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Quality Of Care

Preventing Errors In The Outpatient Setting: A Tale Of Three States

Abstract

 
Although error in medicine has received sustained policy attention recently, the problem of error in the outpatient setting has been relatively neglected. In this paper we review what is known about the incidence and nature of error-related adverse events in physicians’ offices, ambulatory care facilities, and surgicenters. We then analyze policies to improve outpatient safety in New Jersey, New York, and Florida, three states that took very different paths toward this goal. Their experience suggests that accreditation, combined with particular attention to ensuring anesthesia safety, can improve quality of care for outpatients. These actions are best accomplished through proactive legislation and the development of regulations, rather than reactive responses to adverse events.

But the outpatient setting may be an equally important arena on which to focus our efforts. Not only are more and more procedures taking place in nonhospital settings, but such venues are both less regulated and potentially more hazardous than hospital settings are. Yet, as the IOM report notes, "little if any research has focused on errors or adverse events occurring outside of hospital settings, for example, in ambulatory care clinics, surgicenters, office practices, home health, or care administered by patients, their family, and friends at home."¹

In this uncertain and rapidly shifting policy environment, there is no consensus about the appropriate measures that should be taken to ensure patient safety in the outpatient setting. Guidelines exist in some cases, but oversight and enforcement are inadequate. In this paper we review the need for attention to error in the outpatient setting, focusing particularly on outpatient surgery. We then describe in detail the different approaches taken by three states—New Jersey, New York, and Florida—as case studies for potential policy responses to the problem.

Outpatient activity. Both the number and the scope of outpatient procedures are growing rapidly. New techniques, equipment, and pharmaceuticals developed over the past ten years have made ambulatory and office surgery more feasible. Although no regulations ever prohibited physicians from performing surgery in their offices, until recently the technology required for doing so did not exist. Minimally invasive procedures using laparoscopes, arthroscopes, and cystoscopes have reduced patients’ recovery time after surgery.² In general, procedures that can be performed in an outpatient setting are those having low rates of postoperative complications that require intensive physician or nurse management. Today, 65 percent of all surgical procedures do not involve a hospital stay.³

The growth in outpatient surgery has been explosive, from an estimated 400,000 surgeries in 1984 to 8.3 million in 2000.⁴ Ten to twenty percent of all elective surgeries will be done in an estimated 41,000 office-based surgical facilities this year.⁵ As technology improves, we can expect outpatient procedures—and morbidity and mortality due to errors in the outpatient setting—to increase as well.

One reason for this sharp increase in office-based care is the lower costs of surgical procedures done outside hospitals—typically 60–75 percent lower than for comparable inpatient procedures.⁶ Medicare and some health maintenance organizations (HMOs) are aware of the lower costs of outpatient surgery and have reduced reimbursement fees when outpatient procedures are performed in hospitals or even in ambulatory surgery centers (defined as facilities having at least two operating rooms) rather than in physicians’ offices, to encourage procedures to be performed in the lowest-cost setting.⁷ In addition, cosmetic surgical procedures (which are typically not covered by insurance) performed in the office reduce the cost to the patient (since there is no facilities fee) and provide an attractive direct-payment income stream to physicians.⁸

These factors have combined to make surgery more likely to occur in the outpatient setting. The American Society of Plastic Surgeons notes that in 2000, 37 percent of cosmetic procedures and 28 percent of reconstructive procedures performed by plastic surgeons were done in office settings. That same year 35 percent of cosmetic procedures and 60 percent of reconstructive procedures were done in freestanding ambulatory surgical facilities.⁹ Moreover, the number of procedures being performed in office settings is skyrocketing. Between 1992 and 1999 office-based liposuction increased 389 percent; breast augmentation, 413 percent; and eyelid surgery, 139 percent.¹⁰

Outpatient facility regulation. The present regulatory system for outpatient facilities is badly fragmented. Three organizations issue accreditation to ambulatory surgery facilities and office-based practices, and each has somewhat different standards. A few states, including New Jersey, have implemented standards of practice for surgery and anesthesia administration, and many other state legislatures have recently given the matter attention, but most states have no regulations. The wide range of specialties—including plastic surgery, dermatology, anesthesiology, and dentistry—with a stake in office-based surgery means that it is unlikely that a single medical professional group will emerge to lead the way as anesthesiology did in the case of errors in the hospital operating room. Moreover, these specialties often compete for patients and professional dominance, which impedes problem solving. Congress has not passed any legislation on the issue. There is a pressing need for states to address the safety of facilities where outpatient surgical procedures are performed and ensure that only qualified providers perform procedures in offices.

