R E V I E W

Risk Management in Executive Levels of Healthcare

Organizations: Insights from a Scoping Review (2018) This article was published in the following Dove Press journal:

Risk Management and Healthcare Policy

Masoud Ferdosi 1

Reza Rezayatmand 2

Yasamin Molavi Taleghani 3

1Health Management and Economics

Research Center, Department of Health

Services Management, School of

Management and Medical Information

Sciences, Isfahan University of Medical

Sciences, Isfahan, Iran; 2Health

Management and Economics Research

Center, Isfahan University of Medical

Sciences, Isfahan, Iran; 3Department of

Health Services Management, School of

Management and Medical Information

Sciences, Isfahan University of Medical

Sciences, Isfahan, Iran

Background: This study attempted to present a framework and appropriate techniques for

implementing risk management (RM) in executive levels of healthcare organizations (HCOs)

and grasping new future research opportunities in this field.

Methods: A scoping review was conducted of all English language studies, from January

2000 to October 2018 in the main bibliographic databases. Review selection and character-

ization were performed by two independent reviewers using pretested forms.

Results: Following a keyword search and an assessment of fit for this review, 37 studies

were analyzed. Based on the findings and considering the ISO31000 model, a comprehensive

yet simple framework of risk management is developed for the executive levels of HCOs. It

includes five main phases: establishing the context, risk assessment, risk treatment, monitor-

ing and review, and communication and consultation. A set of tools and techniques were also

suggested for use at each phase. Also, the status of risk management in the executive levels

of HCOs was determined based on the proposed framework.

Conclusion: The framework can be used as a training tool to guide in effective risk

assessment as well as a tool to assess non-clinical risks of healthcare organizations.

Managers of healthcare organizations who seek to ensure high quality should use a range

of risk management methods and tools in their organizations, based on their need, and not

assume that each tool is comprehensive.

Keywords: organization risk management, scoping review, risk analysis, health care,

executive levels

Introduction Given the World Health Report (2000), the significance of healthcare organizations

(HCOs) has grown in global health discourse.1 However, in the last decade, HCOs

have faced two contradictions: first, healthcare costs have increased due to popula-

tion aging, the introduction of advanced technologies, and increased medical

errors.2,3 On the other hand, HCOs have become more complicated due to such

factors as efficient customers, biomedical developments, the complexity of services

and an increasing number of healthcare users.2,3 Therefore, demand for healthcare

is significantly higher than the human capacity and resources available in healthcare

departments.4 Corresponding to these limits, three interventional approaches have

been developed at various levels of the HCOs: (i) quality management, (ii) risk

management, and (iii) patient safety.5

In particular, risk management (RM) is a process-oriented method providing a

structured framework for identifying, assessing, and reducing risk at appropriate

times for HCOs.6 RM approach protects healthcare providers against unfavorable

Correspondence: Yasamin Molavi Taleghani Isfahan University of Medical Sciences, School of Management and Medical Informatics, Health Management and Economics Research Center, Hezar Jarib Street, Second Floor, Isfahan, Iran Tel +98 912 7233347 Email [email protected]

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incidents.7 This way, RM plays a major role in shrinking

uncertainties and enhancing rich opportunities for different

areas of the health system.8 Development of RM helps

HCOs and providers to reduce damage due to the probable

occurrence of defective processes through identifying error,

rooting, and strategy development.9 Implementing RM in

HCOs improves allocation of health resources,10 process

management, decision-making, reduced organizational

losses,11 patient safety,11 continuous quality improvement,2

customer satisfaction,2 organizational performance,12 hos-

pital reputation,11 and better community creation.2

A general framework for RM needs to be identified

before implementing the risk process. This framework deter-

mines the strategy of organization for identifying risk, risk

assessment, and risk reduction.13 This strategy outlines how

the RM process should be implemented in the organization. It

determines the resources that are needed, the key roles and

responsibilities for that, the ways risk needs to be identified.

