March 15, 2011 A perinatal safety initiative (PSI) may reduce the risk for adverse obstetric outcomes,

, according to the results of a study reported online March 1 in the Journal for Healthcare Quality. "Since the call to improve patient safety, progress has been generally slow, with notable exceptions in anesthesia, cardiology, and critical care," write Brian Wagner, MD, from North Shore University Hospital and Long Island Jewish (LIJ) Medical Center in Great Neck, New York, and colleagues. "The reasons for the slow change are varied: the complexity of healthcare, medicine's tenacious commitment to the individual, professional autonomy, fear, and skepticism of broad changes. To address the gap in obstetrics, we implemented a multistep, multicomponent ...PSI to evaluate and subsequently decrease adverse obstetric outcomes." At a large tertiary medical center, a comprehensive PSI aimed at reducing adverse obstetric outcomes was incrementally introduced from August 2007 to July 2009. The PSI included evidence-based protocols, formalized team training emphasizing communication, standardization of electronic fetal monitoring (EFM) with mandatory documentation of competence, a simulation program for high-risk obstetric emergencies, and implementation of an integrated educational program among all healthcare providers. A modified Adverse Outcome Index (MAOI) was used to prospectively follow 11 adverse outcome measures, with additional assessments of individual components. During the first year, there was a significant MAOI decrease from 2% to 0.8% (P < .0004), based on logistic regression, and that reduction was maintained during the 2-year period. There were also significant reductions with time in rates of return to the operating room (P < .018) and birth trauma (P < .0022). Implementation of the PSI was also associated with significant improvements in staff perceptions of safety (P < . 0001), in patient perceptions of staff cooperating with one another (P < .028), in management (P < .002) and documentation (P < .0001) of abnormal fetal heart rate (FHR) tracings, and in documentation of obstetric hemorrhage (P < .019). "The importance of the study and its long-term impact is that the safety measures that we introduced have provided better communication among the various healthcare providers," said coauthor Adiel Fleischer, MD, from the Department of Obstetrics and Gynecology at North Shore University Hospital and LIJ Medical Center, in a news release. "There is earlier identification of at-risk patients and team approach to patient care is critical to patient care." Limitations of this study include inability to randomly assign practitioners to different protocols and lack of a structured control group. "We improved patient safety and enhanced both staff and patient experience," said coauthor Kenneth J. Abrams, MD, senior vice president of clinical operations and chief quality officer at the North Shore-LIJ Health System. "This initiative shows that we can reduce adverse events and enhance a culture of safety." The study authors have disclosed no relevant financial relationships. J Healthcare Quality. Published online March 1, 2011. Abstract

Clinical Context
Medical errors may result in as many as 98,000 deaths annually in the United States. Creating a culture of safety is a long-term approach that requires multiple components in a multidisciplinary setting. This is a description of a PSI based on a needs assessment that identified poor communication among providers, lack of standard protocols, and lack of standard interpretation of FHR tracing as areas of need for improvement.

Study Highlights

A multidisciplinary committee composed of physicians, nurses, educators, and administrators examined audit findings to identify steps for the PSI. The PSI was implemented between 2007 and 2009 in steps. To target provider communication, the Team STEPPS program of the Agency for Healthcare Research and Quality was implemented. Daily multidisciplinary teaching rounds were introduced, and the entire perinatal team reviewed and discussed appropriate assessment and management of obstetric service admissions. To standardize EFM, every member completed an online program for the interpretation and management of FHR changes. The electronic medical records were enhanced. Several evidence-based protocols were introduced, including use of oxytocin augmentation during labor, use of antibiotics and thromboembolic prophylaxis for cesarean delivery, use of magnesium for seizure prophylaxis, a protocol for hemorrhage, a protocol for induction of labor, management of intrapartum FHR abnormalities, and an obstetric rapid response team. For elimination of elective deliveries before 39 weeks, the policy of the American College of Obstetricians and Gynecologists was implemented. To address escalation policy, a hemorrhage protocol was instituted to allow the multidisciplinary team to be quickly summoned. An obstetric emergency simulation program in high-risk scenarios was introduced. Such situations included shoulder dystocia, maternal hemorrhage, and seizure. To increase the impact of the PSI, a modified MAOI was used to measure outcomes; 11 measures were used. Among the outcomes, maternal indicators were maternal death, admission to a higher level of care, uterine rupture, peripartum hysterectomy, and return to the operating room. The fetal or neonatal indicators were stillbirth, neonatal death, a 5-minute Apgar score of less than 7, iatrogenic prematurity, birth trauma, and hypoxic-ischemic encephalopathy. Other outcomes were patient and staff perceptions of teamwork and safety. The MAOI rate decreased from 1.95% to 0.89% from 2007 to 2009. The odds ratios for MAOI decreased with time and were 0.77 in the first quarter of 2008 and 0.29 in the first quarter of 2009. They then leveled off to 0.46 for the last 3 quarters of 2009. Of the individual components of the MAOI, only rates of returning to the operating room (maternal) and birth trauma were statistically significant. Other outcomes including uterine rupture, hypoxic-ischemic encephalopathy, Apgar score at 5 minutes, and hysterectomy were not statistically significantly lower. The birth trauma rates were 0.2% vs published rates of 1.6% to 7.1%. The iatrogenic prematurity rate was 0.2% vs the published rate of 5%. Staff perceptions of patient safety increased during the 2 years. Patient perception of staff teamwork also increased during the 2 years. However, there was no significant change in the likelihood of patients recommending the institution during the 2 years. The authors concluded that the PSI improved maternal and fetal outcomes and staff and patient perceptions of safety in an obstetric and neonatal setting.

Clinical Implications
Components of the PSI include formalized team training, new evidence-based protocols, standardized interpretation of EFM, a high-risk obstetric simulation program, and integrated education of all providers. Maternal and fetal adverse outcomes are reduced by the PSI, and staff and patient perceptions of safety improve.

CME Test
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Which of the following protocols is least likely to be a component of the PSI? Team training Use of patient navigators Integrated multidisciplinary education High-risk obstetric simulation program Which of the following outcomes is most likely to be significantly improved at 2 years of the PSI program? Apgar score at 5 minutes Rate of uterine rupture Rate of birth trauma Hysterectomy rate
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Perinatal Safety Initiative May Lower Adverse Obstetric Outcomes

on the Internet at http://www.medscape.org July 25, 2011 Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

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