Cambridge Quarterly of Healthcare Ethics (2017), 26 , 173179 .
Cambridge University Press 2016.
doi:10.1017/S0963180116000748 173
Perspectives
Principles of Ethical Leadership Illustrated
by Institutional Management of Prion
Contamination of Neurosurgical Instruments
TIM LAHEY , JOSEPH PEPE , and WILLIAM NELSON
Introduction
In the Introduction to Managerial Ethics in
Healthcare, 1 the editors argue the most
important responsibility of a healthcare
leader is to protect a hospitals ethical
core values despite challenges. The Joint
Commission, responsible for accrediting
healthcare organizations, likewise
directs the leadership of institutions to
carry out their patient care and business
arrangements in an ethical manner. 2
The ethical principles that are foundational
to organizational values and the
leadership of hospitals include respect
for patient autonomy, prioritizing patient
interests, and the delivery of care in a
just and equitable manner. The Institute
of Medicines six aims for healthcare
deliveryquality, effective, patientcentered,
effi cient, safe, and timely
align perfectly with these fundamental
ethical principles. 3 Taken together, these
values should drive hospital decisions
in a concrete fashion.
This point is unambiguous: ethicsgrounded
values are the core of todays
healthcare organizations, and the success
of a hospital and its leadership is
measured by the alignment of their
decisions and actions with those values.
This is true every day; however, it is
during signifi cant challenges and times
of uncertainty that the true measure of
a hospitals ethical character is tested
and displayed. 4
In this article, we detail how the
leader of Catholic Medical Center in
Manchester, New Hampshire confronted
a challenge that would test his moral
compass of the leadership and overall
character of the hospital: news that
neurosurgical instruments used in the
care of multiple patients may have been
contaminated with a lethal transmissible
infection. In so doing, this leader revealed
key principles of ethical leadership of
healthcare organizations.
We begin with a report of the original
case before delineating next steps in the
hospital investigation and communications
response. In so doing, we discuss
ways in which the leadership of Catholic
Medical Center exemplifi ed ethical leadership
in a time of great challenge.
Brief Case Report
In May 2013, a 70-year-old male presented
to Catholic Medical Center in
Manchester, New Hampshire, with
severe vertigo and diffi culty walking.
Routine blood work, computed tomography
of the brain, and consultation by
neurologists and psychiatrists showed
no explanation for the symptoms, which
worsened despite physical rehabilitation.
Magnetic resonance imaging (MRI)
revealed a brain cyst and signs of elevated
intracranial pressure, but lumbar
puncture and spinal fl uid analysis did
not improve symptoms or reveal additional
diagnoses. Given the diagnostic
uncertainty, and concern that the brain
lesion was contributing to elevated intracranial
pressure, the patient underwent
neurosurgical decompression of the cyst.
Perspectives
174
During the postoperative period, the
patient developed myoclonus, which
was originally attributed to an undefi ned
metabolic derangement. Eventually the
patient was discharged to a rehabilitation
center for postoperative recovery.
Weeks later, the patient was brought to
the emergency department with rapidly
deteriorating neurological symptoms,
including progressive cognitive impairment.
Repeat MRI showed abnormalities
on both sides of the brain regions
known as the caudate and the putamen.
These fi ndings were interpreted as suggestive
of a long list of diagnostic possibilities
including CreutzfeldtJakob
disease (CJD), a rare transmission prion
disease, for which a consulting neurologist
felt the patients symptoms were
atypical.
Physicians admitted the patient to
Catholic Medical Center for additional
evaluation including electroencephalography,
additional brain imaging,
and spinal fl uid analysis, including for
the presence of two proteins found in
patients with CJD, 14-3-3 protein, and
the tau protein. Within days, the hospital
received word that cerebrospinal
fl uid testing showed positive tau protein
and 14-3-3 protein. The National
Prion Center, which by policy contacted
the laboratory director and head of
infection control of Catholic Medical
Center, indicated that these fi ndings
were highly suggestive of the diagnosis
of CJD.
Leadership Response
The same day in mid-August that the
laboratory was notifi ed of the positive
14-3-3 and tau protein results, the executive
leadership team at Catholic
Medical Center alerted the neurosurgeons
involved in the case. Because the
prion agent of CJD can contaminate
neurosurgical instruments in a fashion
not removed by standard sanitation
measures, all neurosurgical instruments
used in the patients brain surgery were
quarantined and all neurosurgery at
Catholic Medical Center was halted
temporarily.
