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W12328
PATIENT SAFETY AT GRAND RIVER HOSPITAL & ST.
MARY’S
GENERAL HOSPITAL
Alex Cestnik and Ashok Sharma wrote this case under the
supervision of Professor Murray Bryant solely to provide
material for
class discussion. The authors do not intend to illustrate either
effective or ineffective handling of a managerial situation. The
authors
may have disguised certain names and other identifying
information to protect confidentiality.
Richard Ivey School of Business Foundation prohibits any form
of reproduction, storage or transmittal without its written
permission.
Reproduction of this material is not covered under authorization
by any reproduction rights organization. To order copies or
request
permission to reproduce materials, contact Ivey Publishing,
Richard Ivey School of Business Foundation, c/o Richard Ivey
School of
Business, The University of Western Ontario, London, Ontario,
Canada, N6A 3K7; phone (519) 661-3208; fax (519) 661-3882;
e-
mail [email protected]
Copyright © 2012, Richard Ivey School of Business Foundation
Version: 2012-11-21
After completing a comprehensive patient safety leadership
fellowship in 2011, Dr. Ashok Sharma reflects
on how he could most positively impact his local medical
community to develop a safety culture and
minimize medical errors. As the chief of staff at both Grand
River Hospital and St. Mary’s General
Hospital in Kitchener-Waterloo, Ontario, Dr. Sharma would like
to influence his practicing physicians
without threatening their professional autonomy or being
perceived as paternalistic.
Despite being recognized as an area for improvement as early as
the 1990s, the patient safety movement is
still in its infancy. Medical error remains a sensitive topic for
patients, physicians, hospital administration
and virtually all who rely on health care, making the issue
increasingly difficult to resolve. Only recently
has the topic been openly addressed, and there remains a
significant gap between the care that is delivered
and that should be delivered.
PATIENT SAFETY
A medical error is considered “the failure of a planned action to
be completed as intended or the use of a
wrong plan to achieve an aim.”1 An adverse event refers to the
additional harm that results from medical
mismanagement rather than the underlying disease. When an
error results in an adverse event, it is
considered a preventable adverse event (see Exhibit 1).
Research has suggested that approximately 10 per
cent of primary care medical errors result in patient harm.2 In
1997, large studies were completed in the
United States suggesting that as many as 98,000 Americans die
each year due to medical error.3 This figure
positions medical error as the eighth leading cause of death,
exceeding the number of deaths from motor
vehicle accidents and breast cancer combined. Such a mortality
rate equates to one jumbo jet crashing each
1 Institute of Medicine (U.S.), To Err is Human: Building a
Safer Health System, National Academy Press, Washington, DC,
2000.
2 Ibid.
3 Ibid.
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Page 2 9B12M080
day. In response to the evident problem of inadequate patient
safety, the National Patient Safety
Foundation (NPSF) was established in 1997. NPSF defines
patient safety as “the avoidance, prevention
and amelioration of adverse outcomes or injuries stemming from
the process of healthcare.”4 In 1999, the
Institute of Medicine (IOM) identified patient safety as an
explicit concern when it proposed the six aims
of high-quality health care: safety, effectiveness, patient-
centeredness, timeliness, efficiency and equity. In
order to improve safety, research has been conducted5 to better
understand the underlying causes of
preventable adverse events. In general, two factors contribute to
the likelihood of errors in any industry:
complexity and coupling. Complexity refers to the
unpredictability of events, and coupling measures the
interdependence of tasks.6 Given that health care is both
complex and tightly coupled, concerted efforts
must be made to prevent adverse events from occurring. There
are a multitude of actions that can reduce
medical errors and improve patient safety, and they begin at an
organizational rather than an individual
level. The IOM emphasizes that safety is a systemic property
rather than an individual physician’s
responsibility:
“Unsafe acts are like mosquitoes: you can try to swat them one
at a time, but there will always be others to
take their place. The only effective remedy is to drain the
swamps in which they breed. In the case of errors
and violations, the “swamps” are equipment designs that
promote operator error, bad communications,
high workloads, budgetary and commercial pressures,
procedures that necessitate violations in order to get
the job done, inadequate organization and missing barriers and
safeguards — the list is potentially long,
but all of these latent factors are, in theory, detectable and
correctable before a mishap occurs.”7
Thus, patient safety is a systemic and cultural problem within
the health care industry and cannot be
addressed by simply correcting or reprimanding the individual
who errs. The solution requires analysis of
systemic failures related to factors such as equipment design
and staff workload (see Exhibit 2). All
clinicians must be transparent about their errors and near misses
in order to resolve underlying systemic
causes. Likewise, hospital administration must foster a safety
culture in which physicians and other
clinicians can feel comfortable discussing errors and proactively
seeking solutions.
Too frequently, physicians consider that patient safety is a
product of a good clinical practice and not as
impacted by the broader system of patient care. A number of
variables beyond an individual’s clinical
practice do play a role in patient safety including: technology,
interdisciplinary care, physician trade-offs,
nursing staff, allied health professionals, medical device and
product design, etc. Furthermore, the
organizational structure of hospitals suggests that
responsibilities are diffused across many individuals. The
additional complexity resulting from the interaction of people
and processes lead to a greater potential for
error.
CANADIAN PATIENT SAFETY INSTITUTE
Following the movement towards improving patient safety,
Health Canada established the Canadian
Patient Safety Institute (CPSI) in 2003 with an aim to “inspire
extraordinary improvement in patient safety
and quality.”8 The institute develops evidence-based best
practices, supports research, measures results,
4 Institute of Medicine (U.S.), To Err is Human: Building a
Safer Health System, National Academy Press, Washington, DC,
2000.
5 Ibid
6 James Reason and Alan Hobbs, Managing Maintenance Error:
A Practical Guide, Ashgate Publishing Company,
Burlington, VT, 2003.
7 Institute of Medicine (U.S.), To Err is Human: Building a
Safer Health System, National Academy Press, Washington, DC,
2000.
