OBA Questions, Problems Just Now Recognized, Being Defined
by Robert C. Morell, MD
As we move into the 21st century, anesthesiologists and nurse anesthetists will increase their participation in and experience with office-based anesthesia (OBA). To insure patient safety in the setting of office-based anesthesia is a complex task. To even define the issues that can impact patient safety is difficult. Many questions are raised: What constitutes our concept of office-based anesthesia? Is it restricted to general anesthesia with TIVA or potent agents or regional anesthesia or does it include conscious sedation or the infiltration of local anesthetics? Do the qualifications of the individuals administering those varied forms of anesthesia influence our concept of office-based anesthesia? Similarly, how much should we be concerned with patient safety in the setting of office-based dental anesthesia? Many of these issues may eventually become the subjects of legislation and regulation. Attempts to do so have occurred in several states including New Jersey, California, Texas, and Florida. Successful legislation requires the establishment and enforcement of regulations by authorities such as state medical boards to be effective. Certainly the recent report by the Institute of Medicine1 has brought national legislative and executive attention to issues of medical errors and patient safety. Right now is a golden opportunity for the specialty of anesthesiology and groups such as the ASA and the APSF to take a leadership role in examining these issues and helping development of appropriate guidelines, recommendations and, where applicable, standards of practice.
As much as some surgeons may talk about patient convenience regarding access and surgeon convenience regarding scheduling, the real driving force behind the increase in office-based anesthesia is largely economic. Office-based anesthesia represents a potential for cost-effective approaches for many surgical procedures. Cost comparisons have demonstrated significant savings for office-based surgical procedures compared to those procedures performed in the hospital. For example, Schultz has reported that the cost of an inguinal hernia repair done in the office setting was $895 compared to $2,237 for the same procedure performed in the hospital.2,3 Lower office overhead may also help to maintain profit margins, the forces largely responsible for the growth in office-based anesthesia. In fact, current estimates anticipate that between 20% and 25% of all surgical procedures performed in the year 2001 will be in office-based settings.2,4
Incidence of Adverse Events
The increases in office surgery and anesthesia will likely be accompanied by increasing reports of adverse events and disasters. The reports that have appeared do not allow calculation of the incidence of adverse events, since the reporting of morbidity and mortality following office-based procedures is not mandatory. Clusters do occasionally surface, such as the 1999 report by Rao of five deaths occurring in New York between 1993 and 1998 associated with the technique of tumescent liposuction.5 During tumescent liposuction, large volumes of dilute lidocaine and epinephrine containing solutions are infiltrated subcutaneously. This solution acts as a hypotonic "wetting" agent that lyses cell walls and emulsifies the fat. The lidocaine is intended to provide local anesthesia and is generally diluted to .05% - .1%. The epinephrine is prepared as 1mg/ml (1:1,000,000) and provides vasoconstriction. Despite the dilute nature of these solutions, the large volumes can lead to total lidocaine dosages that exceed 65mg/kg. and total epinephrine dosages that reach several milligrams.6,7 Assumptions have been made regarding the safety of this technique based on slow absorption with peak serum levels delayed some 12-14 hours after injection. The five deaths occurring in New York including three deaths with precipitous hypotension and bradycardia despite documented oxygen saturation levels of 97%-100% at that time. This scenario is similar to that seen in animal studies with intravascular infusion of toxic dosages of local anesthetics. Other complications are also known to occur with tumescent liposuction including pulmonary emboli, pulmonary edema, necrotizing fasciitis, congestive heart failure, fat emboli and organ perforation. A survey of 1,200 plastic surgeons revealed 95 deaths in nearly 500,000 liposuction procedures; yielding a mortality rate of approximately 1:5000.8 Despite a general lack of requirements for the reporting of office-based morbidity and mortality (with the rare exception, such as New Jersey), reports do make their way into the public domain. Since 1986, at least 41 deaths and over 1,200 injuries have occurred following cosmetic surgery in Florida. Closed malpractice claims in Florida have also identified 830 deaths and approximately 4000 injuries associated with office-based medical care occurring between 1990 and 1999. These office cases represent about 30% of the closed malpractice claims occurring in that state.
The Closed Claims Project of the American Society of Anesthesiologists has acquired seven claims related to office-based surgical anesthesia, excluding pain clinic claims [personal communication from Karen Posner, ASA Closed Claims Project]. The entire closed claims database contains 4459 standardized reviews to date. Five of these seven OBA claims stemmed from incidents occurring between 1980-1989, the remaining two claims occurred in 1990. Five of the office-based claims involved death of a patient. The other two involved an eye injury and an ICU admission following a difficult intubation (with full recovery). All seven of the OBA claims received financial compensation, with payments between $50,000 and $850,000 with a median payment of $600,000. The mean patient age was 44, with an age range of 21-68. These patients were previously in good general health. The procedures involved were three dental extractions, three cosmetic surgical procedures, and one laser eye treatment. Care was judged to have been substandard in four of the five deaths (80%) compared with 39% of hospital based claims. The substandard care issues included esophageal intubation, malignant hyperthermia, and drug administration error and airway obstruction. In one of the dental extraction cases, the patient died following bronchospasm, but the care was judged appropriate. There is generally a five-year lag time between the occurrence of an adverse event and the subsequent claim resolution and entry into the Closed Claims Database. Therefore, the adverse events that are associated with the recent increase in office-based surgery will not enter the database for several years.
Who are the Practitioners?
In 1997, non-plastic surgeons performed 50% of 250,000 liposuction procedures. These individuals included dermatologists, primary care physicians, emergency physicians, and, in some cases, unlicensed individuals representing themselves as licensed physicians. Two Florida ophthalmologists and one anesthesiologist have placed advertisements offering breast augmentation surgery. Several dentists have also been identified as performing hair transplants as well as liposuction. Many of these practitioners have only had weekend courses in cosmetic surgical techniques. Some have referred to themselves as "board certified" after taking a 5-day course. In 1990, Oklahomaís Board of Medical Licensure wisely refused to allow a cosmetic surgeon to refer to himself as "board certified" after brief training by the American Society of Cosmetic Breast Surgery. This was a decision that was upheld by the Oklahoma State Supreme Court in 1993.9 In Houston, Texas police arrested an unlicensed Carlos Chaves for illegally practicing medicine and performing liposuction and cosmetic surgical procedures at a beauty salon located within a shopping mall. He was actually licensed as a cosmetologist. One "surgeon" used kitchen utensils, purchased at a hardware store as his "surgical instruments."
Who are the Victims?
We can have an impact on this situation through education. We can educate ourselves as to known pitfalls and dangerous scenarios, we can educate other physicians through the literature and outreach programs sponsored by our societies, we can educate legislators on areas that are appropriate for regulation, and most importantly, we can educate the public. Patients should be aware of the choices that they have and the questions to ask before undergoing elective office-based anesthesia and surgery. They must become educated consumers and, thus, be protected from those who are selling beauty and convenience at what may well be a very high price.
Dr. Morell is Director, Preoperative Assessment Clinic and Associate Professor of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC.