Decrease liability risks of sedation in your ED

Inappropriate requirements can harm patients

Increasingly, the anesthesia department is directing guidelines and training requirements for procedural sedation in hospitals, including the ED. Is this practice going to increase your liability risks?

Anesthesia should have no more role in directing guidelines for procedural sedation in the ED than emergency physicians have in directing guidelines for the operating room, says James R. Miner, MD, FACEP, associate professor of emergency medicine at University of Minnesota Medical School in Minnetrista and faculty physician in the ED at Hennepin County Medical Center in Minneapolis.

"Procedural sedation in the ED requires a trained emergency physician to be performed adequately," says Miner. "It is much different than sedation in other specialties due to the unpredictable nature of the flow of care in the ED, the wide variation in the medical stability of ED patients, and the unpredictable NPO status of our patients."

Some anesthesia departments allow EDs to perform their own quality assurance and develop their own standards for procedural sedation, while others insist that sedation must be under the control of anesthesia, no matter where it occurs.

At Mount Sinai Medical Center in New York City, anesthesia requires that all physicians performing procedural sedation be certified and recertified in Advanced Cardiac Life Support (ACLS), including ED physicians, reports Sheldon Jacobson, MD, professor and chair of the department of emergency medicine. Also required is a training program in the use of agents and monitoring of patients before and after procedures. If ED physicians use a new drug for sedation, training is required and proof of attendance must be sent to anesthesia.

"We have found it much better politically to just go along with anesthesia's requirements," says Jacobson. "The medical board was persuaded that it is the safest thing to do. For me to say it's unnecessary — that doesn't seem to be a victory I can achieve."

Jacobson was also worried about liability exposure if the ED had overturned the policy successfully and a bad outcome occurred. "If we had fought with them and won, and then had complications, we would have really been at a very big disadvantage because we said we were able to do it without their interference and then had a disaster on their hands," he says. "Sometimes you have to know when to grin and bear it."

Procedural sedation is "probably used less frequently" in the ED as a result of anesthesia's requirements, acknowledges Jacobson. "All these hoops that we have to jump through have made us use procedural sedation less," he says. "We may use an analgesic agent instead of a sedating agent, which is safer, but not the optimal way of doing it."

Poor guidelines hinder ED care

In order to safely perform ED procedural sedation, a physician must be able to balance the risks and benefits of the situation, says Miner. This requires a detailed understanding of the patient's medical condition, the urgency of the need for sedation, and the risk of adverse events.

"Only emergency physicians are adequately trained in the care of patients in the dynamic environment of the ED to make this decision and perform the procedure appropriately," says Miner. "Furthermore, in the setting of adverse events, emergency physicians are the most appropriate physicians to provide airway management and resuscitation to the patient."

When physicians who are not trained or experienced in the care of patients in the ED attempt to make guidelines to direct the care given there, they are unlikely to be helpful, and can hinder the ED physician's ability to provide the care they are trained to give, says Miner.

In some cases, guidelines may prevent ED physicians from using the most appropriate agent for a given situation. "I have been contacted by numerous emergency physicians who are limited to using agents such as midazolam and fentanyl for procedural sedation, even for sedations that are brief or require deep sedation, despite that fact that research has clearly shown these agents to be inferior to agents such as propofol," he says. "It has been my experience that the people making these limits have little experience in the scope and requirements of ED procedural sedation."

Another example is absolute requirements concerning NPO status, which are not appropriate for the ED, says Miner. ED physicians are experts in airway management for patients with variable NPO status, and are better suited and trained to make decisions balancing a patient's need for sedation with their risk of aspiration, he explains.

"An external requirement for NPO status designed for non-emergent patients can result in patients having unnecessary procedural delays, or not receiving sedation when they would have benefited from it," says Miner.

It's inappropriate for anesthesia to require ED physicians to attend ACLS courses to perform procedural sedation, says Miner. "This cannot be compared to the training a board certified emergency physician has received in the care and resuscitation of critically ill patients and the titration of sedative agents," he says.

Miner adds that he has seen credentialing requirements for procedural sedation consisting of a written test with material not relevant to emergency medicine.

"Tests are unlikely to have questions on it that have bearing on ED procedural sedation, unless a board certified emergency physician wrote the questions," he says. "The training requirement to perform procedural sedation on patients in the ED should be board certification in emergency medicine, and nothing else."

Hennepin County's procedure is that board certified emergency physicians, including the residents they train, are deemed qualified to provide procedural sedation. "I do not think non-emergency physicians are qualified to develop training requirements for emergency physicians," says Miner.

Make sure your ED is heard

If guidelines are set up by providers who do not routinely provide sedation in the ED and are not trained in emergency medicine, they are unlikely to be adequate or appropriate, says Miner. "Therefore, they will not improve patient safety or the outcomes of procedural sedation," he says. "It is very important to be involved in sedation guideline development, and to ensure it is designed with the proper practice of emergency medicine in mind."

