Loraine O'Neill, RN, MPH
In my role as a perinatal safety officer in a large academic medical center, I work with all members of the perinatal team that contribute to high-quality safe perinatal care. The team includes, of course, nurses, midwives, and nurse practitioners, as well as pharmacy, laboratory and blood bank personnel, environmental services teams, business associates, patient care assistants, well-baby pediatricians, neonatologists, anesthesiology teams, family medicine teams, physician assistants, obstetric resident physicians in training, obstetric attending physicians, and physician fellows. That's a lot of professionals and departments that need to be in sync and working together.
When I look back at my experience with near-misses or failure to rescue, many of these events occurred when vital signs were overlooked or not appreciated. For example, an incident where a mother immediately post-op after cesarean birth becomes increasingly hypotensive and tachycardic and the anesthesia team push vasopressor medications without communicating with the rest of the team, and subsequently the mother needs to return to the operating room as she has internal concealed bleeding. Likewise, when a nurse passes the relevant information on to the resident physician but does not communicate concisely or escalate when the response is questioned or delayed. My concerns about safe care during the hospitalization for childbirth are related to what I see as a decline in the basic fundamentals of patient care. They include vital signs (including intake and output) and symptoms within the clinical picture, identifying changes over time; communication; team membership; escalation within a culture of psychological safety; lessons learned; and patient education and teach-back.
Timely and Accurate Assessment of Symptoms and Trends
With the introduction of electric medical records (EMR) we have gained legibility, but what are we actually recording about this unique birth experience? Do we observe maternal heart rate, blood pressure, and other important maternal parameters for trends? It is imperative that the team caring for pregnant women pay close attention to vital signs and the full clinical picture so that a rapid response can be summoned and patients can be triaged to higher level units in a timely fashion. Each clinical scenario manifests with changes, no matter how subtle, in vital signs and clinical status, for example, an elevated pulse or lower blood pressure or low temperature. There are currently several obstetric-specific parameters reported in the literature that can be used to guide increased attention to specific patients that include: the modified early obstetrical warning system (MEOWS), the Maternal Early Warning Criteria (MERC), and the Maternity Early Warning Trigger (MEWT) (Mhyre et al., 2014).
In taking care of a somewhat healthy population, we can be fooled. Over the past few years, an extensive amount of work has been undertaken by several states to initiate major changes in all maternity units, regardless of capacity, to reduce the risk of maternal and neonatal adverse outcomes. California took the lead and was followed by several others including New York State, where I live and work. Major areas of focus are hypertensive disorders of pregnancy, prevention of deep vein thrombosis, and postpartum hemorrhage. Results appear to be very promising, as California is the only state to see a reversal of the increased trends in maternal mortality (Main, Markow, & Gould, 2018). One primary element for management of maternal hemorrhage, cumulative quantitative blood loss, is being slowly adopted and incorporated into assessment. Since the 1960s, researchers have been questioning use of estimating blood loss. Many of us have moved to the cumulative quantitative method; however, this has placed a time and workflow burden on nurses. Our experience has shown that having a numerical amount adds to accurate assessment and screening to ensure timely intervention and reduce the possible adverse sequelae of severe postpartum hemorrhage. As a result of our state collaborative, we are now able to adopt evidence-based care bundles, which can help develop multidisciplinary guidelines and encourage a standardized approach and response to certain conditions. Coupled with an escalation chain (which must display the contact information of those identified to assist), this fosters a supportive structure in which to care for new mothers and babies (Witcher, Chazotte, & Chez, 2019).
In the context of more accurate ability to interpret any abnormal parameters of vital signs and basic assessment skills, we must be able to recognize trends and provide timely interventions. That includes putting all of our findings together and communicating concerns appropriately and in a timely manner. Critical language such as Situation, Background, Assessment, and Recommendation (SBAR) can be very helpful as a communication tool. I advise team members to add a caveat of time in their communication, as in “It is now 10 am, what time can I expect you?” The use of critical language is something that we have found vital in many areas of healthcare. Many use CUS (I'm Concerned, I'm Uncomfortable, it is Safety issue) from TeamSTEPPS (Agency for Healthcare Research and Quality, 2019). We adopted the catchphrase “I need clarity”; when a team member hears that phrase, they should stop what they are doing and listen.