Reporting of adverse events. Yet to an even greater extent than is the case with inpatient error, policy is being developed in a vacuum: We know almost nothing about the extent or nature of adverse events in the outpatient setting. Few states require reporting adverse events in the outpatient setting, and those that do have instituted such mandates only in the past year or so. While twenty states require the accreditation of ambulatory surgical facilities by one of the three accrediting organizations, only ten states (Arizona, California, Connecticut, Florida, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, and Texas) have placed any regulations on office-based procedures, and only a handful of states, including California, Florida, New Jersey, New York, and Rhode Island, have reporting systems for outpatient settings.¹¹ New Jersey and Mississippi are the only states that mandate the reporting of adverse events that occur in physicians’ offices.

Types of errors. Only a few studies have documented the types of errors that may occur in the outpatient setting; these studies have focused on anesthesia administration or lipoplasty. A study of ninety-five adverse sedation events in pediatrics between 1969 and 1996 found that the venue (hospital versus outpatient) was not associated with the incidence of respiratory events but that adverse outcomes occurred much more frequently in nonhospital settings. For example, death or permanent neurologic injury occurred in fewer than half (37 percent) of adverse sedation events in the hospital, whereas in the outpatient setting the rate was 93 percent. Inadequate resuscitation contributed to poor outcomes twenty-six times more often in nonhospital facilities than in hospital settings.¹²

Another study based on New York City autopsy reports from 1993 to 1998 identified five deaths attributable to therapeutic complications from liposuction done in an outpatient setting.¹³ Three of the deaths were caused when brachycardia (slowed heartbeat) developed during the procedure. A 1997 survey by the American Society of Plastic and Reconstructive Surgeons identified five deaths in 24,245 liposuction cases, for a fatality rate of 20.6 per 100,000. Likewise, a census of 1,200 aesthetic plastic surgeons revealed that there were ninety-five deaths in 496,245 lipoplasties from 1994 to 1998, a mortality rate of 19.1 per 100,000. The majority (78 percent) of these ninety-five deaths occurred in the outpatient setting. The census consulted only board-certified aesthetic plastic surgeons, who perform only about half the total number of lipoplasties and are the specialty most qualified to perform the procedure; therefore, total mortality is likely even higher.¹⁴ At this rate, mortality from lipoplasty is higher than mortality from motor vehicle crashes (15.2 per 100,000) or homicides (5.9 per 100,000).¹⁵

Sources Of Risk In The Outpatient Setting

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
Several characteristics of the outpatient setting pose potential risks. These fall into two groups, one having to do with the outpatient setting itself and the other, with the actors in that setting. With respect to the setting, the greatest source of risk is inadequate facilities, either to perform the procedures themselves or to deal with an emergency or crisis if it arises. A related problem is that of outdated or inadequately maintained equipment.

With respect to the actors, the relative isolation of the solo practitioner, the lack of peer review, and insufficient training and experience with the procedures being performed all contribute to the risk environment of outpatient surgery. In office-based medicine, particularly cosmetic surgery, the hospital-based process of peer review, which enables colleagues to judge competence, skill, and readiness to perform procedures, is missing. As a result, physicians without a great deal of experience or training may perform cosmetic surgery, sometimes after attending only a weekend seminar or watching a thirty-minute video. Even if physicians are well trained and experienced in the performance of procedures, they may lack training or experience in crisis response, particularly in resuscitation. Moreover, physicians practicing in an office-based setting do not have the level of contact with other physicians that those working in hospitals have. Consequently, it is harder for them to keep abreast of new medical developments and remember all of their training. Finally, physicians in office-based settings are frequently operating without an anesthesiologist or anesthetist in attendance.

Indeed, as the studies by Rama Rao and Charles Coté demonstrate, anesthesia appears to pose a particular risk in the outpatient setting.¹⁶ When persons without adequate experience or equipment administer anesthesia, there can be devastating consequences that are difficult to correct in an office setting. Patients may suffer from malignant hyperthermia, a rare reaction to anesthesia drugs that causes the body to overheat.¹⁷ It can be corrected with dantrolene, an expensive drug that many office practices simply do not stock. Young children are easily susceptible to becoming oversedated during procedures. Children may stop breathing while sedated and can die if not properly monitored. Office-based practices typically do not measure the oxygen levels of their patients or have crash carts, cabinets on wheels that contain resuscitation and emergency therapeutic medication that are standard equipment in the hospital. Despite clear recommendations from the American Society of Anesthesiologists (ASA) on the use of pulse oximetry (which measures blood levels of oxygen), it does not appear to be used consistently in outpatient settings.¹⁸

Setting Standards For Facilities

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
Standards for outpatient surgery facilities vary widely based on the specific practice specialty’s requirements and the standards required by the particular accrediting organization. Three major bodies now issue accreditation of office-based practices: the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Accreditation Association for Ambulatory Health Care (AAAHC), and the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF). Twenty states, including New York and Florida, require the accreditation of ambulatory surgical facilities by one of these three agencies.¹⁹ Only California, Connecticut, Florida, Pennsylania, and Rhode Island require that office-based surgical practices receive accreditation from one of these organizations.²⁰ The New Jersey Board of Medicine regulates outpatient settings with the same standards that are used to regulate hospitals. Some health plans have encouraged outpatient facilities to seek accreditation by reimbursing only those procedures performed in accredited facilities.²¹ However, facilities in many areas are not required to seek any accreditation.

Each of the accrediting organizations has developed its own niche, and each has a specific set of requirements that must be met based on the level of anesthesia involved in the procedure. There are general divisions into classes, with each higher-level class encompassing progressively more advanced procedures. Their differing requirements and procedures have added to the confusion over proper accreditation and standards for office-based surgical procedures.

AAAASF. The AAAASF is predominantly an office-practice accrediting organization that mainly accredits plastic surgery facilities.²² Any facility accredited by the organization must be owned or operated by American Board of Medical Specialties surgeons, who have been board-certified in the procedures they will perform. For all specialties, the physician must have hospital privileges, including transfer privileges, at a nearby facility. The accreditation program addresses the facility layout; patient and personnel records; quality assessment and quality improvement plans; and operating room personnel, equipment, operations, management, and sanitation. Once the inspection is complete, the AAAASF’s Operations Committee and board of directors issue accreditation, provisional accreditation, or denial of accreditation. This process operates on a three-year cycle. In the intervening years facility directors are required to complete a self-evaluation. Failure to do so voids the accreditation.²³

AAAHC. The AAAHC accreditation process is similar to that of the AAAASF. Following an initial self-assessment by the facility seeking accreditation, practicing professionals conduct an on-site survey of the facility. The AAAHC issues six-month, one-year, and three-year accreditation, depending on the facility’s ability to meet all clinical and administrative aspects of ambulatory health care standards. Accredited facilities are required to meet standards in the following core areas: rights of patients, governance, administration, quality of care and quality improvement, clinical records, and facilities and environment.²⁴

JCAHO. The JCAHO accredits the widest range of health care facilities, including office-based practices, ambulatory care facilities, and hospitals. Professional surveyors, who have completed JCAHO training programs, tour the organization’s facilities, examine all patient care areas, interview staff members and patients, review documents and selected patient records, and, at the conclusion of the survey, issue a preliminary report and accreditation decision to the facility. In conducting its examination, the JCAHO looks at the facility’s safety, security, treatment of hazardous wastes and materials, emergency preparedness, patient safety, equipment condition, and utility systems.²⁵ The JCAHO’s accreditation process provides the most exposure of the facility to surveyors and also more flexibility in issuing accreditation. However, the JCAHO is relatively new to the field of accrediting office-based practice facilities. Although separate statistics are not available for office-based procedures, the JCAHO accredits more than 1,100 ambulatory surgery settings. In 2000, 358 facilities underwent a triennial survey. None was denied accreditation; 74 percent received Accreditation with Requirements for Improvement.²⁶

Cosmetic Surgery: A Special Case

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
Cosmetic surgery—especially liposuction—raises the brightest red flag in terms of outpatient surgery. It has certainly captured the most attention in the popular press; since 1990 there have been more than 125 newspaper stories on deaths during liposuction.²⁷ This surgery is entirely elective and is performed on persons in good health, so the tolerance for risk is vanishingly small. As techniques for cosmetic surgery procedures have made them less painful and less invasive, an alarming number of physicians with minimal training have developed office-based practices to perform these procedures. Nearly half of the 250,000 liposuctions performed in 1997 were done by practitioners other than plastic surgeons.²⁸

