Running head: SENTINEL EVENT 1

Sentinel Event Related to the Safe Use of Opioids in Hospitals

Madison Krekow
California State University, Stanislaus



















SENTINEL EVENT 2

Sentinel Event Related to the Safe Use of Opioids in Hospitals
On October 30, 2010 a set of twins were born extremely prematurely in University
Hospital of North Staffordshire (UHNS) in The United Kingdom and were transferred to the
neonatal intensive care unit (NICU) (Hughes, 2013). Under the attention of healthcare
professionals within the UHNS NICU, a medication error occurred that would cost those twin
boys their lives. The medication error that occurred was performed by one of the nurses caring
for the twins that involved the administration of an incorrect dosage of morphine, an opioid
analgesic. While the prognosis of extremely premature infants is never certain, had the correct
dosage of the morphine ordered for the boys been administered, their lives could have been
spared. Correct administration of opioids within hospitals can prevent harm to patients.
Their deaths were a preventable tragedy that consequently sparked a national uproar in protest of
the nurses held responsible for the tragedy.
The twin boys, Alfie and Harry McQuillan, were born at 27 weeks gestation, making
them extremely vulnerable to a wide variety of complications (Hughes, 2013). Immediately
following their birth, they were transferred to the NICU where they would be under the care of
senior nurse Joanne Thompson, and junior nurse Lisa Lucas (Hughes, 2013). The boys had an
order to receive between 50 and 100 micrograms of morphine, and protocol within the UHNS
NICU stated that morphine must be administered by two registered nurses. According to
Hockenberry and Wilson (2009), administration of medications to premature infants should
always include collaboration between nurses to avoid error. On the day that Alfie and Harry
died, the junior nurse Lisa Lucas administered morphine to them without the supervision of
Joanne Thompson. Ms. Lucas administered 600 micrograms of morphine to Alfie, and 850
micrograms to Harry, over 10 times the prescribed amount. This grievous medication error is
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what ultimately caused the death of the twin boys (Hughes, 2013). According to The Joint
Commission (TJC), the deaths of these children, due to the incorrect administration of an opioid
analgesic, constituted a sentinel event (2012).
Sentinel Event
A sentinel event is defined as any unexpected event that results in death or serious
physical or psychological injury (TJC, 2013). Furthermore, serious injury is defined as loss of
function or limb as caused by the event. The death or serious injury that occurs during a sentinel
event is not due to the natural course of disease, or the state the patient was in, during a hospital
stay. In addition to death and serious injuries, other examples of sentinel events include suicide,
patient abduction, discharge of an infant to the wrong family, invasive procedures performed on
the wrong site or wrong patient, and many more (TJC, 2013). The goal of TJCs Sentinel Event
Policy is to improve patient care while reducing the number of sentinel events that occur
throughout the nation. By doing so, the confidence of the public within the health care system
will be maintained, and the safety and quality of the healthcare system will be increased (TJC,
2013). Sentinel Events are called such because they require immediate and swift response when
they occur (TJC, 2013). There is a protocol provided by TJC, that healthcare facilities can
follow, to identify and respond to sentinel events. These steps include performing a root cause
analysis, developing an action plan, implementing the action plan, and monitoring success of the
plan (TJC, 2013).
Opioid administration sentinel events, such as with Alfie and Henry McQuillan, are fairly
common, accounting for 16% of all adverse drug events within the hospital. This statistic places
opioids as one of the most common drugs implicated in adverse drug reactions (TJC, 2012). The
most adverse reaction associated with opioid use is respiratory depression accompanied by over-
SENTINEL EVENT 4

sedation (TJC, 2012). Other common side-effects include dizziness, nausea, vomiting,
constipation, hallucinations, hypotension, and pneumonia. Such risks associated with opioid
analgesics prompted TJC to release Sentinel Event Alert Issue 49 titled Safe Use of Opioids in
Hospitals in an effort to educate healthcare professionals in how to prevent sentinel events
related to their use (TJC, 2012). Upon the occurrence of a sentinel event, it is recommended that
each institution perform a root cause analysis (RCA) to determine the cause of the sentinel
events and prevent similar situations from occurring in the future.
Root Cause Analysis
An RCA is performed after the occurrence of a sentinel event and is a tool that allows
staff members to take an in-depth look at the cause of the event. Primarily, RCAs focus on
process based causes within a healthcare institution rather than on staff performance (TJC,
2013). An RCA should involve hospital leadership, as well as staff working in the hospital that
are closely associated with the event being examined. A thorough and credible RCA examines
singular causes within clinical policy and progresses to common causes within the larger picture
that is the entire organization. The question why? is repeatedly asked as each potential cause is
discovered, in an attempt to discover the ultimate cause of the sentinel event. After repeatedly
answering why this event occurred, the staff performing the RCA should be able to point out
flaws within the system that could be changed, and identify new systems to develop. There
should be no questions left unanswered, nor should there be any contradictions within the RCA.
An RCA should include various categories that are explored in depth that include: policy and
procedure, the environment, people, and technology and equipment.


