Perinatal Safety Intervention Program

Perinatal Safety Intervention Program
Design and Development of a
Perinatal Safety Intervention Program
• Agency for Healthcare Research and Quality
(AHRQ) contract has been awarded to Partners
Promoting Perinatal Safety (P3S), a partnership
between RTI International, Vanderbilt University,
and the University of North Carolina—the
opportunity to bring our considerable experience
in patient safety interventions and perinatal care
to this challenge
• Partners Promoting Perinatal Safety (P3S) have a
One year contract, with options to add a second
and then a third year.
Patient Safety
• emphasizes the prevention of iatrogenic errors
that can lead to adverse events; or “freedom
from injuries or harm to patients from care
that is intended to help them”
• indeed, absolute patient safety would be the
absence of any error, harm, or adverse event
due to health care (zero events)
Perinatal Safety
• although unusual (1.5% of U.S. births), unintended
perinatal harm can have serious and lifelong consequences
for infants, mothers, and physicians at risk of liability
• potential harms that may occur during or as a result of
labor and birth include birth trauma, birth asphyxia,
iatrogenic prematurity, infection, and medication errors,
with potential outcomes ranging from short-term morbidity
to permanent impairment and even maternal or neonatal
• many of these occurrences may be related to preventable
circumstances, including failure to recognize a fetus in
distress, initiate a timely cesarean section, or properly
resuscitate a depressed baby; and inappropriate use of
labor-inducing drugs or vacuum or forceps
Patient Safety Interventions
can be subdivided into several categories:
• Communication Improvement
• Quality Improvement
• Culture of Safety and Learning Organization
• Error Reporting
• Human Factors Engineering
• Technologic Solutions
• Healthcare Information Technology.
• recently, multiple safety initiatives that can impact one safety
concern have been packaged into “bundles”
• a bundle is a group of evidence-based interventions related to a
disease process that, when executed together, result in better
outcomes than when implemented individually
• a small, straightforward set of practices - generally three to five that, when performed collectively and reliably, have been proven to
improve patient outcomes
• successful implementation of the bundles is based on the “all or
nothing” strategy; that is, teams must comply with all components
of the bundle, unless medically contraindicated
• examples of successful bundles are: VAP and CLABSI (Ventilator
Acquired Pneumonia and Central Line-Associated Bloodstream
1) ICU Daily Goals Worksheet
2) Central Line Insertion Checklist
3) Central Line Bundle
• 1. Hand Hygiene
• 2. Maximal Barrier Precautions Upon Insertion
• 3. Chlorhexidine Skin Antisepsis
• 4. Optimal Catheter Site Selection, with Avoidance of
the Femoral Vein for Central Venous Access in Adult
• 5. Daily Review of Line Necessity with Prompt Removal
of Unnecessary Lines
VAP Bundle
• Original VUMC 6-pack bundle
1. Head of the Bed elevated 30O
2. Daily Sedation Vacation
3. Assessment of Readiness to Extubate = Spontaneous Breathing Trial
4. Peptic Ulcer Disease (PUD) Prophylaxis
5. Deep Venous Thrombosis (DVT) Prophylaxis
6. Glycemic control
• Also important, but part of a universal safety initiative: Washing of hands before and
after contact with each patient
• Also included in some protocols: Continuous removal of subglottic secretions; Change of
ventilator circuit no more often than every 48 hours
• More recently, there has been a 4-element bundle:
– 1. Elevation of the Head of the Bed (HOB) between 30 and 45 degrees
– 2. Daily "Sedation Vacations" and Assessment of Readiness to Extubate
– 3. PUD Prophylaxis
– 4. DVT Prophylaxis
• The IHI added a 5th component:
– 5. Daily Oral Care with Chlorhexidine
VAP Bundle
• Despite the publication of positive results of VAP Bundle implementation
and VAP prevention from specific ICU teams on the IHI website, a
systematic literature review on the effectiveness of the IHI Ventilator
Bundle to prevent VAP revealed major methodologic flaws in the design,
reporting, and results of the published studies that were reviewed.(14)
• The methodologic flaws of the studies included bias, confounding, and
lack of generalizability and precluded any conclusive statements about the
bundle's effectiveness or cost-effectiveness.
