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Compliance and regulatory efficacy and sustainability in specialty academic medicine: a longitudinal evaluation study
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Compliance and regulatory efficacy and sustainability in specialty academic medicine: a longitudinal evaluation study
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Content
Running head: COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 1
COMPLIANCE AND REGULATORY EFFICACY AND SUSTAINABILITY IN SPECIALTY
ACADEMIC MEDICINE: A LONGITUDINAL EVALUATION STUDY
by
Dustin D. McLemore
A Dissertation Presented to the
FACULTY OF THE USC ROSSIER SCHOOL OF EDUCATION
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF EDUCATION
(ORGANIZATIONAL CHANGE AND LEADERSHIP)
May 2018
Copyright 2018 Dustin Dru McLemore
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 2
ACKNOWLEDGEMENTS
This effort would not have been possible without my family. My beautiful bride, Dr.
Christine McLemore, was just as invested in this study as I was, albeit with different capital.
There were so many times that she let me lock myself away in my office to make progress to
develop this study, attend a class meeting with colleagues, or get the margin that I needed to
recover. She was, is, and always will be my best friend, confidant, cheerleader, the voice of
reason, and better half. Our amazing daughters Grace and Abigail were patient and encouraged
me while I was working to accomplish this goal.
I would also like to give sincere thanks to my chair, Dr. Lawrence Picus for his guidance,
trust, honest feedback and motivation to produce my best draft. My thanks also go to my
committee, Dr. Patricia Tobey and Dr. Patrick Crispen for challenging me to make a more
compelling case for my work. They also helped bring clarity to the message and curate this
content to be the best something which would add to the body of knowledge in the field, and
develop a meaningful analysis which could be applied to create sustainable intervention
strategies. Finally, I want to thank all of the institutions, clinicians, researchers, and stakeholders
involved in bringing this dissertation to fruition. Without their support and feedback, I would not
have a finished product to help advance compliance and regulatory efficacy and sustainability.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 3
TABLE OF CONTENTS
ACKNOWLEDGEMENTS ............................................................................................................ 2
TABLE OF CONTENTS ................................................................................................................ 3
LIST OF TABLES ........................................................................................................................ 10
LIST OF FIGURES ...................................................................................................................... 14
ABSTRACT .................................................................................................................................. 17
CHAPTER ONE: INTRODUCTION .......................................................................................... 18
Introduction to the Problem of Practice ........................................................................ 18
Overview ................................................................................................................... 18
The Problem of Practice............................................................................................ 18
Background of the Problem ...................................................................................... 19
Unpacking the Problem and Its Context ................................................................... 19
Organizational Context and Mission............................................................................. 21
Organizational Goal ...................................................................................................... 22
Related Literature.......................................................................................................... 23
Care Effectiveness and Population Health Outcomes .............................................. 23
Provider Readiness, Effectiveness, and the Impact on Patient Care ......................... 24
Patient Outcomes, Provider Effectiveness, and Claims Payment ............................. 25
Importance of Evaluation .............................................................................................. 27
Mutually Aligned Goals in the Triple and Quadruple Aims ..................................... 27
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 4
The Cost of Care ....................................................................................................... 28
Regulatory Affairs, Compliance, and Research ........................................................ 31
Description of Stakeholder Groups ............................................................................... 31
Stakeholder Group for the Study .................................................................................. 32
Purpose of the Study and Research Questions .............................................................. 33
Methodological Framework .......................................................................................... 34
Definitions, Terminology, and Acronyms ..................................................................... 34
Organization of the Study ............................................................................................. 40
CHAPTER TWO: REVIEW OF THE LITERATURE ................................................................ 42
Introduction to the Literature Review ........................................................................... 42
Review of the General Literature .................................................................................. 42
Framing Academic Medicine: Patient Care, Research, and Teaching ..................... 42
Framing Accountability: Corporate Compliance and Regulatory Affairs ............... 50
Introduction to Literature and the Gap Analysis Model ............................................... 64
Stakeholder Knowledge and Skills ............................................................................... 67
Knowledge Influences .............................................................................................. 67
Stakeholder Motivation ................................................................................................. 70
Motivational Influences ............................................................................................ 71
Stakeholders and Organizations .................................................................................... 74
Organizational Influences ......................................................................................... 75
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 5
CHAPTER THREE: METHODOLOGY .................................................................................... 81
Introduction ................................................................................................................... 81
Conceptual Framework ................................................................................................. 82
Reminder of the Problem of Practice ........................................................................ 82
Purpose of Conceptual Frameworks ......................................................................... 82
Defining Stakeholder Groups ................................................................................... 83
Stakeholders in the Organizational Context ............................................................. 83
Criterion 2: Regulatory-facing clinical or research staff. ........................................ 85
Interview Recruitment and Rationale ....................................................................... 85
Observation Sampling ............................................................................................... 86
Observation Access and Rationale ............................................................................ 88
Document and Artifact Sampling.............................................................................. 89
Document and Artifact Access and Rationale ........................................................... 89
Data Collection and Instrumentation ............................................................................ 89
Surveys ...................................................................................................................... 90
Interviews .................................................................................................................. 94
Observation ............................................................................................................... 98
Documents and Artifacts ......................................................................................... 101
Summary ................................................................................................................. 105
Data Analysis .............................................................................................................. 107
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 6
Platform, Logic, and Design ................................................................................... 107
Analysis of Quantitative Data ................................................................................. 108
Timeline and Plan ................................................................................................... 109
Credibility and Trustworthiness ...................................................................................110
Validity and Reliability ................................................................................................ 111
Ethics............................................................................................................................113
Summary ......................................................................................................................114
CHAPTER FOUR: RESULTS AND FINDINGS ......................................................................115
Introduction ..................................................................................................................115
Study Goals and Objectives .....................................................................................115
Data Collection and Analysis Details ..........................................................................116
Data Collection Summary ........................................................................................116
Surveys .....................................................................................................................117
Interviews .................................................................................................................119
Observations ........................................................................................................... 120
Document and Artifact Analysis ............................................................................. 121
Overview of Results and Findings .............................................................................. 121
Results and Findings for Research Question One .................................................... 122
Program Elements ................................................................................................... 123
Results and Findings for Research Question Two ...................................................... 133
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 7
Knowledge and Skill Influences ............................................................................. 134
Results and Findings for Research Question Three .................................................... 148
Motivation Influences ............................................................................................. 148
Organizational Influences ....................................................................................... 165
Summary and Implications ......................................................................................... 183
CHAPTER FIVE: SOLUTIONS, EV ALUATION, AND IMPLEMENTATION ...................... 185
Introduction ................................................................................................................. 185
Research Questions, Influences, and Conceptual Framework ................................ 185
Recommendations for Practice to Address KMO Influences ..................................... 187
Knowledge Recommendations ............................................................................... 187
Motivation Recommendations ................................................................................ 193
Organizational Recommendations .......................................................................... 200
Integrated Implementation and Evaluation Plan ......................................................... 206
Implementation and Evaluation Framework ........................................................... 206
Organizational Purpose, Need, and Expectations ................................................... 207
Level 4: Results and Leading Indicators ................................................................ 209
Level 3: Behavior ................................................................................................... 210
Level 2: Learning ................................................................................................... 214
Level 1: Reaction ................................................................................................... 219
Assessment Tools .................................................................................................... 220
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 8
Data Analysis and Reporting .................................................................................. 222
Summary ................................................................................................................. 223
Strengths and Weaknesses of the Approach ................................................................ 224
Limitations and Delimitations ..................................................................................... 225
Future Research .......................................................................................................... 227
Conclusion .................................................................................................................. 228
REFERENCES ........................................................................................................................... 229
APPENDIX A: DATA DICTIONARY CODEBOOK ............................................................... 252
APPENDIX B: SURVEY PROTOCOLS .................................................................................. 301
Welcome E-mail for Survey Respondents .................................................................. 301
Survey Information ..................................................................................................... 302
Title ......................................................................................................................... 302
Design ..................................................................................................................... 302
Time to Completion ................................................................................................ 302
Administration and Logistics ...................................................................................... 302
Delivery System ...................................................................................................... 302
Confidentiality Provisions ...................................................................................... 302
Survey Instrument ....................................................................................................... 304
APPENDIX C: SURVEY RESPONDENT GROUP FIELD MAPPING .................................. 321
APPENDIX D: INTERVIEW PROTOCOLS ............................................................................ 323
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 9
Interview Protocols and Instrument ............................................................................ 323
APPENDIX E: OBSERV ATION PROTOCOLS ....................................................................... 327
Observation Protocols and Instrument ........................................................................ 327
APPENDIX F: DOCUMENT AND ARTIFACT ANALYSIS PROTOCOLS .......................... 331
Document and Artifact Protocols and Instrument ....................................................... 331
APPENDIX G: IMMEDIATE SUMMATIVE EVALUATION SURVEY ................................ 334
Survey Instrument ....................................................................................................... 334
APPENDIX H: LONG-TERM SUMMATIVE EV ALUATION SURVEY ............................... 336
Survey Instrument ....................................................................................................... 336
APPENDIX I: DATA COLLECTION INFORMATION SHEET ............................................. 338
APPENDIX J: SPECIAL QUALITATIVE CODING SUMMARY .......................................... 340
Nodes .......................................................................................................................... 340
Special Nodes: Surveys.............................................................................................. 345
Special Nodes: Interviews.......................................................................................... 345
Special Nodes: Observations ..................................................................................... 346
Special Nodes: Documents and Artifacts ................................................................... 346
APPENDIX K: SURVEY V ARIABLE ATTRIBUTES ............................................................. 347
APPENDIX L: EXTENDED QUANTITATIVE ANALYSIS OF V ARIABLES ...................... 385
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 10
LIST OF TABLES
Table 1. Terms and Definitions Unique to the Study and the Discipline .................................... 34
Table 2. General Clinical Specialties of GME ............................................................................ 44
Table 3. Count of GME Programs by Department at the University of Colorado School of
Medicine ....................................................................................................................................... 45
Table 4. Summary of Assumed Influences on Corporate and Regulatory Compliance in
Specialty and Subspecialty Research Institutions ......................................................................... 66
Table 5. OIG Essential Elements Linked to Organizational Assets ............................................ 75
Table 6. Leadership in Change and Applications in Clinical Practice and Research.................. 78
Table 7. Descriptive Statistics for Completed Stakeholder Interviews (n=8) ............................. 97
Table 8. Descriptive Statistics for Completed Field Observations (n=25) ............................... 100
Table 9. Descriptive Statistics for Completed Document and Artifact Analysis (n=17) .......... 104
Table 10. Research Questions, Conceptual Framework, KMO Influences, and Data
Collection .................................................................................................................................... 106
Table 11. Data Collection Instruments, Fields, Designation, and Item Ranges ........................ 108
Table 12. Study Arms and Events Summary .............................................................................110
Table 13. Data Collection by Instrument ...................................................................................117
Table 14. Study Arms, Planned Events/Cases, Completed Events/Cases ..................................117
Table 15. Interview Subjects by Sampling Criteria (n=8) ........................................................ 120
Table 16. Compliance Efficacy and Sustainability Program Element Evaluation Model ........ 124
Table 17. Validation of Program Elements Derived from HHS OIG (2011) Fundamental
Elements of Effective Compliance Programs ............................................................................. 125
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 11
Table 18. Validation of Practice-based Program Elements Derived from the Literature
Review ........................................................................................................................................ 127
Table 19. Validation of Improvement and Utilization Program Elements Derived from
the Literature Review .................................................................................................................. 128
Table 20. Validation of Program Elements Included in the Conceptual Framework ................ 131
Table 21. Summary of Validation of Program Elements Included in the Conceptual
Framework .................................................................................................................................. 132
Table 22. Stakeholder Assessment of Organizational Performance of General Staff
Knowledge of Compliance Requirements (n=61 of 83) ............................................................. 137
Table 23. Survey Respondent Perception of Organizational Performance Linking
Conceptual Knowledge to Decision-making (n=61 of 83) ......................................................... 138
Table 24. Stakeholder Perceived Knowledge and Skill Requirements based on Response
Count (n=83). .............................................................................................................................. 139
Table 25. Thematic Analysis of USC Rossier School of Education Four Streams ................... 141
Table 26. Stakeholder Assessment of Organizational Performance of Developing
Meaningful Intervention Strategies to Noncompliance Issues and Events (n=61 of 83) .......... 142
Table 27. Stakeholder Perceived Knowledge and Skill Requirements based on Response
Count (n=83) ............................................................................................................................... 145
Table 28. Stakeholder Content Delivery Mechanism Preferences ............................................ 147
Table 29. Stakeholder Perception of Value of Time and Effort for Compliance
Requirements .............................................................................................................................. 150
Table 30. Stakeholder Assessment of Perceived Value of Time and Effort (Relative
Percentage by Role Type) ........................................................................................................... 151
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 12
Table 31. Descriptive Statistics and Frequencies of Stakeholder Time Investment of All
Staff Stakeholder Respondents (n=60) ....................................................................................... 153
Table 32. Descriptive Statistics for Time Investment Ammon Respondent Functional
Domains (n=60) .......................................................................................................................... 155
Table 33. Organizational Efficacy Analysis through Observation of Program Elements ......... 164
Table 34. Frequency Distribution for Stakeholder Perceived Essentiality of Systems for
Managing Adverse and Sentinel Events (n=76 of 83, n=70of 83) .............................................. 170
Table 35. Frequency Distribution for Stakeholder Perceived Existence of Systems for
Managing Adverse and Sentinel Events (n=66 of 83, n=62 of 83) ............................................. 171
Table 36. Impact of Organizational Culture on the Comprehensive Program Element
Listing as Presented in Research Question One ......................................................................... 173
Table 37. Stakeholder Perception of Institutional Performance on Compliance and
Organizational Culture (n=62 of 83) ........................................................................................... 175
Table 38. Stakeholder Perception on Organizational Performance of Compliance and
Regulatory Staff Presence, Knowledge and Collaboration (n=61 of 83) ................................... 176
Table 39. Survey Stakeholder Perception of Organizational Performance on Accountability
and Capacity Variables (n=61 of 83) .......................................................................................... 178
Table 40. Levels of Accountability Noted in Documents and Artifacts (n=33) ........................ 180
Table 41. Gap Analysis Influences and Research Questions .................................................... 185
Table 42. Summary of Knowledge Influences and Recommendations .................................... 188
Table 43. Summary of Motivation Influences and Recommendations ..................................... 193
Table 44. Summary of Organizational Influences and Recommendations. .............................. 200
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 13
Table 45. Outcomes, Metrics and Methods for Internal and External Outcomes tied to
the KMO Influence and Research Question ............................................................................... 209
Table 46. Critical Behaviors, Metrics, Methods, and Timing for KMO Influences and
Research Questions ......................................................................................................................211
Table 47. Required Drivers to Support Critical Behaviors for KMO Influences and
Research Questions ..................................................................................................................... 212
Table 48. Components of Learning for the Program ................................................................ 218
Table 49. Evaluation Analysis Recommendations through the New World Model .................. 219
Table 50. Observational Quantitative Descriptive Statistics (n=25) ......................................... 385
Table 51. Interview Demographic Summary ............................................................................ 385
Table 52. Stakeholder Perception of Essentiality Correlation for HHS OIG Fundamental
Elements (n=76) .......................................................................................................................... 387
Table 53. Stakeholder Perception of Essentiality Correlation for Practice Elements (n=76) ... 388
Table 54. Stakeholder Perception of Essentiality Correlation for Improvement, Utilization
Elements (n=70) .......................................................................................................................... 389
Table 55. Training Delivery Preference by Stakeholder Group ................................................ 391
Table 56. Estimated Distribution Parameters for P-Plots of Time and Effort Scale Variable ... 392
Table 57. Stakeholder Perception of Existence of Policy and Procedures in Institutions
by Role Type ............................................................................................................................... 396
Table 58. Essentiality and Existence Bivariate Correlation Analysis of Program Element
of Implementing Written Policies and Procedures ...................................................................... 396
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 14
LIST OF FIGURES
Figure 1. 2015 National Health Expenditure (NHE) by payer source derived from Centers
for Medicare & Medicaid Services (2016) ................................................................................... 29
Figure 2. 2015 total expenditures by category in billions derived from Centers for
Medicare & Medicaid Services (2016). ........................................................................................ 29
Figure 3. Total NHE compared to the cost of measurable medical errors (billions). .................. 30
Figure 4. Medicare Program Enrollment Growth March 2016 to February 2017
(Centers for Medicare & Medicaid Services, 2017). .................................................................... 58
Figure 5. Study Conceptual Framework. ..................................................................................... 83
Figure 6. Study Conceptual Framework. ....................................................................................116
Figure 7. Geographic heat map of survey respondents within the United States. ......................118
Figure 8. Thematic relationship diagram for the Gap Analysis (KMO) influences, study
Research Questions (RQ), and the Conceptual Framework (CF) element. ................................ 122
Figure 9. Thematic relationship diagram for Research Question One and the Conceptual
Framework. ................................................................................................................................. 123
Figure 10. Thematic relationship diagram for Research Question (RQ) Two, Gap Analysis
Elements Influences, and the Conceptual Framework (CF) Elements. ...................................... 133
Figure 11. Thematic relationship diagram for the Knowledge and Skills Influences,
Research Questions (RQ), and Conceptual Framework (CF) Elements. .................................... 134
Figure 12. Word Cloud for Textual Analysis of Open-Ended Frequencies. .............................. 135
Figure 13. Thematic relationship diagram for Research Question (RQ Three, Gap
Analysis Influences, and the Conceptual Framework (CF) Elements. ....................................... 148
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 15
Figure 14. Thematic relationship diagram for the Motivation Influences, Research
Questions (RQ), and Conceptual Framework (CF) Elements. ................................................... 149
Figure 15. Stakeholder perceived value of time and effort in compliance with respondent
functional domain. ...................................................................................................................... 152
Figure 16. Stakeholder perceived value of time and effort in compliance by respondent
staff level. .................................................................................................................................... 157
Figure 17. Percent of survey respondents as to whether or not they felt involved in
the decision-making process. ...................................................................................................... 159
Figure 18. Frequency interpretation of stakeholder perceived self-efficacy through
knowledge and resource adequacy. ............................................................................................. 161
Figure 19. Frequency interpretation of stakeholder perceptions of organizational readiness
through noncompliance detection. .............................................................................................. 162
Figure 20. Frequency interpretation of stakeholder perceptions of organizational readiness
through the development of interventions. ................................................................................. 163
Figure 21. Thematic relationship diagram for the Organizational Influences, Research
Questions (RQ), and Conceptual Framework (CF) Elements. ................................................... 166
Figure 22. Percent distribution for survey respondents on the essentiality of organizational
assets in improving compliance efficacy and sustainability. ...................................................... 167
Figure 23. Percent distribution for survey respondents on the existence of policies and
procedures within respective institutions. ................................................................................... 168
Figure 24. Study Conceptual Framework. ................................................................................. 187
Figure 25. Kirkpatrick New World Model Four Levels in Reverse (Implementation Design) . 206
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 16
Figure 26. Sample graphic of stakeholder time and effort on conceptual knowledge
acquisition and implementation of procedural knowledge. ........................................................ 223
Figure 27. Survey items aggregated to create the "clinical" respondent category. .................... 321
Figure 28. Survey items aggregated to create the “research” respondent category. .................. 321
Figure 29. Survey items aggregated to create the “healthcare management and operations”
respondent category. ................................................................................................................... 322
Figure 30. Survey items aggregated to create the “other” respondent category. ....................... 322
Figure 31. Survey items aggregated to create the “compliance and regulatory experience”
respondent category. ................................................................................................................... 322
Figure 32. Normal P-P Plot of “How many compliance audits or monitoring sessions have
occurred in your department in the last 12 months?” ................................................................. 393
Figure 33. Detrended Normal P-P Plot of “How many compliance audits or monitoring
sessions have occurred in your department in the last 12 months?” ........................................... 393
Figure 34. Normal P-P Plot of “How many compliance and regulatory training courses
have you completed in the last 12 months?” .............................................................................. 394
Figure 35. Detrended Normal P-P Plot of “How many compliance and regulatory training
courses have you completed in the last 12 months?” ................................................................. 394
Figure 36. Normal P-P Plot of “How many hours do you spend each week working on
tasks that have a regulatory or compliance element to them?” ................................................... 395
Figure 37. Detrended Normal P-P Plot of “How many hours do you spend each week
working on tasks that have a regulatory or compliance element to them?” ............................... 395
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 17
ABSTRACT
The purpose of this study was to develop and test a Conceptual Framework for an
evaluation model for compliance and regulatory programs in specialty academic medicine. The
Framework was built on three research questions to determine the following items within a
specialty academic medical institution: (i) the Program Elements for effective and sustainable
compliance and regulatory programs, (ii) the required knowledge and skills for stakeholder
groups, and (iii) the motivation and organizational influences which improve stakeholder
efficacy and program sustainability. There was a total of 21 Program Elements derived from
both professional and theoretical literature. Those elements were then matched against the gap
analysis model for assessing organizational performance based on knowledge and skills,
motivational, and organizational influences as developed by Clark and Estes (2008). Finally, 15
recommendations were developed, along with each of the required elements for evaluation and
implementation using the New World Model developed by James D. Kirkpatrick and Wendy
Kayser Kirkpatrick (2016). Items such as leading indicators, critical behaviors, required drivers,
and several other components provide content and context for immediate and long-term
summative assessment, to address the program sustainability, aim of the study.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 18
CHAPTER ONE: INTRODUCTION
Introduction to the Problem of Practice
Overview
This dissertation frames specialty academic medicine, and the associated clinical and
research activities, through the lens of corporate compliance and regulatory affairs. While the
study draws on data collected globally, the primary site’s setting is a specialty research hospital
in the state of Colorado. The clinical focus is on specialty medicine in general, and the areas of
basic science or bench, clinical and translational research activities.
Using the Clark and Estes (2008) gap analysis for solving performance problems, the
study will examine essential compliance program elements, as well as knowledge and skills,
motivational, and organizational influences. Those elements and influences help determine
whether compliance programs are building efficacy and long-term sustainability by addressing
the broad array of accountability, ethics, and corporate compliance requirements in academic
medicine. While the practice of healthcare evolves in most organizations, regulatory and
compliance programs often focus too heavily on policy and process. As medicine undergoes a
significant transformation, the integrity and regulatory mechanisms need to adapt to that change.
Traditional compliance training programs often emulate that focus. Academic medicine provides
a unique opportunity to test the advances in scientific discovery, delivery of clinical services and
accountability systems. Failure to do so can have a significant impact on the services that those
organizations provide.
The Problem of Practice
In addition to adverse patient and research outcomes, ineffective compliance and
regulatory programs can cause the following organizational performance problems:
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 19
• creating gaps in clinical service delivery;
• failing to provide for continuity of care;
• impeding the advancement of basic science, clinical and translational research;
• creating a negative experience for patients and study subjects; and
• failing to improve population health outcomes.
Background of the Problem
Healthcare, particularly clinical care and research, is a highly regulated industry with
policy and legal requirements guiding almost every aspect of an organization’s operations.
Considerable literature recognizes that there are not only organizational controls, but also
continuous accountability controls in population health outcomes, the cost of care and patients’
experience and privacy (Berwick, Nolan, & Whittington, 2008). When contextualized in
academic medicine, the competing logistics and demands become even more involved. The
research adds new layers to an already complex regulatory framework. Components such as
human subject protection, special populations, conflict of interest, grants compliance, pharmacy,
laboratory research, and clinical trials create a degree of accountability that may not exist in
other types of institutions. Salman et al. (2014) argued that navigating challenges such as
governance clearance and funding can create an undue burden on both investigators and subjects.
Unpacking the Problem and Its Context
The purpose of this section is to review the key components of the problem of practice,
its role in the organization and provide a framework for the research questions. As the literature
in the previous section indicated, developing a regulatory compliance program is a time and
resource-intensive process. Framing the program through the lens of accountability and then
applying it to the organization at-large requires an understanding of the relationships between the
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 20
stakeholders, regulations, organizational considerations and goals of clinical practice and
research. Working backward from outcomes to elements may best accomplish this aim.
The Triple Aim, patient-centered care, and scientific inquiry. Academic medical
centers like any healthcare organization must balance elements of the Triple Aim and patient-
centered care with the added dimension of conducting timely and innovative research. As an
example, translational science seeks to take the findings from scientific research and
operationalize them into functional clinical practice and service delivery (Callard, Rose, &
Wykes, 2012).
Clinical practice at the individual level is ultimately tied to how the health of one impacts
the population. The Triple Aim is a set of goals that healthcare organizations strive to
implement. Created in a collaborative process through the Institute for Healthcare Improvement
(2013), It intends to tie population health outcomes to the patient experience and the per capita
cost of care. Each goal must be assessed from a strategic perspective when considering what
impact an improvement or change initiative might have. Berwick et al. (2008) described the
Triple Aim's complexity when its understanding was spreading globally to throughout healthcare
systems and organizations. McCarthy and Klein (2010) argued that the Triple Aim is progressive,
meaning that organizations must make continuing efforts to achieve compliance. Those efforts
are part of the more significant trend in healthcare to revolve all clinical service delivery and care
plans around the patient.
The concept of patient-centered care has long been part of the landscape in clinical
practice. However, it impacts healthcare from a resource, cost and quality standpoint. Although
historically part of the primary care landscape, attitudes, and practices of patient-centered care
have found their way into hospitals, especially those that are primarily out-patient facilities
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 21
(Robinson et al., 2016). In many cases, research hospitals operate in a primarily outpatient
environment, often sharing in-patient resources through a Joint Operating Agreement (JOA) with
a local acute care facility. That type of agreement creates shared resources, staffing, clinical
processes and business resources among the institutions involved in the agreement. Proponents
have long argued that the ability to share resources and staff increase productivity and can be a
marked step to achieving better cost-effectiveness and patient care outcomes (Johnson, Holm, &
Godshall, 2000). From a partnership perspective, JOAs facilitates better continuity of care in
both referral sources and care transitions to inpatient facilities when needed. Bird et al. (2012)
find that a JOA relationship creates more significant opportunities for collaborative teaching,
research and student engagement through programs such as residencies and fellowships. The
result for the hospital is increased intellectual and human capital while the academic institution
gains opportunities for faculty, staff, and students.
Connecting practice, research, and accountability. A complex regulatory structure
links the broad spectrum of care delivery and research institutions. While each organization has
unique compliance programs, depending on the type, clinical discipline and service lines,
specific regulations and policies in areas such privacy, security, and fraud, waste, and abuse must
exist in some form or another in each facility (Showalter, 2015). With that in mind, the next
section of the chapter details the organization, its context, and mission.
Organizational Context and Mission
The organization of focus for this study is Breckenridge Valley Health, a medical and
research center principally located in the state of Colorado. The hospital has regional locations
throughout the Rocky Mountain region. In its mission statement, the institution takes an
approach to its services around three major concept areas focusing on respiratory, cardiac and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 22
immune disease through innovative patient care, leading research, and impactful clinical
education. The hospital uses scientific discovery to create, deliver and improve clinical
programs for disease prevention, treatment, and patient rehabilitation. The institution has an
intense focus on educating clinicians, other healthcare professionals and the public at large on
areas of research and service delivery. That is accomplished through a unique team of staff-
scientists, clinicians, research staff, nursing and clinical operations services, support and
administrative team members. Patients and research subjects come from all over the country and
the globe and represent the full spectrum of age, nationality, gender and other social and
economic demographics. The institution also uses partnerships with organizations such as the
Inchan School of Medicine at Mount Sinai in New York, New York, Jefferson Health in the
northeastern United States, and Regency Hospital in Los Angeles to provide comprehensive
service delivery and increase access to services. The institution is a party several Joint Operating
Agreements (JOA) that significantly expand its ability to offer a broad array of services.
Currently, the hospital has nineteen subspecialties across five major clinical departments
including medicine, pediatrics, biomedical research, radiology and nursing. The relationships
intend to increase the institution’s separate and collective impact on health care equity, access,
and demand.
Organizational Goal
For this study, the organizational performance goal is that, by the end of 2018, 85% of the
Breckenridge Valley Health staff and staff will complete a new accountability, regulatory and
compliance action plan designed specifically for their role type and function. Since this is an
evaluation model, the organization did not have a defined goal. Instead, the organizational goal
was developed as part of the study and not based solely on the decision of organizational
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 23
management. Goals will be accomplished through a collective effort across several departments
within the institution including (a) content and subject matter expertise from the Research
Regulatory Affairs and Compliance department, (b) review and organizational development input
by the Human Resources department, and (c) professional development content and structure
from various departments within the institution, depending on staff member role. Goal
attainment will be measured through the development of position-specific Key Performance
Indicators (KPIs) and progress on accountability goals for each employee within the institution.
Related Literature
A considerable amount of research supports the need for well-designed compliance,
ethics and regulatory programs in academic medicine. More precisely the literature frames that
assertion through several directly related to the problem of practice (Showalter, 2015). Through
a macro to microfocus, the research connects the potential for and the reality of adverse
outcomes back to the need for adequate initial and continuing education.
Care Effectiveness and Population Health Outcomes
Sufficient research links failure to improve population to adverse and sometimes
preventable patient care errors, and includes both individual events, facility-level issues, and
more extensive systemic problems (Andel, Davidow, Hollander, & Moreno, 2012; Bos et al.,
2011). In some instances, the inability to improve health conditions causes problems at a
national or even a global level. Peitzmeier, Grosso, Bowes, Ceesay, and Baral (2015) found that
patients in The Gambia avoided or hesitated to seek care not just due to the rising HIV epidemic,
but also because of the potential stigma associated with care. That stigma included feelings of
shame, guilt, and blame because of acquiring HIV, the perception of healthcare workers' attitudes
toward them because of their diagnosis, and the failure of healthcare workers to act in the best
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 24
interest of the patient. The study profiled several critical practices in which healthcare workers
failed to implement accountability measures such as the following:
• Disclosing patient protected health information (PHI) without authorization,
• Denial of services, testing, and treatment for clinical needs and conditions,
• Coercion to perform acts such as pregnancy termination or potentially harmful
methods of labor and delivery.
Clinical outcomes are also affected by the way providers work with patients on the
outlook for their conditions. Literature suggests that patient perception of their health directly
impacts the extent to which they will receive care and perform their self-management (Hevey &
French, 2012). Moreover, their study indicated that lack self-regulation such as worry and desire
for control had the potential to negatively impact clinical outcomes in a broad range of
conditions such as asthma, heart attacks, drug addiction, influenza, and diabetes. Conditions
such as diabetes have deteriorating health effects and put patients at risk for additional health
conditions such as heart disease and stroke (Maddigan, Feeny, & Johnson, 2005). When
contextualized regarding a larger population at-risk populations, the impact can be significant,
straining already limited public health resources and causing significant barriers to accessing
care (Mirza et al., 2014). Therefore, it is important to examine the link between educating the
provider and the ability to impact those events and outcomes.
Provider Readiness, Effectiveness, and the Impact on Patient Care
Bodenheimer and Sinsky (2014) find that provider well-being transitions the Triple Aim
to the quadruple aim. That finding is supported by the fact that clinical training programs, both
from the perspective of research and patient care, are highly regulated. For example, duty hour
regulations limit the number of hours that a resident or medical student may engage in patient
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 25
care (Reed et al., 2008). The literature indicates that it was a necessity which arose after
concerns of patient care were linked to residents and medical students due to problems such as
exhaustion, lack of sleep, and fatigue. A host of additional regulations guides both education and
clinical practice including licensure, standards of care, and professional liability (Ngo et al.,
2016). Also, rules on items such as licensure and professional liability coverage vary by state.
Patient standards of care are regulated at both the federal and state levels. Those requirements
are also part of quality improvement and accreditation requirements for virtually all health care
organizations and clinical specialties, and many facilities and specialty boards integrate them into
professional development standards (Zenlea et al., 2014). Zenlea and colleagues highlighted that
the trainee’s impact on patient safety is a priority for several professional bodies such as the
Association of American Medical Colleges (AAMC), Accreditation Council for Graduate
Medical Education (ACGME). Also, the researchers found that both trainees and program
directors favored implementing performance improvement strategies on patient care and safety.
Some of those strategies include improved communication dynamics, error disclosures, and root-
cause analysis. Within a healthcare context, root-cause is a process by which organizations
retrospectively and systematically review businesses and clinical process to diagnose failures and
improve adverse outcomes and events (Connelly, 2012). Providers and regulatory bodies are not
the only stakeholders in this topic. The next section surveys how insurance carriers are
integrating provider effectiveness and patient outcomes into claims payments.
Patient Outcomes, Provider Effectiveness, and Claims Payment
One of the critical elements of sustainable patient care is the insurance claims
submission and payment process. In Colorado, for example, a report by the Colorado Hospital
Association (2017) found that 84 percent of hospital revenue comes from federal programs and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 26
commercial insurance. The Association's report also indicated that 52 percent of revenue
originates from the Federal programs Medicare and Medicaid. The Centers for Medicare and
Medicaid Services (CMS) exercises regulatory oversight of those Federal programs. Those
programs account for a considerable portion of the nation's total spending on health care. For
example, in 2015, Medicare spending amounted to $642.6 billion, while Medicaid spending
resulted in $545.1 billion of total health care costs (Centers for Medicare & Medicaid Services,
2017). With such a significant amount of total dollars committed to patient care, CMS imposes
strict regulations on the quality of care and compliance with Federal standards. Examples
include without limitation pharmacy and financial reporting, along with other areas already
regulated at the Federal level. An example of those may include patient privacy and the
meaningful use of health care technology ("HIPAA Administrative Simplification: Enforcement,"
2009). Failure to meet those standards can result in health care providers paying fines, having to
pay pack claims which may have been paid through Medicare and Medicaid, and potential
exclusion from participating in such programs in the future. As the regulations evolve, so does
the need for healthcare organizations to demonstrate accountable and patient-centered care.
Commercial insurers also consider provider effectiveness and quality of care to be of
great importance. A study by Kessell et al. (2015) found that commercial providers across
several states have implemented quality and provider effectiveness standards which pay claims
not only on a fee-for-service (FFS) model but also rather a pay-for-performance (PFP) model of
care. That type of payment strategy links the claims submission to the outcomes rather than
simply the patient visits and services provided. While the effectiveness of payment reform itself
is under some debate (Wubulihasimu, Brouwer, & van Baal, 2016), the approach is fast
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 27
becoming the standard for payors and facilities on a global scale. With all the literature in mind,
the next section of the chapter profiles the importance of the problem of practice.
Importance of Evaluation
It is important to evaluate the organization’s performance about their performance goal of
a sustainable regulatory and compliance program for a variety of reasons. Those include, but are
not limited to, ensuring that the organization (a) meets the care quality goals of the triple and
quadruple aims of improved outcomes, cost, care, and workforce wellbeing (b) creates better
health care cost efficiency, and (c) promotes scientific discovery through accountability and
ethical decision-making.
Mutually Aligned Goals in the Triple and Quadruple Aims
It is essential that healthcare organizations maintain compliance and regulatory programs
to meet the purposes of the triple and quadruple aims. This chapter has already profiled the
population health, costs of care, and patient experience goals of the Triple Aim. In the last
several years, changes in the way of provider methods have caused a new consideration to be
added to those goals. The quadruple aim adds the condition of the provider to the existing Triple
Aim concept. Bodenheimer and Sinsky (2014) profile the role of provider well-being as an
essential element in providing high-quality and reliable care. Raising a concern for not only
overall clinician health, but for safe and efficient patient care, the study found that 46 percent of
physicians in the United States experience some form of burnout. The research also found that
environment is a significant factor in burnout among staff. Specifically, the same study indicated
that the burnout rate for nurses who work in settings such as nursing homes is 15 percent higher
than those who work in other settings. Burnout among clinicians and healthcare staff can
contribute to medical errors. Those errors have quantifiable costs and general issues associated
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 28
with them. A recent study of the medical errors put the estimated cost of medical errors at $19.5
billion (Andel et al., 2012). The authors reported that figure was just under one percent of total
healthcare spending in the United States. There are also other important considerations in
ensuring accountable and ethical care, such as the cost of care to commercial and Federally-
funded insurance programs.
The Cost of Care
Safe care and clinical research are a significant portion of how insurance carriers evaluate
patient care and provider effectiveness. Data released by the Centers for Medicare & Medicaid
Services (2016) indicated that, for 2015, the National Health Expenditure (NHE) was $3.2
trillion, or nearly $10,000 went calculated on a per-person basis. The total NHE was up nearly
six percent from the year before. That same data indicates that the NHE figure is almost 18
percent of the United States Gross Domestic Product (GDP). Figure 1 shows the various payer
sources include the NHE – private (commercial) insurance, out of pocket spending, and funding
from Medicare and Medicaid. Figure 2 shows the different costs associate with the spending
detailed in Figure 1.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 29
Figure 1. 2015 National Health Expenditure (NHE) by payer source derived from Centers for
Medicare & Medicaid Services (2016)
Figure 2. 2015 total expenditures by category in billions derived from Centers for
Medicare & Medicaid Services (2016).
The data presented in these tables show that (a) payer funded commercial and federal
programs account for 87 percent of the total spending in payment of the expenditures listed in
Figure 2. In Figure 3, the total expenditure cost is compared with the total cost of medical errors
as listed in Andel et al. (2012).
646.2
545.1
1,072.1
338.1
- 500.0 1,000.0 1,500.0
Medicare
Medicaid
Pirvate health insurance
Out of pocket spending
Total Spending (billions)
Payer Source
1,036.1
634.9
324.6
- 500.0 1,000.0 1,500.0
Hospital
Physician and clinical services
Prescription drug
Total Expenditure (billions)
Expenditure Category
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 30
Figure 3. Total NHE compared to the cost of measurable medical errors (billions).
Although the cost of medical errors is only one percent relative to the total cost of the
NHE, it is important to consider its potential impact. The Associated Press reported that the new
average for health care spending (AHC) per person was $10,345 (Alonso-Zaldivar, 2016).
Equation 1 below shows the impact of total medical error expense (MEE) relative to per capita
cost of care, one of the three legs of the Triple Aim (Institute for Healthcare Improvement, 2013).
𝑟𝑟 𝑟𝑟𝑟𝑟 𝑟𝑟 =
𝑀𝑀𝑀𝑀 𝑀𝑀 𝐴𝐴 𝑟𝑟 𝐴𝐴 =
$1,995,600,000
$10,345
= $192,904.78 (1)
Note. rPHI: Relative Population Health Impact, MEE: Total Merdical Error Expense,
AHC: Average Health Care Spending
Based on the data above, the total cost of medical errors could provide health care
services for nearly 193,000 additional individuals in one year. When contextualized regarding
population density from U.S. Census Bureau (2015), the total PCC impact is larger than the
population of Salt Lake City, Utah. A review of the literature and assessment of expenditure data
establishes a clear need for accountable care and compliant clinical practices. Evaluation of the
status of compliance programs will provide a better understanding of cost efficiency and patient
care. An overview of the relationship between regulatory affairs and research follows.
NHE Expense,
$1,996
Medical
Errors,
$20
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 31
Regulatory Affairs, Compliance, and Research
In an academic medical setting, innovative, ethical and compliant research is essential to
improving how care is delivered and the associated health outcomes and population impact. Y . C.
Lee and Waterer (2013) assert a proper regulatory framework is a fundamental element in
bridging the gap between the laboratory and the hospital itself. Numerous layers of regulations
and policies exist to guide and direct the process of scientific inquiry. Those may include
without limitation, protection of human subjects, the humane treatment of animals (if
applicable), and Federal guidelines, such as clinical trials and the Food and Drug Administration
(FDA) and grant research funded by the National Institute of Health (NIH). Many of the same
regulations that guide clinical practice have a place in research. Some of those may include
without limitation, patient privacy and confidentiality, for example, HIPAA and HITECH,
informed consent, quality improvement, patient and subject safety, and regulatory reporting.
Being that there is a significant regulatory infrastructure around research, an evaluation of the
program that supports the activity is a vital part of actively contributing to improved health
outcomes for populations and individuals alike. The next section details the various stakeholder
groups and their relevance to the problem of practice.
Description of Stakeholder Groups
Though a variety of groups are impacted by this study and its organizational context, staff
are the primary stakeholder group. Clinical staff such as providers and administrators work
across divisions and departments within the institution. Research staff support basic sciences,
clinical and translational research. Key administrative groups, such as the Interdepartmental
Compliance and Hospital Quality Committees, are also comprised of staff members.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 32
The operational staff group includes executive, senior management, administrative,
professional, technical, and research support positions within the organization. Staff supports the
research, patient care and educational activities of the institutions. Postdoctoral fellows are also
included in the operational staff group. There is a close relationship working relationship across
all three stakeholder groups. Staff also support the patient outcomes and provide a bridge to
other areas such as enabling and supportive services to support a stable care environment for
patients beyond the scope of the institution’s clinical services. Such groups may also include
staff both inside and outside of the institution.
Another stakeholder group includes patients including research and clinical trial subjects.
Patients are the direct beneficiaries of the research, teaching and care delivery services of the
institution. The success of population health ultimately links back to the success of the clinical
and translational research activities performed at the hospital.
Stakeholder Group for the Study
While a comprehensive evaluation would include perspectives from and targets for each
stakeholder group, this study will focus on the all groups of institutional staff including clinical,
research, healthcare management and operations, and those with regulatory and compliance
experience. For this study, the staff stakeholder group also includes clinicians (physicians, nurse
practitioners, physician assistants and other providers) and research scientists. One of the
primary reasons for selecting the staff stakeholder group is their work in all aspects of the
organization’s service lines, support departments, and research domains. Staff provides research
and clinical services to patients and subjects. From an education perspective, they provide
patient education, and train, mentor, precept and supervise nursing students, interns, graduate
students, residents, and fellows. Staff also play a fundamental role in shaping institutional policy
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 33
and have a presence across most institutional groups. They serve on the central leadership
committees and represent internal and external partnerships. Additionally, they represent the
most significant single stakeholder group within the institution. Many of the staff also have
longevity, some having been part of the organization for over forty years. Since the institution
has not established separate stakeholder goals, the staff’s performance on the organizational goal
will be measured as the rest of the organizational stakeholders are completed. For those reasons,
the staff is the stakeholder group which can provide the best source of evaluation of the problem
of practice and the organization’s performance goal. The next section of the chapter discusses
the purpose of the project and the dissertation’s research questions.
Purpose of the Study and Research Questions
The goal of this study is to evaluate the degree to which the organization’s compliance
and regulatory program is supporting the staff stakeholder groups to achieve total compliance on
compliance audits, learning plans, and related evaluation tools. Using the Clark and Estes (2008)
gap analysis method as the foundation for research, the dissertation focus on the knowledge and
skills, motivational and organizational influences (KMO) related to achieving the organizational
goal. While a complete evaluation project would concentrate on all stakeholders, for practical
purposes, the stakeholder of focus is Breckenridge Valley Health staff. As such, the following
research questions, within the context of an academic medical institution, guide this evaluation:
1. What are the essential elements and best practices of a regulatory and compliance
program (referred to hereafter as compliance program) that build its efficacy and
long-term sustainability?
2. From the perspective of staff, what are the knowledge, skill and motivational
influences that promote stakeholder compliance efficacy and contribute to building a
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 34
sustainable compliance program; and how should the content relating to those
influences be delivered?
3. From the perspectives of staff, what organizational influences need to exist – and to
what extent – to build stakeholder efficacy and a sustainable compliance program;
and how should those influences be constructed within the institution?
Methodological Framework
To best affect evaluation, this project will employ mixed method data collection and
analysis techniques. An extensive literature review will lay the groundwork for clearly defining
the problem of practice, understanding its context within the organization, and exploring the
related KMO influences. While the specific methods to be used will be detailed in the third
chapter, the dissertation will utilize surveys, focused interviews with the staff stakeholder group,
direct non-participatory behavioral and environmental observation within clinical and research
settings, document analysis of items such as policies, procedures and guidelines, and quantitative
analysis of compliance and outcomes data. The following section organizes terminology,
acronyms, and definitions used in this project.
Definitions, Terminology, and Acronyms
The terms, definitions, and acronyms used in this study are listed in Table 1 below.
Table 1.
Terms and Definitions Unique to the Study and the Discipline
Term or Abbreviation Definition
340B A prescription discount program under which
individuals who meet Medicaid or income-
based requirements participate (Conti &
Bach, 2013)
AAMC Association of American Medical Colleges
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 35
Term or Abbreviation Definition
Academic Health Center A setting in which a medical school and
hospital are attached to a professional school
such as pharmacy.
Academic Medical Center A setting in which a medical school is
attached to a university-based hospital
(AAMC Department of Clinical Services,
1997).
Academic Medicine An interdisciplinary field of education,
training, and research of medical sciences and
practice. More holistically, it is “the
discovery and development of basic
principles, effective policies, and best
practices that advance research and education
in the health sciences, ultimately to improve
the health and well-being of individuals and
populations,” (Kanter, 2008, p. 85). From a
facility perspective, academic medicine
includes academic health centers, academic
medical centers and affiliated community
hospitals(AAMC Department of Clinical
Services, 1997).
ACGME Accreditation Council for Graduate Medical
Acute Care A status where a patient is admitted as an
inpatient to a facility such as a hospital.
Adverse Event A poor or unexpectedly negative patient
outcome associated with the delivery of
clinical care (Forster, Taljaard, Bennett, & van
Walraven, 2012).
Ambulatory Care Patients are seen in an outpatient setting such
as a primary or specialty care facility. That
also includes outpatient surgery within a
hospital or ambulatory surgical center.
Average Health Care Cost (AHC) The average health care spending per year per
person as detailed in Alonso-Zaldivar (2016).
AWAR The Animal Welfare Act (and regulations), 7
U.S.C. 2131 et seq. are federal laws
establishing and progressively revising
compliance standards for the care and use of
animal subjects in clinical and laboratory
research, ("Animal Welfare," 1989).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 36
Term or Abbreviation Definition
Business Associate An organization that performs certain
functions or services involving the use or
potential disclosure of PHI on behalf of, or in
service to, a Covered Entity (Office for Civil
Rights, 2013). In certain cases, Covered
Entities may also be Business Associates to
another Covered Entity.
Business Associate Contract or Business
Associate Agreement (BAA)
A legally binding agreement between a
Covered Entity and a Business Associate, as
required by HIPAA, detailing the terms and
conditions under which a Business Associate
will safeguard the PHI of patients or members
of a Covered Entity (Office for Civil Rights,
2013).
CDC Centers for Disease Control and Prevention
CLIA Clinical Laboratory Improvement
Amendments
CMS Centers for Medicare and Medicaid Services
Common Rule, The The Common Rule, 45 C.FR. 46(A), codifies
provisions originating in the Belmont Report
on the protection of human research subjects,
formalizing regulation on IRB provisions,
informed consent and FWA compliance
("Federal Policy for the Protection of Human
Subjects," 2017).
Continuity of Care Ensuring that there are no gaps in care
provided to patients between practices,
providers or entities. For example, continuity
of care should be assured by making sure that
a patient has a primary care provider assigned
when they are discharged from an inpatient
facility.
Covered Entity An organization covered by the Health
Insurance Portability and Accountability Act
(HIPAA) that is required to implement
privacy and security provisions to safeguard
the PHI of its patients or members; usually
either a health plan, health care provider, or
health care clearinghouse (Office for Civil
Rights, 2013).
Efficiency Achievement of at least a baseline score on
quality and performance on peers within the
industry or field to be assessed as efficient
(Nakata et al., 2016).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 37
Term or Abbreviation Definition
EHR or EMR Electronic Health Record or Electronic
Medical Record
1
EIDM Evidence-informed decision-making
Enabling and supportive services Additional services such as case management,
or other social, educational, or related
services beyond clinical services that a
healthcare facility provides (Health Resources
and Services Administration, 2014).
FDA United States Food and Drug Administration
Federalwide Assurance (FWA) A document submitted to and approved by
OHRP that details the provisions and
activities of an IRB ("Federal Policy for the
Protection of Human Subjects," 2017).
GME Graduate Medical Education
Health outcomes Trends and progression of clinical both before
and after an intervention strategy is applied.
HHS United States Department of Health and
Human Services
HIPAA The 1996 Health Insurance Portability and
Accountability Act (HIPAA), 1996, Pub. L.
No. 104-191, is a piece of federal legislation
focusing on patient PHI privacy, security and
breach notification (Office for Civil Rights,
2013).
HITECH The Health Information Technology for
Economic and Clinical Health (HITECH) Act,
Pub. L. No. 111-5, is a federal law promoting
the meaningful and secure use of health
information technology ("HIPAA
Administrative Simplification: Enforcement,"
2009).
1
For this study, the terms “Electronic Health Record (EHR)” and “Electronic Medical Record
(EMR)” are used interchangeably
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 38
Term or Abbreviation Definition
IACUC Institutional Animal Care and Use Committee
IRB Institutional Review Board
Joint Operating Agreement (JOA) A business arrangement in which two entities
pool shared resources to serve patients or
clients more comprehensively and efficiently.
KMO The knowledge and skills, motivational, and
organizational influences gap analysis method
for identifying and addressing organizational
performance problems as developed by Clark
and Estes (2008).
Knowledge and Skills, Motivation and
Organization (KMO)
The gap analysis used to measure and address
performance problems as detailed in Clark
and Estes (2008).
MEC Medical Executive Committee
National Commission, The The National Commission for the Protection
of Human Subjects of Biomedical and
Behavioral Health Research
National Health Expenditure (NHE) A measure of health care spending, including
the following measures: Historical health
care spending, projections, age and gender,
state health expenditures, and health care
spending by businesses, households,
commercial insurance and government-
funded payor programs (Centers for Medicare
& Medicaid Services, 2016).
NHSN National Healthcare Safety Network
NIH National Institutes of Health
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 39
Term or Abbreviation Definition
NJH Breckenridge Valley Health
OCR United States Department of Health and
Human Services Office for Civil Rights
OHRP Office of Human Research Protections
OIG United States Department of Health and
Human Services Office of the Inspector
General
OSHA Occupational Safety and Health
Administration
Patient panel All of the patients assigned to a particular
clinical provider.
