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IHI Expedition: Preventing Obstetrical Adverse Events
Session 2: Executing Oxytocin Bundles
Peter Cherouny, MD
Deb Bell-Polson, MSN, RNC-OB
These presenters have nothing to disclose
Today’s Host
2
Kayla DeVincentis, Project Coordinator, has
worked at IHI since 2009, starting as an intern in
the Event Planning department. Since then, Kayla
has contributed to the STAAR Initiative, the IHI
Summer Immersion Program, and the IHI
Expeditions. Kayla obtained her Bachelor’s in
Health Science from Northeastern University and
brings her interest in health and wellness to IHI’s
Health and Fitness team.
3
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Schedule of Calls
Session 1 – Introduction to Obstetrical Adverse Events
Wednesday, May 30, 1:00 PM – 2:30 PM ET
Session 2 – Structure and Process for System Redesign
Date: Wednesday, June 13, 1:30 PM – 2:30 PM ET
Session 3 – Executing Oxytocin Bundles
Date: Wednesday, June 27, 1:30 PM – 2:30 PM ET
Session 4 – Designing Reliable Processes
Date: Wednesday, July 11, 1:30 PM – 2:30 PM
Session 5 – Using the Perinatal Trigger Tool to Identify System Harm
Date: Wednesday, July 25, 1:30 PM – 2:30 PM
Session 6 – Results Report-out and Advanced Bundles
Date: Wednesday, August 8, 1:30 PM – 2:30 PM5
Faculty
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Peter Cherouny, MD, Professor of Obstetrics and
Gynecology, University of Vermont College of Medicine,
has strong clinical interests in obstetric health care
quality improvement and is currently serving as Chair of
the Institute for Healthcare Improvement's Perinatal
Improvement Community. He was also the lead author
of the IHI white paper, "Idealized Design of Perinatal
Care." He has been Chair of Quality Assurance and
Improvement and Credentialing for the Women's Health
Care Service of Fletcher Allen Heathcare for the last 15
years. His recent research and work in obstetric quality
improvement is as Chair of the March of Dimes
collaborative, "Improving Prenatal Care in Vermont,"
and as co-investigator of the MedTeams project.
Faculty
7
Deb Bell-Polson, MSN, RNC-OB, is a Masters
prepared Perinatal Nurse with 22 years of experience.
Most recently has worked as a Clinical Nurse Manager
leading a multidisciplinary team that has had great
success in the IHI Perinatal Community. We had proven
results in changing culture for quality and safety and
achieving 95% compliance on the Elective Induction and
Augmentation bundles as well as the Vacuum Bundle.
Also serves on a regional Quality and Safety Network
guidelines team that is working to set regional standards
for care in the Northern New England region. Is most
recently a part of a state wide Committee to review
cases of Sudden unexplained infant Deaths and work to
prevent them in the future. When not working I keep
busy with my family of three sons and a wonderful
husband.
Objectives
1. Review the concept of the reliable design
strategies
2. Use the perinatal bundles as examples
of reliable design
Learning Objectives
At the end of the presentation, the participant:
• Will be able to state what reliable design means in a
clinical setting
• Will be able to describe the oxytocin and vacuum
bundles
• Will be able to implement bundles in their work setting
Questions from Session 2
• Is it recommended to have a written consent for oxytocin
or is documentation in progress notes sufficient?
─ Will be covered in today’s call
• Is peer review an acceptable form for the EFM and case
study review referred to in number 3 and 4 on the deep
dive?
─ Quality improvement work is very different than Peer Review.
• Does anyone have a standardized definition they find
useful for tachysystole when using an external monitor?
─ NICHD and ACOG definition
Why focus on perinatal care?
• Good science exists
• Significant variability in process.
─Care is provider driven rather than standardized.
─This autonomous practice focus contributes to the unreliable delivery of care.
What do we want to do?
• Prevent the preventable
• Defend the unpreventable
What is Idealized Design of Perinatal Care?
