Strictly Clinical
  • It’s Never Just a Block: An Analysis of Regional Anesthesia Closed Claims

    Anesthesia care increasingly includes use of regional anesthesia techniques, either as a primary anesthetic or to reduce the patient’s postoperative pain. Both neuraxial anesthesia and peripheral nerve blockade have several noteworthy functions. These functions include diminishing sensory sensation to pain and potentially producing a motor blockade, both of which may facilitate the surgical procedure. The desire to reduce reliance on opioid medications, protocols to enhance and accelerate patient recovery from surgery, and patient expectations all contribute to the likelihood that use of regional anesthesia will continue to gain popularity. As such, it is essential to understand whether an association exists between regional anesthesia and adverse outcomes of care. The American Association of Nurse Anesthetists Foundation Closed Claim Research Team searched the most current database of closed claims that involved adverse outcomes when either a peripheral nerve block or a neuraxial block was a component of care in the claims. Although there were only 32 claims in the dataset, a thematic analysis resulted in the identification of 3 themes: errors in cognitive decision making, ineffective communication patterns, and production pressure.


    Keywords:
    Closed claims, malpractice, neuraxial block, peripheral nerve block, regional anesthesia.

    Over the past several decades there has been a proliferation in the volume of anesthetics administered that include some form of regional anesthesia.1-3 Reasons for this increase in volume include avoidance of complications traditionally associated with components of general anesthesia, improved resource utilization, and greater patient satisfaction.2 Regional anesthetic techniques can provide excellent perioperative analgesia. Enhanced recovery protocols for a broad variety of surgical procedures increasingly recommend the use of regional anesthetics to help accelerate patient recovery and improve clinical outcomes.4 The impact of regional anesthesia on anesthetic outcomes has been variably described, with recent studies demonstrating improved patient outcomes when regional anesthetics are used.1-3 The use of ultrasound guidance for the placement of peripheral nerve blocks, when feasible, has contributed to the consistency with which successful regional anesthetics are obtained.5

    Although no outcomes studies to date have demonstrated the impact of regional anesthesia on overall anesthetic mortality,6 historically, regional block–related anesthesia malpractice claims are consistently represented in overall anesthesia malpractice claims.7 The frequency of malpractice claims related to regional blocks continues, in contrast to the declining overall rates of complications related to anesthesia.7 Achievement of optimal outcomes during use of regional anesthetics entails application of the necessary knowledge, skills, and abilities to perform these techniques consistent with current standards of practice, as well as avoidance of the issues that were identified through analysis of the regional claims reported here. The purpose of this study was to identify factors that may influence poor outcomes in patients undergoing regional anesthesia.

    Methods

    A team was assembled to analyze closed claims related to regional anesthesia found in the American Association of Nurse Anesthetists Foundation (AANAF) closed claims database. The team was composed of Certified Registered Nurse Anesthetists (CRNAs) who were clinical practitioners or educators. The team leader queried the AANAF closed claims database for claims related to regional anesthesia. The database includes both quantitative and qualitative data consisting of 245 malpractice claims considered closed and involving either a CRNA or a student registered nurse anesthetist from the years of 2003 to 2012.8 The query produced 32 claims related to regional anesthesia. The allegations that comprised the basis for these claims included failure to appropriately monitor the patient following placement of a regional block, improper regional anesthesia technique, inadequate documentation, and failure to identify complications in a timely manner.

    A descriptive analysis using statistical software (SPSS version 19, SPSS Inc) and a thematic analysis of the 32 claims were conducted. Coding and subsequent theme development was prompted by the 4 distinct sections of the closed claims data collection instrument, including the reviewer’s narrative, reviewer’s assessment, list of accusations specific to each claim, and description of lessons learned. Adherence to accepted principles of qualitative research was maintained. Detailed descriptions regarding the generation of the AANAF closed claims database and thematic analysis used in this project can be found in separate articles.8,9

    Results

    Evaluation of the 32 claims related to regional anesthesia revealed that 75% of the claimants were female (n = 24), with a mean age of 41 years. Most patients were identified as physical status class 2 or 3. The regional anesthetics were placed primarily in the surgery suite (n = 13) or in labor and delivery (n = 12). Obstetric, ophthalmologic, and orthopedic procedures were the most prevalent types of procedures associated with regional anesthesia closed claims (Figure 1). Ten claims were deemed preventable, 3 were deemed nonpreventable, and preventability could not be determined in 19. The severity index (SI) associated with each claim was established; 9 injuries resulted in death, and 15 injuries resulted in some degree of permanent injury. Figure 2 shows the SI of all 32 claims. Twenty-four claims (75%) resulted in monetary disbursements to the claimants and ranged from $5,803 to $950,000 (mean = $278,404). The legal allegations that served as the basis for the claims are summarized in Table 1.