It shows how the decision-making process looks like while

using those strategies.13 The available evidence suggests that

despite the existence of a large number of RM techniques, a

few of them have been employed so far in the HCOs.14–16

Risk management is one of the emerging areas in man-

agement systems; there are several reports that have provided

an overview of risk management inHCOs; however, it is

difficult to find studies that have systematically synthesized

risk management models at the executive levels of healthcare

organizations.17–19 This sector is far behind the rest of the

industry in terms of using these techniques. Nowadays, there

is a consensus in the healthcare sectors that the knowledge,

experience, and expertise of other industries in RM can

improve the quality of services provided in the healthcare

sectors.3 Therefore, reviewing the selection of RM techni-

ques seems indispensable. These instruments need to be

tailored to the complexities of the healthcare system and

the causes affecting incidents in this sector.20,21

The organizational structure of the healthcare system

has been classified into executive, administrative and

operational, each of which is exposed to some risks.22

This limited study aims to identify those risks that happen

in executive levels. The study would not consider those

risks that may happen in the operational levels of health-

care organizations and can be considered as a clinical risk.

Mention should be made that the executive levels of

healthcare organizations are the headquarters and deputies

of the HCOs that provides counseling and control over

healthcare delivery units.22 Therefore, the aim of this

review is to scope published different organizational RM

models, identify the strengths and weaknesses of each

model, and this way, propose a framework for implement-

ing RM in the executive levels of HCOs.

The applied purpose of this study was to integrate existing

research on the various areas of RM cycle (risk identification,

risk assessment, & risk management) and ultimately provide a

centralized knowledge base for future research in the executive

levels of HCOs. It is of note that the executive levels of HCOs

are the headquarters and deputies of the HCOs that provides

counseling and control over healthcare delivery units.

Methods The methodological framework of the scope review

described below was guided by such methodologies,

which have been published elsewhere.23,24

Scoping Review Question The first phase was represented by the definition of the

scope of the study in compliance with the objectives and

the underlying research hypotheses.

Based on preliminary studies, the research questions

developed for scoping review are as follows:

RQ1: How are organizational risks identified and cate-

gorized within the executive levels of HCOs?

RQ2: What is the proposed framework for organiza-

tional risk management in the executive levels of

HCOs? Also, what is the status of risk management

in the executive levels of HCOs based on the pro-

posed framework?

RQ3: What techniques and tools are available for

implementing organizational risk management in

the executive levels of HCOs?

Inclusion and Exclusion Criteria To obtain and include relevant and important documents to

concentrate on, a series of inclusion and exclusion criteria

should be defined. The selection of the studies was done

according to the following inclusion criteria:

(i) Studies on organizational RM and assessment tech-

niques and framework in healthcare organizations or

related organizations appropriate for imitation in the

healthcare organization; (ii) articles in English; (iii) 2000

to October 2018.

The following studies were excluded: (i) in the format

of letters, editorials, news, professional commentaries, and

reviews; (ii) without available abstracts or full text or

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references; (v) Models that cannot be imitated in health-

care organizations; (vi) Published in languages other than

English.

Identifying Locating Sources and Relevant

Articles This study was conducted in October 2018 through con-

sulting such databases as Pub Med, ISI, Emerald, Scopus,

IEEE, Springer, ProQuest, Cochrane, and Wiley from

2000 to May 2018. The search strategy was the same for

all the databases.

The identification of the keywords related to the sub-

jects and the objectives of the study are as follows: initi-

ally, keywords were identified by the authors through a

brainstorming process. The identified keywords were

refined and validated by a team composed of two univer-

sity academic members and two healthcare managers. The

search strategy was formulated using Boolean operators.

The formula was searched in the field of title and abstract

in online databases. The search strings used are shown in

Table 1, a search for each research question was per-

formed. Also, the search was repeated two times with the

following search string. In addition, the references were

retrieved from the studies included in the first iteration.

The keywords of references that matched with the search

keywords were chosen.

Study Selection and Data Abstraction The two authors (YMT and MF) independently performed

level 1 (titles and abstracts) and level 2 (full article texts)

screening forms. All screening and extraction were com-

pleted in duplicate. Disagreements were discussed between

the two reviewers and a third-party reviewer (R R) was

contacted if disagreements could not be resolved. After

independent reading of the full texts, the content analyzed

and selected the articles that answer the respective research

questions. Study quality was not assessed during the scop-

ing review as the objective of a scoping review is to identify

gaps in the literature and highlight future areas for systema-

tic review.23,24 The required information extracted based on

the research questions and placed in the designed templates.

Results Three thousand five hundred and seventy-four studies

were screened, excluded 761 duplicates, 1556 on title

review, 1081 on abstract review and 144 in a full-text

review. In total, leaving 37 papers (32 papers first iteration

on the database and five studies from hand searching)

search for critical appraisal. Table 2 shows the flowchart

for the study selection.