• These authors concluded that, to ensure efficient allocation of the limited
healthcare resources, rigorous evaluation of optimal strategies for VAP
prevention is needed to establish best practices and create a benchmark
against which new technologies' value can be assessed.
• At the time of this writing, the VAP bundle is undergoing evidence-based
analysis for determination evidence-based modification of pre-existing
components and proposed new components.(15)
• Proponents of perinatal safety initiatives may learn from the cautionary
tale of the implementation successes and the critiques of these early
safety bundle initiatives.(16)
Goals for this One-year contract
• Evidence Report about Perinatal Safety interventions, particularly
intervention bundles
– Interview experts
• what’s working and why?
• what didn’t work and why?
• what are the barriers to implementation?
• Create PSIP Course and Toolkit
– Training manual
• Field Test
– potential bundles and components (checklists, tools, standardized
procedures, simulation, etc)
• Options Years: train master trainers and deploy PSIP course and
implementation in L&D and nursery, numerous sites
Potential PSIP Components for Bundle(s)
• ‘minimum elements’ defined by AHRQ:
Hospital Survey on Patient Safety Culture
Electronic Fetal Monitoring Course (EFM) with Certification
Checklists for
Shoulder dystocia
Cord Prolapse
– Obstetric Rapid Response Team
– Standardized Procedures for
– Oxytocin
– Magnesium sulphate
– Standardized Tachysystole protocol
– Monthly learning from defects or sensemaking sessions
– (quality improvement, discussing maternal mortality cases)
– Emergency drills using in situ (on the ward) simulation
– SAFE Cesarean Program
OB White Board/Checklist Time Out
Scope of the current perinatal safety problem
• No comprehensive data about perinatal care errors and
preventable deaths across the United States exist.
• Recent data from subsets of perinatal care
demonstrate that adverse events are common in
obstetrics, and a large percentage of major adverse
events are preventable.(23)
• With more than 4.3 million annual births(24), or nearly
12,000 births each day in the United States,(24)
childbirth is the most common reason for hospital
• Between 80,000-400,000 births per year are estimated
to involve adverse events (2%-10%), and at least half of
these are preventable.(25)
Maternal Mortality
The number of maternal deaths in the U.S. is not known, and estimates are likely to be low
because many cases are not reported.(27)
The rate of maternal deaths is estimated to be between 12.7 and 13.3 per 100,000 live births
More problematic is the extraordinarily higher ratio among African-American women: 28.4 to
36.5 deaths per 100,000 births.(29, 31)
Many of the direct maternal deaths are not due to healthcare errors.
The proportion of direct maternal deaths that are avoidable has not been established.
CDC in 1998: more than half of the known direct maternal deaths could have been
Studies conducted since then have determined that 28% to 65% if maternal deaths were
These estimates extrapolate to about 250 preventable maternal deaths annually for the
entire USA.
The U.S. Department of Health and Human Services set our national goal for a maternal
death ratio to be no higher than 3.3 deaths per 100,000 births by 2010.(37). We are now past
the target date, but the country has not achieved the goal; in fact, we are moving in the
wrong direction. (37-39)
Studies from other developed nations provide estimates of preventable maternal mortality.
Norway: 54% avoidable or potentially avoidable(40)
Netherlands: substandard care factors in 96% of cases, and 63% of cases had more than five substandard
care factors.(41, 42)
U.K. (11.4/100,000 maternities): substandard care in 70% of direct deaths and 55% of indirect deaths
Maternal Morbidity
• For 1991 through 2003, the severe maternal morbidity
rate in the U.S. for severe complications and conditions
associated with pregnancy was 50 times more common
than maternal death.(44)
• This estimate extrapolates to more than 25,000 cases
of severe maternal morbidity annually in the USA.