• The development of reliable clinical processes to manage labor and delivery (Perinatal Bundles)
• The use of principles that improve safety
(i.e., preventing, detecting, and mitigating errors)
• The establishment of prepared and activated care teams that communicate effectively with each other and with mothers and families
Reasons for the Reliability Gap In
Healthcare
• Communication─ 84% of sentinel events reported to JCAHO involving
fetal/infant adverse events cited communicationamong care providers as the primary factor
JCAHO. Preventing infant death during delivery. Sentinel event alert No. 30. 2004.
What is Reliability?
• “Reliability is failure free operation over
time.” David Garvin
Harvard Business School
What is Reliability?
Reliability
Bringing the right care to the right patient
every time by designing and building the
right system
Study of “Reliability” in American
Health Care
─Medical records for 6712 patients
─ 439 indicators of clinical quality of care
─ 30 acute and chronic conditions, plus prevention
McGlynn, et al: The quality of health care delivered to adults in the United States. NEJM 2003; 348: 2635-2645 (June 26, 2003)
Participants had received 54.9% of scientifically indicated
care (Acute: 53.5%; Chronic: 56.1%; Preventive: 54.9%)
McGlynn, et al: The quality of health care delivered to adults in the United States. NEJM 2003; 348: 2635-2645 (June 26, 2003)
Study of “Reliability” in American
Health Care
Reasons for the Reliability Gap In Healthcare
• Current Improvement methods in healthcare are highly dependent on vigilance and hard work
• The focus on benchmarked outcomes tends to exaggerate the reliability within healthcare hence giving both clinicians and leadership a false sense of security
• Permissive clinical autonomy creates and allows wide performance margins
• The use of deliberate designs to achieve articulated reliability goals seldom occurs
Improvement Concepts Associated with
10-1 Performance
Primarily can be described as intent, vigilance, and hard work
• Common equipment, standard order sheets, multiple choice protocols, and written policies/procedures
• Personal check lists
• Feedback of information on compliance
• Suggestions of working harder next time
• Awareness and training
Improvement Concepts Associated
with 10-2 Performance
• Uses human factors and reliability science to design sophisticated failure prevention, failure identification, and mitigation
Improvement Concepts Associated
with 10-2 Performance Uses human factors and reliability science to design sophisticated
failure prevention, failure identification, and mitigation
• Decision aids and reminders built into the system
• Desired action the default (based on scientific evidence)
• Redundant processes utilized
• Scheduling used in design development
• Habits and patterns known and taken advantage of in the design
• Standardization of process based on clear specification and articulation is the norm
The Reliability Design Strategy
• Prevent initial failure ─ intent and standardization function
• Identify failure (defects) and mitigate─ Redundancy function
• Measure and then communicate learning from defects─ Redesign function
Mindful Practice
• It is not enough to do your bestyou must know what to do
and then do your best
�W. Edwards Deming
Why Standardize?
• Contributes to building an infrastructure (who does what, when, where, how and with what)
• Support training and competency testing to sustain the process
• Achieve front line articulation of key processes by staff
• Allows the appropriate application of Evidence Based Medicine consistently
• Feedback about errors and application of learning to design is possible
The Clinical Bundle as Standardization
What is a Clinical Bundle?
• A group of clinical events that should happen every time
a given process occurs
• Individual elements based on solid science
• Emphasis initially on process rather than outcome
• Based on failure modes
• Eventual endpoint is outcome improvement
What is a Clinical Bundle?