Population health A holistic focus on clinical and social factors
that influence the health of populations.
Examples of those factors may include, social
determinants, community participation,
access, social justice, prevention and
demographics (Neuwelt et al., 2009)
PP ACA or ACA The Patient Protection and Affordable Care
Act of 2009, 42 U.S.C. § 18001, is federal
legislation that, among other things, creates
federal and state exchanges where consumers
can purchase health insurance from
commercial carriers, establishes premium
subsidies for certain individuals and promotes
coverage enrollment (Rosenbaum, 2011).
Quadruple Aim, The The addition of provider and healthcare
worker wellbeing and work-life balance to the
IHI Triple Aim (Bodenheimer & Sinsky,
2014)
Relative Population Health Impact (rPHI) A population-based metric that evaluates the
total medical error expense compared to the
individual cost of care.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 40
Term or Abbreviation Definition
Sentinel Event Death, permanent harm, or severe temporary
harm and intervention that is required to
sustain life (The Joint Commission, 2017).
Social Determinants (of Health), The Considerations which affect the health of
populations such as economics,
demographics, power, culture, access, and
equity (Marmot, 2005).
Sustainability Creating, implementing, and revising business
and clinical process that are modern,
standardized, and innovative with a focus on
efficiency (Chambers, 2015).
Total Medical Error Expanse (MEE) Total annual spending on medical errors
(Andel et al., 2012).
Translational research The practice of applying scientific discovery
to areas of clinical practice such as treatment
and surgery (Banerjee, 2016).
Triple aim, The A focus on improved population health
outcomes, the patient’s experience of care
received, and the per capita cost of that care
(Institute for Healthcare Improvement, 2013).
Universal precautions Methods which healthcare workers use to
decrease the transmission of infections and
diseases in their daily duties.
USDA United States Department of Agriculture
Organization of the Study
This dissertation is divided into five chapters. Chapter One provides the reader with an
introduction to the problem of practice, a brief survey related literature, and details on the
organization and stakeholder groups. Breckenridge Valley Health (NJH) is the organization of
focus with staff and the study stakeholder group. The first chapter also details research
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 41
questions, the organization of the project, and standard terms and abbreviations found throughout
the study. The second chapter gives a detailed review of relevant research as an expansion of the
concepts and ideas introduced in Chapter One. Chapter Two also profiles each of the KMO
influences in detail about the staff stakeholder group and the research questions. Chapter Three
is an explanation of the data and methodological techniques used in the study. It gives deeper
meaning to the qualitative and quantitative methods as well as human subject protections,
confidentiality, and related details. Chapter Four is an assessment of the outcomes and data
collected during the project. Data gathered during the evaluation process are paired with the
respective KMO influences and program elements. Chapter Five provides solution and
recommendations and details related to the assessment as well as recommendations for an
implementation, evaluation and continuous improvement plan. Next is the literature review.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 42
CHAPTER TWO: REVIEW OF THE LITERATURE
Introduction to the Literature Review
The purpose of this chapter is to survey both the general and learning and motivation
theory literature as a means for developing the conceptual framework used to evaluate regulatory
and compliance programs in academic medicine. The review of relevant research will begin by
focusing on the general literature surrounding regulatory affairs and corporate compliance
programs, as well as introduce the field and institutional environment in an academic medicine
setting. More specifically, research in the general literature section will profile academic
medical centers and the environment for this project – a research respiratory hospital. Following
the general literature section, the chapter will detail transition to a focused study of the
knowledge and skills, motivational and organizational (KMO) influences as developed by Clark
and Estes (2008) specific to this dissertation’s problem of practice. After an introduction the
framework, the chapter will survey the learning, motivation, and organizational theory academic
literature to provide evidence that supports each of the respective KMO influences identified in
the study. Each point is developed to support the organization’s stated performance goal given
that there are no specific stakeholder goals in the study. All the KMO influences, however, are
written from the perspective of Staff as the stakeholder group. A summary of the general and
KMO literature closes the chapter and provides a bridge into Chapter Three, the methodological
and research related components of the dissertation.
Review of the General Literature
Framing Academic Medicine: Patient Care, Research, and Teaching
As the need for access to health care expands, so does the need to train competent and
professional clinicians who can help close the care gap. Academic medicine is the venue in
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 43
which the preparation, training, research and ongoing improvements occur. It is, in essence, a
collaborative and evolving discipline that includes elements of science, liberal arts, philosophy,
engineering, business and many other subjects meshed together into meeting the population
health and care cost and experience goals of the Triple Aim (Institute for Healthcare
Improvement, 2013; Kanter, 2008)
Organizationally, academic medicine is comprised of medical schools, teaching and
research hospitals and affiliated clinical staff, residents, students, and sizable multispecialty
practices staffed by staff from the academic institutions that support those practices (Crabtree,
2015). Guidance from the AAMC Department of Clinical Services (1997) stated that academic
medicine includes (a) academic health centers where professional schools such as pharmacy are
attached to a medical school and a hospital, (ii) academic medical centers in which medical
schools are attached to a university-based hospital, and (iii) community and affiliated hospitals.
Advantages of academic medical centers include broad access to patient care especially in
specialty practices such as pulmonology, oncology, and cardiology, along with a diverse body of
staff, research support, and operational staff members. Barriers, alternatively, are consistent with
the global conversation around large healthcare facilities –location and, consequently, access. As
large medical centers tend are traditionally located in urban population centers, healthcare
administrators are often left with a quandary of how to improve population health in outlying and
rural areas (Schuurman, Fiedler, Grzybowski, & Grund, 2006). Academic medicine, like other
clinical disciplines, continues to develop effective intervention strategies to overcome the health
care equity and access gaps.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 44
Though the field itself is made up of many subject, specialties, and areas of research, this
study focuses specifically on graduate medical education, physician-scientists, clinical practice
and scientific research.
Graduate medical education. Preparation for research and practice does not end at
medical student’s commencement. New physicians spend several years in a residency program
and occasionally more formal training as a fellow. Graduate medical education (GME) is how
physicians prepare for their careers in helping close the care equity and access gaps. In recent
years, GME has become even more essential in addressing the physician supply shortage and
providing care in rural or other areas where demand is high, but access is low (Eden, Berwick,
Wilensky, & Services, 2014). Physicians spend three years in a residency in the subject area
which they would like to practice. Though there are several clinical specialties in GME, they can
be characterized in the areas identified in Table 2.
Table 2.
General Clinical Specialties of GME
Anesthesiology Neurology Physical medicine and rehabilitation Urology
Dermatology Nuclear medicine Plastic surgery Vascular surgery-integrated
Emergency Medicine Obstetrics and Gynecology Plastic-integrated
Family Medicine Ophthalmology Preventative medicine
Internal Medicine Orthopedic surgery Psychiatry
Internal medicine/pediatrics Otolaryngology Radiation oncology
Medical genetics Pathology-anatomic and clinical Surgery
Neurological surgery Pediatrics Thoracic surgery-integrated
Note. Adapted from Eden et al. (2014).
GME and the access gap. Of all clinical specialties and practice areas, primary care is
widely considered the most critical need. Research by Frisch (2013) indicates that, due to a
variety of factors, the greatest clinical needs are internal medicine, family practice, and pediatrics
physicians. The study found that one reason is that those specialties, on average, are among the
lowest ranked in annual earnings. New physicians typically weigh the potential for
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 45
compensation against existing debt such as medical school. Frisch also reported that primary
care physicians are frequently overloaded in office visits and the administrative burden required
to sustain a high patient panel or total group of patient assigned to them. Some solutions aid in
meeting increased demand. New practice models, especially those using the team-based care
approach can create a stable support system for primary care practices (D. G. Goldberg, Beeson,
Kuzel, Love, & Carver, 2013). Also, advanced nurse practitioners and physician assistants are
increasingly important resources to help meet clinical demand, especially in rural areas (Nelson
& Hooker, 2016). While those and similar solutions make progress, GME remains one the
essential pipelines in closing the health care access gap.
Expanding clinical practice. In addition to decreasing the physician shortage, GME also
prepares new clinicians for a broad array of clinical practice areas. For example, the University
of Colorado offers 178 GME programs across Departments listed in Table 3 (2017).
Table 3.
Count of GME Programs by Department at the University of Colorado School of Medicine
Anesthesiology (6) Obstetrics/Gynecology (4) Physical Medicine/Rehabilitation (4)
Dermatology (4) Ophthalmology (6) Psychiatry (5)
Family Medicine (9) Orthopedics (9) Radiation Surgery (1)
Medicine (35) Otolaryngology (2) Radiology (11)
Neurology (13) Pathology (8) Surgery
Neurosurgery (7) Pediatrics (34)
Note. Adapted from the University of Colorado School of Medicine (2017).
With 149 fellowships and 29 residencies, new physicians can pursue virtually any
program of interest. Each training track serves a unique purpose and has different completion
requirements. Residency programs allow new doctors to experience several clinical rotations
and gain a working knowledge of various practice areas and environments. At the same time,
they gain experience and prepare for Board exams in their chosen field. Regarding locales,
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 46
residents may work urban or rural settings, primary care offices, hospitals or emergency
departments. Fellowships allow physicians to gain specialized knowledge in a specialty or
subspecialty such as Osteopathic Manipulation or Pediatric Pulmonology. While not all
physicians complete fellowships, they continue to serve as means for broadening clinical
experience and meeting the nation’s health care needs. Despite the opportunity for specialized
training and potentially higher earnings, the future of certain fellowships is not entirely clear.
Research by Cannada (2014) found that funding for Orthopedic Trauma fellowships is under
increased scrutiny, given the overall cost, time requirements and recruitment efforts. While other
providers such Nurse Practitioners or Physician Assistants can pursue specialized clinical
training, the future of the global health in part depends on a diverse portfolio of GME training.
It is also necessary to discuss the environment and core functions of an academic medicine
environment.
Research, teaching and patient care. Academic medicine settings serve as hubs for
patient care, training, and scientific discovery (AAMC Department of Clinical Services, 1997;
Crabtree, 2015). In the case of research hospitals, patients may receive acute or ambulatory care,
depending on the hospital’s scope of services. Often, hospitals focus on a clinical specialty or
group of closely related specialties such as pulmonology, cardiology, and immunology. GME
activities that occur at research hospitals align with both patient care and clinical research
functions. In specialty hospitals, for example, physician residencies in that institution’s clinical
focus area support daily care by having residents conduct initial and follow-up patient
evaluations rather than the attending physicians alone. Research supports the added value that
GME can have in advancing patient care. Residency programs are often the design and
development vehicles for advanced patient care interventions (Romain, Muench, & Phillips,
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 47
2015). There is also an opportunity for improvement in provider familiarity with technology and
other innovations through GME. Goebel, Occhipinti, and Connolly (2013) found that physicians
who had recently gone a fellowship improved use of Electronic Health Record (EHR) systems
and more effectively implemented attending physician directives into their patient plans of care.
Better utilization of health information technology (HIT) is one of the primary aims of the
HITECH Act. Implemented as part of the American Recovery and Reinvestment Act of 2009,
HITECH requires that healthcare organizations make meaningful use of HIT assets and improve
the storage, transmission, and security of patient PHI ("HIPAA Administrative Simplification:
Enforcement," 2009). Such use and technology are meant to stir innovations in healthcare
technology, consistent with the nature of inquiry and discovery.
Research, patient care, and innovation. Academic medical institutions not only train
and develop clinicians and researchers but also produce advances in population health, patient-
centered practice, and vehicles for further teaching and research. Moreover, these organizations
are the setting for educational innovations as well. Some research draws a significant parallel
with this study’s stakeholder group finding that educational innovations are not only centrally
led, but also by staff members. They continually reevaluate medical trends and conditions to
determine what scientific discoveries can help meet the goals of the Triple Aim. Those findings
set the stage for continuous improvement in medicine as a field. Innovations developed within
academic medicine have far-reaching impacts on other areas such as pharmacology, research
methodology and medical pedagogy (Sklar, 2015). At the same time, however, the challenges
that institutions face is similar to other organizations in which research and education take place.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 48
Academic medicine and accountability. Academic medicine is not immune to
traditional issues and problems found in other educational and healthcare organizations. Two
important topics are managing finite resources and confronting ethical dilemmas.
Resource adequacy. Resource adequacy and ethical decision making are two critical
components of accountability. In most cases, academic medical facilities face the same fiscal,
operational and staffing constraints as traditional universities and other higher education entities.
That includes challenges encountered through research activities. Academic medical centers,
research hospitals, and other facilities compete for limited funding from a major organization
such as the NIH and FDA (Leinhos, 2006). The consideration of resource adequacy also
parallels issues that arise in traditional acute and ambulatory care organizations. Gardner,
Woollett, Daly, Richardson, and Aitken (2010) found that, in a study involving 60 registered
nurses in acute care hospitals, resource adequacy ranked in similar importance to issues such as
foundations for quality of care and staffing. Additional literature indicates that such matters
become of even more concern when applied to special populations. For example, a study
involving nearly 500 acute care hospitals providing pediatric services that factors such as clinical
staffing levels, facility size, and association with other organizations (e.g., pediatric units located
within a larger hospital system) had an impact on the perceived quality of care (Cimiotti &
Barton, 2014). Another critical area of focus is ethics and decision-making.
Ethics and decision-making. Research hospitals, university-affiliated health care
organizations and other academic medical institutions face many of the same ethical dilemmas as
any entity providing medical services. There are, however, added dimensions that may or may
not be unique to academic medicine. Fins, Pohl, and Doukas (2013) describe how ethics plays a
role in clinical consultations, care for special populations and addressing more complex issues
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 49
related to the sociological issues. Citing several seminal works in the field, the researchers found
that staff members, as a matter of general practice, use ethics to inform their research and patient
care practices. An example of practical application is research related to risk reduction and the
Social Determinants of Health. Though a vast amount of research exists profiling the Social
Determinants of Health, Marmot (2005) expressly identify the scope as the quality of life and
access to care related to the distribution of power, income, goods, and access to services. The
research, reviewing health indicators and environmental risk factors from children and adults
across 16 countries, states that solving issues of health equity and access are of critical
importance to improving the health of populations globally. Moreover, the authors assert that
there are political and policy considerations that cannot be ignored. All of those dimensions
ultimately inform clinical research and practice. Each is also a springboard into added concerns
of bioethics.
While practical ethics includes dilemmas such as dealing with the unknown, mitigating
risk and solving multilayered and somewhat perplexing problems, Selgelid (2016) summarizes
bioethics as applying those same interventions to clinical practice, healthcare, biomedical and
life sciences. More holistically, the aim of bioethics may be to guide actions and decision-
making as clinicians confront issues that involve those types of quandaries (Frank, 2017).
Consistent with research by Frank and others, whether it is dealing with moral implications of
concepts such as end-of-life care, substance use, or protection of human subjects, bioethics plays
a critical role in proving safe patient care.
Academic medicine touches every aspect of healthcare in some form or another. Whether
it is training new clinicians or advancing patient care, the discipline has a role in meeting the
goals of the Triple and Quadruple Aims. Resource adequacy, ethics, and decision-making are
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 50
only a few elements of a broader evolving discussion of the role that ethical decision making and
accountability plays in academic medicine. Those issues predicate the need and create the value
proposition for effective regulatory and compliance programs in academic medical institutions.
The next section of the study profiles the potential elements of such programs and their place in
the organization.
Framing Accountability: Corporate Compliance and Regulatory Affairs
As healthcare innovations, technology and scope grow so does the need to ensure that
patient care is delivered with responsibility and efficiency. While there are varying definitions of
efficiency, this study will follow the general idea of efficiency raised in Nakata et al. (2016).
They state that efficiency is defined as achieving a score above the baseline when compared
score on quality and performance metrics with bellwether providers and organizations in the
discipline. Academic medicine brings together three different but related disciplines – research,
teaching and patient care. Adding special research provisions such as the protection of human
subjects and informed consent give the field, and its institutions, a complex regulatory
framework. This section of the general literature review approaches that framework through the
lens of the research, teaching, and patient care, along with their impact and operation within an
academic medicine setting. An essential step in understanding that context is clarifying the
distinction between corporate and regulatory compliance.
2
Corporate versus regulatory compliance. Depending on the institution and its scope of
services, compliance and regulatory requirements are present in all healthcare settings. While
2
For this study, the term "compliance program" will refer to regulatory and compliance
programs. The latter term will still be used during the discussion as well.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 51
both corporate and regulatory compliance efforts focus on an organization, and its employees,
abiding by laws and rules, there are some core differences.
Corporate compliance focuses on systems, internal controls and the behavior of
organizations and their employees to comply with laws and regulations (Parker & Nielsen,
2009). Examples of outputs include organizational policies and procedures, risk management
plans, and monitoring and auditing protocols. Sadiq and Governatori (2015) broaden the scope
of compliance also to include organizational processes, operations and business practices being
executed in alignment with prescribed or agreed upon norms as evidenced by its mission and
vision statements, and management documents such as policies and procedures. Both Parker and
Nielsen (2009), and Sadiq and Governatori (2015), refer back to the elements of the knowledge
and skills, motivations and organizational influences that are at the heart of this study’s
conceptual framework.
Sadiq et al. also asserts that while corporate compliance focuses on the organization, its
influences and people, regulatory compliance link how organizations carry out their function
consistent with requirements from laws and rules set forth by legislative and regulatory bodies.
While both studies confront the affairs and operations of the organizations, it can be argued that
regulatory compliance rely more heavily on external influences. Examples of regulatory
compliance outputs can include accreditation, research compliance with human and animal
subject protections, and peer review. In academic medicine, regulatory affairs functions were
particularly prominent given the research and teaching activities taking place within the
institution. Patient care and related compliance are still an essential consideration. Next is a
discussion of compliance and patient care.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 52
Compliance and patient care. Compliance and regulatory services exist to help
organizations meet the goals of the Triple Aim. Although there many regulations that govern
healthcare as an industry, their applicability and implementation vary depending on the
institution, organization or provider’s scope of services and patient populations served (Pardue,
2016). With that thought in mind, the following section focuses on the role of compliance and
improving the health of populations.
Compliance and population health outcomes. At its core, healthcare exists to improve
outcomes. It does so by using research, teaching, and innovations in patient care to positively
impact both the short and long-term health of individuals and collectively, populations. A
considerable portion of the literature linking compliance to health outcomes focuses on the
behavior of the people who carry out the clinical services that patients receive. One example is
patient safety and infection prevention within healthcare facilities.
Patient safety and infection prevention. One of the most critical aspects of maintaining
improved population health is the way healthcare providers use universal precautions and
practice infection control. Research supports the conclusion that patients are aware of those
methods and the extent to which healthcare workers use them. One study surveyed 194 subjects
at a large hospital to determine that the patients’ perception of the quality of their care and, to an
extent, their health outcomes was driven, in part, by the hand-washing practices of health care
workers within the facility (Longtin, Sax, Allegranzi, Hugonnet, & Pittet, 2009). Regulatory
and best practice agencies such as the Occupational Health and Safety Administration (OSHA),
the Joint Commission and the National Healthcare Safety Network (NHSN) exist to ensure that
healthcare environments are safe for both the patient and the employees that provide care and
supportive services. Those types of agencies set strict standards for ensuring patient safety and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 53
infection prevention in areas such as vaccine administration, materials management, equipment
decontamination and sterilization, and monitoring of high-risk conditions including bloodstream
infections and ventilator-associated pneumonia (Wattal & Khadori, 2014). While focusing on
preventing disease and infections inside a facility is important, there is an equally strong
regulatory infrastructure designed to study epidemiological trends, disease surveillance, and
prevention of individual and population-based adverse outcomes.
Epidemiology, disease surveillance and regulatory requirements. Generally accepted
medical knowledge provides a link between disease intervention activities and the health of
populations. It is of such crucial importance that entire global, federal, state and local entities
exist to deal with disease prevention and population health. Within the United States,
organizations such as the Centers for Disease Control and Prevention (CDC) and state and local
public health departments establish requirements that healthcare providers must follow
epidemiological monitoring requirements. Those regulations exist in the form of disease
surveillance and the mandatory reporting of certain conditions such HIV (human
immunodeficiency virus) and Tuberculosis. Trends and information on such diseases are
collectively analyzed through disease surveillance systems and used to assess trends, monitor
potential outbreaks and evaluate prevention and response efforts (Adekoya, Truman, & Ajani,
2015). Such activities exist across the globe in large and small countries such as Ghana, India,
and China (Adokiya, Awoonor-Williams, Beiersmann, & Muller, 2016; Liang et al., 2014;
Sharma, Karad, Dash, & Chauhan, 2012).
Collectively, areas such as patient safety, infection control, and epidemiological
surveillance make efforts to improve population health starting at the individual level. Another
of the legs of the Triple Aim is improving the patient experience (Institute for Healthcare
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 54
Improvement, 2013). The next section reviews some foundational regulatory functions related to
the way the patient interacts with and receives services from healthcare organizations.
Compliance and the patient experience. Delivery of clinical services is virtually
impossible without strong operational programs. Those processes have a significant impact on
the way patients receive care. Compliance – corporate and regulatory – impacts the patient
experience in many ways, including keeping patient records and data confidential, ensuring
access to care for all individuals and populations, and filling parallel needs through laboratory
and pharmacy services. Each of those, like many others, have regulatory components tied to
successful performance.
Data privacy and health information technology (HIT). Provisions for patient data
privacy and security vary on a global scale, but domestically, are governed by a dense system of
federal and state laws. Two of the most widely known federal regulations in that area are the
Health Insurance Portability and Accountability Act of (HIPAA) and the Health Information
Technology for Clinical and Economic Health Act, Pub. L. No. 111-5, (HITECH). HIPAA,
enacted in 1996 but primarily implemented in 2002, contains three main components known as
the Privacy Rule, Security Rule, and the Breach Notification Rule (Office for Civil Rights,
2013). The Privacy Rule details how Covered Entities and Business Associates must ensure the
confidentiality of the protected health information (PHI) of patients or members whom they
serve. That rule is also the source of legislation governing the requirements for and components
of a Business Associate Agreement (BAA). A BAA is used to contractually obligate parties to
protect the transmission, use, storage, access and maintenance of PHI (Office for Civil Rights,
2008). Under the Security Rule, healthcare organizations must enact Administrative, Technical
and Physical Safeguards to protect PHI adequately.. The Breach Notification Rule requires that
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 55
patient and the Federal government, the U.S. Department of Health and Human Services (HHS)
Office for Civil Rights (OCR), must be notified in the event of a breach or unauthorized
disclosure of patient or member PHI ("HIPAA Administrative Simplification: Enforcement,"
2009).
HITECH, on the other hand, creates more stringent data protection requirements. Under
that regulation, violations are classified into progressively severe levels of fault and assigned the
corresponding penalty amounts up to $1.5 million ("HIPAA Administrative Simplification:
Enforcement," 2009). The broader aim, though, of HITECH is to promote the implementation
and meaningful use of HIT. Murray, Calhoun, and Philipsen (2011) create linkage between the
uses of HIT such Electronic Health Records (EHR) systems and marked improvements in
population health outcomes, reduction in health disparities and increased access to health care
services for patients and families. A considerable portion of the article details implementation
consideration such as training requirements, best practice standards and system utilization and
specifications. Moving away from HIT and data protections, the next operational consideration
focuses on services clinically rooted services that support healthcare delivery.
Laboratory and pharmacy. Ancillary operations such as laboratory and pharmacy
services are essential to both clinical and research functions of an academic medical institution.
From a patient care perspective, labs provide time-sensitive information and result from
diagnostic testing necessary to help providers assess both individual and generalizable
population health outcome assessments, including treatments and need for further testing (Kaye,
Kokia, Shalev, Idar, & Chinitz, 2013). In specialty care and research, diagnostic labs help piece
together puzzles at the molecular level. Research by Cassiman (2012) describes the molecular
lab systems, software, outputs, bioinformatics and other data as essential in adequately
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 56
diagnosing numerous and sometimes very uncommon diseases. Given the importance of timely
and accurate results, diagnostic labs are highly regulated. Bowling (2016) describes how
common regulatory requirements through FDA oversight, compliance with Clinical Laboratory
Improvement Amendments (CLIA) requirements overseen by CMS promote stringent quality
standards for laboratory services. Labs are necessary to supply and translate the information
linking diagnosis to health outcomes.
Just as labs provide translational research support required to apply scientific discovery to
clinical practice, pharmacies support health care services by supplying the treatments necessary
to sustain and improve individual and population health. Given the importance of timely and
accurate treatment, pharmacies are also subject to varying levels of regulation. Like patient
record privacy and security, many of the compliance requirements for U.S. pharmacies are at the
federal and state levels. Factors like payer source, such as Medicaid, Medicare, or commercial
insurance, pharmaceutical patent, and source of manufacturing impact the level of regulation
under which prescriptions are dispensed. For example, some patients qualify for discount
programs such as 340B based on Medicaid qualification and income, and the specific
prescription dispensed. Conti and Bach (2013) detail how that and regulatory changes through
the Patient Protection and Affordable Care Act (PPACA or ACA) encouraged more hospitals,
prescription manufacturers, pharmacies and other healthcare entities increase prescription access
for individuals that might have otherwise been excluded. While pharmacy practice is regulated
heavily by state boards, other agencies are part of the process, each bringing their compliance
requirements. In specialty and subspecialty research, either institutions, pharmaceutical
manufacturers or others sponsor and conduct clinical trials. At the federal level, those activities
are regulated primarily by the FDA to ensure they meet established patient safety, reporting and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 57
outcomes improvement requirements (Speight & Barendse, 2010). An Institutional Review
Board (IRB) is then responsible for ensuring that the proper human subjects protection
provisions, including FDA compliance, are attached to the study protocols that an investigator
submits for review (Whitney, 2016). Moving from operations to the final leg of the Triple Aim,
the next section of the general literature review focuses financial compliance.
Compliance and the cost of care. Regulations regarding health care finance are
extensive and sometimes perceived as conflicting against one another or causing more issues
than they solve. Some legislation aims to increase access through entitlement programs while
others use market-based economics to try to incentivize participation, as was done with the
health care exchanges, premium subsidies and penalties in the Affordable Care Act (ACA).
3
Federal health care programs. Medicare and Medicaid are among the most significant
federal entitlement programs in the United States, and participation is expanding significantly.
Between March of 2016 and February 2017, total Medicare enrollment, across all states and
programs, grew by 1,096,834 total subjects. Figure 4 shows the enrollment growth in Medicare
participation between over 12 months.
3
For this study, the terms “Patient Protection and Affordable Care Act (PPACA)” and
“Affordable Care Act” will be used interchangeably.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 58
Figure 4. Medicare Program Enrollment Growth March 2016 to February 2017 (Centers for
Medicare & Medicaid Services, 2017).
From a Medicaid perspective, the ACA created funding for states to adopt Medicaid expansion,
though not all did.
As the federal agency charged with administering Medicare and Medicaid, CMS creates
strict participation guidelines for healthcare providers. While Medicaid is primarily regulated by
state health care financing departments, CMS maintains direct oversight of Medicare programs.
As for cost containment and program integrity method, CMS has extensive regulations for
federal health care program participation and devotes considerable resources to ensure provider
and patient compliance. Morris (2009) describes the key risk areas that CMS monitors to curtail
fraud, waste, and abuse in Medicare and Medicaid programs, largely in the areas of claims
coding, submission, and payment as well as provider fraud. For all federal health care programs,
responsibility for reducing Fraud, Waste and Abuse is regulated under the oversight of the United
States Department of Health and Human Services Office of the Inspector General (OIG). The
False Claims Act, 31 U.S.C. § 3729-3733, is how the OIG regulates the integrity of claims for
56,643,525
56,736,842
56,851,187
56,975,243
57,118,104
57,241,209
57,358,519
57,476,835
57,563,034
57,653,854
57,712,568
57,740,359
56,500,000
56,750,000
57,000,000
57,250,000
57,500,000
57,750,000
58,000,000
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 59
health care services under Federal programs. The Act allows the OIG to impose civil monetary
penalties on individuals and organizations engaging in fraudulent claims or others to which the
submitter is not entitled ("Health Care Programs: Fraud and Abuse; Revisions to the Office of
Inspector General’s Exclusion Authorities," 2017). Other programs such as the Anti-Kickback
Statute, 42 U.S.C. § 1320a-7b(b), and Stark Law, 42 U.S.C. § 1395nn, allow the OIG to impose
fines and potential program exclusion for improper contracting and referral relationships
("Annual Civil Monetary Penalties Inflation Adjustment," 2017; "Civil Monetary Penalties
Inflation Adjustment," 2016). While monitoring and enforcement is a significant portion of the
OIG’s responsibility, they also play a central role in helping all health care institutions establish
effective compliance programs and create organizational cultures where compliance is an
integral part of the organization’s culture (Office of the Inspector General, 2011). The legislation
is also aimed at increasing access to funding sources other than entitlement programs.
Commercial insurance plans and exchanges. The ACA was a significant attempt to
expand access to small business and individual insurance through state and national health care
exchanges, premium subsidies and the individual mandate that imposed fines on persons who did
not have some form of coverage. The Exchange’s primary goal and any associated improvement
efforts is to create better population health outcomes for those who access them (Cooper &
Gardner, 2016). Critics of the legislation state that the ACA created more barriers through
provisions such as the individual mandate. Additional problems affecting the Exchange’s
effectiveness, and the subsequent need for change, include a lack of quantifiable data to evaluate
performance, legislative and political conflicts, a lack of clear scope of need, the expanding
patient populations and process issues such as claims payment backlogs and availability of
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 60
clinical providers (Fernandez, Mach, Gabe, & Centers for Medicare & Medicaid Services, 2013).
The result is an attempt to control costs while expanding access and coverage.
There is a significant impact on all three legs of the Triple Aim in compliance purposes.
When magnified through the lens of research, those requirements become much more intense.
The final section of the general literature review explores the requirements one can encounter in
specialty and subspecialty research institutions.
Research regulatory affairs in specialty and subspecialty medicine. In academic
medical institutions, patient care and clinical research are combined to produce improved and
sustainable health outcomes. Through translational research, scientific discovery is applied to
many different areas of clinical practices, such as treatment options, the role of ancillary services,
and ability to impact population health (Banerjee, 2016). The span of research crosses
disciplines and specialties and uses many vehicles to pursue advances in scientific inquiry.
Though there are many regulatory requirements in clinical research, specialty, and subspecialty
medicine deal primarily with the protection of human subjects, research grant compliance, and
considerations for animal research. Perhaps the most widely known and highly regulated area of
clinical research is human subject protections.
Research involving human subjects. The result of translational research is to apply
scientific discovery to clinical practice. Human subject research is one of the most visible forms
performed in specialty medicine.
4
There are many implications and forms in which that research
may take place, whether through clinical trials or advanced diagnostic laboratory testing. In
specialty medicine, research often focuses on biological systems and organs, such as tissue. The
4
In this section of the study, the term “specialty” includes applicable subspecialties.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 61
regulatory implications vary depending upon what type of specialty research is conducted. For
example, Coleman (2015) profiles two of the main legal issues in tissue research as for how
biological material is obtained and the extent to which subjects give informed consent.
Whenever research involves human subjects, ethical considerations apply, no matter what
specialty is studied.
The Belmont Report. In 1979, the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (National Commission) issued the Belmont
Report. Ross et al. (2010) describe how the three foundational principles discussed in the report
– namely, justice, beneficence, and respect for persons – gave rise to cardinal human subject
protection requirements in use today. Those include informed consent, risk and benefit
assessment, and ethical human subject recruiting and selection. After Belmont, the world of
human subject research continued to evolve.
Federal and institutional oversight. In addition to regulating many aspects of clinical
practice and PHI, HHS also exercises federal supervision of the human subject research. The
Office of Human Research Protections (OHRP), born out of the National Commission, provides
issues regulatory and policymaking rules, enforces compliance and reporting requirements, and
conducts outreach and educational actives related to human subject protections. OHRP also
regulates Institutional Review Boards (IRB) registration and Federal Wide Assurances (FW A)
which set the standards and rule by which individual an IRB operates or collaborates with
another ("Federal Policy for the Protection of Human Subjects," 2017). Given the broad scope
of OHRP and the number of clinical research activities occurring at any given time, resources to
monitor human subject protections are considerable. Findings by Weil et al. (2010) revealed that
between 2002 and 2007, OHRP issued 762 Citations of Noncompliance and Deficiencies
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 62
covering areas such as IRB-approved consent, policies and procedures, and reporting
requirements.
Individual IRBs regulate human subject research within an institution or group of
institutions, depending on its scope and application. While membership is consistent across
institutions of specialty medicine, there may be physicians and researchers from several clinical
focus areas on the IRB, for example, an immunologist and pulmonologist. A multidisciplinary
IRB is necessary given the ethical requirements that the IRB is charged with ensuring are met.
Whitney (2016) describes an IRB as unlike any other committee within an institution and one
with considerable influence within an institution given that most research, whether FDA or NIH
funded, must go through its approval process. Additionally, federal law requires institutions to
develop Privacy Boards to evaluate the privacy-related implications of human subject research.
Much of the regulation and operation of an IRB and Privacy Board comes from federal
legislation known as The Common Rule, among other sources.
The Common Rule. Many of the regulatory elements found in clinical practice apply to
human subject research. Considerations such as HIPAA, patient safety, and infection prevention
are also included. One of the primary regulatory mechanism in clinical research is the Common
Rule, 45 C.F.R. 46(A). The Common Rule is the codification of many of the provisions found in
The Belmont Report and has been expanded to cover emerging issues in clinical research such as
subject recruiting, while formalizing foundational tenants such as informed consent and the
operation of an institution’s IRB ("Federal Policy for the Protection of Human Subjects," 2017).
In addition to human subjects, it is important to consider that animal subjects are often part of
medical research.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 63
Research involving animal subjects. Much of the research the biological sciences
involves animal subjects. Animal research is primarily conducted in laboratories. Unlike human
subjects, the regulatory oversight mechanisms for animal research are not as established and
sometimes harder to piece together. Radzikowski (2006) profiled international regulations
governing the use of animal subjects in research to develop a framework for implications in the
United States, among other nations. He reported that the International Council for Laboratory
Animal Sciences devoted significant time and resources to (i) harmonizing research regulations
and laboratory standards, and (ii) promoting awareness for ethical stands in the field. As
legislation and widespread adoption of animal subject evolved, institutions began adopting
standards and mobilizing internal resources.
Federal and institutional oversight. One of the primary pieces of legislation for the
regulation of animal subject research is the Animal Welfare Act of 1917, 7 U.S.C. 2131 et seq.
(AWAR). Overseen by the United States Department of Agriculture with support from the Public
Health Service Policy on Humane Care and Use of Laboratory Animals, the AWAR establishes
federal and progressively amends laws related to animals and their role in laboratory research
("Animal Welfare," 1989). One of the regulations evolving from AWAR requires institutions to
create committees, much like an IRB, to regulate their animal research. Richerson (2014)
reported how Institutional Animal Care and Use Committees (IACUC), made up of veterinarians,
scientists and related professionals took on the task of bringing academic medicine and other
facilities into compliance with federal law. Institutions continue to rely on the IACUC to ensure
that animal subject research is carried out safely and ethically, producing translational research
that can be appropriately applied to specialty and subspecialty medicine.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 64
Compliance and regulatory oversight impacts every aspect of clinical practice and
research. As translational research continues to produce outcomes which improve patient care
and experiences, the health of populations and contribute to cost containment, the need for
ethical and compliance practice will exist and will be especially crucial in specialty and
subspecialty medicine. That practice requires that clinicians, researchers, compliance
professionals, and administrators work collaboratively to ensure that academic medicine is ready
for the advances that its science will bring. The next section of this chapter will explore the
literature tied to the Clark and Estes (2008) gap analysis.
Introduction to Literature and the Gap Analysis Model
This section of the dissertation explores the academic and professional literature tied to
the knowledge and skills, motivational, and organizational influences for the gap analysis
(KMO) used in the research. The KMO model stems from research developed by Clark and
Estes (2008) which outlines each of those influences as the primary reasons that performance
gaps exist within organizations Each influence diagnosis a specific area where targeted
improvements can be made. Together, they represent a critical mass in creating interventions
that make organizational change sustainable. In defining sustainability, this study looks at
concepts such as those raised in Chambers (2015). That research describes the need for hospitals
and medical institutions to move toward innovation and standardization in business and clinical
processes. To evaluate the problem of practice in this study, there are elements of each influence
that can be reviewed and improved.
In academic medicine, knowledge and skills are the confluence of professional training,
competency, and credential. Staff members use those elements to practice evidence-informed
decision making (EIDM) toward improved patient outcomes (Yost, Ciliska, & Dobbins, 2014).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 65
Through knowledge transfer, those influences are passed to learners and researchers while being
refined and adapted to respond to changes in the field. The rules, regulations, and policies under
which clinicians, researchers, and institutions operate represent the critical knowledge base for
ethical and compliant practice.
While knowledge and skills focus on setting a goal, motivational influences help move
organizations to the next level. The motivational components of active choice, persistence, and
mental effort help encourage individuals and organizations to move to act on a task or reach a
goal (Clark & Estes, 2008). For example, research by Okello and Gilson (2015) found that
improved motivation was a significant factor in high-performing health care workers delivering
consistent and sound clinical services.
The third component of the KMO conceptual framework deals with organizational
influences. Some of the organizational influences include operational processes and resources
(e.g., policies and procedures), culture, and employee engagement (Berbary & Malinchak, 2011;
"Increasing employee engagement: The role of interpersonal leadership," 2015). In a healthcare
setting, where workload can be unusually high, practicing proactive engagement is necessary to
improve employee productivity, maintain patient and provider safety, and ensure a positive
experience for those whom the institution serves (Jeve, Oppenheimer, & Konje, 2015). Together
all those influences move toward creating better health outcomes, promoting cost efficiency and
containment, ensuring a satisfying and meaningful patient experience, and maintaining the health
and well-being of those who practice in healthcare, including the staff stakeholder group in this
study (Bodenheimer & Sinsky, 2014; Institute for Healthcare Improvement, 2013). The KMO
conceptual framework lays the foundation for promoting organizational change from the inside
out. Table 4 summarizes each influence in the KMO framework with the corresponding
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 66
literature. While some influences have elements of applicability in both general and academic
medicine, particular focus is placed on the context of specialty and subspecialty research.
Table 4.
Summary of Assumed Influences on Corporate and Regulatory Compliance in Specialty and
Subspecialty Research Institutions
Assumed Influence Literature and Regulatory Ties
Knowledge and Skills
Staff needs to know the regulations
applicable to practice and research.
(Conceptual knowledge).
Krathwohl (2002), Monzó and Rueda (2009),
Office for Civil Rights (2013), "Federal
Policy for the Protection of Human Subjects"
2017) Cannoy and Salam (2010); Office of
the Inspector General (2011)
Staff needs to know how to implement
and comply with the relevant
regulations (Procedural knowledge).
Whitby and McLaws (2004), Office of the
Inspector General (2011), Cascardo (2016),
"Federal Policy for the Protection of Human
Subjects" 2017), Whitney (2016)
Motivation Clark and Estes (2008), Locke (1991), May
(2005), Feldman (2011)
Staff needs to feel that the process of
complying with relevant regulations is
with the burden, time and expense
(Expectancy-value theory).
Wigfield and Eccles (2000), Pintrich (2003),
Kilbridge (2003), Carlson (2012), Anthony,
Appari, and Johnson (2014), Venkatesh and
Rai (2011)
Individual staff members and the
stakeholder group need to believe that
regulatory compliance is probable
(Self-efficacy theory).
Bandura (1986), Zimmerman (2000), Esnard
and Roques (2014), J. Lee, Zhang, and Yin
(2011), Tyler and Jackson (2014), Bandura
(1997), Takahashi (2011)
Organizational Influences Clark and Estes (2008), Taylor (2008)
Institutional systems, assets, and
processes need to facilitate systems
need to facilitate implementing and
sustaining compliance in practice and
research (Organizational Assets).
Office of the Inspector General (2011), Clark
and Estes (2008), Nevis, DiBella, and Gould
(1995), Office for Civil Rights (2013),
"Federal Policy for the Protection of Human
Subjects" 2017), Whitney (2016)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 67
Assumed Influence Literature and Regulatory Ties
Institutional leaders and staff need to
create an internal climate fostering
sustained improvement and build on
assumed motivational influences
(Organizational Culture).
Clark and Estes (2008), Agócs (1997),
Krosgaard, Brodt, and Whitener (2002),
Morrison and Milliken (2000), Berwick et al.
(2008), Bodenheimer and Sinsky (2014),
Institute for Healthcare Improvement (2013),
Burke (2002), Ensley, Hmieleski, and Pearce
(2006), Heller and Hindle (1998), Kouzes and
Posner (2013), J. C. Maxwell (2007), J. G.
Miller (2010), Warrick (2011), Gustavson and
Liff (2014), L. K. Lewis (2006), Warrick
(2009), Sarin and O'Connor (2009), , Moore
and Hutchison (2007), Alexander et al. (2013)
Stakeholder Knowledge and Skills
Building a portfolio of knowledge and expertise plays a meaningful role in ensuring the
long-term success of problem-solving and improvement efforts. Those influences are also are
essential considerations in setting, achieving and evaluating business and performance goals,
identifying gaps in learning and performance, and solving future performance problems that may
arise within an organization (Clark & Estes, 2008). Within a patient care and research settings,
staff integrates knowledge and skills into assessing professional competencies of providers and
developing evidence-based solutions to complex population health, quality of care and cost
issues (Argimon-Pallas, Flores-Mateo, Jimenez-Villa, & Pujol-Ribera, 2011; Epstein & Hundert,
2002).
Knowledge Influences
As established in the survey of the general literature, there are a wide array of
regulations, rules, and policies that impact the way in which both clinical research and practice
are carried out. Those requirements become even more complicated when moving into
translational research specialty and subspecialty medicine as validated by human subject
protections and accreditation requirements. That complexity has an impact on long-term
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 68
compliance. Knowledge types are necessary to examine, as they provide a logical framework for
understanding and implementing specific rules and regulations; and all knowledge types are a
consideration in this study. Consistent with Krathwohl (2002) and Rueda (2011), conceptual
knowledge refers to the systems, rule, and regulations themselves, while procedural knowledge
is the methodological approach for how individuals and groups accomplish a task or outcome.
Conceptual knowledge: Regulations, rules, and applicability. Staff members in
academic medicine are often scholar-practitioners. As clinicians and healthcare delivery
professionals, there are norms and regulations which are required due to patient care, while
others are focused on research, and others still cross between both functions. An example of the
latter includes PHI privacy and security as required by HIPAA and HITECH. While more recent
simplifications of HIPAA do create broader provisions for research, elements of the Common
Rule also have privacy implications, covering instances that HIPAA might not ("Federal Policy
for the Protection of Human Subjects," 2017; Office for Civil Rights, 2013). In a study by
Cannoy and Salam (2010), the researchers concluded that both practitioners and academics
found health information security and assurance regulations to be complicated, while still
agreeing that their application was necessary. Guidance from the OIG (2011) emphasizing
efficient and ongoing training and education is essential in building a sustainable compliance
program. Awareness of the regulations is the first step in the implementation of compliant
practices.
Procedural knowledge: Rules and regulations applicability and implementation. In
addition to the standards and regulations themselves, it is important to know what areas each one
applies to and how they are implemented. For example, Whitby and McLaws (2004) found that
in a study of healthcare worker compliance with universal precautions, knowledge of the best
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 69
practices and regulations for handwashing was far more critical than decisions such as where
sinks were placed in the facility. The conclusion was that items such as handwashing frequency,
when to use gloves and what to do after patient contact were more critical to clinicians and staff
regarding their impact patient safety. Returning to guidance from the OIG (2011, p. 1), all seven
of the essential elements of effective compliance programs reference implications for practice
such in addition to the conceptual knowledge influences. Those elements are:
1. Implementing written policies, procedures and standards of conduct.
2. Designating a compliance officer and compliance committee.
3. Conducting effective training and education.
4. Developing effective lines of communication.
5. Conducting internal monitoring and auditing.
6. Enforcing standards through well-publicized disciplinary guidelines.
7. Responding promptly to detected offenses and undertaking corrective action.
Each of the OIG essential elements begins with an action word, implementing,
designating, responding and the like. Taking proactive action is a critical consideration for
effective compliance. In an article reviewing challenges facing providers for effective
compliance, Cascardo (2016) concluded that future federal compliance audits from entities such
as the OIG and OCR would focus on how providers documented and coded patient encounters,
as well as the steps they took to secure PHI and protect the privacy of patients.
The importance of compliance action in research is taken directly from the regulations
themselves. OHRP regulates the procedures of an IRB, while the IRB itself approves protocols
for how research will be conducted by an investigator ("Federal Policy for the Protection of
Human Subjects," 2017; Whitney, 2016). To create protocols that will get past IRB muster, a
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 70
knowledge of how the regulations impact their development is essential as part of the design and
scoping process. From knowledge and skills, the next section of the theory-based literature
review focuses on motivational influences.
Stakeholder Motivation
The literature review in this section will concentrate on motivational theories, influences
and their role in creating sustainable research regulatory and compliance programs. As
previously introduced by Clark and Estes (2008) the concepts of active choice, persistence and
mental effort are aids used in helping close gaps in organizational performance. The same
research also found that active choice focuses on intention to do something, persistence is the
ability actually to complete a task, and mental effort the mental effort that one concentrates on
the task or goal itself. Locke (1991) developed a sequence whereby motivation begins with
needs, moves to value and motives, through goal-setting and intent, to performance, and
ultimately the rewards and fulfillment that someone experiences for completing a task or
achieving a goal.
A considerable amount of research surrounding the essential elements and
implementation of sustainable regulatory programs in academic medicine links motivation to the
success or failure of those efforts. May (2005) distinguishes between mandatory and voluntary
compliance, finding that motivation to act is dependent upon the perception of regulatory entities
and an organization’s (and an individual’s) sense of duty to comply, among other factors.
Feldman (2011) views compliance and motivation through both internal and external value
lenses, stating that compliance is sometimes driven by rewards and incentives.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 71
Motivational Influences
The purpose of the literature analysis in this section is to illustrate how the selected
motivational theories of intrinsic value and self-efficacy impact staff members’ ability to comply
with required rules and regulations; consistent with the organizational and stakeholder goals
identified in this section of the chapter. To more deeply explore the motivational influences and
constructs, the next part of the paper will focus on expectancy-value (intrinsic) through the lens
of stakeholder motivation.
Expectancy-value theory: Compliance is worth the effort. Expectancy-value theory
(EVT) refers to a person’s expectations in task completion and value of the task itself and takes
into account an individual’s active choice and persistence as factors in their performance
(Wigfield & Eccles, 2000). Within EVT, Pintrich (2003) categorizes four components including
intrinsic interest, utility, importance/attainment, and cost. For this study, intrinsic interest refers
to a staff members’ interest in complying with applicable rules and regulations. Utility is the
usability and applicability of the regulations on their work. Importance and attainment relate to
the priority which the staff member place on achieving compliance relative to their overall
responsibilities. Cost refers to time, labor, and resources needed to comply fully.
One of the primary challenges that many compliance departments face, in virtually any
institution, is the need to create buy-in among clinicians. When HITECH first outlined the
meaningful use of HIT, many institutions were facing low rates of adoption of EMR systems by
physicians, researchers, and other staff members. Venkatesh and Rai (2011) found that
physicians who adopted EMR systems did so in large part because of the impact that utility had
on patient satisfaction. Three elements that were present in that study’s case include interest,
utility, and importance; particularly on the improved outcomes and satisfaction of patients.
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Regarding cost, if long-term compliance is an institution’s goal, staff as a critical
stakeholder group must believe that there is a value associated with the expense. For many
years, the cost of compliance has been on the minds of physicians and administrators alike.
When HIPAA was first introduced, an article by Kilbridge (2003) cited American Hospital
Association (AHA) estimates that compliance implementation cost could be up to $3.7 million
for the largest facilities. Even after substantial costs of operationalizing HIPAA compliance, if a
safeguard fails and a breach occurs, fines and other remedy costs can be considerable. Another
article by Carlson (2012) detailed an instance where a large insurance company settled an OCR
suit for a 1.5 million dollar fine, entered into a 450-day corrective action plan, and made other
costly changes because of over 50 hard drives that were stolen containing PHI. If another breach
such as that happened a second time or affected more individuals, the cost could considerably
outpace even the highest implementation cost estimates. The debate of which is worse –
implementation or breach response – is a matter of discussion, and has been for some time. Use
of only short-term vision, however, may be considerably more expensive. Noncompliance
involves more than remuneration. An institution’s trust and credibility, workforce retention,
recruiting and ability to obtain funding for new and existing research may also suffer greatly
(Anthony et al., 2014). Institutions who do not implement efficient and sustainable compliance
programs risk losing resources for care, trust, and well-being of patients, and resource for
ongoing activities and operations (Okello & Gilson, 2015). In specialty and subspecialty
medicine, where improved health outcomes are driven by advances in scientific discovery, such
events are undoubtedly the Achilles’ heel of the institution. The time and labor of implementing
remediation also detract from the ability to perform quality clinical activities and research. A
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 73
business case of potential exertions in cost, time, and effort makes compliance not only
necessary, but vital to staff, staff, administrators, and patients alike.
Self-efficacy theory: Pursuit of the probable. Self-efficacy refers to one's beliefs
about their abilities to accomplish a task or goal (Bandura, 1986). Like other theories such as
EVT, self-efficacy considers, and individual’s active choice, persistence, and mental efforts, but
is distinguished from concepts such as focus, self-confidence, and self-esteem because of its
task-specific focus (Zimmerman, 2000). In specialty and subspecialty care, self-efficacy can
mean the difference between life and death for a patient. If a cardiologist, for example, does not
believe that they can successfully save the life of a patient, then according to self-efficacy theory,
that physician will most likely not be able to accomplish that goal. This analysis of the literature
explores self-efficacy as a means for staff and related stakeholders to successfully implement
sustainable corporate compliance and research regulatory systems and practices into their daily
work. The research profiles both collective and individual self-efficacy.
