This was originally printed in our Second Quarter 2022 issue of The Scope: Medical Edition.
According to a recent joint study1 by MLMIC Insurance Company and MedPro Group of approximately 2,500 inpatient surgical suite and ambulatory surgery center claims closed between 2015 and 2020, an anesthesiologist was identified as the responsible specialty 88% of the time. The same study showed that Certified Registered Nurse Anesthetists (CRNAs) were involved in approximately 39% of the claims made against an anesthesiologist. This article will focus on what the analytics from that study revealed about the top anesthesia-related allegations, the contributing factors related to those allegations and the CRNA influence on anesthesia-related allegations.
Focus on MLMIC Analytics: The Top Anesthesia-Related Allegations
Not surprisingly, the study revealed that dental damage during intubation or extubation made up a third of all anesthesia-related allegations. However, allegations involving dental damage accounted for a negligible amount of the total dollars paid. In sharp contrast, while “improper management of the anesthesia patient” also made up about a third of the anesthesia-related allegations, those allegations made up two-thirds of the total dollars paid.
According to the study, “Improper performance of an anesthesia procedure” made up 24% of the anesthesia-related allegations and accounted for 17% of the total dollars paid. The category “All others” consisted of allegations involving an anesthesiologist but were related to medications, obstetrics (delivery) and pain management.
Focus on MLMIC Analytics: The Top Three Contributing Factors Leading to Anesthesia-Related Allegations
Contributing factors are multilayered issues or failures in the delivery of patient care that contribute to an untoward outcome and/or the initiation of a case, or have a significant impact on case resolution. Contributing factors reflect breakdowns in technical skill, clinical judgment, communication, behavior, systems, environment, equipment/tools and teamwork. In analyzing the data, more than one contributing factor can be identified as contributing to an anesthesia-related claim. We will examine the top three contributing factors leading to anesthesia-related claims.
Technical skill involves procedural skill issues and factors related to the improper use of equipment, medication errors and retained foreign bodies.
Top Technical Skill Contributing Factors: 94% of cases involving a technical skill factor had issues relating to technical performance. Technical performance encompasses poor procedural technique/competency, the failure to manage a known complication, incorrect body positioning and using an inappropriate method of administering medication. Medication errors were a factor in 5% of the cases, improperly utilized equipment was a factor in 5% of the cases, and a retained foreign body was a factor in 2% of the cases.
Clinical judgment, or clinical decision-making, includes factors related to the selection and management of therapy, patient assessment, patient monitoring, any failure/delay in obtaining a consult, the failure to ensure patient safety (e.g., side rails, restraints), the choice of practice setting, the failure to question/follow an order and practicing beyond the scope of practice.
Top Clinical Judgment Contributing Factors: 63% of cases involving clinical judgment as a factor had issues relating to the “selection and management of therapy,” which involves the provider’s judgment concerning the best or most appropriate procedure, the most appropriate location for conducting the procedure, choosing the most appropriate medication and proper patient selection. Patient assessment issues were a factor in 60% of the cases. This encompasses the failure to appreciate relevant signs, symptoms, and/or test results, the failure to escalate, inadequate pre-op assessment and the failure to reconcile changing vital signs.
Patient monitoring was a factor in 43% of the cases. This encompasses the failure to recognize a change in physiological or behavioral status, and any failure or delay in responding to a clinical alarm system.
Other factors identified included the failure or delay in obtaining a consult or referral (5%) and the failure to ensure patient safety (5%).
These factors are related to communication among providers, communication between the patient and/ or the patient’s family and providers, and providing inadequate informed consent.
Top Communication Contributing Factors: 61% of all cases with communication issues were specific to communication between the patient and/or their family and the providers. This involves providers failing to discuss and set patient expectations, issues relating to informed consent (i.e., discussing the treatment risks and benefits, and any alternative options) and patient/family education. A subset of communication factors includes issues with electronic communication such as telemedicine/ telehealth, patient portals and email communication.
Additional Contributing Factors: Supervision and CRNAs
Supervision was found to be a contributing factor that occurred in 21% of all anesthesia files reviewed. In addition, of the files reviewed, CRNAs were involved in 39% of the cases and their actions impacted the patient’s outcome.
Focus on MLMIC Analytics: The Severity of Anesthesia-Related Injuries
The National Association of Insurance Commissioners (NAIC) has a three-tier rating system for injuries: high severity, medium severity, and low severity.
High severity is defined as:
- Permanent Significant — deafness, or the loss of a limb, eye, kidney or lung;
- Permanent Major — paraplegia, blindness, the loss of two limbs or brain damage; or
- Grave — quadriplegia, severe brain damage, requiring lifelong care, a fatal prognosis or death.
Medium severity is defined as:
- Temporary Minor — infection or an improperly set fracture;
- Temporary Major — burns or surgical material retained; or
- Permanent Minor — the loss of a finger or damage to an organ.
Low severity is defined as:
- Emotional Only — e.g., fright; or
- Temporary Insignificant — lacerations, minor scars, or rash.