8 Canadian Patient Safety Institute, “About CPSI,”.
http://www.patientsafetyinstitute.ca/English/About/Pages/defaul
t.aspx,
accessed April 6, 2012.
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Page 3 9B12M080
promotes communication, nurtures partnerships and celebrates
successes. CPSI has implemented projects
and programs to work with all levels of the health care system,
including frontline health care providers,
governments and educators. “Safer Healthcare Now!,” CPSI’s
flagship program, provides clinicians with
the necessary tools and resources to improve health care quality
through safety. CPSI relies on
collaborative efforts with governments, health care
organizations and clinicians to accomplish the goal of
safer health care for all Canadians.
REGULATORY ENVIRONMENT
As awareness of inadequate patient safety increased, Canadian
legislation began to change in order to
promote improvements in health care quality. On June 3, 2010,
the government of Ontario passed Bill 46,
the Excellent Care for All Act, to “make health care providers
and executives accountable for improving
patient care and enhance the patient experience.” In accordance
with Bill 46, hospitals are required to
establish a quality committee to report directly to the board of
directors. Hospitals must also develop and
publicize annual quality improvement plans (QIP). Additionally,
hospitals are mandated to survey patients
yearly and employees every second year to collect their “views
on the quality of care.” Lastly and
importantly, boards of directors are required to ensure that
hospital executives are compensated according
to whether or not QIPs are met.9
In addition to Bill 46, on July 1, 2010, Regulation 156 of the
Ontario Public Hospitals Act came into
effect; it requires that critical incidents be reported to the
medical advisory committee (MAC) and hospital
administrators. A critical incident is “any unintended event that
occurs when patients receive treatment in
hospitals that results in death, serious disability, injury, or
harm, and does not result primarily from the
patient’s underlying condition or a known risk in providing
treatment” (see Exhibits 3 and 4). Hospital
boards and administrators are legally required to ensure
disclosure of critical incidents and establish
systems to analyze the reported incidents for root causes.10
In March 2012, the Ontario Ministry of Health and Long-Term
Care announced that a patient-centred
funding model would be phased in over three years (see Exhibit
5). The intended benefits include a focus
on quality and evidence-based care, improved access and wait
times, and an emphasis on cost containment.
The resulting funding composition for hospitals, community
care access centres and long-term care homes
will ultimately be 70 per cent quality-based. The quality-based
funding will be further divided to include a
40 per cent health-based allocation model (HBAM) and 30 per
cent clinical quality groupings (see Exhibit
6). HBAM allocates a proportion of health care costs to each
Ontario resident based on factors such as age,
sex, socioeconomic status, geography and clinical group. Each
resident’s allocated cost is associated with
the organization that provides their care, and these health care
providers are given funding based on this
predicted cost. Clinical quality grouping funding is calculated
by multiplying the determined price to
provide quality treatment for a particular condition (such as
chronic kidney disease, cataract surgery, hip
replacement, etc.) by the expected volume for the health care
organization. The remaining 30 per cent will
be global funding, reduced from 54 per cent in April 2012.
Overall, the government of Ontario’s funding
reform is intended to increase quality, appropriateness and
sustainability of care for patients and the overall
health care system. 11
9 Ashok Sharma, et al., Physician Matters [Kitchener-
Waterloo], 2010, Web. January 18, 2012.
10 Ibid.
11 “How Does HBAM work?: Step-By-Step Demonstration,”
2012, pages 3-6. Web. April 12, 2012.
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CRITICAL INCIDENT REPORTING AND ANALYSIS
Even prior to Bill 46, disclosure of critical incidents to patients
was mandated by law, and most hospitals
had systems to collect reports on such events. Yet, there remain
several problems with critical incident
reporting in health care organizations. First, underreporting is a
challenge because physicians often fear
professional criticism or legal repercussions. The Quality of
Care Information Protection Act (QCIPA) of
2004 provides statutory protection of information collected for
the purposes of quality assessment and
improvement. Thus, under QCIPA, clinicians are protected from
legal action resulting from information
disclosed to improve quality. Following each critical incident
report, QCIPA reviews are held by hospital
administration with all individuals involved in the critical
incident. The result of QCIPA reviews are
summaries of improvements to be made. However, in addition
to underreporting, clinicians often do not
attend the QCIPA reviews, even if attendance is mandatory,
because they fear legal consequences and
recognize that attendance is not enforceable. Thus, although a
healthcare organization’s chief of staff may
have authoritative power, individual physicians are largely
independent entrepreneurs.
A second challenge with critical incident reporting is that the
information collected from reports is often
inadequate and variable. Reporters tend to cite individual rather
than systemic factors as the root cause of
adverse events. Given that reporters were most often physicians
or clinicians, they are close to the error at
the “proximal side” or “sharp end” of the problem. As a result,
they do not consider latent errors that
occurred in the overall system at the “distal end” of the
problem. Attempts were made to improve this
through educating medical students and practicing clinicians to
develop a “systems” view of medical
operations.
In addition to education, effective reporting requires a non-
punitive environment so that clinicians are
comfortable reporting incidents, including detailed accounts and
sharing near misses. Reporting
questionnaires are most effective when they are open-ended,
allowing the reporter to develop a story of the
event. This format results in reports that provide a broader
systemic picture and often include more detail
than if the survey were more specific. Overall, reporting can be
a useful tool to improve patient safety and
prevent recurrences of critical incidents, yet it remains a
reactive strategy. Greater efforts and initiatives by
all individuals are required to foster a safety culture that
promotes proactive problem-solving.
