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Office-Based Sedation: Don’t Sleep on the Regulations
Office-based procedures that require sedation come with their own set of considerations and potential problems. States currently vary from high sedation regulation to almost no sedation regulation at all when it comes to office-based procedures. With elective procedures being performed more frequently outside of hospitals and accredited ambulatory surgery centers, it is important to know where your state falls on the spectrum of office-based sedation regulation.
Level It Out: Different Levels of Sedation
Texas is at the forefront when it comes to office-based anesthesia regulation. In Texas, all three types of sedation, minimal, moderate, and deep, trigger regulation. It is important to recognize the level of sedation being administered, so the appropriate regulations and guidelines are followed. Minimal sedation is typically delivered by mouth at a dose level low enough to allow the patient to remain ambulatory. Moderate sedation is on just a slightly higher level and is administered either orally or intravenous at a dose level higher than minimal sedation, but still keeping the patient at a conscious state. Lastly, deep sedation includes dangerous drugs administered topically or by injection, which interrupt nerve conduction, temporarily creating a loss of sensation to an affected area and that generate the effect of general anesthesia, regional anesthesia, or monitored anesthesia care.
Spectrum of Office-Based Sedation: High, Middle, Low?
While the use of minimal, moderate, and deep sedation are all regulated in Texas, which puts it on the highest end of the regulation spectrum, New York sits somewhere in the middle by only regulating the use of moderate and deep sedation in office-based procedures. And, while still not on the lowest end of the spectrum, California positions itself low with triggering regulation only for deep sedation.
Texas Administration Code § 192.2, conveniently divides the use of minimal, moderate, and deep sedation into four different levels: Level I, Level II, Level III, and Level IV. The importance of differentiating between the levels is the amount of sedation being used. The higher the sedation, the higher risk to the patient, and therefore, higher the qualified personnel, higher the list of required equipment, and higher the amount of patient monitoring.
During all procedures, at least two personnel will be required, and the higher you go in the levels, the more qualifications needed. Under Levels I, II, III, the required personnel may be either a physician, CRNA, or RN. This is specific to Texas, so it is important to verify in your state who can/cannot administer sedation. But all persons must be American Heart Association (AHA) or American Safety and Health Institute (ASHI) certified in Basic Life Support (BLS), and if you move up to Level II and Level III, one of the personnel must also be certified in Advanced Cardiovascular Life Support (ACLS) or Pediatric Advanced Life Support (PALS).
Patient safety is always of upmost importance, therefore, the higher the sedation level, the more patient monitoring is required. Level I does not require a specific person to conduct patient monitoring, but Levels II requires patient monitoring until the patient is discharged, and Level III requires that one of the two personnel must monitor the patient throughout the entire procedure. The Texas Administration Code has established guidelines for patient monitoring and specific equipment under § 192.2(g).
Level IV includes deep sedation and follows a completely different set of standards than the levels discussed above. This Level requires the qualified personnel to follow the standards and guidelines established by the American Society of Anesthesiologists (ASA) and listed with the Texas Administrative Code.
Middle: New York
New York can be found in the middle by regulating moderate and deep sedation. Under N.Y. Public Health Law §230-d, there are several helpful definitions for deep, moderate, and minimal sedation, as well as general anesthesia. The N.Y. Law defines “Office-Based Surgery” to also includes invasive procedures, but only those procedures that require general anesthesia, moderate, or deep sedation. The remainder of the Law states that these facilities must be accredited to perform procedures that require general anesthesia, deep, or moderate sedation. Minimal sedation is specifically excluded from regulation. The result of this exclusion is that facilities performing procedures with minimal sedation do not have to adhere to these accreditation standards, and are only left with general guidelines.
In California, only deep sedation triggers regulation, which can be found under California Health & Safety Code § 1248 and California Business & Professions Code § 2216. However, even though California has mandated regulation for at least some level of sedation in an outpatient setting, there is very little guidance. Under the Code, the standard at which the sedation is to be administered only has to meet the requirement to be “in compliance with the community standard of practice.” This leaves persons administering sedation in California to their own devices. A low regulated state could leave a facility unequipped and unprepared.
Self-Check: Is Your State Triggered By Regulation?
Shockingly, there are states that fall on the complete other end and have no regulations at all, such as Alaska, Colorado, Georgia, Hawaii, Idaho, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, North Dakota, Oklahoma, South Dakota, Utah, West Virginia, Wisconsin, Wyoming. But at least the state medical boards in Alaska, Colorado, Georgia, Kentucky, Maryland, Massachusetts, North Carolina, and Oklahoma have issued guidelines, policy, or position statements for office-based procedures.
It is easy to see why regulation for all levels of sedation is not only helpful in guiding practitioners, but it also helps to mitigate serious problems that could arise in an office-based setting. Before conducting any office-based procedures, make sure what levels of sedation, if any, trigger regulation in your state. For more information on office-based sedation, reach out to us at email@example.com.
We are grateful for the significant research and drafting contribution to this article from our law clerk Brooklyn Townsend. Brooklyn has graduated from SMU law school and will be joining the ByrdAdatto family fall of 2021.