Legal Issues in Electronic Fetal Monitoring
Rebecca Cady JD
Litigation of Obstetric Cases
Litigation involving claims of substandard care during labor and delivery (L&D) has become commonplace in our society. Griffin, Heland, Esser, and Jones (1998) reported that obstetric care was involved in 61.2% of claims. The 2006 American College of Obstetricians and Gynecologists (ACOG) Survey on Professional Liability showed similar results. Respondents to this survey reported a claim rate of 62.1% during the period of January 2003 through December 2005. Of those claims, the most frequent primary allegation was neurologically impaired infant (30.8%). The second most frequent allegation was stillbirth/neonatal death (15.8%).
Beckman (1996) examined malpractice claims, including allegations of nursing negligence, filed from 1988 through 1993. Of 747 cases alleging nursing negligence, 17.4% pertain to an adverse outcome in the L&D area. The primary cause of fetal injury was linked with inadequate communication of nursing assessment data to the physician. Failure to detect fetal distress in a timely manner due to infrequent assessment of the electronic fetal monitor tracing caused greater than half of the injuries in cases that alleged nursing negligence. Failure to promptly inform the physician of fetal distress caused serious injury to 35 newborns and resulted in 16 deaths. Other causes of injury included failure to implement the chain of command in a timely manner when the physician did not respond appropriately to fetal distress, inadequate fetal assessment, and medication errors. Fetal monitoring interpretation and management are still common issues in litigation over adverse outcomes in pregnancy (Miller, 2005). Additionally, electronic fetal monitoring (EFM) plays a well-documented role in perinatal morbidity and mortality. As of July 2004, 77% of sentinel events involving perinatal death or permanent disability reported to the Joint Commission on Accreditation of Hospital Organizations (JCAHO) involved nonreassuring fetal status, and 34% involved a root cause of inadequate EFM (JCAHO, 2004). Even if L&D nurses are not personally named as defendants in an obstetric lawsuit, they still become involved in the litigation process as percipient witnesses to the care rendered to the patient and fetus by the defendant health care providers. In the claims reported by the ACOG Survey, the categorization of the codefendants included hospitals (42.3%), nurses (12%), and nurse-midwives (3.8%) (ACOG, 2006).
Importance of the Strip Chart to Obstetric Case Litigation
Often the most critical piece of evidence in a birth injury case is the strip chart. Eighty-four percent of monitored labors in the United States are
monitored via EFM (Chez, Harvey, and Harvey, et al., 2000). Seventy percent of all claims concerning intrapartum care in relation to brain damage are based on the cardiotocogram and electronic fetal monitor (Symonds, 1994). One of the most common allegations in suits against obstetrics and gynecology (OB/GYN) physicians is improper treatment of fetal distress (Bentley-Lewis, 1996). Greenwald (1998, p. 19) noted, “No tool is more universally used to demonstrate alleged negligence in obstetric claims than the electronic fetal monitor.” Miller (2005) noted that common system errors related to the use of intrapartum EFM include knowledge deficits, communication failures, and fear of conflict. Therefore, all nurses working in this area must be aware of the legal implications of the tasks they perform related to EFM. These include monitor placement and removal, interpretation of the strip chart data, response to abnormal patterns, documentation, communication of findings to the care provider, and troubleshooting the equipment. Simpson (2000) identified key components of a risk management plan regarding EFM:
monitored via EFM (Chez, Harvey, and Harvey, et al., 2000). Seventy percent of all claims concerning intrapartum care in relation to brain damage are based on the cardiotocogram and electronic fetal monitor (Symonds, 1994). One of the most common allegations in suits against obstetrics and gynecology (OB/GYN) physicians is improper treatment of fetal distress (Bentley-Lewis, 1996). Greenwald (1998, p. 19) noted, “No tool is more universally used to demonstrate alleged negligence in obstetric claims than the electronic fetal monitor.” Miller (2005) noted that common system errors related to the use of intrapartum EFM include knowledge deficits, communication failures, and fear of conflict. Therefore, all nurses working in this area must be aware of the legal implications of the tasks they perform related to EFM. These include monitor placement and removal, interpretation of the strip chart data, response to abnormal patterns, documentation, communication of findings to the care provider, and troubleshooting the equipment. Simpson (2000) identified key components of a risk management plan regarding EFM:
Common EFM language in all professional communication and medical record documentation
Joint nurse-physician education about EFM
Competent care providers
Collaboration and mutual respect among care providers
Clear definition for fetal well-being and assessment of fetal well-being on admission
Ongoing assessment and determination of fetal well-being during labor
Appropriate use of intrauterine resuscitation techniques
Accurate monitoring of fetal heart rate and uterine activity via EFM
Accurate interpretation of EFM data
Organizational resources and systems to support clinically timely interventions when the fetal heart rate is nonreassuring
Continuation of EFM until birth
Neonatal resuscitation team in attendance at birth if any question of fetal compromise
Interdisciplinary case reviews for near misses and adverse outcomes
Costs and Outcome of Obstetric Lawsuits
An obstetric claims study by Farmers Insurance Group Companies’ Professional Liability Division found that between the years 1991 and 1995, L&D claims represented slightly over 6% of the hospital and physician claims occurring in the top seven areas of frequency. These same claims, however, accounted for more than 11% ($37,665,836) of the total dollars spent for indemnity, expenses, and reserves (Rommal, 1996). More than 50% of damages awarded in all health care malpractice cases consisted of settlements and compensation for obstetric malpractice (Fiesta, 1994a).