The use of tumescent liposuction procedures, for example, has enabled physicians to perform cosmetic surgery in the outpatient setting but illustrates the potential dangers of allowing unqualified practitioners to perform these procedures. By 1997 outpatient liposuction under general anesthesia had become the most common aesthetic surgical procedure. Tumescent liposuction involves the subcutaneous injection of highly diluted lidocaine with epinephrine, which allows for nearly bloodless suction of fat and reduces postoperative pain, enabling liposuction to be done in physicians’ offices.²⁹

As patients have demanded the removal of greater volumes of fat, physicians, who sometimes have little formal training in performing liposuction, have administered higher doses of lidocaine and epinephrine. The American Academy of Dermatologists has deemed megadose concentrations of highly diluted lidocaine of up to 35 to 55 mg/kg to be safe for tumescent infiltration anesthesia, even though the Food and Drug Administration (FDA)–sanctioned maximum dosage for regional anesthesia is 7 mg/kg.³⁰ Errors occur when physicians overlook the "highly diluted" caveat and administer large amounts of more concentrated lidocaine.

The bundling of procedures also leads to complications. If liposuction and cosmetic face surgery are performed during the same session, lidocaine is given for both procedures, which raises the risk of complications. Because only two states require the reporting of adverse events occurring in physicians’ offices, it is not known how many complications result from this procedure nationwide.

Setting Standards For Practice

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
Part of the difficulty in establishing regulations on procedures done in physicians’ offices is that while hospitals and ambulatory surgical centers are regulated by each state’s department of health, physicians and their private offices are regulated by the state’s board of medical examiners. Historically, physicians practiced individually and only performed consultations or treated minor ailments in their offices. Therefore, physicians’ office-based practices were not subject to the same extensive regulations as hospitals and ambulatory surgical centers were. To make the same standards of safety apply in physicians’ offices, regulations must be passed by each state’s board of medical examiners or equivalent agency with supervisory authority over physicians.³¹ An alternative is for state legislatures to pass laws that mandate practice standards for office-based settings.

New Jersey, New York, and Florida have all attempted to establish standards of practice to reduce outpatient medical errors, with markedly different outcomes. The New Jersey Board of Medical Examiners implemented regulations that established standards of practice for outpatient office-based surgery and included a mandatory reporting requirement for adverse events and complications. Based on the apparent success of the New Jersey regulations, the New York State Senate developed a task force to draft legislation regulating office-based surgery.³² Alarmed by the number of adverse events resulting from office-based procedures, the Florida Board of Medicine imposed a ninety-day moratorium on Level III office-based surgery (defined as surgery that involves the use of general anesthesia or major conduction anesthesia and preoperative sedation) from 4 August to 8 November 2000 so that the safety of these procedures could be evaluated and regulations could be developed.³³

New Jersey: Board of Medical Examiners regulations. Rather than working with the state legislature to implement standards for office-based surgery, advocates worked with the New Jersey Board of Medical Examiners. The goal was to encourage the board to mandate standards for office-based care. The office regulations went into effect in June 1998.³⁴ By implementing standards identical to those for hospitals and ambulatory surgical centers, New Jersey created a uniform standard of care regardless of inpatient or outpatient status.

The standards address the areas of patient monitoring during procedures, technology implementation, and equipment purchase and maintenance. General anesthesia can be administered only by anesthesiologists or nurse anesthetists working under the direction of an anesthesiologist.³⁵ To practice in an office, an anesthesiologist must have admitting privileges at a nearby hospital.³⁶ Certain physician groups protested this provision, stating that they exclusively practice in offices and do not want to obtain hospital privileges, so an alternative credentialing system is still being developed.³⁷ Obsolete machinery must be replaced, maintenance must be performed by the manufacturer on schedule, and patients must be carefully monitored while under general anesthesia and while in the post-anesthesia care unit (PACU).³⁸ Equipment replacement was mandated to ensure that hospitals, ambulatory surgical centers, and office-based practices invested funds in replacing the machinery. Additionally, a mandatory reporting system was created. Physicians are responsible for reporting any deaths, complications, or adverse events that occur during office-based procedures.