Integrating Lessons Learned into Practice to Promote Safety
As an example of lessons learned, our team reviewed our experience with occurrences of sudden unexplained postnatal collapse of the newborn and identified that we had several near-misses. In the immediate newborn period, how often should we observe the newborn and record vital signs? Minimum requirements can be found in the Guidelines for Perinatal Care (American Academy of Pediatrics & American College of Obstetricians and Gynecologists, 2017). However, as practice has changed to routinely incorporate skin-to-skin care for healthy newborns at birth and during postpartum, heightened newborn observation may be in order (Simpson, 2017b). After review of our then current practice and conducting a search of the relevant literature, a multidisciplinary team met and resolved to adopt the assessment tool called the Respiratory, Activity, Perfusion, and Position Tool (RAPPT) (Ludington-Hoe, Morrison-Wilford, DiMarco, & Lotas, 2018). One of the most valuable assets of my role is that I have a cadre of colleagues, across the country, with whom I exchange my concerns and we share our experiences and work to help mitigate further adverse outcomes.
Patient Education and Teach-Back
During hospitalization for childbirth, there are many opportunities to provide pertinent education to new mothers and their families. There is a lot to learn in a small amount of time and depending on the circumstances, the ability to assimilate all of the essential information may be challenging. When sending a mother home, we need to ensure that she is able to understand the signs and symptoms that she might exhibit with hypertension, fever, increased bleeding and so on such as those outlined in the Postbirth Warning Signs educational handout (Suplee, Kleppel, Santa-Donato, & Bingham, 2017) that can be offered to all women before postpartum discharge (Simpson, 2017a). We must ensure that the new mother and all of her support members understand the need to frequently feed the newborn and to note the numbers of wet and dirty diapers because these are basic signs of neonatal wellness.
There are many barriers to ensuring the basics are back in focus. To overcome these barriers, there must be a commitment to not be overwhelmed by the task. Anything on major scale such as an EMR-generated warning system will entail personnel, cost, and time; with the latter maybe being the scarcest resource. There are many challenges and the perinatal team may feel they are being asked to do yet one more thing or adopt another protocol or practice, when they haven't been able to fully assess the implications of the last practice change. Each perinatal team unit needs to work together to make a pledge to return to the fundamentals of patient care to promote early recognition and ensure increased safety in the delivery of care to mothers and babies.
Loraine O'Neill RN, MPH
Perinatal Patient Safety Officer
Department of OB/GYN
The Mount Sinai Medical Center
New York, NY
Lisa A. Miller, CNM, JD
This year is my 40th year in obstetric nursing. I have had the benefit of working in a variety of settings, from large academic centers to small community hospitals; I have worked in various roles: nursing, maternal transport, midwifery, and management. Since 2002, my primary focus has been on multidisciplinary education and risk management in obstetrics, with a focus on labor and delivery. I believe that we are facing some significant challenges that must be addressed if we are to move forward and improve outcomes for the women and families we serve. Here are my thoughts on five areas that must be considered as priorities for obstetric practice in the United States; they are in no particular order, and it is my opinion that all of these are issues that urgently deserve our attention and resources. Rather than state what is lacking, or express them in the negative, I have provided them as a five-pronged call to action and provide a brief discussion of each. The calls to action are: 1) Improve core clinical knowledge; 2) Address bias and racism; 3) Individualize care; 4) Train for improved communication; and 5) Be wary of “enterprise solutions.” I hope bringing these areas to your attention may provide a framework for our collective efforts.