SAFETY CULTURE
In order for the benefits of CPSI, regulatory advances and
incident reporting to be realized, health care
organizations must develop a safety culture. A safety culture
refers to an environment in which the desire
to achieve greater safety is apparent in intangible beliefs,
attitudes and values in addition to concrete
structures, practices and policies. In a safety culture, clinicians
and administrators do not expect that each
individual will be flawless; rather, they understand that people
are imperfect and that failures are
inevitable. As a result, there is a heightened diligence to detect
errors and to implement defences that will
prevent adverse outcomes. These attitudes and behaviours exist
throughout the organization from the
administration to the frontline clinicians and will persist
through changes ton senior management. Once a
safety culture is achieved, reporting becomes more frequent and
complete, and near misses are willingly
shared for greater quality improvement. In order to achieve such
a result, a significant amount of trust must
exist among care providers so that adverse events may be
openly discussed and solutions developed
through collaboration. A safety culture is not a static state but a
dynamic system that is constantly changing
as opportunities arise.
This document is authorized for use only in Laureate Education,
Inc. 's WAL MMHA 6900 - Healthcare Quality Management at
Laureate Education - Baltimore from Oct 2017 to Nov 2018.
Page 5 9B12M080
GRAND RIVER HOSPITAL & ST. MARY’S GENERAL
HOSPITAL
Grand River Hospital (GRH) is one of Ontario’s largest
community hospitals with over 3,500 staff
members working towards their stated vision of being a “leader
in providing 24/7 patient care programs
through innovation and collaboration, within available
resources.” In 2010/11, 23,391 patients were
admitted with 12,671 day surgery visits, 58,596 emergency
visits and 210,557 ambulatory care visits. GRH
developed a quality framework, which includes a quality and
patient safety committee, a senior quality
team and clinical programs and services quality councils to hold
the hospital accountable for quality and
safety (see Exhibit 7). The hospital continually evaluates itself
on four dimensions: access to care,
appropriateness of care, safety of care and patient experience
with care. GRH uses benchmark indicators to
assess its performance and track its progress. This analysis is
made available to the public to demonstrate
transparency and openness.
St. Mary’s General Hospital (SMGH) has been providing health
care in the Kitchener community since
1924. The hospital has nearly 2,000 staff and volunteers that
annually support more than 7,000 admissions,
100,000 outpatient visits, 47,000 emergency visits and 20,000
surgical procedures. SMGH instituted their
new vision in 2011/12 of becoming the “safest and most
effective hospital in Canada characterized by
innovation, compassion and respect.” University of Waterloo
management science researchers have
partnered with SMGH to conduct deep analyses of actions and
outcomes within the hospital. SMGH
frequently employes “lean” management techniques to achieve
continuous improvement on the frontlines
of health care delivery. To encourage bedside initiatives, SMGH
announced a goal to implement 1,000
measurable improvements in one year and reported on multiple
successes to recognize and celebrate
employees’ efforts. SMGH also has a guiding quality committee
framework and an algorithm of actions
following critical incidents (see Exhibits 8 and 9).
Given their proximity to one another, GRH and SMGH partner
to specialize in certain procedures. They
are both committed to being leaders in patient safety and quality
of care, and as such, have begun various
efforts to accomplish their visions. Nonetheless, Dr. Sharma
believes that significant improvements can
still be made to patient safety in both hospitals. The hospitals
had yet to adopt a true safety culture from
administrative to frontline levels, and this is hindering
improvement to quality of care. As evidenced by
underreporting and poor attendance at QCIPA reviews, there is
a lack of physician buy-in to many quality
improvement efforts. Dr. Sharma’s greatest challenge is
influencing the intangible aspects that define a
safety culture – the attitudes, beliefs and values of clinicians.
Over a decade of pressure from the IOM,
increased legislative requirements, QCIPA legal protection,
administrative encouragement and
demonstrated positive outcomes have all been insufficient to
truly change physicians’ attitudes and
behaviour.
Dr. Sharma has considered making adjustments to the hospitals’
organizational structures to formalize
leadership positions and increase accountability on quality
metrics. He looked to the example of
Mississauga’s Trillium Health Centre, which included patient
safety accountability in the job descriptions
of department chiefs to assign responsibility for quality of care.
They also developed quality competitions
to recognize staff contributions to patient safety improvements.
These initiatives were launched following
a decade’s worth of monthly workshops to collaborate and train
staff. The successes resulting from
Trillium’s efforts are not guaranteed to be replicated in other
health care organizations, but they are
certainly attributable to physician leadership and grassroots
participation.12
Dr. Sharma is also aware of the importance of teamwork and
communication (T&C) skills to provide the
highest levels of patient satisfaction. The IOM recognized the
lack of training in T&C and called for
12 Ashok Sharma, et al., Physician Matters [Kitchener-
Waterloo], 2012, Web. March, 2 2012.
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Page 6 9B12M080
medical education providers to incorporate patient safety into
their curriculums. The Johns Hopkins School
of Medicine developed a model demonstrating that failures of
T&C contribute to the majority of adverse
events. This model was used during a three-day intersession on
patient safety aimed at developing medical
students’ skills in T&C and systems thinking.13 Perhaps Dr.
Sharma could host a similar workshop to
develop the practicing clinicians’ skills, given that team
dynamics had been shown to be directly correlated
to patient satisfaction. He wonders how this could be
implemented and whether it would have a direct
enough impact on the hospitals’ cultures.
A third approach that Dr. Sharma has considered is to conduct
an extensive analysis and process redesign.
Intermountain Healthcare, a much admired health care delivery
system, adopted this approach, measured
variation in care for particular services and analyzed the
quality, efficiency and financial outcomes to
determine best practices. An administrative structure was
created to implement guidelines based on such
standards.14 Although quite successful for Intermountain, Dr.
Sharma is concerned that this approach might
cause physicians to feel their professional autonomy is not
respected.
Evidently, there are advantages and disadvantages with each
approach, but the chief of staff must make a
decision and implement a plan of action to mitigate any
drawbacks. How could Dr. Sharma best influence
the medical community, beginning with the two hospitals for
which he is responsible, to foster a safety
culture and most greatly improve patient safety?
13 Rebecca Lawton, et al., “Development of an Evidence-based
Framework of Factors Contributing to Patient Safety
Incidents in Hospital Settings: A Systematic Review,” BMJ
Quality Safety 10.1136, 2012, pages 1-10. Web. March 16,
2012.