• Bundle example with your life on the line
• Into Thin Air by Jon Krakauer
─Assault on Everest, Spring, 1996
Assault on Everest SummitHard and Fast Rules
• Acclimatization at altitude
• Work together
• Cannot assist someone on the ascent
• Fixed turn around time
• Acclimatization at altitude
• Work together
• Cannot assist someone on the ascent
• Fixed turn around time
Assault on Everest SummitSummit Bundle
• Standard acclimatization techniques─# days and at what altitude
• Work together
• Cannot assist someone on the ascent
• Fixed turn around time
Assault on Everest SummitSummit Bundle
• Standard acclimatization techniques
─# days and at what altitude
• Practice team work (between and among
teams)
• Cannot assist someone on the ascent
• Fixed turn around time
Assault on Everest SummitSummit Bundle
Assault on Everest SummitSummit Bundle
• Standard acclimatization techniques
─# days and at what altitude
• Practice team work (between and among
teams)
• No “short-roping” on the ascent
─No assisting with climbing on the ascent
• Fixed turn around time
Assault on Everest SummitSummit Bundle
• Standard acclimatization techniques─# days and at what altitude
• Practice team work (between and among teams)
• No “short-roping” on the ascent─No assisting with climbing on the ascent
• Turn around time fixed and honored ─(1 PM for most groups)
Assault on Everest SummitSummit Bundle Compliance
• All teams acclimatized but there was no standard
• Teams refused to cooperate on timing through Hilary’s Step (one person rope)
• Some climbers were assisted on the ascent as it was felt they had to summit on this climb
• Turn around time was set but not honored
─ Last summit was about 5 PM
Assault on Everest SummitResult
• Experienced leader; summits at 3PM
• Less experienced leader; assisted two
climbers up
• Inexperienced leader; split group up with
one climber summiting at 5 PM
Assault on Everest SummitResult
• Eleven Deaths
• Survivors
─PTSS
─Marital problems
─Work problems
Assault on Everest SummitSummit Bundle
• Standard acclimatization techniques─# days and at what altitude
• Practice team work (between and among teams)
• No “short-roping” on the ascent─No assisting with climbing on the ascent
• Turn around time fixed and honored ─(1 PM for most groups)
Quality Care in Obstetrics
• Pitocin Bundles as standardization of
care─Developing the Bundles
Quality Care in Obstetrics Birth Trauma
• Causation─Large fetuses
─Operative vaginal deliveries (esp midpelvic & combined)
─Vaginal breech delivery
─ Inappropriate use of pitocin
─Abnormal/excessive traction
─ Inadequate assessment of fetal status
Quality Care in ObstetricsBirth Trauma
• Prevention─Don’t deliver large fetuses
─Don’t do Operative vaginal deliveries
─Don’t do Vaginal breech delivery
─Don’t use pitocin
─Don’t pull too hard
─ Interpret fetal status perfectly
Quality Care in ObstetricsBirth Trauma and Pitocin
• Causation─Large fetuses
─Operative vaginal deliveries (esp midpelvic & combined)
─Vaginal breech delivery
─ Inappropriate use of pitocin (tachysystole)
─Abnormal/excessive traction
─ Inadequate assessment of fetal status
Quality Care in ObstetricsBirth Trauma and Pitocin
• Causation─Large fetuses
─Operative vaginal deliveries (esp midpelvic & combined)
─Vaginal breech delivery
─ Inappropriate use of pitocin (tachysystole)
─Abnormal/excessive traction
─ Inadequate assessment of fetal status
Quality Care in ObstetricsBirth Trauma and Pitocin
• Causation─Large fetuses
─Operative vaginal deliveries (esp midpelvic & combined)
─Vaginal breech delivery
─ Inappropriate use of pitocin (tachysystole)
─Abnormal/excessive traction
─ Inadequate assessment of fetal status
Quality Care in ObstetricsBirth Trauma and Pitocin
• Pitocin is involved in over 50% of the
situations leading to birth trauma
Quality Care in ObstetricsBirth Trauma and Pitocin
• Prevention of Pitocin Related Trauma─ Identify large babies
─Don’t do midpelvic deliveries when macrosomia is suspected
─Limit vaginal breech delivery
─ Identify and respond to tachysystole
─Avoid abnormal/excessive traction
─ Interpret fetal monitor by consensus guidelines
Quality Care in ObstetricsPitocin Use
• Use Pitocin Safely and Effectively
─Know everything about the drug
─Have established protocols and use them
Quality Care in ObstetricsPitocin Use
Requirements for elective labor induction
�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in ObstetricsPitocin Use
Requirements for elective labor induction
�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in ObstetricsElective Labor Induction-Requirements
Assessment of gestational age�Confirmation of Term Gestation
�Iatrogenic prematurity is unacceptable and indefensible
Quality Care in ObstetricsElective Labor Induction-Requirements
Confirmation of Term Gestation
• Fetal heart tones have been documented for 20 weeks
by nonelectronic fetoscope or for 30 weeks by Doppler.
• It has been 36 weeks since a positive serum or urine
human chorionic gonadotropin pregnancy test was
performed by a reliable laboratory.
