Clinical:Patient Safety in Obstetrics

Background

Some 44,000 to 98,000 patients in the U.S. die each year as a result of medical errors, according to the Institute of Medicine. ^[1] Human and systemic errors are inevitable in medicine, and the potential to do harm is great. Adverse events occur in approximately 3% of all hospital admissions; up to 50% are attributed to preventable errors and 10-14% result in death.^[2]

The patient safety movement is an attempt to organize hospital efforts to reduce both anticipated and unanticipated adverse outcomes by creating behaviors and systems designed to prevent errors, accidents, and failures.

The patient safety movement in obstetrics lags behind other specialties like cardiology, anesthesia and intensive care. This is notable because there are four million births every year and pregnancy is the second leading cause for admission to a hospital. Moreover, obstetrics is experiencing a medicolegal crisis, demanding in some cases approximately 50% of hospital risk management budgets. Court awards for birth-related malpractice suits generally cost insurance companies from $500,000 to $2,000,000 per claim.

Patient safety in obstetrics aims to bring in the experiences from other medical and outside disciplines and apply them to the unique environment of labor and delivery, creating novel measures based on the maternity unit. Adverse outcomes in obstetrics are rare, but often substantially devastating as they may affect a previously healthy patient and/or an expectedly healthy child. Given that there are often two (or more) patients involved in birth, the potential for medical mistakes is tremendous. ^[3]

Components of a Patient Safety Effort

The patient safety movement borrows techniques from the defense and airline industries. The airline industry has recognized that not all risk is foreseeable, but the key to safety is recognizing and managing errors and unanticipated events. Over the past 30 years, effective quality-assurance review, simulation training, use of guidelines and checklists, and teamwork exercises have drastically improved airline safety. The medical environment is similar to aviation, in that errors have grave consequences, processes are highly complex, and the integration of multiple disciplines requires effective communication. In fact, as many as 70% of airline accidents occur because of human error in a team setting; in medicine, communication failures account for nearly 70% of adverse events. In both settings, alert and well-trained teams are crucial.

An effective patient safety effort is the culmination of techniques and routines that research has shown to improve outcome for patients. Some of the key components include:

A patient safety nurse is a critical element in implementing a patient safety effort and tracking its progress.^{[4] [5]}

Crew resource management (CRM) aims to improve teamwork and communication skills. In nationwide sentinel event reviews, JCAHO has identified communication failures as the primary cause of adverse/sentinel events. These problems derive from ineffective handoffs between shifts, poor collaborative skills between physicians and nurses, and distinct communication styles among team members that result from dissimilar training backgrounds. Though a randomized controlled trial did not show a reduction in adverse events when CRM was integrated into an obstetrics environment^[6], CRM, as part of a comprehensive effort, has been a component in an overall successful quality improvement activity.^[7]

Checklists are used to create routines to ensure that all elements of a practice are instituted for each event. For example, a preoperative checklist to be used for a cesarean delivery would include surgical consent, preoperative hematocrit and blood bank sample, preoperative antibiotics, anesthesia evaluation, and antacid medications, among other elements. Checklists have been used with success in the operating room^[8] and are beginning to be evaluated in obstetrics.

Protocols and guidelines offer a framework for provision of care and create a “shared mental model” for the level of care required for specific problems. Guidelines for episiotomy and management of the third stage of labor have been implemented with success.^[9]

• Quality assurance oversight means the creation of committees comprised of physicians and nurses to track adverse events, both as they arise and overall trends. In response to adverse events, these bodies create protocols and guidelines.

• Anonymous event reporting provides a web-based tool that any staff member can access to report any adverse event or potentially unsafe situation. This allows for review by quality assurance personnel (the patient safety nurse or the patient safety committee) with resulting corrective actions.

Electronic fetal monitor training is especially important in because it is a core activity on labor and delivery, and is often a part of medicolegal claims. Training in the interpretation and management of electronic fetal monitoring improves communication among staff. ^[10]

In simulation training, staff are trained to cope with rare, emergent events like “stat” cesarean deliveries and shoulder dystocia cases through mock exercises designed to create learning experiences, provide live teamwork drills, and keep providers trained for emergencies. ^{[11] [12] [13]}

Safety Assessment

Safety can be assessed through outcomes measures, which consist of tracking events that happened, and process measures, which review adherence to evidence-based practices that prevent adverse outcomes.