Multiple internal communications
ensued, including e-mails, meetings,
and phone calls among the CEO, hospital
leadership, risk management, infection
control, legal department, and
quality department about the potential
exposure of other patients who had had
neurosurgery procedures following the
index patients procedure. Early on, the
hospital CEO directly contacted the
New Hampshire Department of Health
and Human Services (NH DHHS) to
promise that the ensuing collaboration
between the hospital and the state
would be a model for others to follow.
During these contacts, the hospitals
CEO clarifi ed that patient safety was the
highest priority, above fi nancial, legal,
and personal considerations. NH DHHS
promised full support for Catholic
Medical Center, and initiated an epidemiological
investigation.
Close to this time, the patient died,
and, therefore, state offi cials obtained
permission from his family to conduct
a brain autopsy. Initially, pathologists
at Catholic Medical Center proposed
to take a week to conduct the autopsy.
Concerned that this timeline did not
align with the urgency of the situation,
the CEO contacted the executive team
to emphasize the seriousness of the situation
and to urge a more rapid action.
The autopsy was fi nally completed in
in mid-September.
Prior to knowing the autopsy results,
the CEO convened an incident management
team days after the cerebrospinal
fl uid results were made known. In their
inaugural meeting, the CEO reminded
the incident management team that
although potential contamination of
neurosurgical instruments could not be
changed, the hospital was in control of
Perspectives
175
its reaction to the situation. He called
for leadership, attention, teamwork, and
full engagement. He delegated responsibilities
to individuals based on talent
even when higher-ranked individuals
might have been the default choice. For
example, instead of appointing a hierarchically
default appointee, a vice president,
the CEO appointed the compliance
offi cer as the incident commander. She
was charged with collecting, processing,
and supervising information about
the incident action plan because of
her known attention to detail, sense of
urgency, history of close follow-up, and
team approach to solutions.
The CEOs incident management
team reviewed related hospital policies,
and instigated a root cause analysis.
Alert fl ags were placed in the electronic
medical records of patients on whom
the potentially contaminated neurosurgical
instruments had been used, in the
unlikely event that any of them presented
with the need for invasive treatment,
and notifi cation was made to
another hospital in the same city, which
rented the instruments, to do the same.
The incident management team partnered
with experts in sterilization standards
and other prion-related issues,
including a consultant at the National
Institutes of Health. Hospital risk management
was involved in the investigation;
however, the CEO promised to all
involved that the institutions fi rst priority
was the expeditious and thorough
protection of patient interests. He specifi
ed that the potential legal ramifi cations
of the contaminated neurosurgical
instruments would not preclude the
institution from doing the right thing
for patients, their families, and the
community.
At this time, the CEO and hospital
leadership decided to tell exposed
patients and the community immediately
on confi rmation of the diagnosis
at autopsy. Soon thereafter, the hospital
learned that the results of confi rmatory
testing during autopsy would take several
weeks to return from the National
Prion Laboratory. The CEO felt this was
an unacceptable delay, and decided
to notify potentially exposed patients
and the community immediately rather
than wait for a defi nitive index case
diagnosis.
This decision was controversial. Some
members of the hospitals leadership
team and outside consultants were
hesitant to inform potentially exposed
patients out of concern for infl icting
unnecessary worry on notifi ed patients,
and also because the risk of contracting
CJD from contaminated neurosurgical
instruments is extremely low. (There
have been only four cases reported of
CJD transmission from contaminated
neurosurgical instruments.) 5 This concern
was heightened by the fact that
CJD is invariably lethal, and there is
no test available to determine whether
a potentially exposed patient has truly
been exposed or if that patient will
develop the disease even years later.
There were conversations among senior
hospital management about legal exposure,
bad publicity, and even potential
loss of jobs, including that of the CEO.
The CEO dismissed those concerns as
irrelevant to what patient safety and
institutional trust required.
The CEO emphasized that the institution
had an obligation to be truthful,
and that anxiety among potentially
exposed patients could be mitigated by
ensuring that notifi cation was respectful,
compassionate, and accompanied by
solid education and ongoing counseling.
The CEO felt strongly that potentially
exposed patients needed to know
what had happened so that they could
make informed choices about organ
donation, participate in CJD-related
clinical studies, make end-of-life planning
decisions or, in most cases, do
nothing. He also wanted to ensure that
Perspectives
176
those potentially exposed neurosurgical
patients did not unwittingly risk further
transmission by undergoing additional
neurosurgery in another institution
where their potential exposure was
unknown. The CEO also wanted to protect
patient and community trust in the
hospital by showing that it would act
in a trustworthy manner. To ensure the
institution took the right path, the
hospital CEO consulted ethicists who
supported his decision to disclose the
potential exposure to affected patients.
