Infusion Medication Error Reduction by Two-Person ... · 2016-11-07 · Rajeev Subramanyam, MD,...
Transcript of Infusion Medication Error Reduction by Two-Person ... · 2016-11-07 · Rajeev Subramanyam, MD,...
Infusion Medication Error Reduction by Two-Person Verification: A Quality Improvement InitiativeRajeev Subramanyam, MD, MS, Mohamed Mahmoud, MD, David Buck, MD, Anna Varughese, MD, MPH
Departments of Anesthesiology and Pediatrics, Cincinnati
Children’s Hospital Medical Center, University of Cincinnati
College of Medicine, Cincinnati, Ohio
Dr Subramanyam designed the improvement
project, collected and analyzed the data, and
drafted and revised the manuscript; Dr Mahmoud
assisted with improvement ideas in radiology and
revised the manuscript; Dr Buck assisted with
the PDSA cycles and revised the manuscript;
Dr Varughese assisted with designing the project
and improvement ideas and revised the manuscript;
and all authors approved the fi nal manuscript as
submitted.
DOI: 10.1542/peds.2015-4413
Accepted for publication Jun 2, 2016
Address correspondence to Rajeev Subramanyam,
MD, MS, Department of Anesthesia, Cincinnati
Children’s Hospital Medical Center, University of
Cincinnati School of Medicine, 3333 Burnet Ave,
Cincinnati, OH 45229. E-mail: rajeev.subramanyam@
cchmc.org
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online,
1098-4275).
Copyright © 2016 by the American Academy of
Pediatrics
FINANCIAL DISCLOSURE: The authors have
indicated they have no fi nancial relationships
relevant to this article to disclose.
FUNDING: No external funding.
POTENTIAL CONFLICT OF INTEREST: The authors
have indicated they have no potential confl icts of
interest to disclose.
The anesthesia radiology imaging
service at Cincinnati Children’s
Hospital Medical Center (CCHMC)
is a typical brief procedure,
multilocation area. There were 2
infusion pump programming errors
(resulting in no patient harm)
in our radiology imaging service
area related to incorrect entry of
patient weight or drug dosage on
the infusion pump. These errors
were an impetus for this quality
improvement (QI) project. Many
high-risk infusion medications
(eg, propofol, dexmedetomidine)
are used for sedation, and errors
in programming and operation
can be catastrophic. 1 Common
reasons for intravenous medication
infusion errors are incorrectly
programming weight or drug
dosage, programming the wrong
medication, tampering with infusion
pumps by unauthorized users,
and overriding alerts without
recognizing an error.
abstractOBJECTIVE: Errors made in the administration of intravenous medication
can lead to catastrophic harm. The frequency of hospital settings in which
medication pumps are being used are increasing. We sought to improve
medication safety by implementing a 2-person verification system before
medication administration.
METHODS: Our quality improvement initiative took place in an anesthesia
radiology imaging service at a tertiary pediatric hospital. Key drivers
included frequent educational meetings with clinicians, written reminders,
display of visual reminders, constant feedback in the clinical areas that
carried out the processes, and sharing of knowledge on displayed run
charts. A multidisciplinary team conducted a series of tests of changes to
address the interventions. Data were collected and entered into a database
by an independent and impartial data collector. Data were analyzed via run
charts and statistical process control methods.
RESULTS: The team ran 24 plan–do–study–act ramps. The rate of 2-person
verification of infusion pump programming increased from 0% to 90% and
was sustained. Overall, 4 errors were rectified before the medication was
administered to the patient. There was no delay in case starts (>90% before
and during the project). This project played a key role, as part of a larger
initiative within the department of anesthesia, in reducing medication
errors.
CONCLUSIONS: A brief 2-person verification approach can reduce medication
errors due to inaccurate infusion pump programming. This improvement
was achieved with the use of plan–do–study–act cycles. The impact can be
significant and will promote a hospital safety culture.