The MLMIC MedPro Group study of anesthesia-related injuries in cases between 2015 and 2020 broke down the severity of injuries as follows:
For the anesthesia-related injuries reviewed, “High severity” included death, the need for neurosurgical intervention after cervical epidural steroid injection caused hematoma, and permanent persistent pain. “Medium severity” included postdural puncture headaches and photophobia, allergic reaction to agents used, and aspiration pneumonia. “Low severity” included dental damage during intubation or extubation, inadequate anesthesia during C-section resulting in undue pain and emotional injury.
Supervision of CRNAs and Anesthesiologists’ Liability Risk
A certified registered nurse anesthetist is a licensed registered nurse who has completed additional training in anesthesia in an accredited program and is certified by a national organization to give anesthesia to patients.2 Despite national certification, CRNAs are registered nurses under New York law.
New York Department of Health regulations governing the administration of anesthesia within a hospital permit CRNAs to perform a variety of functions under the supervision of an anesthesiologist who is “immediately available”3 or an operating physician who has agreed to accept responsibility for the CRNA.
It should be noted that a CRNA poses an increased risk of exposure for an anesthesiologist over an operating physician.
- NYS Department of Health regulations do not require the operating physician to attend to a patient during an emergency related to anesthesia.
- A physician’s liability for injuries resulting from the wrongful administration of an anesthetic is more limited.
- The physician does not have the recognized technical expertise of CRNAs in administering anesthesia.
- The physician does not have expertise in the use of specific anesthetics to correct the harmful effects of other anesthetics.
- An anesthesiologist is required to be “immediately available” when supervising a CRNA, which is generally interpreted as being physically present within the hospital, preferably within the operating suite.
- The anesthesiologist must remain physically available for the immediate diagnosis and treatment of emergencies when administering anesthesia.
- An anesthetist must be present to attend to a patient during emergence from anesthesia.
CRNAs may perform many functions under the supervision of a physician. These functions include:
- Obtaining consent to anesthesia while under the supervision of an anesthesiologist or operating physician4
- Performing diagnostic spinal taps
- Inserting bronchoscopes to observe placement of double-lumen endotracheal tubes
- Inserting a “Bougie” device for bariatric procedures
- Placing an endoscope in the esophagus and advancing it while the surgeon directly visualizes the scope, and manipulating the scope from below to ensure that it is in the right place
- Inserting an epidural catheter for pain control in the labor and delivery area of an Article 28 facility
The following case studies illustrate two different clinical scenarios involving claims made against anesthesiologists.
Case Study #1: Patient Selection and Management
The patient was a 23-year-old female with a history of morbid obesity and obstructive sleep apnea, which was diagnosed by an ENT. The ENT opted to perform a uvulopalatopharyngoplasty and tonsillectomy in an outpatient surgical center. The anesthesiologist completed a preoperative anesthesia assessment and assigned Class IV modified Mallampati classification since the soft palate was not visible. The patient had good oral opening, but limited extension. The anesthesiologist assigned ASA III, the highest classification allowed for an outpatient surgery setting. The patient signed only part of the anesthesia consent.
The surgery was completed by the ENT and was uneventful. In the postoperative period, the patient’s oxygen saturation dropped to between 70 and 90%. Once she met extubation criteria, she was extubated, but within five minutes of extubation, her oxygen saturation dropped to the 60s with pulmonary froth.
The anesthesiologist used a mask with positive pressure support and her oxygen saturation increased to 85–90%. The patient was given 12mg of Lasix for pulmonary edema and she stabilized. The patient slept for about 45 minutes and her oxygen saturation remained in the 90s.
Since she was doing well on a non-rebreather mask, a transfer to the hospital was planned.
Twenty minutes after the transfer was planned, the patient needed to use the restroom and nurses assisted her to the sitting position. At that point, the patient started having pulmonary froth and the ENT decided to reintubate. Reintubation was accomplished with anesthesia. After intubation, edema rapidly worsened, which required frequent suctioning, and her blood pressure dropped due to the propofol.
The patient was deemed not stable enough for ground transport and air transport was called. The patient became bradycardic and asystolic, CPR was started, and a weak, irregular pulse was achieved. She was then taken by ground transport to the hospital. During transport the patient again became asystolic. She was unable to be resuscitated and subsequently pronounced dead.
The family claimed the providers improperly assessed the patient’s risk. The procedure should not have been done at an outpatient off-site facility, and the failure to transfer the patient in a timely fashion when she had distress resulted in her death. Ultimately, the total indemnity paid on behalf of the anesthesiologist was $500,000.
Case Study #2: Improper Extubation
The patient was a 67-year-old female requiring extensive rehabilitation after a prolonged hospital stay for an anoxic brain injury. Her history included degenerative joint disease with multiple prior surgeries, osteoarthritis, anxiety, hyperlipidemia, hypertension and hypothyroidism. In early June, the patient was admitted for lumbar laminectomy with posterior lumbar interbody fusion from L2-S1 to be performed by her neurosurgeon.
