Normalization Of Deviance

1. Normalization Of Deviance

4. Driving 100 mph illegal for all Borderline Tolerated Conditions of Use Driving 75 mph – the ‘illegal-illegal’ space (for almost all of us!) Individual Autonomy Individual Pressures Driving 64 mph -the illegal- normal space Perceived Vulnerability VERY UNSAFE SPACE The posted speed limit is 60 mph- the ‘legal’ space Accident Belief in Systems- guidelines <1% 5% 50% 80% 100% percent of drivers PERFORMANCE

5. Defining Normal How safe is normal? When does normal become unsafe? How safe is safe?

6. Normalization Of Deviance in Obstetrics-Goals • Usual obstetric practice frequently deviates from guidelines • Understand what drives deviation from guidelines • Discuss that harm occurs with and without deviation from the guidelines • Discuss that harm may occur during deviation from guidelines and the association with malpractice • Discuss how infrastructure can reduce error

7. Reliably Delivering What The Patient Needs Or Wants When They Need It Each And Every Time Will Ideas Execution

8. Managing Infrastructure Delivering Reliably What The Patient Needs Or Wants When They Need It Each And Every Time Violation of the Standards

9. What drives deviation to the Borderline Tolerated Conditions of Use? • Pressures • Market • Individual • Belief in guidelines • Experiences • Individual or Collective • Perceived vulnerability • Adverse outcome • Detection and punishment

10. Impact that deviation from guidelines has on following care • Operative delivery • Pitocin • Timing of Elective Cesarean

11. Concept of Border-line Tolerated Conditions of Use (BTCU) • Driven by embedded combination of system performance improvement and individual benefits i.e. we save time, avoid conflict • Implicitly (sometimes explicitly) tolerated by the proximal hierarchy i.e. those in charge working closest to us Rene Amalberti, MD, PhD

12. Medical Malpractice • Duty • Standard of Care- Breach (deviation) • Causation-Breach (deviation) caused harm

13. Towner NEJ 1999;341:1709-1714 83,340 singleton, nulliparous Reliability 10-3 10-4

14. Concept of Border-line Tolerated Conditions of Use (BTCU) • Result in a ‘stabilised usual level of performance’ that lies outside the expected safe field of use defined in policy, procedure, and regulations • Are seen first as benefits rather than problems: benefits are immediate payback, additional risks are known and are supposedly under control, and de facto scarcely penalised. • Driven by embedded combination of system performance improvement and individual benefits . • Implicitly (sometimes explicitly) tolerated by the proximal hierarchy Rene Amalberti, MD, PhD

15. 40+0 to +6 = 1 Morrison Br J Ob Gyn 1995 Oct;102 (2):101-6 33,289 deliveries between 37-42 weeks

16. More infant deaths with elective C-sections Procedure has three times higher mortality rate than babies born vaginally Updated: 7:13 p.m. CT Sept 14, 2006 NEW YORK - A new study has found a higher risk of infant deaths among infants born by Caesarean section to mothers who have no medical need for the procedure. While C-sections have saved the lives of "countless" women and babies, and the risk of infant death is still very low, it is crucial to determine the reasons for the higher infant mortality seen with C-section, because the rates of this surgery are becoming increasingly common, Dr. Marian F. MacDorman of the National Center for Health Statistics at the Centers for Disease Control in Hyattsville, Maryland and colleagues conclude. Rates of Caesarean have risen steadily in the U.S., from 14.6 percent of all first-time births in 1996, to 20.6 percent in 2004, MacDorman's group notes in the September issue of Birth.

17. Concept of Border-line Tolerated Conditions of Use (BTCU) • Because we do them regularly with only rare adverse outcomes, we come to feel safer and safer and come to the BTCU as normal and safe. The BTCU becomes the ‘stabilized usual level of performance’ even though it lies outside the expected safe field of use defined in policy, procedure, and regulations • Are seen first as benefits rather than problems: benefits have immediate payback like saving time, additional risks are known and are supposedly under control, and de facto scarcely penalised Rene Amalberti, MD, PhD

18. The result of migration is well known (1) • The result of migrations is a large range of illegal practices... which over time became “normal” for everyone, and which are part of the system’s “normal” operation. • Since these practices are illegal, nothing can be written about them, to comment or to accept their existence. • The only words written about these are ineffective memos reminding the staff about the old, written rule. These practices are only commented upon verbally. • elective forceps, timing of elective delivery, FHT reassuring, fetal weight for induction Rene Amalberti, MD, PhD

19. The result of migration is well known (2) • There is great reluctance to monitor these practices with indicators, since no one really knows what to do with the results obtained (for example, what should be done with inconsistent recording of reassuring/non-reassuring FHT, elective operative delivery, timing of elective delivery). Rene Amalberti, MD, PhD

20. The result of migrations is well known (3) • It is essential to remember that all stakeholders in the system migrate and deviate from standards, even if migrations are different, depending on whether they occur at Senior Management level, in Departments, or with actors on the field. Rene Amalberti, MD, PhD

21. The result of migrations is well known (4) • Migrations stabilize over time • First by the exposure to incidents which eventually make up a shared professional consensus i.e. (elective delivery < 36 weeks) as ‘too unsafe’ Rene Amalberti, MD, PhD