QUALITY REPORTPEDIATRICS Volume 138 , number 6 , December 2016 :e 20154413
To cite: Subramanyam R, Mahmoud M, Buck D,
et al. Infusion Medication Error Reduction by
Two-Person Verifi cation: A Quality Improvement
Initiative. Pediatrics. 2016;138(6):e20154413
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SUBRAMANYAM et al
More than 56 000 adverse events,
710 deaths, and 87 recalls associated
with the use of infusion devices
alone were reported to US Food and
Drug Administration in the 5-year
span from 2005 to 2009. 2 Children
are at higher risk for medication
errors than adult patients because
of the need for precise weight-
based dosing. Most intravenous
medication errors occur when
drugs are administered that require
multiple-step preparation. 3 Although
technological advances have greatly
improved patient safety through
the use of smart pumps, the risk of
intravenous medication infusion
errors related to programming has
not been eliminated. 4, 5 A variety of
approaches to reduce these errors
have been described1; finding
safe ways to prevent intravenous
medication infusion errors remains a
priority. 6
Two-person verification is a process
in which the work of the first person
is checked independently by another
person. 7 Independent checking is
crucial in reducing any bias that
may occur when the second checker
sees what he or she expects to see,
regardless of any errors. 7 Two-
person verification has successfully
reduced wrong-patient or wrong-
study radiology events in a pediatric
hospital 8 and has been proposed
to reduce medication errors. 9 We
organized a multidisciplinary
taskforce consisting of
anesthesiologists, certified registered
nurse anesthetists (CRNAs), and
radiology registered nurses (RNs)
to reduce these errors. Our overall
objective was for ≥90% of the infusion
pump programming to be verified by
2 people before being administered to
the patient in the anesthesia radiology
imaging division.
METHODS
Ethical Considerations
This project was considered a local QI
project. There was no direct contact
with patients or families, and it was
considered non–human subject
research. Data were obtained from a
data collection form created for this
project and were deidentified. The
data were stored on a password-
protected computer.
Standards for Quality Improvement
Reporting Excellence (SQUIRE)
guidelines were followed in the
preparation of this manuscript. 10
Setting
The project was conducted at
CCHMC, an urban tertiary academic
care center with round-the-clock
anesthesia service availability to
provide anesthesia or sedation for
radiologic imaging (∼5000 cases per
year). The Department of Anesthesia
consists of 60 anesthesiologists,
40 CRNAs, and 29 anesthesia
imaging RNs. The setting for this
study consisted of 4 MRI scanners,
2 computed tomography scanners,
1 nuclear scanner, and 1 auditory
brainstem response testing unit.
The Department of Anesthesia
provides anesthesia for children
undergoing radiologic imaging by
a standardized method. Anesthesia
is induced with sevoflurane in a
mixture of oxygen and nitrous
oxide, and an intravenous line is
placed. An infusion of propofol or
dexmedetomidine is started, based
on the clinical indication, to achieve
motion control.
QI Team
The QI team consisted of 3
anesthesiologists, 2 radiology
imaging nurses, 3 CRNAs, and 1
administrative assistant. More than
half of the team have had previous
formal QI training. A QI consultant
and the hospital QI leaders provided
input during the project.
Planning the Intervention
The QI project was conducted
between August 2014 and February
2015. The impetus for this project
was 2 infusion pump programming
errors (resulting in no patient harm)
that occurred in our hospital before
August 2014.
Data were collected via standardized
questionnaires developed by the
QI team to ascertain whether an
infusion pump was used and whether
an error was found and rectified.
The answers were collected as
binary responses. An independent
administrative assistant who was
blinded to the QI project collected
the data forms and entered them
into the database. No patient-
related health information data
were collected. An “error” occurred
when an infusion pump was used for
that particular patient and an error
with programming was found and
rectified (answered “yes” to both
questions). Pilot data were collected
for a period of 4 weeks in August
2014. Elective, urgent, and emergent
cases were included in the project
if they entailed the use of infusion
medications.
The method used in the project
started with small tests of change or
plan–do–study–act (PDSA) cycles. 11
The QI team initially used 2 QI
methods: first, process mapping
( Fig 1) to lay out the whole process of
administering infusion medications
and, second, failure modes and
effects analysis (FMEA) ( Fig 2) to
identify the failures that occurred in
the process. FMEA helped clarify the
lack of process that could potentially
result in a medication error.
The team identified operational
factors or key drivers and their
associated interventions ( Fig 3)
based on the pilot data and from
the FMEA. The team set a goal
of increasing compliance with
2-person verification from 0% to
90%. A national benchmark was not
available for this goal. Because this
is an important safety issue, we had
the goal to achieve at least level 1
reliability, where there is 80% to
90% success (1 or 2 failures out of
10). 12 The PDSA cycle began with 1
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PEDIATRICS Volume 138 , number 6 , December 2016
imaging location and then spread to
other imaging locations.
