As the prevalence of obesity in the general population is rapidly increasing, so too is the incidence of obstructive sleep apnea. Anesthesiologists face significant challenges and risks when treating patients with diagnosed obstructive sleep apnea or patients who exhibit all the signs and symptoms of obstructive sleep apnea.
OBSTRUCTIVE SLEEP APNEA (OSA) DEFINED
Obstructive Sleep apnea (OSA) and obstructive sleep apnea-hypopnea (OSH) represent two forms of the same disorder: upper airway collapse during sleep that may be accompanied by sleep disruption, hypoxemia and arterial oxygen desaturation. OSA is common in obese patients due to the propensity of fat deposition in the pharynx causing the upper airway to close. However, non-obese patients can have OSA from tonsillar hypertrophy or craniofacial abnormalities, especially in pediatric patients.
OSA is defined by no airflow for 10 seconds in the face of continued ventilatory effort for at least five times per hour of sleep. OSH is defined as a decrease of more that 50% in airflow, without a complete absence of airflow, for 10 seconds or more at least 15 times per hour of sleep. Both OSA and OSH disrupt the normal patterns of sleep and result in arousal events that may lead to other symptoms including, but not limited to, hypertension, coronary artery disease, congestive heart failure, fatal arrhythmias, myocardial infarction, daytime somnolence, diabetes, and restrictive pulmonary disease.
STOP-BANG Scoring Model
There are several screening tools and scoring systems available to assist anesthesiologists in evaluating whether a patient might have OSA. However, it should be noted these screening tools and scoring systems have not been clinically validated and should be used as a guide in evaluating patients for OSA. In the absence of a sleep study, a presumptive diagnosis of OSA may be made using the STOP-BANG scoring model.
To receive additional information and insight on the STOP-BANG scoring model, and to read a risk management newsletter discussing OSA in much greater depth:
Preferred Physicians Medical (PPM), industry-leading provider of professional liability insurance for anesthesia practices, participated in a workshop organized by the Anesthesia Patient Safety Foundation (APSF) to address drug-induced respiratory depression in the postoperative period.
Steve Sanford, PPM's President and COO, provided conference attendees with medical liability data suggesting drug-induced respiratory depression remains a significant patient safety concern. In his remarks to the workshop attendees, Mr. Sanford indicated malpractice litigation provides an additional perspective for defining the scope of this patient safety issue.
Adverse Outcomes and Litigation
PPM, in its role as a medical professional liability insurance carrier providing malpractice coverage exclusively to anesthesiologists and their practices, has an anesthesia database of over 10,000 adverse outcomes, including 3,250 malpractice claim and litigation files (2,876 closed and 374 open). Mr. Sanford noted that litigation and loss data by its nature tends to understate the incidence of adverse medical outcomes. Litigation focuses on extreme outcomes; those resulting in significant compensable harm. With respect to drug-induced respiratory depression, non-catastrophic outcomes and close calls, (including cases where the patient is rescued without injury) are unlikely to result in a claim or litigation.
After reviewing its anesthesia database, PPM identified 96 anesthesia claims and litigation files involving postoperative depression or arrest. Almost all the reported cases involved primary allegations of brain damage or death.
Click below to receive your copy of anesthesia claims data and information associated with drug induced postoperative respiratory arrest that was shared at this important patient safety conference.
Allegations of a lack of informed consent for anesthesiologists are routinely included in litigation where the informed consent process is poorly performed or even just poorly documented.
Undermining A Jury's Confidence
The lack of informed consent can become an important issue in a malpractice claim against an anesthesiologist, especially in a jury trial. While it is true that lack of informed consent is rarely the main issue in a lawsuit, the failure to provide a good informed consent provides the plaintiff attorney with an important tactical advantage. Plaintiff attorneys use the lack of a good informed consent process as a methodology for undermining the jury's confidence in the defendant anesthesiologist. They suggest that the anesthesiologist was careless, paternalistic, unengaged with the patient, or even focused primarily on making money. The absence of a good informed consent plays into this perception and leaves the defense at a disadvantage.