According to the ACOG Survey, the respondents reported that 67.4% of claims were dropped or settled without payment (on behalf of the physician); 37.3% were dropped by the defendant; 13% were dismissed by the court; and 17.1% were settled without payment by the obstetrician/gynecologist. Of the outcomes involving payment, 20% of the claims settled prior to the start of trial or before a verdict; 3.4% of the claims closed through arbitration; and 10.2% of the claims closed through jury or court verdict (ACOG, 2006).
The general public’s familiarity with medical malpractice settlements or judgments occurs primarily through media reports or dramatic re-enactments of the more sensational multimillion- dollar verdicts. However, the reality is that the average for all paid claims reported in this survey was $504,925. For the neurologically impaired infant requiring long-term care, the average payment was $1,150,687/case (ACOG, 2006).
Why Do So Many Patients Sue?
Stolte and associates (Stolte, Myers, & Owen, 1994) believe that the use of technologies such as EFM results in higher patient expectations and, therefore, increases the chances for litigation. McRae (1999) notes that the expectation of EFM technology has grown to include its ability to prevent fetal neurologic damage and unnecessary surgical delivery. Such beliefs abound,
despite evidence that EFM has failed to reduce the rate of cerebral palsy (Gimovsky, 1994; Nelson et al., 1996; Sandmire, 1990; Schifrin, 1994; Symonds, 1994). One author believes that much of the blame placed on EFM should be assigned to those who make clinical decisions (Paul, 1994), whereas others contend that the problem rests with a lack of consistent reliable terminology (Flamm, 1994).
despite evidence that EFM has failed to reduce the rate of cerebral palsy (Gimovsky, 1994; Nelson et al., 1996; Sandmire, 1990; Schifrin, 1994; Symonds, 1994). One author believes that much of the blame placed on EFM should be assigned to those who make clinical decisions (Paul, 1994), whereas others contend that the problem rests with a lack of consistent reliable terminology (Flamm, 1994).
Clinical Competency and Interpretation of Fetal Strip Charts
Failing to understand and/or interpret information presented by the electronic fetal monitor clearly falls below the standard of care (Schifrin, 1993). In determining whether a nurse has been negligent in the care of a particular patient, one of the questions to be asked is whether the nurse’s actions complied with nationally recognized standards for L&D nursing. Fiesta (1994b) noted that nursing standards tend to be more uniform than those for physicians, which may make it easier to establish negligence against a nurse. McRae (1999) noted that, although some courts allow for reasonable judgment by the physician as the standard in malpractice negligence, obstetric nurses have no such privilege for practice decisions. This creates a double standard and may serve to strengthen the physician’s defense while weakening that of the nurse. Nurses, therefore, need to ensure that they are intimately familiar with the professional standards and guidelines for EFM. Failure to follow such practice guidelines is likely to lead to a finding of liability if a patient incurs harm.
Despite many advances in obstetric care over the past 20 years, EFM skills are still not being obtained or maintained by all nurses working in the L&D area. As early as 1986, the Nurses Association of the American College of Obstetricians and Gynecologists (NAACOG) mandated that maintaining the quality of individual practice was an inherent responsibility of the professional nurse. The Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN, 2000) continues to maintain the position that only registered nurses (RNs) with expertise in EFM should initiate and evaluate the technology. Nurses should also complete a course of study that includes the core competencies.