SENTINEL EVENT 5

Policy and Procedure
Policies within hospitals dictate how procedures are performed and give a step-by-step
description that health care providers, such as nurses, can use to safely perform a given tas, such
as medication administration. When administering opioid analgesics, it is important to have clear
and concise policies to prevent medication administration errors. There are often online
references for medication administration that nurses can use to ensure that they administering a
medication prescription safely. According to Keers, Williams, Cooke, and Ashcroft (2013),
policy and procedures can be a contributing factor to medication administration error. Most
often, policy regarding medication administration is considered too laborious or inadequate.
Nurses also reported that they were not given enough information regarding the safe mixing and
administration of intravenous medication, such as opioid analgesics. It has also been found that
when policy and procedure calls for a second nurse to perform a second check when
administering medication, that nurses are unclear about the role of the second nurse in
administering high-alert medications such, as opioid analgesics and insulin (Keers, Williams,
Cooke, & Ashcroft, 2013).
Environment
The workplace environment greatly contributes to the safe and successful administration
of opioid analgesics. The general workplace environment, the local working culture, and
supervision and social dynamics all play an important role in safe opioid administration. Within
the work environment, trends in short staffing, busy workload, high patient acuity, and poor
performance of supervisors all contribute to a poorly perceived working environment (Fedoriw,
2013). These trends, seen in hospitals, contribute to opioid administration errors through the
creation of a busy, chaotic, and noisy work setting (Keers et al., 2013).
SENTINEL EVENT 6

The local working culture serves an important role in patient safety. On a floor, nurses
often have the same habits and work in a similar fashion. When nurses pick up bad habits from
one another, the risk for medication administration errors is greatly increased (Keers et al.,
2013). A level of trust between employees also contributes to the risk for medication error. With
a greater level of trust between employees, less medication errors occur on a particular floor
(Keers et al., 2013). The social dynamic between employees and their supervisors is also a
contributing factor within the safe administration of opioid analgesics. A good working
relationship between employees and supervisors can positively impact safe opioid
administration.
Proper supervision by senior colleagues and supervisors as well as effective
communication, contributes to a healthy social dynamic in a healthcare setting. Unfortunately,
this is most often not the case, and opioid administration errors increase in inverse proportion to
the level of supervision of senior employees (Keers et al., 2013). Inadequate supervision by
senior employees includes incorrect and unclear instructions as well as pressuring inexperienced
members of the healthcare team to rush when administering medications. Lack of support and
bullying behaviors from the senior health-care team, such as confrontation with intimidating
behavior and social isolation from colleagues, also contribute to increased medication errors.
People
Patients, nurses, and all other staff are factors that have a role in safe and effective opioid
analgesic pain management. Patient risk factors, training, and experience of the staff have
pronounced influence on the safety of medication administration. Patients who are opioid-nave,
or who have rarely taken opioids, should be initially titrated to an effective dose to prevent
potential complications such as respiratory depression (Chou, 2009). It has been shown that lack
SENTINEL EVENT 7

of IV access and other logistical factors have played a large role in medication errors involving
the wrong time of administration (Keers et al., 2013). The patients ability to communicate their
level of pain and misinterpretation of pain have been shown to result in medication errors.
The level of training and experience of employees has a great impact on the level of
patient safety when receiving opioid analgesics. Inexperienced staff have an increased risk of
medication errors in the acute care setting. Being inexperienced often means being unfamiliar
with particular medications, the environment, and the equipment that is used to administer the
medications prescribed by the primary care provider. All of these factors contribute to increased
levels of medication errors (Keers et al., 2013).
Equipment
The equipment used to administer potentially dangerous drugs, like morphine, is highly
important in ensuring patient safety during their administration. Factors that contribute to
medication error include lack of access to needed equipment, ambiguous equipment design, and
malfunctioning equipment (Keers et al., 2013). Equipment also contributes to medication error in
regards to the pharmacy and automated medication dispensing systems. It is a frequent
occurrence that medications are not stocked in the dispensing system at the appropriate time, that
medications are placed in the wrong compartment, and the wrong concentration of medication
for injection is delivered to the floor (Keers et al., 2013).
Change Theory and Action Plan
Change theories are the driving force behind the action plan that is formulated after the
occurrence of a sentinel event. In order to reduce the likelihood that similar sentinel events will
occur in the future, an action plan must be formulated (TJC, 2013). Kurt Lewins 3-step change
theory is a very effective tool, that can be utilized within the organizational framework of the
SENTINEL EVENT 8