Collective efficacy and compliance interventions. Collective efficacy refers to the belief
that a group or team can complete a task or achieve a goal within a specific setting (Esnard &
Roques, 2014). From a staff perspective, J. Lee et al. (2011) found that when staff has a sense of
collective efficacy about the best possible outcomes, it had an impact on the institution’s
collective efficacy as well. Regarding compliance interventions, Tyler and Jackson (2014) argue
that institutions who advocate for collective efficacy experience increases in both legitimacy and
rule adherence. In an academic medical facility, particularly in institutions focusing on
subspecialties, the shared experiences, mutual commitment and trust among physician-scientists
provide advances for both the staff stakeholder group and the institution.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 74
Individual efficacy and compliance interventions. Individual efficacy refers to the
specific beliefs of a single person on whether they can achieve the degree of effort and
perseverance to achieve a goal (Bandura, 1997). Taking Bandura’s work further, Takahashi
(2011) found that collective efficacy had a direct impact on the individual efficacy of staff when
they believe that their peers will support each other in achieving goals and accomplishing the
task. From a compliance perspective, individual efficacy also has a reciprocal relationship on
collective efficacy. That is the, at least in some form, the nature of an IRB. Members of the
committee rely on the individual efficacy of the investigator to bring forth protocols that will
pass muster. In turn, the investigator relies on the collective efficacy of the board if protocols
and approval to proceed are appropriately validated.
To create sustainable compliance interventions in specialty and subspecialty translational
research institutions, staff members must believe that those practices are worth the time, effort
and cost associated. Also, they must believe in themselves and each other and rely on peer
review, and their practices and protocols to move the patient care and research activities of the
institution forward. The final section of the literature review assesses the organizational
influences of sustainable compliance and regulatory programs in the specified setting.
Stakeholders and Organizations
To this point, the theory-based literature review has profiled the critical elements of
compliance programs and the needs for sustainability from a stakeholder (both individual and
group) perspective. Each stakeholder group, though, is a member of a larger organization. In
this case, the hospital is the organization. This section of the literature review focuses on the
organizational influences where stakeholder groups meet and merge. Of particular consideration
in the following influences is the relationship between staff and administration.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 75
Organizational Influences
One of the primary considerations for facilitating equity and timely access to clinical
services and translational research is a review of the practice’s organizational assets and
influences. No matter how deeply and thoughtfully organizations develop stakeholder
knowledge and motivational influences, success is all but impossible if organizational influences
are missing from the equation (Clark & Estes, 2008; Taylor, 2008). This dissertation will focus
on two primary organizational influences in the internal controls and organizational culture
perspectives. The first organizational influence focuses on internal controls and assets that
institutions can use to implement sustainable regulatory compliance. The second influence deals
with organizational culture and the role of collaboration between staff as a stakeholder group and
institutional leadership.
Organizational assets: Internal controls, systems, and policies. Guidance from the
Office of the Inspector General (2011) puts internal controls at the very heart of sustainable
compliance. In the previous sections of the literature review, the focus was more on the action
words and knowledge components. Each one though has an organizational asset component
associated with it. Table 5 presents that relationship in further detail.
Table 5.
OIG Essential Elements Linked to Organizational Assets
Number Element Organizational Asset(s)
1 Implementing written policies, procedures and
standards of conduct.
Policies, procedures, and
codes of conduct
2 Designating a compliance officer and
compliance committee.
Compliance staff position
descriptions, committee
charters, organizational
bylaws
3 Conducting effective training and education. Training materials, learning
management systems, work
procedures, process maps
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 76
Number Element Organizational Asset(s)
4 Developing effective lines of communications. Compliance email updates,
agenda for town halls,
frequently asked questions
5 Conducting internal monitoring and auditing. Audit guides, monitoring
protocols
6 Enforcing disciplinary standards through well-
publicized guidelines.
Policies, accountability codes
of position descriptions
7 Responding promptly to detected offenses and
undertaking corrective action.
After action reports, risk
management/mitigation plans
Organizational policies have a critical impact on identifying and addressing performance
problems (Clark & Estes, 2008). A trend in change and leadership for many years has been that
of a “learning organization.” In a seminal work on the topic, Nevis et al. (1995) found that
organizations rely on policies, processes and internal structures to both facilitate learning and
change. That concept is essential given the role that training, education, and improvement play
in creating sustainable compliance.
From a HIPAA perspective, organizations must create outputs such as a BAA when
sharing PHI between a Covered Entity and a Business Associate (Office for Civil Rights, 2013).
That document is an attestation that both organizations have the necessary internal controls in
place to prevent and mitigate breaches of patient data privacy and security. In research, OHRP
regulates the policies and procedures related to IRB administration ("Federal Policy for the
Protection of Human Subjects," 2017). When requesting an FWA, the IRB administrator must
attest to the rules and regulations applicable to their institutions and that they have the policies,
procedures, staff, and systems to be able to produce evidence of compliance. Even at the staff
and investigator level, an IRB reviews the study protocols submitted by a researcher to ensure
that ethical standards are strictly observed (Whitney, 2016). Organizational assets, from those of
the institution to the individual staff member, are essential in meeting complex and ever-
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 77
expanding regulatory and ethical requirements. The final influence in the study focuses on the
role of organizational culture in sustainable compliance.
Organizational culture: Internal climate and collaboration. Regardless of how
robust and improved an institution’s assets are, leaders need to work with stakeholder groups to
establish an environment that supports ongoing improvement as aligned with the motivational
influences outlined in this gap analysis. Organizations continuously change in the major areas of
staff, customer base, and leadership. Clark and Estes (2008) argue that as an organization
changes over time, so does the culture. Further, they give specific examples of the relationship
between improvement efforts and cultural shift. Some relevant examples of their suggestions for
improvement concerning culture include ongoing, open and honest feedback, management
visibility, commitment to change, and participation in improvement efforts, and creating realistic
expectations about the commitment to and effort involved in change and policy decisions.
Ongoing, candid and open communication. Clark and Estes (2008) establish an essential
link between active communication and engagement between leaders and teams and the success
of performance improvement and organizational change. Moreover, sufficient evidence validates
the assertion that organizations mired in silence, isolation and disconnection between leaders and
the rest of the organization are at high risk for failure to effectively facilitate change (Agócs,
1997; Krosgaard et al., 2002; Morrison & Milliken, 2000). (Agócs, 1997; Krosgaard et al., 2002;
Morrison & Milliken, 2000). From the perspective of a compliance and effective clinical
practice, open and honest change not only creates atmospheres were an improvement is
successful but also aids organization in achieving the improved patient experience and provider
well-being. All of those items are legs of the Quadruple Aim (Berwick et al., 2008;
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 78
Bodenheimer & Sinsky, 2014; Institute for Healthcare Improvement, 2013). Another critical
factor in organizational culture is the commitment of leadership.
Leadership’s commitment and involvement in change. Accountability drives
compliance and is the essence of many of the federal rules and regulations that academic medical
institutions are charged with following. One of the most fundamental points that organizational
change research creates is the need for leadership engagement, accountability, and participation
in change effort (Burke, 2002; Clark & Estes, 2008). While the KMO gap analysis already
discussed the need for motivation at the staff level, there are deeper components directly
attributable to the leader’s role in change. Table 6 displays the fundamental tenant in leadership,
its applicability in a clinical setting, and supporting literature.
Table 6.
Leadership in Change and Applications in Clinical Practice and Research
Leadership and Change
Concept
Applicability in Clinical
Practice and Research
Supporting Organizational
Change Literature
Build a coalition and create
momentum:
Leaders must create buy-in,
model change, illustrate its
value, encourage its adoption
and maintain its evolution.
Institutional leaders and staff
must edify the motivational
tenants of sustainable
regulatory compliance,
disarm the perceived fear of
change, and walk with staff
through change efforts.
Ensley et al. (2006), Heller
and Hindle (1998), Kouzes
and Posner (2013), J. C.
Maxwell (2007), J. G. Miller
(2010), Warrick (2011)
Empower and encourage
people:
Leaders must assess each
team member’s holistic
abilities, expertise, and talents
and assign deliverables and
milestones that achieve the
best result for the
organization, team and
customer base.
Working toward the best
patient outcomes and
translational research, leaders
and staff must mutually
assess the stakeholder group’s
collective strengths and
efficacy and engage team
members in sustainable
compliance interventions
which capitalize on those
assessments.
Gustavson and Liff (2014),
Heller and Hindle (1998), L.
K. Lewis (2006)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 79
Leadership and Change
Concept
Applicability in Clinical
Practice and Research
Supporting Organizational
Change Literature
Create sweat equity:
Leaders must be a
contributing team member in
as much as they are a team
leader.
As part of the compliance
process, practice leaders must
actively participate in the
improvement and
transformation process,
setting specific goals and
outcomes.
Ensley et al. (2006), J. C.
Maxwell (2007), Sarin and
O'Connor (2009)
Actively follow through:
Leaders must honor
commitments that they make,
both during the change
process and in efforts to
sustain it.
Practice leaders must
mobilize needed resources for
change, support the adoption
of compliance and regulatory
standards, and improve
internal controls and assets.
Leroy, Palanski, and Simons
(2011), J. G. Miller (2010),
Moore and Hutchison (2007)
Setting realistic expectations. Evidence exists to support that claim that effective change
and sustainable interventions take time (Clark & Estes, 2008). Within an academic medicine
setting, where improvement initiatives must be tailored to outcomes both at the patient and
population levels and where multiple internal and external stakeholders are involved, those
improvements efforts must be rapid but also deliberate. Staff and care teams must allocate
enough time to identify problems, establish a baseline and collect data, analyze the results and
develop an intervention strategy, re-measure and execute continuous quality improvement to
ensure that appropriate regulatory requirements, study protocols, and patient care standards have
been met. The amount of time required to execute performance improvement strategies entirely
will vary depending on the specific compliance needs and associated interventions; institutional
size previously conducted training, and the current state of knowledge and motivational
influences (Alexander et al., 2013). When dealing with complex systems and care relationships
specialty physicians and institutional leaders must account for both internal – such as assets,
knowledge and skills, motivation – and external factors – such as the state of relationships with
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 80
primary care providers, acute care facilities, and regulatory authorities. There is a myriad of
instances when creating intervention strategies aimed at improving institutional compliance with
a network of rules and regulations. Both staff (as clinicians and investigators) and administration
must ensure that staff, patients, and partners understand realistic expectation for improving, and
must not lose sight of the mutual benefit of all the stakeholders and customers involved.
Organizational influences play a considerable role in creating conditions where
compliance is probable within an institution. There are expanding needs for translational
research in specialty and subspecialty medicine and the growing demand for access to advanced
patient care. Both staff and institutions themselves must work to ensure that organizational
assets, culture, and partnerships align with the common understanding that regulatory
compliance is a priority, probable for everyone, and worth the time, effort and cost. The next
chapter focuses on the methodology of the study.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 81
CHAPTER THREE: METHODOLOGY
Introduction
This dissertation is an evaluation of the essential components and knowledge and skills,
motivational, and organizational influences of a regulatory compliance program in specialty
academic medicine. Chapter Three explores the research design, conceptual framework, and
methods of data collection and analysis for the remainder of the study. From the role of the staff
stakeholder group, below are the research questions which that analysis supported.
1. What are the essential elements and best practices of a regulatory and compliance
program (referred to hereafter as compliance program) that build its efficacy and
long-term sustainability?
2. From the perspective of staff, what are the knowledge, skill and motivational
influences that promote stakeholder compliance efficacy and contribute to building a
sustainable compliance program; and how should the content relating to those
influences be delivered?
3. From the perspectives of staff, what organizational influences need to exist – and to
what extent – to build stakeholder efficacy and a sustainable compliance program;
and how should those influences be constructed within the institution?
Following the conceptual framework, this chapter profiles the stakeholders, methods of
data collection and analysis. The chapter concludes with a discussion of ethics and credibility,
trustworthiness, validity and reliability.
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Conceptual Framework
Reminder of the Problem of Practice
Ineffectively designed and delivered specialty and subspecialty translational research
institution corporate and regulatory compliance programs can impact adverse patient and
research outcomes including (a) causing gaps in clinical service delivery, (b) failing to provide
for continuity of care, (c) impeding scientific discovery, (d) creating a negative patient
experience and (e) failing to improve population health outcomes.
Purpose of Conceptual Frameworks
To fully understand the size and scope of creating a culture of compliance in any setting,
leaders need to be able to match systems, assets and organic elements of change in a coherent
form. Conceptual frameworks are tools designed to frame those different components in a way
in which perspectives can be assessed with assets such as policies, strategies, and resource (J. A.
Maxwell, 2013). Merriam and Tisdell (2016) view of the role of conceptual frameworks by
stating that they allow theory to be connected to the problem of practice (or research questions).
Conceptual frameworks allow users to see both theory and practice as part of a broader solution
for improving performance problems. For this study, the knowledge and skills, motivational, and
organizational influences as described in Clark and Estes (2008) were paired with program
elements and perspective of the staff stakeholder group. Each of those considerations plays an
essential role in helping the study evaluate the problem, pair it with the research questions, and
glean findings to create a future model from which to assess other institutions. Figure 5 shows
those relationships in summary.
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Figure 5. Study Conceptual Framework.
The model ties all of the research questions together and sets the lens through which they
are analyzed.
Defining Stakeholder Groups
In an academic medical institution, there are a variety of stakeholder groups with many
competing and aligning interests. Each stakeholder group has specific functions and varying
communication styles. For example, the management team formulates policy and casts a vision
while the staff stakeholder group implements the policy and carries out the vision to serve
external stakeholder groups such as patients, partners, donors and the community. For the
problem of practice above, the stakeholder group is institutional staff.
Stakeholders in the Organizational Context
Breckenridge Valley Health has a mission of research, care, and education. Staff
members are an essential member of the research and care delivery teams in an academic
medical facility. In specialty and subspecialty medicine, the number of available physicians due
I.
Program Elements
•HHS OIG (2011)
Fundamental
Elements
•Practice Elements
•Improvement and
Utilization Elements
II.
Knowledge and
Skills
•Rules and
regulations
(Conceptual)
•Implementation
(Procedural)
III.
Motivational
Influences
•Value in time,
effort, (EVT)
•Compliance is
probable (SET)
IV.
Organizational
Influences
•Assets
•Culture, context and
setting
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to the significant shortage include without limitation, registered nurses, licensed practical or
vocational nurses, and mental health providers.
Criterion 1B: Investigators. Potential interview subjects could have been either a
primary or co-primary investigators for an institutional research study.
Rationale. Investigators work with clinical research coordinators to review study
protocols, assess the potential risk to subjects, and report the study’s ongoing status to the
appropriate regulatory body.
Criterion 1C: Clinical, operational, and research support staff. Individuals with
clinical, operational, or research support services as part of their primary scope of responsibility
were also included. To qualify for this criterion, respondents rated themselves in either the
“Clinical Support Staff,” “Research Support staff,” or “Operations and Support staff” category in
survey question S.3.
Rationale. Although all institutional employees and affiliates interact with the
compliance and regulatory processes in some form or another, those with clinical and research
responsibilities have added regulatory requirements that they must satisfy as part of their role.
Criterion 1D: Institutional management and administration. Respondents in this
criterion were staff stakeholders who exercise oversight over either a clinical or research function
but do not serve in a support role. To qualify for this criterion, respondents rated themselves in
the “management” category in survey question S.3.
Rationale. Administrators are in a unique position to assess the various KMO influences
at either a team, department, or institutional level. They often serve on institutional oversight
committees and participate in funding decisions for studies, personnel planning, and clinical
initiatives and activities.
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Criterion 2: Regulatory-facing clinical or research staff. The individual must also
have regularly interacted with compliance and regulatory departments within their institution.
That included individuals such as, without limitation, managers who are responsible for reporting
compliance audit results to the Compliance Office and research coordinators who submit study
protocols to the IRB for review.
Rationale. A proper background in clinical practice or research is necessary to fully
understand the implications of the nexus between research and practice. As the institution’s
activities are focused on clinical and translational research in respiratory medicine, staff need to
be able to findings from research activities, such as clinical trials and systematically apply them
to improving patient health outcomes (Y . C. Lee & Waterer, 2013).
Criterion 3: Survey completion. Potential interview subjects must also have
participated in the survey process and submit a complete survey, indicated a willingness to
participate, and requested contact information.
Rationale. Completion of the survey assessed a potential interviewee’s ability to meet
the criteria defined in this section of the study.
Interview Recruitment and Rationale
A series of individual interviews were conducted with staff members. The sampling
method was purposeful in size and discipline that is as necessary for accurately representing the
institution’s homogeneity. Consistent with guidance from J. A. Maxwell (2013), recruiting
practices attempted to match the breadth and depth of the workforce as a whole.
Recruitment. Recruitment for both interview settings occurred via respondents wishing
to participate as identified during the survey process. Each potential subject completed a
preliminary screening process to ensure that they met all the conditions defined in this chapter.
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Rationale. The overarching goal of stratifying the small group samples is to create a
cross-functional framework for gaining feedback concerning the research questions. The first
research question was addressed by the homogeneity of the participants matching the appropriate
categories. For the second research and third research questions, the respondent's appointment as
staff under the third criterion allowed for feedback on the value of compliance through the lens
of academic medicine.
Observation Sampling
Direct, non-subject observation was the next data collection technique. Observation
varies from other qualitative methods by considering the natural setting in which the activities
occur and allowing the researcher to gain a firsthand account of the functions, interactions and
other artifacts in the study (Merriam & Tisdell, 2016). From a clinical perspective, direct
observation allows the researcher to understand how and why treatments and interventions are
applied during the patient care process, as well as gaining a sense of the various interactions
between physicians and patients (Salloch, Ritter, Wascher, V ollmann, & Schildmann, 2014). For
this study, direct observation allowed for seeing how the elements of the KMO influences are
operationalized in daily research and practice. The criteria that follow defined the litmus test for
whether a site within the research setting appropriately qualifies for inclusion.
Criterion 1: Hospital facility. All direct observations took place at a facility owned or
operated by Breckenridge Valley Health. Those locations included the eight buildings on the
main campus or one of the offsite locations.
Rationale. It was necessary for direct observation to take place at an NJH facility since
those are the settings in which institutional patient care and research activities take place. While
staff may support the practice of other organizations, an NJH facility is the nexus of the
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organization's mission, vision, values, and operations. Performing observation at an NJH facility
also facilitated much easier access to research and clinical functions.
Criterion 2: Patient care area. Observation took place in either a clinic or support
department that engages in direct patient care.
Rationale. Patient care is an essential part of the institution’s operations. One of the
central tenants of an effective compliance program is its alignment with the Triple Aim of
improving population health outcomes, an optimal patient experience, and stewardship in the per
capita cost of care (Institute for Healthcare Improvement, 2013). Further Salloch et al. (2014)
specified outpatient clinic space as one of the three research settings in which physician decision-
making can be most carefully observed. Observation was limited to how individuals and groups
carry out functions which would contribute to or inhibit compliance with rules and regulations
for clinical practice.
Criterion 3: Research area. For this study, a qualifying observational setting must
include both patient care and inquiry activities by conducting activities such as clinical trials or
functions related to clinical and translational research.
Rationale. The very nature of Breckenridge Valley Health is a research facility. The
institution's central philosophy is that all patient care is driven by research and education
activities. Based on that understanding, research activities are part of the institution’s natural
setting where interactions between researchers and study subjects happen each day. Bogdan and
Biklen (2007) argued that the natural setting not be only a primary place for observing subject
interaction but also allows the observer to incorporate field outcomes into the study itself. Those
results directly impact the organizational culture elements of the study’s third research question.
Again, this observation focuses on the behaviors, methods, and interactions which contribute to
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or create barriers for human subject protections and other research-based regulatory
requirements.
Criterion 4: Patient or subject volume. Observation must take place in a research and
practice area with a high patient activity of no less than 100 unique encounters per day.
Rationale. To gain a deeper understanding of the institution’s research and patient care
activities while minimizing the possibility of interference, a high volume of patient and subject
flow is needed. A higher patient volume also allowed the researcher a better opportunity to study
patient care and research practices that are more authentic and applied repetitively instead while
providers might be under higher pressure and stress due to the amount of traffic (Hill, Giles, &
Dornan, 2012).
Criterion 5: Data privacy and security compliance. The observation area must fully
comply with the Federal privacy legislation such as HIPAA Privacy and Security rules and
Meaningful Use ("HIPAA Administrative Simplification: Enforcement," 2009; Office for Civil
Rights, 2013).
Rationale. Breckenridge Valley Health, like any hospital, is a highly-regulated facility.
Federal law requires that the institution take every necessary step to ensure that patient and
participant rights are protected, and any risk of breach or other concern is appropriately
mitigated.
Observation Access and Rationale
Given that Breckenridge Valley Health is an active research and patient care facility, care
must be taken to ensure that the disruption of and impact on clinical and research activities are
minimal. Before beginning the research process, approval from executive leadership was
granted in writing. A clear understanding of direct, nonparticipant observation expectations was
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provided in writing. Consistent with HIPAA privacy requirements, now patient identifying
information was used, disclosed, or recorded. Finally, every care was taken to ensure that
collaborative and meaningful practices are part of the research process. Bogdan and Biklen
(2007) point to the concern that proper relationships and development of trust are essential
factors in relevant data collection and future opportunities for collaboration.
Document and Artifact Sampling
Documents and artifacts which conform to the definition identified in Merriam and
Tisdell (2016) were used. They must communicate a specific message and meaning to the
recipient, have a physical construct, and be in the environment applicable to the subject. The
data collection phase was divided into portions – policies and procedures, and documents and
other artifacts.
Document and Artifact Access and Rationale
Only documents and artifacts which tie to the study’s conceptual framework and research
questions were used. Consistent with the guidelines for exempt research category four,
documents and artifacts must already exist and be de-identified ("Federal Policy for the
Protection of Human Subjects," 2017). Restricted access documents were not used in this study.
Data Collection and Instrumentation
This section focuses on selection, approaches, and protocols for the following data
collection methods: (i) surveys, interviews, observations, and document analysis. Each one of
those methods was used to some extent in the actual dissertation, so profiling all of them is
necessary to ensure full context. Moreover, a related goal of this section is to establish a clear
relationship between the data collection methods and the research questions above. The next
section focuses on surveys. The order of activities is progressive – surveys, interviews,
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observation, and document analysis, because they build off of each other regarding goals and
deliverables. While activities such as surveys and interviews glean the context elements of each
research question, other non-participative activities such as observation and document analysis
give insights into their application. Study data were collected and managed using REDCap
electronic data capture tools hosted at the University of Southern California (Harris et al., 2009).
REDCap is a secure, web-based application designed to support data capture for research studies,
providing (i) an intuitive interface for validated data entry, (ii) audit trails for tracking data
manipulation and export procedures, (iii) automated export procedures for seamless data
downloads to common statistical packages, and (iv) procedures for importing data from external
sources.
Surveys
Surveys are one of the most effective and commonly used data collection methods to both
focus inquiry efforts on specific topics or questions and reach a broader audience of potential
respondents (Zaharatos, 2015). Davino and Fabbris (2013) note that both survey construction,
deployment, and available analytical tools have improved significantly over the past several
years. The authors also illustrate the relationship between surveys as a data collection method
and the ability to perform complex statistical analysis. Due to the customizability of surveys,
there is an opportunity to tie the more clearly to the research questions of the study.
Application to the research questions. Surveys were targeted to the staff stakeholder
group. For research question one, staff was asked to give their perspective on the importance of
common elements found in corporate compliance and research regulatory management
programs. They were also able to add additional items not listed in the closed-ended questions.
Item from the first question flowed to answer the knowledge and skills component of the second.
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Questions were used to help define what conceptual and procedural knowledge ties to each of the
elements originating in research question one. Follow-up survey questions used behavior and
scenario-based responses to the motivation component of the second research question. For
research question three, staff was surveyed about what organizational influences (internal
systems, processes, and the like), help reduce risk exposure and the potential noncompliance
issues. A subset of survey questions also tied all of the previous data to a link between the
institution’s organizational culture and the ability of compliance and regulatory programs to
deliver services sustainably. Administering and conducting surveys is a critical component of the
capacity to apply them to the study’s research questions.
Survey administration. For this study, surveys among the staff stakeholder group were
administered based on the defined sampling criteria, recruiting and rationale. Each survey was
managed through the REDCap online platform. Since staff from across multiple institutions
were queried, physical travel to each site is required for instances where offline administration
occurs. Multiple languages surveys were not used in this study. Respondents received an email
with a link to complete the survey, along with the protocols and privacy practices. Email
addresses were taken from the institution’s public staff web profiles and online directories. Also,
the opportunity to participate was posted on selected web forums. Clear instructions for opting
out were also part of the broadcast emails at both institutions. The survey protocols in Appendix
B list the proposed text of the email to be distributed. REDCap also managed and sent survey
invitations to each staff member listed in the email directory pool. Respondents were afforded
the opportunity to enter contact information in case they would like to participate in interviews.
Survey protocols are listed in Appendix B. The next section of this paper focuses on the survey
approach and design process.
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Survey approach and design. Effective survey approaches and design are an essential
consideration in achieving relevant, timely and high response rates. Properly designed surveys
consistently present and describe facts, systems, and characteristics of both topics and
frameworks (Merriam & Tisdell, 2016). To effectively address this study’s conceptual
framework and relationship to the research questions, the survey began by establishing a
respondent’s relationship with the stakeholder group through demographic questions. That
demographics verification was also crucial in ensuring validity and reliability. These questions
also cover items such as credentials and depth of experience in roles and with topics. Appendix
B contains a sample of the survey instrument used in this study. Assessment of the knowledge,
skills, motivational, and organizational (KMO) influences is built off of the organizational
performance framework by Clark and Estes (2008). The study uses the literature review to
develop closed-ended responses during the KMO portion of the survey. The literature is an
essential basis for establishing the validity of the questions and responses. Considering the
length of the survey is an important part of survey design. Irwin and Stafford (2016) advised
survey designers to consider the number of questions, the expected completion time, any
incentives and the relevance of the questions to the topic. Accordingly, this survey was time-
limited and had no more than ten questions on each KMO influence. The specific design of the
survey is located in the Survey Protocols section (Appendix B).
Methods and tools for analysis. The survey, presented in Appendix B, contained 131
original variables and 115 fields. Those fields correspond to lines 2 through 116 of the Data
Dictionary Codebook, located in Appendix A. One variable was recoded, and five variables
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were added to consolidate demographic fields for a total of 137, to complete the analysis.
5
Data
on demographic items were aggregated to categorize respondents across four discipline-specific
groups, clinical, research, healthcare management and operations, and other. An additional layer
was added to classify respondents with either regulatory or compliance experience as assessed in
the demographic survey items. Appendix C illustrates the mapping of the survey questions to
the aggregated categorical variables.
To conduct analyses of data about the research questions and conceptual framework,
descriptive statistics, tables, and crosstabulations were developed from the survey data. Data
were collected using the REDCap database and survey management tool built primarily for
research in domains related to academic medicine (Vanderbilt University, 2017).
Analysis of qualitative data. Open-ended and free-text fields from the surveys were
analyzed using a coding structure aligned with the study’s research questions and conceptual
framework. Survey analysis was then linked to qualitative analysis in other data collection
methods. Respondents were stored as individuals cases, and closed-ended items were created as
case attributes to compare them by demographics and other relevant values. Nodes were created
for all open-ended questions. An additional layer of textual analysis recognizing specific words
and phrases was also applied to help more rapidly identify themes and patterns not detected in
during the coding process. As a result of the analysis, findings were linked to the appropriate
nodes developed during the coding process.
The next data collection method is subject interviews.
5
Appendix K shows the variables by the level of measurement.
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Interviews
Interviewing is a technique which accounts for much of the data collected in qualitative
research. One significant benefit of interviews is the ability capacity to move fluidly through
time and perspective, connecting each thought to context as the data collection activity unfolds
(Erlandson, Harris, Skipper, & Allen, 1993). There is an opportunity for free-flowing ideas and
covering topics in varying levels of detail.
Applicability to the research questions. Conducting focused interviews with a subset
of institutional staff allowed for deeper exploration of the KMO influences and their applicability
across service lines and departments. Also, interviewing allows for the more targeted
development of intervention strategies by extracting perspectives, exploring lessons learned and
testing the feasibility of best practices through the art of storytelling and meaning-making,
(Byrne, Brugha, Clarke, Lavelle, & McGarvey, 2015). That was mainly helpful as the research
attempts to assess to what extent the KMO influences can be woven into the organizational
culture and institutional operations. When considered with feedback gathered on essential
elements, all three research questions are addressed across a representative sample of the
stakeholder group. While the flow of information and the ability to explore more in-depth topics
is a benefit of interviews, administration, and protocols help ensure credibility and
trustworthiness.
Interview administration. Stakeholder interviews were completed after the survey
process. Respondents were selected from those who indicated that they wish to participate in the
interview process. That aids in credibility and trustworthiness because the respondents had
already been vetted as part of the demographic survey process. Interviews took place either on-
site at the institution at the staff member’s institution or online via the Adobe Connect platform.
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Online interviews were synchronous to build rapport to the extent possible. Online interviews
also allow distance and geography to become less of a barrier to completion (Merriam & Tisdell,
2016). Following the standardized open-ended format, there were ten total questions with an
estimated time limit of 45 minutes. Questions were supported by the responses that the staff
member entered as part of the survey. Additional time, up to 15 minutes, allows for follow-up
questions and possible spillover. Interviews were recorded unless the respondent requests
explicitly that they not be. Each interviewee also received a copy of the Notice of Privacy
Practices and an explanation of the protocols, along with their understanding and willingness to
continue. Further, any data collected during interviews were subject to protections under the
HIPAA Privacy Rule and related regulations governing research and patient confidentiality. No
PHI was collected during interviews, and no patients were part of the interview process.
Complete interview protocols and questions are included in Appendix D.
Interview approach and design. One of the most extensive qualitative activities for this
study is focused one-on-one with stakeholders. Individual interviews allow for candid and more
personalized feedback while small group interviews allow for creating connections among topics
and for participants to give insights and feedback from a shared knowledge perspective
(Gubrium, 2012). For this study, interviews followed a semi-structured format. Merriam and
Tisdell (2016) found that format allows for more flexibility while giving participants guide
points to encourage participation and stimulate discussion. The interview approach, except for
the demographics section, were standardized-open ended. Patton (2002) spoke to both the
flexibility and intentionality of the format by stating that it allows a consistent format and
sequence, combined with the opportunity to explore some topics in more detail. Consistent with
Yin (2009), staff interviews were open-ended as those questions allow the researcher to more
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deeply gather both facts and opinions about a topic. Insights, therefore, are an essential
deliverable of the interview process. With interactive methods discussed, the next section
focuses on observation.
Setting and logistical data. The focused interview instrument consisted of 15
demographic questions, both closed and open-ended, and 12 open-ended content elicitation
questions aligned with the Research Questions and Conceptual Framework of the study. Data
input was completed via the REDCap platform. Seven interviews were completed online using
the Rossier School of Education’s Adobe Connect system, while one was conducted in person.
All interviews were audio-recorded for transcription and analysis. No interviewees objected to
using recordings due to the confidentiality provisions stipulated in advance by the researcher.
Those requirements included redaction of all names both on the platform at the time of the
interview, and during the interview process. At each interview, subjects confirmed their intent to
proceed and acknowledge receipt of the information sheet and opt-out provisions.
Structure, function, and timing. Interviews followed the planned semi-structured
format. As the interviews were completed, the discussion allowed for additional questions
relative to the topics. The effect was the ability to gather other data corresponding to topics
about which the respondent had unique perspective or expertise.
The timing of interviews was kept for tracking and analysis purposes. Duration was
auto-calculated based on the start and stop times of the interview. Basic descriptive statistics
(central tendency and dispersion) were applied to the duration fields. Table 7 presents the results
of that analysis. Across eight completed interviews, the total duration was 223 minutes or 3.72
hours.
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Table 7.
Descriptive Statistics for Completed Stakeholder Interviews (n=8)
Measure
Total Interview Time (Minutes) Total Interview Time (Hours)
Mean 27.86 0.46
Std. Error of Mean 3.67 0.06
Median 26.00 0.43
Mode 12.00
a
0.20
a
Std. Deviation 10.37 0.17
Variance 107.56 .030
Range 31.00 0.52
Minimum 12.00 0.20
Maximum 43.00 0.72
Sum 223.00 3.72
Note. a. Multiple modes exist. The smallest value is shown.
Methods and tools for analysis. This section explores other data collected during
observation activities.
Analysis of qualitative data. A level progressive coding model was applied to the
interview data. The model changed as more interviews were completed. Axial coding formed
the basis for developing identifying and developing the nodes. In the next level, nodes were
categories into themes. Their architecture aligned directly with the research questions and
conceptual framework of the study. A node reconciliation was performed midway through the
interview analysis process and at its conclusion.
6
Also, in vivo coding occurred on key phrases
linked to study themes during the analysis process. A total of 21 in vivo nodes were identified
during analysis of the interview data.
7
The remaining nodes were organized into a general theme
category. To help organize the data in a more usable format, associative relationships were
6
A comprehensive node listing is available in Appendix J.
7
In vivo coded nodes are listed in Appendix J.
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drawn between the nodes in each KMO category and the appropriate research question. An
additional layer of textual analysis recognizing specific words and phrases was also applied to
help more rapidly identify themes and patterns not detected in during the coding process. As a
result of the analysis, findings were linked to the appropriate nodes developed during the coding
process.
The next data collection method is field observation.
Observation
In using observations as a data collection method, researchers can focus on the moment
in time, seeing things as they unfold rather than moving back and forth as with interviews
(Erlandson et al., 1993). Using observation allows researchers to explore subjects, behaviors,
relationships, and interactions in real time. That can serve as both a value and a potential barrier
depending on the environments and circumstances that observations happen. The method itself,
though, does lend support to the research questions in this study.
Application to the research questions. By design, observations not only bolster the
KMO framework, but also the research questions in this study that originate from it. For the first
research question, data on behaviors and elements were observed to see what extent they were
currently implemented, and to what degree they were used. That concept also ties directly to
sustainability in research question three. Moreover, observation allowed the researcher to see
how compliant departments, units, and individuals are with organizational assets such as policies
and procedures, and how deeply the elements of a culture of compliance as discussed in guidance
from the HHS OIG (2011). While surveys and interviews may be more direct in diagnosing
stakeholder knowledge and skills, observations provide insights into motivation. Observations
provide the researcher with a unique opportunity to explore the intersection of beliefs, motives,
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concerns, and culture (Guba & Lincoln, 1981). To some degree, observations allowed seeing if
there is a practical application of the knowledge and skills in research question two. The next
section discusses how observations were administered.
Observation approach, administration, implementation, and design. Protocols for
observation varied from those of any other qualitative data collection method. Like
interviewing, observation is a skill which requires noticing details, similarities, and differences in
connecting outcomes to actions (Merriam & Tisdell, 2016). A representative sample of locations
within the selected site was used. Since this is a longitudinal study, observations occurred in
multiple instances across the same location. Not all locations within the site were observed. To
ensure there is maximum compliance with the HIPAA Privacy Rule, observations were noted in
the REDCap data collection form with no protected health information (PHI) or personally
identifiable information (PII) from patients recorded. Additionally, the institution’s Notice of
Privacy Practices also applied to this covered research activity. For this data collection method,
computer systems and patient records were also assessed only in totality with no specific
information being collected from them. Bogdan and Biklen (2007) draw an essential point that
the focus of observations must be clear for protocols to be approved. The observations in this
study focused on stakeholder participants and related process in which they were involved. They
were both direct and indirect, meaning that the researcher may be actively engaged in the way in
which processes and interactions happen at various times, and not actively involved at others.
Appendix E lists the observation protocols in detail.
Structure, function, and timing. Observational data were collected in the Clinical Field
Observation, Laboratory Field Observation, and Other Field Observation arms of the study’s data
collection phase. Out of the 21 different locations observed, four were assessed longitudinally.
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Follow-ups observations were conducted at random intervals, the shortest being one week and
the longest being three months.
The timing of observation was kept for tracking and analysis purposes. Duration was
auto-calculated based on the start and stop times of the observation. Basic descriptive statistics
(central tendency and dispersion) were applied to the duration fields. Table 8 presents the results
of that analysis. Across 25 completed observations, the total duration was 1,177 minutes or 20
hours. The higher standard deviation indicates that the total duration of observations varied more
significantly than that of the interviews.
Table 8.
Descriptive Statistics for Completed Field Observations (n=25)
Statistic
Total Observation Time
(Hours)
Total Observation Time
(Minutes)
Mean .78 47.08
Std. Error of Mean .11 6.67
Median .73 44.00
Mode 1.00
a
60.00
a
Std. Deviation .56 33.35
Variance .31 1,111.91
Skewness .73 .73
Std. Error of
Skewness
.46 .46
Kurtosis -.39 -.38
Std. Error of
Kurtosis
.90 .90
Range 1.85 111.00
Minimum .15 9.00
Maximum 2.00 120.00
Sum 19.60 1,177.00
Note. a. Multiple modes exist. The smallest value is shown.
Methods and tools for analysis. This section explores other data collected during
observation activities.
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Analysis of other quantitative data. As with the other data collection methods in this
study, field observation included both quantitative and qualitative data. Levels of measurement
included nominal, and scale (interval) data. Ordinal and ratio data were not included.
Quantitative fields linked observations to Program Elements, aimed at answering Research
Question 1, as well as gathering statistical information related to the application (procedural
knowledge) of regulations (conceptual knowledge), aimed at answering Research Question 2.
8
Analysis of qualitative data. Similar to stakeholder interviews, the observation
instrument included several free-text open fields to cases various conditions related to the
research questions and conceptual framework. Analysis of qualitative observation data occurred
after the interviews so that the same progressive coding process could be applied. Observation
data was directly inputted into the form, so no transcription was required. Each observation was
stored as an individuals case, and closed-ended questions were created as case attributes to
compare them by demographics and other relevant values. Nodes were created for all open-
ended questions. An additional layer of textual analysis recognizing specific words and phrases
was also applied to help more rapidly identify themes and patterns not detected in during the
coding process. As a result of the analysis, findings were linked to the appropriate nodes
developed during the coding process. The next section details methods relating to document and
artifact analysis.
Documents and Artifacts
Documents and artifacts provide a unique opportunity to explore the deliverables of
organizations including their culture, systems, behaviors, priorities, and innovation. Document
8
The results of the quantitative observational analysis are presented in Table 50 of Appendix L.
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analysis is an add-on to examining multiple sources of data using some the data collection
methods discussed herein. Sources for document and artifact analysis must purposeful with
direct relevance to a study (Creswell, 2014). Documents accessed during this study included
policies, procedures, standing orders, organizational forms, handbook, process maps and related
records. Artifacts, alternatively, are meant to package and convey meaningful communication to
individuals who may encounter them (Merriam & Tisdell, 2016). Individuals must also consider
the environment in which they are encountered. For this dissertation, it is necessary to examine
the data collection method in the light of the research questions.
Application to the research questions. Document analysis ties closely to all three
research questions in this study. By examining work papers and documents that explore systems,
the research either adds credence or counters the assumptions for research question one raised
during the other methods of data collection. For research question two, document and artifact
analysis ties more closely to knowledge and skills, as they are outputs of those influences.
Perhaps the most directly applicable research question is number three. That is mainly because
organizational assets (system, policies, procedures, and internal controls such as budgets and
audits) are a direct reflection of its priorities and motivations, covering the remaining element of
question two as well. Creswell (2014) emphasized purposeful selection with regards to
documents and artifacts included in a study. Next, protocols for document and artifacts analysis
are discussed in more detail.
Document and artifact data collection approach, design and protocol. With the
business case established for document and artifact data collection, there are some important
considerations to ensuring success in that effort. For organizational controls and assets such as
policies and procedures, only published and approved documents were reviewed. While draft
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documents have value, they may not directly reflect the way in which the organization is
conducting compliance and regulatory activities. Approved documents are also cleared for
implementation by senior and executive management, whereas draft documents are subject to
change. An essential component of document analysis is reduction and mitigation of bias (J. A.
Maxwell, 2013). Vetted and approved documents typically go through several layers of review
and changes before they are finally published. Other potential areas of documents included
external items such as grant announcements, training slide decks, and contracts. They are
important because they establish the protocols and guidelines under which the institution’s
research activities must take place. Other documents collected included but were not limited to,
training presentations, regulatory standards and guidelines, and collaboration documents such as
mind-maps which were publicly available. The same approval standards applied to policies and
procedures may not necessarily apply to these types of documents. For artifacts, only those
which conform to the definition in Merriam and Tisdell (2016), as well as the subject matter for
the study, were selected.
In developing details for how the documents were analyzed, there were a combination of
free-text fields and closed-ended items which directly correspond to the study’s conceptual
framework. Those can ultimately be tied back to specific research questions during the study.
The Document and Artifact Analysis instrument in Appendix F presents the specific fields to be
collected.
Structure, function, and timing. Document and artifact analysis was completed during
the entire five-month data collection phase of the study. There were a total of 17 items
analyzed, four of which were artifacts, and 13 that were documented. The timing of activity was
kept for tracking and analysis purposes. Duration was auto-calculated based on the start and stop
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times of the observation. Table 9 presents the results of that analysis. Across 17 completed
analysis activities, the total duration was 451 minutes or 7.52 hours. The higher standard
deviation indicates that the total duration of observations varied more significantly than that of
the interviews, but less than observations.
Table 9.
Descriptive Statistics for Completed Document and Artifact Analysis (n=17)
Statistics Total Analysis Time
(Minutes)
Total Analysis Time
(Hours)
Mean 26.53 .44
Std. Error of Mean 4.72 .08
Median 25.00 .42
Mode 4.00
a
.07
a
Std. Deviation 19.46 .32
Variance 378.76 .11
Skewness .62 .62
Std. Error of Skewness .55 .55
Kurtosis -.60 -.60
Std. Error of Kurtosis 1.06 1.06
Range 60.00 1.00
Minimum 4.00 .07
Maximum 64.00 1.07
Sum 451.00 7.52
Note. a. Multiple modes exist. The smallest value is shown.
Methods and tools for analysis. This section explores other data collected during
document and artifact analysis activities. Rather topics discussed in Chapter Three, the
information presented is specifically from the post-analysis perspective.
Analysis of other quantitative data. As with the other data collection methods in this
study, field observation included both quantitative and qualitative data. Levels of measurement
included nominal, and scale (interval) data. Ordinal and ratio data were not included.
Quantitative fields linked observations to all components of the Conceptual Framework. The
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structure of the Conceptual Framework section tied to each the respective study Research
Questions. Other quantitative analysis assessed document availability, accessibility, and use.
Analysis of qualitative data. Unlike the other data collection methods, the document and
artifact analysis tool contained only two free-text fields. Specifically, those fields covered usage
and barriers to usage. Based on the data gathered during collection, the responses ultimately
revealed insights on motivation and organizational influences, flowing up to Research Question
3. Each activity was stored as an individuals case, and closed-ended questions were created as
case attributes to compare them by demographics and other relevant values. Nodes were created
for all open-ended questions. An additional layer of textual analysis recognizing specific words
and phrases was also applied to help more rapidly identify themes and patterns not detected in
during the coding process. As a result of the analysis, findings were linked to the appropriate
nodes developed during the coding process. Following is a summary of data collection and
instrumentation.
Summary
Each method of data collection is critical to effectively addressing the research questions
in this study. Creswell (2014) highlighted that all methods must be considered collectively to
ensure relationships between each other and the goals and purposes of the study. Each method
also has protocols and considerations that must be fully accounted for to ensure validity,
reliability, credibility, and trustworthiness. One of the primary goals of a mixed methods study is
to use as many avenues as possible to understand the research questions and their impact on the
organizational performance problem, and the larger conceptual framework. Table 10 shows how
the Research Questions, Conceptual Framework, KMO Influences, and Data Collection
Instruments are tied together.
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Table 10.
Research Questions, Conceptual Framework, KMO Influences, and Data Collection
Research
Question
Conceptual Framework KMO Influence Data Dictionary
Codebook
Reference
RQ 1. What are
the essential
elements and best
practices of a
regulatory and
compliance
program (referred
to hereafter as
compliance
program) in a
specialty
academic medical
institution?
I. Program
Elements
None • Survey lines
30-50
• Interview
lines 147,
151 and 156
• Observation
line 201
• Document
and Artifact
line 215,
219-231
RQ 2. From the
perspective of
staff, what are the
knowledge, skill
and motivational
influences that
contribute to
building and
maintaining an
efficient and
sustainable
compliance
program?
II. Knowledge
and Skills
Staff needs to know
the regulations
applicable to practice
and research.
(Conceptual), Staff
needs to know how to
implement and
comply with the
relevant regulations.
(Procedural)
• Survey lines
51-68
• Interview
lines 148-
150
• Observation
lines 192
and 193
• Document
and Artifact
lines 210,
and 219-231
RQ 3. From the
perspectives of
staff, what
organizational
influences need to
exist – and to
what extent – to
build an effective,
sustainable
compliance
program in a
specialty
III. Motivational
Influences
Staff needs to feel that
the process of
complying with
relevant regulations is
worth the burden,
time, and expense.
(Expectancy-value
theory (EVT)),
Individual staff
members and the
stakeholder group
need to believe that
regulatory compliance
• Survey lines
69-76
• Interview
lines 151-
153
• Observation
lines 196,
197, and 200
• Document
and Artifact
lines 217,
and 232-231
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Research
Question
Conceptual Framework KMO Influence Data Dictionary
Codebook
Reference
academic
medicine setting?
is probable (Self-
efficacy theory (SET)
IV. Organizational
Influences
Institutional systems,
assets, and processes
need to facilitate
implementing and
sustaining compliance
in practice and
research
(Organizational
Assets), Institutional
leaders and staff need
to create an internal
climate fostering
sustained
improvement and
build on assumed
motivational
influences
(Organizational
Culture).
• Survey lines
77-109
• Interview
lines 154
and 155
• Observation
lines 198
and 200
• Document
and Artifact
lines 218-
235
Note. Some codebook lines apply to more than one category.
Data Analysis
Platform, Logic, and Design
Four separate instruments were created for data collection and analysis on REDCap; one
for each separate data collection activity. Table 9 shows the instrument, number of fields, and
designation of each instrument, along with the corresponding item range as defined in the study’s
data dictionary. Table 11 presents each data collection instrument of the study as they were
constructed.
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Table 11.
Data Collection Instruments, Fields, Designation, and Item Ranges
Instrument Fields Type Data Dictionary
Codebook Lines
Staff Stakeholder Survey 116 Survey 1-116
Focused Interview Inputs 50 Form 117-167
Field Observation 37 Form 168-205
Document and Artifact Analysis 32 Form 208-240
A Data Dictionary Codebook for each instrument was developed.
9
Each field was
assigned a unique variable and field name with consistency throughout each instrument. Each
record was automatically assigned a unique record ID upon completion or entry into the form.
That accounted for typicality, and easily allow for survey and form records to be imported into
data analysis software and rapidly interpret unique values for each instrument and item.
Analysis of Quantitative Data
Frequency and percent distributions were used for non-scale quantitative data. For
applicable items requiring descriptive statistics, the central tendency measures of mean, median,
mode, and sum were calculated. Dispersion, where applicable, was also calculated including
standard deviation, variance, range, minimum, maximum, and standard error mean.
Additionally, skewness and kurtosis were applied to scale-level data. Depending on the
construction and possible responses of the item, deeper analysis and alternate methods of coding,
tabulation, and display were also used.
9
A copy of the consolidated Data Dictionary Codebook is located in Appendix A.
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Coding and Analysis of Qualitative Data
For interviews, observations, and document and artifact review, analysis of data was
progressive and continued throughout the data collection phase, analysis, solution development,
and reflection. Interview transcripts and recordings, along with observation field notes were
coded using qualitative analysis software based on a phased approach. In the first phase, open
and empirical coding utilized an a priori method to link each of the foundational elements in the
conceptual framework to a source reference. In phase two, the a priori and empirical codes were
assigned a root node via analytical/axial coding. Root nodes (highest level coding) were built off
of the each of the knowledge and skills, motivational and organizational influence categories
derived from Clark and Estes (2008). In phase three, analysis of those elements of the
conceptual framework was then tied to the larger research questions of the study. Syntheses of
documents and artifacts, where possible, were tied using the same coding methodology to both
the research questions and elements of the study’s conceptual framework. Field annotations and
analytic memos were used to summarize trends and themes for each interview transcript and
qualitative data collection form.
Timeline and Plan
This study was longitudinal. Data collection and analysis consisted of six arms, with
corresponding events. Table 12 lists each arm as they were scheduled, along with the number of
individual planned events. Planned survey and interview events varied due to response rate.
Observations and document had a fixed goal.
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Table 12.
Study Arms and Events Summary
Arm Name Planned Events
Survey Data Collection Varies
Focused Stakeholder Interviews Varies
Clinical Field Observation 15
Laboratory Field Observation 2
Other Field Observation 8
Document and Artifact Analysis 15
Analysis of survey data occurred as responses were received. Transcriptions of
interviews occurred shortly after the event to more rapidly import transcriptions and forms into
the qualitative analysis software for coding. Entry of observation and document and artifact
analysis form occurred either during the event or closely after its conclusion, and cases were then
imported into the qualitative analysis software and coded. The next section of this chapter
details credibility and trustworthiness considerations.
Credibility and Trustworthiness
Like any dissertation or other research endeavors, credible and ethical methods were
essential. The dissertation studied ethics and regulatory requirements that govern clinical
practice and research. As this project employed mixed methods of data collection and analysis,
this section outlines the efforts to maintain credibility and trustworthiness of the qualitative
components. As an evaluation model, the goal of this study was to identify essential information
that supported the research questions. It was necessary to give particular focus to the program
elements and knowledge, motivational and organizational influences that impact ethical
behavior. Sandelowski (1986) links the credibility of research to the association and replication
of human experience, causing those who use and apply the research or reap its benefits to
identify with and personally apply it in their experiences. When conducting interviews with staff
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stakeholders, the goal of data collection was to elicit their practice and professional perspective
on the role of compliance and regulatory programs in their daily and ongoing responsibilities.