Hospitals can be held liable for having nurses who are not proficient in EFM skills perform such duties. JCAHO (1996) requires that an orientation be provided and an assessment conducted on each staff member’s ability to fulfill specific job responsibilities, the purpose being to familiarize staff with their jobs and work environment before undertaking patient care duties. As this relates to EFM, staff nurses in L&D (or other areas that perform EFM) should not be allowed to care for monitored patients independently until certain skill criteria are met (AWHONN, 2006).
CASE EXAMPLES: FAILURE TO ADEQUATELY MONITOR EFM
McRae (1993) reported a case in which a 27-year-old G1P0 was admitted to the hospital at 38 weeks’ gestation, with a blood pressure of 160/100. On admission assessment, the cervix was 2 cm dilated, 65% effaced, and the fetus presented in vertex position at −3 station. The patient was contracting every 3 to 4 minutes. The patient reported a history of elevated blood pressure that preceded hospital admission by 2 weeks. She was noted to have +1 edema and +3 deep tendon reflexes.
Two hours after her admission, magnesium sulfate was administered to the patient intravenously. Five hours post admission, the nursing staff initiated external EFM. At that time, the patient’s blood pressure was 144/86, and the fetal heart rate (FHR) baseline was determined to be 144. Over the next 4 hours, the patient continued to contract every 3 to 5 minutes. The nurses documented the FHR as being within the range of 120 and 144, but failed to document any further EFM assessment. There was no report of baseline variability or the presence or absence of periodic changes. The membranes were artificially ruptured, and a spiral electrode was applied. It was documented that the fluid was clear.
Four hours later (13 hours post admission), the nurse changed the maternal position to the
left side. At this time, the medical record reflects the patient’s blood pressure to be 150/90 and the FHR at 152. No further information about the FHR was documented at that time. Four more hours passed, and an oxytocin infusion was initiated. The patient’s blood pressure was 170/110, and the FHR was noted to be 130. It was recorded in the nurses’ notes that maternal position was changed several times, but that the oxytocin infusion continued despite documentation of tetanic contractions. The physician ordered preoperative blood work for a possible cesarean birth.
left side. At this time, the medical record reflects the patient’s blood pressure to be 150/90 and the FHR at 152. No further information about the FHR was documented at that time. Four more hours passed, and an oxytocin infusion was initiated. The patient’s blood pressure was 170/110, and the FHR was noted to be 130. It was recorded in the nurses’ notes that maternal position was changed several times, but that the oxytocin infusion continued despite documentation of tetanic contractions. The physician ordered preoperative blood work for a possible cesarean birth.
Four hours from the time the oxytocin infusion began, the patient achieved complete dilation. At that time, EFM was discontinued and no further fetal assessment was made until delivery, which occurred 35 minutes later. Upon delivery, seizure activity of the neonate was noted. No Apgar scores were recorded.
At no time during the > 21 hours of labor did the nursing staff document an adequate assessment and evaluation of fetal status. Interestingly, the fetal strip charts were “lost,” as were the hospital’s policy and procedure manuals. The nurse expert for the patient opined that the care provided by the nurses was below the standard of care in the following respects: Failing to adequately assess, interpret, and document fetal status with the use of EFM; failure to assess and document the color of amniotic fluid for the duration of the labor; failure to intervene and discontinue oxytocin in the presence of tetanic contractions; and failure to document the FHR during the final 35 minutes of labor. The jury agreed and found for the plaintiff.
McRae (1993) reported another case in which staff failed to adequately perform EFM assessment. In this case, a 22-year-old G1P0 was admitted at 39 weeks’ gestation reporting SROM 18 hours before admission. Because she was not contracting and was only fingertip dilated, an elective induction was begun 2 hours after admission. At this time, an external EFM was placed. Two hours later, frequent contractions and an obvious decrease in long-term variability were apparent. Although tetanic contractions ensued, the nurses continued to increase the oxytocin every 15 minutes. Five hours after oxytocin was begun, the nursing staff doubled and continued to increase the oxytocin. Two hours after that, a spiral electrode was placed and the tocodynamometer was removed and never reapplied. Twice during the next 20 minutes, the nurses changed maternal position and documented contractions of 90 to 100 seconds’ duration, with only 15 seconds between contractions. Over the next hour, several more position changes were performed. The oxytocin was decreased, discontinued, and then restarted within a 20-minute period. Short-term variability became diminished. After 16.5 hours of oxytocin infusion, a female infant was delivered with Apgars of 2 and 5. The plaintiff’s expert nurse opined that the nurses’ care was below the standard of care for the following reasons: Failure to adequately monitor fetal status, failure to adequately document the color of the amniotic fluid, failure to question the use of oxytocin, failure to challenge inappropriate medical management, failure to administer proper amounts of oxytocin, failure to discontinue oxytocin in light of tetanic contractions, and failure to follow protocols set forth by The Association of Women’s Health, Obstetric, and Neonatal Nurses (AWHONN) regarding oxytocin administration and the nurse’s role in EFM. This case was settled out of court for a substantial amount of money to care for the severely handicapped child.