hospital, to formulate an action plan. The Lewin change theory consists of three steps that
include: unfreezing, moving, and refreezing (Burnes, 2004). With these three steps, an effective
action plan can be formulated to create a safe and harmonious work environment for both
patients and staff. The goal of the action plan is to create fewer adverse drug and sentinel events
associated with the administration of opioid analgesics in the NICU.
Unfreezing
According to Burnes (2004), equilibrium needs to be destabilized (unfrozen) before old
behaviour can be discarded (unlearnt) and new behaviour successfully adopted (p. 985). This is
the core of the unfreezing stage of change; old practices must be abandoned before change can
begin. Unfreezing is allowing the staff, who work within the hospital organization, to understand
why change is necessary (Mind Tools, 2013). During the unfreezing stage, staff must be shown
exactly what is not working. An effective way to display the current faults in the organization is
through quantitative evidence, such as data regarding the number of adverse events associated
with opioid use in the NICU (Mind Tools, 2013). The environment in which staff accepts that
change will take place must not exist within a punitive culture, and should be free from feelings
of impending loss. In essence, staff must feel safe in order to accept change and be willing to
modify current practice (Burnes, 2004).
Moving
As the equilibrium of a system is destabilized and old practice has been demonstrated to
be ineffective, the change stage, or the moving stage begins (Burnes, 2004). The moving stage
consists of implementing necessary changes in a way that will have a long-lasting effect.
Employees must see that the change will benefit them and their patients in order for change to
become permanent (Mind Tool, 2013). The best way for employees to feel like they are
SENTINEL EVENT 9

benefiting from change is to make them feel connected to the organization. Hands-on
management and time spent addressing individual concerns are two key factors that will foster a
successful moving state (Mind Tools, 2013). In preventing further opioid related sentinel events
within the NICU, several changes must be made.
The relationship between physicians and nurses working within the NICU is of the
utmost importance for insuring patient safety and creating trust between the provider prescribing
pain medication and the provider administering pain medication. According to Suarez, Knoppert,
Lee, Pletsch, and Seabrook (2010), implementing standard guidelines for the administration of
opioids in the NICU can reduce medication errors and improve safety. For example, according to
Suarez et al. (2010), a safe and effective administration protocol for morphine in the NICU is as
follows: 100 mcg/kg as a bolus dose, and an infusion dose of 12.3 4.7 mcg/kg/hr. A set of
standard administration protocols, that physicians and nurse practitioners can use when
prescribing pain medication, will create a system that eliminates prescriber preference. When
prescriber preference is decreased and standard medication guidelines are implemented, nurses
feel more comfortable administering high alert medications such as morphine, the level of trust
in the prescriber increases, and the rate of adverse drug events decreases (Suarez et al., 2010).
The technology used to administer high alert medications such as opioid analgesics can
effectively decrease adverse drug events. The NICU will implement a barcode assisted
medication administration (BAMA) system that will reduce medication errors. According to
Morris et al. (2011), BAMA will reduce preventable adverse medication events by more than
half. A second intervention to improve safety of opioid administration in the NICU through
technology is the independent double check when giving medications intravenously (IV) (Child
Health Corporation of America [CHCA], 2008). A second nurse will be required to
SENTINEL EVENT 10

