System Errors in Intrapartum Electronic Fetal Monitoring: A Case Review

Transcription

1 Page 1 of 11 To Print: Click your browser's PRINT button. NOTE: To view the article with Web enhancements, go to: System Errors in Intrapartum Electronic Fetal Monitoring: A Case Review Lisa A. Miller, CNM, JD J Midwifery Womens Health. 2005;50(6): Elsevier Science, Inc. Posted 12/09/2005 Abstract and Introduction Abstract Intrapartum electronic fetal monitoring (EFM) interpretation and management continue to be a common issue in litigation involving adverse outcomes in term pregnancies. This article uses a case study approach to illustrate system errors related to intrapartum EFM. Common system errors related to use of intrapartum EFM include knowledge deficits, communication failures, and fear of conflict. Strategies for reducing error and the promotion of a patient safety approach to risk management in EFM are discussed, with an emphasis on the importance of a true team approach to EFM education, interpretation, and management. Introduction Electronic fetal monitoring (EFM) is currently the most widely used technology in intrapartum care in the United States, despite questions of efficacy. [1] Although arguments for the abandonment of continuous EFM in low-risk pregnancies continue to be proffered and deserve a thoughtful review, this article addresses the risk management issues associated with intrapartum use of EFM. [2] Allegations regarding the interpretation and management of EFM tracings dominate obstetric litigation related to neurologically impaired infants. In addition, obstetric litigation continues to account for a disproportionate share of medical malpractice indemnity payments. [3] Simpson and Knox have identified several common plaintiff's theories, or allegations, related to EFM, including 1) failures in the assessment and treatment of nonreassuring fetal heart rate (FHR) patterns, 2) communication failures, 3) lack of appropriate response by clinicians, and 4) failure to use chain of command to resolve clinical disagreements. [4] Allegations of medical, midwifery, or nursing error made by a plaintiff in a specific case may or may not be accurate. But there is no doubt that medical errors occur, and their occurrence is a significant problem. [5] Research in the arena of medical error tells us that when the allegations are valid (i.e., when errors occur), they are more likely the result of a complex multiplicity of factors, versus the performance failures of single individuals. [6] This approach of examining error is called a systems approach, and it allows recognition of both active failures, which are failures of clinicians directly involved in patient care, and latent failures, which are failures in areas such as administration, design, or implementation. [7] For example, the failure of a clinician to recognize an abnormal FHR pattern may be due to lack of knowledge (active failure) but may be compounded by fatigue due to lengthy call schedules (latent failure), a lack of training in the clinician's original education program (latent failure), or lack of skills assessment by the employer or credentialing body (latent failure). Thus, error prevention is not simply the removal or retraining of the individual clinician involved, but rather, a restructuring and reworking of the system that created the conditions under which error became not just a possibility (there will always be errors in any human endeavor) but a probability, a "more likely than not" scenario. Training and education in EFM vary widely for certified midwives (CMs), certified nurse-midwives (CNMs), physicians, and nurses. [7-9] This fact, coupled with the continued predominance of EFM issues in obstetric negligence claims, make FHR interpretation, management, and communication critical areas of concern for clinical practice as well as risk management. The following case study and analysis serve as an example of common errors in EFM and how a systems approach can provide solutions for future error prevention. The case facts and outcome are presented first, followed by a discussion of the fetal monitoring issues, system errors, and risk management strategies applicable to clinical practice. Case Presentation

2 Page 2 of 11 A 24-year-old primigravida was admitted at term in latent labor during the early morning hours by the CNM on call. The patient had an unremarkable antenatal course and no significant risk factors. Figures 1 to 14 reflect pertinent portions of the FHR tracing; the shaded area in each figure indicates the range of normal baseline rate from 110 to 160 beats per minute (bpm). Figure 1. Patient's admission tracing. Arrows represent RN noting fetal movements. Figure 2. Artificial rupture of membranes (AROM) for clear fluid at 11:45 AM (arrow). Note the minor FHR deceleration,

3 Page 3 of 11 unremarkable when associated with AROM and not repetitive. Figure 3. Normal tracing following AROM, patient requests pain relief and is prepared for and given a paracervical block (PCB) at 12:05 PM (arrow). Figure 4. Within minutes of PCB, FHR bradycardia occurs, with electronic fetal monitor exhibiting doubling of the FHR via Doppler (closed arrows).

