds when defining the initial centroids, and (ii) repeat
    the analysis 100 times and return the most frequent
    result.

    Results
    The results are presented below. First, the development
    of the survey and the risk inventory are explained. Sec-
    ond, the survey application is described, and finally, the
    data from the survey responses are analyzed and
    discussed.

    Survey development: risks and origin
    Twenty-eight risks were selected for inclusion in the risk
    inventory. Table 1 below shows the risks that were iden-
    tified for each guideline. Five additional risks were
    added: disputes with insurance companies regarding re-
    imbursements; security – active shooter; financial batch
    claim emanating from reimbursement reforms; use of
    social communication networks; and union strikes.
    A document that includes risk descriptions, risk sce-

    narios, and risk impacts was developed to constitute the
    healthcare enterprise risk inventory. One of the objec-
    tives of the inventory was for the interviewees to have a
    common understanding of each risk so that meaningful
    results and comparisons could be obtained. Another ob-
    jective of the risk inventory was to educate risk man-
    agers and other interested professionals. The complete
    risk inventory is presented in Additional file 3 through
    an online link.
    One concern that was raised in the interviews with the

    risk managers related to the lack of a common definition
    of a defined risk. The ERM guidelines currently in place
    do not offer sufficiently detailed definitions to allow for
    proper comparisons. For example, regarding the risk of
    fraud, stealing money from Medicare is fraud, but taking

    Etges et al. BMC Health Services Research (2018) 18:578 Page 4 of 16

    a photograph of a medical record is also fraud. With no
    explicit definition, individuals may think of the risk of
    fraud in different ways. A large organization must create
    a taxonomy to develop a common understanding of
    identified risks. The risk inventory created should help
    guide risk managers and other users from different
    levels, backgrounds, positions, and locations. In addition,
    if different organizations use the same inventory, it will
    be possible to develop risk benchmarks around the busi-
    ness aspects of healthcare.
    Another new element that the risk inventory provides

    is the association of each risk with the dimension that
    the risk impacts. The dimensions used are the patient,
    for risks that impact the patient’s care or the patient’s
    family; financial, for risks that impact the organization’s
    finances; legal or regulatory, for risks that are associated
    with lawsuits or regulations; reputation, for risks that

    can impact the hospital’s image; and social, for risks that
    can affect the region around the hospital or a large num-
    ber of people.
    Finally, the risks are categorized by group using the

    ASHRM domains and COSO factors as guidelines. The
    groups are important for the risk analysis and risk as-
    sessment phases. Table 2 below lists the enterprise risk
    events, their groups, the risk descriptions and the impact
    dimensions.

    Survey application
    After the risk inventory was completed, the survey was
    developed. For each risk, the participants were asked if
    they strongly disagreed, somewhat disagreed, neither dis-
    agreed nor agreed, somewhat agreed or strongly agreed
    that the risk is an important enterprise risk in the
    healthcare industry. The survey was anonymous. To

    Table 1 Risk inventory origin

    # Risks Guideline and participants

    COSO ASHRM HIROC NHS AON Participants

    1 Board governance – poor communication or lack of direction x x

    x

    x

    2 Business Interruption Due to Natural Catastrophe

    x

    x x

    3 Clinical batch claim

    x x x

    4 Conflicts due to organizational hierarchy

    x x x x

    5 Cyber security x

    6 Deficiency in development of technology and innovation x x x x

    7 Dependence on insurance companies x

    8 Dispute with insurance companies on reimbursements x

    9 Electronic Health Record (EHR) x x

    10 Environment Protection Agency or similar x

    11 External media communication x x x

    12 Financial batch claim emanating from reimbursement reform x

    13 Fraud committed by a provider x x x x

    14 Government instability x x x

    15 Loss of accreditation x x

    16 Non-compliance with laws and regulations x x x x

    17 Loss of Occupational Safety and Healthcare Administration (OSHA in USA) x x x

    18 Organizational culture

    x x x x x

    19 Physician wellness x x x

    20 Relation between the School of Medicine or Residency program and hospital x

    21 Active Shooter x

    22 Sentinel events x x x

    23 Supply chain x x

    24 Talent retention x x x x

    25 Terrorism x x

    26 Unethical conduct x x x x

    27 Union strike x

    28 Use of social communication networks x

    Etges et al. BMC Health Services Research (2018) 18:578 Page 5 of 16

    Table 2 Risk inventory – group and impacts

    Risk impact

    Risk Risk group Short description Patient Financial Reputation Legal Social

    Board governance – poor
    communication or lack of
    direction

    Financial Relationship with shareholders and the board of the
    organization; transparency in the information and results,
    capacity to prosecute governance. Mergers and
    Acquisitions. Conflict of Interest

    x x

    Business Interruption Due to
    Natural Catastrophe

    Operational Occurrence of internal or external events, which make it
    impossible for an organization to maintain its critical
    activities. Natural disasters must be allocated to this
    event. Earthquake or Hurricane.