• A 2007 review of maternal morbidity and mortality
noted that that 30% to 40% of near-miss and severe
maternal morbidities may be preventable through
changes in patient, healthcare provider, and system
Perinatal Mortality
• The number of perinatal deaths in the U.S. is not known, and estimates
are likely to be low because many cases are not reported. (45)
• The rate of perinatal deaths is estimated to be between 6.8 and 6.9 per
1000 live births. (45) (29) (30) The total number of perinatal deaths
exceeds 28,000 per year.
• Studies from other developed nations indicate many perinatal deaths are
– Netherlands: more than 20% of perinatal deaths were not reported
• substandard care factors were identified in 32% of cases. (46)
• of the cases with substandard care factors, 31% were judged as the probable or very
probable cause of death, and 35% were judged as the possible cause of death
• this means that two-thirds of the perinatal deaths with substandard factors were at least
probably avoidable, and the other one-third were near-misses.
• 22% of perinatal deaths were potentially avoidable.(46)
– Amsterdam: substandard care factors were identified in 35% of all perinatal
– South Australia: 11% deficiencies in professional care.(48)
– USA closed malpractice cases:
• 50% of hospital risk management budgets are allocated for obstetric events, and birthrelated events account for over 75% of claims paid in amounts over $1 million.(49)
• 70% of perinatal claims were associated with substandard care.(50)
• 34% of the adverse outcomes were related to intrapartum hypoxemia, and these cases
accounted for 53% of total dollars paid in verdicts or settlements.(50)
Perinatal Morbidity
• unadjusted rate of birth trauma in the USA has been reported as 25.85 per
1000 live births.(52)
– Main included categorizations of birth trauma are: subdural and cerebral
hemorrhage, epicranial subaponeurotic hemorrhage, fracture of clavicle,
injury to spine and spinal cord, facial nerve injury, injury to brachial plexus,
other cranial and peripheral nerve injuries, and other injuries to scalp and
– Adjustment to birth trauma cases excludes preterm and very preterm
neonates, and cases of osteogenesis imperfecta.
• adjusted rate of birth trauma in the USA is in the range of 5-10 per 1000
live births.(18, 30, 52-55)
• 50% of these birth trauma events were estimated to be preventable.(55)
• Sweden:
– 50% of the metabolic acidosis cases displayed at least one occurrence of
suboptimal care
– oxytocin misuse was described in 47% and failure to respond to a pathologic
EFM pattern and/or uterine tachysystole in 20%
– 40-50% of cases of neonatal metabolic acidosis were preventable.(56)
Near Miss
• Most errors do not result in adverse outcomes; these errors are called
‘near misses’.
• A near miss is the recognition of a potential adverse event, with errors of
commission or omission where harm could have occurred but did not,
either due to chance, prevention, or corrective action.
• Reason described a swiss-cheese model of error and accident causation,
pictured by several slices of swiss-cheese separated by space where the
slices indicated a series of interactions and the holes indicated a potential
for error – in most cases, the holes do not line up and an error at one
point in time may be caught and corrected before a harm occurs. Only
when the holes line up, and a series of errors or misses occurs will a harm
• The practical implementation of maternal near miss concept should
provide an important contribution to improving quality of obstetric care to
reduce maternal deaths and improve maternal health.(58)
• No near-miss data about perinatal safety was found during the handsearch for this manuscript.
Errors during perinatal care
• Major contributing factors to errors include technical
factors such as lack of a standardized protocol, and nontechnical factors such as poor communication among
caregivers, non-escalation, and failure to respond when
• Poor communication increases the risk of error tenfold.(60)
• Poor teamwork accounts for about 55% of active failures in
hospital settings.(61)
• There are four factors in health care contributing to medical
errors that can lead to patient harm: (1) human fallibility,
(2) complexity, (3) system deficiencies, and (4) vulnerability
of defensive barriers.