4 Page 4 of 11 Figure 5. Placement of an ISE reveals FHR bradycardia. Arrow represents discontinuation of pitocin at 12:20 PM. Figure 6. Undulating FHR resembling a sinusoidal pattern [10] (arrow). CNM is on the phone with the physician during this time.

5 Page 5 of 11 Figure 7. Atypical FHR pattern that most closely resembles sinusoidal but lacks the required uniformity. Mistakenly identified as variable decelerations by both the RN and CNM. Figure 8. Another atypical FHR pattern (black arrows), similar to the lambda pattern [11] but lacking normal baseline variability (white arrows).

6 Page 6 of 11 Figure 9. Rising FHR baseline with decreasing variability, classic secondary changes indicative of fetal hypoxia. [10,11] Figure 10. FHR baseline becomes tachycardic and loses all variability.

7 Page 7 of 11 Figure 11. Probable development of subtle late decelerations of FHR (arrows), although interpretation is hindered by lack of uterine activity recording via tocotransducer. Figure 12. Tachycardia and absent variability persist. Physician arrives (arrow) and immediately orders preparations for primary cesarean delivery.

8 Page 8 of 11 Figure 13. Patient is transferred to the operating room (OR) where FHR tracing is continued (arrow). Figure 14. FHR tracing is continued in OR up to point of incision. Infant is delivered with APGAR scores of 3/3/8 at 1, 5, and 10 minutes, respectively. The initial FHR tracing was normal, with a baseline rate of 120 bpm, moderate variability, the presence of FHR accelerations, and the absence of FHR decelerations (Figure 1). The CNM ordered oxytocin augmentation at 10:00 AM, secondary to suspected arrest

