Analysis of patient safety event report categories at one large academic hospital.

Given the persistent safety incidents in operating rooms (ORs) nationwide (approx. 4,000 preventable harmful surgical errors per year), there is a need to better analyze and understand reported patient safety events. This study describes the results of applying the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) supported by the Teamwork Evaluation of Non-Technical Skills (TENTS) instrument to analyze patient safety event reports at one large academic medical center. Results suggest that suboptimal behaviors stemming from poor communication, lack of situation monitoring, and inappropriate task prioritization and execution were implicated in most reported events. Our proposed methodology offers an effective way of programmatically sorting and prioritizing patient safety improvement efforts.

The Effect of a System-Level Tiered Huddle System on Reporting Patient Safety Events: An Interrupted Time Series Analysis.

BACKGROUND: The objective of this research was to evaluate the effect of implementing a system-level tiered huddle system (THS) on the reporting of patient safety events into the official event reporting system. METHODS: A quasi-experimental study using interrupted time series was conducted to assess the impact and changes to trends in the reporting of patient safety events pre- (February-July 2020; six months) and post- (September 2020-February 2021; six months) THS implementation within one health care system (238 clinics and 4 hospitals). The severity of harm was analyzed in July 2021 using a modified Agency for Healthcare Research and Quality (AHRQ) harm score classification. The primary outcome measure was the number of patient safety events reported per month. Secondary outcomes included the number of patient safety events reported per month by each AHRQ harm score classification. RESULTS: The system-level THS implementation led to a significant and immediate increase in the total number of patient safety events reported per month (777.73, 95% confidence interval [CI] 310.78-1,244.68, p = 0.004). Similar significant increases were seen for reported numbers of unsafe conditions, near misses, no-harm events that reached patients, and temporary harm (p < 0.05 for each). Reporting of events with permanent harm and deaths also increased but was not statistically significant, likely due to the small number of reported events involving actual harm. CONCLUSION: These findings suggest that system-level THS implementation may increase reporting of patient safety events in the official event reporting system.

Patient decision aid for trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery: a quasi-experimental pre-post study.

OBJECTIVE: To assess the impact of a web-based decision aid on patient-centered decision making outcomes among women considering a trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery. METHODS: The Birth Decision Aid Study (B-READY) was a quasi-experimental pre-post study of two sequential cohorts. From June 18, 2018 to July 31, 2019, 50 women were enrolled in routine care, followed by 50 women who were enrolled in the decision aid group. Inclusion criteria were singleton pregnancies between 19/0 to 36/6 weeks, ≤2 prior cesareans, and no contraindications to TOLAC. The decision aid group viewed the online Healthwise® "Pregnancy: Birth Options After Cesarean" program. Both groups received the same birth options counseling and completed the same online assessment. Primary patient-centered outcomes were knowledge about birth options and shared decision making at online assessment, and informed, patient-centered decision making about her preferred mode of delivery at delivery admission. RESULTS: Among 100 women participated in this study (50 per group), the mean gestational age at enrollment was 31 weeks, and 71% or 63/89 women who consented to delivery data abstraction had a cesarean delivery. Women in the patient decision aid group gained more knowledge (defined as score ≥ 75%) about birth options compared to those in the routine care group (72% vs. 32%; adjusted odds ratio, AOR: 6.15 [95% CI: 2.34 to 16.14]), and were more likely to make an informed, patient-centered decision (60% vs. 26%; AOR: 3.30 [95% CI: 1.20 to 9.04]. Women in both groups reported similar involvement in shared decision making, as well as satisfaction and values. More than 90% of decision aid users reported it was a useful tool and would recommend it to other TOLAC-eligible women. CONCLUSIONS: A web-based birth options patient-centered decision aid for TOLAC eligible women can be integrated into prenatal Telehealth and may improve the quality of decision making about mode of delivery. TRIAL REGISTRATION: The study was registered with ClinincalTrials.gov and the ID# was NCT04053413 . Registered 12 August 2019 - Retrospectively registered.

Impact of the Agency for Healthcare Research and Quality's Safety Program for Perinatal Care.

