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What Must I Consider to Safely Anesthetize Someone in the Office Setting?
INTRODUCTION
A hospital and a freestanding ambulatory surgery center (ASC) were once considered the only locations in which to perform a safe anesthetic and surgical procedure. Since the latter part of the twentieth century, however, this assumption has been challenged. Private surgical offices have become increasingly viable anesthetizing surgical and procedural locations. This has been made possible, in part, by the introduction of “shorter-acting” anesthetics with fewer hemodynamic side effects , and the development of minimally invasive surgical techniques. The American Society of Plastic Surgeons (ASPS) estimated that, in 2004, 9.2 million cosmetic procedures were performed in plastic surgeons’ private offices. By 2005, the American Hospital Association reported that 82% of all procedures were performed on an ambulatory basis, and of these, 16% were performed in a private office. This number continues to grow each year.
Office-based procedures offer many advantages over traditional procedures at hospitals or freestanding ASCs. These advantages include cost containment, patient privacy, ease of scheduling, and decreased risk for nosocomial infection. , This improvement in surgical convenience is not without its potential costs, however. The lay press has reported that an office-based surgical procedure may not be as safe as the same procedure performed in a traditional hospital or ASC. After analyzing data from Florida office-based surgeries, Vila and colleagues reported as much as a 10% increase in morbidity and mortality rates associated with surgery in an office compared with a hospital or ASC. Nevertheless, contradictory data do exist. An article by Hoefflin and colleagues found no complications after 23,000 procedures conducted in an office under general anesthesia (GA). Fletcher and colleagues retrospectively reviewed the outcomes of an office performing more than 5000 surgical procedures by five independent surgeons, in which no deaths occurred over the 5-year period. A retrospective study of adverse outcomes in 3615 consecutive patients undergoing 4778 procedures in offices between 1995 and 2000, using monitored anesthesia care, reported no deaths. Determining the true safety record of procedures performed in an office is difficult because of the relative lack of data. Currently, the incidence of morbidity and mortality from an anesthetic are approximately 1 in 400,000. Thus, to illustrate whether an office-based anesthetic is equivalent, a large sample size would be required ( Tables 58.1 and 58.2 ). These tables illustrate the concept that if the risk of a complication is very small (1/100,000), very large sample sizes are required to give a true estimation of the risk. Thus, for example, if 50,000 procedures were done safely, one could inaccurately determine the risk to be zero.
TABLE 58.1
Likelihood of Detecting a Complication When the Risk Is 1 per 10,000
| Risk | Risk of “Failure” | Sample Size | Likelihood of “Failure” a | Risk of Complication Occurring | ||
|---|---|---|---|---|---|---|
| 1 : 10,000 | 0.9999 | 10 | 99.9% | 0.1% | ||
| 1 : 10,000 | 0.9999 | 100 | 99.0% | 1.0% | ||
| 1 : 10,000 | 0.9999 | 1000 | 90.5% | 9.5% | ||
| 1 : 10,000 | 0.9999 | 10,000 | 36.8% | 63.2% | ||
| 1 : 10,000 | 0.9999 | 100,000 | 0.0% | 100.0% |
TABLE 58.2
Likelihood of Detecting a Complication When the Risk is 1 Per 100,000
| Risk | Risk of “Failure” | Sample Size | Likelihood of “Failure”* a | Risk of Complication Occurring | ||
|---|---|---|---|---|---|---|
| 1 : 100,000 | 0.99999 | 10 | 100.0% | 0.0% | ||
| 1 : 100,000 | 0.99999 | 100 | 99.9% | 0.1% | ||
| 1 : 100,000 | 0.99999 | 1000 | 99.0% | 1.0% | ||
| 1 : 100,000 | 0.99999 | 10,000 | 90.5% | 9.5% | ||
| 1 : 100,000 | 0.99999 | 100,000 | 36.8% | 63.2% |
Safety in any office-based setting is contingent on a number of factors, all of which must be ensured before an anesthetic procedure is undertaken. Metzner and colleagues reported on the safety concerns for anesthesia performed outside the traditional hospital operating room. They observed that 50% of all lawsuits involving a nonoperating room location resulted from the use of monitored anesthesia care. They also reported that adverse outcomes from respiratory events were more common in this remote location compared with a traditional operating room, and better monitoring could have prevented these injuries (approximately 32%). Finally, the proportion of claims for death was 54% as opposed to 29% in the hospital operating room.
COMPONENTS OF OFFICE SAFETY
Physical Considerations
The physical design of the office (i.e., ensuring adequate space for all operating room functions; consideration for anesthesia equipment, particularly the availability and placement of oxygen lines and venting opportunities; and emergency egress for an anesthetized patient), perioperative monitoring capabilities, office staffing, governance, policies and procedures (including emergency admission planning, fire safety, and infection control), and accreditation status are important components of office safety. Presently, there are several nationally recognized agencies that can accredit an office-based surgical site. These agencies include The Joint Commission (TJC), the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), and the Accreditation Association for Ambulatory Health Care (AAAHC). Most states that regulate office-based surgery and anesthesia require that every office be accredited by one of these bodies or that the office be Medicare-certified under Title XVIII. Additionally, the ASPS has required that all its members operate exclusively in accredited offices or forfeit their societal membership since 1996. It must be noted, however, that accreditation is on a cycle of between 6 months and 3 years, and between site visits, it is imperative that practitioners be constantly vigilant in maintaining a safe anesthetizing location.
Physician Qualifications
The physician performing the office-based procedure should be certified by one of the boards recognized by the American Board of Medical Specialties or the American Osteopathic Association. It is also recommended that the surgeon or proceduralist have privileges to perform the proposed procedure at a local hospital. They should also have admitting privileges in a nearby hospital for an unplanned emergency admission.
For both the anesthesiologist and proceduralist, active license, registration, and Drug Enforcement Administration (DEA) certificate, as well as adequate malpractice coverage, must be maintained and continuing medical education (CME) credit earned. Peer review and performance improvement must occur.
Patient and Procedure Selection
A determination of the procedures to be performed and the appropriateness of individual patients to undergo that procedure in this venue must be clearly defined. Patients with significant comorbidities are not ideal candidates and should be excluded from this type of surgical environment. Specifically, only American Society of Anesthesiologists (ASA) physical status (PS) 1 and 2 patients should undergo GA, although occasionally an ASA 3 patient may be acceptable.
A patient with an anticipated difficult airway may cause a problem for the office-based practitioner. One of the earliest steps in the difficult airway algorithm endorsed by the ASA is to call for help. In the office-based setting, there will likely be no other experienced individuals present. It is therefore intuitive that patients with anticipated difficult airways not be anesthetized in this venue. It would, however, be difficult to design a randomized prospective study to evaluate this issue.
Certain procedures are not suitable to be performed in an office. Procedures that create significant physiologic derangements, including significant pain or large fluid shifts, are better suited for a hospital or ASC. Determining whether a particular procedure is appropriate involves consideration of the patient’s comorbidities. For example, an obese, asthmatic ASA PS 3 patient may safely undergo a cataract extraction in an office with local anesthesia, whereas this patient may not be suitable for a rhytidectomy under GA.
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