9 Page 9 of 11 of dilation and inadequate uterine contractions. The patient's dilation was noted to be 4 cm at this time; however, effacement and station were not recorded. Oxytocin was begun by the labor and delivery nurse (RN) at 10:30 AM. At 11:45 AM, the CNM performed an artificial rupture of membranes (AROM) and noted clear amniotic fluid; the patient was 5 cm, with vertex (vtx) at 1 station (Figure 2). At 12:00 PM, the patient requested pain medication and a paracervical block (PCB) was administered by the CNM at 12:05 PM (Figure 3). Within minutes of instituting the paracervical block, the FHR became bradycardic, and the external Doppler was noted to be doubling the FHR on the tracing printout (Figure 4). A fetal scalp electrode (FSE) was placed, the patient was repositioned several times, and oxygen was administered via a face mask. Oxytocin infusion was discontinued approximately 10 minutes after the bradycardia started (Figure 5). The RN noted at this time that the CNM was on the phone with the physician, but there was no note by either the RN or CNM regarding the details of the conversation about the EFM tracing (Figure 6). Although the patient remained on her left side with oxygen on and the pitocin off, the CNM left the room to attend another birth. The RN became concerned about the FHR tracing (Figure 7) and brought the tracing to the CNM, who reassured her that the FHR pattern was "just some variables." At this point, the second call to the physician was placed by the RN, who questioned the CNM's interpretation of the FHR tracing. The physician told the RN that if the CNM was not concerned, he was not concerned, and declined the RN's request to come to the hospital and personally evaluate the tracing. The RN continued to observe the tracing (Figures 8 and 9) and notified the CNM and physician of the loss of variability and rising baseline at 1:05 PM (Figures 10 and 11). The physician again declined to come in to assess the patient. At 1:10 PM, FHR baseline was 170 bpm with absent variability and questionable late decelerations. The RN called the physician for the third time and informed him of the FHR tracing, at which point he stated he was on his way to the hospital. Arriving at 1:20 PM, the physician immediately decided to perform an emergency cesarean delivery (Figure 12). The patient was taken to the operating room (OR) and monitoring was continued in the OR up to the point of abdominal incision (Figures 13 and 14). The infant was delivered with APGAR scores of 3/3/8 at 1, 5, and 10 minutes, respectively. No cord gases were obtained at birth. The infant was transferred and cared for in the neonatal intensive care unit of a Level III perinatal center nearby, where he remained until his discharge at 5 months of age. He experienced both early-onset multisystem organ involvement and early-onset severe neonatal encephalopathy consistent with an acute intrapartum hypoxic event. Litigation ensued and no settlement offer was proffered by the hospital, CNM, or physician defense teams. At the time of trial, the child was 5 years of age and severely compromised on all levels. One week prior to trial, the child died from complications following a seizure. A settlement was then reached by the parties, the terms of which were undisclosed. Discussion Although this case involved the use of a paracervical block, rarely used today for labor analgesia, the case is actually about the clinical response to the FHR changes occurring after the paracervical block. The plaintiff's allegations primarily focused on 1) the CNM's and the RN's failure to identify an abnormal or nonreassuring FHR tracing; 2) failure to correctly manage the ongoing abnormal tracing; 3) the RN's failure to use chain of command appropriately; and 4) the physician's failure to come in to the hospital and evaluate the tracing earlier. There was no argument that once the physician arrived, the team appropriately proceeded to cesarean delivery. A review of the case based on the plaintiff's allegations of error is helpful. Initially, the FHR tracing meets recognized standards for normal (i.e., it was a reassuring FHR pattern [10-12] in that it had a normal baseline rate, moderate variability, and FHR accelerations). Following the paracervical block, the FHR pattern became bradycardic, a known potential side effect following paracervical block, [13] which often spontaneously resolves within a few minutes and poses no problem for the fetus. In this case, however, the FHR pattern remained bradycardic for greater than 10 minutes (Figures 4-6), a situation clearly indicative of a significant risk for fetal hypoxia. Although the Pitocin was stopped, and intrauterine resuscitative measures were instituted, neither the RN nor the CNM recognized the severity of risk associated with a bradycardia of 60 to 70 bpm, validating the plaintiff's first allegation. The basic error that occurred first was related to lack of knowledge. A review of the depositions of both the RN and the CNM revealed that although the RN had several courses in EFM, she was unfamiliar with the use of paracervical blocks and their effect on FHR, whereas the CNM had limited EFM education (lectures in midwifery school, no other training) and her experience in interpreting variant patterns was minimal. The combined RN/CNM lack of expertise led to the second error, the failure to correctly manage the ongoing abnormal tracing. The unusual patterns the fetus exhibited in Figures 7 and 8 were misinterpreted by the CNM as variables, and although the RN appeared to understand that the FHR pattern was not normal, she acquiesced to the CNM interpretation when told to do so by the physician. Thus, the plaintiff's second allegation is validated, an ongoing error on the part of both the RN and CNM to correctly manage an atypical nonreassuring FHR pattern. The multiple phone calls placed to the physician by the RN demonstrate her awareness that the FHR pattern was abnormal, but her failure to either insist on the physician's presence or use chain of command to engage the assistance of a supervisor or other hospital staff gives credence to the third plaintiff's allegation. Although the failure on the CNM's part to recognize the ongoing abnormalities of the FHR tracing reflects her lack of knowledge, the RN's acquiescence and failure to use chain of command effectively stems from a fear of conflict, an error related to teamwork dysfunction. [7,14]