• All of these factors must be addressed to significantly
improve patient safety.(62)
Causes of errors that lead to perinatal
harms/errors avoidable adverse events
Labor and delivery units operate 24 hours a day and undergo upheavals in volume
and intensity of care.
Commonly described contributing factors to errors include unpredictable surge in
demand, understaffing, and fatigue.
There has not been a comprehensive analysis of the causes of errors across the
spectrum of perinatal adverse events, and therefore we have a patchwork quilt of
hospital studies, statewide database studies, root cause analysis of selected cases,
and malpractice and closed-case analysis.
The Joint Commission reported that non-technical failures in teamwork and
communication accounted for 72 percent of adverse outcome events (sentinel
events) in obstetrics.(45)
In the U.K., substandard care contributed to approximately 50% of maternal
deaths, with poor communication and teamwork being the primary factors in the
substandard care. (63).
Poor communication and coordination in providing care has been identified in 43%
of the closed malpractice claims in obstetrics.(64).
A survey of liability cases with paid claims found that alleged misuse of oxytocin
was a factor in 50%.(65)
Causes of errors that lead to fetal and
neonatal injury (avoidable adverse events)
• Identified factors that accounted for the majority of fetal and
neonatal injury were inability to:
recognize and respond to intrapartum fetal distress,
effect a timely cesarean
appropriately resuscitate a depressed infant
inappropriate use of: oxytocin - leading to uterine hyper stimulation
(tachysystole), uterine rupture, and fetal distress and or death
– inappropriate use of forceps/vacuum -leading to fetal trauma and/or
preventable shoulder dystocia.(66, 67)
• A high proportion of severe post-partum hemorrhage cases involve
patient safety incidents. The major themes in such incidents are:
delay in diagnosis
failure to adhere to protocols
lack of consultant supervision
communication and documentation problems
inefficient teamwork and organizational failure.(68)
Preventable Errors expressed as Failures
• A broad-stroke way of categorizing preventable errors is to group them
into failures to respond and act when a specific condition is present; the
most commonly identified six perinatal failures are:
Preventable Errors Expressed as Failures
Failure to recognize and respond to intrapartum fetal distress(incl. during use of
oxytocin) (3-5)
Failure to recognize and properly resuscitate a depressed newborn infant in distress
Failure to initiate and complete a timely cesarean birth when indicated by maternal or
fetal conditions (4-6)
Failure to adequately control blood pressure in hypertensive women(7)
Failure to adequately diagnose and treat pulmonary edema in women with preeclampsia(7)
Failure to pay attention to vital signs and signs of hemorrhage following Cesarean
Preventable Errors of Commission
Expressed as Inappropriate Use or Misuse
• Correcting the failures involves careful surveillance, timely identification of
complications, appropriate interventions, and activating a team response.
• Three more common preventable perinatal care errors have also been
categorized by commission or omission:
Preventable Errors of Commission Expressed as Inappropriate Use or Misuse
Inappropriate use of labor-inducing drugs (misoprostol, oxytocin) leading to
uterine hyperstimulation (tachysystole), uterine rupture, and fetal distress and
or death (3-6)
Inappropriate use of vacuum or forceps, leading to birth trauma and/or
preventable shoulder dystocia (4-6)
Preventable Errors of Omission
A major error omission, amenable to correction, is VTE prevention in at-risk
patients (7)
Perinatal safety interventions (PSI) that target the
identified causes of errors that lead to adverse events
• Perinatal safety interventions may be implemented as
an individual component, as a bundle, or as a package.
– A package may be implemented during one short period,
or rolled-out in waves over a period of months.