14 Brent C. James and Lucy A. Savitz, “How Intermountain
Trimmed Health Care Costs Through Robust Quality
Improvement Efforts,” Health Affairs 30.6, 2011, pages 1-6.
Web. January 18, 2012.
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Exhibit 1
CONCEPTUAL MODEL OF ADVERSE EVENTS AND
ERRORS
Researchers have begun to question the existence of non-
preventable adverse events. Previously,
examples of non-preventable adverse events included incidents
such as infections at the catheter site.
However, with improved hand washing and sanitation
procedures, such adverse events can be prevented.
As such, a new model is proposed in which errors result in
either a near miss or an adverse event and all
adverse events are considered preventable.
Adverse Events Errors
Near-Misses
Non-Preventable
Adverse
Events
Preventable
Adverse
Events
Adverse
Events
Near-Misses
Errors
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Exhibit 2
FACTORS CONTRIBUTING TO PATIENT SAFETY
INCIDENTS1
1 Rebecca Lawton, et al., “Development of an Evidence-based
Framework of Factors Contributing to Patient Safety
Incidents in Hospital Settings: A Systematic Review,” BMJ
Quality Safety 10.1136, 2012, pages 1-10. Web. March 16,
2012.
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Exhibit 3
CRITICAL INCIDENT LEVELS OF HARM1
Level 0 – Near Miss or Potential Harm/Damage
Circumstances had potential to cause harm/damage. Follow-up
may be required. Disclosure not required.
Level 1 – No Harm/Damage
Event results in no harm/damage. Follow-up may be required.
Disclosure not required.
Level 2 – Temporary or Minor Harm/Damage
Event results in temporary minor harm/damage. Additional
monitoring or follow-up required. Disclosure to the
patient is not required by legislation but is strongly encouraged.
Level 3 – Permanent Harm/Damage
Event results in permanent harm/damage. Additional
monitoring, prolonged stay and extensive follow-up
required (management of critical incidents policy may be
initiated). Disclosure to patient, hospital
administrator and medical advisory committee is required.
Level 4 – Death
Event results in death. Extensive follow-up and investigation
required (management of critical incidents policy
must be initiated). Disclosure to patient, hospital administrator
and medical advisory committee is required.
Exhibit 4
EXAMPLES OF CRITICAL INCIDENTS2
1 St. Mary’s General Hospital, “Policy & Procedure, Subject:
Management of Critical Events/Incidents,” April 12, 2012.
2 Ibid
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Exhibit 5
3-YEAR FUNDING REFORM IMPLEMENTATION1
54%
45%
30%
40%
40%
40%
6%
15%
30%
Year 1 (April 2012) Year 2 (April 2013) Year 3 (April 2014)
Quality Groupings
HBAM
Global
Exhibit 6
ONTARIO MINISTRY OF HEALTH FUNDING REFORM2
1 Ministry of Health and Long-Term Care, “Health System
Funding Reform,” 2012, pages 3-7. Web. April 12, 2012.
2 Ibid.
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Quality
Plan, Goals
& Targets
Reports &
Scorecard
Program
Quality
Reporting Indicators
Senior Quality Team Senior Quality Team
Quality and Patient Safety Committee
Clinical Programs and Services Quality Management
Medical Advisory
Committee
Board
GRH Strategic Plan & Goals
Mission,
Vision,
Values
Lines of
Communication
Lines of
Communication
Quality Framework
Exhibit 7
GRAND RIVER HOSPITAL QUALITY FRAMEWORK1
1 St. Mary’s General Hospital, “Policy & Procedure, Subject:
Management of Critical Events/Incidents,” April 12, 2012.
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Exhibit 8
ST. MARY’S GENERAL HOSPITAL QUALITY
FRAMEWORK1
1 St. Mary’s General Hospital, “Policy & Procedure, Subject:
Management of Critical Events/Incidents,” April 12, 2012.
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Exhibit 9
ST. MARY’S GENERAL HOSPITAL CRITICAL INCIDENT
ALGORITHM FOR ACTION1
1 St. Mary’s General Hospital, “Policy & Procedure, Subject:
Management of Critical Events/Incidents,” April 12, 2012.
The most immediate actions are to ensure the safety and well-
being of the patient. Then, as soon as it is
reasonably appropriate, complete the following five items:
PATIENT/FAMILY NOTIFICATION DOCUMENTATION
STAFF SUPPORT OTHER ACTIONS
Manager /delegate
address immediate
needs of
patient/family
Most responsible
professional(s)
disclose
circumstances of
event
Provide manager’s
name as contact
person to family
Manager/delegate
provides ongoing
updates to family
Involved staff notify
most responsible
physician and
manager/ supervisor
(Clinical On Call)
Manager/supervisor
notifies Program
Director, Clinical-on-
call, Admin.-on-call (if
applicable)
Staff document (factual,
concise, objective,
accurate, timely) specific
facts of events and
immediate follow-up
actions in health record
— avoid personal notes
or subjective
Late chart entries
only as appropriate
with
manager/director
Complete critical
incident report
Manager/delegate
address immediate
needs of staff:
Manager/delegate
provide ongoing
updates to staff as
permitted under
QCIPA
Manager/delegate
secure and label
equipment, supplies,
medication involved
in the event – send to
the Director of Risk
Management for
safekeeping
If Coroner involved:
directed by Coroner
If biomedical
equipment involved,
contact Biomedical
Engineering
Manager to begin
investigation
Manager/delegate
notifies:
patient services
Executive
Management
(e.g., Medical
Director, Chief of
Staff)
Risk Management
to secure chart with
Health Records
Adapted from St. Joseph’s Healthcare,
Complete
Disclosure
Templates
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Exhibit 10
MISCOMMUNICATION AND REDUCED TEAMWORK
CONTRIBUTING TO ADVERSE EVENTS1
1 Rebecca Lawton, et al., “Development of an Evidence-based
Framework of Factors Contributing to Patient Safety
Incidents in Hospital Settings: A Systematic Review,” BMJ
Quality Safety 10.1136, 2012, pages 1-10. Web. March 16,
2012.