McRae (1993) reported a case regarding inadequate EFM assessment of twin pregnancy. In that case, a 30-year-old G1P0 with twin gestation was admitted in labor at term after an uneventful pregnancy. On admission, she was having moderately intense contractions every 2 to 3 minutes, the cervix was 5 to 6 cm dilated, and the FHR was 160 bpm in the left upper quadrant and 130 bpm in the right lower quadrant. A spiral electrode was applied to twin A shortly after admission. There was no nursing assessment of FHR variability, but both FHR baseline rates were documented as being within normal range. For some reason during the labor, the fetuses were not monitored for the same length of time; twin A was
recorded for 100 minutes, and twin B for only 84 minutes. Despite a rapidly progressing labor, the nursing staff not only failed to record observations of FHR but also left the patient alone for an hour at the change of shift, immediately after documentation of a deep, prolonged deceleration. The physician also left the patient alone after having observed the deceleration and ordering an IV to be started. The physician was not notified until 45 minutes later that the FHR tracing indicated a worsening problem. Twin B developed persistent and repetitive decelerations that occurred for more than 60 minutes without intervention. Finally, a cesarean birth was performed. Twin A was delivered in good condition and is healthy. Twin B was born with Apgars of 0 and 1 and required vigorous resuscitation. The initial arterial blood gas was 6.76. The infant suffered the neurologic sequelae of asphyxia. Clearly, the “care” rendered to this patient was far below what the standard requires. This case was settled out of court.
recorded for 100 minutes, and twin B for only 84 minutes. Despite a rapidly progressing labor, the nursing staff not only failed to record observations of FHR but also left the patient alone for an hour at the change of shift, immediately after documentation of a deep, prolonged deceleration. The physician also left the patient alone after having observed the deceleration and ordering an IV to be started. The physician was not notified until 45 minutes later that the FHR tracing indicated a worsening problem. Twin B developed persistent and repetitive decelerations that occurred for more than 60 minutes without intervention. Finally, a cesarean birth was performed. Twin A was delivered in good condition and is healthy. Twin B was born with Apgars of 0 and 1 and required vigorous resuscitation. The initial arterial blood gas was 6.76. The infant suffered the neurologic sequelae of asphyxia. Clearly, the “care” rendered to this patient was far below what the standard requires. This case was settled out of court.
Inter- and Intraobserver Variation in Interpretation of the Fetal Strip Chart
Even nurses and care providers who have been well trained and are proficient in EFM can be inconsistent in how they interpret FHR tracings. For example, a 1998 study (Borgatta, Shrout, & Divon, 1988) revealed that when five perinatologists reviewed 50 strip charts from nonstress tests (NSTs) and then re-reviewed the same FHR tracings, only 11 were classified as the same at both readings by the same perinatologist. Nurses also have the same difficulty. Chez, et al. (1990) found that 16% of nurses interpreted the NST as reactive when it was not. Devane and Lalor (2005) noted that midwives demonstrated the same inter- and intraobserver variability, and suggested that this was an intrinsic characteristic of the interpretation of intrapartum EFM. Murray (1996) discovered that physicians do not necessarily have greater accuracy in interpreting strip charts than do nurses, and that both nurses and physicians have been known to have difficulty in agreeing on interpretation when reviewing the same FHR tracing. Even health care providers who believe they are experts in EFM interpretation can reach different conclusions from the same strip chart. Cohen et al. (1982) presented 14 different FHR patterns to 12 “experts” in the United States. There was nearly perfect agreement on five FHR tracings, fair agreement on five others, and marked disagreement over the remaining four. Nielson and colleagues (1986) had four experienced obstetricians assess 50 thirty-minute-long FHR tracings. Only 11 of the strip charts were assessed by all four obstetricians in the same way, and 20% were assessed differently when reviewed by the same obstetricians 2 months later. Simpson (2000) noted that this variation continues to be a problem, and that this phenomenon especially affects interpretations suggesting fetal compromise.
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