    x x x

    Clinical batch claim Clinical With the increase of technologies and multiples
    techniques applied to patient to treat diseases, the batch
    claims have increased in size and frequency. Batch claims
    are frequently related to poor delivery of clinical service.

    x x x x

    Conflicts due to
    organizational hierarchy

    People Responsibilities, leadership and respect among the
    employees and functions. The relationship between the
    decision-making process and hierarchy. The medical hier-
    archy needs to be balanced in favor of teaching, learning
    and patient safety rather than the exercise of power
    (WALTON, 2006).

    x

    Cyber security Information
    Technology

    Invasion of an internal or external hacker that causes
    damage to the information security of the organization
    or its operational capacity. The use of ransomware is
    frequently present.

    x x x x x

    Deficiency in development of
    technology and innovation

    Clinical Lack of technologic innovation or development of
    innovations that do not meet the organization’s needs. It
    is related organization’s ability to possess, dominate and
    use technological resources that have an effect on its
    operations. Effects on the quality of clinical procedures
    and patient experience, as well as valuation of the
    institution towards insurers can be perceived.

    x x x

    Dependence on insurance
    companies

    Financial Negotiations with one health insurance company that
    accounts for 30% of the billing. The insurance company
    wants to reduce reimbursements for many medical tests
    and procedures.

    x x

    Dispute with insurance
    companies on
    reimbursements

    Financial An insurance company disputes the drugs, devices, or
    procedures used by the providers and hospital. The
    insurance company denies coverage.

    x x x

    Electronic Health Record
    (EHR)

    Information
    Tecnology

    Difficulty in obtaining information due to error in
    communication, loss of processing power or difficulty in
    operating the Hospital’s system.

    x x

    Environment Protection
    Agency or similar

    Compliance Government agency comes to investigate and fines the
    hospital or a department of the hospital.

    x x x x x

    External media
    communication

    Information
    Tecnology

    Healthy external marketing and media communication
    about the hospital and close relations. Organizational
    information being shared before the formal process and
    department of the hospital. The information timing can’t
    be the correct, or the information credibility can cause
    future problems.

    x x x

    Financial batch claim
    emanating from
    reimbursement reform

    Political Financial risk for healthcare organizations associated with
    bundled services or healthcare outcomes.

    x x x

    Fraud committed by a
    provider

    Financial Insurance plan fraud committed by a doctor or a group
    of doctors through prescriptions. In addition, important
    medicines or equipment stolen from the hospital can
    also be considered like a fraud.

    x x x x x

    Government instability Political Reduction in the country’s healthcare budget x x x

    Loss of accreditation Compliance Loss of an important certification or accreditation. x x x x

    Non-compliance with laws
    and regulations

    Compliance A clinical trial is taking place without the proper
    Institutional Review Board (IRB) approval. Patients die

    x x x x x

    Etges et al. BMC Health Services Research (2018) 18:578 Page 6 of 16

    create strata and analyze the responses, additional
    questions were asked to determine the credentials of
    the participants and the type of institution in which
    they work. The questions were used to determine the
    participants’ position, years working in that position,
    number of employees in the company, and whether a
    school of medicine was present. This information was
    used to develop the sample strata. Figure 2 presents
    an example of the risk questions on the platform.
    A total of 69 risk professionals started the survey,

    and 53 completed surveys were obtained during the
    period of study. This sample did not reach our 5%
    confidence interval target; however, it is still under

    the 10% confidence interval (required sample size of
    44 participants).