Close to the same time, the hospital
considered if it should destroy two sets
of potentially contaminated neurosurgical
instruments, as it was not known
which was used in the original case.
This decision was complicated by confl
icting and often unclear recommendations
from the Centers for Disease
Control (CDC) and several consultants.
6 , 7 , 8 , 9 Given this uncertainty, and
the desire to protect future neurosurgical
patients, the instruments (costing
more than $200,000) were permanently
quarantined for later destruction.
Two weeks after Catholic Medical
Center learned of the CJD diagnosis,
representatives of the hospital notifi ed
primary care physicians of the potentially
exposed patients, and educated
them about the risk to patients and
measures that the hospital was taking
to ameliorate it. The hospital provided
reference materials to help primary
care physicians give informed and consistent
advice to patients.
The chief medical offi cer of Catholic
Medical Center and a patient navigator
met with all eight patients (or their
legal representatives) individually. The
patient navigator was chosen based on
a reputation for being a compassionate
and nuanced communicator. In addition
to reviewing the facts of the situation in a
compassionate and respectful manner,
and apologizing for the potential exposure,
hospital representatives provided
patients with written information plus
directions to additional informational
resources. Catholic Medical Center
arranged for patients to have a dedicated
cell phone line that potentially
exposed patients could call at any time
of the day or night.
Once all patients were notifi ed, hospital
representatives communicated to
the hospitals board, medical staff, the
mayor of Manchester, New Hampshire,
the offi ce of the state governor, and then,
all hospital employees. Educational
e-mails, meetings, multimedia documents,
and other reference materials
were delivered to key stakeholders.
The hospital also notifi ed the CEOs of
other hospitals, local business leaders,
and even legislators. The hospital held
a joint press conference with the state
DHHS and the city public health department
and a letter to the community
and FAQs were posted on the hospitals
website.
Soon after these public announcements
were made, news of the contaminated
neurosurgical instruments became
international news. The story appeared
in the Wall Street Journal , and on CNN
and Fox News, among other media outlets.
Most media reports were accurate.
The hospital communications department
corrected errors when needed,
and the CEO called all eight patients
(or their representatives) to address
personally any questions or concerns
prompted by the media coverage.
To preclude contamination of additional
neurosurgical instruments during
procedures performed on the potentially
exposed patients, they were told
to call Catholic Medical Center if they
ever needed any surgical or invasive
procedure. Catholic Medical Center let
them know that they would be contacting
the patients in the future to inquire
about their health and to help answer
any clinical questions or handle additional
health needs.
Perspectives
177
When hospital leadership learned that
one potentially exposed patient was
to undergo additional neurosurgical
and non-neurosurgical procedures at
Catholic Medical Center, the hospital
supplied disposable equipment and
ensured that any instruments that could
not be disposable were quarantined
for disposal at a future date should the
patient someday be diagnosed with CJD.
On September 20, the National Prion
Laboratory confi rmed the diagnosis
of CJD. In the ensuing weeks, Catholic
Medical Center hosted visits from
the Joint Commission, the Center for
Medicare Services, and the Food and
Drug Administration. Each made positive
comments about the way that the
hospital had handled the incident.
A local newspaper praised the hospitals
ethical and transparent response. This
feedback was disseminated to hospital
personnel and the board of directors,
many of whom commented on how
proud they felt to be a part of such a
principled organization.
The root cause analyses undertaken
after the hospital learned of the index
patients CJD diagnosis resulted in some
process changes at Catholic Medical
Center. New checklists for screening
patients preoperatively on certain procedures
were instituted. A new alert in
the electronic medical record was built
to automatically notify the chief medical
offi cer, the vice president of laboratory
services, the nursing coordinator, and
the infection control offi cer whenever
CJD testing was ordered. Education
and root cause analyses are ongoing,
and the hospital continues to provide
clinical and educational support for
the eight potentially exposed patients.
The chief quality offi cer of Catholic
Medical Center presented the case to
the New Hampshire Quality Assurance
Commission, which has representatives
from all New Hampshires hospitals and
ambulatory surgical centers.
Thus far, one potentially exposed
patient has fi led a lawsuit. Most patients
and their families have expressed gratitude
for the information and support
they received.
Summary and Lessons Learned
Ethical healthcare leaders make certain
their institutional mission and values,
including the prioritization of patient
interests, are prioritized over secondary
issues such as fi nancial gain, avoidance
of legal liability, and the protection
of senior management job security.