The following adverse outcomes in obstetrics have been proposed for tracking: • Maternal death • Fetal/Neonatal death • Fetal injury/trauma • Unexpected NICU admit • Apgar score <7 @5min • Cord pH<7.00 • Maternal ICU admission • Maternal return to OR • Shoulder dystocia • Postpartum hemorrhage • Blood transfusion • 3˚/4˚ laceration • Uterine rupture • Hysterectomy

The most common outcomes measure used in the medical literature is the adverse outcomes index (AOI), which includes blood transfusion, maternal death, maternal ICU admission, maternal return to OR or labor and delivery, uterine rupture, third- or fourth-degree laceration, Apgar score < 7 at 5 minutes, fetal traumatic birth injury, intrapartum or neonatal death > 2500g or unexpected admission to neonatal ICU >2500g and for >24 hours.^[14] For this index, the AOI is expressed as the number of deliveries (mothers) with associated adverse events per total deliveries for that period. Notably, this does not include events like shoulder dystocia, cesarean delivery rate or episiotomy use, which also may be important. Process measures that can be assessed on labor and delivery include provision of perioperative antibiotics, perioperative thromboprophylaxis and group B streptococcus antibiotic prophylaxis.

Evidence

In 2009, Pettker found that a comprehensive safety effort including most of the above components was shown to significantly reduce adverse events in an academic obstetric unit that performs 4,600 deliveries a year.^[15] The mean quarterly AOI decreased by approximately 40-60% (from 3.5%-3.75% to 1.5-2.0%) over a three-year period. The change in quarterly AOI showed a statistically significant decrease over the time of the initiative (r2 = 0.50, P = .011) (figure).

Conclusion

Patient safety efforts are a critical component in health care improvement and can be effectively integrated into OB settings. Using tools like checklists, CRM and electronic fetal monitoring training can significantly improve patient safety on an obstetrical service. Further work is necessary to determine the most efficient and cost effective ways of implementing the various measures.

References

1. ↑ Kohn, L., J. Corrigan, et al., Eds. (2000). To Err is Human: Building a Safer Health System. Washington, D.C., National Academy Press.
2. ↑ Brennan, T. A., L. L. Leape, et al. (1991). "Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I." N Engl J Med 324(6): 370-6.
3. ↑ Pettker, C. M., S. F. Thung, et al. (2009). "Impact of a comprehensive patient safety strategy on obstetric adverse events." Am J Obstet Gynecol 200(5): 492 e1-8.
4. ↑ Will, S. B., K. P. Hennicke, et al. (2006). "The perinatal patient safety nurse: a new role to promote safe care for mothers and babies." J Obstet Gynecol Neonatal Nurs 35(3): 417-23.
5. ↑ Pettker, C. M., S. F. Thung, et al. (2009). "Impact of a comprehensive patient safety strategy on obstetric adverse events." Am J Obstet Gynecol 200(5): 492 e1-8.
6. ↑ Nielsen, P. E., M. B. Goldman, et al. (2007). "Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial." Obstet Gynecol 109(1): 48-55.
7. ↑ Pettker, C. M., S. F. Thung, et al. (2009). "Impact of a comprehensive patient safety strategy on obstetric adverse events." Am J Obstet Gynecol 200(5): 492 e1-8.
8. ↑ Haynes, A. B., T. G. Weiser, et al. (2009). "A surgical safety checklist to reduce morbidity and mortality in a global population." N Engl J Med 360(5): 491-9.
9. ↑ Althabe, F., P. Buekens, et al. (2008). "A behavioral intervention to improve obstetrical care." N Engl J Med 358(18): 1929-40.
10. ↑ Macones, G. A., G. D. Hankins, et al. (2008). "The 2008 National Institute of Child Health and Human Development Workshop Report on Electronic Fetal Monitoring: Update on Definitions, Interpretation, and Research Guidelines." Obstet Gynecol 112(3): 661-666.
11. ↑ Draycott, T., T. Sibanda, et al. (2006). "Does training in obstetric emergencies improve neonatal outcome?" Bjog 113(2): 177-82.
12. ↑ Draycott, T. J., J. F. Crofts, et al. (2008). "Improving neonatal outcome through practical shoulder dystocia training." Obstet Gynecol 112(1): 14-20.
13. ↑ (Draycott, Sibanda et al. 2006; Draycott, Crofts et al. 2008; Ellis, Crofts et al. 2008)
14. ↑ Mann, S., S. Pratt, et al. (2006). "Assessing quality in obstetrical care: development of standardized measures." Jt Comm J Qual Patient Saf 32: 497-505.
15. ↑ Pettker, C. M., S. F. Thung, et al. (2009). "Impact of a comprehensive patient safety strategy on obstetric adverse events." Am J Obstet Gynecol 200(5): 492 e1-8.