    Data analysis
    The survey data were exported to a CSV file, and the
    software SPSS was used to conduct the analysis. A total
    of 28 participants believed that their organization had a
    very or moderately effective ERM program. Thirty-eight
    participants worked in non-for-profit organizations, and
    35 were from organizations with a school of medicine or
    a residency program. Twenty-seven participants were
    chief risk officers or executive professionals, and 26 were
    clinical risk managers. A total of 19 participants had

    Table 2 Risk inventory – group and impacts (Continued)

    Risk impact
    Risk Risk group Short description Patient Financial Reputation Legal Social

    while part of the research.

    Loss of Occupational Safety
    and Healthcare
    Administration (OSHA in
    USA)

    Compliance The effect that working laws represent in how
    employees are being contracted. Any change in the
    formal orientations represent an effect for the hospital
    management.

    x x x

    Organizational culture People The healthcare organization needs to be able to share
    and implement its culture among all the employees.
    New and old employees need to work conducted by the
    same values and principles independently of their own
    religion or origins.

    x

    Physician wellness People 50% rate of burnout amongst physicians discovered after
    taking a physician wellness survey that measures burnout
    and professional fulfillment.

    x x x

    Relation between the School
    of Medicine or Residency
    program and hospital

    Clinical Interface between the SoM and the health service that
    may lead to interference of the university model to the
    business or, on the other hand, value the institution due
    to the teaching quality.

    x x x

    Active Shooter Operational Assault and active shooter threats to patients, families
    and hospital employees.

    x x x x

    Sentinel events Clinical Sentinel events, near miss events, incidents or medical
    error that can cause lawsuit.

    x x x x

    Supply chain Operational Materials and equipment control and management.
    Political problems with countries that supply resources
    for hospitals.

    x x x

    Talent retention People Loss of a team of providers that are specialized in certain
    types of procedures. It can happen in function of bad
    recruitment processes, or bad human resources
    management.

    x x x x

    Terrorism Political Terrorism attack close to the hospital. x x x x x

    Unethical conduct Operational Problems related with unethical employee conduct
    whether or not involving patients. Personal information,
    images or objects can be used without the approval of
    patient. Internal problems between employees can result
    in organization impact.

    x x x x x

    Union strike Political Union strikes among different classes of employees that
    can affect the hospital capacity to be operated.

    x x x x

    Use of social communication
    networks

    Information
    Tecnology

    Problems with confidential information being
    communicated through social media. A VIP: executive,
    actor, etc. Information is released on Facebook, what’s
    app or other.

    x x x x

    Total/impact 26 22 18 15 15

    Etges et al. BMC Health Services Research (2018) 18:578 Page 7 of 16

    worked fewer than 7 years in risk management, and 34
    had more than 7 years’ experience working in risk man-
    agement. Finally, 26 participants worked in organizations
    with fewer than 1000 employees, and 27 worked in orga-
    nizations with more than 1000 employees.
    The first analysis aimed to develop a ranking of the 28

    risks. Figure 3 shows the risk ranking ordered by the
    perceived level of risk importance. The y-axis refers to

    the frequency with which each risk was identified, and
    each color bar shows one of the alternative choices.
    Cyber security was ranked first, which highlights the

    importance that risk managers have placed on cyber is-
    sues. The second highest ranked risk was “sentinel
    event”. This result was expected, given the number of
    international regulations and rules to monitor and con-
    trol sentinel events.

    Fig. 2 Risk inventory survey example

    Fig. 3 Risk ranking according to the 53 participants

    Etges et al. BMC Health Services Research (2018) 18:578 Page 8 of 16

    The sentinel events, unethical conduct, organizational
    culture, and conflicts due to organizational culture risks
    demonstrate the importance of employee management
    in the healthcare industry. These risks are associated
    with an organization’s ability to manage human capital
    in alignment with respect for the values, rules and objec-
    tives established by organizational leaders.
    The second analysis (Fig. 4) shows the differences in

    the answers for the four groups representing the strata
    detailed in the methods section. The y-axis represents
    the percentage of each group that agree that the risk is
    an important enterprise risk: i) chief risk officers with
    more than 7 years working in risk management, 18 par-
    ticipants; ii) chief risk officers with fewer than 7 years
    working in risk management, 9 participants; iii) clinical
    risk managers with more than 7 years working in risk
    management, 10 participants; and iv) clinical risk man-
    agers with fewer than 7 years working in risk manage-
    ment, 16 participants.
    Figure 4 shows that chief risk officers tend to agree

    more than clinical risk managers regarding the risks that
    they consider to be important. The average percentage
    in which chief risk officers answered that they strongly
    agreed or somewhat agreed on the importance of each
    risk was 83% (the blue and orange bars in Fig. 4). In
    contrast, the percentage for clinical risk managers was
    73% (the gray and yellow bars in Fig. 4). When consider-
    ing the type of risk management, the difference in the
    average percentage with regard to years of experience is
    small: 76% for more than 7 years and 78% for fewer than
    7 years working in risk management.