This document is authorized for use only in Laureate Education,
Inc. 's WAL MMHA 6900 - Healthcare Quality Management at
Laureate Education - Baltimore from Oct 2017 to Nov 2018.
S w  W12328    PATIENT SAFETY AT GRAND RIVER HOSPI.docx

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S w W12328 PATIENT SAFETY AT GRAND RIVER HOSPI.docx

  • 1. S w W12328 PATIENT SAFETY AT GRAND RIVER HOSPITAL & ST. MARY’S GENERAL HOSPITAL Alex Cestnik and Ashok Sharma wrote this case under the supervision of Professor Murray Bryant solely to provide material for class discussion. The authors do not intend to illustrate either effective or ineffective handling of a managerial situation. The authors may have disguised certain names and other identifying information to protect confidentiality. Richard Ivey School of Business Foundation prohibits any form of reproduction, storage or transmittal without its written permission. Reproduction of this material is not covered under authorization by any reproduction rights organization. To order copies or request permission to reproduce materials, contact Ivey Publishing, Richard Ivey School of Business Foundation, c/o Richard Ivey School of Business, The University of Western Ontario, London, Ontario,
  • 2. Canada, N6A 3K7; phone (519) 661-3208; fax (519) 661-3882; e- mail [email protected] Copyright © 2012, Richard Ivey School of Business Foundation Version: 2012-11-21 After completing a comprehensive patient safety leadership fellowship in 2011, Dr. Ashok Sharma reflects on how he could most positively impact his local medical community to develop a safety culture and minimize medical errors. As the chief of staff at both Grand River Hospital and St. Mary’s General Hospital in Kitchener-Waterloo, Ontario, Dr. Sharma would like to influence his practicing physicians without threatening their professional autonomy or being perceived as paternalistic. Despite being recognized as an area for improvement as early as the 1990s, the patient safety movement is still in its infancy. Medical error remains a sensitive topic for patients, physicians, hospital administration and virtually all who rely on health care, making the issue increasingly difficult to resolve. Only recently has the topic been openly addressed, and there remains a significant gap between the care that is delivered and that should be delivered. PATIENT SAFETY A medical error is considered “the failure of a planned action to be completed as intended or the use of a
  • 3. wrong plan to achieve an aim.”1 An adverse event refers to the additional harm that results from medical mismanagement rather than the underlying disease. When an error results in an adverse event, it is considered a preventable adverse event (see Exhibit 1). Research has suggested that approximately 10 per cent of primary care medical errors result in patient harm.2 In 1997, large studies were completed in the United States suggesting that as many as 98,000 Americans die each year due to medical error.3 This figure positions medical error as the eighth leading cause of death, exceeding the number of deaths from motor vehicle accidents and breast cancer combined. Such a mortality rate equates to one jumbo jet crashing each 1 Institute of Medicine (U.S.), To Err is Human: Building a Safer Health System, National Academy Press, Washington, DC, 2000. 2 Ibid. 3 Ibid. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 2 9B12M080 day. In response to the evident problem of inadequate patient safety, the National Patient Safety Foundation (NPSF) was established in 1997. NPSF defines patient safety as “the avoidance, prevention
  • 4. and amelioration of adverse outcomes or injuries stemming from the process of healthcare.”4 In 1999, the Institute of Medicine (IOM) identified patient safety as an explicit concern when it proposed the six aims of high-quality health care: safety, effectiveness, patient- centeredness, timeliness, efficiency and equity. In order to improve safety, research has been conducted5 to better understand the underlying causes of preventable adverse events. In general, two factors contribute to the likelihood of errors in any industry: complexity and coupling. Complexity refers to the unpredictability of events, and coupling measures the interdependence of tasks.6 Given that health care is both complex and tightly coupled, concerted efforts must be made to prevent adverse events from occurring. There are a multitude of actions that can reduce medical errors and improve patient safety, and they begin at an organizational rather than an individual level. The IOM emphasizes that safety is a systemic property rather than an individual physician’s responsibility: “Unsafe acts are like mosquitoes: you can try to swat them one at a time, but there will always be others to take their place. The only effective remedy is to drain the swamps in which they breed. In the case of errors and violations, the “swamps” are equipment designs that promote operator error, bad communications, high workloads, budgetary and commercial pressures, procedures that necessitate violations in order to get the job done, inadequate organization and missing barriers and safeguards — the list is potentially long, but all of these latent factors are, in theory, detectable and correctable before a mishap occurs.”7 Thus, patient safety is a systemic and cultural problem within
  • 5. the health care industry and cannot be addressed by simply correcting or reprimanding the individual who errs. The solution requires analysis of systemic failures related to factors such as equipment design and staff workload (see Exhibit 2). All clinicians must be transparent about their errors and near misses in order to resolve underlying systemic causes. Likewise, hospital administration must foster a safety culture in which physicians and other clinicians can feel comfortable discussing errors and proactively seeking solutions. Too frequently, physicians consider that patient safety is a product of a good clinical practice and not as impacted by the broader system of patient care. A number of variables beyond an individual’s clinical practice do play a role in patient safety including: technology, interdisciplinary care, physician trade-offs, nursing staff, allied health professionals, medical device and product design, etc. Furthermore, the organizational structure of hospitals suggests that responsibilities are diffused across many individuals. The additional complexity resulting from the interaction of people and processes lead to a greater potential for error. CANADIAN PATIENT SAFETY INSTITUTE Following the movement towards improving patient safety, Health Canada established the Canadian Patient Safety Institute (CPSI) in 2003 with an aim to “inspire extraordinary improvement in patient safety and quality.”8 The institute develops evidence-based best practices, supports research, measures results,
  • 6. 4 Institute of Medicine (U.S.), To Err is Human: Building a Safer Health System, National Academy Press, Washington, DC, 2000. 5 Ibid 6 James Reason and Alan Hobbs, Managing Maintenance Error: A Practical Guide, Ashgate Publishing Company, Burlington, VT, 2003. 7 Institute of Medicine (U.S.), To Err is Human: Building a Safer Health System, National Academy Press, Washington, DC, 2000. 8 Canadian Patient Safety Institute, “About CPSI,”. http://www.patientsafetyinstitute.ca/English/About/Pages/defaul t.aspx, accessed April 6, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 3 9B12M080 promotes communication, nurtures partnerships and celebrates successes. CPSI has implemented projects and programs to work with all levels of the health care system, including frontline health care providers, governments and educators. “Safer Healthcare Now!,” CPSI’s flagship program, provides clinicians with the necessary tools and resources to improve health care quality through safety. CPSI relies on collaborative efforts with governments, health care organizations and clinicians to accomplish the goal of safer health care for all Canadians.
