Risk Factors, Trends, and Outcomes Associated With Postpartum Sepsis Readmissions.

OBJECTIVE: To evaluate the prevalence, timing, clinical risk factors, and adverse outcomes associated with postpartum readmissions for maternal sepsis. METHODS: We conducted a retrospective cohort study of delivery hospitalizations and 60-day postpartum readmissions for females aged 15-54 years with and without sepsis using the 2016-2020 Nationwide Readmissions Database. Temporal trends in sepsis diagnoses during delivery hospitalizations and 60-day postpartum readmissions were analyzed with the National Cancer Institute's Joinpoint Regression Program to estimate the average annual percent change with 95% CIs. Logistic regression models were fit to determine whether delivery hospitalization characteristics were associated with postpartum sepsis readmissions, and unadjusted and adjusted odds ratios with 95% CIs were reported. Adverse outcomes associated with sepsis during delivery hospitalization and readmission were described, including death, severe morbidity, a critical care composite, and renal failure. RESULTS: Overall, 15,268,190 delivery hospitalizations and 256,216 associated 60-day readmissions were included after population weighting, of which 16,399 (1.1/1,000 delivery hospitalizations) had an associated diagnosis of sepsis at delivery, and 20,130 (1.3/1,000 delivery hospitalizations) had an associated diagnosis of sepsis with postpartum readmission. A sepsis diagnosis was present in 7.9% of all postpartum readmissions. Characteristics associated with postpartum sepsis readmission included younger age at delivery, Medicaid insurance, lowest median ZIP code income quartile, and chronic medical conditions such as obesity, pregestational diabetes, and chronic hypertension. Postpartum sepsis readmissions were associated with infection during the delivery hospitalization, including intra-amniotic infection or endometritis, wound infection, and delivery sepsis. Sepsis diagnoses were associated with 24.4% of maternal deaths at delivery and 38.4% postpartum, 2.2% cases of nontransfusion severe morbidity excluding sepsis at delivery and 13.6% postpartum, 15.6% of critical care composite diagnoses at delivery and 30.1% postpartum, and 11.1% of acute renal failure diagnoses at delivery and 36.4% postpartum. CONCLUSION: Sepsis accounts for a significant proportion of postpartum readmissions and is a major contributor to adverse outcomes during delivery hospitalizations and postpartum readmissions.

Wrong-Patient Orders in Obstetrics.

OBJECTIVE: To compare rates of wrong-patient orders among patients on obstetric units compared with reproductive-aged women admitted to medical-surgical units. METHODS: This was an observational study conducted in a large health system in New York between January 1, 2016, and December 31, 2018. The primary outcome was near-miss wrong-patient orders identified using the National Quality Forum-endorsed Wrong-Patient Retract-and-Reorder measure. All electronic orders placed for eligible patients during the study period were extracted retrospectively from the health system data warehouse, and the unit of analysis was the order session (consecutive orders placed by a single clinician for a patient within 60 minutes). Multilevel logistic regression models were used to estimate odds ratios (ORs) and 95% CIs comparing the probability of retract-and-reorder events in obstetric and medical-surgical units, overall, and in subgroups defined by clinician type and order timing. RESULTS: Overall, 1,329,463 order sessions were placed during the study period, including 676,643 obstetric order sessions (from 45,436 patients) and 652,820 medical-surgical order sessions (from 12,915 patients). The rate of 79.5 retract-and-reorder events per 100,000 order sessions in obstetric units was significantly higher than the rate in the general medical-surgical population of 42.3 per 100,000 order sessions (OR 1.98, 95% CI 1.64-2.39). The obstetric retract-and-reorder event rate was significantly higher for attending physicians and house staff compared with advanced practice clinicians. There were no significant differences in error rates between day and night shifts. CONCLUSION: Order errors occurred more frequently on obstetric units compared with medical-surgical units. Systems strategies shown to decrease these events in other high-risk specialties should be explored in obstetrics to render safer maternity care.

Infection prevention and control for labor and delivery, well baby nurseries, and neonatal intensive care units.