    The results shown in Fig. 5, the third analysis, are
    similar to those in the second analysis. The y-axis repre-
    sents the percentage of participants from each group
    that agree that the risk is important. The figure shows
    that the size of a healthcare organization has no impact
    on risk professionals’ perception of risks: the average
    percentage in which participants from organizations
    with fewer than 1000 employees (27 participants) an-
    swered that they strongly agreed or somewhat agreed on
    the importance of each risk was 77% (yellow bar). On
    the other hand, the same percentage for the group from
    companies with more than 1000 (26 participants) em-
    ployees was 76% (gray bar).
    With regard to the presence of a school of medicine, it

    is possible to identify small differences in the percep-
    tions of risks between the two groups. In general, the
    managers from organizations without a school of medi-
    cine or residency program (18 participants) tend to agree
    slightly more about the importance of each risk than
    those with a school of medicine or residency program
    (35 participants), on average 6% more. However, for the
    following risks, the opposite is true, i.e., those who work
    in an organization with a school of medicine or resi-
    dency program agree more about the importance of the
    following risks: security – active shooter, government in-
    stability, use of social media networks, deficiency in de-
    veloping new technology and innovation, relation
    between the school of medicine and hospital and union
    strikes. Figure 6 shows the results, with the y-axis indi-
    cating the percentage of participants who agree about
    the importance of the risk from each group.

    Fig. 4 Type of risk management and time working in risk management

    Etges et al. BMC Health Services Research (2018) 18:578 Page 9 of 16

    The cluster analysis defined four different groups, as
    shown in Table 3.
    The K-means algorithm was used to establish which

    participants were included in each of the four clusters.
    Table 4 shows the results.
    Clusters 1 and 2 include 92% of the sample. The

    remaining 8% is divided among cluster 3 (one member)
    and cluster 4 (three members). Case 6 is a single mem-
    ber of cluster 3, which can be explained by the fact that
    the individual is a health insurance broker focused on
    clinical insurance. The members of cluster 4 are clinical

    risk managers working in not-for-profit companies with
    established ERM processes.
    Subsequently, ANOVA was used to identify which

    questions had statistical significance to the establishment
    of participant group membership. Table 5 presents the
    results.
    Table 5 shows that only 13% (7) of the questions were

    not significant to the identification of cluster members.
    This result indicates that the risks integrated in the en-
    terprise risk inventory captured each risk’s perceived im-
    portance during the survey application because the

    Fig. 5 Differences between participants from hospitals with fewer and more than 1000 employees

    Fig. 6 Differences between participants working in organizations with and without a school of medicine

    Etges et al. BMC Health Services Research (2018) 18:578 Page 10 of 16

    analysis indicates that the majority of the risks were sig-
    nificant to the cluster formation.
    Furthermore, the final analysis shows that all 28 risks

    were confirmed through the survey. More than 50% of
    the managers somewhat agreed or strongly agreed that
    all the risks are important enterprise risks in the health-
    care industry, and this percentage is higher than 70% for
    20 risks (all risks above and including loss of occupa-
    tional safety and healthcare administration in Fig. 7).
    This represents an important advance in healthcare risk
    research and for practical application. Figure 7 shows
    the results, with the y-axis indicating the percentage of
    participants who agreed or disagreed that the risks are
    important.
    The final analysis was performed to examine the free

    text written by the participants in response to an add-
    itional comments question. One item was mentioned by
    many participants: the importance of managing the im-
    pact of a hospital’s external image. The risk inventory
    does not include reputation as a risk but rather as an
    impact. However, two additional risks were reported.
    First, the participants mentioned investments in out-
    patient care and their connection to the hospital’s cap-
    ability to deliver a positive patient experience. The
    second risk mentioned was the growth in healthcare
    technology that has enabled home healthcare through-
    out the world. This risk impacts the support patients re-
    ceive from the hospital after hospitalization.

