Perinatal Patient Safety and Professional Liability Issues



Perinatal Patient Safety and Professional Liability Issues


Kathleen Rice Simpson



CREATING a safe clinical environment during labor and birth requires effective leadership, a shared philosophy, interdisciplinary collaboration, professional behavior, and excellence in key clinical practices. When unit operations and clinical care are based on “What is best (safest) for the mother and baby?”, quality is a natural outcome. Ideally, there are established criteria for ongoing monitoring of quality of care that include structure, process, and outcome measures. This chapter offers recommendations for creating conditions that provide the safest care possible for mothers and babies using a framework for perinatal high reliability that includes each of these essential criteria. Suggestions to minimize risk of professional liability are also provided. The recommendations are based on data concerning the most common causes of preventable injuries to mothers and babies during labor and birth. Data include the Joint Commission (TJC) sentinel event alerts Preventing Infant Death and Injury During Delivery (Joint Commission on Accreditation of Healthcare Organizations [JCAHO], 2004) and Preventing Maternal Death (TJC, 2010), Summary Data of Sentinel Events Reviewed by the Joint Commission (TJC, 2011b), the American College of Obstetricians and Gynecologists’ (ACOG, 2009a) 2009 ACOG Survey on Professional Liability, the Jury Verdict Research (2009) report Current Award Trends in Personal Injury, reports from reviews of professional liability insurance company claims (Clark, Belfort, Dildy, & Meyers, 2008; Crico Strategies, 2010; Greenwald & Mondor, 2003), and experience working with hospitals and healthcare systems to reduce risk of perinatal patient harm and to promote patient safety.

Inpatient obstetric care results in more than 50% of obstetrics and gynecology claims (White, Pichert, Bledsoe, Irwin, & Entman, 2005). In a review of over 800 obstetric malpractice cases from the medical malpractice company owned by the Harvard medical community, the average payment in obstetric-related malpractice claims was more than twice that of other clinical areas, with birth asphyxia, shoulder dystocia, intrauterine fetal death, and maternal hemorrhage accounting for the majority of cases (Crico Strategies, 2010). Contributing factors to the adverse events were noted to be inappropriate management of pregnancy, failure to timely diagnose and treat “fetal distress,” and inappropriate management of the second stage of labor via operative vaginal birth. The number and severity of successful obstetric liability claims and jury awards have steadily increased over the years (Crico Strategies, 2010). Based on a review of 1,213 closed obstetric cases, 44% resulted in payment with the average payment nearly 1 million dollars and 12% over 1 million dollars (Crico Strategies, 2010). Although the number of obstetric claims typically represents only about 5% of all malpractice claims, the dollar amount reserved for current and future payment is usually 25% to 35% of the total financial liability cost to hospitals and healthcare systems. In a study of 8,151 claims against nurses, only 9.9% were related to obstetrical nursing care; however, the amount paid or severity of these claims ranked highest among other specialties, with assessment, monitoring, treatment, and care management making up the bulk of the allegations (Nurses Service Organization, 2009). Increasing patient safety decreases institutional and professional liability risk. All adverse outcomes cannot be prevented; however, defensibility is enhanced when care is consistent with current evidence and national standards and guidelines.



PERINATAL HIGH RELIABILITY

In 1999, the concept, theory, and attributes of high-reliability organizations (those that operate highly complex and hazardous technological systems essentially without mistakes over long periods of time) was applied to clinical perinatal practice (Knox, Simpson, & Garite, 1999). The description of high reliability perinatal units was based on observation differentiating units that produced more or less harm to patients using professional liability claims as a proxy for perinatal injury. The following attributes of low-risk, harm-free, highly reliable obstetric (OB) units were identified:



  • Safety is declared as the hallmark of organizational culture and understood to be the responsibility and duty of every team member. Safety for mothers and babies is the number one priority and takes precedence over institution and provider convenience, production issues, and costs. Safety guides all unit operations and clinical actions. Decisions are made in the context of potential risks and benefits to patients. While institutional costs and financial resources are important and must be considered, patient safety is not at risk due to financial constraints. The administrative leadership team is committed to financially supporting the perinatal unit even if it is not one of the most profitable service lines. This commitment includes providing adequate personnel for leadership and clinical care and updated equipment as needed. Convenience is only a factor in decision making when there is no risk to patient safety. Patients are invited and encouraged to be actively involved in their care and are provided enough information to make decisions through a literacy-appropriate informed consent process.


  • Patient safety is considered a team function rather than an individual function. All clinicians are considered competent, with an obligation to speak up if there is a question of safety. Team interaction is collegial rather than hierarchical. Hierarchy does not hinder any clinician from expressing concern in the face of potential risks. Any member of the team is able to offer opinions and speak up in the context of risk of patient harm. Those alerts and opinions are welcomed by the entire team regardless of discipline or rank.


  • Respectful communication is highly valued and rewarded. Extensive, transparent communication is used to orient, plan, update, and adjust to the unexpected. Routine debriefing is practiced for critical, unusual, or unexpected events. Team members in high-reliability organizations do not wait until there is an adverse outcome to evaluate operations and practices. Evaluation is ongoing through use of established measurement processes.


  • Emergencies are rehearsed and unexpected events anticipated. During board rounds and case conferences, possibilities for adverse events based on clinical situations are discussed and plans are developed and in place should they occur. Team-building exercises and simulation practices for obstetrical emergencies are conducted on a regular basis.


  • Paradoxically, successful operations (absence of maternal, fetal, and neonatal injury) are viewed as potentially dangerous subject to risk of “normalization of deviance” (a degradation of professional, behavioral, and technical standards that occurs over time and increases probability of a major accident or harm). Because major accidents or patient harm occur only infrequently, clinical practice in the absence of professional standards and/or inaccurate processes (e.g., “work-arounds”) may go undetected or deteriorate over long periods of time.

Perinatal units can be highly reliable in the care that is delivered by incorporating these basic principles into daily operations (Knox & Simpson, 2011; Knox, Simpson, & Townsend, 2003; Simpson & Knox, 2006). Other attributes of perinatal high reliability include effective leadership from the top down, professional behavior by all team members, and standardization of key clinical practices involving risk of adverse events that have a cumulative body of evidence and professional standards and guidelines to support development of clinical guidelines, algorithms, or protocols.