    Thematic analysis of the 32 claims yielded 3 overarching themes: errors in cognitive decision making, ineffective communication patterns, and production pressure. These themes were related to the provider, the patient, or the healthcare environment; all identified themes are shown in Table 2. Several individual claims encompassed more than 1 theme.

    Errors in Cognitive Decision Making. Greater than 50% of the claims involved errors in cognitive decision making. Errors in cognitive decision making included gap in care, missed opportunities to identify regional anesthesia–related complications, failure to identify and treat acute physiologic deterioration in a timely manner, lack of use of available technology, and lack of acceptable decision making. An example of gap in care was described when a patient received both midazolam and fentanyl before placement of a retrobulbar block. Unfortunately, the block was performed without any monitors or supplemental oxygen; the anesthesia record indicated the total anesthesia time for the block was 7 minutes. A second CRNA retrieved the patient for surgery approximately 16 minutes later and discovered that the patient was apneic and unresponsive. Documentation is lacking as to who was responsible for care during the interval between placement of the block and arrival of the second CRNA. The patient was resuscitated, and spontaneous circulation eventually returned. However, the patient never regained consciousness. Life support was ultimately discontinued, and the patient died.

    Claims also involved missed opportunities to identify regional anesthesia–related complications, and treatment therefore was delayed. Examples of this phenomenon were in the diagnosis of a spinal cord hematoma, epidural abscess, and meningitis. One claim involved the formation of an epidural abscess following placement of an epidural block for labor and delivery analgesia. The patient’s back was prepared with betadine and not the recommended chlorohexidine.7 The epidural block was successfully placed after 2 attempts and used for both labor and subsequent cesarean delivery (due to failure of labor to progress). Twenty-four hours after delivery, the patient experienced a rash on her back. The CRNA attributed the rash to adhesive tape, and there was no follow-up. The patient returned to the hospital 5 days after discharge with a fever and back and neck pain. Treatment was initiated for an Escherichia coli infection at the incision site, and she was discharged. The neck and back pain were not addressed. Fourteen days later, a magnetic resonance image (MRI) revealed an extensive epidural abscess requiring a surgical laminectomy. The patient sustained permanent central and peripheral nerve deficits.

    An example of lack of acceptable decision making involved a patient with multiple comorbidities who was scheduled for an elective cosmetic procedure in the prone position and at a freestanding surgical facility. The patient’s medical and surgical history included chronic low back pain, probable (unconfirmed) obstructive sleep apnea, and previous lumbar spine surgery. The patient chose the type of anesthesia desired, and the CRNA complied with the wishes for an epidural block. After the CRNA’s 2 attempts at block placement and both times eliciting cerebrospinal fluid, a second CRNA was successful with placement, and results of a test dose of lidocaine with epinephrine were negative for changes in heart rate. The first CRNA resumed care of the patient and administered lidocaine and 2-chloroprocaine through the catheter. In the operating room the patient was assisted into the prone position for the procedure. During the procedure, the oxygen saturation decreased, and the patient’s head and airway were repositioned with anticipation of relieving apparent airway obstruction. Despite this maneuver, desaturation was noted via pulse oximetry. The CRNA was unable to adequately ventilate the patient in the prone position; therefore, the patient was quickly turned supine, endotracheal intubation was performed, and the case was canceled. Both lower extremity sensation and motor function was slow to return; the patient was transferred to the hospital for further evaluation. The MRI revealed a pneumocephalus, and a diagnosis was made for cauda equina syndrome. Rehabilitation ensued for lower extremity motor/sensory deficits and poor bladder/bowel control. The patient eventually regained some lower extremity function but ultimately was found to have permanent disability.

    Ineffective Communication Pattern. Evidence of ineffective communication patterns was found to occur between patients and the CRNA, between anesthesia professionals, and between anesthesia professionals and other members of the perioperative team. An example of this theme involves a parturient who requested labor epidural analgesia. There was a failure on behalf of the patient to inform the CRNA of her history of spina bifida as an infant and a previous surgical procedure to remove a spinal tumor. The patient had informed the anesthesiologist of her previous surgery for spinal tumor removal and spina bifida; however, there was no communication between the anesthesiologist and the CRNA. The CRNA asked the patient about the cause of a scar on her back. The patient communicated to the CRNA that the scar was the result of a lumbar laminectomy. After several unsuccessful attempts to place the epidural by the CRNA, the patient informed the CRNA about the previous spinal tumor and spina bifida. There were no further attempts at placement made; however, after a natural childbirth (no anesthesia), a diagnosis of paraplegia was made. This case represented communication failures between anesthesia providers and between the CRNA and patient.