• An ultrasound measurement at less than 20 weeks
supports gestational age of 39 weeks or greater.
• Amniocentesis and documentation of fetal maturity
ACOG Practice Bulletin #97, August 2008
Quality Care in ObstetricsElective Labor Induction-Requirements
Confirmation of Term Gestation
• An ultrasound measurement at less than 20 weeks
supports gestational age of 39 weeks or greater.
─ Ultrasonography may be considered to confirm
menstrual dates if there is a gestational age
agreement within 1 week by crown–rump
measurements obtained in the first trimester
─ An ultrasound obtained in the second trimester at up
to 20 weeks by multiple biometeric parameters
confirms the gestational age of at least 39 weeks
within 10 days. ACOG Practice Bulletin #97, August 2008
Quality Care in ObstetricsElective Labor Induction-Requirements
Requirements for elective labor induction�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in ObstetricsElective Labor Induction-Requirements
Monitoring fetal heart rate for reassurance�Reassuring Fetal Status – use a common
language (NICHD)
�Personnel familiar with the effects of uterine
stimulants on the fetus
�Physician capable of performing a cesarean
delivery should be readily available and responds
when asked
Quality Care in ObstetricsElective Labor Induction-Requirements
Requirements for elective labor induction�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
What is Tachysystole� > 5 contractions in 10 minutes
� Contractions persistently lasting greater than 2
minutes
� < 60 seconds baseline tone between contractions
� Tachysystole associated with fetal compromise not
necessary
Quality Care in Obstetrics
Elective Labor Induction-Requirements
What is Tachysystole
�> 5 contractions in 10 minutes� Contractions persistently lasting greater than 2
minutes
� < 60 seconds baseline tone between contractions
� Tachysystole associated with fetal compromise not
necessary
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Monitoring uterine contractions for
tachysystole
�Personnel familiar with the effects of uterine stimulants
�Monitoring fetal heart rate and uterine contractions is recommended as for any high-risk patient in active labor
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Requirements for elective labor induction
�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Pelvic assessment
�Cervical evaluation
� Bishop’s Score
�Fetal presentation and size
�Clinical Pelvimetry
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Requirements for elective labor induction
�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Elective Labor Induction Bundle
�Assessment of gestational age
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Elective Labor Induction Bundle
�Gestational age > 39 weeks
�Monitoring fetal heart rate for reassurance
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Elective Labor Induction Bundle
�Gestational age > 39 weeks
�Category I EFM
�Monitoring uterine contractions for tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Elective Labor Induction Bundle
�Gestational age > 39 weeks
�Category I EFM
�Absence of tachysystole with increases in pitocin/Response to tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Elective Labor Induction-Requirements
Elective Labor Induction Bundle
�Gestational age > 39 weeks
�Category I EFM
�Absence of tachysystole with increases in pitocin/Response to tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Augmentation-Requirements
Augmentation Bundle
�Gestational age > 39 weeks
�Category I EFM
�Absence of tachysystole with increases in pitocin/Response to tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Augmentation-Requirements
Augmentation Bundle
�Estimated fetal weight
�Category I EFM
�Absence of tachysystole with increases in pitocin/Response to tachysystole
�Pelvic assessment
Quality Care in Obstetrics
Augmentation-Requirements
Augmentation Bundle
�Estimated fetal weight
�Category I and some Category II EFM
�Absence of tachysystole with increases in pitocin/Response to tachysystole
�Pelvic Assessment
Reliable Design in Obstetrics
Implementing a Clinical Bundle
Composite Measures
• Measure each component of the bundles
individually to determine where to focus
your improvement efforts.
• When you reach 95% or greater, only
collect the all or nothing measurement.
Augmentation Composite
Chart
1
Chart
2
Chart
3
Chart
4
Chart
5
Total
EFW yes yes no no yes 3
Reassuring
FHR
yes yes yes yes yes 5
Pelvic Exam yes no no yes yes 3
Tachysystole no no no yes no 1
12/20=
60%
All or None Measurement
• All-or-none measurement fosters a system
perspective, not parts of the system
• Offers a more sensitive scale for
assessing improvements
Augmentation Bundle
All or None
Chart
1
Chart
2
Chart
3
Chart
4
Chart
5
EFW yes yes no no yes
Reassuring
FHR (not
Category III)
yes yes yes yes yes
Pelvic Exam yes no no yes yes
Tachysystole no no no yes no
TOTAL 0 0 0 0 00%
<70%
80%
90%
Hospital A
Your Experience
• Think of a process or service you think is reliable
• How do you know it is reliable?