  • 7. REGULATORY ENVIRONMENT As awareness of inadequate patient safety increased, Canadian legislation began to change in order to promote improvements in health care quality. On June 3, 2010, the government of Ontario passed Bill 46, the Excellent Care for All Act, to “make health care providers and executives accountable for improving patient care and enhance the patient experience.” In accordance with Bill 46, hospitals are required to establish a quality committee to report directly to the board of directors. Hospitals must also develop and publicize annual quality improvement plans (QIP). Additionally, hospitals are mandated to survey patients yearly and employees every second year to collect their “views on the quality of care.” Lastly and importantly, boards of directors are required to ensure that hospital executives are compensated according to whether or not QIPs are met.9 In addition to Bill 46, on July 1, 2010, Regulation 156 of the Ontario Public Hospitals Act came into effect; it requires that critical incidents be reported to the medical advisory committee (MAC) and hospital administrators. A critical incident is “any unintended event that occurs when patients receive treatment in hospitals that results in death, serious disability, injury, or harm, and does not result primarily from the patient’s underlying condition or a known risk in providing treatment” (see Exhibits 3 and 4). Hospital boards and administrators are legally required to ensure disclosure of critical incidents and establish systems to analyze the reported incidents for root causes.10
  • 8. In March 2012, the Ontario Ministry of Health and Long-Term Care announced that a patient-centred funding model would be phased in over three years (see Exhibit 5). The intended benefits include a focus on quality and evidence-based care, improved access and wait times, and an emphasis on cost containment. The resulting funding composition for hospitals, community care access centres and long-term care homes will ultimately be 70 per cent quality-based. The quality-based funding will be further divided to include a 40 per cent health-based allocation model (HBAM) and 30 per cent clinical quality groupings (see Exhibit 6). HBAM allocates a proportion of health care costs to each Ontario resident based on factors such as age, sex, socioeconomic status, geography and clinical group. Each resident’s allocated cost is associated with the organization that provides their care, and these health care providers are given funding based on this predicted cost. Clinical quality grouping funding is calculated by multiplying the determined price to provide quality treatment for a particular condition (such as chronic kidney disease, cataract surgery, hip replacement, etc.) by the expected volume for the health care organization. The remaining 30 per cent will be global funding, reduced from 54 per cent in April 2012. Overall, the government of Ontario’s funding reform is intended to increase quality, appropriateness and sustainability of care for patients and the overall health care system. 11 9 Ashok Sharma, et al., Physician Matters [Kitchener- Waterloo], 2010, Web. January 18, 2012.
  • 9. 10 Ibid. 11 “How Does HBAM work?: Step-By-Step Demonstration,” 2012, pages 3-6. Web. April 12, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 4 9B12M080 CRITICAL INCIDENT REPORTING AND ANALYSIS Even prior to Bill 46, disclosure of critical incidents to patients was mandated by law, and most hospitals had systems to collect reports on such events. Yet, there remain several problems with critical incident reporting in health care organizations. First, underreporting is a challenge because physicians often fear professional criticism or legal repercussions. The Quality of Care Information Protection Act (QCIPA) of 2004 provides statutory protection of information collected for the purposes of quality assessment and improvement. Thus, under QCIPA, clinicians are protected from legal action resulting from information disclosed to improve quality. Following each critical incident report, QCIPA reviews are held by hospital administration with all individuals involved in the critical incident. The result of QCIPA reviews are summaries of improvements to be made. However, in addition to underreporting, clinicians often do not attend the QCIPA reviews, even if attendance is mandatory, because they fear legal consequences and
  • 10. recognize that attendance is not enforceable. Thus, although a healthcare organization’s chief of staff may have authoritative power, individual physicians are largely independent entrepreneurs. A second challenge with critical incident reporting is that the information collected from reports is often inadequate and variable. Reporters tend to cite individual rather than systemic factors as the root cause of adverse events. Given that reporters were most often physicians or clinicians, they are close to the error at the “proximal side” or “sharp end” of the problem. As a result, they do not consider latent errors that occurred in the overall system at the “distal end” of the problem. Attempts were made to improve this through educating medical students and practicing clinicians to develop a “systems” view of medical operations. In addition to education, effective reporting requires a non- punitive environment so that clinicians are comfortable reporting incidents, including detailed accounts and sharing near misses. Reporting questionnaires are most effective when they are open-ended, allowing the reporter to develop a story of the event. This format results in reports that provide a broader systemic picture and often include more detail than if the survey were more specific. Overall, reporting can be a useful tool to improve patient safety and prevent recurrences of critical incidents, yet it remains a reactive strategy. Greater efforts and initiatives by all individuals are required to foster a safety culture that promotes proactive problem-solving. SAFETY CULTURE
  • 11. In order for the benefits of CPSI, regulatory advances and incident reporting to be realized, health care organizations must develop a safety culture. A safety culture refers to an environment in which the desire to achieve greater safety is apparent in intangible beliefs, attitudes and values in addition to concrete structures, practices and policies. In a safety culture, clinicians and administrators do not expect that each individual will be flawless; rather, they understand that people are imperfect and that failures are inevitable. As a result, there is a heightened diligence to detect errors and to implement defences that will prevent adverse outcomes. These attitudes and behaviours exist throughout the organization from the administration to the frontline clinicians and will persist through changes ton senior management. Once a safety culture is achieved, reporting becomes more frequent and complete, and near misses are willingly shared for greater quality improvement. In order to achieve such a result, a significant amount of trust must exist among care providers so that adverse events may be openly discussed and solutions developed through collaboration. A safety culture is not a static state but a dynamic system that is constantly changing as opportunities arise. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018.