Characteristics of Articles Reviewed Bibliographical information about the 36 articles included

in this review can be obtained from Table 3.

Table 1 Search Strings for Research Questions and Studies

Code Search Strings Online Databases Field Quantity

RQ1 (risk OR failure* OR error* OR event*) AND (source* OR

classification* OR identify* OR category* OR epidemiology) AND

(organization* OR system* OR administration*) NOT clinical*

PubMed Title, Mesh, and Abstract 164

ISI Title, Topic, and Abstract 495

Scopus Title, Abstract, keywords 284

Emerald Title, Abstract, keywords 114

ProQuest Title, Abstract, keywords 102

Cochrane Title, Abstract, keywords 28

Wiley Title, Abstract, keywords 49

Springer Title, Abstract, keywords 30

IEEE Title, Mesh, and Abstract 21

RQ2

And

RQ3

(“risk management*” OR “risk assessment*” OR “management risk*”

OR “assessment risk” OR “ risk analysis*”) AND (model* OR

approach* OR technique* OR method* OR structure* OR tool* OR

process* OR framework*) AND (organization* OR system* OR

administration*)

PubMed Title, Mesh and Abstract 387

ISI Title, topic, and Abstract 273

Scopus Title, Abstract, keywords 838

Emerald Title, Abstract, keywords 235

ProQuest Title, Abstract, keywords 61

Cochrane Title, Abstract, keywords 24

Wiley Title, Abstract, keywords 215

Springer Title, Abstract, keywords 63

IEEE Title, Abstract, keywords 191

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Code Search Strings Online Databases Field Quantity

RQ1 (risk OR failure* OR error* OR event*) AND (source* OR classification* OR identify* OR category* OR epidemiology) AND (organization* OR system* OR administration*) NOT clinical*

PubMed Title, Mesh, and Abstract 164 ISI Title, Topic, and Abstract 495 Scopus Title, Abstract, keywords 284 Emerald Title, Abstract, keywords 114 ProQuest Title, Abstract, keywords 102 Cochrane Title, Abstract, keywords 28 Wiley Title, Abstract, keywords 49 Springer Title, Abstract, keywords 30 IEEE Title, Mesh, and Abstract 21

RQ2 And RQ3

(�risk management*� OR �risk assessment*� OR �management risk*� OR �assessment risk� OR � risk analysis*�) AND (model* OR approach* OR technique* OR method* OR structure* OR tool* OR process* OR framework*) AND (organization* OR system* OR administration*)

PubMed Title, Mesh and Abstract 387 ISI Title, topic, and Abstract 273 Scopus Title, Abstract, keywords 838 Emerald Title, Abstract, keywords 235 ProQuest Title, Abstract, keywords 61 Cochrane Title, Abstract, keywords 24 Wiley Title, Abstract, keywords 215 Springer Title, Abstract, keywords 63 IEEE Title, Abstract, keywords 191

According to Table 3, 11 articles (14.3%) were used to

answer the first research question, 30 articles (38.9%) were

used to answer questions 2, and finally, 36 articles (46.8%)

were used to answer research question 3. (Total papers >36

because each paper may be classified into two or more study

types, or may address two or more review questions.) Also, it

could be recognized that all but four articles were published

in 2009 or later, this is due to the complexity of environment

and type of services provided by organizations and, conse-

quently, use of the RM and risk assessment process as a tool

for reducing errors and incidents in recent years.

As can be seen in Table 3, based on the setting of

the studies, Europe had the most study with (59.5%)

of the authors affiliated with European universities and

Table 2 Paper Selection Process

Phase Number of

Imported

Number of

Excluded

Exclusion Criteria

Identification First iteration on data base

Question 1: 1287 (36.1%)

Question 2, 3: 2287 (63.9%)

3574 – R0: Disproportionate to the goals and

research questions

R1: letters, editorials, news, professional

commentaries, and reviews

R2: No outcome reported

R3: Poor study design

R4: No abstract or full text available

R5: Unclear description

R6: Not applicable for healthcare

organizations.

R7: No systematic approach to error

Screening Duplicate citations – 761

Title screening

Reason excluding papers on the basis of titles:

R0: 998 (64.1%) R1: 198(12.7%)

R6: 286(18.3%) R8:74(4.7%)

2813 1556

Abstract screening

Reason excluding papers on the basis of abstract:

R0: 450 (41.6%) R1: 127 (11.7%)

R2: 42 (3.9%) R3: 39 (3.6%)

R4: 36 (3.3%) R5: 25 (2.3%)

R6: 309 (28.6%) R8: 53 (4.9%)

1257 1081

Eligibility Full-text eligibility

(Agreement rate: 85%).