BACKGROUND: The Safety Program for Perinatal Care (SPPC) seeks to improve safety on labor and delivery (L&D) units through three mutually reinforcing components: (1) fostering a culture of teamwork and communication, (2) applying safety science principles to care processes; and (3) in situ simulation. The objective of this study was to describe the SPPC implementation experience and evaluate the short-term impact on unit patient safety culture, processes, and adverse events. METHODS: We supported SPPC implementation by L&D units with a program toolkit, trainings, and technical assistance. We evaluated the program using a pre-post, mixed-methods design. Implementing units reported uptake of program components, submitted hospital discharge data on maternal and neonatal adverse events, and participated in semi-structured interviews. We measured changes in safety and quality using the Modified Adverse Outcome Index (MAOI) and other perinatal care indicators. RESULTS: Forty-three L&D units submitted data representing 97,740 deliveries over 10 months of follow-up. Twenty-six units implemented all three program components. L&D staff reported improvements in teamwork, communication, and unit safety culture that facilitated applying safety science principles to clinical care. The MAOI decreased from 5.03% to 4.65% (absolute change -0.38% [95% CI, -0.88% to 0.12%]). Statistically significant decreases in indicators for obstetric trauma without instruments and primary cesarean delivery were observed. A statistically significant increase in neonatal birth trauma was observed, but the overall rate of unexpected newborn complications was unchanged. CONCLUSIONS: The SPPC had a favorable impact on unit patient safety culture and processes, but short-term impact on maternal and neonatal adverse events was mixed.

Special considerations--Induction of labor in low-resource settings.

Induction of labor in resource-limited settings has the potential to significantly improve health outcomes for both mothers and infants. However, there are relatively little context-specific data to guide practice, and few specific guidelines. Also, there may be considerable issues regarding the facilities and organizational capacities necessary to support safe practices in many aspects of obstetrical practice, and for induction of labor in particular. Herein we describe the various opportunities as well as challenges presented by induction of labor in these settings.

Training for teamwork through in situ simulations.

In situ simulations allow healthcare teams to practice teamwork and communication as well as clinical management skills in a team's usual work setting with typically available resources and equipment. The purpose of this video is to demonstrate how to plan and conduct in situ simulation training sessions, with particular emphasis on how such training can be used to improve communication and teamwork. The video features an in situ simulation conducted at a labour and delivery unit in response to postpartum hemorrhage.

Robotic-assisted laparoscopic removal of cesarean scar ectopic and hysterotomy revision.

A 38-year-old gravida 6 para 2042 woman presented in consultation regarding management of a uterine defect, or "niche," following resolution of a cesarean scar ectopic pregnancy. She had 3 prior losses, followed by in vitro fertilization that resulted in 2 healthy births, both delivered by cesarean. A third in vitro embryo transfer resulted in the cesarean scar ectopic. After consideration of treatment options, she underwent multiple-dose parenteral methotrexate with eventual termination of the ectopic. Magnetic resonance imaging demonstrated a uterine defect, suspected to contain residual pregnancy tissue. Questions considered in her consultation included whether the defect should be repaired and, if so, from a hysteroscopic or laparoscopic approach, as well as her risk of intrauterine scarring, when, or if, it would be safe to pursue another pregnancy, and her subsequent risk of uterine rupture. Literature review regarding cesarean niche was helpful, but did not seem to completely inform this particular clinical scenario. She elected to proceed with robotic-assisted laparoscopic repair. The vesicovaginal space was opened to expose the defect. Dilute vasopressin was injected circumferentially around the defect to help minimize the use of electrosurgery in opening the hysterotomy. Scar overlying the defect was resected and pregnancy tissue removed. The hysterotomy was closed with delayed-absorbable barbed suture, extrapolating technique from laparoscopic myomectomy. The first layer was imbricated with a second, similar to a 2-layer closure in cesarean delivery. Follow-up magnetic resonance imaging revealed resolution of the defect. After several failed attempts at repeat in vitro fertilization, spontaneous pregnancy was achieved 18 months postoperatively. The pregnancy was uncomplicated and she underwent scheduled cesarean delivery of a healthy neonate at 37 weeks' gestation. The lower uterine segment was thick and developed, with no evidence of a dehiscence.

Influence of neonatal practice variation on outcomes of late preterm birth.

OBJECTIVE: Examine variation in short-term outcomes of late preterm births (34(0/7)-36(6/7) weeks) between a university teaching hospital, teaching community hospital, and nonteaching community hospital. STUDY DESIGN: Review of maternal and newborn data from a random sample of late preterm births at three hospitals in North Carolina from 2008 to 2009. Outcomes included length of stay, neonatal intensive care unit (NICU) admission, respiratory support, antibiotic exposure, phototherapy exposure, and hypoglycemia. RESULTS: We analyzed data from 331 singleton late preterm newborns: 93 (28.1%) from a university teaching hospital, 110 (33.2%) from a teaching community hospital, and 128 (38.7%) from a nonteaching community hospital. Mean gestational age did not vary between hospitals. NICU admission, exposure to antibiotics, and phototherapy were more common at the university teaching hospital after controlling for risk factors, yet length of stay was shortest at the university teaching hospital and longest at the teaching community hospital after adjustment. CONCLUSION: Practice variation contributes to differences in length of stay, NICU admission, and exposure to antibiotics and phototherapy among late preterm newborns. Differences in practice during the birth hospitalization may affect outcomes and health care utilization (e.g., readmission) after discharge.

