The PSI was developed to incrementally introduce multiple safety plans from August 2007 through July 2009, following an internal and external review of sentinel events (root cause analysis). Each month, all obstetrical hemorrhage charts and 10 charts with abnormal fetal heart rate tracings were reviewed. A list of critical criteria was established to evaluate case management and documentation. A single assessor reviewed the charts applying the critical criteria. Charts were then deemed appropriate or not appropriate for management as well as documentation. As a result of this review, the following were identified as potential causes for adverse events: (1) poor communication between providers; (2) inadequate escalation policy; (3) lack of standard protocols; and (4) lack of standardization of interpretation of fetal heart rate tracing. A multidisciplinary perinatal safety committee, comprised of physicians, nurses, educators, and administrators, was charged with addressing audit findings and developing/implementing the PSI.
The PSI utilized several safety initiatives designed to target potential contributing factors to adverse outcomes (see Table 1). To target communication, we implemented the Team STEPPS methodology for team training, which emphasizes communication techniques (Agency for Healthcare Research and Quality, 2010). To facilitate communication, daily multidisciplinary teaching rounds were introduced. The entire perinatal team (attending Maternal Fetal Medicine [MFM], attending obstetrical, resident, PA and RNs, Anesthesiologist, and Neonatologist) reviewed and discussed appropriate assessment/management of obstetrical service admissions.
Table 1. Safety Initiatives Designed to Target the Potential Contributing Factors to Adverse Outcomes
|Team STEPPS||√||√|| || |
|EFM course and exam||√|| ||√||√|
|Multidisciplinary teaching rounds||√||√||√||√|
|Obstetrical emergency simulation||√||√||√|| |
|Introduction of evidence-based protocols||√||√||√|| |
To standardize electronic fetal monitoring (EFM) terminology we instituted an EFM educational course and exam in the interpretation and management of fetal heart rate patterns. We mandated that every member of the perinatal team successfully complete the same online courses on Definition of FHR changes, Pathophysi-ology of FHR changes, the Relationship between FHR and fetal oxygenation, Fetal acid base values, Clinical relevance of FHR changes, and Management scenarios for specific FHR changes.
We also enhanced our electronic medical record (entitled Centricity Perinatal manufactured by General Electric) to require the use of correct National Institute of Child Health and Human Development terminology using prompts (Electronic Fetal Heart Rate Monitoring, 1997). Several evidence-based management protocols were developed and implemented, including: (1) the use of Pitocin augmentation of labor; (2) the use of antibiotics and thromboembolic prophylaxis for cesarean; (3) the use of magnesium for seizure prophylaxis; (4) hemorrhage protocol; (5) protocol for induction of labor; (6) management of intrapartum fetal heart rate abnormalities; and (7) obstetrical rapid response team.
We introduced and standardized a number of evidence-based protocols. To ensure that proper action is taken (decreasing or discontinuing the Pitocin infusion), we empowered all team members to intervene and follow the protocol when presented with an abnormal contraction pattern regardless of the FHR tracing.
Another intervention with a positive impact on the cesarean section and associated maternal morbidity rates was the protocol for elective inductions that confine interventions to patients with a favorable cervix at time of induction.
For situations where severe fetal heart rate abnormalities was noted (fetal bradycardia, prolonged decelerations) a specific protocol was introduced that outlined the intervention timetable and a rapid response team was formed to act in critical situations, particularly with regard to accomplishing delivery within the first 10–12 min from acute change in fetal status.
To eliminate elective deliveries (elective induction or repeat cesarean section) before 39 weeks gestation, we implemented a policy and clinical practice based on the American College of Obstetricians and Gynecologists (ACOG) recommendations (ACOG Practice Bulletin, 1999), instituting an educational process during case scheduling. In situations where gestational age at induction or the indication for intervention was unclear, the case was referred to the attending MFM physician for a final decision at the time of booking rather than after patient admission.
To address escalation policy, a hemorrhage protocol was instituted to enable the multidis-ciplinary team (anesthesia, surgery, critical care) to be quickly summoned in situations associated with massive obstetrical bleeding, thereby minimizing complications with severe hemorrhagic shock.
Finally, an obstetrical emergency simulation program in high-risk care scenarios, including shoulder dystocia, maternal hemorrhage, and seizure was undertaken. Multidisciplinary drills were performed. Nursing and physician staff was required to complete the same fetal monitoring competency, attend the same monthly educational activities, and participate in the same simulated obstetric emergencies together, as a team.
To measure the impact of the PSI, we utilized a modified version of the Adverse Outcome Index (AOI) published in 2006 (Mann et al. 2006). The authors noted their concern with two outcomes (term NICU admissions and third/fourth degree lacerations) because of definition variation. We also surveyed several large obstetrical/neonatal units regarding their indication for NICU admissions of term infants for >24 hr. We could find no specific protocols/guidelines regarding these admissions. Furthermore, admission rates for specific indications varied greatly by covering attending physician, as well as unit. We also found, through retrospective chart review, significant discrepancies between coding for third/fourth degree lacerations and physician documentation regarding this complication. Thus, these two outcomes were excluded from our analysis. Based on these observations, our Modified Adverse Outcome Index (MAOI) included the maternal and fetal/neonatal measures highlighted in Table 2.
Table 2. The Modified Adverse Outcome Index
|Admitted to higher level of care||Neonatal death|
|Uterine rupture||5 min APGAR <7|
|Peripartum hysterectomy||Iatrogenic prematurity|
|Return to OR||Birth trauma HIE|
These 11 MAOI measures were followed prospectively, following the introduction of the PSI. The MAOI was calculated by dividing the number of pregnancies complicated by one or more of these measures by the total number of deliveries for that time period.
To compare our outcomes to other medical centers or national norms, we utilized published data, where available. In addition to these specific outcome measures, we chose to review the management and documentation of two high-risk situations with potential for poor outcome: obstetrical hemorrhage and fetal heart rate abnormalities. The reviews of both outcome and process measures were standardized utilizing a review tool to ensure objective evaluation of these cases.
Patient perceptions of teamwork and commitment to patient safety were continually evaluated by an anonymous questionnaire after discharge from hospital. To do this, two questions: ‘‘Would you recommend the institution?’’ and ‘‘Did the staff work together?’’ were tracked and analyzed over the time period utilizing a Press-Ganey survey instrument (Kaldenberg, Mylod, & Drain, 2003).
Staff perceptions of safety were assessed at the beginning and approximately 18 months after project initiation, using an item from the Safety Culture Climate Survey, publicly available on the Institute for Healthcare Improvement (IHI) website (Sexton & Thomas). It should be noted that only a single question was tracked, which inquired about the culture of safety on the unit.
Incidence rates of MAOI were compared across time points using logistic regression (SAS Version 9.2, SAS Institute, Cary, NC). It is important to note that MAOI rates were computable for each calendar quarter of the years 2008 and 2009; however, quarterly data for 2006 and 2007 were not available without a laborious manual chart review of over 5,400 medical charts. For the purposes of applying the regression model, equal spacing of time-adjacent observations could not be assumed, because it did not apply to 2007. Accordingly, 2007 and each quarter were coded as dummy variables with odds ratios computed relative to the observed MAOI rate in 2007.
Exploratory analyses of the individual components that comprise the MAOI were carried out using exact logistic regression. A linear mono-tonic trend over time was assumed, because the frequencies of the individual components were very small, thus making the coding of calendar quarters as dummy variables infeasible. For comparability, the MAOI analysis was also rerun using the linear trend model.