independently check the order, the medication dosage, the concentration of the medication, the
rate of the pump, whether or not the order follows administration protocol, and the patient
identifiers, before a high alert medication such as morphine can be administered (CHCA, 2008).
Proof of the independent double check will need to be validated by the second nurse in the form
of electronic signature in the electronic medication administration record (eMAR). The eMAR
will prompt the nurse performing the independent double check to provide user name and
password as proof the independent double check was performed. The implementation of the
independent double check for the administration of IV medications will reduce medication errors
and adverse drug events by up to 67 percent (Sharek et al., 2008).
When high alert medications are being administered, standardized evidence-based
assessment tools need to be utilized. The NICU will implement protocol that all patients need to
be assessed for pain and sedation using the COMFORT scale (Mazars et al., 2012). Patients not
receiving opioid analgesics will be assessed every four hours using the COMFORT sale and
every time a painful procedure is performed (Massachusetts General, 2013). When a patient is
receiving opioid analgesics for pain, they must be assessed immediately prior to, and 5 minutes
after administration followed by every four hours using the COMFORT scale (Massachusetts
General, 2013). According to Mazars et al. (2012), the COMFORT scale is a validated and
widely used tool that is extremely effective in improving the pain and discomfort detection in the
NICU. The COMFORT scale is also useful in detecting and preventing over-sedation and
adverse drug events associated with opioid analgesic use. The implementation of a scale that
simultaneously allows nurses to assess pain and sedation is useful in preventing future adverse
drug events associated with opioid analgesics in the NICU (Mazars et al., 2012).
SENTINEL EVENT 11

As all of these changes are being implemented into the NICU, education needs to be a
constant part of the moving stage. The success of the standardized medication administration
protocols, the BAMA system, the independent second check, and the COMFORT pain and
sedation scale all depend on how well the staff understands each of these measures. The last
measure the NICU will implement as part of the action plan is continuing education for each of
the staff members to ensure understanding. According to Cong, Delaney, and Vasquez (2013),
continuing education, and the use of evidence-based assessment tools and protocols correlate
with safe and effective pain management with a reduction in adverse drug events. Continuing
education will boost staff moral and increase compliancy to the new measures by making the
staff feel intimately involved and knowledgeable with the proposed changes (Cong, Delaney, &
Vasquez, 2013). All of the above proposed changes will cost money and require monetary
funding through the hospital in order for them to succeed.
For the action plan to succeed a budget must be created and approved. The implemented
changes must be purchased and funded through the hospital in order to prevent sentinel events
regarding opioid analgesics. To implement standard administration guidelines for the
administration of opioid analgesics in the NICU, the hospital will pay a physician to write the
policy. The hospital will pay an expert to educate all neonatal physicians on the new policy, and
will provide a copy of the policy on all the medication carts and in all of the medication rooms in
the NICU. The hospital will purchase 20 BAMA systems for the NICU, so that each RN will
have access to the new technology. The hospital will also hire a technological support person to
troubleshoot and maintain the new BAMA system. In order to implement the independent double
check and COMFORT pain and sedation scale, the most crucial piece of funding will go towards
continuing education. There will be a four hour workshop for each new policy that all RNs and
SENTINEL EVENT 12

physicians must attend. The hospitals will pay an expert to teach staff and will pay the staff to
attend these continuing education workshops. In total, the changes implemented will cost
$346,700.
Refreezing
The refreezing stage will take time as there are many unanticipated barriers that the
NICU will face in implementing these changes. The refreezing stage is the time period where
changes made in the moving stage become entrenched and an essential part of the culture of the
unit. A sense of stability must be rebuilt into the facility as people reorient themselves into a
changed work environment. Successes must be commended and celebrated and a sense of
community and involvement with the changes must be maintained (Mind Tools, 2013).
The barriers that result as consequences of change must be dealt with appropriately and
with a compassionate and non-punitive culture towards staff since change can be difficult. Some
consequences of change that will arise include an overall resistance to change, fear of the
changes, lack of understanding to changes, and lack of trust in the new protocols and
technologies (Cong, Delaney, & Vasquez, 2013). Ways that these barriers will be over-come
include the appointment of a unit-based safety champion (CHCA, 2008). These safety champions
will be resources to staff for questions and education to ensure that no one feels alone in the
struggle to change. Another way to fight the barriers to change and ensure that the changes are
successful is weekly chart audits. To ensure staff is meeting goals, chart audits should be
performed to ensure that COMFORT scales are being performed per protocol (CHCA, 2008). To
ensure the use of the BAMA system, a goal of zero overrides should be encouraged and met as
often as possible with rewards for those who do so. And lastly, to encourage staff to participate
in changes despite their fear, it is essential to communicate to staff that they do not exist in a
SENTINEL EVENT 13