Improve Core Clinical Knowledge
The last 17 years of traveling across the United States, providing continuing education to nurses, midwives, and physicians have made me acutely aware of the significant knowledge gaps that pervade obstetric care. Time and time again, I see evidence (using audience response technology) that many practicing clinicians simply do not possess the core clinical knowledge to provide safe obstetric care. It is not just lack of knowledge about definitions, rather it is poor or limited understanding of basic physiology: of labor, of uterine activity and its effect on fetal acid-base, and of the signs and symptoms of shock and sepsis. It is not a matter of commitment, as the clinicians I teach are all fully committed to safe care and improving outcomes. Instead it is likely the lack of time and resources provided by the systems where these clinicians work, for example, administrators who believe that one-off training is sufficient; leaders who want technology to do everything; and managers who believe that the response to a poor outcome should be yet another checklist. The time has come for us to collectively recognize that technology and checklists are tools only, and we need clinicians who are critical thinkers using those tools. Education and training must be ongoing, repetitive, and focused on physiology to result in real risk reduction.
Address Bias and Racism
Bias and racism must become issues that are openly discussed at all levels. Cognitive bias in healthcare affects our abilities to learn from errors and our willingness to change practice patterns even when the evidence is clear. Cognitive dissonance may also play a significant role in the ability of a healthcare workforce that is predominately white to effectively address racism. Racial disparity in obstetrics is no secret, and yet it is one of the most painful and difficult subjects to discuss, much less determines how to frame and solve. As early as 2003, the Institute of Medicine (IOM) published a treatise on racial and ethnic disparities in healthcare (IOM, 2003); a safety bundle was published in 2018 (Howell et al., 2018); and a recent population-based study in Chicago showed a clear relationship between perceived discrimination and quality of care (Benjamins & Middleton, 2019). Yet deep dives into cultural competence training for nurses, midwives, and physicians are not common endeavors for healthcare systems. This is an area that urgently deserves our attention and focus if we are to improve outcomes and reduce morbidity and mortality in obstetrics.
Every woman deserves to have safe and attentive care that is tailored to her unique situation. Clinicians must work together to understand that different approaches may be needed based on the individual. A great example is the use of labor curves. Although many clinicians are familiar with what has come to be called the Zhang labor curve (Zhang et al., 2010), they often do not realize that data are limited to women in spontaneous labor. Other labor curves for women undergoing induction of labor, or those with higher body mass indexes may need to be incorporated into clinical practice. Another example of the need for individualizing care is the choice of electronic fetal monitoring versus intermittent auscultation for low-risk women in labor. Clinicians must be comfortable and skilled with both modalities to optimize fetal assessment during labor, and women should be fully informed and involved in the decision-making process. Although policies and protocols can certainly be helpful in this area, once again it comes back to the education of clinicians as the crucial issue. If current information is not effectively disseminated among and between the disciplines of nursing, midwifery, and medicine, women will continue to be subject to risk from outdated or incorrect approaches to labor support and management, unnecessary interventions, and unsafe practices.
Train for Improved Communication
Communication and information transfer continue to be reported as key issues in preventable poor outcomes. The prevalence of hierarchical systems remains significant and continues to be a source of substantial frustration as well as risk. Hospital systems can no longer afford to ignore these challenges and must incorporate teamwork training and communication strategies into daily practice. Cost does not have to be a barrier to access high-quality resources. No-cost options are TeamSTEPPS and Crucial Moments in Healthcare. The TeamSTEPPS program has been recently updated and is available at no cost through the Agency for Healthcare Research and Quality (2019) and the resource Crucial Moments in Healthcare is available at no charge via download (Maxfield & Grenny, 2017) that can be used to effectively begin a dialogue on communication and teamwork, including the barriers we face daily. Recognition of personal, cultural, and systemic factors that may have a negative impact on collaboration with patients and colleagues must also become a routine part of our ongoing training. And although scripted communication is sometimes met with derision by clinicians, standardization of our communication techniques and the value of repetition and practice cannot be overstated. Practice may not make perfect in every case, but it certainly leads to improvement.