During the early months of the COVID-19 pandemic, infection prevention and control (IP&C) for women in labor and mothers and newborns during delivery and receiving post-partum care was quite challenging for staff, patients, and support persons due to a relative lack of evidence-based practices, high rates of community transmission, and shortages of personal protective equipment (PPE). We present our IP&C policies and procedures for the obstetrical population developed from mid-March to mid-May 2020 when New York City served as the epicenter of the pandemic in the U.S. For patients, we describe screening for COVID-19, testing for SARS-CoV-2, and clearing patients from COVID-19 precautions. For staff, we address self-monitoring for symptoms, PPE in different clinical scenarios, and reducing staff exposures to SARS-CoV-2. For visitors/support persons, we address limiting them in labor and delivery, the postpartum units, and the NICU to promote staff and patient safety. We describe management of SARS-CoV-2-positive mothers and their newborns in both the well-baby nursery and in the neonatal ICU. Notably, in the well-baby nursery we do not separate SARS-CoV-2-positive mothers from their newborns, but emphasize maternal mask use and social distancing by placing newborns in isolates and asking mothers to remain 6 feet away unless feeding or changing their newborn. We also encourage direct breastfeeding and do not advocate early bathing. Newborns of SARS-CoV-2-positive mothers are considered persons under investigation (PUIs) until 14 days of life, the duration of the incubation period for SARS-CoV-2. We share two models of community-based care for PUI neonates. Finally, we provide our strategies for enhancing communication and education during the early months of the pandemic.

Neonates With Complex Cardiac Malformation and Congenital Diaphragmatic Hernia Born to SARS-CoV-2 Positive Women-A Single Center Experience.

BACKGROUND: Our understanding of the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on pregnancies and perinatal outcomes is limited. The clinical course of neonates born to women who acquired coronavirus disease 2019 (COVID-19) during their pregnancy has been previously described. However, the course of neonates born with complex congenital malformations during the COVID-19 pandemic is not known. METHODS: We report a case series of seven neonates with congenital heart and lung malformations born to women who tested positive for SARS-CoV-2 during their pregnancy at a single academic medical center in New York City. RESULTS: Six infants had congenital heart disease and one was diagnosed with congenital diaphragmatic hernia. In all seven infants, the clinical course was as expected for the congenital lesion. None of the seven exhibited symptoms generally associated with COVID-19. None of the infants in our case series tested positive by nasopharyngeal test for SARS-CoV-2 at 24 hours of life and at multiple points during their hospital course. CONCLUSIONS: In this case series, maternal infection with SARS-CoV-2 during pregnancy did not result in adverse outcomes in neonates with complex heart or lung malformations. Neither vertical nor horizontal transmission of SARS-CoV-2 was noted.

Is Communication Improved With the Implementation of an Obstetrical Version of the World Health Organization Safe Surgery Checklist?

OBJECTIVE: Communication failures are consistently seen as a root cause of preventable adverse outcomes in obstetrics. We assessed whether use of an Obstetric Safe Surgery Checklist for cesarean deliveries (CDs), based on the WHO Safe Surgery Checklist, can improve communication; reduce team member confusion about urgency of the case; and decrease documentation discrepancies among nursing, obstetric, anesthesia, and pediatric staff. METHODS: Retrospective review of 600 CDs on our 2 labor and delivery suites before and after the introduction of 2 consecutive versions of our obstetric safe surgery checklist (100 cases in each cohort) was undertaken. The first version was released in 2010, and after modifications based on initial findings, our current version was released in 2014. One hundred consecutive CDs were identified from each of the 3 periods at each hospital, and charts for those patients and newborns were abstracted. Notes by obstetricians, nurses, anesthesiologists, and pediatricians were reviewed. We compared the rates of agreement in the documentation of the indication for the CD between the different members of the team. Chi-square analyses were performed. RESULTS: Complete agreement among the 4 specialties in the documented indication for CD before introduction of our initial safe surgery checklist was noted in 59% (n = 118) of cases. After initial checklist introduction, agreement decreased to 43% (n = 86; P = 0.002). We then modified our checklist to include indication for CD and level of urgency and changed our policy to include pediatric staff participation in the timeout. Agreement in a subsequent chart review increased to 80% (n = 160), significantly better than in our initial analysis (P < 0.001) and our interim review (P < 0.001). The greatest improvement in agreement was observed between obstetricians and pediatricians. CONCLUSIONS: Implementation of a safe surgery checklist can improve communication at CDs, but care should be taken when implementing checklists because they can have unanticipated consequences. Ongoing review and modification are critical to ensure safer medical care.

Emerging Role of Drills and Simulations in Patient Safety.