The CRNA induced IV anesthesia and intubated with an ETT. Shortly after induction, surgery was begun and subsequently completed without complications. The patient was given a final dose of rocuronium. However, there was no documentation of neuromuscular monitoring (“train of four”) to indicate paralytics had adequately been reversed. Within 90 minutes, the patient was suctioned, extubated and transported to the PACU with an oral airway in place.
In the PACU, there was no admission that vital signs were documented. The patient was then found to be apneic, but the CRNA was unaware of how long she had not been breathing. The patient’s heart rate dropped, and oxygen saturation dropped to 34%. A code was called and compressions started.
The anesthesiologist intubated the patient. There was return of spontaneous circulation within two minutes and the code ended within seven minutes. The patient was transferred, intubated and moved, unresponsive, to the ICU. An MRI showed no evidence of an acute infarction or other intracranial disease. An EEG showed the patient was comatose. Her movements were involuntary, not purposeful, and she did not respond to commands.
Three weeks later, being unable to be weaned off the ventilator, the patient underwent a tracheostomy and a PEG-tube insertion, and transferred to a rehab facility, where she had a very slow recovery. She was eventually weaned off the ventilator, the tracheostomy was closed and the PEG tube was discontinued.
The patient was discharged to home a month later with residual cognitive, balance, communication and emotional deficits as a result of anoxic brain injury.
A lawsuit was eventually filed by the patient against the CRNA alleging failure to properly monitor and document the patient’s vital signs, negligent use of rocuronium, and delayed intubation.
Experts were critical of the CRNA for:
- allowing inadequate time between rocuronium administration and extubating patient;
- not monitoring respiratory status more closely;
- delaying intubation; and
- using too high of a dose of paralytics.
This case was settled on behalf of the CRNA for $1,000,000.
Beyond the Analytics: What Are the Takeaways from the MLMIC MedPro Group Study for Anesthesia-Related Allegations?
- Practices should conduct ongoing evaluations of the technical skills of their staff and their procedural knowledge and competency with equipment.
- Anesthesiologists must conduct a thorough assessment of the patient preoperatively, and ensure that all testing and specialty evaluations are available for review prior to induction. In an ambulatory setting, these details might not always be as readily available as in the inpatient setting.
- Anesthesiologists must communicate with each other and actively collaborate with other members of the patient’s surgical care team, including all operating and recovery room staff, when coordinating the steps of the patient’s care, including postoperatively.
- Anesthesiologists must also communicate with the patient (or family), elicit a comprehensive patient history and conduct a thorough informed consent with the patient that is separate from the surgical consent.
- Anesthesiologists must document their care thoroughly, as the anesthesia record is critically important for detailing the preoperative patient assessment, intraoperative steps, and postoperative sequence of events. Discrepancies or gaps in the details or timing make it much more difficult to build a supportive framework for defense against potential malpractice cases.
- Anesthesiologists must know, and adhere to, their supervision responsibility for advanced practice providers.
- Anesthesiologists must follow patient safety precautions before, during, and after each procedure, including surgical timeouts and the provision of post-anesthesia specialty coverage.
- Chief anesthesiologists should provide in-service education to the physicians who are to supervise the CRNAs. CRNAs need to understand the modalities of anesthesia that will be used in their procedures, be able to determine what medications may need to be ordered both for the procedure and postoperatively and understand the protocols that are in place should a patient develop complications while under anesthesia. This training should be held at least annually.
This review of the MLMIC MedPro Group Study and its analytics should provide valuable information on the top anesthesia-related allegations, the top contributing factors leading to anesthesia-related allegations, and the CRNA influence on such allegations, as well as provide anesthesiologists, CRNAs, and other healthcare providers with ways to proactively assess and potentially reduce the risk of such allegations.
Al Anthony Mercado is Managing Attorney of the Downstate Region of Mercado May-Skinner, in-house counsel to MLMIC Insurance Company.
1. Data source: MLMIC + MedPro Group closed cases that opened between 2015 and 2020, inpatient surgical suite or ambulatory surgery center as the location (total cases = approx. 2,500).
2. 10 NYCRR 700.2 (b)(22): A certified registered nurse anesthetist or registered nurse anesthetist or nurse anesthetist shall mean a registered professional nurse licensed and currently registered with the New York State Education Department who: (i) has satisfactorily completed a prescribed course of study in a school of nurse anesthesia accredited by the Council on Accreditation of Nurse Anesthesia Education Programs/ Schools or other accrediting body that the commissioner finds to be substantially equivalent; (ii) has passed the national certifying examination given by the Council on Certification of Nurse Anesthetists or other certifying examination that the commissioner finds to be substantially equivalent; and (iii) is currently certified by the Council on Certification of Nurse Anesthetists or by the Council on Recertification of Nurse Anesthetists or other accrediting body that the commissioner finds to be substantially equivalent.
3. “Immediately available” has been interpreted as being physically present within the hospital and preferably in the operating suite. See 10 NYCRR 405.13 (1)(iv).
4. See the New York State Department of Education memo from May 2006, opining that the CRNA is the appropriate person to obtain consent for anesthesia in this scenario.