Advancing obstetric anesthesia practices in Georgia through clinical education and quality improvement methodologies.

OBJECTIVE: To determine whether an integrated program of clinical education and improvement methods regarding the safe use of regional anesthesia for obstetrics would result in improved and sustained practice change in Georgia. METHODS: Between 2006 and 2009, intervention teams undertook several visits to 5 Georgian hospitals. Rates of regional anesthesia for labor and cesarean delivery prior to and following the intervention were collected from participating and non-participating hospitals. There were multifaceted educational activities and quality improvement activities at intervention sites, including protocol development, social marketing, and supply chain logistics. Host hospitals evaluated the program via a questionnaire. RESULTS: The use of general anesthesia for cesarean delivery decreased significantly (P<0.001) and the use of epidural analgesia for labor increased significantly (P<0.001); there was no change in non-participating hospitals. Over the course of the program, medication and supply availability improved. Program evaluations were uniformly positive. CONCLUSION: A structured program of education and quality improvement led to an increase in the use of regional anesthesia for vaginal and cesarean deliveries. Achievements were sustained during periods of economic and political turmoil.

Regional variation in late preterm births in North Carolina.

Late preterm (LPT) neonates (34 0/7th-36 6/7th weeks' gestation) account for 70% of all premature births in the United States. LPT neonates have a higher morbidity and mortality risk than term neonates. LPT birth rates vary across geographic regions. Unwarranted variation is variation in medical care that cannot be explained by sociodemographic or medical risk factors; it represents differences in health system performance, including provider practice variation. The purpose of this study is to identify regional variation in LPT births in North Carolina that cannot be explained by sociodemographic or medical/obstetric risk factors. We searched the NC State Center for Health Statistics linked birth-death certificate database for all singleton term and LPT neonates born between 1999 and 2006. We used multivariable logistic regression analysis to control for socio-demographic and medical/obstetric risk factors. The main outcome was the percent of LPT birth in each of the six perinatal regions in North Carolina. We identified 884,304 neonates; 66,218 (7.5%) were LPT. After multivariable logistic regression, regions 2 (7.0%) and 6 (6.6%) had the highest adjusted percent of LPT birth. Analysis of a statewide birth cohort demonstrates regional variation in the incidence of LPT births among NC's perinatal regions after adjustment for sociodemographic and medical risk factors. We speculate that provider practice variation might explain some of the remaining difference. This is an area where policy changes and quality improvement efforts can help reduce variation, and potentially decrease LPT births.

Advancing obstetric and neonatal care in a regional hospital in Ghana via continuous quality improvement.

OBJECTIVE: To reduce maternal and neonatal death at a large regional hospital through the use of quality improvement methodologies. METHODS: In 2007, Kybele and the Ghana Health Service formed a partnership to analyze systems and patient care processes at a regional hospital in Accra, Ghana. A model encompassing continuous assessment, implementation, advocacy, outputs, and outcomes was designed. Key areas for improvement were grouped into "bundles" based on personnel, systems management, and service quality. Primary outcomes included maternal and perinatal mortality, and case fatality rates for hemorrhage and hypertensive disorders. Implementation and outcomes were evaluated tri-annually between 2007 and 2009. RESULTS: During the study period, there was a 34% decrease in maternal mortality despite a 36% increase in patient admission. Case fatality rates for pre-eclampsia and hemorrhage decreased from 3.1% to 1.1% (P<0.05) and from 14.8% to 1.9% (P<0.001), respectively. Stillbirths were reduced by 36% (P<0.05). Overall, the maternal mortality ratio decreased from 496 per 100000 live births in 2007 to 328 per 100,000 in 2009. CONCLUSION: Maternal and newborn mortality were reduced in a low-resource setting when appropriate models for continuous quality improvement were developed and employed.

The impact of occiput posterior fetal head position on the risk of anal sphincter injury in forceps-assisted vaginal deliveries.