That was one of the purposes of identifying respondents who had experience leading or
supporting the completion of research studies. The research-related findings were derived
directly from the stakeholder and applied in their context. As the focus turns to observation,
Merriam and Tisdell (2016) find that one of the threats to credibility in observational data
collection is the impact and presence of the researcher. This study utilized indirect observation,
where the researcher was analyzing behaviors, work processes, compliance with policies and
other activities, from outside of the primary interactions within the setting. Additionally, as
observations happened in research and patient care areas, notes and observations were limited
only to the scope allowed to answer the research questions and removed any potential for
identification of patients or use and disclosure of protected health information.
Regarding trustworthiness, Merriam and Tisdell (2016) establish a direct link
between the credibility of the researcher and the overall perception of the study. The researcher
had vetted experience in regulatory and compliance subject matter and served as an existing
resource to the staff and staff involved in both research and patient care activities. Protocols that
aligned with both the university and site IRB policies and procedures were vetted in preparation
for submission and were reviewed under the direction of the Department leadership. Approval
from institutional executive leadership was also received before performing any on-site
activities. The next section explores validity and reliability.
Validity and Reliability
In the quantitative elements of this study, validity and reliability were important parts of
establishing the instruments, developing the protocols, collecting the data and analyzing results.
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For surveys, validity is the extent to which results align with “reality” (Nolte, Shauver, & Chung,
2015). Although validity takes many forms and has various considerations, vetting the survey
instrument was an essential strategy in this study. Heale and Twycross (2015) identify content
validity, for example, as the extent to which the instrument measures the various aspects of the
construct or subject. They further find that construct validity focuses on whether it measures
what was intended. Finally, the authors identify criterion validity as to what degree the
instrument is related to similar instruments of purpose, scope and construct focus. One approach
to achieve each of those forms of validity was to use review of the professional and theoretical
literature to ensure that the instrument correctly posed questions to focus and gathered the right
types of data, which were the most meaningful and relevant.
A confidence interval was used to the extent to that results were consistent with the mean
of the sample, as with guidance from Creswell (2014). In the data analysis phase, a confidence
interval of 95 percent was applied to corresponding statistical calculations. All study instruments
were screened by university faculty, researcher’s dissertation committee, and the Institutional
Review Board (IRB) before use. Concerning bias in quantitative studies, Lash, Fox, Cooney, Lu,
and Forshee (2016) discuss the importance of employing methods which are transparent and
under regular and welcome scrutiny. With that in mind, protocols, instruments, and results went
through a peer review process before implementation, use or analysis. The peer review process
was particularly helpful in ensuring continuity and consistency of the tools, creating the
possibility of better application of the findings of this evaluation. The final section of this
Chapter details ethical considerations associated with the study.
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Ethics
This study was carried out in strict compliance with Federal and institutional guidance on
the protection of human subjects and OHRP Regulations. The University Park IRB at the
University of Southern California determined that this study met the criteria for exempt research.
Participation in all data collection activity was strictly voluntary and remained confidential.
Participants were coded and de-identified in data collection. The code was known only to the
researcher. At each subject-facing data collection activity, a copy of the study’s information
sheet was made available.
10
Subjects had the option to terminate their participation in the study
at any time.
For all activities, risks related to potential HIPAA breaches were mitigated before data
collection. There was no direct use or disclosure of protected health information. The only
instances in which patients might have been involved in the study were indirectly when passing
through observation environments. No images, recordings, or other information was gathered
which could have potentially identified any patients or non-direct research subjects.
Observations did not include specific patient appointments, nor were any patients, staff members
or staff members by name identified.
The research was conducted solely by the dissertation’s author. Transcription used an
outside organization. No conflicts of interest were identified or encountered during the study.
Before entering each area for observation, appropriate approval was sought as detailed in this
Chapter and the observation protocols. The research activities would have immediately ceased if
requested by either a participant, patient (de-identified), staff, or any institutional staff member.
10
An example of the Information Sheet is provided in Appendix I.
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Although related, the activities carried out in this study were separate and distinct from the
author’s regular daily responsibilities. As this study is an evaluation model only, no preexisting
or encountered bias was part of either the data collection or analysis processes.
Summary
This dissertation used a mixed-methods approach across several arms and instruments.
Three Research Questions guided the study and associated data collection and analysis. Validity,
reliability, credibility, and trustworthiness were each addressed in preparation for and throughout
all activities. Ethics and compliance were thoughtfully addressed, and every effort was taken to
mitigate risk to subjects and sites. No risk or adverse events were encountered during data
collection and analysis.
Chapter Four details the study’s findings and results.
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CHAPTER FOUR: RESULTS AND FINDINGS
Introduction
Study Goals and Objectives
Chapter Four of the dissertation presents the study’s summary of data analysis, findings,
and answers to the problem of practices and associated research questions, through the lens of
the conceptual framework. The problem of practice explored in this research is the impact that a
lack of program sustainability and stakeholder efficacy has on clinical and research outcomes. A
majority of the conceptual framework and two of the study’s research questions are based
primarily on the knowledge and skills, motivation, and organizational influences (KMO) model
developed by Clark and Estes (2008). Because this study is an evaluation model, the rest of the
framework and the remaining research question explore the essential elements of effective
compliance and regulatory efforts as they relate to improving stakeholder efficacy and long-term
program sustainability. The study’s research questions are stated below.
1. What are the essential elements and best practices of a regulatory and compliance
program (referred to hereafter as compliance program) that build its efficacy and
long-term sustainability?
2. From the perspective of staff, what are the knowledge, skill and motivational
influences that promote stakeholder compliance efficacy and contribute to building a
sustainable compliance program; and how should the content relating to those
influences be delivered?
3. From the perspectives of staff, what organizational influences need to exist – and to
what extent – to build stakeholder efficacy and a sustainable compliance program;
and how should those influences be constructed within the institution?
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The conceptual framework amalgamated the research questions through the lens of the
Clark and Estes (2008) gap analysis model, as shown below in Figure 6.
Figure 6. Study Conceptual Framework.
The study’s Conceptual Framework draws on the elements of all of the Research
Questions,
Data Collection and Analysis Details
To answer the research questions, the study employs a mixed method approach for data
collection and analysis through surveys, focused interviews, direct site observation (both
participatory and non-participatory), and document and artifact analysis. Findings gleaned
related to the data collection, and analysis process is presented below.
Data Collection Summary
A total of 133 cases were collected during the five-month data collection period. Table
13 lists the total number of cases by data collection instrument.
I.
Program Elements
•HHS OIG (2011)
Fundamental
Elements
•Practice Elements
•Improvement and
Utilization Elements
II.
Knowledge and
Skills
•Rules and
regulations
(Conceptual)
•Implementation
(Procedural)
III.
Motivational
Influences
•Value in time,
effort, (EVT)
•Compliance is
probable (SET)
IV.
Organizational
Influences
•Assets
•Culture, context and
setting
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Table 13.
Data Collection by Instrument
Instrument Number of Cases
Surveys 83
Interviews 8
Field Observations 25
Documents and Artifacts 17
Note. This table relates to the study arms listed in the table below.
11
Data collection followed the six-arm structure described in Chapter Three of the study.
Table 14 presents the number of cases planned compared to the number completed by study arm.
For comparison purposes, events and cases both refer to each unique data record collected during
this phase of the study.
Table 14.
Study Arms, Planned Events/Cases, Completed Events/Cases
Arm Name Planned Cases Completed Cases Variance
Survey Data Collection Varies 83 N/A
Focused Stakeholder Interviews Varies 8 N/A
Clinical Field Observation 15 15 0
Laboratory Field Observation 2 2 0
Other Field Observation 8 8 0
Document and Artifact Analysis 17 17 0
Note. This table lists each study arm corresponding to the order in which they were completed. Some
were completed simultaneously.
There was no variance in observations, but two additional documents were collected due
to their assessed impact on the conceptual framework and research studies.
Surveys
During the survey data collection period, a total of 83 usable surveys were collected. In
this instance, the term “usable” describes a survey in which sufficient data existed to analyze in
11
See Table 14 for more information.
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sections beyond the demographic information. The number of responses was higher than
anticipated given the length of the data collection instrument. It was assumed that consistent
with research by Jepson, Asch, Hershey, and Ubel (2005), the length of the survey would
adversely impact the number of responses received. The study’s overall survey completion rate
was 79.0 percent when compared to the study’s total survey sample pool of 105 respondents who
expressed an interest in participating.
Respondent characteristics. Survey data was captured globally from individuals
meeting the stakeholder group criteria as defined in Chapter Three. The majority of respondents
came from the United States. Figure 7 presents the location of the respondents by state.
Figure 7. Geographic heat map of survey respondents within the United States.
12
12
Yellow indicates lower rates of response while green represents the state with the highest
number of responses, in this case, the state of Colorado. White states are those with no respondents.
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Interviews
Focused interviews were completed in the second arm of data collection. The interview
instrument, located in Appendix D, lists all of the questions presented. There were a total of 50
data fields, which are linked to lines 117 through 167 of the Data Dictionary Codebook.
13
No
additional fields were added during the data analysis phase for interviews.
As described in Chapter Three of this study, interview subjects were recruited from the
pool of survey respondents. For a respondent to be considered eligible for the interview, they
must have: (i) met the criteria defined in the “Interview Sampling” section of Chapter Three, (ii)
provided the appropriate contact information and authorization to participate, and (iii) indicated a
willingness to proceed upon receipt of the invitation to interview. From the pool of 83 usable
surveys, a total of 26 (or 31.32 percent) met the eligibility criteria for interview participation.
From the eligible respondent pool, a total of 13 subjects responded to the interview invitation,
and eight subjects (or 30.76 percent) completed the interview process. The most common
reasons for subjects declining to participate were time requirements and alignment of the study’s
scope to their role. The final interview completion rate represents 9.63 percent of the valid
survey pool.
Participant characteristics. Interview participants spanned both the criteria for
participation and the United States. Participants were located in Colorado, Florida, and Ohio.
Table 15 below describes the alignment of interview respondents to selection criteria defined in
Chapter Three of the study. “Validated” indicates that at least 25 percent of the respondents met
the criterion. Some participants met more than one of the requirements listed. Consistent with
13
See Appendix A to review the study’s Data Dictionary Codebook.
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criteria definitions in Chapter Three, participants may have appeared in either Criterion 1C or
1D, but not both. Not all subjects met the definition for either criterion.
14
Table 15.
Interview Subjects by Sampling Criteria (n=8)
Criterion
Number
Criterion Description Total
Participants
Percent of
Pool
Validated
1A Providers or licensed clinical
support staff
2 25.00 Yes
1B Investigators 3 37.50 Yes
1C Clinical, operational, and
research support staff.
0 .00 No
1D Institutional management and
administration
8 100.00 Yes
2 Regulatory-facing clinical or
research staff.
8 100.00 Yes
3 Survey completion 8 100.00 Yes
Note. This table references the number of participants in each criterion as outlined in Chapter Three.
The next section describes data relating to completed observations.
Observations
Field observations were completed using the instrument in Appendix E. The final
instrument contained 37 fields, corresponding to lines 168 through 205 in the codebook.
15
A
total of 25 direct and indirect field observations were completed over a five-month period.
While all observations were limited to one institution, multiple sites were observed.
Observations were longitudinal, meaning that some locations within each site were observed
more than once. A randomization strategy was employed to select sites which would be
14
A more comprehensive review of interview respondent demographics is presented in Table 51
of Appendix L.
15
See Appendix A to review the study’s Data Dictionary Codebook.
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revisited. While all sites were covered during the observation period, not all departments and
operating units were observed.
Document and Artifact Analysis
Analysis of documents and artifacts was completed using the instrument in Appendix F.
The final instrument contained 33 fields, corresponding to lines 206 through 239 in the
codebook.
16
A total of 17 documents and artifact were analyzed over a five-month period across
multiple sites. For confidentiality purposes, site identifying information was redacted from each
document and not included in the data collection process.
Overview of Results and Findings
Based on data collection, this section details the results and findings specific to the
study’s Research Questions and Conceptual Framework. Based on the data analyzed as a result
of data collection, the most effective means to communicate the results and findings was through
the lens of the Clark and Estes (2008) gap analysis model referenced throughout the study.
Research Questions and Conceptual Framework Elements will be linked to their respective
influence, except Research Question1 and Framework Element I which have application across
all three influence domains. Figure 8 below presents the how each influence ties to a Research
Question and Conceptual Framework Elements.
16
See Appendix A to review the study’s Data Dictionary Codebook.
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Figure 8. Thematic relationship diagram for the Gap Analysis (KMO) influences, study
Research Questions (RQ), and the Conceptual Framework (CF) element.
17
Results and Findings for Research Question One
In Research Question One, Program Elements are assessed. This Research Question
applies to Conceptual Framework Element I. Figure 9 presents the direct and indirect
relationships graphically.
17
The Conceptual Framework Element corresponds to the items in Figure 6 of this
Chapter.
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Figure 9. Thematic relationship diagram for Research Question One and the Conceptual
Framework.
Program Elements
This section presents findings and results for the essential Program Elements to answer
the study’s first research question. The element model is derived from both the Seven
Fundamental Elements of an Effective Compliance Program as developed by the Health and
Human Services (HHS) Office of the Inspector General (2011) and from the review of relevant
research as listed in Chapter Two of this dissertation. Elements are broken up into three
categories based on their source and purpose.
Category: OIG Fundamental Elements. Elements in this category are the Seven
Fundamental Elements of Effective Compliance Programs as developed by the HHS Office of
the Inspector General (OIG) (2011) and described in Chapter Two.
Category: Compliance though Practice. Elements in this category are the practice-
based elements as derived from the literature review. Specifically, these elements involve actual
practices that institutions can undertake to improve compliance efficacy and sustainability.
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Category: Compliance through Improvement and Utilization. Elements in this category
are those needed for utilization and program improvements as derived from the literature review.
Specifically, these elements involve specific processes, characteristics, and influences that
organizations can optimize to improve compliance efficacy and sustainability. Table 16 presents
all assessed elements.
Table 16.
Compliance Efficacy and Sustainability Program Element Evaluation Model
No. Program Element HHS OIG
Derived
Literature
Derived
OIG Fundamental Elements
H1 Implementing written policies and procedures Yes No
H2 Designating a compliance officer and compliance
committee
Yes No
H3 Conducting effective training and education Yes No
H4 Developing effective and open lines of communication Yes No
H5 Conducting internal compliance monitoring and
auditing
Yes No
H6 Enforcing standards through well-publicized
disciplinary guidelines
Yes No
H7 Responding promptly to detected problems and
undertaking corrective action
Yes No
Compliance through Practice
P1 Developing and implementing systems for tracking
adverse and sentinel events
No Yes
P2 Performing risk management and quality activities such
as peer review and clinical risk
No Yes
P3 Creating visibility and transparency in developing and
implementing institutional policies and procedures
No Yes
P4 Creating management and staff buy-in for
implementing compliance requirements
No Yes
P5 Practicing ongoing practice and process improvement No Yes
Compliance through Improvement and Utilization
I1 Organizational assets No Yes
I2 Dedicated compliance and regulatory staff No Yes
I3 Compliance and regulatory training and ongoing
professional development
No Yes
I4 Organizational culture No Yes
I5 Monitoring and auditing systems for adverse and
sentinel events
No Yes
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No. Program Element HHS OIG
Derived
Literature
Derived
I6 Root cause analysis, investigations, and implementation
of interventions
No Yes
I7 Clinical risk management and process improvement
projects
No Yes
I8 Compliance strategic and work plans No Yes
Feedback mechanisms No Yes
Note. This table lists each of the 21 Program Elements in the Conceptual Framework according to the
source from which they were derived.
Validation of elements. Gathered during survey data collection, validation of a Program
Element was based on stakeholder perception of the element’s essentiality. Scoring used a
predefined threshold to validate the Program Element. The review of relevant research did not
specify a validation test to be used in the analysis of this kind of data. Accordingly, the
following method was used to determine a test. For each element, ratings of “Highly Essential”
and “Essential” were added to create a subtotal both in the N and Percent. To derive the
threshold, a mean of all percent subtotals was calculated – resulting in a value of 91.7. Elements
were considered validated if the percent subtotal was greater than or equal to 91.7.
Validation results. Validation was broken into three categories as listed in Table 16
above. Presentation of results follows those three categories. Final validation determinations
will be presented in a summary table with all three categories.
Category: OIG Fundamental Elements. Table 17 presents the validation analysis of the
Seven Fundamental Elements as developed the HHS OIG (2011).
Table 17.
Validation of Program Elements Derived from HHS OIG (2011) Fundamental Elements of
Effective Compliance Programs
Influence Possible Rating
N Percent
H1 Implementing written policies and procedures Highly essential 65 85.53
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 126
Influence Possible Rating
N Percent
Essential 10 13.16
Subtotal 75 98.68
Somewhat essential 1 1.32
Nonessential 0 .00
Cannot assess 0 .00
H2 Designating a compliance officer and
compliance committee
Highly essential 44 57.89
Essential 22 28.95
Subtotal 66 86.84
Somewhat essential 8 10.53
Nonessential 1 1.32
Cannot assess 1 1.32
H3 Conducting effective training and education Highly essential 64 84.21
Essential 9 11.84
Subtotal 73 96.05
Somewhat essential 2 2.63
Nonessential 1 1.32
Cannot assess 0 .00
H4 Developing effective and open lines of
communication
Highly essential 59 77.63
Essential 15 19.74
Subtotal 74 97.37
Somewhat essential 1 1.32
Nonessential 1 1.32
Cannot assess 0 .00
H5 Conducting internal compliance monitoring
and auditing
Highly essential 41 53.95
Essential 29 38.16
Subtotal 70 92.11
Somewhat essential 5 6.58
Nonessential 1 1.32
Cannot assess 0 .00
H6 Enforcing standards through well-publicized
disciplinary guidelines
Highly essential 23 30.26
Essential 36 47.37
Subtotal 59 77.63
Somewhat essential 14 18.42
Nonessential 2 2.63
Cannot assess 1 1.32
H7 Responding promptly to detected problems
and undertaking corrective action
Highly essential 58 76.32
Essential 17 22.37
Subtotal 75 98.68
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 127
Influence Possible Rating
N Percent
Somewhat essential 0 .00
Nonessential 1 1.32
Cannot assess 0 .00
Note. This table references stakeholders' perception of program element essentiality. Respondents rated
survey the items using a Likert scale.
18
An element was considered validated if the subtotaled percent
value is 91.7 or higher. A confidence interval of 95 percent was used in the calculation.
The next category represents practice-based Program Elements as derived from the
review of relevant research.
Category: Compliance through Practice. Table 18 presents the validation analysis of
the practice-based elements as derived from the literature review.
Table 18.
Validation of Practice-based Program Elements Derived from the Literature Review
Influence Possible Rating
Count Percent
(%)
P1 Developing and implementing systems for
tracking sentinel events
Highly essential 38 50.00
Essential 31 40.79
Subtotal 69 90.79
Somewhat essential 6 7.89
Nonessential 1 1.32
Cannot assess 0 .00
P2 Performing risk management and quality
activities such as peer review and clinical risk
Highly essential 30 39.47
Essential 39 51.32
Subtotal 69 90.79
Somewhat essential 6 7.89
Nonessential 1 1.32
Cannot assess 0 .00
P3 Creating visibility and transparency in
developing and implementing institutional
policies and procedures
Highly essential 43 56.58
Essential 27 35.53
Subtotal 70 92.11
18
This table corresponds to the matrix choices in lines 30 through 36 of the Data Dictionary
Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 128
Influence Possible Rating
Count Percent
(%)
Somewhat essential 5 6.58
Nonessential 1 1.32
Cannot assess 0 .00
P4 Creating management and staff buy-in for
implementing compliance requirements
Highly essential 47 61.84
Essential 26 34.21
Subtotal 73 96.05
Somewhat essential 2 2.63
Nonessential 1 1.32
Cannot assess 0 .00
P5 Practicing ongoing practice and process
improvement
Highly essential 43 56.58
Essential 30 39.47
Subtotal 73 96.05
Somewhat essential 2 2.63
Nonessential 1 1.32
Cannot assess 0 .00
Note. This table references stakeholders' perception of program element essentiality. Respondents rated
survey the items using a Likert scale.
19
An element was considered validated if the subtotaled percent
value is 91.7 or higher. A confidence interval of 95 percent was used in the calculation.
The next category represents Program Elements based on their improvement and
utilization as derived from the review of relevant research.
Category: Compliance through Improvement and Utilization. Table 19 presents the
validation analysis of the elements needed for utilization and program improvements as derived
from the literature review.
Table 19.
Validation of Improvement and Utilization Program Elements Derived from the Literature
Review
19
This table corresponds to the matrix choices in lines 37 through 41 of the Data Dictionary
Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 129
Influence Possible Rating
N Percent
(%)
I1 Organizational assets (Policies, procedures,
processes. committees, etc.)
Highly essential 37 52.86
Essential 30 42.86
Subtotal 67 95.71
Somewhat essential 3 4.29
Nonessential 0 .00
Cannot assess 0 .00
I2 Dedicated compliance and regulatory staff
(Compliance officers, IRB staff, etc.)
Highly essential 49 70.00
Essential 17 24.29
Subtotal 66 94.29
Somewhat essential 4 5.71
Nonessential 0 .00
Cannot assess 0 .00
I3 Compliance/regulatory training and ongoing
professional development
Highly essential 44 62.86
Essential 23 32.86
Subtotal 67 95.71
Somewhat essential 3 4.29
Nonessential 0 .00
Cannot assess 0 .00
I4 Organizational culture (Communication,
management support of compliance initiatives,
etc.)
Highly essential 46 65.71
Essential 21 30.00
Subtotal 67 95.71
Somewhat essential 2 2.86
Nonessential 1 1.43
Cannot assess 0 .00
I5 Monitoring and auditing systems for adverse and
sentinel events
Highly essential 36 51.43
Essential 31 44.29
Subtotal 67 95.71
Somewhat essential 3 4.29
Nonessential 0 .00
Cannot assess 0 .00
I6 Root cause analysis, investigations, and
implementation of interventions
Highly essential 35 50.00
Essential 33 47.14
Subtotal 68 97.14
Somewhat essential 2 2.86
Nonessential 0 .00
Cannot assess 0 .00
Highly essential 29 41.43
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 130
Influence Possible Rating
N Percent
(%)
I7 Clinical risk management and process
improvement projects;
Essential 37 52.86
Subtotal 66 94.29
Somewhat essential 4 5.71
Nonessential 0 .00
Cannot assess 0 .00
I8 Compliance strategic and work plans Highly essential 23 32.86
Essential 34 48.57
Subtotal 57 81.43
Somewhat essential 12 17.14
Nonessential 0 .00
Cannot assess 1 1.43
I9 Feedback mechanisms such as town hall
meetings, listening sessions, and suggestion boxes
Highly essential 19 27.14
Essential 25 35.71
Subtotal 44 62.86
Somewhat essential 23 32.86
Nonessential 3 4.29
Cannot assess 0 .00
Note. This table references stakeholders' perception of program element essentiality. Respondents rated
the items using a Likert scale. An element was considered validated if the subtotaled percent value is
91.7 or higher.
20
A confidence interval of 95 percent was used in the calculation.
The next section discusses the determinations resulting analysis of the results in the
sections above.
Element validation determination. The determination of validation analysis based on the
threshold is presented below in Table 20. Lines in bold are validated Elements according to the
formula described in the tables above.
20
This table corresponds to the matrix choices in lines 42 through 50 of the Data Dictionary
Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 131
Table 20.
Validation of Program Elements Included in the Conceptual Framework
Program Element HHS
Derived
Literature
Derived
N Percent
(Test: ≥
91.7)
Validated
Yes (No)
OIG Fundamental Elements
H1 Implementing written policies
and procedures
Yes No 75 98.68 Yes
H2 Designating a compliance officer
and compliance committee
Yes No 66 86.84 No
H3 Conducting effective training
and education
Yes No 73 96.05 Yes
H4 Developing effective and open
lines of communication
Yes No 74 97.37 Yes
H5 Conducting internal
compliance monitoring and
auditing
Yes No 70 92.11 Yes
H6 Enforcing standards through
well-publicized disciplinary
guidelines
Yes No 59 77.63 No
H7 Responding promptly to
detected problems and
undertaking corrective action
Yes No 75 98.68 Yes
Compliance through Practice
P1 Developing and implementing
systems for tracking adverse and
sentinel events
No Yes 69 90.79 No
a
P2 Performing risk management and
quality activities such as peer review
and clinical risk
No Yes 69 90.79 No
a
P3 Creating visibility and
transparency in developing and
implementing institutional policies
and procedures
No Yes 70 92.11 Yes
P4 Creating management and staff
buy-in for implementing
compliance requirements
No Yes 73 96.05 Yes
P5 Practicing ongoing practice
and process improvement
No Yes 73 96.05 Yes
Compliance through Improvement and Utilization
I1 Organizational assets No Yes 67 95.71 Yes
I2 Dedicated compliance and
regulatory staff
No Yes 66 94.29 Yes
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 132
Program Element HHS
Derived
Literature
Derived
N Percent
(Test: ≥
91.7)
Validated
Yes (No)
I3 Compliance and regulatory
training and ongoing professional
development
No Yes 67 95.71 Yes
I4 Organizational culture No Yes 67 95.71 Yes
I5 Monitoring and auditing
systems for adverse and sentinel
events
No Yes 67 95.71 Yes
I6 Root cause analysis,
investigations, and
implementation of interventions
No Yes 68 97.14 Yes
I7 Clinical risk management and
process improvement projects
No Yes 66 94.29 Yes
I8 Compliance strategic and work
plans
No Yes 57 81.43 No
I9 Feedback mechanisms No Yes 44 62.89 No
Note. An element was considered validated if the subtotaled percent value is 91.7 or higher. A
confidence interval of 95 percent was used in the calculation. a.
Values of 90.79 were not validated due
to percent mean, but only varied by one response from the required N to reach the threshold.
Analysis. Of all 21 elements, 15 were validated. For elements derived from Office of
the Inspector General (2011), five of the seven were validated. For elements from the literature
review, 10 out of 15 were validated. The validation percentage for all elements and each source
was 71.4 percent. Table 21 presents the categorical validation results.
Table 21.
Summary of Validation of Program Elements Included in the Conceptual Framework
Category Number of
Elements
Number
Validated
Percent
Validated
OIG Fundamental Elements 7 5 71.42
Compliance through Practice 5 3 60.00
Compliance through Improvement
and Utilization
9 7 77.77
Total 15 21 71.42
Note. This table aggregates the validation of all 21 elements in the Program Elements section of the
Conceptual Framework.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 133
In two instances, Compliance through Improvement and Utilization derivative of the
literature review were expansions of some of the seven elements stated in Office of the Inspector
General (2011). Those included “Compliance and regulatory training and ongoing professional
development” and “Feedback mechanisms.”
21
The next section of the chapter details results and
findings for Research Question Two.
Results and Findings for Research Question Two
In Research Question Two, Knowledge and Skills influences were assessed. This
question applies to Conceptual Framework Elements II. Figure 10 presents the direct and
indirect relationships graphically.
Figure 10. Thematic relationship diagram for Research Question (RQ) Two, Gap Analysis
Elements Influences, and the Conceptual Framework (CF) Elements.
21
A correlation analysis of all elements to stakeholder perceived existence is available in Table
52, Table 53, and Table 54 of Appendix L.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 134
Knowledge and Skill Influences
This section applied to Research Questions 1 and 2, as well as Conceptual Framework
Elements I and II. Figure 10 presents the direct and indirect relationships graphically.
Figure 11. Thematic relationship diagram for the Knowledge and Skills Influences, Research
Questions (RQ), and Conceptual Framework (CF) Elements.
General analysis. Analysis of data reinforced the assumption that conceptual and
procedural knowledge is foundational in building a model for evaluating the efficacy and
sustainability of regulatory compliance programs. The knowledge and skill influences studied in
this dissertation are conceptual and procedural knowledge. Each data collection activity
consistently referred to both the need for comprehensive knowledge about rules, regulations, and
requirements (Conceptual Knowledge). Also, reference was made to the steps required to
implement them, audit and monitor ongoing compliance, and perform course corrections and
continuous improvement through planning, formative, and summative assessment (Procedural
Knowledge). Another important consideration also explored in this section is the mechanism by
which that content is communicated in a way that promotes knowledge transfer and ability to
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 135
apply. Interview data also indicated that availability of knowledge was a potential barrier to
compliance.
Conceptual knowledge results and findings. Analysis across data collection arms and
instruments consistently revealed conceptual knowledge as a key component of evaluating the
efficacy and sustainability of regulatory compliance programs in academic medicine institutions.
Importance of conceptual knowledge. Conceptual knowledge, in this study, refers to
rules, regulations, and requirements that stakeholders are required to follow in the performance
of their duties. During the data analysis process, the importance of the concept came up in
several instances. Figure 12 illustrates the synonym level textual analysis word cloud based on
the frequency of occurrence. When running textual analysis synonym grouping across open-
ended fields, the word “requirements” was one of the top three most frequently referred to across
all data collection instruments, occurring 809 times (or with a weighted percentage of 1.49).
Figure 12. Word Cloud for Textual Analysis of Open-Ended Frequencies.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 136
Of the 17 documents and artifacts analyzed, 15 of them directly addressed conceptual
knowledge as one of their components. All documents espoused rules and regulations that
stakeholders were expected to follow. Examples include without limitation:
• Business Associate Agreements (BAA) for protecting, using and disclosing
individual health information;
• Compliance training slides for Medicare and Medicaid Fraud, Wastes, and Abuse
• Policies and procedures for Institutional Review Boards;
• Accreditation reports detailing institutional performance on standards such as life
safety, infection prevention, and patient rights and responsibilities; and
• Personnel policies and procedures.
Those and other documents represent a significant number of rules, regulations, and
institutional requirements that staff is expected to know, understand and implement.
Conceptual knowledge and organizational performance. Several items in the data
collection instruments focused on a link between conceptual knowledge and organizational
performance. The link between the two is described in Clark and Estes (2008).
Conceptual knowledge prevalence and transfer. The various methods of data collection
reinforce the prevalence, significance, and types of conceptual knowledge identified in the study.
In the survey, stakeholders were asked to rate their institution’s performance of promoting
knowledge transfer based on an assessment of staff members’ knowledge of the rules,
regulations, and requirements that they were required to follow. Of the 61 respondents
(approximately 73.5 percent of the total pool), the majority of respondents rated their
institution’s performance as only moderate. The results reveal that even though rules,
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 137
regulations, and requirements are widespread and available, staff knowledge of what those
requirements are is more varied. Table 22 presents the results of the survey question.
22
Table 22.
Stakeholder Assessment of Organizational Performance of General Staff Knowledge of
Compliance Requirements (n=61 of 83)
Response
Frequency (N) Percent
High performing 18 29.51
Moderately performing 30 49.18
Low performing 12 19.67
Cannot assess 1 1.64
Total 61 100.00
Matrix Choice: General staff knowledge of compliance requirements
Note. This table references stakeholders' perception of their institution’s performance promoting staff
knowledge of general compliance requirements (conceptual knowledge). Respondents rated the
following item using a Likert scale: “General staff knowledge of compliance requirements.”
Conceptual knowledge and decision-making. This section analyzes stakeholder
perception of their respective institutions’ ability to relate decision-making to the rules,
regulations, and requirements that staff members are required to follow. Examples of decision-
making include how they develop policies, procedures, and other organizational assets, or make
personnel and financial decisions. Respondents rated their organization’s overall performance as
moderate and high, indicating that respondents believe that there is a discernable link between
the decision made and the laws, rules, regulations, and requirements from which they are
22
See line 104 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to
the survey item.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 138
derived. Responses were received from approximately three-quarters of the total sample pool.
Table 23 lists the results of that question on the stakeholder survey.
23
Table 23.
Survey Respondent Perception of Organizational Performance Linking Conceptual Knowledge
to Decision-making (n=61 of 83)
Response
Frequency (N) Percent
High performing 23 37.70
Moderately performing 30 49.18
Low performing 7 11.48
Cannot assess 1 1.64
Total 61 100.00
Note. This table references stakeholders' perception of their institution’s performance at linking decision-
making to regulatory requirements. Respondents rated the following item using a Likert scale: “Clear ties
between regulatory requirements and program decisions.”
Types of conceptual knowledge. The review of relevant research in Chapter Two
profiled the specific types of conceptual knowledge required for the evaluation model.
Specifically, it included references to regulations such as HIPAA, HITECH, and the Common
Rule. The sections that follow profile types of compliance-related conceptual knowledge needed
by stakeholders to improve their ability to implement compliance requirements and improve the
overall sustainability of compliance programs.
Stakeholder perceived conceptual knowledge needs. When assessed in light of the data,
respondents indicated that the cache of conceptual knowledge needed to improve stakeholder and
program compliance performance was broad and included more than only the laws, regulations,
23
See line 100 in the Data Dictionary Codebook (Appendix A) for this survey item and
corresponding choices.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 139
rules, and requirements to which they would be held accountable. Table 24 illustrates
respondents’ assessment of needed conceptual knowledge and skills.
Table 24.
Stakeholder Perceived Knowledge and Skill Requirements based on Response Count (n=83).
Possible Response N N %
Laws, rules, regulations, and standards (C) 68 90.67
Institutional policies and procedures (C/P) 65 86.67
How the requirements and regulations affect me, my department, and my
institution (C/P)
57 76.00
Auditing and monitoring compliance requirements within the institutions (C) 52 69.33
A deeper understanding of the institution's systems and processes (C) 48 64.00
Root-cause analysis and problem-solving (C/P) 40 53.33
An understanding of how other institutions have implemented similar
requirements (C)
36 48.00
Developing intervention strategies (C/P) 27 36.00
A better understanding of efficiency and sustainability (C) 17 22.67
Other 4 5.33
Note. This table references stakeholders' perception of the required conceptual knowledge and skills
when implementing compliance requirements. In the possible choices, (C) refers to conceptual
knowledge only, while (C/P) refers to a response that is both conceptual and procedural. More than one
selection may be made by an individual respondent. A confidence interval of 95 percent is used in
calculations. Responses are sorted by N percent from greatest to least.
Technical, conceptual knowledge. Analysis of the survey data above indicates
respondents believe that laws, rules, and regulations are only part of the needed knowledge and
skills inventory to improve compliance efficacy and program sustainability. Stakeholders also
need to understand the application of regulatory requirements at the institutional level, as well as
skills best practices for problem-solving and developing sustainable interventions. When
comparing the analysis of the total survey population to respondents with compliance and
regulatory experience, the variance was minimal. In some cases, values were the same, while in
others the variance was only minus one. In interview data, technical, conceptual knowledge fell
into either clinical or functional research domains. Clinical conceptual knowledge included
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 140
hospital accreditation standards by entities such as The Joint Commission, as well as compliance
standards, interpretive guidance, and technical assistance issued by CMS, and state rules and
regulations. In the research domain, conceptual knowledge included guidance on Good Clinical
Practice (GCP), the Common Rule, and guidelines issued by the NIH and FDA.
Non-technical conceptual knowledge. Seen primarily through the analysis of qualitative
data, themes and patterns related to non-technical knowledge emerged. Revisiting the textual
analysis from across all data collection instruments discussed at the beginning of this section, the
same data (analyzed at the root and stemmed level) revealed themes such as “time,” “process,”
and “change.” The findings reveal that consistent with Escribá-Carda, Balbastre-Benavent, and
Teresa Canet-Giner (2017), employees need to understand how the requirements impact their
roles, generation of ideas, and implications for performance.
The USC Rossier Four Streams. A separate layer of analysis was done on all of the open-
text fields across all four data collection instruments with specific regard to the Four Streams of
the Rossier School of Education which are leadership, accountability, learning, and diversity.
The analysis was done at a thematic level, meaning that elements from each course in the USC
Rossier Organizational Change and Leadership (OCL) program were incorporated. The results
of that analysis, compiled from textual data across all of the study instruments and arms, are
listed in Table 25.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 141
Table 25.
Thematic Analysis of USC Rossier School of Education Four Streams
Stream Total References Percent of Total Total Sources
Learning 436 43.13 27
Leadership 322 31.85 26
Accountability 201 19.88 27
Diversity 52 5.14 19
Total 1,011 100.00 --
Note. This table illustrates the number of times each theme occurred in the textual analysis in all open-
ended fields of all instruments and study arms.
The strong presence of learning reinforced comments elicited from stakeholder
interviews such as the importance of training and development. Leadership elements such as
team management and communication were also strongly represented. As a critical component
of compliance and regulatory affairs (Emanuel & Emanuel, 1996; Prescott, 2012), the presence
of themes such as resource adequacy, reporting, appeared prominently. Diversity was also a
consideration. Themes such as ability and power were the most prevalent in this portion of the
analysis. The next section details findings related to procedural knowledge.
Procedural knowledge results and findings. Consistent with the natural progress
between conceptual and procedural knowledge raised in Clark and Estes (2008), analysis of the
study’s data revealed that implementation specifications were the next step in understanding the
required knowledge and skill influences.
Importance of procedural knowledge. The same methods and measures of analysis were
applied to procedural knowledge as that of conceptual. Concepts such as process, utilization of
resources, and implementation of requirements appeared consistently throughout the qualitative
analysis process. The research indicated a strong symbiotic relationship between content
(conceptual knowledge) and its application (procedural knowledge). Of the 17 documents and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 142
artifacts analyzed, 10 of them directly addressed procedures knowledge as one of their
components, all but one covered policies and procedures as one of their program components.
Procedural knowledge and organizational performance. When asked to rate their
organization’s performance at translating conceptual knowledge (policies) into procedural
knowledge (compliance intervention strategies), the reaction from survey respondents was
mixed. The majority of respondents indicated that their organization performed only moderately
well in that capacity. This response could indicate a higher level of trust between staff members
and institutional management regarding responding to specific compliance issues. Table 26
presents the results of the survey question.
24
Table 26.
Stakeholder Assessment of Organizational Performance of Developing Meaningful Intervention
Strategies to Noncompliance Issues and Events (n=61 of 83)
Response
Frequency (N) Percent
High performing 18 29.51
Moderately performing 27 44.26
Low performing 10 16.39
Cannot assess 6 9.84
Total 61 100.00
Note. This table references stakeholders' perception of their institution’s performance at developing
intervention strategies based on the use of conceptual knowledge. Respondents rated the following item
using a Likert scale: “Developing meaningful intervention strategies to noncompliance issues and
events.”
Prevalence and application of procedural knowledge. Procedural knowledge appeared in
most of the documents analyzed during data collection. Other methods of data analysis revealed
consistency in that finding. For example, in 22 out of 25 observations (88 percent) policies and
24
See line 108 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to
the survey item.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 143
procedures were actively referenced and utilized, supporting several elements of the conceptual
framework. Application among specific types of procedural knowledge varied. For example,
observations regarding development and implementation of tracking systems for adverse events
had an occurrence rate of only 16 percent. At the same time, however, application of ongoing
practice and process improvement had a 56 percent occurrence rate. Both types of procedural
knowledge appear in both the Program Elements and knowledge and skills sections of the study’s
Conceptual Framework.
Dissemination and implementation of procedural knowledge based on stakeholder level
and role. The depth of procedural knowledge dissemination and implementation had some
qualifying characteristics. Feedback from the interview process validated the variance of
application of procedural knowledge when measured against organizational echelons such as
executive, middle management, and individual contributors. How quickly and to what extent
procedural knowledge was implemented also depended on the type of role the stakeholder might
have. For example, one interview participant in a regulatory role remarked on the connection of
management to faculty in a research role. “We would discuss how we are going not just to
implement, but how we are going to inform our researchers.” Another participant in a clinical
role stated the following: “I think as a team we collectively take a look at them to see how it
impacts practice and potential impact on practice. Moreover, then we go right to process because
we are so clinically focused. We have to implement that into workflow right away.” At the same
time, however other interview participants remarked that new initiatives and requirements must
go through a feasibility study, which involves multiple layers of organizational interpretation and
review. That was primarily due to the need to assess the level of risk and its impact on the
institution.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 144
Types of procedural knowledge. As with conceptual knowledge, the review of relevant
research in Chapter Two focused on specific types of procedural knowledge. Analysis of data
revealed the emergence of new tools and methods, specifically for improving existing practices
and processes for institutional compliance.
Procedural knowledge and the Conceptual Framework. From the literature review, a
preliminary model for Program Elements was developed. It included a combination of the seven
fundamental Program Elements issued by OIG (2011) and five additional elements derived from
the literature. Those elements were then assessed in data collection. The primary instruments of
evaluation for Conceptual Framework elements included surveys, observation, and document
and artifact analysis. Each element begins with an action word which creates its procedural
component. Both elements of the OIG plan, as well as additional elements from the literature
review, had high percentages of occurrence when assessed against all of the cases. Observation
percentages based on occurrence within the model were smaller due to the spread of twelve
separate elements.
Stakeholder perceived procedural knowledge needs. While conceptual framework
elements are an essential consideration of procedural knowledge, it is important to consider that
observations were limited to only one institution with one site. A broader net was cast during the
survey process. Stakeholders rated procedural knowledge needs during the survey. The results
of the analysis are presented in Table 27.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 145
Table 27.
Stakeholder Perceived Knowledge and Skill Requirements based on Response Count (n=83)
Possible Response Frequency
(N)
Percent
Laws, rules, regulations, and standards (C) 68 90.67
Institutional policies and procedures (C/P) 65 86.67
How the requirements and regulations affect me, my
department, and my institution (C/P)
57 76.00
Auditing and monitoring compliance requirements within the
institutions (C)
52 69.33
A deeper understanding of the institution's systems and
processes (C)
48 64.00
Root-cause analysis and problem-solving (C/P) 40 53.33
An understanding of how other institutions have implemented
similar requirements (C)
36 48.00
Developing intervention strategies (C/P) 27 36.00
A better understanding of efficiency and sustainability (C) 17 22.67
Other 4 5.33
Note. This table references stakeholders' perception of the required conceptual knowledge and skills
when implementing compliance requirements. In the possible choices, (C) refers to conceptual
knowledge only, while (C/P) refers to a response that is both conceptual and procedural. More than one
selection may be made by an individual respondent. A confidence interval of 95 percent is used in
calculations. Responses are sorted by N percent from greatest to least.
Technical procedural knowledge. In this study, technical procedural knowledge refers to
the specific procedures, processes, and associated skills that stakeholders must have to
implement conceptual knowledge successfully. As noted in the table above, technical procedural
knowledge assets include institutional procedures associated with implementing policies and
directives. Policies and procedures had high rates of occurrence in both the survey and
observation arms of data collection. Other high-occurrence procedural knowledge included the
impact of procedural knowledge on role and process improvement. Procedural knowledge on
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developing intervention strategies was not as frequently cited as a stakeholder knowledge when
compared to its occurrence in observations.
Non-technical procedural knowledge. Another knowledge type emerged with high rates
of occurrence; the content related to root-cause analysis, problem-solving methods, and
continuous improvement, both from a practice and process perspective. Examples of non-
technical procedural knowledge assets include, as described in the table above include process
improvement methodologies and guidelines for implementing best-practice concepts and tools.
Problem-solving and root-cause analysis knowledge were rated as a procedural knowledge need
in slightly more than half of the respondent pool. At the same time, ongoing practice and process
improvement occurred in observations at nearly the same rate. Interviews revealed specific types
of procedural knowledge in this category. Examples included the SAFER Matrix developed by
The Joint Commission (2016), SBAR (situation, background, assessment, recommendations) as
used by an interview subject and profiled by Haig, Sutton, and Whittington (2006), and the Three
R concept including reduction, refinement, and replacement referenced by another interview
subject and explored for application by A. M. Goldberg, Zurlo, and Rudacille (1996). While
those are not the only concepts of their type observe red in data analysis, they are some of the
most prevalent in the discipline and related literature.
Delivery of knowledge content. Similar to the type of content for knowledge and skills,
the study explored the various mechanisms by which the content might be delivered. While
related to content delivery, results and findings related to training and systems will be explored in
more detail in the organizational influences section. Survey respondents were asked specifically
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about which methods of content delivery they believe promote knowledge transfer. Results of
that item for all respondent categories are presented below in Table 28.
25
Table 28.
Stakeholder Content Delivery Mechanism Preferences
Content Delivery Mechanism
Frequency
(N)
Percent
On-boarding and orientation 49 28.30
Annual in-person refresher training 30 17.30
Annual on-line computer-based training 35 20.20
Team-based training at staff meetings and huddles 52 30.10
Other 7 4.00
Total 173 100.00
Note. More than one selection may be made by an individual respondent. A confidence interval of 95
percent is used in calculations. Respondents rated the following item using a Likert scale: “What
methods of delivery work best for compliance and regulatory training?”
The overall most preferred mechanisms were through-team based training in huddles and
staff meetings. As an example, utilization of huddles occurred in some form in both interview
and observation activities across six different data sources. Orientation was the second most
preferred means of content delivery. All of the remaining methods were closely rated.
26
Summary of knowledge influences. Conceptual and procedural knowledge have
substantial implications for compliance efficacy and program sustainability. While traditional
sources of both conceptual and procedural knowledge remain present in institutions, emerging
concepts such as continuous improvement and the need for meaningful problem-solving gain
increased notoriety and usage. Content delivery is also an important consideration. Both of the
25
See lines 66 and 67 in the Data Dictionary Codebook (Appendix A) for possible choices and tie
to the survey item.
26
Table 55 in Appendix L profiles delivery list by respondent type.
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highest-rated mechanisms, onboarding, and team-based training, speak to the collective efficacy
aspect of compliance because they are group and team-based. With that in mind, the next section
describes results and findings related to motivational influences.
Results and Findings for Research Question Three
In Research Question Three, Motivational and Organizational Influences are assessed.
This question applies to Conceptual Framework Elements III and IV . Figure 13 presents the
direct and indirect relationships graphically.
Figure 13. Thematic relationship diagram for Research Question (RQ Three, Gap Analysis
Influences, and the Conceptual Framework (CF) Elements.
Motivation Influences
This section applies to Research Question 3, as well as Conceptual Framework Element
III, as displayed in Figure 14.
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Figure 14. Thematic relationship diagram for the Motivation Influences, Research Questions
(RQ), and Conceptual Framework (CF) Elements.
General analysis. One of the core concepts in this study is efficacy; in this case, the
concept that compliance is not only possible but probable. The motivational influences studied
in this dissertation are self-efficacy theory (SET) (both individual and collective), and (EVT)
expectancy-value theory. In addition to the probability of compliance, stakeholder perceived
value in time and effort was also measured. All of the data collection instruments and arms in
this study measured at least one dimension of both theoretical concepts, and their application in
improving the ability of both programs and stakeholders to implement, improve, and sustain
regulatory compliance.
Expectancy-value theory results and findings. Analysis of EVT contained elements
across all data collection instruments and arms. While the initial purpose of analysis in this
section was to measure the perceived value of time, and effort, on stakeholder regulatory
compliance, additional considerations emerged as the data collection and analysis process
progressed.
Value of time and effort. Time and effort was the basis of the EVT component of the
Conceptual Framework. Stakeholder response on the topic varied. Using a Likert Scale item in
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the survey, respondents were asked the question as to whether or not they believe that the time
and effort required to comply with applicable rule, regulations, and policies justified the
outcome. Results of that item for all respondent categories are presented below in Table 29.
27
Table 29.
Stakeholder Perception of Value of Time and Effort for Compliance Requirements
Response
Frequency Percent
Strongly agree 18 25.35
Agree 30 42.25
Somewhat agree 13 18.31
Neutral 1 1.41
Somewhat disagree 8 11.27
Disagree 1 1.41
Strongly Disagree 0 .00
Total 71 100.0
Note. This table references stakeholders’ perception of the value of time and effort required to learn,
understand, and implement compliance requirements applicable to their role, department, and
organization. Respondents rated the following question using a Likert scale: “I believe that the amount of
time and effort required to comply with rules, regulations, and policies is reasonable and necessary.”
A majority of respondents, or 57.8 percent, agreed that outcomes justified the time and
effort required to comply with applicable rules and regulations. When analyzing the results, an
important consideration is a specific focus on which outcomes to which the stakeholder group
might be referring. For example, clinical respondents and those with a healthcare management
and operations background often associate outcomes with the legs of the Triple Aim;
improvement in population health, cost of care, and the patient experience (Berwick et al., 2008).
Research respondents might also focus on clinical outcomes but through the lens of expanding
the body of knowledge and improving evidence-based practice (Chiappelli, 2010). Table 30
27
See line 69 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
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shows the results of the same item among respondents group according to the functional domain
in relative percentage, while Figure 15 presents the results graphically.
Table 30.
Stakeholder Assessment of Perceived Value of Time and Effort (Relative Percentage by Role
Type)
Response Clinical
Respondents
(N Percent)
Research
Respondents
(N Percent)
Health Care
Management
and Operations
Respondents
(N Percent)
Other
Respondents
(N Percent)
Strongly agree 23.08 24.19 26.67 28.57
Agree 46.15 45.16 44.44 28.57
Somewhat
agree
15.38 17.74 15.56 14.29
Neutral .00 1.61 2.22 .00
Somewhat
disagree
11.54 9.68 11.11 14.29
Disagree 3.85 1.61 .00 14.29
Strongly
disagree
.00 .00 .00 .00
Note. This table presents the result of the survey item on the perceived value of time and effort by the
respondent’s functional domain. Some respondents may have more than one associated domain.
Respondents rated the following item using a Likert scale: “I believe that the amount of time and effort
required to comply with rules, regulations, and policies is reasonable and necessary.”
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Figure 15. Stakeholder perceived value of time and effort in compliance with respondent
functional domain.
