Anesthesia for Office-Based Surgery: Are We Paying Too High a Price for Access and Convenience?

Abstract

In his 1988 book, Doctors: The Biography of Medicine,1Nuland SB Doctors: The Biography of Mediane. Alfred A Knopf, New York, NY1988: 263-303Google Scholar The historian and surgeon Sherwin B. Nuland teaches that advances in medicine in the past 2500 years have come not from a continuum of progress, but instead from quantum leaps in knowledge and practice. One of these quantum leaps is attributed to the introduction of surgical anesthesia (ie, the ability to provide surgery without pain). This advancement, which began with Crawford Long's use of diethyl ether anesthesia in 1842, is described by Nuland as America's “greatest gift to the art of healing.”1Nuland SB Doctors: The Biography of Mediane. Alfred A Knopf, New York, NY1988: 263-303Google Scholar In the 158-yearhistory of surgical anesthesia, The focus of care has shifted from simply rendering the patient senseless during surgical intervention to providing anesthesia safely. In this regard, progress made in the last decade of the 20th century has been awe-inspiring. According to figures collected by the American Society of Anesthesiologists (ASA), in that decade, estimates for the number of deaths attributed to anesthesia have dropped 25-fold, from 1 in 10,000 anesthetics to 1 in 250,000 anesthetics today.2American Society of Anesthesiologists.website available at: http://www.asiihn.org/Google Scholar If there is debate regarding quantified risk for patients cared for in hospitals and ambulatory surgical centers, it is in some measure because the low death rates complicate accurate calculation. This progress has occurred even though a broader range of anesthesia services is provided for increasingly sicker patients, further, among those experiencing adverse effects from anesthesia, morbidity and mortality are intimately linked to the patients’ primary pathology and physiology prior to receiving the anesthetic.3Silber JH Williams SV Krakauer H Schwartz JS Hospital and patient characteristics associated with death after surgery: a study of adverse occurrence and failure to rescue.Med Care. 1992; 30: 615-629Crossref PubMed Scopus (635) Google Scholar, 4Warner MA Shields SE Chute CG Major morbidity and mortality within 1 month of ambulatory surgery and anesthesia.JAMA. 1993; 270: 1437-1441Crossref PubMed Scopus (345) Google Scholar The opposite side of this relationship is that healthy patients now experience previously unimaginably low risks for death from anesthesia. The basis of this advancement for all patients at all ages has resulted from a host of factors. Surgical anesthesia is more and more likely to be provided by highly trained anesthesia providers, and these providers contribute to good outcomes.3Silber JH Williams SV Krakauer H Schwartz JS Hospital and patient characteristics associated with death after surgery: a study of adverse occurrence and failure to rescue.Med Care. 1992; 30: 615-629Crossref PubMed Scopus (635) Google Scholar These individuals typically practice in hospitals or ambulatory surgery centers that are closely scrutinized by accrediting agencies. They have access to safe and powerful drugs, and their practice benefits from highly sophisticated equipment. Modern anesthesiologists, certified registered nurse anesthetists (CRNAs), and anesthesiologist assistants (AAs; ie, graduate physician assistants who have satisfactorily completed an AA training program5American Society of Anesthesiologists 2000 Directory of Members. American Society of Anesthesiologists, Park Ridae, III2000: 480-510Google Scholar), whether in academic or private practice, daily address the risks of anesthesia and intervene to improve practice. Risk reduction is also a focal issue for national organizations such as the 35,000-member ASA, the 28,000-member American Association of Nurse Anesthetists, and the Anesthesia Patient Safety foundation. When these and others scan the horizon in 2000 and ask what is the biggest risk factor that needs to be addressed by anesthesia providers, the answer is invariably “office-based anesthesia.” In contrast to the celebration of reduced risk for anesthesia in the hospital-based practice, there has been an outcry to address unreasonable risk in the office-based setting. The problem is that inattention to proper standards in many (but certainly not all) office-based surgery practices has returned death rates for healthy office-based patients today to the death rates for sick hospitalized patients decades ago. Out of concern for this issue, New Jersey, Florida, and Texas have recently passed legislation in an attempt to lessen the risks. The hue and cry are so loud because patients receiving anesthesia for relatively minor surgery in the office-based setting are generally very healthy. Thus, they should carry a very low risk for anesthesia-related death. When such a patient dies undergoing a minor procedure (or a procedure perceived as minor), the family understandably becomes upset. An editorial in the St Petersburg Times quoted the national rate for anesthesia-related deaths in outpatient surgery (ie, surgery in which the patient arrives at a hospital or ambulatory surgery center, is treated, and is discharged on the same day) at 1 in 400,000.6Toughen in-office surgery rules [editorial] St Petersburg Times. October 8, 1999; Google Scholar The same editorial cites the death rate for office-based surgery in Florida at 1 in 8500.6Toughen in-office surgery rules [editorial] St Petersburg Times. October 8, 1999; Google Scholar Aside from newspaper reports such as this, it is difficult to get an accurate assessment of the extent of the problem, simply because there is no requirement for physicians to report results obtained in the office setting. Further, there is concern that physicians and offices experiencing the most complications (from anesthesia, surgery, or the combination of the two) may practice in