Be Wary of “Enterprise Solutions”
Just as we need to learn to individualize our care of women and families, we must understand that when it comes to process improvement and safety, one size does not fit all. Most hospitals are now part of large healthcare systems, and large healthcare systems look for “enterprise solutions” to risk management, such as the implementation of standardized protocols and approaches to care, or the purchase of technology promising artificial intelligence. Although on the surface these solutions are widely accepted as the best way to ensure safety, they must be balanced with the recognition that the issues and challenges pertinent to risk reduction at a large academic center located in Chicago may be very different than those faced by a small community hospital in rural Illinois. Yet with both hospitals part of the same health system, the dangers of applying a one-size-fits-all solution to a risk reduction effort related to something like cesarean birth or induction of labor may be significant. Although protocols and policies may be standardized, their acceptance and implementation will likely need to be individualized to the particular institution's culture, workflow, and even physical space. There is certainly a place for standardization across hospitals within a system; however, there must be recognition of the varied needs and challenges faced by individual hospitals is crucial to the success of such initiatives.
Patient safety and risk reduction in obstetrics is a complex subject. It is a subject that deserves both our attention and the allocation of significant resources, including the development of effective patient safety and quality improvement programs. The five key suggestions presented here, addressing clinical knowledge, pervasive bias and racism, need for individualization of care, ongoing communication training, and implementation of individualized clinical solutions are areas I believe to be of utmost importance to the health of women and families. It is my hope that nurses, midwives, and physicians will use these suggestions to begin or continue dialogues in safety and risk reduction, and to build on current work in these areas, allowing us to continue the forward momentum in better care and better outcomes for mothers and babies.
Lisa A. Miller, CNM, JD
Perinatal Risk Management & Education Services
Annie J. Rohan, PhD RN NNP-BC CPNP-BC FAANP
In the 20 years since the Institute of Medicine (IOM) released its report, To Err is Human: Building a Safer Health System (Kohn, Corrigan, Donaldson, & Institute of Medicine Committee on Quality of Health Care in America, 1999), there have been numerous efforts to develop consistent methods to evaluate and improve quality of care and patient safety in perinatal settings. For example, The Joint Commission (TJC, 2019b) requires reporting on rate of missed opportunities to administer antenatal steroids to at-risk women; incidence of healthcare-associated bloodstream infections in newborns; and rate of unexpected complications in term newborns as part of their perinatal care performance measures for accredited hospitals with 300 or more annual live births or hospitals seeking perinatal care certification. In 2004, another report by the IOM, Keeping Patients Safe: Transforming the Work Environment of Nurses, called upon nurses to construct safe workplace process and environments and create a culture of safety (Institute of Medicine Committee on the Work Environment for Nurses and Patient Safety, 2004). Assuring patient safety soon became recognized as requiring a comprehensive team approach for considering human factors, engineering to improve system process and structure, and monitoring to detect improvement in outcomes.
Adverse patient safety events are those resulting in undesirable outcomes that are more likely a consequence of healthcare process than the consequence of a patient's disease. The Joint Commission (2019a) terms the most concerning adverse safety events as “sentinel events” because they result in death, severe temporary harm, or permanent harm. Sentinel events unique to the neonatal setting include unanticipated death of a full-term infant, and discharge of an infant to the wrong family. The Agency for Healthcare Research and Quality (2019) similarly describes “never events” (i.e., those that should never occur). Never events unique to the neonatal setting include infant abduction and death or serious injury of a neonate during labor or birth after a low-risk pregnancy. Sentinel and never events call for immediate investigation and response, and are often a source of great stress to members of the healthcare team. Promoting a culture of safety and avoidance of severe adverse events is particularly important in the fast-paced environment of the neonatal intensive care unit (NICU), where complex processes and extreme patient vulnerability are ever-present threats to patient safety. Improving processes associated with sentinel or never events is a priority because meaningful improvements can reduce adverse patient outcomes, minimize associated disruptions in the healthcare system, and lessen anguish for providers and families. In the neonatal setting, three priority areas are identified for process improvement to enhance patient safety: 1) medication administration; 2) newborn identification; and 3) infant sleep management.