Healthcare leaders need to recognize
that every decision they make on behalf
of the organization has the potential to
diminish or enhance the moral foundation
of the organization. In its core values,
Catholic Medical Center specifi cally
trumpets compassion, human dignity,
excellence, respect, and patient-centered
care in its mission statement. Therefore,
when the leadership of Catholic Medical
Center aligned its response to potentially
contaminated neurosurgical instruments
on these values, they exhibited ethical
leadership.
A key feature of Catholic Medical
Centers ethical leadership response
was to signal the specialness and urgency
of the situation. Without the explicit
recognition that an unusual and defi ning
ethical challenge was before them,
leadership at all levels would have
been less likely to refl ect which actions
were most ethical, or the need to act
decisively. Many subsequent ethical
decisions therefore fl owed from this
early articulation that a seminal moment
had come that would test leaderships
adherence to institutional values and
justifi cation of public trust.
From this moment, the CEO of Catholic
Medical Center felt that his role was
to champion institutional mission and
values in the face of a challenge. This
role conception fi ts the understanding of
Perspectives
178
moral leadership outlined by Chervenak
and McCullough in 2001: 10 that neither
competent management skills nor protecting
the organizations economic
interest qualify as moral leadership.
A moral healthcare executives primary
responsibility is to lead the organization
toward the goal of fulfi lling the
organizational and professional moral
foundation of excellence in patient care.
Had the CEO instead pursued more
pedestrian priorities, such as to aggrandize
his own power in the institution,
to appease the interests of key allies in
the organization, or shield the institution
from bad press, Catholic Medical
Centers responses to the discovery of
potentially contaminated neurosurgical
instruments may not have been as
admirable or effective.
Public statements of importance
and urgency of mission are important,
but must be followed rapidly by the
appointment of a specifi c team who
feels personally accountable for the
success of the plan. Examples in the
Catholic Medical Center response include
appointment of the chief compliance
offi ce to a key leadership position, and
the identifi cation of a skilled patient
navigator to interface with concerned
patients recently notifi ed of a potentially
lethal exposure. Calling upon individual
team members to align their personal
execution of the CJD contamination
event response plan was key to ensuring
that the plan was enacted effectively.
Attention to such logistical details such
as the creation of a high-performance
team whose skills, values, and mission
are aligned 11 can be crucial to the conversion
of ethical talk into ethical action.
The prioritization of timely responses,
such as communicating to the patients
and the press before a fi nal autopsy
evaluation of the source patient, was
key to averting the appearance of foot
dragging, which could have led to
undermining public trust.
Following the problem articulation,
leadership opted for transparency
and collaboration. Both are critical.
In so doing, Catholic Medical Center
was able to engage regional and even
national expert support, and to show the
integrity of their actions to the public.
Examples include strong collaboration
with news outfi ts and state public health
agencies. Such collaboration can entail
explicit recognition of the ego-driven
temptation to hide the problem.
When the next realization of an ethical
challenge arises, it can be tempting
to develop a short-term plan that gives
the appearance of rectitude but is not
followed by sustained engagement in
patient-centered action. Therefore, the
enactment of a root cause analysis that
resulted in sustained systems redesign
helped protect future patients at Catholic
Medical Center from similar risks. This
exemplifi es the learning health system
in which new evidence is mobilized to
redesign systems of care that work better
for patients. 12 A key feature of such
continuous system change activities is
the use of ongoing assessment strategies
that ensure that change improves
the quality of clinical care in a durable
fashion over time. 13 Therefore, the
development of a long-term patient
follow-up plan and sustained interactions
between Catholic Medical Center
and patients, for example, as news
reports evolved, was essential to the
delivery of ethically mandated care in
the wake of the CJD contamination
event. The articulation of a long-term
timeline with concrete deliverables
through the application of quality
improvement thinking, methods, and
assessments tools was a key approach
to ensuring sustained engagement and
organizational success.
The sustained enactment of plans to
ensure ethical care for people potentially
affected by the CJD contamination event
requires continuing institutional will.
Perspectives
179
The CEO of Catholic Medical Center
stated he knew I had to be steadfast to
the organizations values and my moral
character no matter what we fi nd
or what distractions take place. He
resolved personally that the organization
would focus on what was right for
patients even if, for example, bad press
or legal complications arose, and planned
in advance of his ethical response to such
potentialities. By succeeding in preserving
the moral foundation of Catholic
Medical Center over other considerations,
he brought acknowledgment
to a public expectation; a true service
mission.
Conclusions
The Catholic Medical Center response to
the discovery of potentially contaminated
neurosurgical instruments exemplifi
ed many facets of ethical leadership,
including signaling that a defi ning ethical
moment had occurred, forming a
high performing team, communicating
transparently, and creating a learning
health system to prevent similar ethical
problems in the future.