an environment that is overlooked by surveys and other accounting mechanisms. Thus, practice problems may persist, remote from the typical checks and balances found in a typical hospital-based practice. Many offices in which surgery and anesthesia are performed arc not accredited by the Joint Commission for Accreditation of Healthcare Organizations (JCAHO), the American Association for Ambulatory Health Care, or the American Association for Accreditation of Ambulatory Surgical facilities. In an attempt to save money, these practices may purchase antiquated equipment, and the equipment may not meet the ASA basic standards for intraoperative monitoring.2American Society of Anesthesiologists.website available at: http://www.asiihn.org/Google Scholar, 5American Society of Anesthesiologists 2000 Directory of Members. American Society of Anesthesiologists, Park Ridae, III2000: 480-510Google Scholar Cases may be done without an oxygen analyzer (which measures the amount of oxygen in the anesthesia circuit), pulse oxmeter (which measures the amount of oxygen contained within the patient's blood), capnograph (which measures carbon dioxide in the patient's expired ventilation and as such assures that ventilation is taking place), or disconnect alarm (which determines that the anesthesia circuit-patient unit is intact). When a cardiac arrest occurs, there are no assurances that the anesthesiologist, CRNA, AA, or surgeon is well-versed in current resuscitation techniques, as evidenced by recent, successful completion of the American Heart Association's programs for Basic Cardiac Life Support (BCLS)7American Heart Association Basic Life Support for Healthcare Providers. American Heart Association, Dallas, Tex1997Google Scholar or Advanced Cardiac Life Support (ACLS).8American Heart Association Advanced Cardiac Life Support. American Heart Association, Dallas, Tex1997Google Scholar Since cardiac arrests are unusual with modern-day anesthesia, office-based anesthesia providers (including those who have not maintained their life support training) may be unable to respond appropriately to such a rare emergency, failure to provide routine preventive maintenance for surgical equipment, anesthesia machines, monitors, and defibrillators (ie, factors regularly provided by specially trained individuals in the hospital setting, as required by the JCAHO) may also contribute to bad outcomes. There may be an inadequate pharmacy to treat unexpected complications (eg, unusual cardiac arrhythmias, severe bronchospasm). The absence of rapid availability of intensive care unit support for the patient having a major complication, as well as inadequate emergency transportation plans to get patients from the office-based surgery environment to an emergency health care facility, may likewise contribute to morbidity or mortality. During office-based surgery, patients may not be monitored at all or they may be inadequately monitored. Of additional concern, the task of intraoperative monitoring may be assigned to clerical staff who also provide care during postanesthetic recovery. If a bad outcome results from this practice, no process is in place to assure an appropriate review. Inadequate evaluation of patients prior to anesthesia may also contribute to bad outcomes. Thus, the patient may never have an anesthesia-appropriate history, physical examination, or laboratory evaluation. Given these limitations, sudden, seemingly minor intra-anesthetic or post-anesthetic disturbances of physiology may result in tragic complications. Why is surgery being done in offices rather than in hospitals or ambulatory surgery centers?. A major reason is to avoid the facility fee. Much of office-based surgery is “an uncovered service,” and patients have a difficult time paying “full price.” frequently a package price is offered, and the patient has to arrange a payment schedule to a single entity. Convenience to the patient and surgeon also comes into play, but at what price? A physician or a dentist who may not meet the criteria to be credentialed for a procedure by a hospital or ambulatory surgical center to provide a specific surgical procedure may still perform that procedure in an office-based practice, without having to go through a credentialing process. A certificate on the wall may have been purchased or obtained after a brief-duration course that failed to provide adequate education and training. According to Rod Rohrich, a plastic surgeon in Dallas recently quoted in USA Today,9Cosmetic surgery that could kill you: “seductive simplicity” hides liposuclion risks.USA Today. January 18, 2000; PubMed Google Scholar “A doctor can attend a seminar at a hotel and learn how to perform liposuction within a few hours.” lie added, “Patients should assume nothing. Anyone can do liposuction. Even dentists have been doing it.” The cavalier attitude for providing liposuction (a procedure commonly performed in the office setting) in the out-of-hospital environment, sometimes at the hands of undertrained individuals, is undoubtedly influenced by an assumption that the procedure carries a low risk for complications. However, this assumption is not correct. As recently reported by Glazer and de Jong10Grazer FM de Jong RH Fatal outcomes from liposuction: census survey of cosmetic surgeons.Plast Reconstr Surg. 2000; 105: 436-444Crossref PubMed Scopus (310) Google Scholar in the journal Plastic and Reconstructive Surgery, the risk of death from liposuction is high, regardless of the practice setting or the skills of the surgeon. At the annual meeting of the ASA in October 1999, the ASA House of Delegates adopted “Guidelines for Office Based Anesthesia” and a related “Statement on Qualifications of Anesthesia Providers in the Office-Based Setting.”