  • 12. Page 5 9B12M080 GRAND RIVER HOSPITAL & ST. MARY’S GENERAL HOSPITAL Grand River Hospital (GRH) is one of Ontario’s largest community hospitals with over 3,500 staff members working towards their stated vision of being a “leader in providing 24/7 patient care programs through innovation and collaboration, within available resources.” In 2010/11, 23,391 patients were admitted with 12,671 day surgery visits, 58,596 emergency visits and 210,557 ambulatory care visits. GRH developed a quality framework, which includes a quality and patient safety committee, a senior quality team and clinical programs and services quality councils to hold the hospital accountable for quality and safety (see Exhibit 7). The hospital continually evaluates itself on four dimensions: access to care, appropriateness of care, safety of care and patient experience with care. GRH uses benchmark indicators to assess its performance and track its progress. This analysis is made available to the public to demonstrate transparency and openness. St. Mary’s General Hospital (SMGH) has been providing health care in the Kitchener community since 1924. The hospital has nearly 2,000 staff and volunteers that annually support more than 7,000 admissions, 100,000 outpatient visits, 47,000 emergency visits and 20,000 surgical procedures. SMGH instituted their new vision in 2011/12 of becoming the “safest and most effective hospital in Canada characterized by innovation, compassion and respect.” University of Waterloo
  • 13. management science researchers have partnered with SMGH to conduct deep analyses of actions and outcomes within the hospital. SMGH frequently employes “lean” management techniques to achieve continuous improvement on the frontlines of health care delivery. To encourage bedside initiatives, SMGH announced a goal to implement 1,000 measurable improvements in one year and reported on multiple successes to recognize and celebrate employees’ efforts. SMGH also has a guiding quality committee framework and an algorithm of actions following critical incidents (see Exhibits 8 and 9). Given their proximity to one another, GRH and SMGH partner to specialize in certain procedures. They are both committed to being leaders in patient safety and quality of care, and as such, have begun various efforts to accomplish their visions. Nonetheless, Dr. Sharma believes that significant improvements can still be made to patient safety in both hospitals. The hospitals had yet to adopt a true safety culture from administrative to frontline levels, and this is hindering improvement to quality of care. As evidenced by underreporting and poor attendance at QCIPA reviews, there is a lack of physician buy-in to many quality improvement efforts. Dr. Sharma’s greatest challenge is influencing the intangible aspects that define a safety culture – the attitudes, beliefs and values of clinicians. Over a decade of pressure from the IOM, increased legislative requirements, QCIPA legal protection, administrative encouragement and demonstrated positive outcomes have all been insufficient to truly change physicians’ attitudes and behaviour. Dr. Sharma has considered making adjustments to the hospitals’
  • 14. organizational structures to formalize leadership positions and increase accountability on quality metrics. He looked to the example of Mississauga’s Trillium Health Centre, which included patient safety accountability in the job descriptions of department chiefs to assign responsibility for quality of care. They also developed quality competitions to recognize staff contributions to patient safety improvements. These initiatives were launched following a decade’s worth of monthly workshops to collaborate and train staff. The successes resulting from Trillium’s efforts are not guaranteed to be replicated in other health care organizations, but they are certainly attributable to physician leadership and grassroots participation.12 Dr. Sharma is also aware of the importance of teamwork and communication (T&C) skills to provide the highest levels of patient satisfaction. The IOM recognized the lack of training in T&C and called for 12 Ashok Sharma, et al., Physician Matters [Kitchener- Waterloo], 2012, Web. March, 2 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 6 9B12M080 medical education providers to incorporate patient safety into their curriculums. The Johns Hopkins School
  • 15. of Medicine developed a model demonstrating that failures of T&C contribute to the majority of adverse events. This model was used during a three-day intersession on patient safety aimed at developing medical students’ skills in T&C and systems thinking.13 Perhaps Dr. Sharma could host a similar workshop to develop the practicing clinicians’ skills, given that team dynamics had been shown to be directly correlated to patient satisfaction. He wonders how this could be implemented and whether it would have a direct enough impact on the hospitals’ cultures. A third approach that Dr. Sharma has considered is to conduct an extensive analysis and process redesign. Intermountain Healthcare, a much admired health care delivery system, adopted this approach, measured variation in care for particular services and analyzed the quality, efficiency and financial outcomes to determine best practices. An administrative structure was created to implement guidelines based on such standards.14 Although quite successful for Intermountain, Dr. Sharma is concerned that this approach might cause physicians to feel their professional autonomy is not respected. Evidently, there are advantages and disadvantages with each approach, but the chief of staff must make a decision and implement a plan of action to mitigate any drawbacks. How could Dr. Sharma best influence the medical community, beginning with the two hospitals for which he is responsible, to foster a safety culture and most greatly improve patient safety? 13 Rebecca Lawton, et al., “Development of an Evidence-based