In the past 2 decades, numerous threats to medication safety have been mitigated with technological solutions, such as computerized provider order entry and barcoding, and through dosing system changes, such as “IV-only” connectors, transition to single-dose vials, and use of unit-based pharmacists. As structures and processes in healthcare evolve, however, new threats emerge. A recent review of medication errors in hospitalized patients compared errors in neonates to errors across other pediatric and adult populations. Medication errors due to patient misidentification and overdosing were particularly prevalent in neonates, with nearly half of administration errors involving at least tenfold overdoses (Krzyzaniak & Bajorek, 2016).
Potential Barriers to Medication Safety: Single-Patient Rooms
Evolution of NICU design toward single-patient rooms, postulated to improve neurodevelopmental outcomes compared with open bays, has introduced new barriers to medication safety. Single-patient rooms create challenges for bedside nurses in maintaining optimal situational awareness and efficiently conducting two-nurse medication checks. Nurses report difficulty in monitoring the status of multiple patients in single-patient room designs and have expressed concern that novice nurses might not recognize subtle changes or receive the informal vigilance of experienced nurses (Carlson, Walsh, Wergin, Schwarzkopf, & Ecklund, 2006). There is an ample opportunity to reengineer NICU structures and processes for greater nurse proximity or nurse interaction in the single-patient room setting so that novice nurses are continuously listening to expert nurses teaching parents, interacting with other providers, or troubleshooting alarms. Promising innovations that have the potential to improve processes in units with single-patient rooms include: novel staffing methods to facilitate two-nurse checks (such as a designated “floating” nurse); tactical military-grade radios for nurse-to-nurse communication; and structural changes to facilitate situational awareness, such as targeted placement of half walls or windows (instead of full walls).
Newborn misidentification is a leading cause of medication errors in the NICU (Krzyzaniak & Bajorek, 2016; Raju, Suresh, & Higgins, 2011) and is a central theme in discharge of an infant to the wrong family. Newborns are at high risk for misidentification due to lack of distinguishable features, common multiplicity, and inability to communicate in a meaningful way. Nondistinct naming conventions have been long associated with an increased rate of wrong-patient errors. Nurseries commonly distinguish siblings from each other only by adding a single character (e.g., A, B) at the end of a temporary name. Sex is also less useful an identifier in newborns than in older children and adults. Furthermore, the letter “B” has been used to represent “Baby,” “Boy,” and the second sibling of multiples. Despite the availability of evidence and national recommendations for using more distinct naming conventions, a recent national survey showed that only 18% of NICUs used a nondistinct naming convention (Adelman et al., 2015).
Potential Barrier to Newborn Identification Safety: Band-Based Nomenclature System
The Joint Commission (2018) recently created a requirement for hospitals to use distinct methods of identification of newborns (e.g., using the mother's first/last name and the newborn's sex) and standardized practices and communication tools for banding. Although this is a step toward improved newborn identification, new challenges have emerged. Many electronic systems truncate these long and hyphenated names, potentially removing identifiers and resulting in siblings having identical names. Limited space on infant name bands results in condensed labeling, or in the need for handwritten, and often illegible, labels. Fragile patients are commonly band-intolerant, or wear bands that are unable to be accessed by barcoding devices. There is an ample opportunity to develop an innovative nomenclature system for newborns, novel methods for the physical identification of infants, and better name management in electronic systems. Promising innovations that have the potential to improve processes around infant identification include: novel band materials and designs; chip technologies; color-coding for multiples; distinct naming conventions that are fully operationalized by electronic medical record systems; and distancing or removing foot printing from identification processes to promote evidence-based practice.