–5American Society of Anesthesiologists 2000 Directory of Members. American Society of Anesthesiologists, Park Ridae, III2000: 480-510Google Scholar ‘ITiese guidelines are common-sense recommendations stating that the standards currently used by anesthesiologists in hospitals apply to office-based anesthesia as well. One major statement is,-1Nuland SB Doctors: The Biography of Mediane. Alfred A Knopf, New York, NY1988: 263-303Google Scholar “In any location in which anesthesia is administered, there should be appropriate anesthesia apparatus and equipment which allows monitoring consistent with ASA ‘Standards for Basic Anesthetic Monitoring’ and documentation of regular preventive maintenance as recommended by the manufacturer.” Another safety hazard in the office-based setting is the inappropriate use of drugs to provide “conscious sedation” tie, a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, maintain the airway, and sustain adequate spontaneous ventilation-6Toughen in-office surgery rules [editorial] St Petersburg Times. October 8, 1999; Google Scholar) to patients without the benefit of a qualified individual to monitor the patient. In some patients undergoing tumcscenl liposuction, gross overdoses of local anesthetics have caused major complications.11de Jong RH Grazer FM “Tumescent” liposuction alert: deaths from lidocaine eardioloxieity.Am J Forensic Med. Pathol. 1999; 20: 101Crossref PubMed Scopus (28) Google Scholar Prolonged surgical procedures have resulted in death because of hidden blood loss, accumulation of sedative drugs, or prolonged hypoxeinia. During prolonged procedures, polyphannacy (the simultaneous or set]ucntial use of multiple pharma-cologic agents) is frequently used. Addition or potentiation of the sedative and depressant effects of the drugs frequently contributes to the bad result. Inappropriate use of “reversal agents” may also be implicated. This can pose multiple problems. The so-called reversal agents may have direct, immediate adverse effects with implications for patient safety, l'urtlier, many reversal agents have a pharma-cologic half-life shorter than that of the depressant drug. Ilius, any immediate beneficial arousing effects resulting from the reversal agent may dissipate with time, and the patient may again come under the influence of a previously administered sedative or anesthetic. Yhe seriousness of this phenomenon is enhanced if the return to a sedated stale occurs in an unmonitored or minimally monitored environment. Because of the notoriety associated with bad results in the office-based practice, Texas, New Jersey, and Florida are attempting to solve the problem through legislative mandates. In Texas the law requires both the Texas State Board of Medical Examiners and the Board of Nurse Exaininers to adopt rules governing the provision of anesthesia services in outpatient surgical settings that are not a part of a licensed hospital or licensed ambulatory surgical center. An anesthesiologist or a CRNA practicing in such a facility is required to register with the respective board. On request from the anesdiesiologist or the CRNA, an on-site inspection of the facility may be done. This law went into effect on September 1, 1999 and the 2 boards were required to adopt the rules by January 7, 2000. The impetus behind this legislation is to improve both facilities and equipment. The law also mandates that the patient receive an appropriate preanesthetic assessment, and informed patient consent must be obtained. The ASA “Standards for Basic Anesthetic Monitoring” are also mandated, as are other ASA Guidelines or Standards (ie, “Basic Standards for Preanesthesia Care,” “Standards for Postanesthesia Care,” “Position on Monitored Anesthesia Care,”. “The ASA Physical Status Classification System,” “Guidelines for Nonoperating Room Anesthetizing Locations,” “Guidelines for Ambulatory Anesthesia and Surgery,” and “Guidelines for Office-Based Anesthesia”).2American Society of Anesthesiologists.website available at: http://www.asiihn.org/Google Scholar, 5American Society of Anesthesiologists 2000 Directory of Members. American Society of Anesthesiologists, Park Ridae, III2000: 480-510Google Scholar Further, there must be evidence of an appropriate plan for immediate patient care and triaging in the event of an emergency. The New Jersey law, which served as a template for the Texas law, mandates similar standards. In addition, it states that if a physician is to administer general anesthesia, the physician must be credentialed “by a hospital or the Board”12New Jersey Register. June 15,1998; § 13:35-4A.6.Google Scholar- to provide general anesthesia services. If a CRNA is to administer general anesthesia, regional anesthesia, or conscious sedation, the CRNA must be supervised by a physician who meets the above requirements. The latter portion of the bill is currently under challenge (oral communication, Roger Moore, MD), assistant treasurer, American Society of Anesmesiologists, January 2000). It is a sad commentary that legislation is required to improve patient safety. It is abundantly clear that self-regulation by the medical profession, nursing profession, and hospital administration has not worked. Now that the problem has been recognized, adherence to certain guidelines and standards will improve patient safety. Careful patient selection as well as performance of procedures suitable for the office setting will also help. The definition for managed care applies to office-based anesthesia: “the right care, the right procedure in the right setting, in the right amount, and at the right price.” However, to this definition, we should add “by the right health care provider.” The new, short-acting drugs with minimal adverse effects arc safe only if they arc in the hands of well-trained, competent, and properly credentialed health care professionals who are using well-maintained equipment and adequate medical supplies. We need to make sure that wherever patients undergo elective surgery and anesmesia, they are afforded a level of safety equal to the hospital environment. Patients must demand no less; physicians and other health care providers must provide no less.