LEADERSHIP

Leadership structures and systems must be established to ensure that there is organization-wide awareness of patient safety performance gaps, direct accountability of leaders for those gaps, adequate investment in performance improvement abilities, and actions taken to ensure safe care of every patient served (National Quality Forum [NQF], 2010). Without effective leaders, staff members are challenged to implement essential criteria for safe care. The leadership team, composed of top hospital administrators, physician department chairs, department nurse leaders, unit nurse managers, clinical nurse specialists, educators, and charge nurses, must be enthusiastic participants actively engaged in promoting safe care as the number one priority. The fundamental goal of keeping patients safe from harm is worthy of sustained leadership attention and focus. Patient safety is a matter of integrity (Ryan, 2004). Leaders must be fully committed and have the will to do the right thing for mothers and babies, their families, their caregivers, and the institution, even when faced with the pressures of economics, productivity, and perceived provider convenience. This includes insisting on research-based, safe clinical practices and a professional environment
where physicians and nurses are encouraged to work as a team, interact as colleagues, and collaborate on clinical solutions in a respectful manner. Our moral and ethical responsibility to do the right thing is discussed in detail in the Code of Ethics for Nurses (American Nurses Association [ANA], 2010). Adequate financial and personnel resource allocation and support for practices based on research findings that demonstrate safe and effective care are critical foundations of our moral and ethical responsibility to patients (ANA, 2010; Ryan, 2004).

A healthy work environment is critical to promoting patient safety. In 2005, the American Association of Critical-Care Nurses (AACN) published standards for establishing and sustaining healthy work environments. These standards have been endorsed by the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). The role of nurses as integral members of the healthcare team and their contributions to patient outcomes are covered in detail. Support of the leadership team of the healthcare organization is essential for success. The AACN (2005) standards are summarized as follows:



  • Skilled communication: Nurses must be as proficient in communication skills as they are in clinical skills.


  • True collaboration: Nurses must be relentless in pursuing and fostering true collaboration.


  • Effective decision making: Nurses must be valued and committed partners in making policy, directing and evaluating clinical care, and leading organizational operations.


  • Appropriate staffing: Staffing must ensure the effective match between patient needs and nurse competence.


  • Meaningful recognition: Nurses must be recognized and must recognize others for the value each brings to the work of the organization.


  • Authentic leadership: Nurse leaders must fully embrace the imperative of a healthy work environment, authentically live it, and engage others in its achievement.

These standards offer a method of measuring performance of individual nursing units, healthcare organizations, and systems and reaffirm that safe and respectful environments are fundamental, requiring systems, structures, and cultures that support communication, collaboration, decision making, staffing recognition, and leadership (AACN, 2005). Implementation can lead to excellence when adoption and continued support occurs at every level of the healthcare organization from the bedside to the boardroom (AACN, 2005).

In 2011, the Society for Maternal-Fetal Medicine (SMFM) invited representatives from professional organizations involved in the care of mothers and babies to develop a call to action for quality care during labor and birth. Participating organizations included the American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), American College of Nurse Midwives (ACNM), ACOG, and AWHONN. Recommendations from Quality Patient Care in Labor and Delivery: A Call to Action (Lawrence et al., 2012) include:



  • Ensure that patient-centered care and patient safety are organizational priorities that guide decisions for organizational policies and practices.


  • Foster a just culture of openness by encouraging and promoting the active communication of good outcomes and opportunities for improvement.


  • Develop forums to facilitate communication and tracking of issues of concern.


  • Provide resources for clinicians to be educated in the principles of teamwork, safety, and shared decision making.


  • Develop methods to systematically track and evaluate care processes and outcomes.


  • Facilitate cross-departmental sharing of resources and expertise.


  • Ensure that quality obstetric care is a priority that guides individual and team decisions.


  • Identify and communicate the safety concerns and work together to mitigate potential safety risks.


  • Disseminate and use the best available evidence, including individual and hospital-level data, to guide practice patterns.

These recommendations are based on the belief that mutual respect, patient-centered care, and shared decision making are essential for providing quality obstetric care (Lawrence et al., 2012). Improving safety requires teamwork and effective communication at multiple levels within the organization. With all professional disciplines working together, patient outcomes and satisfaction can be improved (Lawrence et al., 2012). Consensus on what needs to be accomplished for safe intrapartum care by these leading professional organizations is a powerful message to patients, healthcare providers, and administrators of shared goals for optimal outcomes. Leaders of the administrative and clinical teams in each hospital and healthcare team should support these recommendations and work to make them reality to promote the safest care possible for mothers and babies during labor and birth.


SHARED PHILOSOPHY OF CARE

In a high-reliability unit, there is an agreement that clinical practice will be based on the cumulative body of evidence and national professional standards and guidelines (Knox & Simpson, 2011). This shared philosophy should serve as a guide to develop
unit policies and protocols and, ultimately, for how perinatal care is provided daily. An interdisciplinary practice committee, co-chaired by nurse and physician leaders, should be in place to guide unit operations and clinical care. This committee should include representatives from all disciplines (nurses, midwives, physicians) and specialty practice areas (obstetric, family medicine, pediatrics, neonatal, anesthesia), as well as leaders and direct care providers. The committee should be empowered to make policy changes as needed. There should be a standing agenda item each month to review the most recently published science and standards and guidelines from professional organizations and regulatory agencies such as ACOG, AAP, AWHONN, ACNM, the National Association of Neonatal Nurses (NANN), the Association of peri-Operative Registered Nurses (AORN), the American Society of PeriAnesthesia Nurses (ASPAN), the American Society of Anesthesiologists (ASA), TJC, the Centers for Disease Control and Prevention (CDC), the Institute for Safe Medication Practices (ISMP), the United States Department of Health and Human Services (HHS), the U.S. Preventative Services Task Force, and the U.S. Food and Drug Administration (FDA). Assigning committee members specific organizations to review each month and/or rotating responsibility among committee members for this review process will facilitate a comprehensive appraisal of recently published standards and guidelines and provide the committee with evidence upon which to promote practice changes. Discussion during the committee meetings should focus on how and when new standards and guidelines will be incorporated into unit operations and daily practice.