  • 16. Framework of Factors Contributing to Patient Safety Incidents in Hospital Settings: A Systematic Review,” BMJ Quality Safety 10.1136, 2012, pages 1-10. Web. March 16, 2012. 14 Brent C. James and Lucy A. Savitz, “How Intermountain Trimmed Health Care Costs Through Robust Quality Improvement Efforts,” Health Affairs 30.6, 2011, pages 1-6. Web. January 18, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 7 9B12M080 Exhibit 1 CONCEPTUAL MODEL OF ADVERSE EVENTS AND ERRORS
  • 17. Researchers have begun to question the existence of non- preventable adverse events. Previously, examples of non-preventable adverse events included incidents such as infections at the catheter site. However, with improved hand washing and sanitation procedures, such adverse events can be prevented. As such, a new model is proposed in which errors result in either a near miss or an adverse event and all adverse events are considered preventable. Adverse Events Errors Near-Misses Non-Preventable Adverse Events Preventable Adverse Events Adverse Events Near-Misses
  • 18. Errors This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 8 9B12M080 Exhibit 2 FACTORS CONTRIBUTING TO PATIENT SAFETY INCIDENTS1 1 Rebecca Lawton, et al., “Development of an Evidence-based Framework of Factors Contributing to Patient Safety Incidents in Hospital Settings: A Systematic Review,” BMJ Quality Safety 10.1136, 2012, pages 1-10. Web. March 16, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 9 9B12M080
  • 19. Exhibit 3 CRITICAL INCIDENT LEVELS OF HARM1 Level 0 – Near Miss or Potential Harm/Damage Circumstances had potential to cause harm/damage. Follow-up may be required. Disclosure not required. Level 1 – No Harm/Damage Event results in no harm/damage. Follow-up may be required. Disclosure not required. Level 2 – Temporary or Minor Harm/Damage Event results in temporary minor harm/damage. Additional monitoring or follow-up required. Disclosure to the patient is not required by legislation but is strongly encouraged. Level 3 – Permanent Harm/Damage Event results in permanent harm/damage. Additional monitoring, prolonged stay and extensive follow-up required (management of critical incidents policy may be initiated). Disclosure to patient, hospital administrator and medical advisory committee is required. Level 4 – Death Event results in death. Extensive follow-up and investigation required (management of critical incidents policy must be initiated). Disclosure to patient, hospital administrator and medical advisory committee is required.
  • 20. Exhibit 4 EXAMPLES OF CRITICAL INCIDENTS2 1 St. Mary’s General Hospital, “Policy & Procedure, Subject: Management of Critical Events/Incidents,” April 12, 2012. 2 Ibid This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 10 9B12M080 Exhibit 5 3-YEAR FUNDING REFORM IMPLEMENTATION1 54% 45% 30% 40% 40%
  • 21. 40% 6% 15% 30% Year 1 (April 2012) Year 2 (April 2013) Year 3 (April 2014) Quality Groupings HBAM Global Exhibit 6 ONTARIO MINISTRY OF HEALTH FUNDING REFORM2 1 Ministry of Health and Long-Term Care, “Health System Funding Reform,” 2012, pages 3-7. Web. April 12, 2012. 2 Ibid. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 11 9B12M080
  • 22. Quality Plan, Goals & Targets Reports & Scorecard Program Quality Reporting Indicators Senior Quality Team Senior Quality Team Quality and Patient Safety Committee Clinical Programs and Services Quality Management Medical Advisory Committee Board GRH Strategic Plan & Goals Mission, Vision, Values Lines of Communication Lines of Communication
  • 23. Quality Framework Exhibit 7 GRAND RIVER HOSPITAL QUALITY FRAMEWORK1 1 St. Mary’s General Hospital, “Policy & Procedure, Subject: Management of Critical Events/Incidents,” April 12, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 12 9B12M080 Exhibit 8 ST. MARY’S GENERAL HOSPITAL QUALITY FRAMEWORK1 1 St. Mary’s General Hospital, “Policy & Procedure, Subject: Management of Critical Events/Incidents,” April 12, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at
  • 24. Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 13 9B12M080 Exhibit 9 ST. MARY’S GENERAL HOSPITAL CRITICAL INCIDENT ALGORITHM FOR ACTION1 1 St. Mary’s General Hospital, “Policy & Procedure, Subject: Management of Critical Events/Incidents,” April 12, 2012. The most immediate actions are to ensure the safety and well- being of the patient. Then, as soon as it is reasonably appropriate, complete the following five items: PATIENT/FAMILY NOTIFICATION DOCUMENTATION STAFF SUPPORT OTHER ACTIONS Manager /delegate address immediate needs of patient/family Most responsible professional(s) disclose
  • 25. circumstances of event Provide manager’s name as contact person to family Manager/delegate provides ongoing updates to family Involved staff notify most responsible physician and manager/ supervisor (Clinical On Call) Manager/supervisor notifies Program Director, Clinical-on- call, Admin.-on-call (if applicable) Staff document (factual, concise, objective, accurate, timely) specific facts of events and immediate follow-up actions in health record — avoid personal notes or subjective Late chart entries
  • 26. only as appropriate with manager/director Complete critical incident report Manager/delegate address immediate needs of staff: Manager/delegate provide ongoing updates to staff as permitted under QCIPA Manager/delegate secure and label equipment, supplies, medication involved in the event – send to the Director of Risk Management for safekeeping If Coroner involved:
  • 27. directed by Coroner If biomedical equipment involved, contact Biomedical Engineering Manager to begin investigation Manager/delegate notifies: patient services Executive Management (e.g., Medical Director, Chief of Staff) Risk Management to secure chart with Health Records
  • 28. Adapted from St. Joseph’s Healthcare, Complete Disclosure Templates This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018. Page 14 9B12M080 Exhibit 10 MISCOMMUNICATION AND REDUCED TEAMWORK CONTRIBUTING TO ADVERSE EVENTS1 1 Rebecca Lawton, et al., “Development of an Evidence-based Framework of Factors Contributing to Patient Safety Incidents in Hospital Settings: A Systematic Review,” BMJ Quality Safety 10.1136, 2012, pages 1-10. Web. March 16, 2012. This document is authorized for use only in Laureate Education, Inc. 's WAL MMHA 6900 - Healthcare Quality Management at Laureate Education - Baltimore from Oct 2017 to Nov 2018.