  • Discussion
  • ERM is applied across the board and is subject to the
    strategic positioning of organizations, which have the
    autonomy to manage processes and provide informa-
    tional support when making strategic decisions [12].
    When conducting ERM program, it is important that
    employees with different expertise and from different
    positions work together to incorporate the specific char-
    acteristics of the market in which the program will be
    implemented [10, 12, 22]. Therefore, it is particularly im-
    portant for individuals with diverse expertise and experi-
    ence to have a common understanding and specific
    definitions of risk events [11]. The results of this study
    show that having a personal background in risk manage-
    ment (clinical or enterprise) was a characteristic that

    showed a small difference in the perceived importance
    of the risks from the proposed risk inventory. These re-
    sults highlight the necessity for clinical risk managers to
    work closely with chief risk officers to create a risk cul-
    ture across the entire organization [9, 12, 23]. The length
    of time working in risk management and the number of
    employees in an organization do not show substantial
    differences with regard to the answers in Figs. 4 and 5.
    The cluster analysis also confirmed these results, as par-
    ticipants’ background had no influence on cluster mem-
    bership. Both types of backgrounds were found in
    participants in all 4 clusters.
    With regard to the small difference in how risk man-

    agers from organizations with and without a school of
    medicine agree with the risk results, an argument made
    during the first phase of the interviews (15 managers)
    deserves attention. A possible explanation is that organi-
    zations associated with schools of medicine are more ex-
    posed to students posting on social media than
    organizations that have formal contracts with employees
    [24]. Additionally, schools of medicine connect organiza-
    tions to government funding, which can lead to instabil-
    ity. Hospitals associated with schools of medicine and
    residency programs also must contribute to research and
    innovation capability [25].
    When ASHRM started to include ERM in its own

    principles in 2011, one objective was to connect ERM
    concepts from other industries to the traditional risk
    management concepts present in healthcare organiza-
    tions [26]. The developed risk inventory innovates in the
    risk identification phase of ERM by highlighting ways
    that enterprise risks affect patient care. Of the 28 risks
    identified, 26 can impact patient care or the patient’s
    family. ERM teams in healthcare organizations need to
    develop transparent processes that include the clinical
    impact of risks, irrespective of whether the initial risk
    event was clinical. This approach would help make pa-
    tient care and the patient experience the focus to guide
    the strategic decision-making process.
    With regard to the other characteristics explored

    among the study participants, it is possible to assume a
    near consensus regarding risk perceptions independent
    of the type of risk management performed or the length
    of time working in risk management, as demonstrated
    by the cluster analysis. Although we were not able to
    identify participant characteristics that lead to member-
    ship in clusters 1 and 2, the presence of clinical risk
    managers, chief risk officers, and employees with differ-
    ent levels of experience working in risk management led
    us to conclude that the length of time working in risk
    management as well as the participants’ background had
    no influence on cluster membership. Therefore, as the
    previous descriptive statistics analysis suggests, it is pos-
    sible to assume that risk perceptions are not directly

    Table 3 Number of cases per cluster

    Number of cases in each cluster

    Cluster 1 15.000

    2 34.000

    3 1.000

    4 3.000

    Valid 53.000

    Missing .000

    Etges et al. BMC Health Services Research (2018) 18:578 Page 11 of 16

    associated with the length of time working in risk man-
    agement and the type of risk management performed
    (clinical or enterprise). This result can be explained by
    the fact that a risk manager in a healthcare organization
    is involved in many areas: accounting, actuarial sciences,
    the healthcare business, information technology, and
    people management, among others [9, 12]. Thus, the
    organizational structure does not greatly affect the way
    that risk managers think about risk. Some participants
    reported that it is individuals’ responsibility to stay
    current on the innovations in risk management and to
    be completely engaged in the cause.
    Cyberattack-related risk was identified as the num-

    ber one enterprise risk for healthcare organizations,
    and this result is supported by the attention and in-
    vestment allocated to combatting hackers. The last re-
    port developed by AON suggests that healthcare
    organizations are increasingly purchasing data breach
    coverage to protect their sensitive patient information
    [27]. This is mainly driven by the HIPAA legislation,
    which outlines data privacy and security provisions
    for safeguarding medical information and that now
    holds organizations responsible in the event of a
    breach [27].
    The year 2017 will be remembered for the large

    number of cyberattacks targeting healthcare organiza-
    tions. Hackers accessed hospital databases throughout
    the world, interrupting operations and stealing data
    from millions of patients and thousands of companies.
    The National Health Service in England and Scotland
    announced in May 2017 that it would spend
    €60,000,000.00 per year on the NHS’ cyber system to
    improve its security [28]. By August 2017, the health-
    care sector reported 233 breach incidents to the US
    Department of Health and Human Services in which
    more than 3.16 million patient records were breached
    [29]. These events align with the results found in this
    research and justify the investments in research and
    the dollars spent to improve information systems to
    keep hospital data safe.