Reason excluding papers on the basis of full text:

R0: 39(27.4%) R1: 8(5.6%) R2: 10(6.94%) R3: 18

(12.5%) R4: 7(4.9%) R5: 6 (4.2%)

R6: 27(19%) R7: 29(20.4%)

176 144

Included Relevant papers found from the search on

database

Responsiveness rate of studied divided by each

research question:

Question 1: 10(14.7%) Question 2: 27(39.7%)

Question 3: 31(45.6%)

32 –

Relevant references on references of relevant

papers

Responsiveness rate of studied divided by each

research question:

Question 1: 1(20%) Question 2: 3 (30%)

Question 3: 5 (50%)

5 –

Achieving the relevant papers

Responsiveness rate of studied divided by each

research question:

Question 1: 11(14.3%) Question 2: 30(38.9%)

Question 3: 36(46.8%)

37 –

Note: Each study may answer several research questions.

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Phase Number of Imported Number of Excluded Exclusion Criteria

Identification First iteration on data base 3574 � R0: Disproportionate to the goals and research questions R1: letters, editorials, news, professional commentaries, and reviews R2: No outcome reported R3: Poor study design R4: No abstract or full text available R5: Unclear description R6: Not applicable for healthcare organizations. R7: No systematic approach to error

Question 1: 1287 (36.1%) Question 2, 3: 2287 (63.9%)

Screening Duplicate citations � 761

Title screening 2813 1556 Reason excluding papers on the basis of titles: R0: 998 (64.1%) R1: 198(12.7%) R6: 286(18.3%) R8:74(4.7%) Abstract screening 1257 1081

Reason excluding papers on the basis of abstract: R0: 450 (41.6%) R1: 127 (11.7%) R2: 42 (3.9%) R3: 39 (3.6%) R4: 36 (3.3%) R5: 25 (2.3%) R6: 309 (28.6%) R8: 53 (4.9%)

Eligibility Full-text eligibility 176 144 (Agreement rate: 85%). Reason excluding papers on the basis of full text: R0: 39(27.4%) R1: 8(5.6%) R2: 10(6.94%) R3: 18 (12.5%) R4: 7(4.9%) R5: 6 (4.2%) R6: 27(19%) R7: 29(20.4%)

Included Relevant papers found from the search on database 32 –

Responsiveness rate of studied divided by each research question: Question 1: 10(14.7%) Question 2: 27(39.7%) Question 3: 31(45.6%) Relevant references on references of relevant papers

Responsiveness rate of studied divided by each research question: Question 1: 1(20%) Question 2: 3 (30%) Question 3: 5 (50%) Achieving the relevant papers 37 –

Responsiveness rate of studied divided by each research question: Question 1: 11(14.3%) Question 2: 30(38.9%) Question 3: 36(46.8%)

Table 3 Bibliographical Sources of the Studies Included in the Literature Review

Code First Author Year of

Publication

Research Designs of the Articles Included in the Literature Review Answering Which