Informed Consent...The Early Rounds
During litigation, the plaintiff attorney typically gets to present first. He/she decides which witnesses will be called, the order in which they are called and the focus of the direct examination. In the typical case, much like a 10 round boxing match, the plaintiff is throwing all the early punches and the defendant doctor is merely playing defense and trying to deflect as many punches as possible in the first 5 rounds. The case turns once the defense gets to put on its case. Under this framework, the lack of informed consent becomes a useful tactic that the patient's attorney will use to turn the jurors against against the doctor in the early rounds.
The medical issues themselves may be complex and subject to debate, but jurors will relate to and often share the frustration with respect to a lack of input into their own health care decisions. Most jurors have all felt rushed through doctors visits or believed little time was afforded for questions or concerns. Not having a sound informed consent process allows the plaintiff to undermine the perception of the defendant anesthesiologist in a way the plaintiff attorney may not be able to do with regard to the actual medical care.
Informed Consent...The Verdict Is In
By the time the plaintiff is done with their half of the case, the anesthesiologist may be on the mat. Even if the anesthesiologist and defense team are able to fight their way up from the mat, the plaintiff attorney has inflicted injuries and rather than focusing on the actual medical care, the defense team is forced to rehabilitate the anesthesiologist in terms of his training, skills and compassion, etc. Rather than focusing on the medical issues in the case, the lack of informed consent becomes a distraction as the attempt is made to demonstrate to the jury that the anesthesiologist is in fact a good and caring doctor. A good informed consent removes this tactic from the plaintiff's arsenal and the defense can spend the entire case going head to head on the "real" medical issues.
Download a free copy of an anesthesia specific informed consent document that has been used successfully numerous times at trial.
Contributed by Brian Thomas, PPM Director of Risk Management
Opioid addiction remains a significant issue in the anesthesia workplace. While anesthesiologists may suffer from addiction to alcohol and other substances, the drug of choice for most anesthesiologists entering treatment programs continues to be opioids.
Addiction to opioids and other substances puts patient safety at risk and devastates anesthesiologists' lives, families and professional careers. From a professional liability perspective, allegations that an anesthesiologist was under the influence of narcotics or other substances while rendering care and treatment to a patient significantly increases liability exposure to both the individual anesthesiologist and the anesthesia practice group.
How Your Professional Liability Coverage is Affected
It is also important to note that nearly all professional liability insurance policies exclude coverage for liability arising from substance abuse. While mere allegations of substance abuse do not typically result in a denial of coverage, insurance carriers must make a case-by-case determination based on the specific allegations, facts and evidence.
If allegations 
of substance abuse are ultimately proven in a medical negligence lawsuit, the addicted anesthesiologist may be faced with no insurance coverage. Further, the addicted anesthesiologist may be faced with personally paying the considerable cost of defending a lawsuit.
Additionally, allegations of substance abuse often result in punitive or exemplary damage claims. Punitive or exemplary damages arise when the defendant's acts are determined to have been intentional, willful, malicious, wanton, fraudulent, or criminal. Many professional liability insurance policies exclude coverage for liability arising from punitive or exemplary damage claims.
Anesthesia practice groups that employ an addicted anesthesiologist may also face significantly increased liability exposure in the event of a lawsuit with allegations of substance abuse. In addition to the possibility the individual addicted anesthesiologist may not have insurance coverage, the anesthesia practice group's corporate assets may be at risk due to punitive or exemplary damage claims.
Click below to receive our risk management newsletter, Anesthesia & the Law, which addresses anesthesia workplace addiction...
Prevention of intra-operative fires begins with operating room fire safety education. Operating room fire safety includes, but is not limited to, knowledge of institutional fire safety protocols and participation in institutional fire safety education. All anesthesia providers should have fire safety education with an emphasis on the risk created by an oxidizer-enriched atmosphere. Additionally, all members of the surgical care team should periodically (annually at a minimum) participate in operating room fire drills with the entire surgical care team. This formal rehearsal should take place during dedicated educational time, not during patient care.