New York: legislating policy. In February 1999 the New York State Senate Committee on Investigations, Taxation, and Government Operations convened a committee to study problems of office-based surgery. The investigation was conducted as the New York State Public Health Council simultaneously drafted clinical guidelines for office-based surgery. Unfortunately, the guidelines, which were issued in June 1999, are nonbinding, so there is no incentive for physicians to comply with them and no way for patients or state officials to know whether or not physicians are following them.³⁹ The council stipulated that all physicians in New York receive a copy of the guidelines and that they be posted on a Web site. The committee recommended that the legislature empower the New York State Department of Health to issue regulations on office-based surgery, just as it already issues regulations for hospitals and ambulatory surgical centers. The regulations would have ensured that practitioners were credentialed in the fields in which they were doing procedures, established restrictions on administering anesthesia, and created minimum levels of equipment and maintenance schedules.⁴⁰ State inspections of facilities would be conducted to ensure compliance. Had this legislation passed, it would likely have helped to improve the safety of office-based surgery in New York.

However, using the legislature as the means for creating regulations was not effective in New York. The lobbying of special-interest groups, especially the Medical Society of New York and the New York State Association of Nurse Anesthetists, and partisan interests of legislators killed support for the legislation.⁴¹ In 1999 a weaker measure, which calls for the reporting of complications and deaths from office-based procedures, was passed.⁴² New York State’s health commissioner is responsible for compiling outcomes data based on reported events to determine whether errors occurred, so that the legislature can evaluate whether additional legislation is needed. Still, the end result of New York’s effort fell short of its original goal and casts doubt on whether such attempts in other states can succeed.

Florida: fierce opposition to a ban on surgery. In March 2000 the Florida legislature gave the Florida Department of Health Board of Medicine the authority to require physicians to report adverse incidents that occur in their offices. On 4 August 2000 the first adverse-incident reports were reviewed. Statistics provided by the state’s Agency for Health Care Administration revealed that twenty adverse events, including five deaths (four of which were related to complications from plastic or cosmetic surgery), had been reported since March. All of these events required patients to be transferred to hospitals.⁴³ This number was shocking to the board, but it is likely an underestimate, in part because adverse events that did not require hospitalization did not have to be reported. Three-fourths of the adverse events were related to surgical procedures, and 45 percent of the surgical procedures were related to plastic or cosmetic surgery.

Ban on surgery. The Board of Medicine responded by placing a moratorium on Level III procedures. The board specifically cited concern with inadequate monitoring of patients who had received anesthesia and the bundling of too many different procedures into a single, long operation.⁴⁴ The board hoped to discover why office-based settings had much higher incidences of adverse events than hospital and ambulatory surgery center settings had and to propose safeguards.⁴⁵

Physicians’ opposition. The board’s decision was immediately controversial. The Florida Medical Association (FMA) filed a petition in a Florida District Court of Appeals seeking an emergency stay or immediate injunction to block the board’s decision.⁴⁶ The move was unsuccessful, as was an FMA proposal to modify the extent of the procedures covered by the ban. The FMA protested the sudden ban on procedures, arguing that the action eliminated many physicians’ main source of income and infringed upon their professional autonomy. The FMA also argued that while some physicians may not be qualified to perform procedures in their office, the large majority are competent. Barring all physicians from performing procedures in their offices was characterized as harming patients, who were forced to move their procedures to a hospital or wait until after the ban was lifted.

Information collection. During the ban the Board of Medicine and the FMA joined forces to create an ad hoc independent Outpatient Surgical Safety Commission, which collected information on surgeries performed in offices, ambulatory surgical settings, and hospitals and then reported its findings to the Department of Health.⁴⁷ The study provided a preliminary understanding of the differences between office-based surgical procedures and procedures in hospitals and ambulatory surgery centers.

Two new rules. On 7 November 2000 the moratorium expired, and the board allowed office-based Level III surgery to resume, with the addition of two emergency regulations. The first rule prohibits the combination of abdominoplasty with liposuction and liposuction with other surgical procedures.⁴⁸ The second rule requires offices performing Level II and Level III procedures to implement risk management systems and submit all surgical logs to the Department of Health.⁴⁹ The new rules also prohibit Level III procedures for patients with severe systemic diseases and require patients with certain conditions to obtain a complete physical before undergoing a procedure in an office setting.