Patient safety must take priority over convenience, productivity, and costs. Standard unit polices and protocols should be in place for key clinical practices that are known to be associated with risk of adverse outcomes (Knox & Simpson, 2011). These include, but are not limited to, cervical ripening, labor induction, fetal assessment, perinatal group B streptococcus (GBS) prophylaxis, second-stage labor care, vaginal birth after cesarean birth (VBAC), operative vaginal birth, emergent cesarean birth, and neonatal resuscitation. All members of the interdisciplinary team must adhere to the unit policies. In rare cases where there may be a need to practice outside of unit policy, interdisciplinary discussion should occur, medical record documentation should be appropriately descriptive, and the case should be evaluated through the quality review process.

Patient safety is created through accountability based on standardization, simplification, and clarity, as supported by the principles of safety science (Kohn, Corrigan, & Donaldson, 1999). While standardization of unit practices and policies may be perceived as an inconvenience to some team members, it should be acknowledged that the collective good of mothers and babies is the primary concern. There is a growing body of evidence that establishing standardized clinical guidelines can lead to improved patient safety and clinical outcomes as well as a positive effect on malpractice litigation (Kirkpatrick & Burkman, 2010). Examples of standardized clinical guidelines include algorithms of care, templates for electronic medical records, standard provider order sets, surgical checklists, patient hand-off processes, and other protocols designed to improve patient care. Successful implementation has been shown to require more than just encouragement and educational efforts for the healthcare team members in some cases. Although voluntary participation is ideal, some healthcare systems have learned that “hard stops” and disciplinary or credentialing actions may be required to enforce clinical guidelines (Clark et al., 2010).

A conservative approach to perinatal practice based on cumulative evidence and published professional standards creates conditions that promote safer care and decrease the probability of preventable adverse outcomes. However, attempts to standardize basic aspects of care based on current evidence, standards, and guidelines can be met with resistance and may require much effort on the part of the leadership team. Barriers to changing practice include individual practice and clinician autonomy placed at a higher priority than patient safety (“No one is going to tell me how to practice”); a general aversion to change (“I like the status quo”), a false reassurance based on small numbers (“I’ve never had a problem doing it this way”), lack of accountability (“Peer review is nonexistent”), and hierarchical deference. Table 1-1 lists common barriers in promoting evidence-based care via quality improvement projects (Bingham & Main, 2010). Some hospitals and healthcare systems have implemented changes in practice through quality improvement projects. Strategies for successful implementation are listed in Table 1-2 (Bingham & Main, 2010). Each of these strategies requires sustained support and commitment from the administrative leadership team, the clinical leadership team, and front-line clinicians if it is to be successful. One key to success is putting patient safety and the needs of mothers and babies above all other priorities.

Maintaining a healthy work environment and supporting a quality workforce can be instrumental in providing quality care on a routine basis. When all team members have adequate education and support, feel part of the team, and get positive feedback on their efforts to provide optimal care, quality is enhanced. The Agency for Healthcare Research and Quality (AHRQ) (McHugh, Garman, McAlearney, Song, & Harrison, 2010) offers suggestions for workforce practices to
support high quality performance in their practical resource Using Workforce Practices to Drive Quality Improvement: A Guide for Hospitals (see Display 1-1).








Table 1-1. COMMON BARRIERS TO IMPLEMENTATION OF EVIDENCE-BASED CLINICAL GUIDELINES AND PARTICIPATION IN QUALITY IMPROVEMENT PROJECTS





































Leader barriers


Lack of leader knowledge to:


Design, plan, and implement quality improvement (QI)


Perform QI data analysis


Assess how to enhance their individual QI leadership abilities


Leader attitudes (beliefs and assumptions) that affect:


Topic selection QI topic goals


Selection of QI implementation tactics Definitions of success


Leader practices


Lack of clarity of QI project goals


Backing down or stop trying


Lack of time and other resources


Inadequate practices to ensure sustainability (e.g., new hires, staff returning from vacation, leaves of absences)


Clinician barriers


Lack of clinician knowledge:


About their own practices (lack adequate feedback)


New or inexperienced


Lack knowledge of the QI project


Clinician attitudes (beliefs and assumptions):


Not persuaded to change


Want autonomy


Clinician practices:


Inertia—no motivation to change


Forget


Changes add more work or slow down usual work flow


Characteristics of the QI project



Positive or negative effect(s) on clinician income or time


Complexity of the QI project (e.g., how many groups work flow is affected by the QI project changes)


Implementation climate



Type of hospital


Amount of resources


Type of community or population of patients


From Bingham, D., & Main, E. K. (2010) . Effective implementation strategies and tactics for leading change on perinatal units. Journal of Perinatal and Neonatal Nursing, 24(1), 32-42.


Professional registered nurse staffing should be adequate to meet the needs of the service. The AWHONN (2010) staffing guidelines provide detailed recommendations for registered nurse staffing for perinatal units including various types of patients and clinical situations. These guidelines can be used as a basis for planning and implementing safe nurse staffing.








Table 1-2. STRATEGIES FOR SUCCESSFUL IMPLEMENTATION OF EVIDENCE-BASED CLINICAL GUIDELINES




































































Education strategy


Examples of educational tactics


Definition


Grand rounds


Physician educational sessions that are often held once a week.


Classes or conferences


Formal educational sessions developed on specific topics.


Simulation training


Simulation training is education that allows clinicians to practice skills and knowledge through a fabricated situation that mimics a complicated situation that they will face and need to practice how to respond.


Competence fairs, tests, learning fairs, demonstrations


Clinicians demonstrate their knowledge of a new concept or demonstrate their ability to perform a clinical skill.


On-line learning


The use of the internet for the transfer of information.


Date strategy


Examples of data tactics



Audit and feedback (group and individual)


An examination of clinical records in order to gather specific pre-determined information. The information gathered is summarized and shared with the relevant group or individuals.


Public release of data


Details of care patterns and outcomes are reported openly to the community in such a way that anyone can access this information.


Discourse strategy


Examples of discourse tactics


Definition


Meetings


Group discussions (e.g., staff meetings).


One-to-one discussions


A discussion between a change leader and someone else whom they are seeking to influence to change.


Academic detailing


A review of relevant academic research by one leader meeting with one clinician at a time. A common tactic utilized by pharmaceutical representatives.


Reminders


A method for helping someone remember to perform specific tasks (e.g., checklists, order set).


Newsletters


A formal written update that is periodically distributed.