22. Deviation • We all deviate all the time • Usually without harm • Deviation based on specific clinical criteria improves outcomes

23. Managing Infrastructure Delivering Reliably What The Patient Needs Or Wants When They Need It Each And Every Time Violation of the Standards Measure

25. Ascension Health • 2004 process to eliminate birth trauma • Feb 2004 Seton Family of Hospitals in Austin, Texas -9005 births in 2004 • Feb 2004 St Marys in Evansville, Indiana-2081 births in 2004 • Dec 2004 Our Lady Lourdes Binghampton New York-1021 births in 2004

26. What did Ascension do? • In 2000, the Health System Board committed to have zero injuries • Created bundles • Elective induction of labor • Augmentation of labor • Operative vaginal delivery • Executed the process of implementing the bundle

27. Birth Trauma • Category C-Birth Trauma and required evaluation • Facial nerve injury 767.5 • Injury to brachial plexus 767.6 • Other injury to other cranial nerves and peripheral nerves 767.7 • Other specified birth trauma *767.8 • Unspecified birth trauma *767.9 • Category D-severe birth trauma with NICU admission • Subgaleal hemhorrage-epicranial subaponeurotic massive 767.11 • Subdural or cerebral hemorrhage (secondary to trauma or anoxia or hypoxia) **767.0 • Intraventricular and intracerebral hemorrhage **772.1 • Subarachnoid hemorrhage 772.2 • Other injuries to skeleton (excludes clavicle) ***767.3 • Injury to spine and spinal cord ***767.4 • Fetal blood loss/hemorrhage requiring transfusion-772.0 & procedure code 99.0 • *Exclude minor injuries codes as unspecified or other • ** Exclude preterm infant < 2500 grams and < 37 weeks or < 34 weeks • *** Excludes any diagnostic codes of osteogenesis imperfecta 756.51

29. What did Ascension do? • In 2000, the Health System Board committed to have zero injuries • Created bundles • Elective induction of labor • Augmentation of labor • Operative vaginal delivery • Executed the process of implementing the bundle

30. Ascension's Augmentation Bundle • Estimated fetal weight • Pelvic assessment • Monitoring fetal heart rate for reassurance • Monitoring and management of hyperstimulation

31. Ascension’s Elective Induction Bundle • Assessment of gestational age (ensuring gestational age > 39 weeks) • Monitoring fetal heart rate for reassurance • Pelvic assessment • Monitoring and management of hyperstimulation

32. Operative Delivery Bundle • ACOG criteria for timing and indications for operative delivery • Limit vacuum applications to 3. Limit application time to no more than 20 minutes • Documentation of vacuum pressure not to exceed 500-600 mm Hg • Limit vacuum to > 34 weeks • Complete a progress note on all operative deliveries

33. Managing Infrastructure to reliably ensure safe administration of pitocin each and every time Power Passenger Passage Monitoring and Management of hyperstimulation Monitoring FHT Pattern For Reassurance

36. 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 & number of pop-offs predetermined • Exit strategy available Cesarean & resuscitation team available

37. Key Learning Points • Hard work and vigilance although commendable is not a good design principle • Characteristics of processes with 80-90% compliance • Standard order sheets • Written policies/procedures • Personal check lists • Feedback of information on compliance • Suggestions of working harder next time • Awareness and training • Provider/patient autonomy

38. Key Learning Points • Hard work and vigilance although commendable is not a good design principle • Characteristics of processes with 80-90% compliance • Standard order sheets • Written policies/procedures • Personal check lists • Feedback of information on compliance • Suggestions of working harder next time • Awareness and training • Provider/patient autonomy

39. Key Learning Points • Hard work and vigilance although commendable is not a good design principle • If 95-99.5% change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design • Characteristics of processes with 95-99.5% compliance • 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

40. Key Learning Points • Hard work and vigilance although commendable is not a good design principle • If 10-2 change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design • Benchmark outcomes against the industry best

41. Key Learning Points • Hard work and vigilance although commendable is not a good design principle • If 10-2 change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design • Benchmark outcomes against the industry best • Measure processes against a specific reliability goal (>95%)

42. Hard work and vigilance although commendable is not a good design principle If 10-2 change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design Benchmark outcomes against the industry best Measure processes against a specific reliability goal (10-2) Biology Protects Us Shoulder dystocia incidence 0.6%-1.4% Permanent Brachial Plexus Injury (10% shoulder dystocias (0.06-0.14%) Key Learning Points

43. Key Learning Points Consider less than 100% Compliance With The Bundles A Near Miss • Hard work and vigilance although commendable is not a good design principle • If 10-2 change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design • Benchmark outcomes against the industry best • Measure processes against a specific reliability goal (10-2) • Biology Protects Us • Monitor more than the sentinel event-the near miss

44. Why do our processes fail? • Intentional Violation of the Standards • Unintentional Violation of the Standards • Current processes in healthcare are highly dependent on vigilance and hard work • There is an inordinate focus on outcomes rather than process • Poor understanding of how to design reliable processes • Failure to design standard work which can be used in testing and training • Infrastructure isn’t optimal