Failure to document anesthesia care in an office setting

by Wayne Wenske, Senior Marketing Strategist‍

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Presentation

A 63-year-old woman came to a pain management physician upon referral from her orthopedic surgeon. The patient was experiencing pain, swelling, weakness, tingling, and limited movement in her left shoulder, arm, and hand. Her history included surgical repair of a tendon rupture two months earlier. The patient’s orthopedic surgeon referred her for evaluation of complex regional pain syndrome secondary to surgery. 

Physician action
The pain management physician examined the patient and diagnosed her with type II complex regional pain syndrome of the upper left arm. He noted that the patient’s left hand was mottled with dysesthesia and hyperalgesia. The pain management physician recommended a left stellate ganglion block to treat the patient’s symptoms. 

The pain management physician scheduled the procedure to take place in the office instead of a surgery center to reduce costs for the patient, who was a self-pay patient.

The patient returned to the office two days later for the procedure. The pain management physician obtained informed consent. The patient was given fentanyl 100 mcg (0.1 mg) and 2 mg of midazolam intravenously. The physician anesthetized the skin with 1 percent lidocaine and used a 20-gauge echogenic needle with ultrasound guidance to inject the C6 tubercle. 

After negative aspiration of blood and cerebral spinal fluid (CSF), the steroid and bupivacaine solution was injected. After every 2 cc of injection, the needle was aspirated to ensure blood and CSF were not present. The pain management physician injected a total of 8 cc of the steroid and bupivacaine solution and documented that all of the patient’s vascular structures were avoided during the procedure.  The physician also documented that the patient tolerated the procedure.

Upon completion of the procedure at 8:55 a.m., the patient became apneic and unresponsive; no carotid pulse was detected. The pain management physician started CPR with a bag valve mask. The patient’s heart rate was in the 60s with normal sinus rhythm and pulse oximetry in the 60s. The patient’s pulse and heart sounds soon became undetectable. 

The pain management physician administered 1 mg of epinephrine. Emergency services were called at 9:02 a.m. 

EMS arrived at 9:16 am and attempted to resuscitate the patient. The pain management physician suggested to the paramedics that they clear the patient’s airway and intubate her, but one paramedic stated that, because pulse oximetry readings were in the 60s and 70s, intubation was considered “elective.” 

According to EMS records, return of spontaneous circulation occurred at 9:20 a.m. A laryngeal mask airway was placed on the patient as a temporary means to maintain an open airway, but the pain management physician noted that the capnography was poor. The patient was taken to a nearby hospital by ambulance.

The patient was admitted to the emergency department. She was described as unresponsive, “severely acidotic,” and unable to maintain oxygen saturations or blood pressure. She was intubated and pressor support was started. A chest X-ray showed “patchy opacity within the mid-left lung” which may have suggested “atelectasis or infiltrate.” 

Emergency Medicine Physician A noted that the patient may have received a high cervical spine block. 

Two days later, a brain MRI revealed global hypoxic anoxic injury. The patient died the next day. 

The autopsy report suggested that the patient experienced an obstruction of the airway and that the brain was edematous. The report concluded that the death was an accident caused by respiratory collapse from the stellate ganglion block procedure. 

Allegations

A lawsuit was filed against the pain management physician. The allegations were:

• failure to have the correct number of qualified anesthesia personnel present during the procedure;
• failure to comply with standards published by the American Society of Anesthesiologists (ASA); 
• failure to maintain and provide oxygen supplementation; and
• failure to comply with requirements established by the Texas Medical Board (TMB) for office-based anesthesia.

Legal implications

The plaintiff’s anesthesiology consultant stated that the pain management physician failed to follow several ASA guidelines and TMB standards for office-based anesthesia. Specifically, that the physician failed to have the correct number of qualified anesthesia personnel present before, during, and after the procedure to:

• administer intravenous sedatives and anesthesia; 
• conduct airway management; 
• provide life-saving oxygen supplementation or use appropriate airway maintenance devices; 
• monitor vital signs; and 
• address any issues that may have occurred during the procedure. 

An anesthesiology consultant who reviewed this case for the defense noted that the patient’s BMI was within the “obese” range, which may present an increased chance of respiratory complications. This consultant criticized the pain management physician for not providing supplemental oxygen to the patient during the procedure and not monitoring the patient’s respirations with a pulse oximeter. 

This consultant also pointed out that another anesthesiologist was not required because this procedure involved “moderate sedation.” ASA guidelines for “moderate sedation” are less stringent than those for “office-based anesthesia.” 