Posters and bulletin boards


A collection of data and information that is organized for display on poster board or a bulletin board.


E-mails


Electronic communications using either the Internet or Intranet that can be one-to-one or one-to-many.


Rewards


Something given in compensation for reaching a pre-determined goal (e.g., professional recognition, a bonus).


Disciplinary discussions


A discussion that is held by someone in the position to give employee feedback and a formal review of performance in order to outline how current behavior does not meet required expectations of job performance.


From Bingham, D., & Main, E. K. (2010) . Effective implementation strategies and tactics for leading change on perinatal units. Journal of Perinatal and Neonatal Nursing, 24(1), 32-42.





PROFESSIONAL BEHAVIOR

Professionals should conduct themselves in a professional manner at all times. Expectations for professional behavior should be outlined explicitly in institutional policies for good citizenship and reaffirmed both by the leaders as well as each team member annually during contract renewal and performance reviews. Respectful, collegial interactions between nurses and physicians and with patients are the bedrock of the unit culture. The different but equal contribution of nurses to the care process and ultimate clinical outcomes should be recognized and valued. Poor behavior (e.g., throwing instruments or medical records, intimidation, having temper tantrums, making demeaning comments to team members and/or patients, or using profanity) should not be defined or qualified by discipline. Exceptions should not be made because “he or she is a good clinician otherwise,” “we need his patient volume,” or “she’s one of the few who is always willing to work overtime.”

Disruptive behavior can be overt, such as yelling; using profanity; throwing instruments; slamming charts; physically threatening or abusing others; berating someone; displaying a rude, demeaning attitude; lying; not answering pages; and slow or no response when called for a bedside evaluation (Porto & Lauve, 2006). More subtle examples are disrespect, gossiping, nonverbal devaluation, eye rolling when a colleague makes a suggestion, not speaking to certain colleagues, gender discrimination, or sexual innuendo (Weber, 2004). Disruptive behavior is a significant threat to patient safety. After an experience with a disruptive clinician, many victims intentionally avoid additional interactions to minimize further opportunities for abuse (Rosenstein & O’Daniel, 2005). During labor, this can involve the nurse not calling the physician about an indeterminate or abnormal fetal heart rate (FHR) pattern because the last time they interacted, the nurse felt berated and demeaned (Simpson, James, & Knox, 2006; Simpson & Lyndon, 2009). Nurses may feel pressured to increase oxytocin rates during tachysystole and avoid speaking up to prevent another unpleasant encounter with the physician who believes more oxytocin will speed labor (Simpson et al., 2006). A nurse may be reluctant to seek advice from a nurse colleague concerning FHR interpretation because of past inferences of inadequacy during similar consultation. Because most (but not all) indeterminate FHR patterns are not the result of fetal acidemia and most (but not all) tachysystole will not cause maternal or fetal harm, these avoidance strategies will work for some time, until the inevitable adverse outcome occurs.

Respectful, collegial, professional behavior should be valued equally to competent clinical practice and patient volume. Processes for reporting disruptive behavior should be widely disseminated and their use actively encouraged and supported by the leadership team. There should be accountability for individual actions and meaningful follow-up with clear, actionable implications when disruptive behavior occurs. Each instance of disruptive behavior should be addressed in a timely manner, rather than delaying interventions until trends become apparent. Competent clinical practice is a basic expectation and cannot be substituted for irresponsible, inappropriate, dysfunctional, or abusive behavior. In the Joint Commission Sentinel Event Alert Number 40, Behaviors that Undermine a Culture of Safety, specific recommendations are listed for promoting professional behavior (TJC, 2008) (see Display 1-2). TJC has a leadership standard that addresses disruptive and inappropriate behaviors in
two of its elements of performance: (1) the hospital/organization has a code of conduct that defines acceptable and disruptive and inappropriate behaviors; (2) leaders create and implement a process for managing disruptive and inappropriate behaviors (TJC, 2012). Further, standards in the medical staff chapter list core areas of competence that must be covered in the credentialing process, including interpersonal skills and professionalism (TJC, 2012). Similar expectations for ongoing competence validation are in effect for nurses (ANA, 2010; TJC, 2012).



COMMON AREAS OF LIABILITY AND PATIENT HARM IN CLINICAL PRACTICE

Following is a summary of the most common foci of professional perinatal liability claims, together with the most current applicable evidence and published standards and guidelines from professional associations and regulatory agencies (Simpson & Knox, 2003a, 2003b). The purpose of this discussion is to provide a framework for reviewing existing institutional protocols and
developing future policies and guidelines that decrease professional liability exposure and minimize the risk of iatrogenic injury to mothers and babies.

Note that most publications about clinical practice from professional organizations include disclaimers that their recommendations are guidelines rather than standards of care. However, when clinical care results in litigation, both the plaintiff and defense teams frequently offer these professional publications as standards to support their case. Thus, while the intention is to offer guidelines based on the best evidence to date, publications from professional organizations such as ACOG, AAP, ASA, AWHONN, and ACNM do in fact become standards of care for all practical purposes in legal proceedings.

Allegations against nurses, nurse midwives, physicians, and/or institutions often result from a lack of knowledge of or commitment to practice based on current standards, guidelines, and evidence. In other cases, care is based on personal experience and history of practice over a long period during which the care provider has not experienced an adverse outcome. In obstetrics, complications leading to death are rare because mothers and babies are generally healthy. Even care that would be judged by expert peers to be substandard rarely results in injury or death. Without personal involvement in an adverse outcome, some practitioners tend to continue as they have in the past regardless of their true capabilities and limitations (Chauhan, Magann, McAninch, Gherman, & Morrison, 2003).