Ensuring patient safety and optimizing outcomes in obstetrics and gynecology through improving technical skills, enhancing team performance, and decreasing medical errors has resulted in significant interest in incorporating drills and simulation into medical training, continuing education, and multidisciplinary team practice. Drills and simulations are ideal because of their wide range of application with various learners and settings. They provide a safe space to learn and maintain technical skills and to improve knowledge, confidence, communication, and teamwork behaviors, particularly for less common, high-stakes clinical scenarios.

Anesthesia Exposure in Children: Practitioners Respond to the 2016 FDA Drug Safety Communication.

In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.

Development and internal validation of the multivariable CIPHER (Collaborative Integrated Pregnancy High-dependency Estimate of Risk) clinical risk prediction model.

BACKGROUND: Intensive care unit (ICU) outcome prediction models, such as Acute Physiology And Chronic Health Evaluation (APACHE), were designed in general critical care populations and their use in obstetric populations is contentious. The aim of the CIPHER (Collaborative Integrated Pregnancy High-dependency Estimate of Risk) study was to develop and internally validate a multivariable prognostic model calibrated specifically for pregnant or recently delivered women admitted for critical care. METHODS: A retrospective observational cohort was created for this study from 13 tertiary facilities across five high-income and six low- or middle-income countries. Women admitted to an ICU for more than 24 h during pregnancy or less than 6 weeks post-partum from 2000 to 2012 were included in the cohort. A composite primary outcome was defined as maternal death or need for organ support for more than 7 days or acute life-saving intervention. Model development involved selection of candidate predictor variables based on prior evidence of effect, availability across study sites, and use of LASSO (Least Absolute Shrinkage and Selection Operator) model building after multiple imputation using chained equations to address missing data for variable selection. The final model was estimated using multivariable logistic regression. Internal validation was completed using bootstrapping to correct for optimism in model performance measures of discrimination and calibration. RESULTS: Overall, 127 out of 769 (16.5%) women experienced an adverse outcome. Predictors included in the final CIPHER model were maternal age, surgery in the preceding 24 h, systolic blood pressure, Glasgow Coma Scale score, serum sodium, serum potassium, activated partial thromboplastin time, arterial blood gas (ABG) pH, serum creatinine, and serum bilirubin. After internal validation, the model maintained excellent discrimination (area under the curve of the receiver operating characteristic (AUROC) 0.82, 95% confidence interval (CI) 0.81 to 0.84) and good calibration (slope of 0.92, 95% CI 0.91 to 0.92 and intercept of -0.11, 95% CI -0.13 to -0.08). CONCLUSIONS: The CIPHER model has the potential to be a pragmatic risk prediction tool. CIPHER can identify critically ill pregnant women at highest risk for adverse outcomes, inform counseling of patients about risk, and facilitate bench-marking of outcomes between centers by adjusting for baseline risk.

The utility of bedside simulation for training in critical care obstetrics.

Over the last 2 decades, the maternal mortality ratio in the United States has doubled from 7.4/100,000 live births in 1986 to 14.5/100,000 today. Despite great advances in health care, increasing rates of maternal morbidity and mortality in the United States have prompted calls to action to reverse this disturbing trend. Assisted reproductive technology has allowed women to delay childbearing to more advanced ages, resulting in a greater number of pregnancies complicated by one or more of the diseases associated with aging, such as cardiovascular disease, cancer, type 2 diabetes, and hypertension. The obesity epidemic, increasing rates of chronic diseases affecting pregnancy, steadily rising cesarean delivery rate with resulting complications, and medical advances allowing women with rare, but serious diseases to conceive contribute to rising maternal morbidity and mortality rates. Obstetric critical care simulation training may result in improved multidisciplinary teamwork and patient outcomes; and fewer medical and communication errors.

Simulation in maternal-fetal medicine: making a case for the need.

Medical error remains a cause for concern in obstetrics. Studies have shown that the most important contributing factors to adverse events in obstetrics often relate to poor teamwork and ineffective communication. A potential solution to these problems includes transforming institutions, obstetric departments, and maternal-fetal medicine divisions into high-reliability organizations. Simulation is a valuable tool which can be utilized, in obstetrics and maternal-fetal medicine, as an integral part of programs designed to advance knowledge and technical skills; improve communication and team function; and identify and correct systems issues. Simulation should be an integral part of our journey towards high reliability with the ultimate goal of improving patient safety and quality of care in obstetrics.