Infant Sleep Management
Despite a >50% decline in the rate of sudden infant death syndrome (SIDS) in the first decade following the 1994 introduction of the American Academy of Pediatrics (AAP) Back to Sleep (now Safe to Sleep) campaign (Trachtenberg, Haas, Kinney, Stanley, & Krous, 2012), SIDS remains the leading cause of postneonatal infant mortality in the United States. Deaths from SIDS consistently account for the largest proportion of sudden unexpected infant death (SUID) (Centers for Disease Control and Prevention, 2019). The risk for SUID, including accidental suffocation, strangulation, and entrapment in bed among preterm infants remains high (Malloy, 2013).
In 2016, AAP instituted new guidelines for sleep positioning including (1) supine positioning (wholly on back and never on side); (2) use of a firm sleep surface designed for infants; (3) elimination of soft/loose objects from the infant sleep surface; and (4) bedroom sharing by infant and parent for at least first six months of age, with infant on a separate sleep surface (Moon & Task Force on Sudden Infant Death Syndrome, 2016). The AAP guidelines encourage preterm infants be placed in the supine position for sleep as soon as medically stable and by 32 weeks postmenstrual age (Moon & Task Force on Sudden Infant Death Syndrome, 2016). In hospitals, it remains common practice to place premature infants nonflat, nonsupine, or with positioning aids beyond 32 weeks (Naugler & DiCarlo, 2018), although the developmental and medical literature guides against these practices. Despite the strength of evidence and widely endorsed clinical practice guidelines for infant sleep safety, there is inconsistent modeling of safe sleep practices by perinatal and neonatal nurses (Kellams et al., 2017; McMullen, Fioravanti, Brown, & Carey, 2016; Patton, Stiltner, Wright, & Kautz, 2015).
Potential Barrier to Infant Sleep Safety: “Sacred Cows” of Gastroesophageal Reflux Treatment
To reduce the rate of SIDS and SUID, it is imperative to address “sacred cows” of gastroesophageal reflux (GER) that are barriers to modeling safe sleep practices for neonates and infants in the hospital. Evidence supports modeling by nurses is integral to parent compliance with safe sleep recommendations after discharge (Grazel, Phalen, & Polomano, 2010; Naugler & DiCarlo, 2018), yet only a small percentage of nurses report feeling that parents would respond to education or mimic modeling (Barsman, Dowling, Damato, & Czeck, 2015). There is opportunity to develop interventions to increase nurse confidence in evidence-based guidelines for positioning infants with GER, thereby promoting the modeling of safe sleep positions that reduce risk of SUID and SIDS. Evidence-based guidelines, endorsed by AAP and the North American Society for Pediatric Gastroenterology and Nutrition, call for supine positioning of infants with GER, on a flat and firm surface, “with the exception of rare infants for whom the risk of death from GER is greater than the risk of SIDS” (Eichenwald, 2018, p.4). Promising innovations that have the potential to change unit culture toward safer infant sleep include: distinct unit policies promoting Safe-to-Sleep clinical practice guidelines; distinct unit guidelines promoting evidence-based management of GER; and use of commercially available sleep sacks to increase consecutive hours of sleep and improve perceptions of infant comfort in the supine position.
Building a Safer System
Three priority areas for process improvement to optimize patient safety in the NICU have been identified, along with barriers to optimal patient safety, and promising innovations that have the potential to improve process and promote patient safety. Building work cultures that support information sharing, encourage and promote transparency, and acknowledge human fallibility requires commitment, trust, and resources. Across all of our patient safety challenges, a key vehicle for improvement is communication. Improvements in current existing communication processes are important, as well as a willingness to embrace new process, new innovations, and release our sacred cows.
Annie J. Rohan, PhD, RN, NNP-BC, CPNP-BC, FAANPChair of Graduate Studies & Director of Doctor of Nursing Practice Program
Associate Professor & Director of Pediatric Research
College of Nursing
SUNY Downstate Health Sciences University
Brooklyn, New York