Perinatal Safety Intervention Program

(PSIP)

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 death

• 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.

Bundles• 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 Infection)

CLABSI Bundle

1) ICU Daily Goals Worksheet2) 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 Patients • 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 (combined)– 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:– TeamSTEPPS– Hospital Survey on Patient Safety Culture – Electronic Fetal Monitoring Course (EFM) with Certification – Checklists for

– Hemorrhage– Shoulder dystocia– Eclampsia– 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 admission.

• 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 (

28-30) • 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 prevented.(32) • Studies conducted since then have determined that 28% to 65% if maternal deaths were

preventable.(33-36)• 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 factors.(36)

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

preventable. – 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 deaths.(47) – South Australia: 11% deficiencies in professional care.(48)– USA closed malpractice cases:

• 50% of hospital risk management budgets are allocated for obstetric events, and birth-related 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 skeleton.

– 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 result.(57)

• 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 hand-search for this manuscript.

Errors during perinatal care• Major contributing factors to errors include technical factors

such as lack of a standardized protocol, and non-technical factors such as poor communication among caregivers, non-escalation, and failure to respond when needed.(59)

• 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 (4-6)

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 pre-eclampsia(7)Failure to pay attention to vital signs and signs of hemorrhage following Cesarean section(7)

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 en-mass

TeamSTEPPS• 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)

Non-Technical• 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– TeamSTEPPS(75)– 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)Technical• Simulation and practicing emergency drills

– (on-site simulation, off-site simulation; for high-risk scenarios: shoulder dystocia, emergency Cesarean, maternal hemorrhage, neonatal resuscitation)(3, 23, 45, 82-85)

• 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– 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 BundleTable 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 BundleTable 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 weightAssessment 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 oxytocinContinuous monitoring and management of potential hyperstimulation (tachysytole) during use of oxytocinStandardized 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 augmentationEstimated fetal weightDocumentation of fetal well-being via 30-min EFM strip prior to augmentationStandardized order set with check-boxes and fill-in blanksContinuous electronic monitoring of the fetal heart rate (EFHRM) for reassurance during use of oxytocinContinuous monitoring and management of potential hyperstimulation (tachysytole) during use of oxytocinStandardized documentation with check-boxes and fill-in blanks

Sample BundleTable 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 ageNo combined usage of forceps and vacuum unless clinically compelling and justifiedNo more than 3 pop-offs or 20 minutes maximum total time of application

Evidence

• Before and After Studies– Risk of bias:

• Different subjects, different time periods, many uncontrolled variables

• Self-reporting bias• Publication bias

• No validated measure• Rare events– Low power

• Law of diminishing returns when target is zero or 100%

Evidence

• 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

Evidence

• 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?