    Production Pressure. Gaba et al10 described production pressure as the pressure to put efficiency, output, or continued production ahead of patient safety. Production pressure was found to be a factor in almost one-third of the regional anesthesia claims and involved deviations from the AANA Standards for Nurse Anesthesia Practice (AANA Standards), inappropriate patient selection for facility, and inappropriate staffing. Lack of informed consent, inadequate/missing preanesthetic evaluation, poor documentation, and failure to monitor the patient represented the most common violations of standard of care. Table 3 shows frequently violated Standards for Nurse Anesthesia Practice found in the claims.

    Production pressure, inappropriate patient selection for the facility, and subsequent deviations from the practice standards are described in a claim involving a young, morbidly obese (body mass index of 42 kg/m2) individual with multiple comorbidities including obstructive sleep apnea. The patient was scheduled for a lower extremity orthopedic procedure in a freestanding surgical facility. The CRNA had reservations about providing anesthesia for the patient in this setting but agreed to proceed. A spinal anesthetic was placed, and intravenous sedation was facilitated with a propofol infusion. During the anesthetic both hypotension and airway obstruction occurred. The patient’s airway was intubated to relieve the airway obstruction, and vasoactive medications were administered to counteract the hypotension. Details of care were not adequately documented, and it was difficult to ascertain when vasoactive medications were given or if there was any response to them. Furthermore, the medical record was appended on the second and fourth postoperative days (however, this did not offer clarity to the sequence of events). The patient ultimately received a diagnosis of anoxic encephalopathy and died less than 2 weeks after the surgery.

    Another claim is worth noting here. A patient was scheduled for cataract surgery in a freestanding surgical facility. A CRNA administered a retrobulbar block to the patient without connecting the patient to monitors, providing the patient supplemental oxygen, or documenting vital signs. Once the block was complete, the CRNA left the patient’s bedside without transferring care to another provider. The CRNA who provided the block was not the CRNA who was scheduled to provide anesthesia for the procedure. The patient became apneic and unresponsive, did not regain consciousness after resuscitation, and life support was eventually discontinued. The pressure to do many cases may have created a scenario in which lack of patient monitoring and poor documentation were considered acceptable.

    Another claim that appears related to production pressure and to breech of standards involves a laboring parturient who was accidentally given a wrong medication via her epidural catheter. A student registered nurse anesthetist who “felt rushed” administered magnesium sulfate instead of ropivacaine via the epidural catheter. This error was not detected for several hours despite numerous complaints of pain by the patient. Over the course of 4 hours, the patient received 3 additional lidocaine boluses and a new epidural catheter, none of which resolved the patient’s pain. Finally, the epidural infusion was discontinued in preparation for an MRI to evaluate for an epidural abscess. When the patient was taken to the radiology suite 4 hours later, the patient was unable to move her legs, and the CRNA discovered magnesium sulfate was the drug in the epidural pump. The patient sustained permanent neurologic injury.

    Discussion

    Analysis of the data specific to anesthesia closed malpractice claims offers the opportunity to acknowledge factors that appear contributory to adverse outcomes. The benefits are noteworthy irrespective of the type of anesthesia. The themes identified in these regional anesthesia claims were similar to those found in other anesthesia closed claims studies.11-13 This finding suggests that although the volume of regional anesthesia is exponentially increasing, and for a plethora of sound scientific reasons, it is not free from its own unique set of complications.

    Errors in Cognitive Decision Making. Errors in cognitive decision making were found in more than half of the claims. Frequently, these errors are attributed to increased cognitive workload.14 Cognitive workload is defined as the psychological effort necessary to complete a particular task.15 Excessive cognitive workload can result in information overload and healthcare professionals experiencing a decreased ability to process new information.16 Information overload makes it challenging for clinicians to separate relevant from irrelevant information to inform optimal clinical decision making.17 If information overload is sustained over time, it may cause mental fatigue and contribute to cognitive errors (ie, errors in decision making) that increase the likelihood of medical errors.14 Excessive cognitive workload results in medical errors,18-22 by decreasing vigilance and situational awareness.21,23

    Situational awareness and vigilance are 2 interrelated concepts that are important in preventing errors in cognitive decision making.24 The defining attributes of situational awareness include an individual’s perception of his or her surroundings, comprehension of his or her observations, and initiating clinical actions based on that comprehension.24 For example, situational awareness involves a CRNA observing changes in a patient’s physiologic condition, comprehending the implications of the physiologic changes to formulate a corrective intervention, and then actually implementing the intervention. Vigilance is defined as sustained awareness during a single task and is related conceptually to situational awareness.25 Vigilance is a prerequisite for situational awareness, but situational awareness is not a prerequisite for vigilance.25 For example, a CRNA can be vigilant of a patient’s physiologic vital signs but be unaware of surgical activity or blood loss (ie, lack of situational awareness).