10 Page 10 of 11 The physician's misplaced trust in the CNM's ability to accurately interpret the EFM tracing, coupled with his lack of trust of the nurse's assessment that the CNM was incorrectly interpreting the pattern, resulted in his late arrival on the scene, and the validation of the fourth allegation of error, resulting in a delay in delivery of well over 1 hour following the onset of the bradycardia. The physician's deposition revealed that he made no assessment of the CNM's EFM interpretation skills upon hiring her, and he assumed she had the requisite knowledge to interpret intrapartum FHR patterns. He agreed that the tracing was abnormal following the paracervical block, but he maintained that neither the RN nor CNM had informed him of the significant abnormalities until the tachycardia and loss of variability were reported to him (Figure 10). This is another type of teamwork dysfunction, which can be described as avoidance of accountability or responsibility shifting. [14,15] Although it is impossible to determine whether this child's outcome would have been different had a cesarean delivery been performed immediately, even the most generous review of the case facts reveal a failure on the part of the RN and CNM to appropriately recognize and respond to a nonreassuring tracing, and the poor communication between team members resulting in a serious delay in intervention. None of the clinicians made these errors intentionally. How could the system be designed (or in this case, redesigned) to prevent similar errors in the future? Risk Management Strategies The Nature of Accidents Although it is beyond the scope of this article to address organizational accident theory in detail, a brief overview is helpful to the risk management discussion that follows. Organizational accidents have been defined by Reason as rare but catastrophic events that occur in high-risk, high-technology systems. [15] Perinatal units have been identified as one such system, and the application of principles of organizational behavior to perinatal units, while in its infancy, is not new. [16] Perinatal units, like other high-risk, hightechnology organizations, operate with many built-in defense mechanisms that work to prevent errors from occurring. Maintaining appropriate staffing levels, the credentialing of health care providers, proper training of staff, and individual accountability for competency are only a few examples of these defenses against error, which form what can be conceptualized as multiple layers of protection against accident or error. In a perfect world, all the defenses against error would function without flaw. But in reality, every layer of defense has the potential for flaws or vulnerability. These "holes" in the layers of defenses may create "windows of opportunity" for serious accidents to occur. [15] This framework for understanding accidents is called the "Swiss Cheese model," and it has been used in understanding causation of adverse perinatal outcomes by Simpson and Knox. [17] Application of this type of accident framework to the case at hand reveals a number of identifiable weaknesses that, in conjunction with one another, created a situation that resulted in an adverse outcome. Inadequate Knowledge In the preceding case, there were three key areas that created the probability of error. Inadequate knowledge on the part of the RN and CNM was the first crucial area. Multiple authors have recommended the establishment of multidisciplinary EFM education programs in an effort to ensure an adequate knowledge base for all clinicians. [3,4,7,9,16] In addition, the adoption of a standardized nomenclature for EFM is recommended. [4,7,9] In 1997, a standardized nomenclature was published after a interdisciplinary group of experts was convened by the National Institute of Child Health and Human Development. [12] Current EFM textbooks use the standardized nomenclature, [10,11] and a sample hospital policy for adoption of the nomenclature has been published. [7] Finally, a plan for ongoing EFM competency should be every clinician's responsibility, whether it is through formal continuing education programs, self-study modules, or hospital-based programs. [3,4] Team Dysfunction: Fear of Conflict and Poor Communication Unfortunately, even the most well-educated clinician will be set up to fail if operating in a system where communication is problematic. The recent Sentinel Event Alert issued by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) found that communication issues were identified as root causes in 72% of the reviewed cases of perinatal death or permanent disability, with more than half of the institutions identifying organizational culture as a barrier to successful communication and team cooperation. [18] Nurses, CMs, CNMs, and physicians have a responsibility to ensure the safety of the patient at all times. The concept of chain of command, or chain of communication, enables clinicians to reach out beyond the immediate clinical circle when circumstances warrant. But if any team member is anxious about communicating due to fear of conflict, a serious defense against error may be compromised. In the case above, the RN was concerned that the CNM was not correctly interpreting the FHR tracing and attempted to get the physician to come in to personally evaluate the tracing. Her failure to institute chain of communication illustrates a classic fear of conflict scenario. As Greenwald and Mondor note, "Some nurses are often so reluctant to 'cause trouble' and so fearful of the consequences that such trouble might represent that they refuse to use chain of command." [2](p. 104) Teamwork training, similar to the type of training used in the airline industry and now being applied to medicine, is one method that may help reduce the fear of conflict by making all the players (e.g., clinicians) equally important when a matter of patient safety is at issue. [18,19]