In February 2001 Florida’s Board of Medicine proposed that the temporary regulations be adopted permanently. The Board of Medicine continues to analyze reports of adverse events and surgical logs submitted by offices. Florida is continuing to develop comprehensive regulations to address the problems highlighted by the adverse-event reports. However, the state is doing so in a much more reactionary, piecemeal way than New Jersey is.

Policy Recommendations

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
Maintain physicians’ knowledge base. As other states consider action to improve patient safety in the outpatient setting, they should target three broad areas. First, to minimize the number of medical errors that occur as a result of ignorance, office-based physicians must be encouraged to continue to review the current best-practice methods and interact with other physicians so that they are able to maintain and share their knowledge base. Professional organizations should encourage their member physicians to devote time and attention to keeping up with new developments. Conferences and seminars provide forums for physician interaction and are a source of information about current medical developments within a practitioner’s specialty. A straightforward electronic and print newsletter, such as the one published by the Department of Veterans Affairs’ National Center for Patient Safety, could provide a way for physicians to remain aware of best-practice methods. Informally, physicians practicing alone or in small groups should be encouraged to consult one another and discuss treatment options for difficult cases.

Require accreditation of outpatient facilities. Second, accreditation is a valuable way to ensure the safety of ambulatory surgical facilities and offices where surgical procedures are performed, so we recommend that both types of facilities be required to obtain accreditation from the JCAHO, AAAASF, or AAAHC. Once clinics and surgical centers receive accreditation, they are still under considerable pressure to maintain the standards needed to obtain approval. However, the current system, with varying standards and methods for accreditation, is confusing to patients, physicians, office staffs, and regulators alike.

Instead of having overall facility standards approved for centers that perform very different types of procedures, standards could be created for each specialty. It would be better for anesthesiologists to use the standards described in the various ASA guidelines as benchmarks for providing appropriate care instead of adhering to the anesthesia accrediting standards of the three organizations.⁵⁰ Professional societies should consider implementing standards for facilities performing procedures within their field, using the ASA guidelines as a model.

However, the accreditation organizations are useful for ensuring that the sites where office-based procedures are being performed have adequate safeguards. State and federal authorities should encourage office-based facilities to obtain accreditation; one way to do so is to make Medicare and Medicaid reimbursement contingent on obtaining "deemed status," as is the case with hospitals. Accreditation is useful in determining whether the facilities of a physician’s office are appropriate and meet the standards necessary to provide safe patient care. The issue of whether the provider is qualified to perform a procedure is a separate issue, best addressed through other means.

Regulate cosmetic surgery procedures. Third, the postoperative complications that have occurred during outpatient cosmetic procedures and the elective nature of such surgery mandate that special attention be paid to this area. Standards for length and types of patient monitoring are needed to minimize unnecessary complications from anesthesia. One possibility is to mandate the use of licensed anesthesiologists when major liposuction procedures are performed in office settings. Major could be defined by either the amount of fat the patient wishes to have removed or the expected duration of the procedure. For example, Rhode Island recently implemented regulations on all office-based procedures that place a four-hour time limit on procedures that can be performed in offices without being reported to state regulators.⁵¹ Inadequate training may also be a cause of adverse events in the outpatient setting. While surgery and plastics training that is board certified may not be necessary for all cosmetic procedures, medical professionals whose only training is a thirty-minute video can now market themselves as cosmetic surgeons. Some errors in cosmetic surgery might be averted through consumers’ awareness of a physician’s level of training; many would likely elect not to have the procedure done with a particular physician.

Enlist the help of professional organizations. Up until now, a number of factors have prevented the field from being better regulated. Physicians have been reluctant to criticize members of other specialties for fear of being accused of self-interest and because of the desire for greater profits. This argument is particularly relevant in cosmetic surgery because patients pay directly for most procedures, and insurance companies are not involved. Efforts to regulate the cosmetic surgery industry in Florida have been supported by plastic surgeons but opposed by medical societies, which are dominated by physicians representing other specialties.⁵² Reducing the number of errors in cosmetic surgery will demand the involvement of trained plastic and general surgeons to encourage greater restrictions on who can perform these procedures. State or federal regulatory bodies working to develop regulations for cosmetic procedures should enlist the help of professional organizations, particularly the American Society of Plastic Surgery, which already evaluates the safety of various plastic surgery techniques.