• Technical and non-technical interventions
• Interventions have focused on technical interventions,
such as guidelines and checklists and use of
information technology, and on non-technical
interventions, such as team and individual training,
communication enhancement, and education.(2, 72)
Non-technical interventions
adopting a culture of safety
safety education
adequate nurse staffing
optimal communication and teamwork
multidisciplinary shift-to-shift hand-off reports
debriefs after an adverse outcome.(73)
• High-reliability organizations (HRO), such as the airline
industry, use a package of human factor techniques called
crew resource management (CRM), including briefings,
assertion, situational awareness, and recognition of red
flags.(74) These non-technical safety interventions are
usually combined into a large bundle and implemented enmass
• A team training intervention that emphasizes communication
techniques is known as TeamSTEPPS (Team Strategies and Tools to
Enhance Performance and Patient Safety).(75)
• TeamSTEPPS is a program of team building training to support the
transition of evidence-based best practices into tools and strategies
that maximize team performance in the delivery of healthcare.
• TeamSTEPPS defines the standards of effective communication as
being complete, clear, brief, and timely.
• TeamSTEPPS has several tools to help achieve these goals; a
significant technique is the ‘‘check back,’’ a technique in which the
receiver of information repeats the information back to the speaker
to ensure that it has been heard correctly and understood. (21)
Technical interventions
Technical interventions may be implemented universally, such as hand-washing,
electronic medical records (EMR) , or computerized physician order entry (CPOE).
Another universal technical implementation is in-situ simulation of perinatal
critical events, consisting of at least five components: briefing, in-situ simulation
activity, debriefing, rapid-cycle follow-through with process improvements, and
repetition to reinforce skills and create resiliency.
A technical intervention with broad application is training in the recognition of
non-reassuring and abnormal electronic fetal heart rate monitoring (EFM). (77)
Technical interventions may be implemented at the beginning of a specific episode
of care, such as induction of labor, or decision to perform cesarean, or diagnosis of
eclampsia. These interventions are targeted at safety concerns that are associated
with these episodes of care.
– use of oxytocin has been associated with preventable adverse outcomes, including uterine
rupture, stillbirth, and birth asphyxia.(78)
hyperstimulation of uterine contractions or tachysystole is a red flag warning that use of oxytocin may
be causing harm.
– Perinatal safety intervention (PSI) bundles exist for the induction of labor episode of care and
the augmentation of labor episode of care
These bundles are initiated simultaneously with the consideration of misoprostol or oxytocin
induction or augmentation and before the order to commence induction or augmentation.
– A standardized operating procedure is recommended for the response to fetal distress during
oxytocin administration .(79)
Another technical intervention would be standardized orders for prophylactic
antibiotics and for venous thromboembolic prophylaxis for patients who will
undergo Cesarean section.
Categories of Perinatal Safety Interventions (PSI)
• Patient Safety Climate Survey(21)
• CUSP implementation (Comprehensive Unit-based Safety Program)
• Team sessions, monthly (learning from defects, sensemaking sessions,
quality improvement, discussing maternal mortality cases)
• Team-Training and Communication(21)
Crew Resource Management and MedTeams
Standardized Communication – SBAR
Communication package
• Interdisciplinary Rounding
• Escalation Policy
• Accountability and responsibility
– Leadership structures and systems (organization-wide awareness of patient
safety performance and gaps, direct accountability of leaders for those gaps,
and adequate investment in performance improvement abilities, and that
actions are taken to ensure safe care of every patient served)(21, 80, 81)
Categories of Perinatal Safety Interventions (PSI)
• Simulation and practicing emergency drills
EFM training, testing, certification (proof of competency, refreshing)