    Table 4 Cluster membership

    Case number Cluster Distance

    17 4 7.659

    21 4 9.309

    23 4 7.394

    6 3 .000

    2 2 8.886

    4 2 6.735

    5 2 9.196

    7 2 6.615

    8 2 5.874

    9 2 6.131

    10 2 6.537

    11 2 6.927

    12 2 8.148

    13 2 8.315

    14 2 8.841

    15 2 7.964

    16 2 6.633

    18 2 5.666

    19 2 7.694

    20 2 12.066

    24 2 8.969

    26 2 7.694

    27 2 7.179

    30 2 11.298

    32 2 7.398

    34 2 6.769

    39 2 11.399

    41 2 5.686

    42 2 9.645

    43 2 5.366

    44 2 7.195

    46 2 10.550

    47 2 6.422

    50 2 5.461

    52 2 6.633

    53 2 6.242

    37 2 8.783

    38 2 9.007

    1 1 10.223

    3 1 11.056

    22 1 13.069

    25 1 8.844

    28 1 9.005

    29 1 10.025

    Table 4 Cluster membership (Continued)

    Case number Cluster Distance

    31 1 9.911

    33 1 7.960

    35 1 12.624

    36 1 10.444

    40 1 9.997

    45 1 9.036

    48 1 7.046

    49 1 7.779

    51 1 11.854

    Etges et al. BMC Health Services Research (2018) 18:578 Page 12 of 16

    Patient data security in hospitals that operate with
    high levels of technology is fundamental to delivering
    high quality and safe care to patients. The identification
    of cyberattacks at the top of the risk ranking reflects the
    importance that healthcare risk managers are placing on
    this risk by allocating time and other resources.
    Sentinel events are a specific characteristic of health-

    care organizations, which have been encouraged by
    international institutions such as JCI to reduce sentinel
    events through safety and quality practices [30, 31]. Hu-
    man errors represented a starting point for advances in
    the clinical risk management literature since the publica-
    tion of To Err is Human [32] and “Crossing the Quality
    Chasm” by the Institute of Medicine [33]. These publica-
    tions suggest that between 3.7–16.7% patients suffer an
    adverse event, and it is estimated that a half of these
    events could be prevented through better risk manage-
    ment practices. These events and the attention paid to

    this issue by international institutions were highlighted
    during this research, as the participants confirmed the
    importance of all risks associated with employee man-
    agement and human relations in healthcare
    organizations.
    Addressing clinical teams’ emotional exhaustion is es-

    sential to ensuring a high level of patient safety [34]. In-
    deed, Wallace et al. [35] concluded that physician
    wellness might not only benefit the individual physician,
    it could also be vital to the delivery of high-quality
    healthcare. The authors suggest that physician wellness
    may be an organizational indicator of quality [35]. The
    sequence of risks noted as important in the survey, in-
    cluding unethical conduct, the organizational culture,
    and conflicts due to the organizational culture are asso-
    ciated human capital management. The fact that health-
    care organizations are sustained by human capital is
    clearly an important issue for risk management [25].

    Table 5 Analysis of variance of cluster members

    Questions Cluster mean square df Error mean square df F sig.

    Clinical Batch Claim 27.262 3 2.234 49 12.204 .000

    Conflicts Due To Organizational Hierarchy 28.863 3 2.493 49 11.577 .000

    Dependence on health insurance 47.235 3 2.074 49 22.777 .000

    Dispute with insurance companies in reimbursement 33.268 3 2.987 49 11.136 .000

    Environmental protection agency 32.966 3 3.428 49 9.617 .000

    External media communication 16.074 3 2.019 49 7.960 .000

    Fraud commited by a provider 67.311 3 2.077 49 32.411 .000

    Non-compliance with laws and regulations 20.580 3 1.552 49 13.257 .000

    Loss of occupational safety and healthcare administration (OSHA in USA) 23.920 3 3.024 49 7.911 .000