Key Drivers and Interventions
Education
In this key driver, education was
targeted to the small percentage
of anesthesiologists and CRNAs
who regularly provided anesthesia
for radiologic imaging. The first
step to make this process work
was to provide education about
the importance of a safety check
to reduce patient medication
errors. Education about the use of
standardized pump programming
was provided to stakeholders
with a job aid (anesthesiologists,
CRNAs, RNs), and education
about anesthesia medications was
provided to RNs. The specific roles
of each person were clarified. A
data form was created, and the RN
who was involved in caring for the
patient completed the data form.
One challenge during this process
was resistance to a culture change
from old processes to the 2-person
verification process. This challenge
was discussed at departmental
meetings.
Visual Aids
The first visual aid was a sticker,
which was to be signed by 2 people to
confirm that the 2-person verification
was completed. Although considered
a significant advance, this process
met with a lot of resistance from the
staff because of space constraints in
the anesthesia workspace. Therefore,
this sticker was abandoned.
The second visual aid was developed
midway through the improvement
project, and acted as a reminder.
The visual reminder was placed in
locations where failures most often
occurred to remind the clinical staff
to complete the 2-person verification.
Stakeholder Buy-In
The initial resistance to culture
change was converted successfully
with buy-in from stakeholders.
The key driver diagram and the
weekly updated run charts were
continuously displayed in the work
area to achieve support, provide a
constant reminder of the project,
and share knowledge. Constant
reminders and a presentation of
the process during the monthly QI
meeting were also performed. During
the QI project, 4 programming errors
were detected and were rectified
before they could affect the patient.
These instances of error rectification
were a major impetus for stakeholder
buy-in.
e3
FIGURE 1Process mapping showing the process of programming the infusion pump from the start to the end. The 2-person verifi cation is incorporated in the red circle. RN, registered nurse.
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Modifi cations to Electronic Medical Records and Procedural Timeout
The electronic medical record (EMR)
was modified to accurately document
2-person verification of the infusion
pump programming. The procedural
timeout is a routine check performed
before the procedure and start of
anesthesia or sedation. 13 The QI team
representatives worked to locally
add the 2-person verification process
for infusion pump programming to
the procedural timeout to ensure
sustainability.
Performance of the Verifi cation Process
The first person to perform the
verification process (anesthesiologist
or CRNA) fully programmed the
pump. Subsequently, the second
person (another anesthesiologist
or CRNA, RN) walked through
each step in the infusion pump
programming and cross-verified
the drug, with particular emphasis
placed on patient weight and drug
dosage programming. These steps
were taken before the medication
was administered to the patient and
before procedural timeout.
Study of Interventions
The QI team assessed how well the
interventions were implemented
and their impact on the goal after
the completion of the project. The
data collection was continued after
completion of the project to ensure
sustainability. After changes in the
EMR documentation process and
the procedural timeout, impact on
the radiology anesthesia service was
assessed. On a monthly basis, the
QI team reviewed the reports, and
the information was conveyed to
perioperative staff through regular
meetings and poster boards.
Methods of Evaluation and Analysis
The primary (process) measure
was the proportion of 2-person
verification of infusion pump
programming (goal ≥90%). The
secondary outcome measure was
the reduction in medication errors
related to administration of infusion
pump medications (goal = 0%).
Balancing measure refers to no
delays in first case starts in radiology
e4
FIGURE 2Failure mode and effects analysis.
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PEDIATRICS Volume 138 , number 6 , December 2016
(goal >90%). Case start was defined
as the time at which the anesthetic or
sedative medication administration
was started. In addition, a cross-
sectional analysis was done via
Survey Monkey to assess delays in
case starts.
The number of data forms available
each day was cross-verified with
the number of cases where infusion
medication was used that day by 1
of the 4 independent patient flow
coordinator RNs to ensure that no
data were overlooked. The number
of cases conducted per week was
monitored to ensure that the data
captured were representative of
the sample population. The process
measure directly collected the data
for the outcome measure (eg, if the
nurse completed the double-check
form, that form was used to check
whether the first person made an
infusion pump medication “potential”
error).