• What makes it reliable?
Your Experience
• What is the first step or most critical step
in the process?
• Are there steps in the process where…
─ if you asked each person who does that step how they do it, would there be differences?
─ there are no tools for the step or there are several different tools?
─ if the step fails, how people respond is different?
Discuss your process
Are there steps where….
─people must rely on memory to complete any portion of the step (no reference, tool, etc.)?
─a distraction or interruption during the step would likely lead to failure of the step?
─are there >10 things a person must do at this step?
─a new or untrained person is much more likely to encounter error or failure with the step?
Lessons from Human Factors
• Reliance on memory
• Distractions / interruptions
• Fatigue
• Sleep deprivation
• Shift work
• Lack of training and experience
• Overload
• Psychosocial factors
Do you know if you do what you say you do…??
For one patient, for one shift,
with one nurse, with one
doctor?
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Always ask:
What is the real problem we are
trying to solve?
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Does your data look like this?
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Ju
ne
06
Ju
ly 0
6
Au
g 0
6
Se
pt
06
Oc
t 0
6
No
v 0
6
De
c 0
6
Ja
n 0
7
Feb
07
Mar
07
Ap
r 0
7
May
07
Ju
ne
07
Ju
ly 0
7
Au
g 0
7
Oc
t 0
7
No
v 0
7
De
c 0
7
Ja
n 0
8
Feb
08
Ap
r 0
8
May
08
Ju
ne
08
Ju
ly 0
8
Au
g 0
8
Se
pt
08
No
v 0
8
De
c 0
8
Ja
n 0
9
Feb
09
Ap
ril
09
May
09
Ju
ne
09
Ju
ly 0
9
Au
g 0
9
Se
pt
09
Oc
t 0
9
No
v 0
9
Induction Bundle - Gest Age≥39wks
86
Or like this?
87
In August, 4 infants were electively
delivered prior to 39 weeks gestation
and were transferred to NICU/SCN.
What are your conversations like?
Test for Reliability
Ask 5 different clinicians the following:
What is the definition of
tachsystole?
IHI’s Oxytocin Bundles-
References
1. ACOG Practice Bulletin Number 10, 1999 “Induction of Labor”:
2. ACOG Practice Bulletin Number 49, 2003 “Dystocia and Augmentation of Labor”
3. ACOG Practice Bulletin Number 70, 2005 “Intrapartum Fetal Heart Rate Monitoring.
4. ACOG Practice Bulletin Number 97, September 2008, “Fetal Lung Maturity”
Oxytocin Bundle References
5. The 2008 National Institute of Child
Health and Human Development
Workshop Report on Electronic Fetal
Monitoring, VOL. 112, NO. 3,
SEPTEMBER 2008. OBSTETRICS &
GYNECOLOGY.
Tools for Bundle Success
• One stop documentation- all bundle
elements rolled into a sticker/stamp
• Decision aids/reminders built into the
system.
• Everyone on the same page and
understanding of expectations.
Make it easy!
Tools for Bundle SuccessExamples
• Hard stop in booking elective cases- no
elective inductions (or elective
cesareans) prior to 39 weeks GA.
1. Stopped at the booking point
2. Prenatal record required on unit prior to booking of any procedure.
3. Supported by the Physician Champion and backed up by the OB/GYN Department.
Perinatal Care and IHI Perinatal Bundle
• Results
─Measure, Measure, Measure
Expedition Communications
• If you would like additional people to
receive session notifications please send
their email addresses to
• We have set up a listserv for the
Expedition to enable you to share your
progress. To use the listserv, address an
email to [email protected].
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Next Session
Session 4 – Designing Reliable
Processes
Date: Wednesday, July 11, 1:30 PM – 2:30 PM
Remember: Continuously add your data to your Storyboard!
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