    Physician wellness 16.601 3 1.559 49 10.650 .000

    Sentinel event 16.908 3 1.143 49 14.797 .000

    Board governance-Poor communication or lack of direction 19.512 3 2.992 49 6.522 .001

    Active shooter 23.871 3 4.210 49 5.670 .002

    Financial batch claim emanating from Reimbursement reform 30.082 3 5.108 49 5.889 .002

    Cyber security 5.239 3 .970 49 5.401 .003

    Unethical conduct 11.637 3 2.165 49 5.376 .003

    Supply chain 6.196 3 1.380 49 4.491 .007

    Union strike 18.470 3 4.808 49 3.841 .015

    Business Interruption due to natural catastrophe 13.759 3 3.754 49 3.666 .018

    Relationship between the school of medicine (SOM) and Hospital 13.718 3 3.886 49 3.531 .021

    Electronic Health Record (EHR) 7.338 3 2.234 49 3.285 .028

    Terrorism 14.222 3 5.269 49 2.699 .056

    Organizational Culture 4.998 3 1.915 49 2.610 .062

    Loss of Accreditation 8.363 3 3.252 49 2.571 .065

    Government Instability 7.226 3 2.971 49 2.432 .076

    Deficiency in developing new technology and innovating 8.506 3 4.223 49 2.014 .124

    Talent retention 5.491 3 2.781 49 1.974 .130

    Use of social communication networks 2.744 3 2.176 49 1.261 .298

    Etges et al. BMC Health Services Research (2018) 18:578 Page 13 of 16

    According to some of the interviewed managers, this
    highlights the necessity of having a well-described risk
    inventory and a defined risk management process to
    minimize interpersonal conflicts based on the exist-
    ence of a document that establishes rules for profes-
    sionals [19]. The hierarchy among employees in a
    healthcare organization and professionals’ dependency
    on such employees deserve attention when imple-
    menting a proactive and strategic risk management
    process because only by engaging all professionals in
    ERM can a risk culture be created and a safer envir-
    onment achieved [36–39].

    Conclusion
    The results provide important progress for the strategic
    healthcare management process and ERM programs. In
    addition to defining specific risk scenarios, the enterprise
    risk inventory presented in this research can be used to
    educate professionals, guide the risk identification phase
    in future ERM programs, and thereby contribute to the
    development of a risk culture.
    Establishing cyberattacks and the risks associated

    with human capital management (organizational cul-
    ture, use of electronic medical records and physician
    wellness) at the top of the risk ranking is an import-
    ant contribution of this research. Cyber security is at
    the top of the risk list for most industries, including
    healthcare. Employee wellness is also a theme that
    has been growing in importance in many industries.
    There are now opportunities to investigate and de-
    velop solutions to manage and assess those risks for
    healthcare organizations.

    The results also demonstrate that the qualitative char-
    acteristics of risk managers from large organizations, the
    length of time working in risk management, and the
    presence of a school of medicine do not alter the per-
    ceived importance of the risks. Clinical risk managers
    and chief risk officers have small differences of opinion
    on the risks, but not enough to group them in the same
    cluster. This finding enables us to conclude that the per-
    sonal background of each employee is a more important
    factor than the organization’s structure or the employee’s
    own risk perception capability.
    For future research, the authors suggest evaluating the

    benefits of using the risk inventory at the beginning of
    the risk identification phase, that is, during the baseline
    phase of the E2RMhealthcare. To demonstrate the value
    of the risk inventory, a comparative study that explores
    the ability to disseminate an ERM program in an
    organization should be conducted.

  • Additional files
  • Additional file 1: Interviewees description. (XLSX 35 kb)

    Additional file 2: The enterprise risk inventory survey. (DOCX 29 kb)

    Additional file 3: The enterprise risk inventory. (DOCX 32 kb)

  • Abbreviations
  • ASHRM: American society for healthcare risk management; COSO: Committee
    of sponsoring organizations of the treadway commission; ERM: Enterprise risk
    management; HIPAA: Health insurance portability and accountability act;
    HIROC: Healthcare insurance reciprocal of Canada; ISO: International
    organization for standardization; JCI: Joint commission of international
    standards for hospitals; NHS: The national health service in England;
    USA: United States of America

    Fig. 7 Agree x disagree – risk inventory confirmation

    Etges et al. BMC Health Services Research (2018) 18:578 Page 14 of 16

    https://doi.org/10.1186/s12913-018-3400-7

    https://doi.org/10.1186/s12913-018-3400-7

    https://doi.org/10.1186/s12913-018-3400-7

  • Acknowledgements
  • We acknowledge The Risk Authority Stanford for providing us the
    opportunity to contact managers from North American health organizations
    and The Federal University of Rio Grande do Sul for providing the
    orientation for the PhD research behind this paper. In addition, we
    acknowledge all the participants.

