2Design 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 challengePartners Promoting Perinatal Safety (P3S) have a One year contract, with options to add a second and then a third year.
3Patient Safetyemphasizes 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)
4Perinatal Safetyalthough unusual (1.5% of U.S. births), unintended perinatal harm can have serious and lifelong consequences for infants, mothers, and physicians at risk of liabilitypotential 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 deathmany 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
5Patient Safety Interventions can be subdivided into several categories:Communication ImprovementQuality ImprovementCulture of Safety and Learning OrganizationError ReportingHuman Factors EngineeringTechnologic SolutionsHealthcare Information Technology.
6Bundlesrecently, 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 individuallya small, straightforward set of practices - generally three to five - that, when performed collectively and reliably, have been proven to improve patient outcomessuccessful 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 contraindicatedexamples of successful bundles are: VAP and CLABSI (Ventilator Acquired Pneumonia and Central Line-Associated Bloodstream Infection)
7CLABSI Bundle 1) ICU Daily Goals Worksheet 2) Central Line Insertion Checklist3) Central Line Bundle1. Hand Hygiene2. Maximal Barrier Precautions Upon Insertion3. Chlorhexidine Skin Antisepsis4. Optimal Catheter Site Selection, with Avoidance of the Femoral Vein for Central Venous Access in Adult Patients5. Daily Review of Line Necessity with Prompt Removal of Unnecessary Lines
8VAP Bundle Original VUMC 6-pack bundle 1. Head of the Bed elevated 30O2. Daily Sedation Vacation3. Assessment of Readiness to Extubate = Spontaneous Breathing Trial4. Peptic Ulcer Disease (PUD) Prophylaxis5. Deep Venous Thrombosis (DVT) Prophylaxis6. Glycemic controlAlso important, but part of a universal safety initiative: Washing of hands before and after contact with each patientAlso included in some protocols: Continuous removal of subglottic secretions; Change of ventilator circuit no more often than every 48 hoursMore recently, there has been a 4-element bundle:1. Elevation of the Head of the Bed (HOB) between 30 and 45 degrees2. Daily "Sedation Vacations" and Assessment of Readiness to Extubate (combined)3. PUD Prophylaxis4. DVT ProphylaxisThe IHI added a 5th component:5. Daily Oral Care with Chlorhexidine
9VAP BundleDespite 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)
10Goals for this One-year contract Evidence Report about Perinatal Safety interventions, particularly intervention bundlesInterview expertswhat’s working and why?what didn’t work and why?what are the barriers to implementation?Create PSIP Course and ToolkitTraining manualField Testpotential 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
11Potential PSIP Components for Bundle(s) ‘minimum elements’ defined by AHRQ:TeamSTEPPSHospital Survey on Patient Safety CultureElectronic Fetal Monitoring Course (EFM) with CertificationChecklists forHemorrhageShoulder dystociaEclampsiaCord ProlapseObstetric Rapid Response TeamStandardized Procedures forOxytocinMagnesium sulphateStandardized Tachysystole protocolMonthly learning from defects or sensemaking sessions(quality improvement, discussing maternal mortality cases)Emergency drills using in situ (on the ward) simulationSAFE Cesarean ProgramOB White Board/Checklist Time Out
12Scope 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 births per year are estimated to involve adverse events (2%-10%), and at least half of these are preventable.(25)
13Maternal MortalityThe 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
14Maternal MorbidityFor 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)
15Perinatal MortalityThe 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 reportedsubstandard 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 deaththis 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)
16Perinatal Morbidityunadjusted rate of birth trauma in the USA has been reported as 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 careoxytocin 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)
17Near MissMost 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.
18Errors 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)
19Causes 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)
20Causes 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 cesareanappropriately resuscitate a depressed infantinappropriate use of: oxytocin - leading to uterine hyper stimulation (tachysystole), uterine rupture, and fetal distress and or deathinappropriate 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 diagnosisfailure to adhere to protocolslack of consultant supervisioncommunication and documentation problemsinefficient teamwork and organizational failure.(68)
21Preventable 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 FailuresFailure 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)
22Preventable 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 MisuseInappropriate 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 OmissionA major error omission, amenable to correction, is VTE prevention in at-risk patients (7)
23Perinatal safety interventions (PSI) that target the identified causes of errors that lead to adverse eventsPerinatal 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 interventionsInterventions 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)
24Non-technical interventions adopting a culture of safetysafety educationadequate nurse staffingoptimal communication and teamworkmultidisciplinary shift-to-shift hand-off reportsdebriefs 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
25TeamSTEPPSA 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)
26Technical 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 careThese 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.
27Categories of Perinatal Safety Interventions (PSI) Non-TechnicalPatient 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 MedTeamsTeamSTEPPS(75)Standardized Communication – SBARCommunication packageInterdisciplinary RoundingEscalation PolicyAccountability and responsibilityLeadership 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)
28Categories of Perinatal Safety Interventions (PSI) TechnicalSimulation 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, MgSO4Intrauterine resuscitation during nonreassuring FHR patterns (see Table XX-FSFTRPT)(79)Early term birth3rd/4th laceration (perineum/perianal)Post-partum hemorrhage (PPH)Cesarean: instrument count (OB Whiteboard) and Time-Out checklistVTE prophylaxisClinical bundlesInduction (see Table XX-IoL)Augmentation (see Table XX-AoL)Vacuum or forceps delivery (Instrumented Delivery – see able XX-ID)Shoulder dystociaRapid response team (multi-disciplinary)Emergency CesareanMaternal hemorrhage – antepartum and postpartumOther perinatal emergencies
29Non-technical and Technical Packages 2008 Ascension Health – Seton Family of Hospitals2009 CHP – Catholic Health Partners2009 Kaiser Permanente2010 CHI – Catholic Health Initiatives2011 HCA2011 Yale-New Haven Hospital2011 North Shore-Long Island Jewish Health System
30Sample Bundle Table XX-EFHRM Electronic FHR Monitoring Bundle EFM training credentialed staff: qualified and certified to appropriately interpret and respond to fetal heart rate tracingsEscalation policy related to worrisome tracingsA known responsible providerOrganized capability for rapid response of multiple disciplines
31Sample 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 inductionEstimated 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 inductionStandardized 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
32Sample BundleTable 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
33Sample Bundle Table XX-ID: Instrumented Delivery Bundle (10, 12) Estimated fetal weight, fetal position, cephalic position, and station known and documented in the medical recordCesarean and resuscitation teams availableNo 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
34Evidence Before and After Studies No validated measure Rare events Risk of bias:Different subjects, different time periods, many uncontrolled variablesSelf-reporting biasPublication biasNo validated measureRare eventsLow powerLaw of diminishing returns when target is zero or 100%
35Evidence Quality Strength Poor (high risk of bias) 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 effectInsufficient = available evidence inadequate for conclusion: too weak, too sparse, too inconsistent
36Evidence 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?