culture of punishment but rather self-reporting of adverse drug events will be commended
(CHCA, 2008).
Targeted Population and Stakeholders
The targeted stakeholders affected by this change include nurses, patients and their
families, and physicians. Nurses will be affected through the change in protocol and the
implementation of new technology. It has been reported that only 44 percent of nurses working
in NICUs feel that patient pain is well managed and only 43 percent feel that the pain assessment
tool is evidenced-based (Cong, Delaney, & Vasquez, 2013). The nurses attitudes may be a
challenge in implementing changes, so providing them with evidence-based research regarding
why each proposed change is important may be effective in addressing their attitudes. Physicians
are stakeholders in the change because their prescribing preferences will now be dictated by
protocol. Patients and their families are stakeholders in this change because the quality of their
care will be directly improved by these changes.
Conclusion
Sentinel events involving the safe use of opioids in hospitals affect a large majority of
patients in the acute care setting. It is of the utmost importance that when these sentinel events do
occur, there is a timely response involving a root cause analysis and an action plan. With the use
of evidence based changes, the safety of the inpatient setting can be improved not just for
patients, but for staff as well. With the collaboration of all employees within the hospital setting,
changes can be made so that no sentinel events regarding the use of opioid analgesics ever have
to occur again. With an effective combination of policy and procedure, environment, people, and
equipment, an evidence-based climate of safety for patients and staff will prevent further sentinel
events involving the use for opioid analgesics.
SENTINEL EVENT 14

References
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Child Health Corporation of America. (2008). Change package, adverse drug events: Sustain
and spread. Retrieved on October 25, 2013 from www.chca.com/mm/pdf/
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Chou, R. (2009). 2009 clinical guidelines from the American pain society and the American
academy of pain medicine on the use of chronic opioid therapy in chronic noncancer
pain. The Journal of Pain, 10(2), 113-130. doi:10.1016/j.jpain.2008.10.008
Cong, X., Delaney, C., & Vazquez, V. (2013). Neonatal nurses perception of pain assessment
and management is NICUs. Advances in Neonatal Care, 13(5), 353-360. doi:
10.1097/ANC.0b013e31829d62e8
Fedoriw, K. B. (2013). Safe and pratical: a guide for reducing the risks of opioids in the
treatment of chronic pain. North Carolina Medical Journal, 74(3), 232-236. Retrieved
from http://www.ncmedicaljournal.com/wp-content/uploads/2013/05/74312.pdf
Hockenberry, M. J., & Wilson, D. (2009). Wongs essentials of pediatric nursing. St. Louis,
Missouri: Mosby Elsevier.
Hughes, T., (2013, March 16). Nurse stays after deaths. Daily Star. Retrieved from
http://www.dailystar.co.uk
Keers, R. N., Williams, S. D., Cooke, J., & Ashcroft, D. M. (2013). Causes of medication
administration errors in hopitals: a systematic review of quantitative and qualitative
evidence. Advance online publication. doi: 10.1007/s40264-013-0090-2
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Massachusetts General Hospital for Children. (2013). Pediatric intensive care unit: The comfort
scale. Retrieved on October 25, 2013 from www2.massgeneral.org/painrelief
/App_N_COMFORT_scale_Peds.pdf
Mazars, N., Milesi, C., Carbajal, R., Mesnage, R., Combes, C., Novais, A. R. B., & Cambonie,
G. (2012). Implementation of a neonatal pain management module in the computerized
physician order entry system. Analysis of Intensive Care, 2(38). Retrieved from
http://www.annalsofintensivecare.com/content/2/1/38
Mind Tools. (2013). Lewins change management model: Understanding the three stages of
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/newPPM_94.htm
Morris, F. H., Abramowitz, P. W., Nelson, S. P., Milavetz, G., Michael, S. L., & Gordon, S. N.
(2011). Risk of adverse drug events in neonates treated with opioids and the effect of a
bar-code-assisted medication administration system. American Journal of Health-Systems
Pharmacology, 68, 57 62. doi: 10.2146/ajhp090561
Sharek, P. J., McClead, R. E., Taketomo, C., Luria, J. W., Takata, G. S., Walti, B., Frederico,
F. (2008). An intervention to decrease narcotic-related adverse drug events in childrens
hospitals. Pediatrics, 122, e861-e866. doi: 10.1542/peds.2008-1011
Suarez, A., Knoppert, D. C., Lee, D. S. C., Pletsch, D., & Seabrook, J. A. (2010). Opioid
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The Joint Comission. (2012). Sentinel event alert: Safe use of opioids in hospitals (Issue 49).
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The Joint Comission. (2013). Sentinel events. Retrieved from www.jointcommission.org
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