Although it is generally thought that practitioners with more experience have accumulated more knowledge and clinical skills and, therefore, provide higher quality care, researchers found the opposite to be true (Choudhry, Fletcher, & Soumerai, 2005). Physicians with more experience have less factual knowledge, are less likely to practice based on current science and standards from their professional associations, and are more likely to have a poor patient outcome when compared to physicians with fewer years of experience (Choudhry et al., 2005). While this study was about physicians, likely the same implications apply to nursing. Admittedly, some of the scientific evidence is counterintuitive and different from what we all learned years ago. For example, it seems likely that more oxytocin at higher rates will produce a more effective labor process and a clinically significant shorter labor. It also seems that pushing immediately at 10 cm and continuing to push despite an indeterminate or abnormal FHR pattern is the best and quickest way to deliver the baby. However, there is a growing body of evidence to the contrary. Given the odds of an adverse outcome for generally healthy patients and a practitioner’s years of experience (with practice that may be no longer consistent with current standards, guidelines, and evidence), practitioners are often surprised when the rare adverse outcome does occur (Chauhan et al., 2003). Moving toward a science-based clinical practice environment rather than “the way we’ve always done it” remains a significant challenge to promoting safe care. It should be noted that many times there is no cause-and-effect relationship between the allegations and an injury to a mother or baby. All adverse events are not preventable. There are times when patient are injured despite the best intentions of care providers based on multiple factors outside of their control. However, practices inconsistent with current standards, guidelines, and evidence offer opportunity for the plaintiff to demonstrate “breach of the standard of care,” which can be challenging to overcome during a legal proceeding. There have been numerous discussions about strategies to decrease professional liability risk through liability reform legislation. These discussions have not led to significant changes in malpractice litigation processes or outcomes. One way to reduce liability exposure is to provide better care. In a study of 189 closed obstetric claims from a single liability insurance provider, 70% of claims were judged by expert reviewers to have involved substandard care (Clark et al., 2008). Similarly, in another study of 1,213 closed obstetric claims, 77% were found to involve substandard clinical judgment (Crico Strategies, 2010). Therefore, opportunities exist to improve care obstetric practices for mothers and babies to minimize risk of preventable harm and promote safe outcomes.


TELEPHONE TRIAGE


Common Allegations



  • Failure to accurately assess maternal-fetal status over the telephone


  • Failure to advise the woman to seek clinic, office, or inpatient evaluation and treatment


  • Failure of the nurse to correctly communicate maternal-fetal status to the primary healthcare provider


  • Failure of the physician/nurse midwife to come to the hospital to see the patient when requested by the nurse


Standards, Guidelines, and Recommendations



  • Telephone advice to pregnant patients from labor and delivery nurses should be limited to two comments: “Call your primary healthcare provider” or “Come to the hospital to be evaluated.” Ruling out labor and possible maternal-fetal complications cannot be done accurately over the phone. The liability for assessing and diagnosing conditions of pregnancy and labor should remain with the primary care providers rather than being assumed by the institution.



OBSTETRICAL TRIAGE


Common Allegations



  • Failure to perform a medical screening exam for all pregnant women who present for care in the hospital


  • Failure to include a timely assessment of fetal status as part of the maternal medical screening exam


  • Delays in performing a medical screening exam (e.g., sending pregnant women who present for care to the waiting room before maternal-fetal status has been determined)


  • Failure to have a policy in place delineating conditions that require bedside evaluation by a physician or midwife prior to discharge after medical screening exam by a labor nurse


  • Failure of the provider to provide a bedside evaluation for pregnant women who present with high-risk medical or obstetric conditions


  • Discharge of a pregnant woman without establishing fetal well-being (e.g., for women at 28 weeks or greater, a reactive nonstress test)


  • Discharge of a pregnant woman who is unstable for discharge (e.g., in labor or with ongoing high-risk medical or obstetric conditions requiring inpatient care)


  • Failure to meet all aspects of the Emergency Medical Treatment and Labor Act (EMTALA) regulations in assessing, treating, and discharging a pregnant women who presents for care


Standards, Guidelines, and Recommendations



  • EMTALA imposes specific obligations on healthcare providers who offer triage care (a) to perform a medical screening examination to determine whether an emergency medical condition exists (including both the mother and the fetus), (b) to provide necessary stabilizing treatment when an emergency medical condition exists, and (c) to stabilize the patient, or, if the healthcare provider certifies that the benefits of transfer outweigh the risks, arrange for proper transfer to another hospital (The Consolidated Omnibus Budget Reconciliation Act [COBRA], 1985; United States Department of Health and Human Services, Centers for Medicare & Medicaid Services 2003, 2009). It is specifically prohibited to use the patient’s insurance status and/or ability to pay for care as factors to determine whether a medical screening examination will be provided.


  • Pregnant women may come to a hospital’s labor and delivery area not only for obstetric care but also for evaluation and treatment of nonobstetric illness. Departments should agree on the conditions best treated in the labor and delivery area and those that should be treated in other hospital units. A pregnant woman who presents for care should be evaluated in a timely (not currently defined by AAP & ACOG, 2012) fashion. Minimally, the evaluation by an obstetric nurse should include assessment of maternal vital signs, FHR, and uterine contractions. Further evaluation includes assessment for vaginal bleeding, acute abdominal pain, temperature of 100.4°F or higher, preterm labor, preterm premature rupture of membranes, hypertension, and indeterminate or abnormal FHR pattern. If these findings are present or suspected, the responsible obstetric care provider should be promptly informed (AAP & ACOG, 2012).


  • The initial triage process (10 to 20 minutes) requires one nurse to one woman presenting for care. This ratio may change to one nurse to two to three women as maternal-fetal status is determined to be stable, until patient disposition (AWHONN, 2010).


  • Any patient suspected to be in labor or who has ruptured membranes or vaginal bleeding should be evaluated promptly (not currently defined by AAP & ACOG, 2012). Minimally, the following should be assessed: maternal vital signs; frequency and duration of uterine contractions; documentation of fetal well-being; urinary protein concentration; cervical dilatation and effacement, unless contraindicated (such as with placenta previa and preterm premature rupture of membranes), or cervical length as ascertained by transvaginal ultrasonography; fetal presentation and station of the presenting part; status of the membranes; estimated fetal weight; and assessment of maternal pelvis. Along with these assessment data, date and time of the patient’s arrival and notification of the primary obstetric care provider should be included in the medical record (AAP & ACOG, 2012).


  • If the woman has received prenatal care and a recent examination has confirmed the normal progress of pregnancy, her triage evaluation may be limited to an interval history and physical examination directed at the presenting condition. Previously identified risk factors should be considered and reassessed. If no new risk factors are found, attention may be focused on the following historical factors: time of onset and frequency of contractions; presence or absence of bleeding; fetal movement; history of allergies; time, content, and amount of the most recent food or liquid ingestion; and use of any medications (AAP & ACOG, 2012).