For office-based anesthesia, ASA guidelines recommend that qualified anesthesia personnel be continuously present to monitor the patient and provide anesthesia care. While guidelines for “moderate sedation” require continuous presence of an “individual other than the practitioner performing the procedure to monitor the patient’s appropriate physiologic parameters and to assist in any supportive or resuscitation measures, if required, throughout the procedure. The individual responsible for monitoring the patient must be trained in the recognition of apnea and airway obstruction and be authorized to seek additional help.” ¹  

The defense consultant disagreed with the plaintiff’s expert, and stated his belief that the patient’s respiratory collapse was likely caused by inadvertent injection of long-acting local anesthetic (bupivacaine) into the patient’s vertebral artery.

All consultants who reviewed this case were also critical of the documentation. Specifically, 

pointing to the absence of documented patient vital signs or a log of what was being done and when during and after the code. The operative report was described as insufficient due to a lack of ultrasound images to indicate correct placement of the needle and no record that the injection of local anesthetic and steroid was observed under real-time ultrasound. 

Disposition

This case was settled on behalf of the pain management physician. 

Risk management considerations

One factor that made this case difficult to defend was the lack of adequate (often absent) documentation. Accurate and thorough documentation is a necessary component of safe, high-quality patient care and helps establish a physician’s credibility. Good documentation is important to help successfully defend medical liability cases.

According to the ASA, anesthesia care is made up of three general phases: preanesthesia, intraoperative/intraprocedural anesthesia, and postanesthesia care. The ASA instructs providers to ensure that “accurate and thorough documentation is accomplished for all three phases of anesthesia-related care." ²

It is important for offices and practices to develop and strictly adhere to documentation policies and procedures that include all required anesthesia or sedation information to fulfill state and national guidelines. 

These policies and procedures should include protocols for transferring a patient in the event of an emergency or complication during an office-based procedure to a qualified acute care facility or surgery center. The ASA’s “Statement on Documentation of Anesthesia Care” provides thorough documentation guidelines and is found on their website. ²

Some states have their own laws or regulations regarding office-based sedation or anesthesia care. Office-based anesthesia may be defined differently state-to-state. The Texas Medical Board (TMB) assigns multiple “levels” of anesthesia within their Office-Based Anesthesia rules. Levels II-IV require physicians to register with the TMB as providers of office-based anesthesia.  Each level of care is defined, and requirements for personnel, training, and emergency equipment and supplies, are outlined in detail. 

“Level III” services include “delivery of analgesics or anxiolytics other than by mouth, including intravenously, intramuscularly, or rectally.” ³ Prior to offering office-based services, physicians should familiarize themselves with any regulatory requirements in their state regarding provision of sedation or anesthesia in an office setting.

In this case, the pain management physician elected to perform the procedure in an office setting to reduce costs for the patient. When choosing whether to perform a procedure in a surgery center or in an office setting, it is important that the physician first consider the patient’s overall health before opting for an office-based procedure. This includes carefully evaluating the patient’s history; making a focused examination of the patient; and considering all consultations with other providers and specialists. All pre-procedure evaluations should be fully documented and include the physician’s reasoning for deciding upon an office-based procedure. ³

Sources

1. American Society of Anesthesiologists. Statement on granting privileges for administration of moderate sedation to practitioners who are not anesthesia professionals. Last amended October 13, 2021. Available at https://www.asahq.org/standards-and-practice-parameters/statement-on-granting-privileges-for-administration-of-moderate-sedation-to-practitioners-who-are-not-anesthesia-professionals. Accessed February 1, 2024.
2. American Society of Anesthesiologists. Statement on documentation of anesthesia care. Last amended October 18, 2023. Available at https://www.asahq.org/standards-and-practice-parameters/statement-on-documentation-of-anesthesia-care. Accessed February 1, 2024.
3. Texas Administrative Code. Texas Medical Board Rules, Part 9, Chapter 192. Office-Based Anesthesia Services. Available at https://texreg.sos.state.tx.us/public/readtac$ext.ViewTAC?tac_view=4&ti=22&pt=9&ch=192&rl=Y. Accessed February 28, 2024.
4. American College of Surgeons. Statement on patient safety principles for office-based surgery utilizing moderate sedation/analgesia. September 1, 2019. Available at https://www.facs.org/about-acs/statements/patient-safety-principles-for-office-based-surgery-utilizing-moderate-sedation-analgesia/#:~:text=Physicians%20should%20select%20patients%20for,medical%20specialists%2C%20should%20be%20documented. Accessed February 6, 2024.