Paths To Outpatient Safety

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 
The examples of New Jersey, New York, and Florida are not enough to draw complete conclusions about the best way to implement standards for office-based surgery. However, it is clear that New Jersey was most successful in its efforts to implement standards by concentrating on developing regulations rather than legislation. Other states should work with their boards of medical examiners and departments of health to provide equally rigid standards in hospitals, ambulatory surgical centers, and physician offices. Although medical examiners’ boards do feel pressure from competing physician specialties, legislators are likely to feel these same pressures, plus outside pressure from special-interest lobbying groups and fellow political party members. Legislation may be useful as a complement to regulations. New agencies or regulatory bodies may be created through legislative action to monitor the adherence of office facilities to newly established standards. What is most important, however, is that both legislation and regulations be developed proactively, rather than as reactive measures implemented in response to news of alarming events in the outpatient setting.

To encourage this state action, the U.S. Department of Health and Human Services (HHS) should mandate that all states create standards of care for office-based surgery and procedures involving anesthesia within a designated number of years. The standards should address areas including patient monitoring during procedures, technology implementation, and equipment purchase and maintenance. Additionally, statewide required reporting systems should be established for the purpose of gathering information about the frequency and nature of adverse events and near-misses. This information could then be analyzed and compared to determine which aspects of office-based medicine need to be altered to prevent additional medical errors.

Greatly reducing the number of medical errors associated with office-based procedures should be part of the effort to improve health care quality. To protect the public from unqualified providers, state regulations are needed to define the qualifications to perform particular procedures, as well as the setting in which such procedures may take place. New Jersey, New York, and Florida have pursued very different paths to outpatient safety. Of these three, New Jersey’s comprehensive and collaborative approach promises to yield the greatest improvement in health care quality.

Editor's Notes

 
Elizabeth Lapetina is a research analyst with the Lewin Group in Falls Church, Virginia. At this writing, she was completing her bachelor’s degree at Princeton University. Elizabeth Armstrong is assistant professor of sociology and public affairs at Princeton’s Woodrow Wilson School of Public and International Affairs.

The authors thank Ervin Moss for his help in explaining the regulations in New Jersey and New York and Judie Miller for her assistance in preparing the manuscript.

NOTES

Top Sources Of Risk In... Setting Standards For Facilities Cosmetic Surgery: A Special... Setting Standards For Practice Policy Recommendations Paths To Outpatient Safety NOTES

 