The Fire Triad
The anesthesia provider, the surgeon and the nursing staff each control and are responsible for at least one of the elements of the "fire triad" or "fire triangle." Therefore, every member of the surgical team plays an important role in preventing intra-operative fires. Before starting a high risk procedure, the surgical care team should agree upon a team plan and team roles for preventing and managing an intra-operative fire. Prevention of intra-operative fires includes:
1) Minimizing or avoiding an oxidizer-enriched atmosphere near the surgical site;
2) Safely managing fuels, and
3) Safely managing ignition sources
Intra-operative fires are potentially devastating preventable complications. Each member of the surgical care team has responsibility to minimize or eliminate the risk of intra-operative fire. Hospitals and other health care facilities should have operating room fire safety policies and protocols to educate all members of the surgical care team about intra-operative fire prevention and management. The anesthesia provider's safety education should focus on the risk created by an oxidizer-enriched atmosphere.
For a more comprehensive overview of intra-operative fires, including case studies defending anesthesiologists in the courtroom.....
For the first time since 2005, the American Society of Anesthesiologists (ASA) House of Delegates approved a change in the ASA Standards for Basic Anesthetic Monitoring. Effective July 1, 2011, the ASA Standards for Basic Anesthetic Monitoring were revised.
ASA's Former Standard For Basic Anesthesia Monitoring Read:
During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and/or monitoring for the presence of exhaled carbon dioxide.
Effective July 1, 2011, ASA's New Standard For Basic Anesthesia Monitoring Reads:
During regional anesthesia (with no sedation) or local anesthesia (with no sedation), the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs. During moderate or deep sedation, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure or equipment.
New ASA Standard and Patient Safety
Preferred Physicians Medical (PPM), an industry leading provider of professional liability insurance for anesthesia practices, has recently encouraged its policyholders to review and update their practice protocols to reflect the revised ASA Standards for Basic Anesthesia Monitoring. According to Brian Thomas, PPM’s Director of Risk Management, ASA standards are designed to provide guidance to improve decision-making and promote beneficial outcomes for the practice of anesthesiology. While they are not intended as unique or exclusive indicators of appropriate care, PPM’s considerable litigation experience strongly suggests plaintiff attorneys will argue that the ASA Standards do create a national standard of care for all anesthesiologists. For this reason, PPM continues to believe that compliance with the newly revised standard will be key to defending anesthesiologists in the courtroom.
For additional information on the ASA Standards, PPM recommends reviewing information at the ASA website at www.asahq.org
For a list of Frequently Asked Questions regarding complying with the new ASA Standard...
Posted by
Nancy Kuhn on Tue, Aug 23, 2011 @ 12:38 PM
Nerve Damage from Regional Blocks Placed In Anesthetized/Sedated Patients
Whether regional blocks should be placed in adult anesthetized/sedated patients is still being debated within the anesthesiology community. The debate stems from the fact there is no current peer-reviewed, evidence-based medical literature concluding this technique increases the risk of nerve injury. However, from the vantage point of defending more than 4,000 lawsuits over the past 23 years, Preferred Physicians Medical (PPM) continues to strongly recommend against using this technique, based on the difficulty of defending injuries resulting when regional blocks are placed while the patient is either anesthetized or sedated.
Issues That Could Occur
One obviou
s problem with placing regional blocks in anesthetized/sedated patients is the patient is unable to respond to the pain associated with needle or catheter-induced paresthesias or intraneural injections. Perhaps the advent and increased use of nerve stimulator needles and ultrasound to assist needle placement may have increased anesthesiologists' comfort level in placing blocks without reliance on physiologic responses. Nevertheless, there is credible medical literature criticizing the placement of regional blocks in anesthetized patients as inappropriately risky in most cases. This literature has become an important tool for plaintiff attorneys in recovering substantial settlements and is a challenging obstacle in defending anesthesiologists using this technique. There are also numerous well-credentialed anesthesiology experts who will readily testify in court this technique is ill-advised and below the standard of care.
Adding to the challenge, the most common reasons cited by anesthesiologists using this technique are:
- medical convenience, and
- patient comfort
While these may appear to be legitimate reasons to consider using this technique, the anesthesiologist must weigh and balance the increased risk of nerve injury with those rather modest benefits. PPM's considerable experience in defending these claims suggests that medical convenience or patient comfort will rarely provide a compelling justification, especially when defending catastrophic nerve damage litigation.
