Zero Birth Injury Initiative

1. Zero Birth Injury Initiative Phillip N. Rauk, MD Associate Professor, Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women’s Health, University of Minnesota Medical School and Medical Director of the Birthplace at UMMC-Fairview Hospital

2. Objectives • Basic safety improvement strategies • Definition of birth trauma • Brief story from Ascension Health • Bundle science and IHI obstetrics bundles • Impact of shoulder dystocia • Where are we at Fairview?

3. Why are we doing this? • Overall goal of the initiative is to reduce birth injury • UMMC birth injury rate 2007 – 0.03% • Birth injury is devastating to all involved • “Right thing to do” • Improve patient safety • Improve perinatal outcomes • Reduce medical and nursing errors

4. Preventable Perinatal Harm and Obstetrical Liability • Failure to recognize fetal distress/non-reassuring fetal status • Failure to effect a timely cesarean section • Failure to properly resuscitate a depressed baby • Inappropriate use of oxytocin/misoprostol • Inappropriate use of vacuum/forceps • Failure to manage shoulder dystocia

5. Characteristics of a Successful Safety Change Initiative High functioning team rather than expert individuals Shared mental models Situational awareness Common language Policies and order sets support these initiative

6. Strategy to create HighlyReliable Teams within a culture of organizational learning In Situ™ Simulation Experiential learning & application, test for gaps In the “real world” High Reliability Just Culture™ Principles of risk, Accountability, Behavioral choices, Drift, and use of Coaching after errors TeamSTEPPS™ Define the team, Curriculum Training & implementation of Action Plans “ME-YOU-US” Stan Davis, MD, FACOG & Kristi K Miller RN, MS

7. Adverse Outcome Index Measure and Weighting Score Index Measure Score Maternal Death 750 Intrapartum and Neonatal Death 400 Uterine Rupture 100 Maternal Admission to ICU 65 Birth Trauma 60 Return to OR/L&D 40 Admission to NICU 35 APGAR <7 25 Blood Transfusions 20 3rd and 4th degree perineal laceration 5

8. Birth Trauma as defined for the AOI Measure • In-born infants only and diagnosis of • 767.0 Subdural and Cerebral Hemorrhage (due to trauma or to intrapartum anoxia or hypoxia) • 767.11 Epicranialsubaponeurotic hemorrhage (massive) • 767.3 Injuries to skeleton (excludes clavicle) • 767.4 Injury to spine and spinal cord • 767.5 Facial nerve Injury • 767.6 Injury to brachial plexus* • 767.7 Other cranial and peripheral nerve injuries • * Not used in AHRQ PSI 17 measure for Birth Trauma Infant

9. AHRQ Patient Safety Indicator (PSI) 17 - Birth Trauma • • Numerator • – Discharges among cases meeting the inclusion and exclusion rules • for the denominator with ICD-9-CM code for birth trauma in any • diagnosis field • Exclude infants • With any diagnosis code of pre-term infant (denoting birth weight of • less than 2,000 grams) • With any diagnosis code of osteogenesisimperfecta (756.51) • With any diagnosis code of injury to brachial plexus (767.6)

10. Birth Trauma as defined by the AHRQ PSI 17Birth Trauma Infant • 767.0 Subdural and Cerebral Hemorrhage (due to trauma or to intrapartum anoxia or hypoxia) • 767.11 Epicranialsubaponeurotic hemorrhage (massive) • 767.3 Injuries to skeleton (excludes clavicle) • 767.4 Injury to spine and spinal cord • 767.5 Facial Nerve Injury • 767.7 Other cranial and peripheral nerve injuries • 767.8 Other specified birth trauma* *Not used in AOI Birth Trauma Measure

11. Story at Ascension Health • Three hospital sites were selected for implementation of: • Standardized order sets specific to augmentation and induction of labor • Complete adherence to a IHI induction, augmentation and operative delivery bundles • Best practices sharing across all disciplines • Effective communication strategies using SBAR and culture change

12. Story at Ascension Health • From February 2004 to June 2006 • Bundle compliance achieved the goal of 95% compliance • Elective inductions before 39 weeks fell to zero • Operative delivery rate fell from 7.4% to 4.8% • Birth trauma rate fell from 0.2% to 0.03% • Primary cesarean rate remained unchanged at 22.5%

13. Ascension Health Birth Trauma

14. Quality Care in ObstetricsAddressing Harm Using Bundles • The Bundle Science • Individual components supported by evidence based medicine/professional guidelines • Required to be performed for every patient, every time • Bundle compliance measured by fulfilling all parts of the bundle • Focus on system

15. Bundle Science • A bundle is a group of evidence-based interventions related to a disease or care process that, when executed together, result in better outcomes than when implemented individually. • All components of the bundle must be met to achieve the desired better outcome

16. The Oxytocin Bundles • Augmentation Bundle • Documentation of Estimated Fetal Weight • Reassuring Fetal Status • Pelvic Exam prior to the start of Oxytocin • Recognition and management of Hyperstimulation • Elective Induction Bundle • Gestational Age > 39 weeks • Reassuring Fetal Status • Pelvic Exam prior to the start of Oxytocin • Recognition and management of Hyperstimulation

17. No Elective Inductions at < 39 weeks No Elective Late-Preterm Infants • Hypoglycemia • Rehospitalization for any cause • Rehospitalization for neonatal dehydration • Death • Feeding difficulties • Long term behavioral problems • RDS • TTN • Pulmonary infection • Unspecified respiratory failure • Recurrent apnea • Temperature instability • Jaundice that delays discharge • Bilirubin induced brain injury (Pediatrics, September 2006. 118:1207)