  • Availability of data and materials
  • The datasets used and/or analyzed during the current study are available
    from the corresponding author upon reasonable request.

  • Authors’ contributions
  • APBSE: invited the participants to answer the survey and to participate in the
    first phase of interviews, applied the survey, conducted the data analysis,
    analyzed the papers, was involved in the entire writing process. VG: invited
    the participants to answer the survey and to participate in the first phase of
    interviews, applied the survey, conducted the data analysis, analyzed the
    data, and was involved in the entire writing process. ML: applied the survey,
    conducted the data analysis, and reviewed the paper. RBS: analyzed the data
    and reviewed the paper. JSS: reviewed the methods, the results and the
    paper. KFN: reviewed the methods, the results and the paper. EAF: reviewed
    the methods, the results and the paper. All authors read and approved the
    final version of the manuscript.

  • Authors’ information
  • APBSE, Msc. Eng.: is a Researcher at the National Health Technology
    Assessment Institute (CNPq, Brazil), is a Professor at the School of
    Technology of PUCRS (Brazil), and serves as a consultant in Brazil for projects
    focused on measuring the economic impact of risks, assessing health
    technologies and developing models to improve companies’ ability to make
    strategic decisions.
    VG, Actuary: is a fully trained actuary and serves as the Managing Director of
    Guy Carpenter & Company, LLC.
    ML, Data Scientist: serves as a Data Scientist at The Risk Authority Stanford.
    RBS, Msc. Eng.: is a researcher and a PhD student in the Industrial
    Engineering Program at The Federal University of the South of Brazil
    (UFRGS).
    JSS, PhD. Msc. Eng.: serves as a Professor in the Industrial Engineering
    Program at The Federal University of the South of Brazil (UFRGS) and also
    conducts research focused on enterprise risk management.
    KFN PhD. Msc. Eng.: serves as a Professor in the Industrial Engineering
    Program at The Federal University of the South of Brazil (UFRGS) and also
    conducts research focused on cost management and economic analysis.
    EAF PhD. Msc. MD.: serves as a Professor in the School of Medicine at The
    Federal University of the South of Brazil (UFRGS) and also conducts research
    focused on clinical and enterprise risk management.

  • Ethics approval and consent to participate
  • All interviewees (the 15 managers in the first interviews and the 53
    participants) were invited to participate and agreed to have their data
    analyzed.
    This research was conducted by the Industrial Engineering Department of
    the Federal University from the South of Brazil, which approved the conduct
    of the research.

  • Consent for publication
  • Not applicable.

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

  • Publisher’s Note
  • Springer Nature remains neutral with regard to jurisdictional claims in
    published maps and institutional affiliations.

  • Author details
  • 1School of Technology, PUCRS, Avenida Ipiranga, 6681, Porto Alegre
    90619-900, Brazil. 2National Health Technology Assessment Institute, CNPq,
    Porto Alegre, RS, Brazil. 3Department of Industrial Engineering, UFRGS, Porto
    Alegre, RS, Brazil. 4The Risk Authority Stanford, Palo Alto, California, USA.

    5Department of Anesthesiology, School of Medicine, UFRGS, Porto Alegre, RS,
    Brazil. 6Guy Carpenter, LLC, New York, NY, USA.

    Received: 14 February 2018 Accepted: 16 July 2018

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    https://doi.org/10.1016/j.hcmf.2013.05.004

      Abstract
      Background
      Method
      Results
      Conclusions
      Background
      Methods
      Survey development
      Survey application
      Data analysis
      Results
      Survey development: risks and origin
      Survey application
      Data analysis
      Discussion
      Conclusion
      Additional files
      Abbreviations
      Acknowledgements
      Availability of data and materials
      Authors’ contributions
      Authors’ information
      Ethics approval and consent to participate
      Consent for publication
      Competing interests
      Publisher’s Note
      Author details
      References

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