    Cognitive biases can influence cognitive decision making. A cognitive bias is a type of cognitive error that results from faulty thought processes.26 The faulty thought process can include an error in collecting or processing clinical information.26 Cognitive biases that result in medical errors are commonly caused by a knowledge deficit.27 More than 100 types of cognitive biases are currently described in the literature.27 A strategy suggested in the literature to mitigate cognitive bias is self-reflection to identify personal bias and incorrect thought processes.26 Some examples of cognitive bias relevant to anesthesia include diagnostic momentum, framing, and anchoring.26 Diagnostic momentum occurs during transfer of patient care when a new team assumes care of the patient and accepts the previous clinician’s diagnosis of a specific disease or complication, but no new assessment is performed.26 Framing occurs when a clinician makes assumptions based on current clinical care being provided (eg, missing an internal hemorrhage because the surgical procedure is not normally associated with it).26 Anchoring occurs when clinicians make an assumption based on the patient’s medical history (eg, patient with insulin-dependent diabetes must be noncompliant with diet at home).26 It is important for anesthesia providers to be aware of potential causes of errors in cognitive decision making and to understand how to mitigate them.

    Ineffective Communication Pattern. This analysis cited ineffective communication as a causal factor in several claims. Effective communication between healthcare team members and with patients is essential for the provision of safe patient care. The Joint Commission estimates that approximately 80% of serious medical errors occur due to miscommunication during the transfer of care.28 Most commonly, communication failures occur between different professional members of a team, such as between the anesthesia provider and surgeon, or between the surgeon and a nurse.29,30 Poor information sharing by the team during the intraoperative care has been shown to contribute to an increased risk of complications or death regardless of a patient’s physical status class.31

    Communication failures may be the result of conflicting communication styles, inattention to concerns/failure to voice concerns, differing “world views,” or even disruptive behaviors.32 Communication failures between providers and patients or providers and family also contribute to poor patient outcomes. A healthcare provider may be highly technically skilled, yet ineffective communication on his or her part may lead to patient dissatisfaction or complications.33 An anesthesia provider may fail to obtain a thorough preanesthesia history, contributing to the selection of an inappropriate plan of care. In some cases, a patient either withholds information or does not understand the need to disclose all his or her medical history.

    A patient’s understanding of questions may be limited by the technical jargon used by healthcare providers when obtaining a history, resulting in an incomplete clinical picture for the anesthetist. Babitu and Cyna34 found that nearly half of patients misunderstood 1 or more terms during a preanesthesia assessment, and that technical terms were used by all the anesthetists observed. Patients presenting for anesthesia care are typically stressed or anxious, hungry and/or thirsty, and tired, or may be in pain or otherwise distracted during the preanesthesia assessment. A thorough history is the basis of any anesthetic plan. As anesthesia providers, we must ensure that we are using effective communication skills and allocating adequate time to these essential interactions with patients.

    Obtaining an informed consent requires that a patient be given accurate and timely information regarding the risks and benefits of all anesthetic options. Specifically, with regional anesthesia, investigators have found that patients wish to receive information about minor (eg, nausea, urinary retention) complications as well as more serious potential complications (eg, permanent neurologic injury, high spinal anesthesia) when informed consent is obtained.35 Ideally, discussions about anesthetic-related risks and benefits should occur when both the patient and anesthetist can provide the attention needed to have a meaningful exchange free from the distractions of pain, anxiety, or production pressure. In many cases, regional anesthesia is performed as an adjunct to general anesthesia or is nonessential,11 mandating that communication regarding risks and benefits is particularly prudent.

    Methods to reduce the occurrence of communication failures between care providers during handoff is the focus of a 2017 Sentinel Event Alert issued by the Joint Commission.36 The use of checklists and standardized tools, training in teamwork and nontechnical skills, and verbal readback or closed loop communication are all suggestions to improve communication in healthcare.37 Increasingly, it has become accepted that formal instruction in interprofessional communication skills must be included in healthcare education to improve patient safety and satisfaction.38-40

    Production Pressure. As previously noted, production pressure is the pressure to put efficiency, output, or continued production ahead of patient safety.10 Recent articles identify production pressure as a known factor related to anesthesia delivery.41,42 A few examples of production pressure include avoidance of case cancellations and delayed starts of cases, proceeding with cases despite inadequate preoperative evaluation and/or despite patient comorbidities, rapid turnovers between cases, removal of anesthesia monitors during emergence, lack of available resuscitative equipment during regional anesthesia administration, failure to monitor neuromuscular blockade during administration of neuromuscular blocking agents, and poor hand hygiene.10,41,42 When we are rushed, we are more likely to cut corners or take shortcuts to save time or money.41 Most of these examples also represent a failure to follow AANA Standards of Practice.