18. Vacuum Bundle • Alternative labor strategies considered • Prepared patient • Informed consent discussed and documented • High probability of success • EFW, fetal position and station known • Maximum application time and number of pop-offs predetermined • Exit strategy available • Cesarean and resuscitation team available

19. Vacuum Delivery Incidence of operative vaginal delivery is 10 – 15% Compared with SVD (SVD vs Vacuum) Rate of Death is 1/5000 vs 1/3333 Rate of IVH is 1/1900 vs 1/860 Rate of all injury is 1/216 vs 1/122 Includes nerve injury, seizure, CNS depression, mechanical ventilation Vacuum and Forceps rate of death is 1/1666 and rate of IVH is 1/280. ACOG 2000

20. Pop-Offs “Pop-offs” are defined as a sudden complete detachment of the vacuum from the head with a rapid loss of pressure from the green zone to zero pressure. The number of “pop-offs” correlates with birth trauma, ranging from abrasions to subgaleal hemorrhage Generally > 3 increases the risk for birth injury

21. Maximum Pulls A pull is defined as use of traction during each contraction not the number of pulls within each contraction. There is no clear definition of the maximum pulls that should be attempted before the procedure is abandoned. Most experts feel up to 3-4 pulls is appropriate if progression in descent is noted with each subsequent pull. Failure to abandon the procedure when progress has not occurred is associated with an increase in birth trauma

22. Application Time There is limited data on application time Longer application times are associated with an increased risk for failure and for neonatal morbidities Most experts believe that consistent with other guidelines in the use of vacuum (i.e maximum pulls and progress) that 10 – 20 minutes is appropriate and that failure of any descent after 10 minutes predicts a high rate of failure

23. Other Considerations Poor technique also effects maternal and neonatal morbidity and mortality Improper application both with respect to placement on the head and station/position Lack of training and credentials to perform the procedure Use of a rocking motion or rotation Inattention to number of “pop-offs” and pulls

24. Shoulder Dystocia Facts And Strategies • Most often unpredictable; 0.2 – 3.0% of deliveries • Most brachial plexus injuries will resolve within a year but you can’t be sure in advance which one’s will. • Standard of care is to perform correctly when it is encountered. (In Situ Simulations) • When there are risk factors, it is probably prudent to inform the parents and discuss options. It is also reasonable and acceptable to make a recommendation based on your knowledge and experience. • Get credit for meeting the standard with appropriate documentation • Shift to the “management of bad results” mode of care when injury occurs.

25. What Does ACOG Say? November, 2002. The following recommendations are based on limited or inconsistent scientific evidence: • Shoulder Dystocia cannot be predicted or prevented because accurate methods for identifying which fetuses will experience this complication do not exist. • Elective induction of labor or elective cesarean delivery for all women suspected of carrying a fetus with macrosomia is not appropriate.

26. What Does ACOG Say? November, 2002. The following recommendations are based primarily on consensus and expert opinion: • In patients with a history of shoulder dystocia, EFW, gestational age, maternal glucose intolerance, and the severity of the prior neonatal injury should be evaluated and the risks and benefits of cesarean delivery discussed with the patient. • Planned cesarean delivery to prevent shoulder dystocia may be considered for suspected fetal macrosomia with estimated fetal weights exceeding 5,000 grams in women without diabetes and 4,500 grams in women with diabetes. • There is no evidence that any one maneuver is superior to another in releasing an impacted shoulder or reducing the chance of injury. However, performance of the McRoberts maneuver is a reasonable initial approach.

27. Are We There Yet? • Induction and Augmentation Bundles • Everyone knows about it but still not at 100% • Problems with EFW • Operative Vaginal Delivery Bundle • >70% compliance but not integrated into system practice yet. • We do have a 70% reduction in birth trauma and 30% reduction in AOI at UMMC-Riverside

28. Acknowledgements • Becky Gams, R.N., M.S., A.P.N.L., University of Minnesota Medical Center, Fairview • Phillip Rauk, M.D., University of Minnesota Medical Center, Fairview • Samantha Sommerness, R.N., M.S.N., C.N.M., A.P.N.L., Fairview Southdale Hospital • Ann Page, R.N., M.S.N., C.N.M. , University of Minnesota Medical Center, Fairview • Charlie Hirt, M.D., Fairview Southdale Hospital • Kristi Miller, R.N., M.S., Fairview Hospitals, Patient Safety • Stan Davis, M.D., Fairview Hospitals, Patient Safety • Carol Clark, R.N., M.S.N., C.N.P., Fairview Ridges Hospital • Suzin Cho, M.D., Fairview Ridges Hospital • Cass Dennison, R.N., B.S.H.A., Fairview Lakes Medical Center • Ralph Magnusson, M.D., Fairview Lakes Medical Center • Jan Gilmore, R.N.C, M.S,H.A., Fairview Red Wing Medical Center • William Saul, M.D., Fairview Red Wing Medical Center • Char Dekraker, R.N., I.B.C.L.C., Fairview Northland Medical Center • Kathy Abrahamson, M.D., Fairview Northland Medical Center • Tom George, M.D., University of Minnesota Medical Center, Fairview • Ted Thompson M.D., University of Minnesota Medical Center, Fairview • Michelle O’Brien, M.D., University of Minnesota Medical Center, Fairview