Clinical checklists (hemorrhage, shoulder dystocia, eclampsia, cord prolapse, fetal tachysystole)
Standard Operating Procedures (SoP) (standard orders, CPOE, nursing policy, algorithm)
Oxytocin, misoprostol, MgSO4
Intrauterine resuscitation during nonreassuring FHR patterns (see Table XX-FSFTRPT)(79)
Early term birth
3rd/4th laceration (perineum/perianal)
Post-partum hemorrhage (PPH)
Cesarean: instrument count (OB Whiteboard) and Time-Out checklist
VTE prophylaxis
Clinical bundles
(on-site simulation, off-site simulation; for high-risk scenarios: shoulder dystocia, emergency Cesarean,
maternal hemorrhage, neonatal resuscitation)(3, 23, 45, 82-85)
Induction (see Table XX-IoL)
Augmentation (see Table XX-AoL)
Vacuum or forceps delivery (Instrumented Delivery – see able XX-ID)
Post-partum hemorrhage (PPH)
Shoulder dystocia
Rapid response team (multi-disciplinary)
Emergency Cesarean
Shoulder dystocia
Maternal hemorrhage – antepartum and postpartum
Other perinatal emergencies
Non-technical and Technical Packages
2008 Ascension Health – Seton Family of Hospitals
2009 CHP – Catholic Health Partners
2009 Kaiser Permanente
2010 CHI – Catholic Health Initiatives
2011 HCA
2011 Yale-New Haven Hospital
2011 North Shore-Long Island Jewish Health System
Sample Bundle
Table XX-EFHRM Electronic FHR Monitoring Bundle
EFM training credentialed staff: qualified and certified to
appropriately interpret and respond to fetal heart rate tracings
Escalation policy related to worrisome tracings
A known responsible provider
Organized capability for rapid response of multiple disciplines
Sample Bundle
Table XX-IoL: Induction of Labor Bundle (10, 12-16)
Documentation of: indication for induction; pelvic assessment for adequacy; status
of the cervix – prior to initiation of induction
Estimated fetal weight
Assessment of gestational age (ensuring that gestational age is ≥ 39 weeks)
Documentation of fetal well-being via 30-min EFM strip prior to initiation of induction
Standardized order set for misoprostol with check-boxes and fill-in blanks (based
on ACOG/AWHONN guidelines)
Standardized order set for oxytocin with check-boxes and fill-in blanks (based on
ACOG/AWHONN guidelines)
Continuous electronic monitoring of the fetal heart rate (EFHRM) for reassurance
during use of oxytocin
Continuous monitoring and management of potential hyperstimulation (tachysytole)
during use of oxytocin
Standardized documentation with check-boxes and fill-in blanks
Sample Bundle
Table XX-AoL: Augmentation of Labor Bundle (10, 12-14, 16)
Documentation of: indication for augmentation; pelvic assessment for
adequacy; status of the cervix; station – prior to initiation of augmentation
Estimated fetal weight
Documentation of fetal well-being via 30-min EFM strip prior to augmentation
Standardized order set with check-boxes and fill-in blanks
Continuous electronic monitoring of the fetal heart rate (EFHRM) for
reassurance during use of oxytocin
Continuous monitoring and management of potential hyperstimulation
(tachysytole) during use of oxytocin
Standardized documentation with check-boxes and fill-in blanks
Sample Bundle
Table XX-ID: Instrumented Delivery Bundle (10, 12)
Estimated fetal weight, fetal position, cephalic position, and station
known and documented in the medical record
Cesarean and resuscitation teams available
No vacuum applied for fetus prior to 36 weeks of gestational age
No combined usage of forceps and vacuum unless clinically compelling
and justified
No more than 3 pop-offs or 20 minutes maximum total time of
• Before and After Studies
– Risk of bias:
• Different subjects, different time periods, many uncontrolled
• Self-reporting bias
• Publication bias
• No validated measure
• Rare events
– Low power
• Law of diminishing returns when target is zero or
• Quality
– Poor (high risk of bias)
• Strength
– Low to Insufficient
• (high risk of bias, heterogeneity means no consistency,
few direct outcome measures, minimal precision stats)
• Low = not confident of true effect, further research
likely to change confidence and estimate of effect
• Insufficient = available evidence inadequate for
conclusion: too weak, too sparse, too inconsistent
• Apples and Oranges?
• Should the standards used for studies of
interventions targeted to improve diseases
and conditions (studies of effectiveness and
harm) be applied to interventions targeted to
prevent iatrogenic harms?