Data obtained were analyzed each
week in terms of proportions. The
primary and secondary outcomes
were represented with statistical
control charts and presented to the
QI team on a monthly basis. Median
was applied to assess the statistical
process control. These charts helped
display and analyze any variations
in the time series data. Special cause
variation was used to evaluate the
effectiveness of interventions. Special
cause variation was considered
to be present based on a shift (≥8
consecutive points), a trend (6
consecutive points), or alternating
points (14 consecutive data points). 14
Any special cause variation was
investigated to learn about the
reason for the change, and the charts
were annotated. The process was
regarded as having a change, and a
new baseline was created when the
special cause coincided temporally
with a plausible explanation.
RESULTS
A total of 24 PDSA ramps were
tested. The baseline data are shown
for 4 weeks. In the first few months
of testing the key interventions,
the run chart showed special cause
variations, specifically 8 consecutive
points above the centerline ( Fig 4).
The centerline remained consistently
above the goal of 90% during the rest
of the time period. The stakeholder
buy-in was remarkable, and there
was minimal variation with the
process. The 2-person verification
process was incorporated during the
procedural timeout during the time
annotated in the run chart ( Fig 3).
Fifteen months after the project
started, the centerline was still above
e5
FIGURE 3Key driver diagram for the improvement project presenting the overall project aim, key drivers, and interventions (ideas for change).
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the goal, with minimal variation.
The EMR was modified to record
the 2-person verification. Given the
success, we were able to scale the
process to other anesthesia locations
of the hospital. The stakeholders
were eager to emulate this process in
other areas.
During the initial period of the
project, 4 programming errors
were identified and rectified before
medication administration ( Fig 5).
Two errors were due to incorrect
dosage or weight programming,
and the other 2 resulted from
programming the incorrect infusion
pump module. The “no delay in case
starts” rate was >90% before project
start, during the project, and after
project completion. In the cross-
sectional analysis performed via
Survey Monkey, 95% of stakeholders
indicated there was no delay in case
starts.
DISCUSSION
A standardized, team-based approach
to reduce the number of intravenous
medication infusion administration
errors in a high-turnover area
of the hospital where anesthesia
and sedation are administered
is described. Implementation of
2-person verification resulted in
>90% medication programming
being double-checked before
medication administration. This
change was sustained through human
factor–dependent processes, such as
reminders and procedural timeouts,
and human factor–independent
processes with inclusion in the
EMR. This standardized patient-
centered approach decreased the
number of medication errors by
early identification of programming
errors. This project played a key role,
as part of a larger initiative in the
department of anesthesia, to reduce
medication errors. Over the course
of 2 years, this initiative decreased
e6
FIGURE 4Run chart showing overall compliance with 2-person verifi cation. The solid red line represents the average number of infusion pumps that are 2-person verifi ed as a percentage of the number of infusion pump medications used per week. Special cause is shown by 2 shifts of the centerline based on 8 consecutive points above the centerline. The yellow boxes represent PDSA interventions at specifi c time intervals. (PDSA 1, job aids; PDSA 2, run chart display; PDSA 3, stickers; PDSA 4, written reminders; PDSA 5, presentation; and PDSA 6, changes to EMR.)
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PEDIATRICS Volume 138 , number 6 , December 2016
medication errors from a rate of
4 errors per month to 1 error per
month.
The US Pharmacopeia Medication
Errors Reporting Program showed
a significantly higher rate of
medication error resulting in
harm or death of 31% in pediatric
patients as compared with 13% in
adult patients. 15 The occurrence
of potential adverse drug events
(those not causing harm) is also 3
times higher in pediatric patients
as compared with adult patients. 16
Intravenous fluids are the most
common product implicated in
pediatric medication errors. 15 Errors
with high-hazard drugs can be
catastrophic. Although the infusion
pumps used to administer pediatric
medications are “smart pumps, ” they
are not completely error-free because
of their dependence on human
factors. 4 In our project, we found that
although there were hard limits in
the infusion pump drug library, there
were also soft limits that allowed
high override rates. Therefore, a
continuous QI process was important
to improve their safe use.4 An
infusion pump informatics analytics
system can be used to design a
smart pump drug library. 17 For a
system transitioning from a paper
ordering system to a computer-based
ordering, it is important to know
that this transition can introduce
new types of medication errors, and
the system should be designed to
recognize such errors. 18 Integration
of barcodes on a smart infusion
pumps and creation of closed-loop
systems will also reduce intravenous
medication infusion errors.