28
When analyzing time and effort in other data collection instruments, results and findings
varied. For example, in document and artifact analysis, only one item, an institutional
accreditation report contained criteria relative to the topic. Only one observation directly
referenced observational effort.
29
Time investment. During the survey, respondents were asked to measure the time spent
on three areas of compliance listed below.
28
Some respondents may have more than one associated domain. Respondents rated the
following item using a Likert scale: “I believe that the amount of time and effort required to comply with
rules, regulations, and policies is reasonable and necessary.”
29
See lines 110-112 in the Data Dictionary Codebook (Appendix A) for possible responses and
tie to the survey item.
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1. Number of compliance auditing and monitoring activities that have occurred in
the last 12 months;
2. Number of compliance and regulatory training sessions completed in the last 12
months; and
3. Hours spent per week on tasks that have compliance or regulatory element;
Table 31 below displays the summary statistical analysis of time investment among
stakeholders who responded to the survey.
30
Table 31.
Descriptive Statistics and Frequencies of Stakeholder Time Investment of All Staff Stakeholder
Respondents (n=60)
Statistic
How many
compliance
audits or
monitoring
sessions
have
occurred in
your
department
in the last 12
months?
How many
compliance and
regulatory training
courses have you
completed in the
last 12 months?
How many hours do
you spend each week
working on tasks that
have a regulatory or
compliance element
to them?
Mean 26.33 5.28 23.63
Std. Error of Mean 5.42 1.08 2.01
Median 5.50 2.00 22.50
Mode 2.00 2.00 40.00
Std. Deviation 41.98 8.33 15.60
Variance 1,762.02 69.46 243.49
Skewness 2.02 3.38 .06
30
A complete analysis of time investment is available in the following tables and figures of
Appendix L: Table 56, Figure 32, Figure 33, Figure 34, Figure 35, Figure 36, and Figure 37.
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Statistic
How many
compliance
audits or
monitoring
sessions
have
occurred in
your
department
in the last 12
months?
How many
compliance and
regulatory training
courses have you
completed in the
last 12 months?
How many hours do
you spend each week
working on tasks that
have a regulatory or
compliance element
to them?
Std. Error of Skewness .31 .31 .31
Kurtosis 3.44 14.07 -1.35
Std. Error of Kurtosis .61 .61 .61
Range 180.00 50.00 49.00
Minimum .00 .00 1.00
Maximum 180.00 50.00 50.00
Sum 1,580.00 317.00 1,418.00
Note. This table presents descriptive statistics for all three survey items.
31
The standard deviation of the number of auditing and monitoring sessions was high
indicating a large spread among the sample population in total activities. Note in the table,
above some tasks which had a regulatory or compliance element to them represented the least
amount of skewness or symmetry diversion. When analyzed by stakeholder discipline, new
trends were observed. Table 32 presents the central tendency of each activity by stakeholder
functional domain.
31
These items correspond to 110 through 112 in the Data Dictionary Codebook (Appendix A).
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Table 32.
Descriptive Statistics for Time Investment Ammon Respondent Functional Domains (n=60)
Survey Respondents by Role Type
Clinical
respondents
Research
respondents
Health care
Management
and
operations
respondents
Other
respondents
Respondent
with
compliance
and
regulatory
experience
How many
compliance audits or
monitoring sessions
have occurred in
your department in
the last 12 months?
Mean 29.27 24.22 34.25 32.71 26.27
Median 5.00 5.00 9.00 2.00 5.00
Mode 5.00 5.00 2.00
a
2.00 2.00
Minimum .00 .00 .00 .00 .00
Maximum 180.00 180.00 150.00 180.00 180.00
Range 180.00 180.00 150.00 180.00 180.00
Standard
Deviation
50.82 41.16 43.95 66.50 42.33
Variance 2,583.16 1,693.97 1,931.74 4,422.24 1,792.17
How many
compliance and
regulatory training
courses have you
completed in the last
12 months?
Mean 3.14 5.33 6.86 5.86 5.17
Median 2.00 2.00 3.00 3.00 2.00
Mode 2.00 1.00
a
1.00
a
3.00 2.00
Minimum .00 .00 .00 .00 .00
Maximum 15.00 50.00 50.00 25.00 50.00
Range 15.00 50.00 50.00 25.00 50.00
Standard
Deviation
3.75 8.76 9.75 8.61 8.36
Variance 14.03 76.67 95.04 74.14 69.87
How many hours do
you spend each
week working on
tasks that have a
regulatory or
compliance element
to them?
Mean 16.86 22.82 25.69 32.14 23.53
Median 17.00 20.00 27.50 40.00 20.00
Mode 20.00 40.00 40.00 40.00 40.00
Minimum 1.00 1.00 1.00 5.00 1.00
Maximum 40.00 50.00 50.00 50.00 50.00
Range 39.00 49.00 49.00 45.00 49.00
Standard
Deviation
13.50 15.97 14.93 16.55 15.72
Variance 182.12 254.91 222.85 273.81 246.98
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Note. This table presents the result of the survey item on time spent on the compliance activities listed as
measured by the respondent's functional domain. Some respondents may have more than one associated
domain. a. Multiple modes exist. The smallest value is shown.
Analysis of the results indicates that the total time investment for all three activities was
higher for research respondents then healthcare management and operations respondents.
Consistent with expectations, respondents with regulatory or compliance experience had the
highest time investment. With that in mind, the next section of the study focuses on the
perceived burden of regulatory and compliance activities.
Perceived regulatory burden. When assessing expectancy-value in other capacities,
several themes emerged. Regulatory burden, or the amount of complexity that proper
implementation of requirements demands, has been a persistent theme among healthcare
organizations for years; especially with regards to standards compliance (Lovern, 2001). In
focused interviews, the topic was referenced among multiple participants. In response to a
question about assessing and implementing requirements, one respondent stated the following
statement. “Well, the launching of the changes was labor-intensive because we had to come up
with a process and a policy, and then both of those had to be approved by the [committee], and it
involved a significant amount of research to find out what was going to be appropriate for the
process and the policy, of course, based on the process.” In response to the same question,
another participant discussed the impact on staff as a whole.
“I think that there's an opinion that they are just regulations that are written to
drive us nuts and not because that there's any sort of clinical reasoning behind it
or patient safety reasoning. It is just a regulation to be a regulation. Moreover, I
think I got into this field because I believe the opposite, but I am not frontline
staff. So, I think that the perspective of frontline staff on how they see these
regulations is the barrier more than actually the regulations and how they are
being enforced.”
Relationships between time, effort, and burden. One of the key findings from that quote
is the assessment of regulatory burden depending on the staff level. The significance of the
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statement is that management might have a different perceived value of time and effort as a
result of regulatory burden, then do staff members. Figure 16 presents the results of the time and
effort question among respondents group according to staff level in relative percentage,
graphically.
32
Figure 16. Stakeholder perceived value of time and effort in compliance by respondent staff
level.
33
The analysis of survey data revealed that the perceived value of time and effort is higher
among providers, researchers, and managers than that of staff in a support role. While there is
32
See line 69 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
33
Respondents rated the following item using a Likert scale: “I believe that the amount of time and effort
required to comply with rules, regulations, and policies is reasonable and necessary.”
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 158
not enough data available to establish a direct causal link, a positively correlated relationship
between the two variables can be established. Next, the study examines efficacy.
Self-efficacy theory findings and results. Stakeholder and program efficacy is one of
the leading themes of the study. Efficacy is addressed from both a collective and individual
perspective. Apart from EVT, SET as applied in the study addresses the factors that improve a
stakeholder’s likelihood of compliance and that boost an institution’s compliance program
impact on improving stakeholder efficacy. Issues addressed in this section include, but are not
limited to, perceptions on resource adequacy, availability and transfer of conceptual and
procedural knowledge, stakeholder involvement in decision-making, meaningful and relevant
compliance strategies, use of additional resources, and the strength of organizational assets and
systems.
34
Stakeholder individual self-efficacy. Stakeholder efficacy, in this study, refers to the
individual’s perception that relevant factors create an environment in their respective
organizations, that compliance is not only possible but probable. While there are many different
factors associated with self-efficacy, a set of them were identified as being those impactful in the
context of the study, and thus were selected for data collection and analysis. It should be noted
that the factors in consideration in individual self-efficacy are impacted both by those raised in
the EVT analysis and the collective efficacy section that follows this one; however, they are
examined in different capacities.
Perceived stakeholder engagement. For individual self-efficacy, one of the factors
considered improving compliance likelihood was the role of the individual stakeholder and the
34
This is a separate and distinct factor that the organizational assets and systems themselves,
which are addressed in the Organizational Influences section of the study.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 159
impact of organizational dynamics. For example, one question in the survey asked respondents
whether or not they felt that they had a voice in the decision-making and policy development
processes at their respective institution.
35
Figure 17 shows the breakout of respondents by
selection.
Figure 17. Percent of survey respondents as to whether or not they felt involved in the decision-
making process.
While the majority of respondents agreed with the statement, over 25 percent felt some
level of uncertainty, whether it be neutral or disagreement. When asked about their response to
the question, one of the interview respondents provided more context by stating that they felt the
35
See line 71 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 160
level of input depended upon whether the question was asked in a team context. It was also
noted that while the participant was unsure of the impact of their concerns, they might be
observing a culture change. “I have a voice. How strong that would change things at this point,
[is] not so much. However, from what I understand the direction is going, that may change.”
Another participant framed their response through alignment with organizational objectives. “I
think if it aligns with other priorities, yes. So, my voice matters when they want to hear me, and
they want to use me as a [reason].” Engagement is not the only factor in assessing individual
self-efficacy.
Perceived individual capacity for compliance. From the perspective of capacity, several
items lent themselves to consideration. One question in the stakeholder survey dealt with
availability of conceptual and procedural knowledge, as well as resources availability.36 The
figure shows the responses along with an interpolation line for trend analysis. The majority of
respondents felt that they had the necessary resources to improve their own ability to comply
with the rules, regulations, standards, and policies that impacted their own role, as well as that of
their team, departments, and institutions. The trend was consistent in respondents with a
compliance and regulatory role or background. Figure 18 presents aggregated responses to the
survey item across all stakeholder groups with interpolation.
36
See line 70 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
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Figure 18. Frequency interpretation of stakeholder perceived self-efficacy through knowledge
and resource adequacy.
37
Collective efficacy and organizational performance. Several items in data collection
referenced an organization’s ability to maintain, sustain, and improve compliance efficacy.
While some considerations touch on organizational influences themselves, the intention in this
section of the study, both during data collection and analysis, was to assess the consideration’s
role in improving efficacy among stakeholders as a whole. Items for review in this section
37
Respondents were asked to rate their response on a Likert scale to the statement: “I believe that
I have the training and resources necessary to effectively comply with rules and regulations that affect
me, my team, and my organization.”
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include organizational readiness through assets, systems, and subject matter experts in
compliance.
Collective efficacy and organizational readiness. From a readiness perspective, the
stakeholder survey queried respondents regarding resources, systems, and human assets such as
compliance staff members and subject matter experts. Regarding systems, respondents were
asked whether or not they believed that their institution had a compliance infrastructure in place
for detecting, deterring, mitigating and preventing noncompliance events.
38
Results of the
analysis for all respondents, with interpolation, are presented in Figure 19 below.
Figure 19. Frequency interpretation of stakeholder perceptions of organizational readiness
through noncompliance detection.
39
38
See line 72 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
39
Respondents were asked to rate their response on a Likert scale to the statement: “I believe that
my institution has a viable and sustainable system to detect, deter, mitigate, and prevent adverse events
and issues of noncompliance.”
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The results reveal that, unlike in considerations of individual self-efficacy regarding
resource adequacy, the organizational assessment had higher rates of negative perception. The
stakeholder survey also asked respondents about organizational interventions arising from data
gleaned from those systems.
40
Figure 20 below presents the results to the question of targeted
interventions that improve compliance efficacy.
Figure 20. Frequency interpretation of stakeholder perceptions of organizational readiness
through the development of interventions.
41
40
See line 73 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
41
. Respondents were asked to rate their response on a Likert scale to the statement: “I believe
that my institution develops targeted, relevant, and achievable intervention strategies to make compliance
meaningful, possible, and probable.”
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Analysis indicates that more individuals had a moderate level of agreement or higher
with the survey item, and a decreased level of disagreement when compared to questions
regarding systems.
Collective efficacy and organizational performance. Translating that finding into
outputs, observations and documents and artifacts addressed the implementation of those
systems, policies, and interventions. When reviewing, only one item out of 17 (or 5.9 percent)
addressed the issue of compliance efficacy. It was the same document identified in the EVT
section. In observations, the percentage of activities where efficacy was observed in practice
rose to 16 percent (or 4 out of 25 instances).
Collective efficacy and Program Elements in the Conceptual Framework. In observation
activities, an analysis was completed of the implementation of compliance Program Elements as
indicated in the conceptual framework. Table 33 presents the results of that analysis.
Table 33.
Organizational Efficacy Analysis through Observation of Program Elements
Element Responses
Frequency
(N)
Percent
Implementing written policies and procedures 22 16.06
Designating a compliance officer and compliance committee 1 .73
Conducting effective training and education 8 5.84
Developing effective and open lines of communication 18 13.14
Conducting internal compliance monitoring and auditing 7 5.11
Enforcing standards through well-publicized disciplinary
guidelines
15 10.95
Responding promptly to detected problems and undertaking
corrective action
14 10.22
Developing and implementing systems for tracking adverse
events and near misses.
4 2.92
Performing risk management and quality activities such as peer
review and clinical risk
4 2.92
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Element Responses
Frequency
(N)
Percent
Creating visibility and transparency in developing and
implementing institutional policies and procedures
16 11.68
Creating management and staff buy-in for implementing
compliance requirements
14 10.22
Practicing ongoing practice and process improvement 14 10.22
Total 137 100.00
Note. Dichotomy group tabulated at value 1.
The organization had high occurrences of policy and procedure implementation,
communication activities, and standards enforcement. Issue response was also greater, linking to
the higher perceived-implementation of intervention strategies queried in the stakeholder
analysis survey. Elements derived from the literature review beyond the first seven as developed
by the HHS OIG (2011) had considerable presences, with all except one appearing in more than
half of the observations completed. Shifting from organizational performance and compliance
elements, the final section in this chapter examines organizational influences which impact
efficacy and program sustainability.
Organizational Influences
This section applied to Research Questions 3, as well as Conceptual Framework Element
IV, as displayed in Figure 21. When examined in this section, relationships emerge between
Research Questions 1 and 3, as well as Conceptual Framework Elements I and IV .
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Figure 21. Thematic relationship diagram for the Organizational Influences, Research Questions
(RQ), and Conceptual Framework (CF) Elements.
General analysis. The organization is the setting for this entire study. Each
organizational influence impacts other conceptual framework elements and research questions
when examined in this construct. The organizational influences studied in this dissertation are
assets and culture. Assets examples are policies and procedures and systems and processes.
Examples of cultural influences are leadership commitment, and the institution’s ability to study,
implement and adapt to change. Data in this section was collected from every instrument and
study arm.
Organizational assets. Both Clark and Estes (2008) and Rueda (2011) categorize
organizational assets as a fundamental influence in analyzing and improving performance. In the
case of this study, organizational assets include those items which operationalize regulatory
compliance, taking it from Program Elements, knowledge, skills, and motivation to actual
output. Examples, without limitation, include policies, procedures, processes (clinical, work, and
business), and systems. This dissertation gathered and analyzed data on assets through those
elements, through all study arms and data collection instruments. The relationship between
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Conceptual Framework elements I and IV are especially apparent when viewing them through
the lens of organizational assets. For example, the stakeholder survey asked for feedback from
respondents on operationalizing the HHS OIG (2011) and literature-derived Program Elements
within their institutions. When asked about the overall essentiality of assets in improving
compliance efficacy and program sustainability, respondents considered them essential overall,
as presented in Figure 22.
42
Figure 22. Percent distribution for survey respondents on the essentiality of organizational assets
in improving compliance efficacy and sustainability.
Following are some examples of utilizing assets for compliance.
42
See line 42 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item
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Policies and procedures. Policies and procedures are a bedrock asset defined in
organizational compliance programs (Bradford, Hurdle, LaSalle, & Facelli, 2014; Herold &
Beaver, 2014; Office of the Inspector General, 2011). When asked about the extent to which the
asset existed in their organization, survey respondents were generally positive about their
development and utilization. Figure 23 shows the percent distribution for all stakeholders
according to response.
43
Figure 23. Percent distribution for survey respondents on the existence of policies and
procedures within respective institutions.
43
See line 77 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item. Table 57 in Appendix L presents both frequency and percent distribution by stakeholder role
type (group).
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When compared with the essentiality of implementing policies and procedures as
assessed in the Program Elements section of Research Question 1, a positively correlated
relationship can be determined. The Pearson’s r correlation is scale-invariant, making it useful
for Likert values and others. Essentiality had a mean of 1.16, a standard deviation of .402 –
indicating a low spread relative to the sample. Existence had a mean of 1.73, a standard
deviation of .972 – indicating a higher spread relative to the sample. Analysis revealed a
correlation of 0.262 between Essentiality and Existence.
44
Other data collection efforts involved policies and procedures. Field observations
allowed the opportunity to validate the implementation findings within the selected sites. The
criterion of implementing written policies and procedures was present in 22 out of 25, or 88
percent, of completed observations.
45
In document and artifact analysis, 16 out of 17 samples, or
94.1 percent, included some element of policies and procedures in their design or usage.
46
When
compared to the type of document analyzed, seven were policies or 41.2 percent, and 6 were
procedures or 35.3 percent.
47
In most instances, policies and procedures were grouped into the
same case. While substantial evidence exists for the importance and comprehensive
implementation of policies and procedures, there are other assets which are necessary to review.
44
Bi-variate correlation was supported by equal two tailed significance of, Sum of Squares and
Cross-products, and Covariance among both variables. The full correlation is available in Table 58 of
Appendix L.
45
Criterion is listed in line 201, box one of the Data Dictionary Codebook (Appendix A).
Multiple criteria may apply to observation.
46
Criterion is listed in line 218, box two of the Data Dictionary Codebook (Appendix A).
Multiple criteria may apply to one case.
47
Criterion is listed in line 221, boxes four and five of the Data Dictionary Codebook (Appendix
A). Multiple criteria may apply to one case.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 170
Systems. Within in the institution, other means of mechanizing the first three elements of
the Conceptual Framework are systems and the associated processes. Systems, as used in this
study, related mostly to those who manage compliance-related processes. Two literature-derived
Program Elements studied systems for managing adverse and sentinel events. The first element
was developing and implementing systems for developing and implementing systems for
tracking such events, while the second was monitoring and auditing. While each was assessed
separately in the stakeholder survey, results are presented together for comparison purposes.
48
Table 34 lists the results by level of essentiality.
Table 34.
Frequency Distribution for Stakeholder Perceived Essentiality of Systems for Managing Adverse
and Sentinel Events (n=76 of 83, n=70of 83)
Essentiality Response Frequency Percent
Developing and implementing systems for
tracking sentinel events
Highly essential 38 50.00
Essential 31 40.79
Somewhat
essential
6 7.89
Nonessential 1 1.32
Cannot assess 0 .00
n (of 83) 76 100.00
Monitoring and auditing systems for adverse
and sentinel events
Highly essential 36 51.43
Essential 31 44.29
Somewhat
essential
3 4.29
Nonessential 0 .00
Cannot assess 0 .00
n (of 83) 70 100.00
48
See lines 37 and 46 in the Data Dictionary Codebook (Appendix A) for possible responses and
tie to the survey items.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 171
Note. This table presents the result of the survey items on systems essentiality. Responses were queried
on a Likert scale. A confidence interval of 95 percent was used in the calculation.
The majority of respondents ranked both elements as either essential or highly essential
in program design. When asked about their existence within the respective institutions,
respondents, the trend was somewhat different. Table 35 presents the result of perceived
existence as indicated in the respective survey item.
49
Table 35.
Frequency Distribution for Stakeholder Perceived Existence of Systems for Managing Adverse
and Sentinel Events (n=66 of 83, n=62 of 83)
Existence Response Frequency Percent
Developing and implementing systems for
tracking sentinel events
Firmly existent 21 31.82
Mostly existent 20 30.30
Somewhat
existent
15 22.73
Nonexistent 3 4.55
Cannot assess 7 10.61
n (of 83) 66 100.00
Monitoring and auditing systems for adverse
and sentinel events
Firmly existent 23 37.10
Mostly existent 24 38.71
Somewhat
existent
12 19.35
Nonexistent 1 1.61
Cannot assess 2 3.23
n (of 83) 62 100.00
Note. This table presents the result of the survey items on systems essentiality. Responses were queried
on a Likert scale. A confidence interval of 95 percent was used in the calculation.
49
See lines 84 and 93 in the Data Dictionary Codebook (Appendix A) for possible responses and
tie to the survey items.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 172
While the over half of the respondents ranked each item as either firmly or mostly
existent, more responses appeared in the lower echelon categories than did those when asked
about essentiality. Given the trend variance, another bivariate correlation of the Program
Elements was completed. For system design and implementation, results indicate a positive
relationship in both Pearson’s r correlation and covariance. While covariance and correlation
were positive, a significant correlation was not found. Essentiality had a mean of 1.61, a
standard deviation of 0.694 – indicating a lower spread relative to the sample. Existence had a
mean of 2.32, a standard deviation of 1.267 – indicating a higher spread relative to the sample.
Analysis revealed a correlation of 0.173 between Essentiality and Existence.
Results development and implementation indicate a positive relationship in both
Pearson’s r correlation and covariance. While covariance and correlation were positive, a
significant correlation was not found. Essentiality had a mean of 1.53, a standard deviation of
0.583 – indicating a lower spread relative to the sample. Existence had a mean of 1.95, a
standard deviation of 0.965 – indicating a higher spread relative to the sample. Analysis revealed
a correlation of 0.057 between Essentiality and Existence.
References in this capacity dealt more specifically systems as a barrier to compliance.
One participant discussed how their organization did not have sufficient assets such as a learning
management system to disseminate conceptual and procedural knowledge and check for
understanding. Another described their institution’s systems as archaic, and not able to manage
the workflows and load associated with their regulatory review processes. The context was
provided from both research and clinical participants. Using context as a transition point, the
final influence studied in this dissertation is organizational culture.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 173
Organizational culture. Organizational culture is perhaps one of the broadest and most
complex of the organizational influences in the performance gap analysis model (Clark & Estes,
2008; Rueda, 2011). Analysis of the study data relationship significant relationship between
culture and both knowledge and motivational influence. The concept of stakeholder efficacy
also reemerged as a trend. While this chapter details several results and findings related to
organizational culture, the first is a comparison between culture and the Program Elements, as
identified in element 1 of the Conceptual Framework. Three key culture themes were identified
as a result of fusing data analysis with a review of the literature. Those include (i) Compliance
Staff Management, (ii) Accountability and Capacity as defined in Fernald et al. (2011), and (iii)
Communication.
Culture and compliance program elements. Several elements both from the HHS OIG
(2011) list and the literature-derived additions directly impact organizational culture. Table 36
below illustrates those elements and impacts as noted in data collection.
Table 36.
Impact of Organizational Culture on the Comprehensive Program Element Listing as Presented
in Research Question One
Program Element HHS OIG
Derived
Literature
Derived
Documented
Organizational Culture
Impact/Theme
Implementing written policies and
procedures
Yes
Designating a compliance officer and
compliance committee
Yes Yes – Compliance Staff
Management
Conducting effective training and
education
Yes
Developing effective and open lines
of communication
Yes Yes – Communication
Conducting internal compliance
monitoring and auditing
Yes
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 174
Program Element HHS OIG
Derived
Literature
Derived
Documented
Organizational Culture
Impact/Theme
Enforcing standards through well-
publicized disciplinary guidelines
Yes Yes – Accountability and
Capacity
Responding promptly to detected
problems and undertaking corrective
action
Yes Yes – Accountability and
Capacity
Compliance Through Practice
Developing and implementing
systems for tracking adverse and
sentinel events
Yes
Performing risk management and
quality activities such as peer review
and clinical risk
Yes
Creating visibility and transparency
in developing and implementing
institutional policies and procedures
Yes Yes – Accountability and
Capacity
Creating management and staff buy-
in for implementing compliance
requirements
Yes Yes – Accountability and
Capacity
Practicing ongoing practice and
process improvement
Yes Yes – Accountability and
Capacity
Compliance Through Improvement and Utilization
Organizational assets Yes
Dedicated compliance and regulatory
staff
Yes Yes – Compliance Staff
Management
Compliance and regulatory training
and ongoing professional
development
Yes
Organizational culture Yes Yes – Direct Link
Monitoring and auditing systems for
adverse and sentinel events
Yes
Root cause analysis, investigations,
and implementation of interventions
Yes
Clinical risk management and
process improvement projects
Yes
Compliance strategic and work plans Yes Yes – Accountability and
Capacity
Feedback mechanisms Yes Yes - Communication
Note. This table includes all of the Program Elements for the Conceptual Framework as identified in the
corresponding portion of this Chapter.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 175
When asked about the presence of compliance cultural elements in their organizations,
stakeholders had varying viewpoints, with only 62.9 percent of total respondents rating it as
firmly or mostly existence. The sample also had a high standard deviation, indicating that
responses were widely spread throughout the population. Table 37 presents the result of that
survey item.
50
Table 37.
Stakeholder Perception of Institutional Performance on Compliance and Organizational Culture
(n=62 of 83)
Existence Response Frequency
(N)
Percent
Organizational culture
(Communication, management support
of compliance initiatives, etc.)
Firmly existent 19 30.65
Mostly existent 20 32.26
Somewhat existent 18 29.03
Nonexistent 4 6.45
Cannot assess 1 11.61
Note. This table presents the result of the survey item on a compliance-focused organizational culture.
Responses were queried on a Likert scale. A confidence interval of 95 percent was used in the
calculation.
Following is a more detailed analysis of results and findings of each of identified themes.
Compliance staff management. Having a viable compliance staffing infrastructure was a
critical component of this study. Workforce management and development concepts were
present in all three areas of the Program Elements identified and validated in Research Question
One. It was also impacted by both knowledge and skills, and motivational influences as
50
See line 92 in the Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 176
identified in Research Questions Two and Three. Data collection on the topic occurred across all
instruments and study arms.
The concept of staffing was multidimensional in this study. Among other topics,
perceptions and requirements of dedicated compliance staff, proper job roles and designations,
and succession planning were investigated. For example, in two of the Program Elements
discussed in Research Question One, staffing was the main topic.
51
When asked about the
essentiality of dedicated compliance, and regulatory staff, survey respondents overwhelmingly
affirmed its importance with a total of 79.5 percent rating the item as either essential or highly
essential. As with the sample population as a whole, the concept of dedicated staffing as a whole
seemed to resonate more among respondents with compliance and regulatory experience, than
did individual appointment as described in one of the Seven Fundamental Elements of Effective
Compliance Programs by HHS OIG (2011).
Access to or presence of regulatory, along with their knowledge and ability to collaborate
staff was two other items surveyed.
52
Respondents were asked to rate the performance of their
institution in those areas. Table 38 presents the results of those survey items.
Table 38.
Stakeholder Perception on Organizational Performance of Compliance and Regulatory Staff
Presence, Knowledge and Collaboration (n=61 of 83)
Performance Response Frequency
(N)
Percent
High performing 39 63.93
51
See lines 43, 78, 90, 98, and 99 in the Data Dictionary Codebook (Appendix A) for possible
responses and tie to the survey items.
52
See lines 98 and 99 in the Data Dictionary Codebook (Appendix A) for possible responses and
tie to the survey items.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 177
Performance Response Frequency
(N)
Percent
Access to or presence of compliance and
regulatory staff
Moderately
performing
19 31.15
Low performing 2 3.28
Cannot assess 1 1.64
n (of 83) 61 100.00
Availability, knowledge, and collaboration
of compliance and regulatory staff
High performing 39 63.93
Moderately
performing
17 27.87
Low performing 4 6.56
Cannot assess 1 1.64
n (of 83) 61 100.00
Note. This table presents the result of the survey items on a compliance-focused organizational culture.
Responses were queried on a Likert scale. A confidence interval of 95 percent was used in the
calculation.
Approximately 95 percent of respondents felt that their institutions performed either well
or moderately at having compliance staff on-hand. The value dropped slightly to 91.8 percent
when asked about the availability, knowledge, and collaboration of those staff members; and had
twice as many respondents rate their institution as low performing in that area. When asked
about the logic of the gap, one interviewee framed it through the lens of mutual collaboration and
respect. They remarked that staff members in departments such as Quality Improvement and
Compliance needed to recognize each other’s workload and improve their commitment and
respect for it. While that is most likely the only reason for the trend, it points to the next
element of culture profiled in the study, accountability, and capacity.
Accountability and capacity. Perhaps one of the most frequently occurring elements of
organizational culture in this study was the concept of accountability and capacity for improving
compliance efficacy and sustainability. The topic was multidimensional during the development
of data collection instruments and frequently resurfaced during the collection and analysis
process. Six of the 21 Program Elements identified in Research Question One dealt with
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 178
accountability and capacity. While the essentiality of those topics was previously discussed,
organizational performance on the topic was also assessed during the study.
Several other dynamics were studied in this topic. During the stakeholder survey,
respondents were asked to rate their organization’s performance in six of those areas. While
some are unique, several relate to influences previously discussed in this study. Table 39
presents the results of that analysis.
53
Table 39.
Survey Stakeholder Perception of Organizational Performance on Accountability and Capacity
Variables (n=61 of 83)
Variable Performance Frequency
(N)
Percent
Clear ties between regulatory requirements
and program decisions
High performing 23 37.70
Moderately
performing
30 49.18
Low performing 7 11.48
Cannot assess 1 1.64
Institutional and management commitment
to compliance and ethical behavior
High performing 30 49.18
Moderately
performing
22 36.07
Low performing 8 13.11
Cannot assess 1 1.64
Opportunities for input into creating
institutional policy
High performing 16 26.23
Moderately
performing
27 44.26
Low performing 14 22.95
Cannot assess 4 6.56
Reducing redundant or burdensome
regulatory, ethical or compliance
requirements
High performing 11 18.03
Moderately
performing
28 45.90
53
See lines 100 through 108 in the Data Dictionary Codebook (Appendix A) for possible
responses and tie to the survey items.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 179
Variable Performance Frequency
(N)
Percent
Low performing 17 27.87
Cannot assess 5 8.20
General staff knowledge of compliance
requirements
High performing 18 29.51
Moderately
performing
30 49.18
Low performing 12 19.67
Cannot assess 1 1.64
Time to effectively implement regulatory
requirements
High performing 14 22.95
Moderately
performing
31 50.82
Low performing 13 21.31
Cannot assess 3 4.92
Training and development resources High performing 14 22.95
Moderately
performing
30 49.18
Low performing 16 26.23
Cannot assess 1 1.64
Institutional committee performance (e.g.,
IRB, IACUC, etc.)
High performing 21 34.43
Moderately
performing
26 42.62
Low performing 3 4.92
Cannot assess 11 18.03
Developing meaningful intervention
strategies to noncompliance issues and
events.
High performing 18 29.51
Moderately
performing
27 44.26
Low performing 10 16.39
Cannot assess 6 9.84
Note. This table presents the result of the survey items on stakeholder perceived assessment of
organizational performance. Responses were queried on a Likert scale. A confidence interval of 95
percent was used in the calculation.
While the majority of responses cluster in moderate performance, the highest incidences
of low-performance ratings occur in a reduction in regulatory burden, staff opportunities to have
input in decision-making, and institutional use and availability of training and development
resources. Respondents generally rated institutional commitment to compliance and ethical
behavior as the highest performing variable in the series.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 180
Accountability and capacity were also discussed during stakeholder interviews. Three
interviewees rated leadership engagement as being a high performing characteristic of their
institutions. One participant described the variety of individuals from the executive level to
department managers who wanted not only ongoing compliance accountability updates but also
to engage in developing and mobilizing resources to improve stakeholder compliance efficacy
and the overall sustainability efforts of the compliance program. Regarding visibility, another
interviewee remarked the institution had made significant progress, but still did not have the
desired level of transparency and foresight in decision-making, possibly reinforcing the silo type
of isolation that occurred in the organization previously.
In reviewing documents and artifacts, four dimensions of accountability were analyzed.
Those included individual, team, management, and organization.
54
Table 40 illustrates the
frequency with which those categories appeared in the cases.
Table 40.
Levels of Accountability Noted in Documents and Artifacts (n=33)
Accountability Level
Cases
Frequency (N) Percent
Team 2 6.06
Management 6 18.18
Organization 14 42.42
Individual 11 33.33
Note. Dichotomy group tabulated at value 1.
54
Criterion is listed in line 218, boxes six through nine of the Data Dictionary Codebook
(Appendix A). Multiple criteria may apply to one case.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 181
Organizational and individual accountability occurred most frequently. While the
organizational accountability value reinforces the stakeholder perceptions identified in the
survey, the lack of management accountability in documents and artifacts does not fully support
the perception that the level is high in many organizations. It should be noted, however, that
documents and artifacts were not analyzed from all of the institutions of all of the respondents,
though there may be some crossover.
Regarding capacity, recurring themes such as the importance and proper construction of
business continuity, disaster planning, and individual job description documents fostered
improvement. Capacity was linked to clear contingency planning and awareness of expectations.
The final culture influence studied in this dissertation is communication.
Communication. Like the other influences under the umbrella of culture,
communication was a frequently referenced topic across all study arms. In revisiting the
Program Elements identified in Chapter One, two referenced communication directly. As
discussed in that section of the chapter, the second element was an implementation means of the
first. While the essentiality percent subtotal for developing open lines of communication was
high at 97.4 percent, the feedback mechanisms element had a lower rating with an essentiality
subtotal percent of 62.9. When attempting to explain the disconnect between the two, a
additional review data provided more dimensions of the impact of communication on
compliance.
The presence of the HHS OIG (2011) communication element within survey respondents’
organizations was relatively high, with 73.3 percent of respondents stating that it was firmly or
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 182
mostly existent.
55
When evaluated in field observations, the influence was noted in 72 percent of
cases.
56
During analysis of documents and artifacts, there were two opportunities for
identification; communication as a program element, and as an organizational culture dynamic.
There were six seven occurrences of communication in document and artifact cases.
57
Interviews had several references to communication as a means to improve compliance efficacy
and sustainability. They included, without limitation, communication of conceptual and
procedural knowledge to stakeholders, developing tools for communication, meeting
management to communicate critical information, and awareness of compliance risks, events,
interventions, and mitigation at every level of the organization. Similarly, several interviewees
remarked that there were instances in which a lack of communication was a barrier to
compliance. It caused delays in receiving critical information, created additional risk
vulnerability, and limited the effectiveness of interventions and mitigation efforts.
The multiple occurrences of communication reinforced the importance of the influence,
and its positive use, in improving stakeholder compliance efficacy and program sustainability. It
also revealed it as a potential barrier to compliance and a factor in increasing risk when the right
information is not delivered to the right audience at the time needed using the appropriate means.
The chapter concludes with a summary.
55
See line in the 80 Data Dictionary Codebook (Appendix A) for possible responses and tie to the
survey item.
56
Criterion is listed in line 201, box four through nine of the Data Dictionary Codebook
(Appendix A). Multiple criteria may apply to one case.
57
Criteria are listed in line 215, box three and line 218, box four of the Data Dictionary
Codebook (Appendix A). Multiple criteria may apply to one case.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 183
Summary and Implications
Across 133 cases, each of the research questions in this study was analyzed in depth.
58
The data covered all three types of influences in the Clark and Estes (2008) gap analysis model
and all four elements from the study’s Conceptual Framework. Research Question One analyzed
stakeholder feedback and additional results and findings regarding the first element of the
Conceptual Framework, Essential Elements for Compliance Programs of the 21 elements
identified 15 were validated. The results and findings revealed that while most of the original
HHS OIG (2011) elements remain valid, additional dimensions such as stakeholder buy-in,
visibility and transparency, and improved systems and process could increase the likelihood of
stakeholder compliance and overall sustainability of compliance and regulatory programs.
Research Question Two analyzed stakeholder feedback on Knowledge and Skills
Influence, which is also the second element of the Conceptual Framework. Stakeholder
knowledge and skills require both conceptual knowledge, the specific rules, regulations, and
policies that they are expected to follow, and procedural knowledge on how to implement and
maintain ongoing compliance. The best means of communicating content and promoting
knowledge transfer varies depending on the role of the stakeholder, the institution’s
communication infrastructure, and the subject matter of the content. Additional information such
as the type of specialty which the institution practices, along with its size, scope, and
predominant patient needs must also be considered when assessing this influence.
Research Question Three reported and interpreted data on stakeholder feedback regarding
Motivational and Organizational Influences, which are also elements three and four of the
58
See Table 14 in the first section of this Chapter for the count of cases by instrument and study
arm.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 184
Conceptual Framework. Both expectancy-value theory and self-efficacy theory must be
considered when building the evaluation model for compliance and regulatory programs.
Factors such as time and effort and perceived regulatory burden impact whether or not
stakeholders believe that compliance is worth the cost and that it is not only possible but
probable. The cost of noncompliance continues to be a powerful motivator to improve
compliance, but it must be outcomes-focused rather than punitive.
Organizational influences must be considered when building a compliance program
evaluation model. Assets are the means by which conceptual and procedural knowledge are
implemented and continually utilized. Assets such as policies, procedures, systems, and
processes must be meaningful, relevant to the institution’s scope of services, and continually
reviewed to ensure that they are both current and usable. Culture has several dynamics, and they
all impact organizational performance and the functionality of compliance and regulatory
programs. Having compliance and regulatory staff available and ready to collaborate is a
recurring theme to improve the ability of stakeholders to comply and for institutional programs
to be successful in their goals and objectives. Accountability must be clearly documented
through items such as policies, job descriptions, handbooks, and other means. Capacity must be
a consideration. Critical activities such as business continuity and succession planning impact
the ability of institutions and stakeholders to maintain compliance capacity. Communication is
an essential consideration in evaluating compliance efficacy and sustainability. Subject matter,
audience, the flow of communication, and style are critical factors of impacting the success of
communication. Failure to foster communication can reduce compliance efficacy, increase risk,
and result in segmentation and compartmentalization among stakeholders. The final chapter
develops the recommendations and other critical elements to operationalize this study’s research.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 185
CHAPTER FIVE: SOLUTIONS, EV ALUA TION, AND IMPLEMENTA TION
Introduction
The purpose of this Chapter is to discuss recommendations and solutions based on
analysis of the Research Questions, Influences, and Conceptual Framework Elements in
presented in Chapter Four. Additionally, the Chapter will detail proposed plans and tools
associated with implementing those recommendations and provide a means for evaluating
viability and sustainability, both in immediate and long-term summative assessment. The
recommendations and associated plans follow the New World Model developed by James D
Kirkpatrick and Wendy Kayser Kirkpatrick (2016). While there is some debate about the
usefulness and applicability of the New World Model in academia, for this study, it was
especially important. That is primarily due to the flipped structure of continuous evaluation.
While not all pieces of the model are used, it is consistent the general evaluation framework used
in studies of this type. Following are the Research Questions for the study.
Research Questions, Influences, and Conceptual Framework
The following table lists the Research Questions, and associated knowledge and skills,
motivational, and organizational influences following the gap analysis model developed by Clark
and Estes (2008).
Table 41.
Gap Analysis Influences and Research Questions
Number Content
Research Questions
RQ1 What are the essential elements and best
practices of a regulatory and compliance
program (referred to hereafter as compliance
program) in a specialty academic medical
institution?
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 186
Number Content
RQ2 From the perspective of staff, what are the
knowledge, skill and motivational influences
that contribute to building and maintaining an
efficient and sustainable compliance
program?
RQ3 From the perspectives of staff, what
organizational influences need to exist – and
to what extent – to build an effective,
sustainable compliance program in a specialty
academic medicine setting?
Knowledge and Skills Influences
K1 Staff needs to know the regulations applicable
to practice and research. (Conceptual)
K2 Staff needs to know how to implement and
comply with the relevant regulations.
(Procedural)
Motivational Influences
M1 Staff needs to feel that the process of
complying with relevant regulations is worth
the burden, time, and expense. (Expectancy-
value theory (EVT)).
M2 Individual staff members and the stakeholder
group need to believe that regulatory
compliance is probable (Self-efficacy theory
(SET)
Organizational Influences
O1 Institutional systems, assets, and processes
need to facilitate implementing and sustaining
compliance in practice and research
(Organizational Assets).
O2 Institutional leaders and staff need to create
an internal climate fostering sustained
improvement and build on assumed
motivational influences (Organizational
Culture).
The Conceptual Framework Elements are presented in Figure 24 below. Each quadrant is
tied to specific influences and Research Questions as detailed in the analysis presented in
Chapter Four.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 187
Figure 24. Study Conceptual Framework.
The study’s framework is drawn from the KMO gap analysis model (Clark & Estes,
2008) and Program Elements as derived from the review of relevant research.
Recommendations for Practice to Address KMO Influences
Knowledge Recommendations
Introduction. The knowledge influences in Table 42 and the probability of validation
are based on the review of relevant research, including the formation of knowledge influences as
identified in Clark and Estes (2008). As this dissertation is an evaluation model, the essential
elements identified in the first Research Question form the foundation of the knowledge and skill
influences. Those essential elements, identified in research and validated in data collection, give
the associated knowledge influences a higher probability of validation themselves. The first
knowledge influence is conceptual and refers to the regulations, policies, and their applicability
found in specialty academic medicine. Moving from conceptual to procedural knowledge, the
influences in that category focus on how institutions need to implement and maintain compliance
I.
Program Elements
•HHS OIG (2011)
Fundamental
Elements
•Practice Elements
•Improvement and
Utilization Elements
II.
Knowledge and
Skills
•Rules and
regulations
(Conceptual)
•Implementation
(Procedural)
III.
Motivational
Influences
•Value in time,
effort, (EVT)
•Compliance is
probable (SET)
IV.
Organizational
Influences
•Assets
•Culture, context and
setting
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 188
with the program elements and conceptual knowledge influences. Table 42 shows the assumed
influences, the probability of validation, priority, and recommendation in context.
Table 42.
Summary of Knowledge Influences and Recommendations
Assumed
Knowledge
Influence:
Cause, Need,
or Asset*
Validated
Yes, High
Probability,
or No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
Staff needs to
know the
regulations
applicable to
practice and
research. (C)
V Y Align knowledge and
skills training
objectives with
business and
performance goals.
Clark and Estes
(2008)
Compliance and
regulatory training
should be broad and
geared toward
stakeholder buy-in
and understanding.
Bower (2011)
Develop a curriculum focus
group of stakeholders with
both longevity and
relatively recent arrival to
evaluate usability and
comprehensive of
compliance training.
K1: Staff
needs to
know the
regulations
applicable to
practice and
research. (C)
V Y Knowledge and skills
should be
communicated in
such a way that they
are easily transferable
to the stakeholder’s
role.
Clark and Estes
(2008)
Stakeholders need to
understand the
relationships of
Embed compliance
responsibilities into job
descriptions of all
stakeholders. Ensure that
they are linked to the
institution’s mission in the
job description document.
Develop job aides that staff
can use to cross-reference
with assigned
responsibilities and
required knowledge.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 189
Assumed
Knowledge
Influence:
Cause, Need,
or Asset*
Validated
Yes, High
Probability,
or No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
conceptual
knowledge and their
own scope of
practice.
Rueda (2011), Kezar
(2001)
K1: Staff
needs to
know the
regulations
applicable to
practice and
research. (C)
V Y When educating
stakeholders on
knowledge and skills,
build a framework for
training stakeholders
on emerging issues in
the field.
Clark and Estes
(2008)
As rules, regulations,
and compliance
requirements evolve,
stakeholders need to
stay abreast of those
changes to apply
procedural
knowledge correctly.
Bower (2011)
Partner with other specialty
research institutions to
share curriculum on annual
compliance refresher
training, and conduct a gap
analysis. Use the gap
analysis to share updates on
sections which both
institutions may be missing.
K2: Staff
needs to
know how to
implement
and comply
with the
relevant
regulations.
(P)
V Y Use audience-focused
training, job aids,
guided feedback, and
educational tools for
communicating
procedural
knowledge,
especially when it is
new to the
stakeholder.
Conduct organizational and
team-based compliance
training, as well as ongoing
annual walk-throughs,
focused on procedural
knowledge (implementation
and maintenance of
compliance requirements).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 190
Assumed
Knowledge
Influence:
Cause, Need,
or Asset*
Validated
Yes, High
Probability,
or No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
Clark and Estes
(2008)
Procedural
knowledge needs to
be communicated in
such a way as to
ensure broad
institutional
implementation of
conceptual
knowledge and
minimize potential
conflict in
stakeholder groups.
(Bower, 2011)
K2: Staff
needs to
know how to
implement
and comply
with the
relevant
regulations.
(P)
V Y Ensure that training is
provided for
unanticipated
problems and
contingency
planning.
Clark and Estes
(2008)
Built on an
understanding of the
relationship between
their scope of practice
and compliance
requirements
(conceptual
knowledge),
stakeholders need to
develop
contingencies to
Conduct an assessment of
barriers to implementing
compliance in three key
venues.
1) Through feedback
from supervisor and
employee one-on-one
meetings;
2) Feedback sessions
directly for stakeholders to
interact directly with
compliance office staff;
3) Individual
interviews and team
meetings with a broad
cross-section of members
of the stakeholder group.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 191
Assumed
Knowledge
Influence:
Cause, Need,
or Asset*
Validated
Yes, High
Probability,
or No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
overcome
implementation
roadblocks.
Ruddy, Thomas-
Hemak, and Meade
(2016)
K2: Staff
needs to
know how to
implement
and comply
with the
relevant
regulations.
(P)
V Y Ensure that
stakeholders
understand the
reasons and outcomes
of adverse or
ineffective
implementation and
application of
conceptual and
procedural
knowledge.
Clark and Estes
(2008)
Stakeholders need to
be cognizant of the
consequences of
failure to properly
apply procedural
knowledge – from a
clinical, research, and
organizational
perspective; this
includes
understanding the
cost of
noncompliance.
Kilbridge (2003),
George et al. (2013)
Use case studies at new
employee orientations,
team training, and annual
refresher training to focus
on the ripple effects of
noncompliance. In addition
to required noncompliance
training (i.e., civil and
monetary penalties), focus
on more organic costs
linked to the institution's
mission and vision; such as
such as widening the health
equity and access gaps, and
the inability to hire new
staff for research,
education, and patient care
activities.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 192
Conceptual knowledge solutions, or description of needs or assets. The conceptual
knowledge solutions focus on three key areas (i) alignment with organizational objectives and
stakeholder roles and responsibilities, (ii) buy-in and personal meaning, (iii) and promotion of
knowledge transfer and continuous updates as new conceptual knowledge emerges. Clark and
Estes (2008) discuss knowledge alignment, transferability, and the need for regular updates as
subparts of the knowledge and skills gap in solving performance problems. At the same time in
research from the compliance and regulatory field, Bower (2011) takes those influences and
applies then specifically to training, development, and related functions within a healthcare
facility. All of the procedural and conceptual influences were validated based on analysis,
results, and findings. The specific recommendations were gleaned from stakeholder feedback
and provide the appropriate support to bolster the conclusions.
Built on the alignment objective discussed in Clark and Estes, the development of a
curriculum focus group brings together stakeholders across multiple disciplines within the
institution. The primary function of that group is to vet the content while also providing
feedback on alignment with the mission and objectives at an organizational, departmental, and
even individual level. The group also helps to strike a balance between broad applicability and
role-specific conceptual knowledge needed to be successful. That supports Bower’s requirement
for stakeholder buy-in, while also increasing the credibility and trustworthiness of the content,
and its meaningfulness to the individual (Kezar, 2001; Rueda, 2011) and by virtue, the
Compliance and Regulatory Program. A critical consideration of conceptual knowledge, as
validated both in the professional and theoretical literature is the need to maintain a constant
flow and transfer of new knowledge (Clark & Estes, 2008; Prescott, 2012). Just as the field’s
body of knowledge in specialty medicine changes, so do a host of regulatory and statutory
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 193
requirements to which the institution is held accountable. That is further important in an
academic medical facility that practices patient care, research, and educational activities.
While contingency planning is important, Kilbridge (2003) and George et al. (2013)
remind stakeholders and leaders of the cost of noncompliance and failure to implement
procedural knowledge correctly. However, in addition to providing procedural knowledge on the
regulatory and legal cost of noncompliance, the institution needs to make it personal and
relatable to stakeholders. That includes elements such as the impact on the health equity and
access gaps, lack of future opportunities for research studies, and inability to bring on new talent
to meet the changing needs in population health, and failure to adequately train and equip
stakeholders to respond to compliance obligations.
Motivation Recommendations
Introduction. Knowledge and skills are only the first steps to improving compliance and
regulatory programs. Overwhelmingly, the study found that found that the proper motivation
influences must be in place to increase both the likelihood of stakeholder compliance and the
sustainability of compliance and regulatory programs. Stakeholder feedback was elicited on self-
efficacy theory and expectancy-value theory. Table 43 presents the motivational influences and
associated recommendations.
Table 43.
Summary of Motivation Influences and Recommendations
Assumed Motivation
Influence: Cause,
Need, or Asset*
Validated
Yes, High
Probability,
No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
M1: Staff needs to feel
that the process of
complying with
V Y Active choice,
persistence and
mental effort are aids
Utilizing the
institution’s
existing Internal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 194
Assumed Motivation
Influence: Cause,
Need, or Asset*
Validated
Yes, High
Probability,
No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
relevant regulations is
worth the burden, time,
and expense.
(Expectancy-value
theory (EVT)).
in helping close
performance gaps.
Clark and Estes
(2008)
Improving
stakeholder EVT
must account for
intrinsic interest,
utility, importance,
attainment, and cost.
Pintrich (2003)
Compliance
Committee, made
up of staff leaders
from across
departments,
conduct a value
analysis project.