FETAL HEART RATE PATTERN INTERPRETATION, COMMUNICATION, AND DOCUMENTATION


Common Allegations



  • Failure to accurately assess maternal-fetal status


  • Failure to accurately distinguish, assess, and record FHR tracings of all fetuses in a multiple gestation pregnancy



  • Failure to determine that the tracing being recorded is of maternal rather than fetal origin


  • Failure to appreciate a deteriorating fetal condition


  • Failure to appropriately treat an indeterminate or abnormal FHR in a timely manner (e.g., initiate intrauterine resuscitation measures based on the FHR pattern and/or plan for expeditious birth when appropriate)


  • Failure to accurately communicate the maternal-fetal status to the physician/nurse midwife


  • Failure to convey specific requests for bedside evaluation based on concern for fetal status to the physician/nurse midwife


  • Failure of the physician/nurse midwife to respond appropriately when notified of indeterminate or abnormal fetal status


  • Failure to institute the chain of consultation when there is a clinical disagreement between the nurse and responsible physician/nurse midwife regarding fetal status


Standards, Guidelines, and Recommendations



  • Use the terminology recommended by the National Institute of Child Health and Human Development (NICHD) (Macones, Hankins, Spong, Hauth, & Moore, 2008), ACOG (2010a), and AWHONN (Lyndon & Ali, 2009) to describe FHR patterns in all professional communication and medical record documentation concerning fetal assessment via electronic fetal monitoring (EFM).


  • Establish ongoing interdisciplinary fetal monitoring education (JCAHO, 2004). Knowledge and skills in fetal assessment are not discipline specific. Ensure and document that all care providers are competent to interpret EFM data (Minkoff & Berkowitz, 2009).


  • All members of the team should participate in regularly scheduled case reviews that include the FHR tracing and offer suggestions for future care improvement.


  • Include baseline rate, variability, presence or absence of accelerations and decelerations, clinical context, and pattern evolution in communication between team members about indeterminate or abnormal FHR patterns (Fox, Kilpatrick, King, & Parer, 2000).


  • Establish a clear and agreed-upon definition of fetal well-being (e.g., accelerations 15 beats per minute above the baseline rate lasting for 15 seconds for the term fetus; a baseline rate within normal limits; no recurrent late, variable, or prolonged decelerations; and moderate variability) and document fetal well-being on admission prior to administration of pharmacologic agents for cervical ripening and labor induction, initiation of epidural analgesia, transfer to another unit, and discharge.


  • Consider an initial assessment of fetal status via EFM on admission for women in labor when intermittent auscultation is planned for the primary method of fetal surveillance.


  • Ensure ongoing, timely, and accurate assessment and determination of fetal well-being during labor.


  • During absent or minimal baseline FHR variability, use stimulation to evaluate fetal well-being.


  • Develop common expectations for intrauterine resuscitation based on the presumed etiology of the FHR pattern, including maternal repositioning, an intravenous fluid bolus of at least 500 mL of lactated Ringer’s solution, oxygen administration at 10 L/min via nonrebreather facemask, reduction of uterine activity, correction of maternal hypotension, amnioinfusion, and modification of maternal pushing efforts during second stage labor (ACOG, 2010a; Simpson & James, 2005b).


  • Establish agreement among team members concerning which type of FHR patterns require bedside evaluation by the primary care provider and the time frame involved (Fox et al., 2000).


  • If continuous EFM is ordered, monitoring of FHR and uterine activity via EFM should continue until birth.


  • Confirm maternal heart rate (HR) by palpation of maternal pulse during initiation of EFM and compare with FHR; repeat this confirmation periodically during labor. Be aware of abrupt changes in FHR that may indicate maternal HR is tracing. Recognize clinical situations that could result in maternal HR being recorded as FHR, including maternal tachycardia, contractions, maternal movement such as walking with the cordless transducer or telemetry, inaccurate transducer placement, extremes of maternal weight/size, and second stage labor pushing (e.g., accelerations with every contraction) (Simpson, 2011).


  • Ensure that there are organizational resources and systems to support timely interventions (including emergent cesarean birth) when the FHR is indeterminate or abnormal.


ELECTIVE INDUCTION OF LABOR


Common Allegations



  • Failure to fully inform the woman of the potential risks and benefits of elective induction


  • Failure to accurately determine gestational age prior to elective induction


  • Iatrogenic prematurity as the result of elective induction before 39 completed weeks of pregnancy


  • Excessive doses of oxytocin resulting in uterine tachysystole (with or without the presence of an indeterminate or abnormal FHR pattern)


  • Failure to accurately assess maternal-fetal status during labor induction

(See also FHR pattern interpretation, communication, and documentation; uterine tachysystole.)



Standards, Guidelines, and Recommendations



  • Obtain informed consent and document it in the medical record (ACOG, 2009b; TJC, 2012). Ensure that the informed consent process is at the appropriate literacy level and in a language that the woman can understand (TJC, 2012).


  • An established gestational age of at least 39 completed weeks by at least one of the following criteria should be documented prior to elective induction: (1) ultrasound measurement at less than 20 weeks of gestation supports gestational age of 39 weeks or greater; (2) fetal heart tones have been documented as present for 30 weeks by Doppler ultrasonography; (3) it has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test result (ACOG, 2009b). Testing for fetal lung maturity should not be performed, and is contraindicated, when birth is mandated for fetal or maternal indications. Conversely, a mature fetal lung maturity test result before 39 weeks of gestation, in the absence of appropriate clinical circumstances, is not an indication for birth (ACOG, 2008a).


  • Adhere to ACOG/AWHONN recommendations for dosages of pharmacologic agents (see misoprostol and oxytocin) (ACOG, 2009b; Simpson, 2013).


  • Ensure adequate personnel are available to monitor maternal-fetal status (ACOG, 2009b) (e.g., one nurse to one woman receiving oxytocin for labor induction or augmentation) (AWHONN, 2010).


  • Adhere to ACOG/AWHONN recommendations for maternal-fetal assessment: Assess characteristics of uterine activity and the FHR every 15 minutes during the active phase of the first stage of labor and every 5 minutes during the second stage of labor; assess maternal vital signs at least every 4 hours or more often if indicated (AAP & ACOG, 2012).