To read about case summaries highlighting the devastating injuries that can occur when placing regional blocks in anesthetized/sedated patients....
The propofol shortage began in 2009 when two manufacturers halted distribution and recalled several lots of propofol products because of quality problems. In July, 2009, Teva Pharmaceuticals (Teva) recalled five lots of its propofol after 20 patients who received the drug had adverse reactions with flu-like symptoms. Teva discovered high levels of endotoxin, apparently linked to contaminated egg yolk used in the manufacturing process, in vials of the sedative pulled from the affected lots. In November, 2009, Teva recalled eight more lots as a precaution and in May, 2010, Teva informed the FDA it had halted all manufacturing of propofol and wouldn't resume production or distribution of the drug.
Drug shortages can have a profound effect on patient care since they limit the treatment options available to health care practitioners and patients. As well, anesthesiologists face significant potential liability exposure from the risks associated with misusing a product. Anesthesiologists should scrupulously adhere to label instructions for the use of any drug, even during a time of shortage; and, this is especially important for sterile, injectable products such as propofol. The FDA has received numerous reports of adverse events resulting from multiple entries into single-use vials of propofol to obtain multiple doses, contrary to label recommendations. This dangerous practice has resulted in life threatening illnesses due to contamination.
To read more about how the propofol shortage continues to create patient safety concerns and risks for anesthesia providers, download our anesthesia specific risk management newsletter discussing this issue in greater depth.
In order to minimize losses caused by dental injuries, it is recommended the risk of dental injury be discussed with all patients undergoing general anesthesia and this risk be included on anesthesia consent forms. Informed consent is a key factor in managing dental claims. Documentation of the risk of dental injury helps to establish reasonable patient expectations and diminishes the perception of medical negligence.
During the pre-anesthesia evaluation, attention should be directed to the condition of the patient's teeth. Any existing damage should be noted on the record. Patients with existing crowns are particularly susceptible to injuries, which frequently require expensive repairs. Pre-existing dental conditions not only increase the patient's susceptibility to injury, but the higher cost associated with repairing such injuries greatly increases the liklihood the patient will pursue a claim.
In the event a dental injury occurs, the patient should be notified and advised to consult with a dentist. During these discussions, the patient will often ask, "who is going to pay my dental bill?" Unless the anesthesiologist has previously discussed the manner in which dental claims are handled, this is the time to contact your insurance company before assuming responsibility for a patient's dental bill. This provides your insurance company with an opportunity to review and discuss the options for handling such claims.
It is extremely important to avoid an assumption of responsibility. First, dental injuries, especially those involving bridges, may be more expensive than expected. Assuming responsibility in advance may contractually obligate the anesthesiologist to pay damages that did not result from anesthesia care. In a large percentage of dental injuries, the patient had significant pre-existing dental disease or conditions, which caused or contributed to the injury.
To receive our risk management newsletter, which includes three dental injury lawsuits against anesthesiologists, sign up below.
Due to the high prevalence of undiagnosed OSA in the surgical patient population, anesthesiologists should be aware of the clinical presentation. If OSA is diagnosed or suspected, many guidelines and clinical recommendations include:
- Ask patient if a sleep study has been ordered, document if ordered and refused
- Communicate the patient's OSA high risk status to the surgeon and recommend SpO2 with monitoring.
- Document the OSA conversation with the patient and surgeon on the anesthesia record.
- Notify PACU staff about patients with OSA high risk status.
- If formal diagnosis of OSA with CPAP, have patients bring CPAP machine and use postoperatively.
- Consider preoperative testing of arterial blood gases to document the severity of OSA and the baseline PaCO2.
- Airway issues - consider awake intubation, have alternate means to secure airway available, pay attention to positioning ("ramped" position may be indicated)
- Monitor OSA patients a median of 3 hours longer than non-OSA patients and 7 hours after last episode of airway obstruction.
- Educate patients and caregivers about the risks of OSA and the need for caregivers to monitor patients more closely; have caregiver sign discharge instructions.
- If patient is admitted, orders and monitoring must be reviewed; use of CPAP should continue.