Those leaders pair
current regulations
with desired
improvements in
processes,
operations,
population health
and research
functions through
modeling and
emulation.
M1: Staff needs to feel
that the process of
complying with
relevant regulations is
worth the burden, time,
and expense.
(Expectancy-value
theory (EVT)).
V Y Stakeholders must
understand that the
cost of
noncompliance has an
adverse impact on
institutional, clinical,
patient experience,
cost containment, and
research outcomes.
Kilbridge (2003)
As part of improving
stakeholder EVT,
staff must understand
that noncompliance
has an adverse impact
on the reputation and
credibility of the
institution and the
field.
During team-based
training, annual
refreshers, and new
employee
orientations
conduct a “core
values session” in
which compliance
with cardinal
regulations is
paired with a
component of the
institution’s
mission. Rather
than training on the
cost of non-
compliance, have
training
participants
develop their list of
costs (both
tangible and
intangible), and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 195
Assumed Motivation
Influence: Cause,
Need, or Asset*
Validated
Yes, High
Probability,
No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
Okello and Gilson
(2015), Anthony et
al. (2014)
rank them in order
of priority.
M1: Staff needs to feel
that the process of
complying with
relevant regulations is
worth the burden, time,
and expense.
(Expectancy-value
theory (EVT)).
V Y Tools for improving
task completion must
be usable by
stakeholders, to
improve EVT.
Clark and Estes
(2008)
Tools, such as
Electronic Medical
Records, when
implemented and
trained poorly can
reduce the likelihood
that stakeholders will
use them
meaningfully, even
when tied to
regulatory
requirements.
Kilbridge (2003)
Have departments
which own tools
used in tasks
related to
compliance and
regulatory
requirements
conduct annual
feedback studies to
gauge user trust,
motivation, and
possible
improvements to
encourage and
increase adoption.
Link that to the
value of
compliance
examined in the
second
recommendation.
M2: Individual staff
members and the
stakeholder group need
to believe that
regulatory compliance
is probable (Self-
efficacy theory (SET),
Individual efficacy)).
V Y In order objectives,
stakeholders to
accomplish
performance must
believe that they can
do so.
Bandura (1986)
The motivation of
individuals to
accomplish a task
improves when they
believe that peers will
support them in
Use team-building
to weave
compliance and
regulatory
education and
implementation
with ongoing
activities and
priorities of the
group at a small
team or workgroup
level.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 196
Assumed Motivation
Influence: Cause,
Need, or Asset*
Validated
Yes, High
Probability,
No
(V , HP, N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
reaching a goal or
completing a task.
Bandura (1997),
Takahashi (2011)
M2: Individual staff
members and the
stakeholder group need
to believe that
regulatory compliance
is probable (Self-
efficacy theory (SET),
Collective efficacy).
V Y The likelihood of
completing more
challenging goals and
tasks increases when
a stakeholder group
works collectively.
Esnard and Roques
(2014)
Institutions who
advocate for and
encourage collective
efficacy experience
increases in both
legitimacy of
compliance and
regulatory programs,
and the likelihood of
rule adherence.
Tyler and Jackson
(2014)
Use team-based
and individual
accountability
through either job
descriptions or
departmental
operating guides to
plan for teams to
work together,
rather than solely
by themselves, in
fulfilling
compliance and
regulatory
requirements.
Expectancy-value theory. As a precursor to efficacy, organizations need to create a
value-proposition for sustainable compliance and change. The concepts of active choice,
persistence and mental effort all play a role in stakeholders believing that change is worth the
effort (Clark & Estes, 2008). Additional research suggests, though, that the value proposition for
changes must also consider the personal or intrinsic value of the stakeholder to change,
attainment (linked to both individual and collective efficacy), and that the cost-benefit is
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 197
reasonable and worth the effort (Pintrich, 2003). There needs to be a direct link between all of
those items and the perception of the individual to realize value.
By utilizing an already existing committee made up of departmental leaders to conduct a
value analysis, only minimal new resources are required such as time and people. The recurring
meeting of the interdepartmental compliance committee is already on everyone’s calendar.
Additionally, the decision-makers are already together with representation from across the
institution. Arriving at a consensus allows for the value proposition to have collective buy-in and
flow downstream to each department’s team and staff members. Further, those leaders
represented at the committee can relate the value of compliance to the specific implications for
their departments and staff members.
Moving to a more global context at the organizational level, defining value needs to be
tied to the organization’s mission, vision, and core values. Employees join the organization, not
just the team, and dedication to mission and vision are part of the experience of a team member.
By linking compliance requirements to institutional values and operations, management sets the
stage for the outcomes focus requirement in sociocognitive causal structure as defined by
Bandura (1998). The cost of non-compliance is already covered during employee onboarding.
Additionally, CMS (2017) requires that organizations share the specific civil and monetary
penalties that can result from failure to follow fraud, waste, and abuse regulations. Making that
intrinsic and applicable to the organization, teams, and staff members create a causal connection
between the employee and the outcome, thereby boosting the value proposition.
As the final means of addressing expectancy-value in motivation, the last
recommendation takes accountability back from the organization to departments, teams, and
individuals. Each department has specific tools that they are responsible for, and which
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 198
ultimately comprise the organization’s operating functions and ability. As the owner of
processes, tools, and other organizational assets, the respective stakeholder best knows how the
compliance requirement impacts that item. By seeking external feedback on how the asset can
be improved to facilitate compliance better, the owner practices continuous improvement. They
also build trust with internal and external customers, improve the reliability of their asset, and is
prepared to account for future evolution and change in compliance requirements; and ultimately
understand the value, and implement the change expediently and efficiently.
Self-efficacy theory. The recommendations related to self-efficacy theory (SET) address
considerations of both individual and collective efficacy. The underlying consideration in the
SET section is movement from merely possible to probable.
Individual efficacy. In individual efficacy, as it relates to this study and topic, the
primary means to bolster the recommendations in that context are (i) outcomes-impact, (ii)
perception of self-ability, and (iii) likelihood of support from others. Built off of the assessment
of sociocognitive causal structure (Bandura, 1998), individuals must connect the potential
outcomes of failure to make a change. Otherwise, the likelihood of change is minimal.
Outcomes-focused awareness is what moves the stakeholder from possible to probable. That
connection is especially apparent when considering causal impact through the lens of individual
efficacy. Bandura’s fundamental assumption is that people must realize how their own habits
and practice impact their health outcomes. When applying sociocognitive causal structure in an
organizational setting, leaders must also take into account Bandura’s previous work which moves
the likelihood of change forward in the process from possible to probable, by combining impact
with the ability to implement the change (1986). The critical assertion, in this case, is that
individual self-confidence increases the likelihood that stakeholders will comply and implement
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 199
the needed change. Finally, about individual efficacy, both Bandura (1997) and Takahashi (2011)
emphasize the importance of trust that the whole collective support the individual members’
ability and efforts to achieve change.
The team-building recommendation takes sociocognitive causality, individual ability, and
trust in the collective into account. Dyer, Dyer, Dyer, and Dyer (2013) emphasize the critical role
that team-building plays in building a sense of trust and commitment to the team and its
members. By using team-building paired with compliance requirements as a means to improve
individual self-efficacy, they can (i) develop a shared vision and commitment to outcomes built
on the organization’s mission and the regulatory requirements, (ii) acknowledge each member’s
individual and collective abilities, and (iii) deepen the sense of trust that they share.
Collective efficacy. Built off of the trust, shared vision, and confidence in abilities
derived from the individual efficacy exercise, the second recommendation turns the attention to
the effort of the whole. The second recommendation, using team-based and individual
accountability, moves the effort from probable to sustainable. By frequently checking in with
each other on individual and collective performance, the team improves the likelihood of
success, consistent with Esnard and Roques (2014). Further, this recommendation also moves
the consideration from the individual to the team, and then to the organization as a whole. Tyler
and Jackson (2014) link the ability of the individual and the group to accomplish the change to
their perception that not just the team itself, but also to the organization’s belief in them.
The advantage of job descriptions as a means of formalizing accountability is that they
are both multi-functional and general, covering the various roles and responsibilities that a staff
member might encounter (Limpert & Will, 2010). Also, since they are an organizational
document, shared commitment also exists between the organization, the staff member, and their
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 200
team leader or manager. Although not specific to employees, the same is true for policies and
procedures. Limpert and Will (2010) also state that policies that are well-written use collective
and ongoing feedback, and focus on behavior as a critical means of accountability are likely to
improve individual, team, and organizational success.
Organizational Recommendations
Introduction. The organizational influence represents the confluence and final outputs
of the motivational influences. In this study, the specific influences profiled included
organizational assets and culture. Like the influences, the organizational recommendations build
off of those in the knowledge, skills, and motivation sections above. In Table 44,
recommendations linked to the associated organizational influences are presented.
Table 44.
Summary of Organizational Influences and Recommendations.
Assumed
Organization
Influence:
Cause, Need, or
Asset*
Validated
Yes, High
Probability,
No (V , HP,
N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
O1: Institutional
systems, assets,
and processes
need to facilitate
implementing and
sustaining
compliance in
practice and
research
(Organizational
Assets).
V Y Organizational
processes and
systems need to
align with its culture
and goals.
Clark and Estes
(2008)
For a sustainable
change, policies and
procedures must
work to remove
barriers rather than
create them.
Re-engineer the work
processes for developing
and reviewing
institutional policies and
procedure. Instead of
simply a regulatory
review, use the
compliance committee
developed in the
motivation section to
assess what potential
barriers that the policy
change might cause.
Develop contingencies
for those potential
barriers as part of the
policy redesign process.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 201
Assumed
Organization
Influence:
Cause, Need, or
Asset*
Validated
Yes, High
Probability,
No (V , HP,
N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
L. J. Miller and Lee
(2014)
O1: Institutional
systems, assets,
and processes
need to facilitate
implementing and
sustaining
compliance in
practice and
research
(Organizational
Assets).
V Y Effective
organizations ensure
that
organizational
messages, rewards,
policies
moreover,
procedures that
govern the work of
the
organization are
aligned with or are
supportive of
organizational goals
and values.
Clark and Estes
(2008)
The conduct of
research and patient
care and the rules
and regulations
associated with it
must focus on
When announcing
policy changes and
implementation, use
intrinsic value
messaging to create the
buy-in for institutional
leadership. Pair the
announced policy
change with a principle
of the conduct of
responsible research
such as beneficence or
respect for persons.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 202
Assumed
Organization
Influence:
Cause, Need, or
Asset*
Validated
Yes, High
Probability,
No (V , HP,
N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
beneficence, ethics,
and protection of the
subject, consistent
with established
principles and
regulations.
Cowley (2012);
Ross et al. (2010)
O2: Institutional
leaders and staff
need to
create an internal
climate fostering
sustained
improvement and
build on
assumed
motivational
influences
(Organizational
Culture).
V Y Effective change
begins by
addressing
motivation
influencers; it
ensures the group
knows why it needs
to change. It then
addresses
organizational
barriers and then
knowledge and
skills needs.
Clark and Estes
(2008).
Effective change
takes the levels of
culture into account.
Believes and
assumptions need to
flow from values
rather than merely
to them.
Building off of the
team-building activities
and compliance
committee redesign in
the motivation
recommendations,
create a culture
committee composed of
senior leaders, directors,
managers, faculty, and
front-line staff. Make
this a cross-sectional
group representing the
diversity of the
institution, but no more
than 15 members to
ensure that the work is
productive. In that
committee discuss the
organizational barriers
to effective compliance
such as communication,
trust, and related items.
Develop an action plan
to address each one of
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 203
Assumed
Organization
Influence:
Cause, Need, or
Asset*
Validated
Yes, High
Probability,
No (V , HP,
N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
Schein (2004)
Managerial
involvement in
creates more
sustainable
organizational
change.
Kirkpatrick (2006)
those obstacles within a
specified time. Hold
periodic check-in
sessions to assess
progress on
implementation to
ensure sustainability.
Revise the plan as
needed.
O2: Institutional
leaders and staff
need to
create an internal
climate fostering
sustained
improvement and
build on
assumed
motivational
influences
(Organizational
Culture)
V Y Communication of
organizational
change is a
multidisciplinary
process that must
take both policy
requirements and
purposeful
bidirectional
feedback into
account.
Laurie K. Lewis
(2011)
Measures for
detecting and
preventing
noncompliance must
be paired with
purposefully
creating a culture of
compliance and
integrity. That
responsibility begins
Hold quarterly town-hall
meetings focused on
improving ethics,
integrity, and
accountability across the
organization. Using a
means to create a safe
environment for
communication, allow
any individual the
opportunity to ask
senior leaders why a
policy decision is being
made. Moderate
bidirectional feedback to
ensure that it provides
precise information but
respectful to the
organization’s need to
moderate
communication.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 204
Assumed
Organization
Influence:
Cause, Need, or
Asset*
Validated
Yes, High
Probability,
No (V , HP,
N)
Priority
Yes, No
(Y, N)
Principle and
Citation
Context-Specific
Recommendation
with organizational
leaders.
Biegelman and
Bartow (2012)
Organizational assets. The organizational recommendations are deeply connected, not
only to those outlined in the knowledge and motivation sections but also to each other. They
represent a tiered approach to creating improved efficacy and sustainable change in compliance
programs. Core to technical compliance competency is the laws and regulations that form the
basis for programs. Within a medical research institution, the policies, procedures, processes,
and systems operationalize those requirements. As stated by Boulet and van Zanten (2014), in
specialty medicine, that operationalization varies, in large part due to discipline-specific quality
and regulatory requirements such clinical licensure, training, and accreditation.
An institution’s clinical specialty creates the framework for the organization’s entire
structure, research, and delivery of clinical services. At the same time, Clark and Estes (2008)
consistently emphasize that the successful execution of those processes must align with an
organization’s culture and goals if they are to prove sustainable. That is why development of
crucial guidance documents such as policies and procedures must be sensitive to the ebbs and
flows of an institution’s processes, goals, and culture and goals. By engaging in continuous
revalidation of those documents, they become more usable, and take into account critical factors
such as changes in resources and risk, and create more sustainable planning for future events and
shifts (Amadei, 2016). Another critical consideration of early and consistent adoption is the idea
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 205
of purpose and meaning. One of the key focuses of this dissertation is efficacy, both individual
and collective. A fundamental consideration in bioethics and human subject protections in the
conduct of research in alignment with the principles outlined in The Belmont Report and
codified in the Common Rule (Ross et al., 2010). Holding true to core research values such as
beneficence and protection of the individual when developing and revising guidance documents
can create a more sustainable framework for ongoing compliance.
Leadership and organizational culture. Level Two of Kirkpatrick’s (2006)
foundational research in organizational effectiveness describes the involvement of leadership as a
means for success. Staff often take their cue for what constitutes effective performance from a
leader’s feedback. Senge (1990) reinforces the notions that feedback from a leader directly
contributes to a team member’s learning and success. Communication, focus, and commitment
set the tone for organizational culture. Ultimately, as described in Anna, Igor, and Natalia (2015)
it is that culture, and the ability of leadership to communicate, manage, and implement it defines
either success or failure for the organization.
The concept of team-building has appeared regularly throughout the discussion of the
recommendations in this chapter. The recommendations, built off of Clark and Estes (2008),
Schein (2004), and Kirkpatrick (2006), create complementary spaces where every faculty and
staff member, from executive leaders to individual contributors use both participatory decision-
making. They also use ongoing accountability and transparency to connect the culture of the
institution to the way that its policies, procedures, priorities and business decisions are developed
and implemented. Flowing from that sense of collaboration, regular points of communication
between leaders and staff allow for those who have to abide by and implement the policy to
understand the ‘why’ and the ‘how.' Fix and Sias (2006) find that the communication
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 206
mechanism that leaders used to interact with staff affect longevity, employee satisfaction, and
productivity. It is vital that communication on regulatory issues, accompanying policies
changes, and their logic is not generic. While there must be broad institutional applicability,
leaders need to tune the message to dynamics, culture, and responsibilities of their departments
and teams.
Integrated Implementation and Evaluation Plan
Implementation and Evaluation Framework
In that this dissertation is an evaluation model, an appropriate means to evaluate
the recommendation is required. To that end, this study uses The New World Kirkpatrick Model
to provide the necessary evaluation framework (James D Kirkpatrick & Wendy Kayser
Kirkpatrick, 2016). This model uses four progressive but differing levels to evaluate
organizational training. Those levels, working in reverse and consistent with implementation,
are listed below in Figure 26.
Figure 25. Kirkpatrick New World Model Four Levels in Reverse (Implementation
Design)
1-Reaction
Customer
Satisfaction
Engagement Relevance Monitor and Adjust
2-Learning
Knowledge and
Skill
Attitude Confidence Committment
3-Behavior
Critical Behaviors Required Drivers On-the-Job Learning
4-Results
Leading Indicators Desired Outcomes
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 207
By working backward, the Kirkpatrick New World Model creates a conceptual
framework specifically for evaluation; starting with Results and building behavior, learning (and
all of the associated tangents), and reaction from the perspective of both the stakeholder and the
constituent. Since evaluation is results-oriented, institutions can use the framework to (i)
continually evaluate the effectiveness, adoption, relevance, and scalability of recommendations
and associated deliverables, (ii) make course corrections in real-time implementation, and (iii)
use continuous improvement methodologies to re-evaluate and adjust short and long-term goals
for each recommendation related to this study, consistent with practices profiled in van
Aartsengel (2013).
Organizational Purpose, Need, and Expectations
Relationship of recommendations and research to the organization. The
recommended interventions in this study must proceed from the Research Questions, the
problem of practice, and the mission and composition of the institution. That mission, for
Breckenridge Valley Health, is to heal, discover, and educate as a preeminent healthcare
institution. The problem of practice for this study is two-fold. First, a lack of efficacy and
sustainability of compliance and regulatory programs can cause the adverse patient outcome,
dramatically increase the cost of care, and widen the health equity and access gap. Second, it can
create several organizational performance problems, including:
• Creating gaps in clinical service delivery;
• Failing to provide for continuity of care;
• Impeding the advancement of research; and
• Creating a negative patient experience.
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To operationalize solutions and recommendations, it was necessary to develop them from
three fundamental Research Questions:
1. What are the essential elements and best practices of a regulatory and compliance
program (referred to hereafter as compliance program) in a multisite subspecialty
academic medical institution?
2. From the perspective of staff, what are the knowledge, skill and motivational influences
that contribute to building and maintaining an efficient and sustainable compliance
program?
3. From the perspectives of staff, what organizational influences need to exist – and to what
extent – to build an effective, sustainable compliance program in a multisite subspecialty
academic medicine setting?
Relationship of recommendations and research to the stakeholder group. The
stakeholder group of focus for this study is staff in a specialty academic medical institution. That
group drives the institution’s core operational services, provides and supports research activities
and the delivery of clinical services, and is one of the most populous and predominant voices in
shaping the institution, its policies, and its culture and context. Without the staff stakeholder
group, the hospital cannot meet its defined mission of healing, education, and discovery. This
study aims to develop an evaluation model by which organizations can measure, and ultimately
improve the efficacy of compliance and regulatory programs, their sustainability, and the ability
of staff to utilize them in the various facets in which they interact with the institution. That
includes both individual and collective efficacy. Hospital employees are the individuals and
comprise the teams that must apply the regulatory requirements in clinical practice, education,
and research. A compliance and regulatory program must be built in such a way as to set
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 209
employees up for success, provide the needed resource, and be a critical access point for
changing regulations and continuous improvement.
Level 4: Results and Leading Indicators
Level 4 of the New World Model focuses specifically on the impact of training and
development as a means to measure goal attainment, support, and accountability (James D
Kirkpatrick & Wendy Kayser Kirkpatrick, 2016). In this instance, those goals flow from the
KMO Influences. In Table 5, each of the outcomes is paired with the appropriate metrics,
methods of evaluation, the KMO influence, and applicable Research Question. Methods are
intended to direct the outcome and will be evaluated against the stated metrics. Table 45 presents
the measured outcomes, influences, Research Questions, and associated metrics.
Table 45.
Outcomes, Metrics and Methods for Internal and External Outcomes tied to the KMO Influence
and Research Question
Outcome Metrics(s) Methods(s) KMO RQ
Internal Outcomes
1) Increased staff
knowledge applicable
to their clinical practice
and research scope.
Two examples per
employee of studies or
quality projects that are
directly impacted by
foundational
regulations.
Create and assess case
studies from the
developed curriculum
for each role.
K1 RQ1,
RQ2
2) Increased staff
knowledge of how to
implement and apply
the regulatory
requirements
applicable to their
clinical scope and
research.
A score of 90 percent or
higher on compliance
walkthroughs.
Develop audit guides
for each department
and team (as
applicable) based on
training and job aids.
K2 RQ1,
RQ2
3) Increased staff
perception that
compliance
requirements are worth
Feedback scores of 90
percent or higher on
annual compliance
engagement surveys.
Use listening sessions
and core values to
develop engagement
surveys.
M1 RQ2
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 210
Outcome Metrics(s) Methods(s) KMO RQ
the expense, time,
burden and effort.
4) Increased staff self-
assessment of the
likelihood of high
compliance.
Three examples per
employee of suggested
improvements in
business and clinical
processes when
compared to
compliance
requirements.
Assessed as part of the
engagement surveys in
outcome 3.
M2 RQ2
5) Increase effectiveness
and staff adoption of
organizational assets
for improving
compliance efficacy
and sustainability.
A minimum of three
policies per department
that needs to be
developed, revised or
retired.
Develop guidelines for
evaluating policy
effectiveness based on
identified barriers.
O1 RQ3
6) Increased staff
perception of
improving
communication and
leadership buy-in.
A score of 90 percent or
higher in the
organizational
performance and
communication section
of the annual
compliance
engagement survey.
Building on developed
engagement surveys
asks specific
evaluation questions
on leadership
commitment and
visibility for
compliance
requirements.
O2 RQ3
External Outcomes
7) Increased institutional
scores and reduced
findings of
accreditation and
regulatory site surveys.
Elimination of all
findings at the
conclusion of a
regulatory site survey.
Assess scores from
formal the Joint
Commission and CMS
validation surveys.
All All
Level 3: Behavior
Level 3 of the Kirkpatrick New World Model assesses the degree to which behavior is
impacted by learning (James D Kirkpatrick & Wendy Kayser Kirkpatrick, 2016). More
specifically, the evaluation determines whether or not behavior indicate positive trending and
normative action toward the internal and external outcomes in Level 4. If evaluating normative
action, Tausch et al. (2011) found that behavior should indicate positive efficacy related to the
outcome.
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Critical behavior. The stakeholders of focus in this study are institutional staff members
responsible for knowing and implementing compliance requirements that impact their scope of
practice, role or research. The first critical behavior is that staff will regularly meet as teams and
departments to develop and share progress on their case studies. The second critical behavior is
that staff members will actively participate in the annual compliance engagement survey process.
The third critical behavior is that individuals (with a special focus on managers and above),
teams, and departments from across the institution will actively take part in the process and
policy redesign initiatives. Table 46 lists the specific metrics, methods, and timing of each
outcome behavior linked to each KMO influence and Research Question.
Table 46.
Critical Behaviors, Metrics, Methods, and Timing for KMO Influences and Research Questions
Critical Behavior Metrics(s) Methods(s) Timing KMO RQ
1) Staff will
regularly meet
as teams and
departments to
develop and
share progress
on their case
studies.
Completion
percentage on case
studies tied to
modules and job
aides.
Compliance
Office managers
will assess
process through
the Learning
Management
System (LMS).
Bi-weekly for
the first six
months and
on a monthly
basis after
that.
K1,
K2
RQ1,
RQ2
2) Staff members
will actively
participate in
the annual
compliance
engagement
survey process
Completion rate of
annual compliance
engagement surveys
measured at the
individual,
department, team,
and organizational
levels.
Compliance
Office managers
will monitor
completion
throughout the
engagement
period.
Weekly
throughout
the 30-day
engagement
period.
M1,
M2
RQ2
3) Individuals
(with a special
focus on
managers and
above), teams,
and departments
from across the
Some policies and
process documents
identified versus
number completed.
Office managers
will monitor
completion
throughout the
Policy and
Procedure
Bi-weekly for
the first six
months and
monthly basis
after that.
O1,
O2
RQ3
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Critical Behavior Metrics(s) Methods(s) Timing KMO RQ
institution will
actively take
part in the
process and
policy redesign
initiatives.
Management
System
Required drivers. Required drivers are those organizational assets which monitor,
reinforce, encourage, reward, and course-correct critical behaviors (James D Kirkpatrick &
Wendy Kayser Kirkpatrick, 2016). When considered through the lens of Tausch et al. (2011),
required drivers push stakeholder behavior towards positive trending and normative action. The
staff stakeholder group requires support, the perception of value, and buy-in from institutional
management to achieve the critical behaviors. Reinforcement is active engagement of leaders to
the compliance efficacy and efforts of staff. Encouragement is illustrating value and buy-in so to
improve expectancy-value and efficacy – both individual and collective. Rewards are incentives
and recognition for positive trending toward normative action and goal attainment. Course-
corrections are the intervention necessary to minimize risk and deviation from progress toward
the goal. Table 47 lists the required drivers about the categories above, which are essential if
staff members are to accurately illustrate the critical behaviors, normative action, and progress
towards the goals.
Table 47.
Required Drivers to Support Critical Behaviors for KMO Influences and Research Questions
Methods(s) Timing Critical
Behaviors
Supported
KMO RQ
Reinforcing
1) Create job aids, annual refreshers, and LMS
modules which prepare employees for work on
Ongoing 1 K1,
K2
RQ1,
RQ2
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Methods(s) Timing Critical
Behaviors
Supported
KMO RQ
case studies. Focus on both conceptual and
procedural content.
2) Provide training to managers and above on how
to assess their team’s performance toward the
goal attainment.
Ongoing 1 K1,
K2
RQ1,
RQ2
Encouraging
3) Managers, to the extent feasible and
comfortable, share their own progress on a case
study and survey completion, as well as their
reasons for responding in the way that they do.
Ongoing 1,2,3 All All
4) Senior leaders (department directors and
executive level staff members), to the extent
feasible and comfortable, share their own
progress on case studies and survey completion
with their respective departments and the
organization as a whole (for executive level
staff).
Ongoing 1,2,3 All All
5) Share exceptionally crafted job aids and case
study responses with the entire institution giving
credit to the individuals and teams who create
them.
Ongoing 1 All All
Rewarding
6) Implement team-building activities to improve
collective efficacy on progress towards case
study completion and participation in
compliance engagement surveys.
Annually 1,2,3 All All
7) Establish incentives for the highest rate of case
study and engagement survey completion at the
team, department, and institutional levels.
Annually 1,2,3 All All
Monitoring and Course-Correction
8) Create a timeline for completion and of required
deliverables and requirements for improvement
if an individual or group does not maintain
compliance.
Ongoing 1,2,3 All All
9) Create a recurring agenda items at department
and institutional leadership team meetings to
discuss progress on completion of training, case
studies, and engagement surveys.
Ongoing 1 All All
10) Develop and implement an early warning
system when an individual or group falls behind
the targeted timeline for deliverables
completion.
Ongoing 1,2,3 All All
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 214
Methods(s) Timing Critical
Behaviors
Supported
KMO RQ
11) Create peer-mentors for individuals identified as
at-risk through the early warning system. Those
peer-mentors will help evaluate the employee’s
progress on completion of case studies and
training, and will regularly report to the
individual’s manager on progress and
recommendations for improvement.
1,2,3 All All
Organizational support. To promote stakeholder compliance, normative action, and
progress on required drivers, the institution must ensure that regular communications occur at all
levels of the institution regarding the expectations, goals and outcomes, and requirements for
improvement. Managers must ensure that employees have the time and bandwidth necessary to
achieve and maintain compliance. Also, decision-making related to budgets and procurement
should include line-items with appropriate resources necessary to achieve compliance. Finally,
progress both a department level and institutional level on completion of requirements, required
drivers, leading indicators, and goal attainment should be shared at quarterly town-halls. Active
recognition of progress and strategies for improvement are necessary to ensure accountability.
Level 2: Learning
Learning goals. Upon completion of the recommendations, learning goals should be
realized across multiple stakeholder groups. Though the interventions focus primarily on the
staff stakeholder group, there is a value proposition for management and administration as well.
Specifically, the learning goals for this study are:
1. Organization
a. Articulating foundational compliance regulations and requirements for all
institutional staff (Knowledge and Skills: Conceptual);
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b. Articulate implementation and ongoing compliance procedures regarding
foundational compliance regulations and requirements for all institutional
staff (Knowledge and Skills: Procedural); and
c. Framing and creating buy-in on the value proposition of sustained
institutional compliance, including risk mitigation and ongoing process
improvement (Motivation (EVT): Value in time, effort, and burden;
Organization: Culture).
d. Utilize organizational resources to effectively create both a compliance
work plan for the institution and individualized learning plans for staff
stakeholders (Knowledge and Skills: Conceptual and Procedural;
Motivation (SET): Collective Efficacy, Organization: Assets and
Culture).
2. Individuals and Teams
a. Articulating foundational compliance regulations and requirements for
departments, teams, and individual roles (Knowledge and Skills:
Conceptual);
b. Articulating implementation and ongoing compliance procedures
regarding foundational compliance regulations and requirements for
departments, teams, and individual roles (Knowledge and Skills:
Procedural, Motivation (SET): Collective and Individual Efficacy);
c. Understand, be able to use, and train other team members on internal and
external resources to improve and sustain compliance efforts (Knowledge
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and Skills: Procedural, Motivation (SET) – Individual Efficacy,
Organization: Assets).
d. Confidently perform event-level compliance interventions based on
acquired knowledge, skills, and available organization resources
(Knowledge and Skills: Conceptual and Procedural, Motivation (SET):
Individual Efficacy, and Organization: Assets and Culture);
e. Perform after-action analysis to measure the effectiveness of the
interventions implemented (Knowledge and Skills: Procedural,
Organization: Assets and Culture).
Program. The learning goals listed in the above section are iterative. They are produced
both as the result of a program and ongoing compliance efforts linked to the recommendations
listed in the respective sections of this chapter. Once executive leadership has approved the
development of the program and the implementation of the recommendations, communication
opportunities will be established. The first will be a presentation at the next available
management team meeting. Following that will be a series of e-mail communications to
familiarize staff with the program. The program will formally begin with a town-hall style kick-
off event. All faculty and staff will be invited to participate. The purpose of that event is to
introduce the concept to all stakeholders within the institution. During that event, stakeholders
will hear about the purpose and history of the program, its justification, and the value
proposition. This message will be delivered by the President of the institution to help reinforce
the concept of management buy-in. Department and team managers will then conduct a review
of the program as it applies to their team specifically at staff meetings held in the proceeding
weeks. Also, all managers and supervisors will schedule one-on-one meetings with staff
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 217
members on their team to explain the motivation for the program, the goals and expectations, its
application to their roles, and the resources available to staff as participate. Compliance staff will
be available to present at team meetings as requested by department leadership. Also,
compliance staff will maintain standard office-hours over the initial six-month implementation of
the program to ensure that departments and staff members have sufficient time to become
familiar with the compliance requirements and the associated recommendations applicable to
their role and scope. Compliance staff will also assist stakeholders in the reflection process by
helping staff understand the applicability of specific regulatory requirements and how staff
members can weave compliance interventions into their daily responsibilities, increasing
confidence and minimizing the possibility of burnout. Finally, through peer mentoring, senior
individual contributors will partner with newer employees to help facilitate the implementation
of compliance requirements and plans, develop questions for knowledge checks, and shape the
newer employee’s compliance plan.
As the program progresses, all new faculty and staff will be introduced to the program as
part of the orientation process. Managers and supervisors will conduct the same individual
follow-up with new hires as they do with existing staff. Compliance onboarding will become a
specific part of each new employee’s intake and assimilation process. At each biannual town hall
meeting, the President will include a Compliance Update as part of the presentation. Managers
will feature compliance topics monthly as they become available and required for
implementation. Finally, the Compliance Office will develop a Compliance Progress Report at
the individual, department and institutional level and report those results to the executive team
on an annual basis. The report will include an action plan for addressing any deficiencies
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identified as part of the analysis. Follow-up timelines will be associated with the action plan and
disposition of the interventions will be reported to management.
Components of learning. The activities performed as part of the program, and learning
goals are listed in Table 8. Each goal and activity are tied to either knowledge and skills,
motivation or organizational influence with many having more than one. The regulations and
requirements themselves are built on conceptual knowledge. Procedural knowledge covers the
implementation and ongoing compliance activities. Confidence, efficacy, and value proposition
are part of the motivational influences. Assets and culture comprise the organizational
influences. Table 48 defines the critical components of the learning plan as driven by the study’s
content and James D Kirkpatrick and Wendy Kayser Kirkpatrick (2016).
Table 48.
Components of Learning for the Program
Method(s) or Activity(ies) Timing
Conceptual Knowledge “I know what it is.”
Knowledge checks using job aids, evaluation
tools, and case studies.
At program-kick off as part of department
staff meetings, individual supervisor meetings
and through employee onboarding.
Knowledge checks through peer review and
mentoring.
At the time of hire for new staff and monthly
for both new employees and those with under
12 months of service.
Knowledge checks through supervisor
evaluation.
At program-kick off as part of department
staff meetings, individual supervisor meetings
and through employee onboarding.
Procedural Knowledge and Confidence “I can do it correctly and apply it to my role.”
Proficiency demonstrations through an
explanation of implementation and continued
compliance requirements to supervisors.
Supervisors will then give thoughtful
feedback as part of the evaluation process.
At program-kick off as part of department
staff meetings, individual supervisor meetings
and through employee onboarding.
Case study application development through
peer review and mentoring.
At the time of hire for new staff and monthly
for both new employees and those with under
12 months of service.
The value “It means something to me, and I believe it is worth doing correctly.”
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 219
Method(s) or Activity(ies) Timing
Feedback from managers and supervisors as
part of employee case studies, knowledge
checks and evaluation processes. Feedback
should be linked to one or more of the
organization’s core values and the mission
statement.
Monthly following individual supervisor
meetings and through employee onboarding.
Group discussions on compliance
requirements and the cost of non-compliance
including patient care and research impact.
Monthly, as part of staff meetings.
Executive leadership is illustrating the
business case for continued compliance.
Biannually at institutional town hall meetings.
Commitment “I will do it correctly and continually.”
Application of reflective feedback into
personalized learning plans
Monthly following individual supervisor
meetings and through employee onboarding.
Shared wins and compliance success stories at
the team and department level.
Monthly, as part of staff meetings.
Highlighting exceptional compliance
successes and development of innovative and
sustainable interventions.
Quarterly via email and biannually at
institutional town hall meetings.
Level 1: Reaction
This section explores the evaluation of the recommendations themselves as interventions
through the lens of the Kirkpatrick New World Model. Table 49 pairs both the methods and tools
with the timing, appropriate influence(s), and New Word Model level.
Table 49.
Evaluation Analysis Recommendations through the New World Model
Method(s) or Tools(s) Timing KMO
Influence(s)
Level(s) Accountability
Engagement
Checks on employee
case studies.
Monthly as part of
supervisor
meetings.
KS: Conceptual
and Procedural,
M: Efficacy and
Value, O: Assets
2,3,4 Individual
Progress reports from
department managers to
the Compliance Office
and executive
leadership.
Quarterly via
email.
KS: Conceptual
and Procedural,
M: Efficacy and
Value, O: Assets
and Culture
2,3,4 Team and
Department
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Method(s) or Tools(s) Timing KMO
Influence(s)
Level(s) Accountability
“State of Compliance”
presentation by the
President of the
institution.
Annually at one of
the biannual town
hall meetings.
KS: Conceptual
and Procedural,
M: Efficacy and
Value, O: Assets
and Culture
2,3,4 Organization
Relevance and Satisfaction
Compliance engagement
survey of all
stakeholders.
Annually
conducted in the
fall.
M: Efficacy and
Value, O: Assets
and Culture
3,4 Organization
and Individual
Summary reports to
executive leadership
including
recommendations for
change.
Annually after the
engagement
survey.
M: Efficacy and
Value, O: Assets
and Culture
3,4 Organization
“State of Compliance”
presentation by the
President of the
institution.
Annually at one of
the biannual town
hall meetings
following the
engagement
survey.
KS: Conceptual
and Procedural,
M: Efficacy and
Value, O: Assets
and Culture
2,3,4 Organization
Revised curriculum for
compliance learning
plans and onboarding.
Annually after the
engagement and
review of the
curriculum.
KS: Conceptual
and Procedural,
M: Efficacy and
Value, O: Assets
and Culture
2,3,4 Organization
and Individual
Assessment Tools
Formative assessment. Assessment will occur at various point during the program
through the use of a variety of tools. Formative assessment occurs during implementation and is
intended to determine if the program and its participants are meeting the learning objectives and
to make whatever program course corrections are required to facilitate achievement (Rueda,
2011). To conduct a formative assessment, the program uses knowledge checks and case studies
to evaluate transfer and application of conceptual and procedural knowledge. The assessment
process is meant to not only evaluate program effectiveness but also whether or not the efficacy
and sustainability aims of the program are being met. In-program course correction allows for
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immediate real-time improvements and creates better customization of the program unique to the
stakeholder and institutional needs. Consistent with the Kirkpatrick New World Model,
formative assessment is most commonly linked to the tools demonstrating learning in Level 2.
Immediate summative assessment (evaluation). Summative assessment (evaluation)
is conducted after program implementation, or training is complete (Rueda, 2011). Upon
program completion, an immediate summative assessment will be completed using the
Summative Assessment Survey identified in Appendix G. The survey has several aims including
(i) measuring overall program conceptual and procedural knowledge transfer, (ii) evaluate
program relevance to the stakeholder and the institution, and (iii) determine whether or not the
delivery mechanisms, learning tools, and facilitators were supported the efficacy aim of the
overall program.
Delayed evaluation. A separate assessment tool, the Long-Term Summative Assessment
Survey presented in Appendix H, directly assesses whether or not the evaluation model
adequately addressed the sustainability element of the program. The long-term assessment
instrument will be given to stakeholders at a predetermined interval, most likely 30, 60, 90 and
120 days after program implementation. The regular follow-up period provides regular intervals
for appropriate follow-up. Its purpose is to assess long-term knowledge transfer, retention, and
application. At various points when the tool is given, an additional iteration of the program may
have already started, either at a different institution or with a new group of stakeholders in the
current organization. One crucial difference in the delayed summative assessment is that, due
to the time period passed since program implementation and the regular time intervals at which it
is administered, it is in a better position than the immediate summative assessment to evaluate
the motivation and organizational influences portion of the program’s conceptual framework.
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The delayed evaluation period allows stakeholders to reflect on the program’s training content
and the effectiveness of all levels of the model. Also, it better measures the Level 1
characteristics of satisfaction, engagement, and relevance.
Data Analysis and Reporting
Summative assessment data collection will be conducted via survey instruments. The
instruments use a combination of nominal and ordinal variables (on a Likert scale) to quantify
the data. Rather than using Likert scale items to assess whether or not the stakeholders believed
the program achieved its stated objectives, a simple two-point nominal scale (1=Yes, 2=No)
allows respondents to more definitively respond. Following the foundational nominal scale
items, the same five-point Likert scale on content and resource essentiality and stakeholder
agreement that was used in the study’s original stakeholder survey are implemented again. The
scale is already familiar to program respondents and aligns closely with the conceptual
framework that has been introduced to them at various points during the program. It is important
to remember that this program is an evaluation model, so consistency in implementation and
assessment is imperative. It directly affects the replication of the model, ultimately assisting in
achieving the program’s sustainability objective.
One of the critical differences between the two assessment tools is the content of the
open-ended questions. While in the immediate summative assessment tool, those items focus
more on proof of knowledge transfer and retention, the long-term summative assessment tool
allows stakeholders to reflect on their own practices since the program ended. From a reporting
perspective, that process allows institutional administrators and program facilitators to glean
insights that otherwise would not be possible during the immediate summative assessment
because not enough time had passed.
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With subsequent iterations of the model, either in other institutions or within the same
organization, adjustments can be made as the program progresses. The latter is especially true if
the implementation of the solutions and interventions is piloted in only one or two departments,
and administrators consider replication and scalability to the entire facility. Data gathered from
the survey and tracking tools such as time and effort evaluation, will be used as a portfolio of
resources that leaders can use for that purposes. For reporting purposes, data will be
communicated in tabular format with an added presentation in graphic form such as the
histogram and normal curve distribution below in Figure 26.
Figure 26. Sample graphic of stakeholder time and effort on conceptual knowledge acquisition
and implementation of procedural knowledge.
Summary
The interventions and recommendations in this section frame the study’s findings using
the New World Model as developed by James D Kirkpatrick and Wendy Kayser Kirkpatrick
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(2016). Following the reverse, construct beginning at Level 4, Results and Leading Indicators,
and progressively moving backward to Level 1, Reaction tools can be paired with program
interventions themselves to assess knowledge acquisition, transfer, and application better. The
utilization of the Kirkpatrick New World Model is unique because of its intense focus on the
learner, or in the case of this study, the staff stakeholder. The two primary aims of the study,
through the Research Questions, are to assess an institutional compliance program’s impact on
stakeholder efficacy and overall program sustainability. By using the New World Model, the
stakeholder remains the focal point of the program and takes advantage of the environment, the
organizational culture, leadership, peers, and the institution’s assets to increase efficacy and long-
term viability directly.
Strengths and Weaknesses of the Approach
The approach used in this study is multifaceted. Built on a mixed-methods design to
collect, analyze, interpret and report data. The study uses the Clark and Estes (2008) gap
analysis model to build the Research Questions, and combine the influence types with a Program
Elements component to form the Conceptual Framework. While the Framework was built and
tested in a specialty academic medical facility, it can be applied to any institution with both
clinical and research functions. Additionally, the study builds an evaluation model which
focuses on both improving stakeholder efficacy and the overall sustainability of regulatory
compliance programs. The recommendations are built on analysis of environments and
documents, along with direct stakeholder feedback from institutions across the United States.
Each type of influence targets explicitly knowledge, skills, behaviors, logic, motivational
considerations and organizational components that will promote efficacy and sustainability,
while remaining general enough to provide for replication, scalability, and customization in
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 225
various types of institutions. The James D Kirkpatrick and Wendy Kayser Kirkpatrick (2016)
New World Model builds recommendations, implementation and evaluation plans tied directly to
each of the types of influences. Additionally, the New World Model facilitates the development
of assessment tools, leading indicators, required drivers, and behaviors which encourage
continuous improvement. That directly supports the sustainability aim of the study.
Though the approach is strategically developed, like any original model, it does have
potential weaknesses. One possible perceived drawback is that conceptual and procedural
knowledge does not necessarily cover specific types of content. That is by design, because the
type of knowledge will depend mainly upon the scope of services, and needs of the institution to
which it is applied. It allows for specific knowledge to be nested into the model as it is
developed and implanted within an organization. Another possible consideration is that there are
not specific knowledge checks and job aids developed in the study. As before, that is by design,
because the application depends on the scope of the individual’s role and the institution’s
services and patient base. The literature review provides some common knowledge and skills
that will be necessary for any academic medical facility. That is content is used to build both the
Program Elements and Knowledge and Skill Influences described in the Conceptual Framework.
Limitations and Delimitations
As with any work contributing both new and existing information to the discipline’s body of
knowledge, there are some limitations in this study. This research included live conversations
and observation activities and there was the possibility of unanticipated delays or events which
limited the data collection activities from being carried out. Patient care and research activities
were the ultimate processes that the study was developed to serve. Due to the nature of patient
care facilities and the nature of the work, those delays were unavoidable. Instead, it was
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necessary to add additional data collection activities such as doing additional observations to
reach the required threshold. Despite the ongoing patient care and research activities the planned
number of observations was still reached. Contingencies for unanticipated delays or barriers to
completion were developed and explored during the preparation of data collection activities. The
delimitation created additional value by helping determine optimal times and conditions for
observation. There were instances in which patient care, privacy or confidentiality impacted
both interviews and observations due to institutional obligations with HIPAA and policies. In
those cases, one delimitation was that activities were rescheduled when possible while risk
mitigation activities such as de-identifying data and refraining from the use of any records
containing protected health or individually identifiable information. The use of REDCap as a
platform for facilitating this study was also a delimiting factor because it expedited those
processes and easily de-identified any cases and identifiers information that the cases contained.
The ongoing duties of some respondents who wanted to be included in the interview
process originally precluded their participation. While this may have attributed to lower res[onse
rates, it allowed for more time to be spent on data collection activities and subject interaction,
especially in interviews. In turn, that allowed for deeper content to be gleaned as a result of the
longer interactions. Ultimately, the sample size and participant experience as was still large and
diverse enough and to avoid potential issues with validity and reliability of data. For document
analysis, some policies and procedures were in draft form and thus could not be included in the
study. In those cases, the delimitation was to look at additional souces such as other institutions
to find a published document on the same topic that met the content requirements for inclusion in
the study. That allowed for the scope of available documents to be expanded without increasing
or decreasing the total number analyzed. Finally, observations were done at only one institution,
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 227
across multiple sites while other study arms were national. The delimitation, in this case, was to
do observations at more than one of the institution’s locations. Additionally, content derived
from observations can be applied in most academic medical facilities as it is indicative of the
clinical, research and educational activities occurring in those types of institutions.
Opportunities for future research might include the nuances of one type of speciality care facility
versus another, the size and scope of various institutions, and their connection to other
organizations such as universities.
Future Research
There are some potential opportunities to expand and build on the research developed in
this dissertation. The study’s Conceptual Framework included a Program Elements section
included components based on traditional guidance by the Health and Human Services Office of
the Inspector General (OIG) (2011), as well as derived from the literature. There may be more
elements that emerge as research in the field of specialty academic medicine evolves.
Additionally, in light of stakeholder perception of essentiality and existence raised in this study, a
more in depth review of the HHS OIG Elements could be warranted. Other opportunities for
future study include focusing more intensely on specific types of stakeholder groups such as
physician-scientists, post-doctoral fellows, research coordinators, and operations staff members.
This study included feedback from each but grouped them into one large pool. The model has
strong potential for transferability as it was developed both for the discipline and the institution
of focus. Elements can be modified to fit the scope of services of many different healthcare
facilities. Evaluation in those environments also creates an opportunity for study. Finally, the
Conceptual Framework may be impacted by results derived and trends observed as a result of the
immediate and summative assessment tools described in this Chapter. There may be
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 228
unanticipated considerations resulting from implementation and evaluation processes that need to
be considered when creating a revised implementation plan. Additional elements may also need
to be added to the evaluation tool, as this is an iterative process. Ultimately, the model is only
sustainable if it remains relevant and comprehensive.
Conclusion
This dissertation sought to determine what Program Elements a compliance program
evaluation model should include when assessing its sustainability. While some of the original
HHS OIG (2011) elements were validated, the research revealed that they might need to be
revised and expanded to include appropriately implement the knowledge and skills, motivational,
and organizational influences recommendations associated with this study. Conceptual
knowledge needs to be based on relevance and applicability at the institution, department, team
and individual stakeholder levels. Procedural knowledge must adequately address the
implementation of conceptual knowledge. Stakeholders must believe that compliance is
probable, both individually and collectively. Also, the value and perceived burden of compliance
must be mitigated by a focus on improved clinical and research outcomes, healthier patient
populations, cost containment in care, and a patient-centered experience. Organizational assets
must tie knowledge and decision-making, and be usable, available, and relevant to stakeholders.
Culture needs to promote stakeholder and leadership engagement, break down walls and silos to
improve corporate and regulatory compliance and maintain a focus on continuous ongoing
improvement. The field of healthcare evolves rapidly, and compliance must make every effort to
keep up.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 229
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APPENDIX A: DATA DICTIONARY CODEBOOK
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Survey Data Dictionary Codebook
1 record_id Record ID Text
2 welcome_letter RE: Corporate Compliance
and Research Regulatory
Programs
Dear Participant,
You have been invited to
participate in a brief survey
concerning the evaluation of
corporate compliance and
regulatory research programs
in academic medicine
settings. This survey is part of
data collection on a
dissertation that explores the
essential elements of such
programs, as well as the
knowledge, skills, motivation
and organizational influences
that make them relevant,
usable and sustainable. The
study focuses specifically on
those elements and influences
from the perspective of staff
members as stakeholders.
Your results will remain
confidential. Any personally
identifiable information is
coded and available only to
the investigator and
dissertation chair. If desired,
you may request aggregated
results of the findings at the
conclusion of the dissertation
process. Please allow
approximately 20-30 minutes
to complete the survey.
If you have any questions,
please contact me using the
information below. You may
also contact my dissertation
chair, Dr. Lawrence Picus, at
lpicus@rossier.usc.edu.
Thank you for your
Descriptive
Field Annotation: Welcome
Letter
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
commitment to enhancing
compliance and regulatory
programs.
Sincerely,
Dustin McLemore, MBA,
MPA
Doctoral Candidate
USC Rossier School of
Education
University of Southern
California
P: 213.373.1536
E: dustin.mclemore@usc.edu
3 info_sheet Please download the attached
information sheet before
continuing with the survey.
By continuing, you
acknowledge that you have
read and agree with its
contents.
Descriptive
Field Annotation: Info Sheet
4 acknowledge_info_sheet I acknowledge that I have
downloaded and reviewed the
information sheet and that I
would like to continue with
the survey.
Select "yes" if you agree or
"no" if you disagree.
Yes/No
1 Yes
0 No
Field Annotation:
Acknowledgement
Stop actions on 0
5 demo_class Section Header: Demographic
Information (used for
statistical purposes only)
Which of the following best
describes your employment
classification at your
institution?
Radio
1 Regular full-time
2 Regular part-time
3 Contract or affiliate
4 Other (please specify below)
Question number: S.1
Field Annotation: Staff
Classification
6 demo_class_other
Show the field ONLY if:
[demo_class] = '4'
Other employment
classification (if other
selected above)
Text
Question number: S.2
Field Annotation: Other
Employment Classification
7 demo_role Which selection best
describes your role in the
institution?