MISOPROSTOL (CYTOTEC) FOR CERVICAL RIPENING/LABOR INDUCTION


Common Allegations



  • Excessive doses of misoprostol that resulted in uterine tachysystole (with or without an indeterminate or abnormal FHR pattern)


  • Uterine rupture as a result of misoprostol administration


  • Use of misoprostol for a woman with a history of a prior cesarean birth or uterine scar


  • Failure to accurately assess maternal-fetal status during labor induction

(See also FHR pattern interpretation, communication, and documentation; uterine tachysystole.)


Standards, Guidelines, and Recommendations



  • Obtain informed consent and document in the medical record. Ensure that the informed consent process is at the appropriate literacy level and in a language that the woman can understand (TJC, 2012).


  • Have pharmacist prepare the tablets (100-microgram [mcg] tablets are not scored) (Simpson, 2013).


  • Use the lowest possible dose to effect cervical change and labor progress (ACOG, 2009b).


  • The initial dose should be 25 mcg (1/4 of 100-mcg tablet) inserted into the posterior vaginal fornix. The dose can be repeated every 3 to 6 hours, up to six doses in 24 hours as needed. There are lower rates of uterine tachysystole with lower dosages (25 mcg) and longer intervals between doses (q 6 hours rather than q 3 hours) (ACOG, 2009b).


  • Re-dosing should be withheld if three or more contractions occur within 10 minutes, adequate cervical ripening is achieved with a Bishop score of 8 or more, the cervix is 80% effaced and 3 cm dilated, the patient enters active labor, or the FHR is indeterminate or abnormal (Simpson, 2013).


  • If oxytocin is needed, it should not be given until at least 4 hours after the last dose (ACOG, 2009b).


  • Misoprostol should be administered at or near the labor and birth suite, where uterine activity and FHR can be monitored continuously (Simpson, 2013).


  • Misoprostol should not be administered to women with a history of prior cesarean birth or uterine scar (ACOG, 2009b, 2010b).


OXYTOCIN FOR LABOR INDUCTION/AUGMENTATION


Common Allegations



  • Initiation of oxytocin in the absence of evidence of fetal well-being


  • Failure to accurately assess maternal-fetal status during labor induction


  • Excessive doses of oxytocin resulting in uterine tachysystole, with or without an indeterminate or abnormal FHR pattern

(See also FHR pattern interpretation, communication, and documentation; uterine tachysystole.)


Standards, Guidelines, and Recommendations



  • Establish fetal well-being prior to initiation of oxytocin.


  • Administer the lowest possible dose to achieve cervical change and labor progress (ACOG, 2009b).


  • Starting at 1 to 2 mU and increasing by 1 to 2 mU/min no more frequently than every 30 to 40 minutes
    will result in successful induction of labor for most women. Approximately 90% of women at term will have labor successfully induced with 6 mU/min or less (Arias, 2000).


  • Based on physiologic and pharmacokinetic principles, a 30 to 40-minute interval between oxytocin dosage increases is optimal. The full effect of oxytocin on the uterine response to increases in dosage cannot be evaluated until steady-state concentration has been achieved. Increasing the infusion rate before steady-state concentration is achieved results in laboring women receiving higher than necessary doses of oxytocin, which increases risk of side effects such as uterine tachysystole and indeterminate or abnormal fetal status (Arias, 2000; Crane & Young, 1998; Phaneuf, Rodriguez-Linares, Tambyraja, MacKenzie, & Lopez Bernal, 2000).


  • Titrate the dosage to the fetal response and uterine activity/labor progress (ACOG, 2009b; Simpson, 2013).


  • Avoid uterine tachysystole and treat (decrease or discontinue oxytocin) in a timely manner if it occurs (ACOG, 2009b, 2010a; Simpson, 2013).


  • If labor is progressing at 1 cm/hr cervical dilation, there is no need to increase the dosage rate (Crane & Young, 1998; Simpson, 2013).


  • If using an active management of labor (AMOL) protocol, follow all aspects of the published protocol rather than just the oxytocin dosages and infusion frequencies. The protocol was designed to be used for nulliparous women in spontaneous active labor. The Dublin AMOL protocol is precisely described and, under these conditions, was found to be safe, although three subsequent studies in the United States (Frigoletto et al., 1995; Lopez-Zeno, Peaceman, Adashek, & Socol, 1992; Rogers, Gilson, Miller, Izquierdo, Curet, & Qualls, 1997) did not find that it led to a decrease in cesarean births: Candidates include only nulliparous women in spontaneous active labor with a singleton pregnancy, cephalic presentation, and no evidence of fetal compromise. To exclude false and prodromal labor, true labor is specifically defined as contractions with either bloody show, spontaneous rupture of membranes, or complete (100%) cervical effacement. Once labor is diagnosed, the woman receives continuous one-to-one labor support from a birth attendant (midwife). An amniotomy is performed if membranes are not spontaneously ruptured within 1 hour after labor has been diagnosed. If cervical dilation does not progress at least 1 cm/hr, oxytocin augmentation is initiated beginning at 6 mU/min, increasing by 6 mU/min every 15 minutes until adequate labor is established, to a maximum dose of 40 mU/min. “Hyperstimulation” of uterine activity is defined as more than seven contractions over 15 minutes (O’Driscoll, Jackson, & Gallagher, 1970).


  • To enhance communication among members of the perinatal healthcare team and to avoid confusion, oxytocin administration rates should always be ordered by the physician or certified nurse midwife as mU/min and documented in the medical record as mU/min (Simpson, 2013).


  • Ensure adequate personnel are available to monitor maternal-fetal status (ACOG, 2009b) (e.g., one nurse to one woman receiving oxytocin for labor induction or augmentation) (AWHONN, 2010).


UTERINE TACHYSYSTOLE


Common Allegations



  • Failure to appropriately identify and treat uterine tachysystole (with and without an indeterminate or abnormal FHR pattern) in a timely manner


  • Failure to decrease or discontinue the oxytocin infusion or delay the next dose of misoprostol during uterine tachysystole


  • Physician/nurse midwife orders to continue oxytocin or administer misoprostol despite being notified of uterine tachysystole


  • Failure to communicate with the physician/nurse midwife when uterine tachysystole occurs


  • Failure to institute the chain of consultation when there is a clinical disagreement between the nurse and responsible physician/nurse midwife

(See also FHR pattern interpretation, communication, and documentation; elective induction of labor; misoprostol for cervical ripening/labor induction; oxytocin for labor induction/augmentation [Cytotec].)