OBJECTIVE: A forceps-assisted vaginal delivery is a well-recognized risk factor for anal sphincter injury. Some studies have shown that occiput posterior (OP) fetal head position is also associated with an increased risk for third- or fourth-degree lacerations. The objective of this study was to assess whether OP position confers an incrementally increased risk for anal sphincter injury above that present with forceps deliveries. STUDY DESIGN: This was a retrospective cohort study of 588 singleton, cephalic, forceps-assisted vaginal deliveries performed at our institution between January 1996 and October 2003. Maternal demographics, labor and delivery characteristics, and neonatal factors were examined. Statistical analysis consisted of univariate statistics, Student t test, chi2, and logistic regression. RESULTS: The prevalence of occiput anterior (OA) and OP positions was 88.4% and 11.6%, respectively. The groups were similar in age, marital status, body mass index, use of epidural, frequency of inductions, episiotomies, and shoulder dystocias. The OA group had a higher frequency of rotational forceps (16.2% vs 5.9%, P = .03), greater birth weights (3304 +/- 526 g vs 3092 +/- 777 g, P = .004), and a larger percentage of white women (48.8% vs 34.3%, P = .04). Overall, 35% of forceps deliveries resulted in a third- or fourth-degree laceration. Anal sphincter injury occurred significantly more often in the OP group compared with the OA group (51.5% vs 32.9%, P = .003), giving an odds ratio of 2.2 (CI: 1.3-3.6). In a logistic regression model that controlled for occiput posterior position, maternal body mass index, race, length of second stage, episiotomy, birth weight, and rotational forceps, OP head position was 3.1 (CI: 1.6-6.2) times more likely to be associated with anal sphincter injury than OA head position. CONCLUSION: Forceps-assisted vaginal deliveries have been associated with a greater risk for anal sphincter injury. Within this population of forceps deliveries, an OP position further increases the risk of third- or fourth-degree lacerations when compared with an OA position.

Acute pulmonary edema in pregnancy.

OBJECTIVE: To describe the incidence, predisposing conditions, and inciting factors culminating in pulmonary edema in the pregnant patient. METHODS: A review of 62,917 consecutive pregnancies delivered at our institution from January 1, 1989 to June 1, 1999 was undertaken for the diagnosis of pulmonary edema. Each chart was reviewed for maternal demographics, admission diagnoses, medication use, gestational age at diagnosis, fluid balance, coexisting maternal illness, tocolytic use, evidence of preeclampsia, and diagnostic criteria. After careful review of the records, the most likely cause of pulmonary edema was assigned. RESULTS: Fifty-one women (0.08%) were diagnosed with acute pulmonary edema during pregnancy or in the postpartum period. The mean patient age at the time of diagnosis was 27.6 +/- 6.4 years. The mean gestational age at the time of diagnosis was 31.5 +/- 6.8 weeks. The diagnosis of pulmonary edema was made during the antepartum period in 24 patients (47%), the intrapartum period in seven (14%), and the postpartum period in 20 (39%). The most common attributable causes were tocolytic use (13 patients [25.5%]), cardiac disease (13 patients [25.5%]), fluid overload (11 patients [21.5%]), and preeclampsia (nine patients [18%]). Those with fluid overload identified as the likely etiology had a significantly greater mean positive fluid balance (6022 +/- 3340 mL). All patients whose pulmonary edema was secondary to tocolytic use received multiple simultaneous tocolytic agents; the most common combination was intravenous magnesium sulfate and subcutaneous terbutaline. Six of the 13 women with cardiac disease were found to have previously undiagnosed structural heart disease. CONCLUSION: The most common causes of pulmonary edema are the use of tocolytic agents, underlying cardiac disease, fluid overload, and preeclampsia.

Late postpartum eclampsia: a preventable disease?

OBJECTIVE: The purpose of this study was to determine whether there is a shift in the timing of eclampsia in relation to delivery and whether traditional symptoms precede impending postpartum eclampsia. STUDY DESIGN: A multicenter analysis of data from patients with eclampsia from March 1996 through February 2001 at the University of Cincinnati, the University of Tennessee, Memphis, and Central Baptist Hospital, Lexington. Data were collected regarding the relationship of the patient's first seizure to delivery, prodromal symptoms, neuroimaging studies, use of magnesium sulfate, antihypertensive therapy, and follow-up medical care. The analysis focused on women who had late postpartum eclampsia. RESULTS: During the study period, 89 patients were diagnosed with eclampsia. Twenty-nine women (33%) had postpartum eclampsia, of whom 23 women (79%) had late onset (>48 hours). Interestingly, only 5 of these 23 women (22%) had been previously diagnosed with preeclampsia. Twenty-one patients (91%) with late postpartum eclampsia had at least 1 prodromal symptom, and 12 patients (52%) had >1 symptom that heralded the seizure: 20 women (87%) had headache; 10 women (44%) had visual changes; 5 women (22%) had nausea or vomiting; and 2 women (9%) experienced epigastric pain. Only 7 of these 21 women (33%) sought care for their symptoms, of whom 6 women (86%) had clinical evidence of preeclampsia that was not considered by the treating physician. Among all patients with eclampsia, there were 7 cases of aspiration pneumonia, 3 cases of pulmonary edema, 3 cases of pleural effusion, 2 cases of disseminated intravascular coagulation, and no cases of maternal death. CONCLUSION: Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. To reduce the rate of late postpartum eclampsia, efforts should be directed to the education of the health care providers and patients regarding the importance of prompt reporting and evaluation of symptoms of preeclampsia during the postpartum period.