If inappropriate guidelines or training are being required for your ED, there is plenty of research you can refer to, advises Miner. "There is a great deal of literature on the subject of procedural sedation in the ED," he says. "If guidelines are not following these recommendations, this can be referred to in arguments concerning the hospital's guidelines."

If the anesthesia department creates complicated or unrealistic requirements for your ED, approach the issue with a "multi-pronged effort," says John Burton, MD, residency program director of the department of emergency medicine at Albany (NY) Medical Center. He recommends citing evidence from the medical literature — both anesthesiology and emergency medicine — and specialty recommendations with evidence-based positions published in peer-reviewed literature.

Requirements for ED procedural sedation are "well described" in the medical literature, says Burton. He points to recommendations from the American College of Emergency Physicians, the American Academy of Pediatrics, and the American Society of Anesthesiologists. "Ensure that your ED's policies and procedures are consistent with the views of these groups, particularly those positions that are consistent throughout the literature," says Burton.

When debating about procedural sedation requirements, patient safety should remain a primary focus, says Burton. "Do not allow the turf interests that so commonly fuel these issues to dictate emergency medicine practice," he says.

If you feel that guidelines or criteria are inappropriate or inadvisable for your ED, make sure that a representative from the ED has the opportunity to be heard on the issue before the medical executive committee, says Vicki L. Searcy, CPMSM, practice director for credentialing and privileging at The Greeley Company, based in Marblehead, MA.

"It is in the best interests of an organization to make sure that there is thorough discussion while criteria and guidelines are being established, and that the final product is one that all practitioners who provide procedural sedation can and will follow," says Searcy.

There are two major liability risks associated with training requirements for procedural sedation: Failing to adhere to your organization's criteria, or having criteria inconsistent with accepted medical practice, says Searcy. Research the literature to be sure your criteria for which practitioners are eligible to be granted privileges for procedural sedation are defensible, she advises.

If specific training or monitoring of the amount of the practitioner's clinical activity in this area is required, your ED must have a system in place to collect this information. "Do this to avoid the situation of having an untoward occurrence and then finding out that the practitioner didn't meet the criteria to perform the privilege," says Searcy.

What are the biggest risks?

One major liability risk with procedural sedation involves failing to have proper preparation, with oxygen, suction, oral airway devices, and other supportive equipment readily available for rescue intervention in the case of prolonged apnea or laryngospasm, says Burton.

"Caregivers overseeing procedural sedation should be individuals who have had adequate rescue airway training for complications such as apnea, larnyngospasm, and hypoxemia," he adds.

Another liability risk is failing to dedicate one-on-one nursing care for patient monitoring from the inception of an altered level of consciousness to the return of a pre-sedation level of consciousness.

"While much attention is given to the current debate as to whether there should be two physicians in addition to the dedicated nurse, the cases I've seen in liability review have not focused on this question, but rather on the provision of one-on-one care throughout the period of impaired consciousness by any caregiver," says Burton.

The bottom line is that if a patient's level of consciousness is expected to be taken into levels of moderate or deep sedation during ED procedural sedation, there should be dedicated one-on-one monitoring until the patient returns to a pre-procedural level of alertness, says Burton.

The known risks of procedural sedation include aspiration pneumonia, hypotension, hypoxia, and emergence phenomenae, says Miner. "But they are so rare that the rates are not clear, and surrogate markers tend to be used in research," he says. Miner says he is not aware of any data showing that specific training requirements make any difference in outcomes.

In addition, complications in different settings are difficult to compare. For example, the sedation of trauma patients with displaced fractures for reduction is going to have a different complication rate than patients undergoing elective endoscopy in a gastrointestinal laboratory. "This makes the comparison of rates based on different training requirements difficult to do," says Miner.

Research on specific monitoring modalities continues to build, with a current area of debate involving the routine use of capnography during ED procedural sedation encounters, says Burton. However, the current science on rescue interventions and the training of caregivers for deep procedural sedation levels is "very clear and solid," he says. "We know what the risks of procedural sedation are in the ED setting, and the training and skills to address these risks is clear as well," he says.

Sources

For more information, contact:

  • John Burton, MD, Residency Program Director, Department of Emergency Medicine, Albany Medical Center, 47 New Scotland Avenue, MC 139, Albany, NY 12208. Phone: (518) 262-4050. E-mail: burtonj@mail.amc.edu
  • Sheldon Jacobson, MD, Professor and Chair, Department of Emergency Medicine, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1620, New York, NY 10029. Phone: (212) 659-1660. E-mail: sheldon.jacobson@mssm.edu
  • James R Miner, MD, FACEP, Associate Professor of Emergency Medicine, University of Minnesota Medical School, 1635 Sunnybrook Circle, Minnetrista, MN 55364. Phone: (612) 347-8791. E-mail: miner015@umn.edu
  • Vicki L. Searcy, CPMSM, Practice Director, Credentialing & Privileging, The Greeley Company, P.O. Box 1168, 200 Hoods Lane, Marblehead, MA 01945. Phone: (951) 506-9845. Fax: (951) 848-0720. E-mail: vsearcy@greeley.com