Standards, Guidelines, and Recommendations



  • A clear definition of tachysystole (e.g., a series of single contractions lasting 2 minutes or more, a contraction frequency of more than 5 in 10 minutes [averaged over 30 minutes], or contractions of normal duration occurring within 1 minute of each other [ACOG, 2003, 2009b; Macones et al., 2008; Simpson, 2013]) is essential in each institution because clinical management strategies, policies, and protocols should include expected actions when tachysystole is identified.


  • All perinatal healthcare providers in each institution should be aware of clinical criteria established for tachysystole and the expected actions.


  • While tachysystole can be the result of endogenous maternal oxytocin and prostaglandins, most excessive uterine activity is the result of administration of exogenous pharmacologic agents (Crane, Young, Butt, Bennett, & Hutchens, 2001).


  • Treat tachysystole by decreasing or discontinuing oxytocin based on the individual clinical situation.



  • Avoid prolonged periods of tachysystole that lead to progressive deterioration in fetal status (Bakker, Kurver, Kuik, & Van Geijn, 2007; Bakker & Van Geijn, 2008; Simpson & James, 2008) and subsequent indeterminate or abnormal FHR patterns (ACOG, 2010a; ACOG & AAP, 2003). Interventions for tachysystole should not be delayed until there is evidence of indeterminate or abnormal fetal status (Simpson, 2013).


  • Empower and encourage all members of the perinatal team to be appropriately assertive in their actions and communications with colleagues to advocate for patient safety if they feel pressured to increase oxytocin rates during uterine tachysystole and/or indeterminate or abnormal FHR patterns (Clark, Simpson, Knox, & Garite, 2009; Simpson et al., 2006).


PAIN RELIEF DURING LABOR AND BIRTH


Common Allegations



  • Failure to accurately identify and treat labor pain


  • Use of “ability to pay” or insurance status as criteria for treatment of labor pain


Standards, Guidelines, and Recommendations



  • Provide adequate pain relief for all women in labor as per their request regardless of ability to pay or whether they sought prenatal care (ACOG, 2006; TJC, 2012).


  • Pain management is a moral imperative, a professional responsibility, and the duty of people in the healing professions (Institute of Medicine [IOM], 2011).


  • Labor results in severe pain for many women. There is no other circumstance under which it is considered acceptable for a person to experience untreated severe pain, amendable to safe intervention, while under a physician’s care. In the absence of a medical contraindication, maternal request is a sufficient medical indication for pain relief during labor and birth (ACOG, 2006). Maternal request represents sufficient justification for pain relief (ASA, 2007).


  • The choice of technique, agent, and dosage should be based on patient preference, medical status, and contraindications. Decisions should be closely coordinated among the obstetrician, the anesthesia provider, the patient, and skilled support personnel (ACOG, 2006).


  • There are conflicting data about the effect of epidural analgesia/anesthesia on the risk of cesarean birth; however, based on what is known at present, if the patient desires an epidural during the early stages of labor, there is no reason to deny that request if the denial is related to potential risk of cesarean birth (ACOG, 2006).


NURSES’ ROLE DURING REGIONAL ANESTHESIA


Common Allegations



  • Administration of bolus or change in medication rate of epidural anesthesia that resulted in subsequent maternal and/or fetal harm


  • Nurses’ actions beyond the scope of practice as defined by their professional association (AWHONN, 2012)


Standards, Guidelines, and Recommendations



  • Adhere to the AWHONN clinical position statement that describes the role of the nurse during epidural anesthesia. Require that only qualified, credentialed anesthesia providers adjust the dosage for labor epidurals, including boluses, and increases or decreases in rate. Require that only qualified, credentialed anesthesia providers program the epidural pumps during regional anesthesia for labor (AWHONN, 2012).


  • Acknowledge and support the responsibility of registered nurses to practice within the guidelines of their professional association. Expect that anesthesia providers will acknowledge this right and duty as well.


FUNDAL PRESSURE DURING THE SECOND STAGE OF LABOR


Common Allegations



  • Application of fundal pressure during second stage of labor that resulted in shoulder dystocia and/or other maternal-fetal injuries


  • Application of fundal pressure during shoulder dystocia that further affected the shoulder and delayed the birth, resulting in maternal-fetal injuries

(See also shoulder dystocia.)


Standards, Guidelines, and Recommendations



  • Fundal pressure applied during the second stage of labor is associated with risks of adverse outcomes to the mother and the baby (Simpson & Knox, 2001).


  • Risks to the baby include inadvertent shoulder dystocia, which in turn places the baby at risk for brachial plexus injuries; fractures of the humerus and clavicles; hypoxemia, asphyxia, and death; an increase in fetal intracranial pressure, resulting in significant decreases in cerebral blood flow and indeterminate or abnormal FHR patterns; umbilical cord compression negatively affecting maternal-fetal exchange; functional alterations in the placental intervillous space, which increases the risk of fetal hypoxemia and
    asphyxia; subgaleal hemorrhage; and spinal cord injuries (ACOG, 2002; Simpson & Knox, 2001).


  • Risks to the mother include perineal injuries such as third- and fourth-degree lacerations, anal sphincter tears, uterine rupture and uterine inversion, pain, hypotension, respiratory distress, abdominal bruising, fractured ribs, and liver rupture (Simpson & Knox, 2001).


  • Avoid fundal pressure to shorten an otherwise normal second stage of labor (Simpson & Knox, 2001).


  • Avoid fundal pressure during shoulder dystocia (ACOG, 2002).


  • Avoid clinical disagreements about fundal pressures at the bedside in front of the patient by having an agreed-upon policy.


SHOULDER DYSTOCIA


Common Allegations



  • Failure to accurately predict risk of shoulder dystocia


  • Failure to diagnose labor abnormalities


  • Failure to appropriately initiate shoulder dystocia corrective maneuvers


  • Failure to perform a cesarean birth


  • Application of forceps or vacuum at high station or continued application without evidence of fetal descent, resulting in shoulder dystocia


  • Application of fundal pressure during shoulder dystocia, further affecting the shoulder and delaying birth, thereby resulting in maternal-fetal injuries


May 22, 2016 | Posted by in NURSING | Comments Off on Perinatal Patient Safety and Professional Liability Issues
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