    Production pressure can influence clinical decision making, such as failing to follow AANA Standards, which may result in anesthesia mishaps.10,41,42 Failure to follow AANA Standards was found in more than half of the claims related to regional anesthesia. The most common violation in this study was failure to monitor (AANA Standard 9). In the entire AANAF closed claims database, the most commonly violated AANA Standards were Standard 3 (plan for anesthesia care) and Standard 9 (monitoring, alarms).8 It is crucial that CRNAs be cognizant of and follow AANA Standards, which exist to help ensure safe anesthesia practice.

    Although errors in decision making and ineffective communication may occur independently, it is worthwhile to note that production pressure likely contributes to all the identified themes. Therefore, it is imperative that a CRNA remains vigilant to the risk of patient harm that may occur when experiencing increased production pressure. Some suggested solutions to decrease production pressure include to increase provider vigilance, adopt and use standardized protocols, evaluate/reevaluate one’s own work practices and adopt current evidence-based practices, and place patient safety above all other factors.10,41,42 Adoption of a culture of safety empowers individuals to stop a procedure if they perceive that production pressure is threatening patient safety.

    Lessons Learned. The analysis of this cohort of regional anesthesia–related closed anesthesia claims offers an opportunity to provide recommendations to improve the safety of patient care. Table 4 offers recommendations to improve the safety of patient care during neuraxial anesthesia. Some general recommendations to help prevent adverse events and reduce risk in patients undergoing all types of regional anesthesia are presented in Table 5.

    Conclusion

    The gaining popularity of regional anesthesia techniques, either as the primary anesthetic or to manage surgical pain, reinforces the importance of critical analysis of adverse events related to these techniques. The decision to use a regional anesthesia technique should receive the same degree of consideration as administration of a general anesthetic, and adherence to standards of practice should be maintained. Risks exist with all anesthetic techniques. Thoughtful preparation, diligence, and appropriate vigilance will help to ensure a safe experience for patients undergoing regional anesthetic techniques.

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    AUTHORS

    Maria Hirsch, DNAP, CRNA, is the director of Anesthesia Services for the Carilion Clinic in Roanoke, Virginia, and a clinical assistant professor for the Virginia Commonwealth University Department of Nurse Anesthesia, Richmond, Virginia. Email: mthirsch@carilionclinic.org.

    Marjorie Geisz-Everson, PhD, CRNA, FNAP, is adjunct faculty at Johns Hopkins University School of Nursing Baltimore, Maryland and per diem CRNA at Benefis Hospital Great Falls, Montana.

    Beth Ann Clayton, DNAP, CRNA, FAAN, is an associate professor of clinical nursing and the Nurse Anesthesia Program director for the University of Cincinnati College of Nursing, Cincinnati, Ohio.

    Bryan A. Wilbanks, PhD, DNP, CRNA, is an assistant professor at the University of Alabama at Birmingham School of Nursing, Birmingham, Alabama.

    Mary Golinski, PhD, CRNA, is an assistant professor in the School of Nursing at Oakland University in Rochester, Michigan. She also is the assistant program director for the Oakland University–Beaumont Graduate Program of Nurse Anesthesia in Michigan.

    Michael Kremer, PhD, CRNA, FAAN, is a professor at the Rush University College of Nursing and the codirector for the Rush Center for Clinical Skills and Simulation in Chicago, Illinois. He has served on the AANA Foundation Closed Claim Research Team since its inception in 1995.

    Kelly Wiltse Nicely, PhD, CRNA, is the program director for the Nell Hodgson Woodruff School of Nursing, Nurse Anesthesia Program, at Emory University in Atlanta, Georgia.

    DISCLOSURES

    The authors have declared no financial relationships with any commercial entity related to the content of this article. The authors did not discuss off label use within the article.

    ACKNOWLEDGMENTS

    We wish to acknowledge Lorraine Jordan, PhD, CRNA, CAE, FAAN, and the American Association of Nurse Anesthetists Foundation for supporting this study and CNA Insurance Companies for providing data for this study.

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