Research question Article

Type*

Data

Collection*

Country/

Setting of the

Studies

Context/Study

Population

1 Molavi

Taleghani 25

2016 4 1,2,3,4,5 Iran Emergency surgery ward

in hospital

2,3

2 Gervais 26

2012 3 2,4,5 Ireland Pharmaceutical

manufacturing

environment

2,3

3 Bernardini 27

2013 3 2 Italy Complex and mission-

critical systems

2,3

4 Cagliano 8

2011 3 6 Italy Pharmacy department in a

large hospital

2,3,1

5 Parand 28

2017 4 1,4,5 England+ Italy Medication administration

within homecare

1,2,3

6 Sendlhofer 29

2015 3 2,6 Austria Large university hospital 2,3

7 Lopez 30

2010 4 2,3 USA Clinical cell therapy in

regenerative medicine

2,3

8 Emblemsvag 31

2002 3 6,2 Norway Manufacturing

environment

1,2,3

9 Jaberidoost 32

2015 4 1,2,3,5 Iran Pharmaceutical industry 2,3

10 Wierenga 33

2009 3 5,3 Netherlands Two hospital 2,3

11 Niel-Laine 34

2011 2 2,5 France A central sterile supply

department

2,3,1

12 Trucco 35

2006 2 1,2,4,3 Italy Drug therapy management

process

2,3

13 Emre

Simsekler 36

2018 4 1,2,6 England Gastroenterology Unit in

Hospitals

1,3

14 Bonnabry 37

2005 4 5 Switzerland Pediatric parenteral

nutrition process

2,3

15 Rezaei 38

2018 4 2,5,1,3 IRAN Surgery ward in hospital 2,3

16 Domanski 39

2016 3 1,2,3 Poland Nonprofit Organizations 1,2,3

17 Ramkumar 40

2016 4 2,5,6 India E-procurement systems 1,2,3

18 Beauchamp-

Akatova 41

2013 3 2,3,6 Netherlands Air transport systems 2,3

19 Faiella 42

2017 4 2,3,6 Uk Administration of

medication in the home

setting

2,3

20 Usman Tariq 43

2013 3 6,2 Saudi Arabia Iodine development

industry

1,2,3

(Continued)

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Code First Author Year of Publication Research Designs of the Articles Included in the Literature Review Answering Which Research question Article Type

(see note * on page 6)

Data Collection (see note * on page 6)

Country/ Setting of the Studies

Context/Study Population

1 Molavi Taleghani (see endnote 25 on page 28)

2016 4 1,2,3,4,5 Iran Emergency surgery ward in hospital

2,3

2 Gervais (see endnote 26 on page 27)

2012 3 2,4,5 Ireland Pharmaceutical manufacturing environment

2,3

3 Bernardini (see endnote 27 on page 27)

2013 3 2 Italy Complex and mission- critical systems

2,3

4 Cagliano (see endnote 8 on page 27)

2011 3 6 Italy Pharmacy department in a large hospital

2,3,1

5 Parand (see endnote 28 on page 28)

2017 4 1,4,5 England+ Italy Medication administration within homecare

1,2,3

6 Sendlhofer (see endnote 29 on page 28)

2015 3 2,6 Austria Large university hospital 2,3

7 Lopez (see endnote 30 on page 28)

2010 4 2,3 USA Clinical cell therapy in regenerative medicine

2,3

8 Emblemsvag (see endnote 31 on page 28)

2002 3 6,2 Norway Manufacturing environment 1,2,3

9 Jaberidoost (see endnote 32 on page 28)

2015 4 1,2,3,5 Iran Pharmaceutical industry 2,3

10 Wierenga (see endnote 33 on page 28)

2009 3 5,3 Netherlands Two hospital 2,3

11 Niel-Laine (see endnote 34 on page 28)

2011 2 2,5 France A central sterile supply department 2,3,1

12 Trucco (see endnote 35 on page 28)

2006 2 1,2,4,3 Italy Drug therapy management process

2,3

13 Emre Simsekler (see endnote 36 on page 28)

2018 4 1,2,6 England Gastroenterology Unit in Hospitals

1,3

14 Bonnabry (see endnote 37 on page 28)

2005 4 5 Switzerland Pediatric parenteral nutrition process

2,3

15 Rezaei (see endnote 38 on page 28)

2018 4 2,5,1,3 IRAN Surgery ward in hospital 2,3

16 Domanski (see endnote 39 on page 28)

2016 3 1,2,3 Poland Nonprofit Organizations 1,2,3

17 Ramkumar (see endnote 40 on page 28)

2016 4 2,5,6 India E-procurement systems 1,2,3

18 Beauchamp- Akatova (see endnote 41 on page 28)

2013 3 2,3,6 Netherlands Air transport systems 2,3

19 Faiella (see endnote 42 on page 28)

2017 4 2,3,6 Uk Administration of medication in the home setting

2,3

20 Usman Tariq (see endnote 43 on page 28)

2013 3 6,2 Saudi Arabia Iodine development industry 1,2,3

institutions. Asia was the next one with (21.6%) of the

studies, followed by America (13.5%), Oceania

(2.7%), and Africa with 2.7%. Also, most of the stu-

dies examined in developed countries. Thus, at this

point, we can already identify a need for more

research into risk management in developing countries.

As for design, 2(5.4%) studies were empirical quanti-

tative, 5 (13.5%) empirical qualitative, 12 (32.4%) con-

ceptual/theoretical and 18 (48.7%) mix method.

How are Organizational Risks Identified

and Categorized Within Executive Levels

of