Two-person verification is used
by high-reliability organizations
such as the nuclear industry, the
US Department of Defense, and
the airline industry. In health care,
2-person verification has been used
for a long time with blood component
transfusion and is mandated by the
Joint Commission to achieve patient
safety. In the radiology imaging
service, this 2-person verification
was deemed a value-based approach
because 2 anesthesia personnel
or 1 anesthesia staff person and
an imaging nurse care for every
patient. Because infusion pump
errors related to programming and
operation are common, 1 we deemed
2-person verification a reasonable
approach to ensure patient safety,
akin to reducing clerical errors with
transfusion.
e7
FIGURE 5Run chart showing the rate of medication errors detected and verifi ed before reaching the patient during the project. The solid red line represents the number of infusion pump programming errors as a percentage of the number of infusion pump medications used per week. The median does not exist for these data.
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SUBRAMANYAM et al
Although this project is done in the
setting of an anesthesia radiology
imaging service, the implications
of the project relate to all areas of a
hospital where infusion medications
are used. With the increasing use
of sedatives and other infusion
medications across the hospital,
reducing medication errors related
to infusion pump programming
is critical. The sustainability of
2-person verification was reviewed
and analyzed on a weekly basis. 19
The culture of change has been
sustained to date by incorporating
the process into the procedural
timeout. Procedural timeout is a
checklist created by World Health
Organization to address surgical and
procedural safety. 13 The checklist
helps with effective communication
and teamwork and helps health
care teams remember critical
information about the patient before
administering anesthesia. 20 The use
of a checklist is imperative for patient
safety, and the radiology anesthesia
service at CCHMC is 100% compliant
with the use of this surgical checklist.
Checklist compliance is monitored
by a radiology anesthesia nurse and
is overseen by the nursing clinical
director of radiology anesthesia
imaging. Therefore, incorporating
the 2-person verification as part of
the procedural timeout checklist also
enabled new staff to comply with the
verification process.
One limitation of this QI work is that
a few PDSA cycles were introduced
in a period of 6 months; it is hard
to discern which of those had the
highest impact. Different aspects of
our approach, including constant
communication and the display of
the outcome measure run chart
with reduction in medication errors,
had the greatest impact, given the
interaction with stakeholders.
Another limitation is the
nonavailability of QI infrastructure
at hospitals trying to replicate the QI
method.
CONCLUSIONS
Our QI project was successful in
implementing a 2-person verification
process to enable safe medication
administration by identifying a set of
key drivers and testing interventions.
Analysis-driven modifications to
the 2-person verification process
and reduction of medication errors,
which was refined via a model for
improvement, led to a safe culture
for intravenous medication infusion
administration at a large tertiary
children’s hospital. Education,
constant communication, impact
demonstration, and sustainability
were critical to the QI effort.
Pediatricians can follow this
method to acquire competence in
QI 21 and to apply this competence
in their own practices. The safety
impact is generalizable and can be
implemented in any busy location
of the hospital where critical
intravenous medication infusion is
used for emergency, urgent care,
or routine elective procedures. We
suggest that as a part of continuous
QI, health care facilities develop a
local policy to maintain and address
medication errors.
ACKNOWLEDGMENTS
We thank all the members of the QI
team: Lois Curtwright (radiology
anesthesia imaging, nursing clinical
director), John Holcomb, Kelly
Buczak, anesthesiologists, CRNAs,
radiology imaging nurses, and
radiology technicians.
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ABBREVIATIONS
CCHMC: Cincinnati Children’s
Hospital Medical Center
CRNA: certified registered nurse
anesthetist
EMR: electronic medical record
FMEA: failure modes and effects
analysis
PDSA: plan–do–study–act
QI: quality improvement
RN: registered nurse
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PEDIATRICS Volume 138 , number 6 , December 2016
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originally published online November 9, 2016; Pediatrics Rajeev Subramanyam, Mohamed Mahmoud, David Buck and Anna Varughese
Improvement InitiativeInfusion Medication Error Reduction by Two-Person Verification: A Quality
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originally published online November 9, 2016; Pediatrics Rajeev Subramanyam, Mohamed Mahmoud, David Buck and Anna Varughese
Improvement InitiativeInfusion Medication Error Reduction by Two-Person Verification: A Quality
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by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397. the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 2016has been published continuously since 1948. Pediatrics is owned, published, and trademarked by Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
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