11 Page 11 of 11 Fear of conflict is only one aspect of team dysfunction. The lack of response by the physician in this case, even when contacted multiple times by the RN, was another example of team dysfunction. Perhaps the RN could have been more assertive, or perhaps the lack of a standardized nomenclature hampered adequate communication between the RN and physician about the FHR tracing abnormalities. Clearly, it would have been better to have had the physician's evaluation earlier rather than later. Physician presence to evaluate a patient at the request of a nurse is a characteristic of perinatal units at low risk for adverse outcomes. [16] CMs/CNMs should welcome and encourage physician involvement when issues of competing EFM interpretations arise between themselves and nursing staff. Conclusion Lack of knowledge, fear of conflict, and poor communication are three areas that contribute to error in obstetrics and especially in EFM interpretation and management. There are many other error-producing conditions, such as fatigue and excessive workload, which need to be addressed in the interest of patient safety. As advocates for women and families, CMs and CNMs must be willing to look at errors systematically, without blame, and with an eye toward reducing error and making patient safety a primary concern. In the area of EFM, this includes not only proper patient selection, but ensuring that all clinicians using EFM share an adequate knowledge base and an environment that encourages open communication and a true team approach to care. References 1. Parer JT. Electronic fetal heart rate monitoring: A story of survival. Obstet Gynecol Surv 2003;58: Curtin SC, Park MM. Trends in the attendant, place, and timing of births, and in the use of obstetric interventions: United States, Centers for Disease Control and Prevention. Natl Vital Stat Rep 1999;47: Greenwald LM, Mondor M. Malpractice and the perinatal nurse. J Perinat Neonat Nurs 2003;17: Simpson KR, Knox GE. Common areas of litigation related to care during labor and birth: recommendations to promote patient safety and decrease risk exposure. J Perinat Neonat Nurs 2003;17: Institute of Medicine. In Kohn LT, Corrigan JM, Donaldson MS. To err is human. Washington (DC): National Academy Press, Shojania KG, Wald H, Gross R. Understanding medical error and improving patient safety in the inpatient setting. Med Clin North Am 2002;86: Miller LA. Safety promotion and error reduction in perinatal care: Lessons from industry. J Perinat Neonat Nurs 2003;17: Murphy AA, Halamek LP, Lyell DJ, Druzin ML. Training and competency in electronic fetal monitoring: A national survey. Obstet Gynecol 2003;101: Simpson KR, Knox GE. Risk management and electronic fetal monitoring: Decreasing risk of adverse outcomes and liability exposure. J Perinat Neonat Nurs 2000;14: Menihan CA, Zottoli EK. Electronic fetal monitoring: concepts and applications. Philadelphia (PA): Lippincott, Williams & Wilkins, Freeman RK, Garite TJ, Nageotte MP. Fetal heart rate monitoring, 3rd ed. Philadelphia (PA): Lippincott, Williams & Wilkins, National Institute of Child Health and Human Development Research Planning Workshop. Electronic fetal heart rate monitoring: Research guidelines for interpretation. Am J Obstet Gynecol 1997; 177: Parer JT. Handbook of fetal heart rate monitoring, 2nd ed. Philadelphia (PA): W. B. Saunders, Lencioni P. The five dysfunctions of a team. San Francisco (CA): Jossey-Bass, Reason J. Managing the risks of organizational accidents. Burlington (VT): Ashgate, Knox GE, Simpson KR, Townsend KE. High reliability perinatal units: Further observations and a suggested plan for action. J Healthcare Risk Manage 2003;23: Knox GE, Simpson KR. Adverse perinatal outcomes. Recognizing, understanding, & preventing common accidents. AWHONN Lifelines 2003;7: JCAHO. Preventing infant death and injury during delivery. Sentinel Event Alert 2003;30: Helmreich RL, Schaefer HG. Team performance in the operating room. In Bogner MS. Human error in medicine. Hillsdale (NJ): Lawrence Erlbaum Associates, 1994: Reprint Address Address correspondence to Lisa A. Miller, CNM, JD, 2014 West Cullom, Chicago, IL address: [email protected] Lisa A. Miller, CNM, JD, teaches multidisciplinary fetal monitoring programs nationally and is president of Perinatal Risk Management and Education Services. She is in clinical practice as a certified nurse-midwife at Saint Anthony Hospital in Chicago, Illinois.