Radio
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 254
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
1 Providers (Physicians, nurse
practitioners, physician
assistants, etc.)
2 Clinical support staff
(Nurses, medical assistants,
infection preventionists,
clinical quality, etc.)
3 Research support staff
(clinical research
coordinators, laboratory
scientists and technicians,
etc.)
4 Operations and support staff
(customer services, safety,
security, facilities, physical
plant, IT, etc.)
5 Management and
organizational administration
(Executive, academic affairs,
human resources, legal,
compliance and regulatory
services, etc.)
6 Other (please specify below)
Question number: S.3
Field Annotation: Staff Role
8 demo_role_other
Show the field ONLY if:
[demo_role] = '6'
Other staff role (if other
selected above)
Text
Question number: S.4
Field Annotation: Other Staff
Role
9 demo_educ What is your highest level of
education completed?
Radio
1 Research or professional
doctorate (DO, MD, Ph.D,
Ed.D, JD, Pharm.D, etc.)
2 Clinical masters (MSN,
MSW, MPAS, etc.)
3 Professional and other
masters (MA/MS, MBA,
MPA, MPH, etc.)
4 Bachelors degree
5 None of the above
Question number: S.5
10 demo_clinicalbackground Do you have a background or
current responsibilities in
patient care or clinical
operations?
Yes/No
1 Yes
0 No
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 255
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Question number: S.6
11 demo_credential_yn Do you hold a clinical
credential (e.g. Physician,
RN, Physical Therapist, etc.)?
Yes/No
1 Yes
0 No
Question number: S.7
12 demo_credential
Show the field ONLY if:
[demo_credential_yn] = '1'
Which, if any, of the
following credentials do you
hold?
Please select all that apply.
Checkbox
1 demo_credential_
__1
Physician
(MD/DO)
2 demo_credential_
__2
Nurse
Practitione
r (FNP,
PNP-BC,
APN, etc.)
or
Certified
Nurse
Midwife
(CNM)
3 demo_credential_
__3
Physician
Assistant
(PA-C,
PA, etc.)
4 demo_credential_
__4
Registered
Nurse
(RN)
5 demo_credential_
__5
Behavioral
Health
Provider
(Psy.D,
LPC, etc.)
6 demo_credential_
__6
Social
Worker
LCWS,
LMSW,
etc.)
7 demo_credential_
__7
Clinical
Research
(ACRP-
CP,
CCRA,
CCRC,
CPI, etc.)
8 demo_credential_
__8
Physical or
Occupatio
nal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 256
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Therapist
(DPT,
OTRI,
etc.)
9 demo_credential_
__9
None of
the above
Question number: S.8
Field Annotation: Staff
Credential
13 compliance_facing Does your role have corporate
compliance responsibilities
such as HIPAA compliance,
reporting, developing policies
and procedures, conducting or
attending compliance training,
or any other related activities?
Yes/No
1 Yes
0 No
Question number: S.9
Field Annotation: Compliance
Facing
14 compliance_previous
Show the field ONLY if:
[compliance_facing] = '0'
Do you have any previous
experience in those areas?
Yes/No
1 Yes
0 No
Question number: S.10
Field Annotation: Compliance
Facing
15 regulatory_facing Does your role have research
regulatory responsibilities
such as submitting
applications and protocols to
your organization's
Institutional Review Board
(IRB), obtaining and
reporting informed consent,
monitoring clinical trials, or
any other related activities?
Yes/No
1 Yes
0 No
Question number: S.11
Field Annotation: Compliance
Facing
16 regulatory_previous
Show the field ONLY if:
[regulatory_facing] = '0'
Do you have any previous
experience in those areas?
Yes/No
1 Yes
0 No
Question number: S.12
Field Annotation: Compliance
Facing
17 demo_x_years_pc
Show the field ONLY if:
[demo_clinicalbackground] =
'1'
Section Header: How many
years of experience do you
have in the following
functions?
Direct patient care
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 257
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
5 16 years or more
Question number: S.13
18 demo_x_years_hcmo
Show the field ONLY if:
[demo_clinicalbackground] =
'1'
Health care management and
operations
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.14
19 demo_x_years_clinres
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Clinical research Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.15
20 demo_x_years_txnres
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Translational research Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.16
21 demo_x_years_bsbr
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Basic science or bench
research
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.17
22 demo_x_years_nursing
Show the field ONLY if:
[demo_clinicalbackground] =
'1'
Nursing Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.18
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 258
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
23 demo_x_years_ptr
Show the field ONLY if:
[demo_clinicalbackground] =
'1'
Physical therapy and
rehabilitation
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.19
24 demo_x_years_irb
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Section Header: How many
years of experience do you
have in the following roles?
Institutional Review Board
(IRB) member, reviewer,
designated reviewer,
administrator, or staff member
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.20
25 demo_x_years_iacuc
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Institutional Animal Care and
Use Committee (IACUC)
member, reviewer, designated
reviewer, administrator, or
staff member
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.21
26 demo_x_years_picoi
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Principal or co-principal
investigator
Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.22
27 demo_x_years_rssup
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Research support staff Radio (Matrix)
1 0 years
2 1 to 5 years
3 6 to 10 years
4 11 to 15 years
5 16 years or more
Question number: S.23
28 demo_inst_workforce_size Section Header: Institution
Information (used for
statistical purposes only)
Radio
1 Less than 500
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Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
What is the size of your
institution's total workforce
including regular full-time,
part-time, contract, and
affiliate faculty and staff?
2 501-1,000
3 1,001-1,500
4 1,501-2,000
5 2,001 or more
Question number: S.24
Field Annotation: Institution
Workforce Size
29 demo_inst_site_state In which state is your
institution located?
If your institution is multi-
state, please select the
principal location only. If not
in the U.S., select "Non-U.S."
Dropdown (autocomplete),
Identifier
1 Alabama (AL)
2 Alaska (AK)
3 American Samoa (AS)
4 Arizona (AZ)
5 Arkansas (AR)
6 California (CA)
7 Colorado (CO)
8 Connecticut (CT)
9 Delaware (DE)
10 Dist. of Columbia (DC)
11 Florida (FL)
12 Georgia (GA)
13 Guam (GU)
14 Hawaii (HI)
15 Idaho (ID)
16 Illinois (IL)
17 Indiana (IN)
18 Iowa (IA)
19 Kansas (KS)
20 Kentucky (KY)
21 Louisiana (LA)
22 Maine (ME)
23 Maryland (MD)
24 Marshall Islands (MH)
25 Massachusetts (MA)
26 Michigan (MI)
27 Micronesia (FM)
28 Minnesota (MN)
29 Mississippi (MS)
30 Missouri (MO)
31 Montana (MT)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 260
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
32 Nebraska (NE)
33 Nevada (NV)
34 New Hampshire (NH)
35 New Jersey (NJ)
36 New Mexico (NM)
37 New York (NY)
38 North Carolina (NC)
39 North Dakota (ND)
40 Northern Marianas (MP)
41 Ohio (OH)
42 Oklahoma (OK)
43 Oregon (OR)
44 Palau (PW)
45 Pennsylvania (PA)
46 Puerto Rico (PR)
47 Rhode Island (RI)
48 South Carolina (SC)
49 South Dakota (SD)
50 Tennessee (TN)
51 Texas (TX)
52 Utah (UT)
53 Vermont (VT)
54 Virginia (VA)
55 Virgin Islands (VI)
56 Washington (WA)
57 West Virginia (WV)
58 Wisconsin (WI)
59 Wyoming (WY)
60 Non-U.S.
Question number: S.25
Field Annotation: Institution Site
State
30 ee_hhs_pol
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Section Header: How
essential are the elements
listed below in ensuring
effective and sustainable
regulatory and corporate
compliance?
Implementing written policies
and procedures
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 261
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Question number: S.26
Field Annotation: HHS, 2011
31 ee_hhs_cco
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Designating a compliance
officer and compliance
committee
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.27
Field Annotation: HHS, 2011
32 ee_hhs_trn
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Conducting effective training
and education
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.28
Field Annotation: HHS, 2011
33 ee_hhs_com
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Developing effective and
open lines of communication
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.29
Field Annotation: HHS, 2011
34 ee_hhs_aud
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Conducting internal
compliance monitoring and
auditing
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.30
Field Annotation: HHS, 2011
35 ee_hhs_dis
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Enforcing standards through
well-publicized disciplinary
guidelines
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 262
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
4 Nonessential
5 Cannot assess
Question number: S.31
Field Annotation: HHS, 2011
36 ee_hhs_det
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Responding promptly to
detected problems and
undertaking corrective action
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.32
Field Annotation: HHS, 2011
37 ee_sys
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Developing and implementing
systems for tracking adverse
and sentinel events
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.33
38 ee_ris
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Performing risk management
and quality activities such as
peer review and clinical risk
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.34
39 ee_vis
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Creating visibility and
transparency in developing
and implementing
institutional policies and
procedures
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.35
40 ee_mgt
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Creating management and
staff buy-in for implementing
compliance requirements
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
5 Cannot assess
Question number: S.36
41 ee_pim
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Practicing ongoing practice
and process improvement
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.37
42 ee_ast
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Section Header: Please rate
the importance of the
following elements in
ensuring effective corporate
and regulatory compliance.
Organizational assets
(Policies, procedures,
processes. committees, etc.)
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.38
43 ee_stf
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Dedicated compliance and
regulatory staff (Compliance
officers, IRB staff, etc.)
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.39
44 ee_trn
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Compliance/regulatory
training and ongoing
professional development
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.40
45 ee_cul
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Organizational culture
(Communication,
management support of
compliance initiatives, etc.)
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.41
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 264
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
46 ee_mon
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Monitoring and auditing
systems for adverse and
sentinel events
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.42
47 ee_rca
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Root cause analysis,
investigations, and
implementation of
interventions
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.43
48 ee_crm
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Clinical risk management and
process improvement
projects;
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.44
49 ee_wrk
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Compliance strategic and
work plans
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.45
50 ee_fdb
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Feedback mechanisms such as
town hall meetings, listening
sessions, and suggestion
boxes
Radio (Matrix)
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
Question number: S.46
51 kmo_ks_rra_irb
Show the field ONLY if:
Section Header: How are
familiar are you with these
research regulatory topics?
Radio (Matrix)
1 Very familiar
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 265
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Human Subjects Research
(IRB)
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.47
52 kmo_ks_rra_iacuc
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Animal Subjects Protections
(IACUC)
Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.48
53 kmo_ks_rra_ic
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Informed Consent Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.49
54 kmo_ks_rra_hipaa
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
HIPAA Privacy and Security
(Research applications)
Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.50
55 kmo_ks_rra_ethics
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Bioethics and research ethics Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.51
56 kmo_ks_rra_pro
Show the field ONLY if:
[regulatory_facing] = '1' or
[regulatory_previous] = '1'
Development and submission
of research protocols
Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.52
57 kmo_ks_cc_fwa
Show the field ONLY if:
Section Header: How are
familiar are you with the
Radio (Matrix)
1 Very familiar
2 Familiar
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 266
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
[compliance_facing] = '1' or
[compliance_previous] = '1'
following corporate
compliance activities?
Fraud, Waste, and Abuse
regulations
3 Somewhat familiar
4 Unfamiliar
Question number: S.53
58 kmo_ks_cc_cmsg
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
General CMS Compliance Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.54
59 kmo_ks_cc_coi
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Conflict of Interest Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.55
60 kmo_ks_cc_crmpr
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Clinical Risk Management
(CRM) and Peer Review
Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.56
61 kmo_ks_cc_hipaa
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
HIPAA compliance Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.57
62 kmo_ks_cc_accred
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Accreditation (The Joint
Commission, AAAHC,
NCQA, etc.)
Radio (Matrix)
1 Very familiar
2 Familiar
3 Somewhat familiar
4 Unfamiliar
Question number: S.58
63 kmo_ks_eff What knowledge and training
do you need to effectively
implement compliance
requirements?
Checkbox
1 kmo_ks_eff___
1
Laws, rules,
regulations,
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 267
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
and
standards
2 kmo_ks_eff___
2
A deeper
understandi
ng of the
institution's
systems and
processes
3 kmo_ks_eff___
3
Institutional
policies and
procedures
4 kmo_ks_eff___
4
Root-cause
analysis and
problem-
solving
5 kmo_ks_eff___
5
A better
understandi
ng of
efficiency
and
sustainabilit
y
6 kmo_ks_eff___
6
Developing
intervention
strategies
7 kmo_ks_eff___
7
Auditing
and
monitoring
compliance
requirement
s within the
institutions
8 kmo_ks_eff___
8
An
understandi
ng of how
other
institutions
have
implemente
d similar
requirement
s
9 kmo_ks_eff___
9
How the
requirement
s and
regulations
affect me,
my
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 268
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
department,
and my
institution
1
0
kmo_ks_eff___
10
Other
(please
specify)
Question number: S.59
Field Annotation: Knowledge
and Skills Effective Items
64 kmo_ks_eff_other
Show the field ONLY if:
[kmo_ks_eff(10)] = '1'
Other training (if other
selected above)
Notes
Question number: S.60
Field Annotation: KS Other
Elements
65 kmo_ks_other_2 In addition to the rules and
regulations, and their
implementation requirements,
what other knowledge and
skills do you need to
effectively implement comply
with requirements affecting
you and your institution?
Notes
Question number: S.61
Field Annotation: KMO Other 1
66 kmo_ks_train What methods of delivery
work best for compliance and
regulatory training?
Checkbox
1 kmo_ks_train___
1
On-
boarding
and
orientatio
n
2 kmo_ks_train___
2
Annual
in-person
refresher
training
3 kmo_ks_train___
3
Annual
on-line
computer-
based
training
4 kmo_ks_train___
4
Team-
based
training at
staff
meetings
and
huddles
5 kmo_ks_train___
5
Other
(please
specify)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 269
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Question number: S.62
Field Annotation: KMO
Knowledge and Skills Training
67 kmo_ks_train_other
Show the field ONLY if:
[kmo_ks_train(5)] = '1'
Other training delivery (if
other selected above)
Notes
Question number: S.63
Field Annotation: EE Other
Elements
68 kmo_ks_other In addition to training,
policies, and procedures, what
other items increase the
likelihood that you can
effectively comply with all
required rules and
regulations?
Notes
Question number: S.64
Field Annotation: Knowledge
Other
69 kmo_m_tim Section Header: Within your
institution, please indicate
your level of agreement with
statements below.
I believe that the amount of
time and effort required to
comply with rules,
regulations, and policies is
reasonable and necessary.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.65
70 kmo_m_res I believe that I have the
necessary training and
resources necessary to
effectively comply with rules,
regulations, and policies that
affect me, my team, and my
organization.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.66
71 kmo_m_voi I have a voice in the decision-
making and policy
development processes at my
institution.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Question number: S.67
72 kmo_m_sys I believe that the institution
has a viable and sustainable
system to detect, deter,
mitigate, and prevent adverse
events and issues of
noncompliance
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.68
73 kmo_m_inv I believe that the institution
develops targeted, relevant,
and achievable intervention
strategies to make compliance
meaningful, possible and
probable.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.69
74 kmo_m_mgt I believe that institutional
leadership is committed to
making compliance a priority.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.70
75 kmo_m_stf I believe that the regulatory
and compliance team at my
institution is available,
approachable, and tasks my
questions and suggestion
seriously.
Radio (Matrix)
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
Question number: S.71
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 271
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
76 kmo_m_other In addition to time, effort, and
resources, what other
motivational influences affect
your ability to effectively
comply with required rules
and regulations?
Notes
Question number: S.72
Field Annotation: KMO Other
Motivation
77 kmo_o_hhs_pol
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Section Header: To what
extent do the following
compliance elements exist
within your institution?
Implementing written policies
and procedures
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.73
Field Annotation: HHS, 2011
78 kmo_o_hhs_cco
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Designating a compliance
officer and compliance
committee
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.74
Field Annotation: HHS, 2011
79 kmo_o_hhs_trn
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Conducting effective training
and education
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.75
Field Annotation: HHS, 2011
80 kmo_o_hhs_com
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Developing effective and
open lines of communication
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.76
Field Annotation: HHS, 2011
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 272
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
81 kmo_o_hhs_aud
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Conducting internal
compliance monitoring and
auditing
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.77
Field Annotation: HHS, 2011
82 kmo_o_hhs_dis
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Enforcing standards through
well-publicized disciplinary
guidelines
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.78
Field Annotation: HHS, 2011
83 kmo_o_hhs_det
Show the field ONLY if:
[compliance_facing] = '1' or
[compliance_previous] = '1'
Responding promptly to
detected problems and
undertaking corrective action
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.79
Field Annotation: HHS, 2011
84 kmo_o_sys Developing and implementing
systems for tracking adverse
and sentinel events
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.80
85 kmo_o_ris Performing risk management
and quality activities such as
peer review and clinical risk
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.81
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 273
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
86 kmo_o_vis Creating visibility and
transparency in developing
and implementing
institutional policies and
procedures
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.82
87 kmo_o_mgt Creating management and
staff buy-in for implementing
compliance requirements
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.83
88 kmo_o_pim Practicing ongoing practice
and process improvement
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.84
89 kmo_o_ast Section Header: To what
extent do the following
compliance elements exist
within your institution?
Organizational assets
(Policies, procedures,
processes. committees, etc.)
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.85
90 kmo_o_stf Dedicated compliance and
regulatory staff (Compliance
officers, IRB staff, etc.)
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.86
91 kmo_o_trn Compliance/regulatory
training and ongoing
professional development
Radio (Matrix)
1 Firmly existent
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Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.87
92 kmo_o_cul Organizational culture
(Communication,
management support of
compliance initiatives, etc.)
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.88
93 kmo_o_mon Monitoring and auditing
systems for adverse and
sentinel events
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.89
94 kmo_o_rca Root cause analysis,
investigations, and
implementation of
interventions
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.90
95 kmo_o_crm Clinical risk management and
process improvement
projects;
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.91
96 kmo_o_wrk Compliance strategic and
work plans
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 275
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Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
4 Nonexistent
5 Cannot assess
Question number: S.92
97 kmo_o_fdb Feedback mechanisms such as
town hall meetings, listening
sessions, and suggestion
boxes
Radio (Matrix)
1 Firmly existent
2 Mostly existent
3 Somewhat existent
4 Nonexistent
5 Cannot assess
Question number: S.93
98 kmo_org_prf_stf Section Header: Please rate
your institution's performance
on the following compliance
and regulatory areas.
Access to or presence of
compliance and regulatory
staff
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.94
99 kmo_org_prf_k Availability, knowledge, and
collaboration of compliance
and regulatory staff
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.95
100 kmo_org_prf_tie Clear ties between regulatory
requirements and program
decisions
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.96
101 kmo_org_prf_mgt Institutional and management
commitment to compliance
and ethical behavior
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.97
102 kmo_org_prf_inp Opportunities for input into
creating institutional policy
Radio (Matrix)
1 High performing
2 Moderately performing
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Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
3 Low performing
4 Cannot assess
Question number: S.98
103 kmo_org_prf_red Reducing redundant or
burdensome regulatory,
ethical or compliance
requirements
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.99
104 kmo_org_prf_gen General staff knowledge of
compliance requirements
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.100
105 kmo_org_prf_tim Time to effectively implement
regulatory requirements
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.101
106 kmo_org_prf_trn Training and development
resources
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.102
107 kmo_org_prf_cmt Institutional committee
performance (e.g. IRB,
IACUC, etc.)
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
4 Cannot assess
Question number: S.103
108 kmo_org_prf_inv Developing meaningful
intervention strategies to
noncompliance issues and
events.
Radio (Matrix)
1 High performing
2 Moderately performing
3 Low performing
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 277
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Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
4 Cannot assess
Question number: S.104
109 kmo_o_other In addition to organizational
assets (e.g. policies and
procedures), communication,
and management buy-in, what
other organizational
considerations affect your
ability to effectively
implement compliance
requirements?
notes
Question number: S.105
Field Annotation: KMO Other 3
110 audit_count Section Header: Frequencies
How many compliance audits
or monitoring sessions have
occurred in your department
in the last 12 months?
Text (number, Min: 0, Max: 999)
Question number: S.106
Field Annotation: Audit Count
111 train_count How many compliance and
regulatory training courses
have you completed in the last
12 months?
Text (number, Min: 0, Max: 999)
Question number: S.107
Field Annotation: Training Count
112 task_count How many hours do you
spend each week working on
tasks that have a regulatory or
compliance element to them?
Text (number, Min: 0, Max: 999)
Question number: S.108
Field Annotation: Task Time
113 receive_data_yn Section Header: Follow-up
Preferences
Would you like to receive an
aggregated analysis of the
survey data for this study?
Yes/No
1 Yes
0 No
Question number: S.109
Field Annotation: Receive Data
YN
114 interview_y_n Would you be willing to
participate in a 10 question
stakeholder interview at a
later date?
Please note: Although there is
no direct compensation,
benefits include a chance to
shape compliance program
structures, improved
institutional processes, and
service to the profession.
Interviews will take place
either in-person or via the
USC Rossier School of
Education Adobe Connect
system. Although
Yes/No
1 Yes
0 No
Question number: S.110
Field Annotation: Interview Yes
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 278
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
recommended, a web-cam is
not required. A thank-you
letter will be provided if
requested.
115 email_adx
Show the field ONLY if:
[receive_data_yn] = '1' or
[interview_y_n] = '1'
Please enter your e-mail
address.
If you completed this survey
via an e-mail invitation, your
email address is filled on this
page. To change it, please
contact
dustin.mclemore@usc.edu.
Text (email)
Question number: S.111
Field Annotation: Receive Data
Email Address
116 staff_stakeholder_survey_co
mplete
Section Header: Form Status
Complete?
dropdown
0 Incomplete
1 Unverified
2 Complete
Interview Data Dictionary Codebook
117 i_survid Section Header: Scheduling
Survey Record ID
Text (number), Required
118 i_initialemailsent Invitation E-mail Sent Yes/No, Required
1 Yes
0 No
119 i_initialemaildatetime
Show the field ONLY if:
[i_initialemailsent] = '1'
Initial Email Date and Time Text (datetime_ymd), Required
120 i_subjectresponded
Show the field ONLY if:
[i_initialemailsent] = '1'
Subject Responded Yes/No, Required
1 Yes
0 No
121 i_subjectproceeding
Show the field ONLY if:
[i_subjectresponded] = '1'
Subject Proceeding Yes/No, Required
1 Yes
0 No
122 i_subjectnpreason
Show the field ONLY if:
[i_subjectproceeding] = '0'
Reason Subject Not
Proceeding
Radio, Required
1 Time Requirements
2 Change in
Priorities/Deliverables
3 Scope Alignment
4 Perceived/Disclosed Conflict
of Interest
5 Logistics
6 Other
123 i_subjectnpreason_o
Show the field ONLY if:
[i_subjectnpreason] = '6'
Reason Subject Not
Proceeding Other (Specify)
Text, Required
124 i_interviewscheduled Interviewed Scheduled Yes/No, Required
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 279
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Show the field ONLY if:
[i_subjectproceeding] = '1'
1 Yes
0 No
125 i_interviewscheddatetime
Show the field ONLY if:
[i_subjectproceeding] = '1'
Interview Scheduled Date and
Time
Text (datetime_ymd), Required
126 i_begins
Show the field ONLY if:
[i_subjectproceeding] = '1'
Section Header: Required
Elements
Interview Start Time
Text (datetime_ymd), Required
127 i_subj_infosheet_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Did the subject acknowledge
receipt of the study
information sheet?
Yes/No, Required
1 Yes
0 No
Field Annotation: Interview
Study Information Sheet
128 i_subj_optout_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Did the subject acknowledge
the opt-out provisions?
Yes/No, Required
1 Yes
0 No
Field Annotation: Interview Opt-
out Provisions
129 i_subj_responses_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Does the subject want a copy
of the responses?
Yes/No, Required
1 Yes
0 No
Field Annotation: Receive
Responses
130 i_subj_email_adx
Show the field ONLY if:
[i_subj_responses_yn] = '1'
What is the subject's email
address to receive a copy of
the responses?
Text (email), Required
Field Annotation: Subject
Responses E-mail Address
131 i_subj_clinical_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Section Header:
Demographics Information
Does the subject have a
clinical focus?
Yes/No, Required
1 Yes
0 No
Field Annotation: Subject
Research Focus
132 i_subj_research_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Does the subject have
research a research focus?
Yes/No, Required
1 Yes
0 No
Field Annotation: Subject
Research Focus
133 i_date_interview
Show the field ONLY if:
[i_subjectproceeding] = '1'
What is the date of the
interview?
Text (date_dmy), Required
Field Annotation: Interview Date
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 280
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
134 i_date_entry
Show the field ONLY if:
[i_subjectproceeding] = '1'
What is the date of data entry? Text (date_dmy), Required
Field Annotation: Entry Date
135 i_subj_edu
Show the field ONLY if:
[i_subjectproceeding] = '1'
What is the subject's highest
level of education completed?
Radio, Required
1 Doctoral degree
2 Specialist degree
3 Masters degree
4 Bachelors degree
5 Other
Field Annotation: Subject highest
degree
136 i_subj_edu_other
Show the field ONLY if:
[i_subj_edu] = '5'
Enter the education level here
if "other" was specified
above.
Text, Required
Field Annotation: Other
Education Type
137 i_subj_prov_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Is the subject a medical or
behavioral health provider?
Yes/No, Required
1 Yes
0 No
138 i_subj_prov_type
Show the field ONLY if:
[i_subj_prov_yn] = '1'
What type of provider is the
subject?
Radio, Required
1 Behavioral Health Provider
2 Nurse Practitioner
3 Physical or Occupational
Therapist
4 Physician
5 Physician Assistant
6 Other
Field Annotation: Subject
Provider Type
139 i_subj_prov_type_other
Show the field ONLY if:
[i_subj_prov_type] = '6'
Enter the provider type here if
"other" was specified above.
Text, Required
Field Annotation: Other Provider
Type
140 i_subj_phys_spec
Show the field ONLY if:
[i_subj_prov_type] = '4'
What is the provider's
specialty or subspecialty?
Dropdown (autocomplete),
Required
1 Allergy and asthma
2 Anesthesiology
3 Cardiology
4 Dermatology
5 Endocrinology
6 Gastroenterology
7 General surgery
8 Hematology
9 Immunology
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 281
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
10 Infectious disease
11 Nephrology
12 Neurology
13 Obstetrics/Gynecology
14 Oncology
15 Ophthalmology
16 Orthopedics
17 Otorhinolaryngology
18 Physical therapy and
rehabilitative medicine
19 Psychiatry
20 Pulmonary
21 Radiology
22 Rheumatology
23 Urology
24 Other
25 None
Field Annotation: Physician
Speciality
141 i_subj_nonprov_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Is the subject a non-provider
licensed health care
professional?
Yes/No, Required
1 Yes
0 No
142 i_subj_nonprov_type
Show the field ONLY if:
[i_subj_nonprov_yn] = '1'
What type of licensed health
care professional is the
subject?
Radio, Required
1 Certified Registered Nurse
Anesthetist
2 Nurse
3 Pharmacist
4 Pharmacy Tech
5 Physical or Occupational
Therapy Tech
6 Social Worker
7 Other (please specify below)
Field Annotation: Subject
Licensure Type
143 i_subj_nonprov_type_other
Show the field ONLY if:
[i_subj_nonprov_type] = '7'
Enter the licensure type here
if "other" was specified
above.
Text, Required
Field Annotation: Other Provider
Type
144 i_subj_research_picoi
Show the field ONLY if:
[i_subj_research_yn] = '1'
Is the subject a current or
previous Principal
Investigator or Co-principal
Investigator?
Yes/No, Required
1 Yes
0 No
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 282
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Field Annotation: Current or
Previous PI or Co-PI
145 i_subj_research_irb_yn
Show the field ONLY if:
[i_subj_research_yn] = '1'
Is the subject a current or
previous IRB member?
Yes/No, Required
1 Yes
0 No
Field Annotation: Current or
Previous IRB member
146 i_subj_research_iacuc_yn
Show the field ONLY if:
[i_subj_research_yn] = '1'
Is the subject a current or
previous IACUC member?
Yes/No, Required
1 Yes
0 No
Field Annotation: Current or
Previous IACUC member
147 i_resp_gencompliance
Show the field ONLY if:
[i_subjectproceeding] = '1'
Section Header: Interview
Responses
Describe your general process
for reviewing and responding
to general compliance
requirements.
Notes, Required
Field Annotation: Response
General Compliance
148 i_resp_grant
Show the field ONLY if:
[i_subjectproceeding] = '1'
and [i_subj_research_yn] = '1'
Describe your general process
for reviewing and responding
to compliance requirements
specifically for grant-funded
studies.
Notes, Required
Field Annotation: Response
Grant-Funded Compliance
149 i_resp_ii
Show the field ONLY if:
[i_subjectproceeding] = '1'
and [i_subj_research_yn] = '1'
Describe your general process
for reviewing and responding
to compliance requirements
specifically for investigator-
initiated studies.
Notes, Required
Field Annotation: Response
Investigator Initiated Compliance
150 i_resp_spon
Show the field ONLY if:
[i_subjectproceeding] = '1'
and [i_subj_research_yn] = '1'
Describe your general process
for reviewing and responding
to compliance requirements
specifically for sponsored
studies.
Notes, Required
Field Annotation: Response
Sponsored Studies Compliance
151 i_resp_orgchange
Show the field ONLY if:
[i_subjectproceeding] = '1'
How have you seen the
regulatory environment in
research change since your
tenure began at the
institution?
Notes, Required
Field Annotation: Response
Institution Changes
152 i_resp_pc
Show the field ONLY if:
[i_subjectproceeding] = '1'
and [i_subj_research_yn] = '1'
How do ongoing patient care
responsibilities impact your
ability to meet research
regulatory requirements?
Notes, Required
Field Annotation: Response
Patient Care Impact
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 283
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
153 i_resp_orgperf
Show the field ONLY if:
[i_subjectproceeding] = '1'
Tell me about why you
ranked the organization's
performance and
implementation of compliance
elements the survey.
Notes, Required
Field Annotation: Response
Organizational Performance
154 i_resp_resources
Show the field ONLY if:
[i_subjectproceeding] = '1'
If the institution were to
allocate additional resources
and training to staff to achieve
sustainable regulatory
compliance, what would those
be?
Notes, Required
Field Annotation: Response
Needed Resources
155 i_resp_resources_rationale
Show the field ONLY if:
[i_subjectproceeding] = '1'
What is your rationale for
selecting those resources?
Notes, Required
Field Annotation: Response
Resources Rationale
156 i_resp_fieldchange
Show the field ONLY if:
[i_subjectproceeding] = '1'
How do you see regulatory
requirements in patient care
and research evolving over
the next ten years?
Notes, Required
Field Annotation: Response Field
Change
157 i_response_other
Show the field ONLY if:
[i_subjectproceeding] = '1'
Section Header: Additional
Information
What were other topics
discussed?
Notes, Required
Field Annotation: Other Topics
(if any)
158 i_response_additional
Show the field ONLY if:
[i_subjectproceeding] = '1'
What additional comments or
clarifying questions did the
subject have?
Notes, Required
Field Annotation: Additional
Comments or Clarifying
Questions (if any)
159 i_ends
Show the field ONLY if:
[i_subjectproceeding] = '1'
Interview End Time Text (datetime_ymd), Required
160 i_length_min
Show the field ONLY if:
[i_subjectproceeding] = '1'
Total Interview Time
(Minutes)
Calculation, Required
Calculation:
datediff([i_begins],[i_ends],"m","
y-m-d h:m")
161 i_length_hr
Show the field ONLY if:
[i_subjectproceeding] = '1'
Total Interview Time (Hours) Calculation, Required
Calculation: ([i_length_min]/60)
162 i_transcribed_yn
Show the field ONLY if:
[i_subjectproceeding] = '1'
Section Header: Interview
Tasks
Has the interview been
transcribed?
Yes/No, Required
1 Yes
0 No
Field Annotation: Interview
Transcribed
163 i_nvivo_yn
Show the field ONLY if:
[i_transcribed_yn] = '1'
Has the transcriptions been
entered into NVivo?
Yes/No, Required
1 Yes
0 No
Field Annotation: NVivo Entry
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 284
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
164 i_interview_link
Show the field ONLY if:
[i_subjectproceeding] = '1'
Provide a link to the interview
session here.
Text, Required
165 i_transcript_upload
Show the field ONLY if:
[i_subjectproceeding] = '1'
Provide the interview
transcript here.
File, Required
166 i_followup
Show the field ONLY if:
[i_subjectproceeding] = '1'
What date and time was a
follow-up sent?
Text (datetime_ymd), Required
167 focused_interview_inputs_co
mplete
Section Header: Form Status
Complete?
Dropdown
0 Incomplete
1 Unverified
2 Complete
Field Observation Data Dictionary Codebook
168 o_begins Section Header: Clinical Site
Information
Observation Start Date and
Time
Text (datetime_ymd), Required
Field Annotation: Observation
Start Date and Time
169 o_weekday Observation Day of the Week Dropdown (autocomplete),
Required
1 Sunday
2 Monday
3 Tuesday
4 Wednesday
5 Thursday
6 Friday
7 Saturday
Field Annotation: Observation
Week Day
170 o_staff_present Staff Present? Yes/No, Required
1 Yes
0 No
Field Annotation: Staff
Participants YN
171 o_counts_staff Approximate Number of Staff
Present at Time of
Observation
Text (number, Min: 0, Max:
999), Required
Field Annotation: Staff Present
Count
172 o_staff_provider Section Header: Staff Present
Physicians and Providers
Radio (Matrix)
1 Yes
2 No
173 o_staff_nurse Nursing Staff Radio (Matrix)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 285
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
1 Yes
2 No
174 o_staff_clinsupport Clinical Support (M.A., Lab,
etc.)
Radio (Matrix)
1 Yes
2 No
175 o_staff_otherlicensed Other Licensed/Credentialed
Staff
Radio (Matrix)
1 Yes
2 No
176 o_staff_otheroperations Other Operations Radio (Matrix)
1 Yes
2 No
177 o_staff_otheradmin Other Administrative Radio (Matrix)
1 Yes
2 No
178 o_staff_othermgmt Other Management Radio (Matrix)
1 Yes
2 No
179 o_staff_contractors Contractors or Affiliates Radio (Matrix)
1 Yes
2 No
180 o_staff_volunteers Volunteers Radio (Matrix)
1 Yes
2 No
181 o_staff_other Other Radio (Matrix)
1 Yes
2 No
182 o_stafftype_other_note
Show the field ONLY if:
[o_staff_other] = '1'
Other individuals (Specify) Notes, Required
183 o_pt_present Patients Present Yes/No, Required
1 Yes
0 No
Field Annotation: Patients
Present YN
184 o_encountercount
Show the field ONLY if:
[o_pt_present] = '1'
Approximate Number of
Encounters Observed
Text (number, Min: 0, Max:
999), Required
185 o_clininc_spec Clinic Specialty 1
Select "none" if not a clinic
area.
Dropdown (autocomplete),
Required
1 Allergy and asthma
2 Anesthesiology
3 Cardiology
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 286
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
4 Dermatology
5 Endocrinology
6 Gastroenterology
7 General surgery
8 Hematology
9 Immunology
10 Infectious disease
11 Nephrology
12 Neurology
13 Obstetrics/Gynecology
14 Oncology
15 Ophthalmology
16 Orthopedics
17 Otorhinolaryngology
18 Physical therapy and
rehabilitative medicine
19 Psychiatry
20 Pulmonary
21 Radiology
22 Rheumatology
23 Urology
24 Other
25 None
Field Annotation: Clinic
Specialty
186 o_clinic_spec_other
Show the field ONLY if:
[o_clininc_spec] = '24'
Other 1 (please specify) Text, Required
187 o_clinic_spec_additional Clinic Additional Speciality Yes/No, Required
1 Yes
0 No
188 o_clininc_spec2
Show the field ONLY if:
[o_clinic_spec_additional] =
'1'
Clinic Specialty 2
Select "none" if not a clinic
area.
Dropdown (autocomplete),
Required
1 Allergy and asthma
2 Anesthesiology
3 Cardiology
4 Dermatology
5 Endocrinology
6 Gastroenterology
7 General surgery
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 287
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
8 Hematology
9 Immunology
10 Infectious disease
11 Nephrology
12 Neurology
13 Obstetrics/Gynecology
14 Oncology
15 Ophthalmology
16 Orthopedics
17 Otorhinolaryngology
18 Physical therapy and
rehabilitative medicine
19 Psychiatry
20 Pulmonary
21 Radiology
22 Rheumatology
23 Urology
24 Other
25 None
Field Annotation: Clinic
Specialty
189 o_clinic_spec_other2
Show the field ONLY if:
[o_clininc_spec2] = '24'
Other 2 (please specify) Text, Required
190 o_clininc_subspec_yn Clinic Has Subspecialty Yes/No, Required
1 Yes
0 No
Field Annotation: Clinic
Subspecialty YN
191 o_clininc_subspec
Show the field ONLY if:
[o_clininc_subspec_yn] = '1'
Clinic Subspecialty Text, Required
Field Annotation: Clinic
Subspecialty
192 o_phi_disclosed PHI Disclosed Yes/No, Required
1 Yes
0 No
Field Annotation: PHI Disclosed
193 o_nppgiven NPP Given to Patients Radio, Required
1 Yes
2 No
3 N/A
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 288
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#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
194 o_environment Description of Environment Notes, Required
195 o_trafficpattern Traffic Pattern Notes, Required
Field Annotation: Traffic Pattern
196 o_staffpractices Section Header: Observations
Observations of Staff
Confidentiality Practices
Notes, Required
Field Annotation: Staff Practices
197 o_issues Issues Detected Notes, Required
Field Annotation: Issues
Detected
198 o_resourcesused Resources Staff Referenced Notes, Required
Field Annotation: Resources
Staff Referenced
199 o_genconditions General Conditions of
Observation
Notes, Required
Field Annotation: General
Conditions
200 o_followup Follow-up Requested or
Needed
Notes, Required
Field Annotation: Follow-up
Requested or Needed
201 o_elements Elements of Compliance
Observed
Checkbox, Required
1 o_elements__
_1
Implementin
g written
policies and
procedures
2 o_elements__
_2
Designating
a compliance
officer and
compliance
committee
3 o_elements__
_3
Conducting
effective
training and
education
4 o_elements__
_4
Developing
effective and
open lines of
communicati
on
5 o_elements__
_5
Conducting
internal
compliance
monitoring
and auditing
6 o_elements__
_6
Enforcing
standards
through
well-
publicized
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
disciplinary
guidelines
7 o_elements__
_7
Responding
promptly to
detected
problems
and
undertaking
corrective
action
8 o_elements__
_8
Developing
and
implementin
g systems for
tracking
adverse
events and
near misses.
9 o_elements__
_9
Performing
risk
management
and quality
activities
such as peer
review and
clinical risk
1
0
o_elements__
_10
Creating
visibility and
transparency
in
developing
and
implementin
g
institutional
policies and
procedures
1
1
o_elements__
_11
Creating
management
and staff
buy-in for
implementin
g
compliance
requirements
1
2
o_elements__
_12
Practicing
ongoing
practice and
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 290
Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
process
improvement
Field Annotation: Elements
Observed
202 o_ends Observation End Date and
Time
Text (datetime_ymd), Required
Field Annotation: Observation
End Date and Time
203 o_length_min Length of Observation
(Minutes)
Calculation, Required
Calculation:
datediff([o_begins],[o_ends],"m"
,"y-m-d h:m")
Field Annotation: Observation
Length
204 o_length_hr Lengths of Observation
(Hours)
Calculation, Required
Calculation:
(round(([o_length_min]/60),2))
Field Annotation: Obs length hrs
205 clinical_observation_form_co
mplete
Section Header: Form Status
Complete?
dropdown
0 Incomplete
1 Unverified
2 Complete
206 d_startdate Start Date and Time of
Analysis
Text (datetime_ymd), Required
Field Annotation: Analysis Start
Date
207 d_itemtype Item Type Radio, Required
1 Document
2 Artifact
Field Annotation: Item Type
Document and Artifact Analysis Codebook
208 d_focus Focus of Document or
Artifact
Checkbox, Required
1 d_focus___1 Clinical
2 d_focus___2 Operational
3 d_focus___3 Research
4 d_focus___4 Administration
5 d_focus___5 Regulatory
6 d_focus___6 Other
209 d_focus_other
Show the field ONLY if:
[d_focus(6)] = '1'
Other (Please Specify) Text, Required
210 d_focus_hr HR or Personnel Focused Yes/No
1 Yes
0 No
211 d_itemorig Item Origination Radio, Required
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
1 Internal
2 External
Field Annotation: Item Type
212 d_itemsource
Show the field ONLY if:
[d_itemorig] = '2'
Item Source Notes, Required
213 d_item_sourcetype
Show the field ONLY if:
[d_itemorig] = '2'
External Source Type Checkbox, Required
1 d_item_sourcet
ype___1
College/Uni
versity
2 d_item_sourcet
ype___2
Acute Care
Hospital
3 d_item_sourcet
ype___3
Research
Hospital
4 d_item_sourcet
ype___4
Health
System
5 d_item_sourcet
ype___5
Regulatory
or
Government
Agency
6 d_item_sourcet
ype___6
Other
214 d_item_sourcetype_other
Show the field ONLY if:
[d_item_sourcetype(6)]='1'
Other External Source Type Text, Required
215 d_cf_ee Section Header: Conceptual
Framework
Applicable Conceptual
Framework Influences
(Program Elements)
Checkbox
1 d_cf_ee__
_1
Systems
2 d_cf_ee__
_2
Policies/Procedur
es
3 d_cf_ee__
_3
Communication
4 d_cf_ee__
_4
Knowledge base
5 d_cf_ee__
_5
Auditing/monitor
ing
216 d_cf_kmo_k Applicable Conceptual
Framework Influences (KMO
- Knowledge and Skills)
Checkbox
1 d_cf_kmo_k__
_1
Rules and
Regulations
(Conceptual)
2 d_cf_kmo_k__
_2
Implementati
on
(Procedural)
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
217 d_cf_kmo_m Applicable Conceptual
Framework Influences
(Motivational)
Checkbox
1 d_cf_kmo_m___
1
Value in
Time and
Effort
(Expectanc
y Value
Theory)
2 d_cf_kmo_m___
2
Complianc
e is
Probable
(Self-
efficacy
Theory)
218 d_kmo_o Applicable Conceptual
Framework Influences
(Organizational)
Checkbox
1 d_kmo_o___
1
Policies and
Systems
(Assets)
2 d_kmo_o___
2
Resource
Adequacy
(Assets)
3 d_kmo_o___
3
Collaboration
between
Echelons
(Culture)
4 d_kmo_o___
4
Communicati
on Dynamics
(Culture)
5 d_kmo_o___
5
Diversity
(Culture)
6 d_kmo_o___
6
Individual
Accountabilit
y (Culture)
7 d_kmo_o___
7
Team
Accountabilit
y
8 d_kmo_o___
8
Management
Accountabilit
y
9 d_kmo_o___
9
Organizationa
l
Accountabilit
y
1
0
d_kmo_o___
10
Context and
Setting
219 d_doctitle
Show the field ONLY if:
[d_itemtype] = '1'
Section Header: Content
Fields
Text, Required
Field Annotation: Doc Title
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Document Title
220 d_docpurpose
Show the field ONLY if:
[d_itemtype] = '1'
Document Purpose Notes, Required
221 d_doctype
Show the field ONLY if:
[d_itemtype] = '1'
Document Type
Select all that apply.
Checkbox, Required, Identifier
1 d_doctype___
1
Brainstormi
ng and Mind
mapping
2 d_doctype___
2
Form
Template -
External
3 d_doctype___
3
Form
Template -
Internal
4 d_doctype___
4
Handbook
5 d_doctype___
5
Policy
6 d_doctype___
6
Procedure
7 d_doctype___
7
Process
Instructions
and
Diagrams
8 d_doctype___
8
Scholarly
Literature
9 d_doctype___
9
Standards
and
Guidelines -
Accreditatio
n and
Recognition
1
0
d_doctype___
10
Standards
and
Guidelines -
Regulatory
1
1
d_doctype___
11
Other
(please
specify)
Field Annotation: Doc Type
222 d_doctype_other
Show the field ONLY if:
[d_itemtype] = '1' and
[d_doctype(11)] = '1'
If other, specify here. Text, Required
223 d_docstatus
Show the field ONLY if:
Document Status Radio, Required
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
[d_itemtype] = '1'
1 Draft
2 Approved
3 Superseded
4 Cancelled
5 Archived
Field Annotation: Doc Status
224 d_docversion
Show the field ONLY if:
[d_itemtype] = '1'
Document Version Number Text (number)
Field Annotation: Document
Version Number
225 d_docapprovertitle
Show the field ONLY if:
[d_itemtype] = '1'
Document Approver Title text
Field Annotation: Document
Approver Title
226 d_approvedate
Show the field ONLY if:
[d_itemtype] = '1'
Document Approval Date Text (date_ymd)
Field Annotation: Document
Approval Date
227 d_artname
Show the field ONLY if:
[d_itemtype] = '2'
Artifact Name Text, Required
Field Annotation: Artifact Name
228 d_artdesc
Show the field ONLY if:
[d_itemtype] = '2'
Artifact Description Notes, Required
Field Annotation: Artifact
Description
229 d_artpurpose
Show the field ONLY if:
[d_itemtype] = '2'
Artifact Purpose Notes, Required
Field Annotation: Artifact
Purpose
230 d_publicavail_yn Document or Artifact Publicly
Available
Yes/No, Required
1 Yes
0 No
Field Annotation: Document
Publicly Available
231 d_public_warning
Show the field ONLY if:
[d_publicavail_yn] = '0'
If the document is not
publicly available, please
ensure that it has been
appropriately redacted before
uploading it to this form.
Descriptive
232 d_easylocate Document or Artifact Easy to
Locate
Yes/No, Required
1 Yes
0 No
Field Annotation: Document or
Artifact Easy to Locate
233 d_used_yn Document or Artifact
Actively Used
Yes/No, Required
1 Yes
0 No
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
Field Annotation: Document
Publicly Available
234 d_used_desc Document or Artifact Usage Notes, Required
Field Annotation: Document or
Artifact Usage
235 d_barriers Possible Barriers to
Document or Artifact Usage
Notes, Required
Field Annotation: Barriers to
Document or Artifact Usage
236 d_attachment Attach Document/Artifact if
Available
file
237 d_enddate End Date and Time of
Analysis
Text (datetime_ymd), Required
Field Annotation: Analysis End
Date
238 d_length_min Total Analysis Time
(Minutes)
Calculation, Required
Calculation:
datediff([d_startdate],[d_enddate]
,"m","y-m-d h:m")
239 d_length_hr Total Analysis Time (Hours) Calculation, Required
Calculation: ([d_length_min]/60)
240 document_and_artifact_analy
sis_complete
Section Header: Form Status
Complete?
dropdown
0 Incomplete
1 Unverified
2 Complete
241 eval_intro The survey is designed assess
your perceptions of the
Compliance Efficacy and
Sustainability Evaluation
program implementation. For
each statement below, please
select the response that most
closely aligns with your
perception. Also, please
ensure that you download the
information sheet associated
with this study.
Descriptive
242 eval_core_assess This program improved my
ability to assess the efficacy
and sustainability of my
institution's regulatory and
corporate compliance
program.
Yes/No, Required
1 Yes
0 No
243 eval_kmo_c_trn_improve The content provided in this
training improved by
knowledge and skills
regarding rules and
regulations applicable to my
role and organization.
Yes/No, Required
1 Yes
0 No
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
244 eval_kmo_p_trn_improve The content provided in this
training improved by
knowledge and skills
regarding how to implement
rules and regulations
applicable to my role and
organization.
Yes/No, Required
1 Yes
0 No
245 eval_materialvalue_kmo I found the job aides, case
studies, knowledge checks,
and other materials valuable
in improving my knowledge
of the rules and regulations,
and how to implement them.
Yes/No, Required
1 Yes
0 No
246 eval_e_ks_conceptual Section Header: Please select
the statement that most
closely aligns with your
perceptions on the essentially
of the following program
elements in improving your
ability and desire to comply
with the appropriate rules
and regulations for your role
and institution.
Content on rules, regulations,
and other regulatory
requirements
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
247 eval_e_ks_procedural Content for implementation of
rules, regulations, and other
regulatory requirements
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
248 eval_e_ks_materials Job aides, case studies, and
other materials presented in
the program
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
249 eval_e_m_guidance Guidance on peer mentoring,
supervisor coaching, and
leadership development
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
250 eval_e_m_team Guidance on team
development activities
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
251 eval_e_m_evt Guidance on creating buy-in
on team, effort, and perceived
burden of compliance
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
252 eval_e_m_eff Guidance on helping staff
believe that compliance is
possible and probable
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
253 eval_e_o_assets Content for developing
effective organizational assets
and system
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
254 eval_e_o_culture Guidance on improving
communication,
demonstrating leadership
commitment, improving
resource adequacy, and
improving the institution's
compliance culture
Radio (Matrix), Required
1 Highly essential
2 Essential
3 Somewhat essential
4 Nonessential
5 Cannot assess
255 eval_ks_open Please describe one specific
regulation applicable to your
role, the reason compliance is
necessary, and the
requirements needed to
implement and sustain
compliance.
Notes, Required
256 eval_o_open What institutional resources
will you need to ensure
compliance with the above
referenced regulation?
Notes, Required
257 eval_evaluation_open Please describe your method
of evaluating individual
Notes, Required
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
compliance with the above
referenced regulation.
258 eval_future_open What would you like to see
included in future training
programs of this nature?
Notes
259 recommendations_evaluation
_survey_complete
Section Header: Form Status
Complete?
dropdown
0 Incomplete
1 Unverified
2 Complete
260 eval_intro_v2 The survey is designed assess
your perceptions of the
Compliance Efficacy and
Sustainability Evaluation
program implementation. For
each statement below, please
select the response that most
closely aligns with your
perception. Also, please
ensure that you download the
information sheet associated
with this study.
Descriptive
261 eval_core_assess_v2 This program improved my
ability to assess the efficacy
and sustainability of my
institution's regulatory and
corporate compliance
program.
Yes/No, Required
1 Yes
0 No
262 eval_kmo_c_trn_improve_v2 The content provided in this
training improved by
knowledge and skills
regarding rules and
regulations applicable to my
role and organization.
Yes/No, Required
1 Yes
0 No
263 eval2_ks_conceptual Section Header: Please select
the statement that most
closely aligns with your
perceptions on the items
below since you completed the
program.
I have applied the conceptual
knowledge (technical details,
rules, and regulations) in my
role and my organization.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
264 eval2_ks_procedural I have applied the procedural
knowledge (requirements,
procedures, and processes) for
implementing the conceptual
knowledge.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
265 eval2_ks_set1 The program's training
content has made
implementing long-term
compliance easier in my role.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
266 eval2_ks_set2 The program's training
content has improved the
likelihood that I will continue
to comply with rules and
regulations.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
267 eval2_ks_evt1 The conceptual and
procedural requirements, and
the outcomes they produced,
were worth the time, effort,
and burden of compliance.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
268 eval2_ks_evt2_o_culture As a result of the program, I
can see the value to the
organization of implementing
and maintaining compliance
with the required rules and
regulations.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
269 eval2_o_assets As a result of the program,
my institution has developed
the and maintained the
required resources and assets
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
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Line
#
Variable / Field Name Field Label
Field Note
Field Attributes (Field Type,
Validation, Choices,
Calculations, etc.)
necessary to facilitate long-
term compliance.
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
270 eval2_o_culture My organization's
commitment, and that of its
leaders, is apparent as a result
of the implementation of this
program.
Radio (Matrix), Required
1 Strongly agree
2 Agree
3 Somewhat agree
4 Neutral
5 Somewhat disagree
6 Disagree
7 Strongly disagree
271 eval_challenge_open Please describe any
challenges that you faced
implementing the technical
and functional requirements
derived from the Compliance
Efficacy and Sustainability
Evaluation program.
Notes, Required
272 eval_kmo_p_o_assets_open Describe the procedures and
resources that you used to
successfully implement
program requirements?
Notes, Required
273 eval_evaluation_open_v2 Please describe your method
of evaluating of the program's
overall success within your
role and the institution.
Notes, Required
274 eval_future_open_v2 How did your institution
demonstrate the value of
continued compliance and its
commitment to the success of
the program?
Notes, Required
275 eval_future_improve_open How can the Compliance
Efficacy and Sustainability
Evaluation Program be
improved to promote
continued institutional
compliance?
Notes, Required
276 formative_longterm_program
_evaluation_survey_2_compl
ete
Section Header: Form Status
Complete?
Dropdown
0 Incomplete
1 Unverified
2 Complete
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 301
APPENDIX B: SURVEY PROTOCOLS
Welcome E-mail for Survey Respondents
Date
RE: Corporate Compliance and Research Regulatory Programs
Dear Staff Member,
You have been invited to participate in a brief survey concerning the evaluation of
corporate compliance and regulatory research programs in academic medicine settings. This
survey is part of data collection on a dissertation that explores the essential elements of such
programs, as well as the knowledge, skills, motivation and organizational influences that make
them relevant, usable and sustainable. The study focuses specifically on those elements and
influences from the perspective of staff members as stakeholders. Your results will remain
confidential. Any personally identifiable information is coded and available only to the
investigator and dissertation chair. If desired, you may request aggregated results of the findings
at the conclusion of the dissertation process. Please allow approximately 20-30 minutes to
complete the survey.
If you have any questions, please contact me using the information below. You may also
contact my dissertation chair, Dr. Lawrence Picus, at lpicus@rossier.usc.edu. Thank you for
your commitment to enhancing compliance and regulatory programs.
Sincerely,
Dustin McLemore, MBA, MPA
Doctoral Candidate
USC Rossier School of Education
University of Southern California
P: 303.731.5021
E: dustin.mclemore@usc.edu
You may opt-out of any further communications on this study, by unsubscribing through this link
.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 302
Survey Information
Title
Staff Stakeholder Survey
Design
The survey had 111 possible fields, depending upon branching logic, broken into the
following sections.
• Demographic Questions with 25 possible fields (S.1 – S.25)
• Program Elements with 21 possible fields (S.2 – S.46)
• Knowledge and Skills Influences with 16 possible fields (S.47 – S.64)
• Motivational Influences with eight possible fields (S.65 – S.72)
• Organizational Influences with 33 possible fields (S.73 – S.105)
• Time and Effort with three possible fields (S.106 – S.108)
• Follow-up Preferences with two possible fields (S.109 – S.111)
Time to Completion
The expected time to completion was 30 – 45 minutes.
Administration and Logistics
Delivery System
The survey was delivered via REDCap the internet. Email addresses were loaded into the
survey platform and sent to qualified potential respondents. The general survey link was also
posted on selected discussion forums.
Confidentiality Provisions
Survey respondents were coded. The coding logic is available only to the researcher. Data
will be aggregated to perform analysis functions. Personalized survey links were not used.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 303
Personally identifiable information was only solicited in cases when the respondent indicated
that they wanted to participate in the interview process or receive a copy of the survey results.
Once the analysis was complete, that information was redacted.
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Survey Instrument
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APPENDIX C: SURVEY RESPONDENT GROUP FIELD MAPPING
Figure 27. Survey items aggregated to create the "clinical" respondent category.
Figure 28. Survey items aggregated to create the “research” respondent category.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 322
Figure 29. Survey items aggregated to create the “healthcare management and operations”
respondent category.
Figure 30. Survey items aggregated to create the “other” respondent category.
Figure 31. Survey items aggregated to create the “compliance and regulatory experience”
respondent category.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 323
APPENDIX D: INTERVIEW PROTOCOLS
Interview Protocols and Instrument
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APPENDIX E: OBSERV ATION PROTOCOLS
Observation Protocols and Instrument
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APPENDIX F: DOCUMENT AND ARTIFACT ANALYSIS PROTOCOLS
Document and Artifact Protocols and Instrument
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APPENDIX G: IMMEDIATE SUMMATIVE EVALUATION SURVEY
Survey Instrument
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APPENDIX H: LONG-TERM SUMMATIVE EV ALUATION SURVEY
Survey Instrument
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 337
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APPENDIX I: DATA COLLECTION INFORMATION SHEET
University of Southern California
Rossier School of Education
Waite Phillips Hall
Los Angeles, CA 90089-4034
INFORMATION/FACTS SHEET FOR EXEMPT NON-MEDICAL RESEARCH
Fine Tuning the Microscope: Evaluating the Efficacy and Sustainability of the Compliance
and Research Regulatory Program in a National Specialty Academic Medicine Institution
You are invited to participate in a research study. Research studies include only people who
voluntarily choose to take part. This document explains information about this study. You should
ask questions about anything that is unclear to you.
PURPOSE OF THE STUDY
The study has two main aims. First, it is intended to evaluate institutional, corporate compliance
and regulatory research programs to determine the essential elements of sustainability and
efficiency. Second, it attempts to evaluate the knowledge, skills, motivational and organizational
influences that support those elements from the perspective compliance-facing staff members.
PARTICIPANT INVOLVEMENT
Data collection for this study is divided into two phases. If you agree to the first phase, you will
participate in a brief survey that should take no longer than 30 minutes. The survey gathers non-
identifiable demographic information for statistical purposes only. Most of the content is devoted
to your perceptions and knowledge in corporate and regulatory compliance. At the end of the
survey, you may be asked if you wish to participate in the interview phase.
If you participate in the second portion of the process, a brief interview will be conducted.
Interviews are conducted either in person or virtually. It will take approximately one hour to
complete. While it is requested that the interview is recorded, it is not required to participate.
PAYMENT/COMPENSATION FOR PARTICIPATION
Although there is no direct compensation provided for your participation in this study, benefits
include a chance to shape compliance program structures, improved institutional processes, and
service to the profession. A thank-you-note can be provided if requested.
ALTERNATIVES TO PARTICIPATION
Your alternative is not to participate. Your relationship with your employer or institution will not
be affected whether you participate or not in this study.
Last edits made on: August 21, 2017– Information Sheet for Exempt Applications
UPIRB#: UP-17-00433
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 339
CONFIDENTIALITY
Any identifiable information obtained in connection with this study will remain confidential. Your
responses will be coded with a false name (pseudonym) and maintained separately. The audiotapes
will be destroyed once they have been transcribed.
The members of the research team, the funding agency and the University of Southern California’s
Human Subjects Protection Program (HSPP) may access the data. The HSPP reviews and monitors
research studies to protect the rights and welfare of research subjects.
When the results of the research are published or discussed in conferences, no identifiable
information will be used.
INVESTIGATOR CONTACT INFORMATION
Principal Investigator Dustin McLemore via email at ddmclemo@usc.edu or phone at (213) 373-
1536 or Faculty Advisor Dr. Lawrence Picus at lpicus@rossier.usc.edu or (213) 740-2175
IRB CONTACT INFORMATION
University Park Institutional Review Board (UPIRB), 3720 South Flower Street #301, Los
Angeles, CA 90089-0702, (213) 821-5272 or upirb@usc.edu
Last edits made on: August 21, 2017– Information Sheet for Exempt Applications
UPIRB#: UP-17-00433
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 340
APPENDIX J: SPECIAL QUALITATIVE CODING SUMMARY
Nodes
Name Sources References
General Themes 0 0
Awareness 1 2
Barriers to Compliance 4 13
Attitude 1 2
Availability of Knowledge 1 1
Culture 5 12
Education and Training 2 4
Feasibility 1 1
Funding 2 2
Power 1 1
Redundancy 1 1
Regulatory Burden 3 11
Resource Adequacy 2 6
Subject Matter 1 1
Time 3 14
Change 1 1
Collective Efficacy 5 14
Cost Reduction 1 1
Efficacy 4 7
Evaluation 1 2
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 341
Name Sources References
Improving Compliance 4 9
Efficiency Improves Compliance 2 2
People 3 8
Tools and Culture Improve Compliance 3 5
Individual Efficacy 0 0
Leadership Engagement 3 5
Metacognition 1 1
Outlook 3 3
Personnel 1 1
Process Change 3 6
Research and Clinical 2 4
Service Delivery 1 1
Stakeholder Engagement 1 3
Standardization 1 6
Sustainability 1 4
Tools 3 7
1x1 Instruction 2 2
Case Studies 1 1
Certification 1 1
Email Notifications - Institutional 1 1
Job Aides 1 1
ListServ 1 1
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 342
Name Sources References
LMS 1 1
Mentoring 1 1
Resources 1 2
Risk Assessment 1 1
Training 5 12
Transparency 1 1
Trust 1 2
Workload 1 2
Clinical 0 0
Research 1 1
KMO 0 0
Knowledge and Skills 2 3
Acquisition 6 8
Assimilation 2 3
Certification 1 1
Conceptual Knowledge 6 13
Dissemination 4 8
Knowledgebase 3 5
Procedural Knowledge 7 23
SME 2 2
Motivation 1 1
EVT 3 6
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 343
Name Sources References
SET 6 13
Organizational Influences 1 1
Asset and Needs 4 7
Organizational Structure 1 1
Policies and Procedures 1 1
New Node 0 0
Staff 1 2
On boarding 1 1
Systems 3 3
Org Culture 8 34
Buy-In 4 5
Communication 6 16
Leadership Engagement 4 6
Staff Bandwidth 2 5
Staff Selection and Recruitment 2 2
Team Cohesion 2 2
RQ's 0 0
RQ 1 0 0
Content Delivery 1 3
Program Elements 1 1
Auditing and Monitoring 5 8
Reporting 2 3
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 344
Name Sources References
Risk Assessment 1 1
RQ 2 0 0
Content Delivery 1 3
Knowledge and Skills 2 3
Acquisition 6 8
Assimilation 2 3
Certification 1 1
Conceptual Knowledge 6 13
Dissemination 4 8
Knowledgebase 3 5
Procedural Knowledge 7 23
SME 2 2
RQ 3 0 0
Motivation 1 1
EVT 3 6
SET 6 13
Organizational Influences 1 1
Asset and Needs 4 7
Organizational Structure 1 1
Policies and Procedures 1 1
New Node 0 0
Staff 1 2
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 345
Name Sources References
On boarding 1 1
Systems 3 3
Org Culture 8 34
Buy-In 4 5
Communication 6 16
Leadership Engagement 4 6
Staff Bandwidth 2 5
Staff Selection and Recruitment 2 2
Team Cohesion 2 2
Special Nodes: Surveys
Name Sources References
kmo_ks_eff_other 1 83
kmo_ks_other 1 83
kmo_ks_other_2 1 83
kmo_ks_train_other 1 83
kmo_m_other 1 83
kmo_o_other 1 83
Special Nodes: Interviews
Name Sources References
Speaker 0 0
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 346
Name Sources References
S1 5 173
S2 5 181
Special Nodes: Observations
Name Sources References
Description of Environment 1 25
Event Name 1 25
Follow-up Requested or Needed 1 25
General Conditions of Observation 1 25
Issues Detected 1 25
Observations of Staff Confidentiality Practices 1 25
Resources Staff Referenced 1 25
Traffic Pattern 1 25
Special Nodes: Documents and Artifacts
Name Sources References
d_artdesc 1 17
d_artpurpose 1 17
d_barriers 1 17
d_docpurpose 1 17
d_doctitle 1 17
d_itemsource 1 17
d_used_desc 1 17
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 347
APPENDIX K: SURVEY V ARIABLE ATTRIBUTES
record_id
Value
Standard Attributes Label Other
Measurement Nominal
demo_class
Value
Standard Attributes Label Which of the
following best
describes your
employment
classification at your
institution?
Measurement Nominal
demo_class_other
Value
Standard Attributes Label Other employment
classification (if other
selected above)
Measurement Nominal
demo_role
Value
Standard Attributes Label Which selection best
describes your role in
the institution?
Measurement Nominal
demo_role_other
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 348
Standard Attributes Label Other staff role (if
other selected above)
Measurement Nominal
demo_educ
Value
Standard Attributes Label What is your highest
level of education
completed?
Measurement Nominal
demo_clinicalbackground
Value
Standard Attributes Label Do you have a
background or current
responsibilities in
patient care or
clinical operations?
Measurement Nominal
demo_credential_yn
Value
Standard Attributes Label Do you hold a clinical
credential (e.g.
Physician, RN,
Physical Therapist,
etc.)?
Measurement Nominal
demo_credential___1
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 349
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Physician
(MD/DO))
Measurement Nominal
demo_credential___2
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Nurse
Practitioner (FNP,
PNP-BC, APN, etc.)
or Certified Nurse
Midwife (CNM))
Measurement Nominal
demo_credential___3
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Physician
Assistant (PA-C, PA,
etc.))
Measurement Nominal
demo_credential___4
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 350
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Registered
Nurse (RN))
Measurement Nominal
demo_credential___5
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Behavioral
Health Provider
(Psy.D, LPC, etc.))
Measurement Nominal
demo_credential___6
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Social
Worker LCWS,
LMSW, etc.))
Measurement Nominal
demo_credential___7
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 351
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Clinical
Research (ACRP-CP,
CCRA, CCRC, CPI,
etc.))
Measurement Nominal
demo_credential___8
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=Physical or
Occupational
Therapist (DPT,
OTRI, etc.))
Measurement Nominal
demo_credential___9
Value
Standard Attributes Label Which, if any, of the
following credentials
do you hold?
(choice=None of the
above)
Measurement Nominal
demo_compliance_facing
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 352
Standard Attributes Label Does your role have
corporate compliance
responsibilities such
as HIPAA
compliance,
reporting, developing
policies and
procedures,
conducting or
attending compliance
training, or any other
related activities?
Measurement Nominal
demo_compliance_previous
Value
Standard Attributes Label Do you have any
previous experience
in those areas?
Measurement Nominal
demo_regulatory_facing
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 353
Standard Attributes Label Does your role have
research regulatory
responsibilities such
as submitting
applications and
protocols to your
organizations
Institutional Review
Board (IRB),
obtaining and
reporting informed
consent, monitoring
clinical trials, or any
other related
activities?
Measurement Nominal
demo_regulatory_previous
Value
Standard Attributes Label Do you have any
previous experience
in those areas?
Measurement Nominal
demo_x_years_pc
Value
Standard Attributes Label Direct patient care
Measurement Ordinal
demo_x_years_hcmo
Value
Standard Attributes Label Health care
management and
operations
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 354
demo_x_years_clinres
Value
Standard Attributes Label Clinical research
Measurement Ordinal
demo_x_years_txnres
Value
Standard Attributes Label Translational research
Measurement Ordinal
demo_x_years_bsbr
Value
Standard Attributes Label Basic science or
bench research
Measurement Ordinal
demo_x_years_nursing
Value
Standard Attributes Label Nursing
Measurement Ordinal
demo_x_years_ptr
Value
Standard Attributes Label Physical therapy and
rehabilitation
Measurement Ordinal
demo_x_years_irb
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 355
Standard Attributes Label Institutional Review
Board (IRB) member,
reviewer, designated
reviewer,
administrator, or staff
member
Measurement Ordinal
demo_x_years_iacuc
Value
Standard Attributes Label Institutional Animal
Care and Use
Committee (IACUC)
member, reviewer,
designated reviewer,
administrator, or staff
member
Measurement Ordinal
demo_x_years_picoi
Value
Standard Attributes Label Principal or co-
principal investigator
Measurement Ordinal
demo_x_years_rssup
Value
Standard Attributes Label Research support
staff
Measurement Ordinal
demo_inst_workforce_size
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 356
Standard Attributes Label What is the size of
your institutions total
workforce including
regular full-time,
part-time, contract,
and affiliate faculty
and staff?
Measurement Ordinal
demo_inst_site_state
Value
Standard Attributes Label In which state is your
institution located?
Measurement Nominal
ee_hhs_pol
Value
Standard Attributes Label Implementing written
policies and
procedures
Measurement Ordinal
ee_hhs_cco
Value
Standard Attributes Label Designating a
compliance officer
and compliance
committee
Measurement Ordinal
ee_hhs_trn
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 357
Standard Attributes Label Conducting effective
training and
education
Measurement Ordinal
ee_hhs_com
Value
Standard Attributes Label Developing effective
and open lines of
communication
Measurement Ordinal
ee_hhs_aud
Value
Standard Attributes Label Conducting internal
compliance
monitoring and
auditing
Measurement Ordinal
ee_hhs_dis
Value
Standard Attributes Label Enforcing standards
through well-
publicized
disciplinary
guidelines
Measurement Ordinal
ee_hhs_det
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 358
Standard Attributes Label Responding promptly
to detected problems
and undertaking
corrective action
Measurement Ordinal
ee_sys
Value
Standard Attributes Label Developing and
implementing
systems for tracking
sentinel events
Measurement Ordinal
ee_ris
Value
Standard Attributes Label Performing risk
management and
quality activities such
as peer review and
clinical risk
Measurement Ordinal
ee_vis
Value
Standard Attributes Label Creating visibility
and transparency in
developing and
implementing
institutional policies
and procedures
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 359
ee_mgt
Value
Standard Attributes Label Creating management
and staff buy-in for
implementing
compliance
requirements
Measurement Ordinal
ee_pim
Value
Standard Attributes Label Practicing ongoing
practice and process
improvement
Measurement Ordinal
ee_ast
Value
Standard Attributes Label Organizational assets
(Policies, procedures,
processes.
committees, etc.)
Measurement Ordinal
ee_stf
Value
Standard Attributes Label Dedicated
compliance and
regulatory staff
(Compliance officers,
IRB staff, etc.)
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 360
ee_trn
Value
Standard Attributes Label Compliance/regulator
y training and
ongoing professional
development
Measurement Ordinal
ee_cul
Value
Standard Attributes Label Organizational
culture
(Communication,
management support
of compliance
initiatives, etc.)
Measurement Ordinal
ee_mon
Value
Standard Attributes Label Monitoring and
auditing systems for
adverse and sentinel
events
Measurement Ordinal
ee_rca
Value
Standard Attributes Label Root cause analysis,
investigations, and
implementation of
interventions
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 361
ee_crm
Value
Standard Attributes Label Clinical risk
management and
process improvement
projects
Measurement Ordinal
ee_wrk
Value
Standard Attributes Label Compliance strategic
and work plans
Measurement Ordinal
ee_fdb
Value
Standard Attributes Label Feedback
mechanisms such as
town hall meetings,
listening sessions,
and suggestion boxes
Measurement Ordinal
kmo_ks_rra_irb
Value
Standard Attributes Label Human Subjects
Research (IRB)
Measurement Ordinal
kmo_ks_rra_iacuc
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 362
Standard Attributes Label Animal Subjects
Protections (IACUC)
Measurement Ordinal
kmo_ks_rra_ic
Value
Standard Attributes Label Informed Consent
Measurement Ordinal
kmo_ks_rra_hipaa
Value
Standard Attributes Label HIPAA Privacy and
Security (Research
applications)
Measurement Ordinal
kmo_ks_rra_ethics
Value
Standard Attributes Label Bioethics and
research ethics
Measurement Ordinal
kmo_ks_rra_pro
Value
Standard Attributes Label Development and
submission of
research protocols
Measurement Ordinal
kmo_ks_cc_fwa
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 363
Standard Attributes Label Fraud, Waste, and
Abuse regulations
Measurement Ordinal
kmo_ks_cc_cmsg
Value
Standard Attributes Label General CMS
Compliance
Measurement Ordinal
kmo_ks_cc_coi
Value
Standard Attributes Label Conflict of Interest
Measurement Ordinal
kmo_ks_cc_crmpr
Value
Standard Attributes Label Clinical Risk
Management (CRM)
and Peer Review
Measurement Ordinal
kmo_ks_cc_hipaa
Value
Standard Attributes Label HIPAA compliance
Measurement Ordinal
kmo_ks_cc_accred
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 364
Standard Attributes Label Accreditation (The
Joint Commission,
AAAHC, NCQA,
etc.)
Measurement Ordinal
kmo_ks_eff___1
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Laws, rules,
regulations, and
standards) (C)
Measurement Nominal
kmo_ks_eff___2
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=A deeper
understanding of the
institutions systems
and processes) (C)
Measurement Nominal
kmo_ks_eff___3
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 365
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Institutional
policies and
procedures) (C/P)
Measurement Nominal
kmo_ks_eff___4
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Root-cause
analysis and problem-
solving) (C/P)
Measurement Nominal
kmo_ks_eff___5
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=A better
understanding of
efficiency and
sustainability) (C)
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 366
Measurement Nominal
kmo_ks_eff___6
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Developing
intervention
strategies) (C/P)
Measurement Nominal
kmo_ks_eff___7
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Auditing and
monitoring
compliance
requirements within
the institutions) (C)
Measurement Nominal
kmo_ks_eff___8
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 367
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=An
understanding of how
other institutions have
implemented similar
requirements) (C)
Measurement Nominal
kmo_ks_eff___9
Value
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=How the
requirements and
regulations affect me,
my department, and
my institution) (C/P)
Measurement Nominal
kmo_ks_eff___10
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 368
Standard Attributes Label What knowledge and
training do you need
to effectively
implement
compliance
requirements?
(choice=Other (please
specify))
Measurement Nominal
kmo_ks_eff_other
Value
Standard Attributes Label Other training (if
other selected above)
Measurement Nominal
kmo_ks_other_2
Value
Standard Attributes Label In addition to the
rules and regulations,
and their
implementation
requirements, what
other knowledge and
skills do you need to
effectively implement
comply with
requirements
affecting you and
your institution?
Measurement Nominal
kmo_ks_train___1
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 369
Standard Attributes Label What methods of
delivery work best for
compliance and
regulatory training?
(choice=On-boarding
and orientation)
Measurement Nominal
kmo_ks_train___2
Value
Standard Attributes Label What methods of
delivery work best for
compliance and
regulatory training?
(choice=Annual in-
person refresher
training)
Measurement Nominal
kmo_ks_train___3
Value
Standard Attributes Label What methods of
delivery work best for
compliance and
regulatory training?
(choice=Annual on-
line computer-based
training)
Measurement Nominal
kmo_ks_train___4
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 370
Standard Attributes Label What methods of
delivery work best for
compliance and
regulatory training?
(choice=Team-based
training at staff
meetings and
huddles)
Measurement Nominal
kmo_ks_train___5
Value
Standard Attributes Label What methods of
delivery work best for
compliance and
regulatory training?
(choice=Other (please
specify))
Measurement Nominal
kmo_ks_train_other
Value
Standard Attributes Label Other training
delivery (if other
selected above)
Measurement Nominal
kmo_ks_other
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 371
Standard Attributes Label In addition to
training, policies, and
procedures, what
other items increase
the likelihood that
you can effectively
comply with all
required rules and
regulations?
Measurement Nominal
kmo_m_tim
Value
Standard Attributes Label I believe that the
amount of time and
effort required to
comply with rules,
regulations, and
policies is reasonable
and necessary.
Measurement Ordinal
kmo_m_res
Value
Standard Attributes Label I believe that I have
the necessary training
and resources
necessary to
effectively comply
with rules,
regulations, and
policies that affect
me, my team, and my
organization.
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 372
kmo_m_voi
Value
Standard Attributes Label I have a voice in the
decision-making and
policy development
processes at my
institution.
Measurement Ordinal
kmo_m_sys
Value
Standard Attributes Label I believe that the
institution has a
viable and sustainable
system to detect,
deter, mitigate, and
prevent adverse
events and issues of
noncompliance
Measurement Ordinal
kmo_m_inv
Value
Standard Attributes Label I believe that the
institution develops
targeted, relevant, and
achievable
intervention strategies
to make compliance
meaningful, possible
and probable.
Measurement Ordinal
kmo_m_mgt
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 373
Value
Standard Attributes Label I believe that
institutional
leadership is
committed to making
compliance a priority.
Measurement Ordinal
kmo_m_stf
Value
Standard Attributes Label I believe that the
regulatory and
compliance team at
my institution is
available,
approachable, and
tasks my questions
and suggestion
seriously.
Measurement Ordinal
kmo_m_other
Value
Standard Attributes Label In addition to time,
effort, and resources,
what other
motivational
influences affect your
ability to effectively
comply with required
rules and regulations?
Measurement Nominal
kmo_o_hhs_pol
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 374
Standard Attributes Label Implementing written
policies and
procedures
Measurement Ordinal
kmo_o_hhs_cco
Value
Standard Attributes Label Designating a
compliance officer
and compliance
committee
Measurement Ordinal
kmo_o_hhs_trn
Value
Standard Attributes Label Conducting effective
training and
education
Measurement Ordinal
kmo_o_hhs_com
Value
Standard Attributes Label Developing effective
and open lines of
communication
Measurement Ordinal
kmo_o_hhs_aud
Value
Standard Attributes Label Conducting internal
compliance
monitoring and
auditing
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 375
Measurement Ordinal
kmo_o_hhs_dis
Value
Standard Attributes Label Enforcing standards
through well-
publicized
disciplinary
guidelines
Measurement Ordinal
kmo_o_hhs_det
Value
Standard Attributes Label Responding promptly
to detected problems
and undertaking
corrective action
Measurement Ordinal
kmo_o_sys
Value
Standard Attributes Label Developing and
implementing
systems for tracking
sentinel events
Measurement Ordinal
kmo_o_ris
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 376
Standard Attributes Label Performing risk
management and
quality activities such
as peer review and
clinical risk
Measurement Ordinal
kmo_o_vis
Value
Standard Attributes Label Creating visibility
and transparency in
developing and
implementing
institutional policies
and procedures
Measurement Ordinal
kmo_o_mgt
Value
Standard Attributes Label Creating management
and staff buy-in for
implementing
compliance
requirements
Measurement Ordinal
kmo_o_pim
Value
Standard Attributes Label Practicing ongoing
practice and process
improvement
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 377
kmo_o_ast
Value
Standard Attributes Label Organizational assets
(Policies, procedures,
processes.
committees, etc.)
Measurement Ordinal
kmo_o_stf
Value
Standard Attributes Label Dedicated
compliance and
regulatory staff
(Compliance officers,
IRB staff, etc.)
Measurement Ordinal
kmo_o_trn
Value
Standard Attributes Label Compliance/regulator
y training and
ongoing professional
development
Measurement Ordinal
kmo_o_cul
Value
Standard Attributes Label Organizational
culture
(Communication,
management support
of compliance
initiatives, etc.)
Measurement Ordinal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 378
kmo_o_mon
Value
Standard Attributes Label Monitoring and
auditing systems for
adverse and sentinel
events
Measurement Ordinal
kmo_o_rca
Value
Standard Attributes Label Root cause analysis,
investigations, and
implementation of
interventions
Measurement Ordinal
kmo_o_crm
Value
Standard Attributes Label Clinical risk
management and
process improvement
projects;
Measurement Ordinal
kmo_o_wrk
Value
Standard Attributes Label Compliance strategic
and work plans
Measurement Ordinal
kmo_o_fdb
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 379
Standard Attributes Label Feedback
mechanisms such as
town hall meetings,
listening sessions,
and suggestion boxes
Measurement Ordinal
kmo_org_prf_stf
Value
Standard Attributes Label Access to or presence
of compliance and
regulatory staff
Measurement Ordinal
kmo_org_prf_k
Value
Standard Attributes Label Availability,
knowledge, and
collaboration of
compliance and
regulatory staff
Measurement Ordinal
kmo_org_prf_tie
Value
Standard Attributes Label Clear ties between
regulatory
requirements and
program decisions
Measurement Ordinal
kmo_org_prf_mgt
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 380
Standard Attributes Label Institutional and
management
commitment to
compliance and
ethical behavior
Measurement Ordinal
kmo_org_prf_inp
Value
Standard Attributes Label Opportunities for
input into creating
institutional policy
Measurement Ordinal
kmo_org_prf_red
Value
Standard Attributes Label Reducing redundant
or burdensome
regulatory, ethical or
compliance
requirements
Measurement Ordinal
kmo_org_prf_gen
Value
Standard Attributes Label General staff
knowledge of
compliance
requirements
Measurement Ordinal
kmo_org_prf_tim
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 381
Standard Attributes Label Time to effectively
implement regulatory
requirements
Measurement Ordinal
kmo_org_prf_trn
Value
Standard Attributes Label Training and
development
resources
Measurement Ordinal
kmo_org_prf_cmt
Value
Standard Attributes Label Institutional
committee
performance (e.g.
IRB, IACUC, etc.)
Measurement Ordinal
kmo_org_prf_inv
Value
Standard Attributes Label Developing
meaningful
intervention strategies
to noncompliance
issues and events.
Measurement Ordinal
kmo_o_other
Value
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 382
Standard Attributes Label In addition to
organizational assets
(e.g. policies and
procedures),
communication, and
management buy-in,
what other
organizational
considerations affect
your ability to
effectively implement
compliance
requirements?
Measurement Nominal
audit_count
Value
Standard Attributes Label How many
compliance audits or
monitoring sessions
have occurred in your
department in the last
12 months?
Measurement Scale
train_count
Value
Standard Attributes Label How many
compliance and
regulatory training
courses have you
completed in the last
12 months?
Measurement Scale
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 383
task_count
Value
Standard Attributes Label How many hours do
you spend each week
working on tasks that
have a regulatory or
compliance element
to them?
Measurement Scale
recoded_demo_inst_site_state
Value
Standard Attributes Label In which state is your
institution located?
Measurement Nominal
new_demo_clinical_yn
Value
Standard Attributes Label Clinical respondents
Measurement Nominal
new_demo_research_yn
Value
Standard Attributes Label Research respondents
Measurement Nominal
new_demo_hcmo_yn
Value
Standard Attributes Label Health care
management and
operations
respondents
Measurement Nominal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 384
new_demo_other_yn
Value
Standard Attributes Label Other respondents
Measurement Nominal
new_demo_comreg_yn
Value
Standard Attributes Label Respondents with
compliance and
regulatory experience
Measurement Nominal
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 385
APPENDIX L: EXTENDED QUANTITATIVE ANALYSIS OF V ARIABLES
Table 50.
Observational Quantitative Descriptive Statistics (n=25)
Statistic
Total
Observation
Time (Hours)
Total
Observation
Time
(Minutes)
Approximate
Number of
Encounters
Observed
Approximate
Number of Staff
Present at Time
of Observation
Mean .78 47.08 9.93 13.96
Std. Error
of Mean
.11 6.67 1.94 2.44
Median .73 44.00 8.00 10.00
Mode 1.00
a
60.00
a
3.00 5.00
a
Std.
Deviation
.56 33.35 7.25 12.22
Variance .31 1,111.91 52.53 149.29
Skewness .73 .73 1.04 1.99
Std. Error
of
Skewness
.46 .46 .60 .46
Kurtosis -.39 -.38 -.03 4.76
Std. Error
of Kurtosis
.90 .90 1.15 .90
Range 1.85 111.00 22.00 54.00
Minimum .15 9.00 3.00 1.00
Maximum 2.00 120.00 25.00 55.00
Sum 19.60 1,177.00 139.00 349.00
Note. a. Multiple modes exist. The smallest value is shown.
Table 51.
Interview Demographic Summary
Item Value Frequency
(N)
Percent
Does the subject have a clinical focus? Yes 7 87.50
No 1 12.50
Does the subject have research a
research focus?
Yes 5 62.50
No 3 37.50
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 386
Item Value Frequency
(N)
Percent
What is the subject’s highest level of
education completed?
Doctoral degree 2 25.00
Specialist degree 0 .00
Masters degree 3 37.50
Bachelors degree 3 37.50
Other 0 .00
What type of provider is the subject? Behavioral Health
Provider
1 50.00
Nurse Practitioner 0 .00
Physical or
Occupational Therapist
1 50.00
Physician 0 .00
Physician Assistant 0 .00
Other 0 .00
Is the subject a medical or behavioral
health provider?
Yes 2 25.00
No 6 75.00
Is the subject a non-provider licensed
health care professional?
Yes 1 12.50
No 7 87.50
What type of licensed health care
professional is the subject?
Certified Registered
Nurse Anesthetist
0 .00
Nurse 1 100.00
Pharmacist 0 .00
Pharmacy Tech 0 .00
Physical or
Occupational Therapy
Tech
0 .00
Social Worker 0 .00
Other 0 .00
Is the subject a current or previous
Principal Investigator or Co-principal
Investigator?
Yes 3 60.00
No 2 40.00
Is the subject a current or previous
IACUC member?
Yes 1 20.00
No 4 80.00
Is the subject a current or previous IRB
member?
Yes 1 20.00
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 387
Table 52.
Stakeholder Perception of Essentiality Correlation for HHS OIG Fundamental Elements (n=76)
Variable Correlation H1 H2 H3 H4 H5 H6 H7
H1 Pearson
Correlation
1.00 .27
*
.27
*
.23
*
.41
**
.33
**
.37
**
Sig. (2-tailed)
--
.02 .02 .04 .00 .00 .00
Sum of Squares
and Cross-
products
12.11 6.89 4.47 3.84 8.37 8.32 5.84
Covariance .16 .09 .06 .05 .11 .11 .08
H2 Pearson
Correlation
.27
*
1.00 .39
**
.12 .35
**
.25
*
.19
Sig. (2-tailed) .02
--
.00 .30 .00 .03 .11
Sum of Squares
and Cross-
products
6.89 52.36 13.53 4.16 15.13 13.18 6.16
Covariance .09 .70 .18 .06 .20 .18 .08
H3 Pearson
Correlation
.27
*
.39
**
1.00 .48
**
.22 .30
**
.41
**
Sig. (2-tailed) .02 .00
--
.00 .06 .01 .00
Sum of Squares
and Cross-
products
4.47 13.53 22.63 10.79 6.16 10.42 8.79
Covariance .06 .18 .30 .14 .08 .14 .12
N 76.00 76.00 76.00 76.00 76.00 76.00 76.00
H4 Pearson
Correlation
.23
*
.12 .48
**
1.00 .46
**
.21 .36
**
Sig. (2-tailed) .04 .30 .00
--
.00 .06 .00
Sum of Squares
and Cross-
products
3.84 4.16 10.79 22.74 12.95 7.53 7.74
Covariance .05 .06 .14 .30 .17 .10 .10
H5 Pearson
Correlation
.41
**
.35
**
.22 .46
**
1.00 .28
*
.52
**
Sig. (2-tailed) .00 .00 .06 .00
--
.01 .00
Sum of Squares
and Cross-
products
8.37 15.13 6.16 12.95 34.79 12.11 13.95
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 388
Variable Correlation H1 H2 H3 H4 H5 H6 H7
Covariance .11 .20 .08 .17 .46 .16 .19
H6 Pearson
Correlation
.33
**
.25
*
.30
**
.21 .28
*
1.00 .34
**
Sig. (2-tailed) .00 .03 .01 .06 .01
--
.00
Sum of Squares
and Cross-
products
8.32 13.18 10.42 7.53 12.11 53.95 11.53
Covariance .11 .18 .14 .10 .16 .72 .15
H7 Pearson
Correlation
.37
**
.19 .41
**
.36
**
.52
**
.34
**
1.00
Sig. (2-tailed) .00 .11 .00 .00 .00 .00
--
Sum of Squares
and Cross-
products
5.84 6.16 8.79 7.74 13.95 11.53 20.74
Covariance .08 .08 .12 .10 .19 .15 .28
Note. *. Correlation is significant at the 0.05 level (2-tailed). **. Correlation is significant at the 0.01
level (2-tailed). Elements refer to the same numbers as those listed in Table 17.
Table 53.
Stakeholder Perception of Essentiality Correlation for Practice Elements (n=76)
Element
Correlation P1 P2 P3 P4 P5
P1 Pearson Correlation 1.00 .61
**
.56
**
.44
**
.61
**
Sig. (2-tailed)
--
.00 .00 .00 .00
Sum of Squares and Cross-products 36.16 21.32 19.79 14.03 19.61
Covariance .48 .28 .26 .19 .26
P2 Pearson Correlation .61
**
1.00 .60
**
.53
**
.60
**
Sig. (2-tailed) .00
--
.00 .00 .00
Sum of Squares and Cross-products 21.32 33.63 20.58 16.55 18.71
Covariance .28 .45 .27 .22 .25
P3 Pearson Correlation .56
**
.60
**
1.00 .43
**
.49
**
Sig. (2-tailed) .00 .00
--
.00 .00
Sum of Squares and Cross-products 19.79 20.58 34.95 13.63 15.53
Covariance .26 .27 .47 .18 .21
P4 Pearson Correlation .44
**
.53
**
.43
**
1.00 .38
**
Sig. (2-tailed) .00 .00 .00
--
.00
Sum of Squares and Cross-products 14.03 16.55 13.63 28.67 10.93
Covariance .19 .22 .18 .38 .15
P5 Pearson Correlation .61
**
.60
**
.49
**
.38
**
1.00
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 389
Element
Correlation P1 P2 P3 P4 P5
Sig. (2-tailed) .00 .00 .00 .00
--
Sum of Squares and Cross-products 19.61 18.71 15.53 10.93 28.99
Covariance .26 .25 .21 .15 .39
Note. Correlation is significant at the 0.01 level (2-tailed). Elements refer to the same numbers as those
listed in Table 18.
Table 54.
Stakeholder Perception of Essentiality Correlation for Improvement, Utilization Elements (n=70)
Ele. Corr.
I1 I2 I3 I4 I5 I6 I7 I8 I9
I1 Pearson
Correlation
1.00 .34
**
.35
**
.38
**
.38
**
.36
**
.54
**
.32
**
.25
*
Sig. (2-
tailed)
--
.00 .00 .00 .00 .00 .00 .01 .04
Sum of
Squares and
Cross-
products
23.49 8.14 8.09 9.60 8.97 7.97 12.86 10.11 8.86
Covariance .34 .12 .12 .14 .13 .12 .19 .15 .13
I2 Pearson
Correlation
.34
**
1.00 .24
*
.28
*
.45
**
.30
*
.20 .28
*
.15
Sig. (2-
tailed)
.00
--
.05 .02 .00 .01 .09 .02 .21
Sum of
Squares and
Cross-
products
8.14 24.07 5.64 7.00 10.79 6.79 4.93 8.86 5.43
Covariance .12 .35 .08 .10 .16 .10 .07 .13 .08
I3 Pearson
Correlation
.35
**
.24
*
1.00 .34
**
.16 .17 .27
*
.23 .34
**
Sig. (2-
tailed)
.00 .05
--
.00 .19 .17 .02 .05 .00
Sum of
Squares and
Cross-
products
8.09 5.64 22.99 8.40 3.67 3.67 6.36 7.31 11.86
Covariance .12 .08 .33 .12 .05 .05 .09 .11 .17
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 390
Ele. Corr.
I1 I2 I3 I4 I5 I6 I7 I8 I9
I4 Pearson
Correlation
.38
**
.28
*
.34
**
1.00 .17 .22 .35
**
.30
*
.40
**
Sig. (2-
tailed)
.00 .02 .00
--
.17 .07 .00 .01 .00
Sum of
Squares and
Cross-
products
9.60 7.00 8.40 26.80 4.20 5.20 9.00 10.20 15.00
Covariance .14 .10 .12 .39 .06 .08 .13 .15 .22
I5 Pearson
Correlation
.38
**
.45
**
.16 .17 1.00 .47
**
.60
**
.45
**
.11
Sig. (2-
tailed)
.00 .00 .19 .17
--
.00 .00 .00 .38
Sum of
Squares and
Cross-
products
8.97 10.79 3.67 4.20 23.44 10.44 14.21 14.23 3.71
Covariance .13 .16 .05 .06 .34 .15 .21 .21 .05
I6 Pearson
Correlation
.36
**
.30
*
.17 .22 .47
**
1.00 .58
**
.17 .23
Sig. (2-
tailed)
.00 .01 .17 .07 .00
--
.00 .15 .06
Sum of
Squares and
Cross-
products
7.97 6.79 3.67 5.20 10.44 21.44 13.21 5.23 7.71
Covariance .12 .10 .05 .08 .15 .31 .19 .08 .11
I7 Pearson
Correlation
.54
**
.20 .27
*
.35
**
.60
**
.58
**
1.00 .56
**
.33
**
Sig. (2-
tailed)
.00 .09 .02 .00 .00 .00
--
.00 .01
Sum of
Squares and
Cross-
products
12.86 4.93 6.36 9.00 14.21 13.21 24.07 18.14 11.57
Covariance .19 .07 .09 .13 .21 .19 .35 .26 .17
I8 Pearson
Correlation
.32
**
.28
*
.23 .30
*
.45
**
.17 .56
**
1.00 .42
**
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 391
Ele. Corr.
I1 I2 I3 I4 I5 I6 I7 I8 I9
Sig. (2-
tailed)
.01 .02 .05 .01 .00 .15 .00
--
.00
Sum of
Squares and
Cross-
products
10.11 8.86 7.31 10.20 14.23 5.23 18.14 43.09 20.14
Covariance .15 .13 .11 .15 .21 .08 .26 .62 .29
I9 Pearson
Correlation
.25
*
.15 .34
**
.40
**
.11 .23 .33
**
.42
**
1.00
Sig. (2-
tailed)
.04 .21 .00 .00 .38 .06 .01 .00
--
Sum of
Squares and
Cross-
products
8.86 5.43 11.86 15.00 3.71 7.71 11.57 20.14 52.57
Covariance .13 .08 .17 .22 .05 .11 .17 .29 .76
Note. **. Correlation is significant at the 0.01 level (2-tailed). *. Correlation is significant at the 0.05
level (2-tailed). Elements refer to the same numbers as those listed in Table 19.
Table 55.
Training Delivery Preference by Stakeholder Group
Method
Survey Respondents by Role Type
Clinical
respondents
Research
respondents
Health care
management
and
operations
respondents
Other
respondents
Respondents
with
compliance
and
regulatory
experience
On-boarding and
orientation
38.78 83.67 67.35 8.16 97.96
Annual in-person
refresher training
40.00 86.67 66.67 6.67 100.00
Annual on-line
computer-based
training
40.00 85.71 60.00 11.43 97.14
Team-based training
at staff meetings and
huddles
36.54 84.62 67.31 7.69 98.08
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 392
Method
Survey Respondents by Role Type
Clinical
respondents
Research
respondents
Health care
management
and
operations
respondents
Other
respondents
Respondents
with
compliance
and
regulatory
experience
Other 28.57 100.00 71.43 14.29 100.00
Table 56.
Estimated Distribution Parameters for P-Plots of Time and Effort Scale Variable
Normal
Distribution
How many compliance
audits or monitoring
sessions have occurred
in your department in
the last 12 months?
How many
compliance and
regulatory training
courses have you
completed in the last
12 months?
How many hours do
you spend each week
working on tasks that
have a regulatory or
compliance element to
them?
Location 26.33 5.28 23.63
Scale 41.98 8.33 15.60
Note. The cases are unweighted.
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 393
Figure 32. Normal P-P Plot of “How many compliance audits or monitoring sessions have occurred in
your department in the last 12 months?”
59
Figure 33. Detrended Normal P-P Plot of “How many compliance audits or monitoring sessions have
occurred in your department in the last 12 months?”
60
59
See Line 110 in the Data Dictionary Codebook (Appendix A).
60
See Line 110 in the Data Dictionary Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 394
Figure 34. Normal P-P Plot of “How many compliance and regulatory training courses have you
completed in the last 12 months?”
61
Figure 35. Detrended Normal P-P Plot of “How many compliance and regulatory training courses have
you completed in the last 12 months?”
62
61
See Line 111 in the Data Dictionary Codebook (Appendix A).
62
See Line 111 in the Data Dictionary Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 395
Figure 36. Normal P-P Plot of “How many hours do you spend each week working on tasks that have a
regulatory or compliance element to them?”
63
Figure 37. Detrended Normal P-P Plot of “How many hours do you spend each week working on tasks
that have a regulatory or compliance element to them?”
64
63
See Line 112 in the Data Dictionary Codebook (Appendix A).
64
See Line 112 in the Data Dictionary Codebook (Appendix A).
COMPLIANCE IN SPECIAL TY ACADEMIC MEDICINE 396
Table 57.
Stakeholder Perception of Existence of Policy and Procedures in Institutions by Role Type
Response
Survey Respondents by Role Types
Clinical
respondents
Research
respondents
Management
and operations
respondents
Other
respondents
Compliance
and
regulatory
respondents
N Percent N Percent N Percent N Percent N Percent
Mostly
existent
6 28.57 14 26.92 7 19.44 1 16.67 16 26.67
Firmly
existent
10 47.62 28 53.85 23 63.89 4 66.67 32 53.33
Somewhat
existent
4 19.05 8 15.38 5 13.89 1 16.67 10 16.67
Nonexistent 0 .00 0 .00 0 .00 0 .00 0 .00
Cannot
assess
1 4.76 2 3.85 1 2.78 0 .00 2 3.33
Note. Some respondents may have more than one associated domain. Respondents rated the following
item using a Likert scale: “Implementing written policies and procedures.”
Table 58.
Essentiality and Existence Bivariate Correlation Analysis of Program Element of Implementing
Written Policies and Procedures
Element Correlation H1 Existence H1 Essentiality
H1 Existence Pearson Correlation 1.00 .262*
Sig. (2-tailed) -- .044
Sum of Squares and Cross-products 12.105 5.400
Covariance .161 .092
N 76 60
H1 Essentiality Pearson Correlation .262* 1.00
Sig. (2-tailed) 0.44 --
Sum of Squares and Cross-products 5.400 55.733
Covariance .092 .945
N 60 60
Note. *. Correlation is significant at the 0.05 level (2-tailed).
Abstract (if available)
Abstract
The purpose of this study was to develop and test a Conceptual Framework for an evaluation model for compliance and regulatory programs in specialty academic medicine. The Framework was built on three research questions to determine the following items within a specialty academic medical institution: (i) the Program Elements for effective and sustainable compliance and regulatory programs, (ii) the required knowledge and skills for stakeholder groups, and (iii) the motivation and organizational influences which improve stakeholder efficacy and program sustainability. There was a total of 21 Program Elements derived from both professional and theoretical literature. Those elements were then matched against the gap analysis model for assessing organizational performance based on knowledge and skills, motivational, and organizational influences as developed by Clark and Estes (2008). Finally, 15 recommendations were developed, along with each of the required elements for evaluation and implementation using the New World Model developed by James D. Kirkpatrick and Wendy Kayser Kirkpatrick (2016). Items such as leading indicators, critical behaviors, required drivers, and several other components provide content and context for immediate and long-term summative assessment, to address the program sustainability, aim of the study.
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Asset Metadata
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McLemore, Dustin Dru
(author)
Core Title
Compliance and regulatory efficacy and sustainability in specialty academic medicine: a longitudinal evaluation study
School
Rossier School of Education
Degree
Doctor of Education
Degree Program
Organizational Change and Leadership (On Line)
Publication Date
02/13/2018
Defense Date
01/29/2018
Publisher
University of Southern California
(original),
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(digital)
Tag
Academic Medicine,assessment,clinic,Compliance,compliance programs,continuous improvement,education,ethics,evaluation,formative assessment,gap analysis,good clinical practice,health sciences,health sciences education,HIPAA,Hospital,ideal model,improvement,Institutional Animal Care and Use Committee (IACUC),Institutional Review Board (IRB),leadership,Medical education,medical errors,Medicine,OAI-PMH Harvest,OIG,organizational change,organizational influences,program evaluation,quality improvement,regulatory,Research,speciality medicine,stakeholder efficacy,stakeholder knowledge and skills,stakeholder motivation,summative assessment,sustainability
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Tags
compliance programs
continuous improvement
education
evaluation
formative assessment
gap analysis
good clinical practice
health sciences
health sciences education
HIPAA
ideal model
improvement
Institutional Animal Care and Use Committee (IACUC)
Institutional Review Board (IRB)
medical errors
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organizational change
organizational influences
program evaluation
quality improvement
regulatory
speciality medicine
stakeholder efficacy
stakeholder knowledge and skills
stakeholder motivation
summative assessment
sustainability