1. L.T. Kohn, J.M. Corrigan, and M.S. Donaldson, eds., To Err Is Human: Building a Safer Health System (Washington: National Academy Press, 2000), 25.
2. S.J. Lazarov, "Office-Based Surgery and Anesthesia: Where Are We Now?" World Journal of Urology 16, no. 6 (1998): 384–385.[Medline]
3. Society for Ambulatory Anesthesia, "Patient Information," www.sambahq.org/patient-info.html (30 November 2001, no longer available).
4. Lazarov, "Office-Based Surgery," 384; and C. Luz, "JCAHO Offers Accreditation for Office-Based Surgery Practices," 20 June 2001, www.ada.org/prof/pubs/daily/0106/0620acc.html (8 April 2002).
5. Rebecca Twersky, chair, Anesthesia Patient Safety Foundation, Committee on Ambulatory Surgical Care, interview with Elizabeth Lapetina, 2 January 2001; Luz, "JCAHO Offers Accreditation"; and American Society of Anesthesiologists, "Office-Based Anesthesia and Surgery," 2001, www.asahq.org/PublicEducation/OBAbrochure.htm (4 April 2002).
6. American Association for Accreditation of Ambulatory Surgery Facilities, "About AAAASF," www.aaaasf.org/AboutAAAASF/about.cfm (29 November 2001).
7. Lazarov, "Office-Based Surgery," 385; and J.H. Sutton, "Office-Based Surgery Regulation: Improving Patient Safety and Quality of Care," Bulletin of the American College of Surgeons (February 2001): 8–12.
8. J.F. Arens, "Anesthesia for Office-Based Surgery: Are We Paying Too High a Price for Access and Convenience?" Mayo Clinic Proceedings (March 2000): 225–228; and F.M. Grazer and R.H. de Jong, "Fatal Outcomes from Liposuction: Census Survey of Cosmetic Surgeons," Plastic and Reconstructive Surgery (January 2000): 436–448.
9. American Society of Plastic Surgeons, "2000 General Information," www.plasticsurgery.org/mediactr/stats-03.pdf (3 April 2002).
10. Sutton, "Office-Based Surgery Regulation."
11. The twenty states are Arizona, California, Delaware, Florida, Georgia, Indiana, Kansas, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Utah, and Wyoming. Accreditation Association for Ambulatory Health Care, "About AAAHC," www.aaahc.org/about/about2.shtml (29 November 2001). In addition, Oregon has a voluntary regulation system for office-based practices, and the Mississippi Board of Medical Licensure requires reporting of office-based adverse events as of January 2002. R. Twersky, "Standards for Office Anesthesia Vary Widely or Do Not Exist," Anesthesia Patient Safety Foundation Newsletter (Spring 2000); L.O. Prager, "Florida Bans Some Office-Based Surgeries," American Medical News, 4 September 2000; and AAAHC, "Legislative Information: Ambulatory Health Care Accreditation State Laws and Regulations," wsm.sgsnet.com/cgi-bin/osform/headline?osform_template=display.oft&oid=abcaaa3105fbf2ab (17 May 2002).
12. C.J. Coté et al., "Adverse Sedation Events in Pediatrics: A Critical Incident Analysis of Contributing Factors," Pediatrics 105, no. 4 (2000): 805–814.[Abstract/Free Full Text]
13. R.B. Rao, S.F. Ely, and R.S. Hoffman, "Deaths Related to Liposuction," New England Journal of Medicine (13 May 1999): 1471–1475.
14. Grazer and de Jong, "Fatal Outcomes from Liposuction."
15. A.M. Minino and B.L. Smith, "Deaths: Preliminary Data for 2000," National Vital Statistics Reports 49, no. 12 (Hyattsville, Md.: National Center for Health Statistics, 2001).
16. Rao et al., "Deaths Related to Liposuction"; and Coté et al., "Adverse Sedation Events in Pediatrics."
17. L. Neergaard, "Deaths Raise Concern about Sedation in Offices," Associated Press, 17 March 1999.
18. Arens, "Anesthesia for Office-Based Surgery."
19. Twersky, "Standards for Office Anesthesia Vary Widely or Do Not Exist."
20. Ibid.; Prager, "Florida Bans Some Office-Based Surgeries"; and AAAHC, "Legislative Information."
21. AAAHC, "About AAAHC."
22. AAAASF, "About AAAASF."
23. AAAASF, "Process," www.aaaasf.org/Process/process.cfm (29 November 2001).
24. AAAHC, "Who, What, Why," www.aaahc.org/about/whowhatwhy.shtml (29 November 2001).
25. Joint Commission on Accreditation of Healthcare Organizations, "Office-Based Surgery Accreditation Overview," www.jcaho.org/accred/amb/obs_accred_overview.html (29 November 2001).
26. Mark Forstneger, JCAHO media relations specialist, to Elizabeth Armstrong, personal communication, 5 April 2002.
27. This figure was derived from a Lexis-Nexis search of major newspapers for 4 April 1992–4 April 2002.
28. R.H. de Jong, "Mega-Dose Lidocaine Dangers Seen in ‘Tumescent’ Liposuction," Anesthesia Patient Safety Foundation Newsletter (Fall 1999): 1.
29. Ibid., 26.
30. Rao et al., "Deaths Related to Liposuction," 1473.
31. Ervin Moss, primary author of New Jersey’s Board of Medical Examiners’ regulations on surgical and anesthesia standards of practice, interview with Lapetina, 3 November 2000.
32. Ibid.
33. Florida Department of Health Board of Medicine, "Specific Reason for Finding an Immediate Danger to the Public Health, Safety, or Welfare," Rule no. 64B8ER00-1, 4 August 2000, www.fmaonline.org/about/index.cfm?pageaction=press&showpage=legal_office_mora (29 November 2001).
34. Moss interview with Lapetina, 3 November 2000.
35. E. Moss, "MD-Office Safety Regs Stalled in New Jersey," Anesthesia Patient Safety Foundation Newsletter (Winter 1997): 3.
36. Ibid.
37. Moss interview with Lapetina, 3 November 2000.
38. Moss, "MD-Office Safety Regs Stalled in New Jersey."
39. New York State Senate Committee on Investigations, Taxation, and Government Operations, "Problems of Office Surgery," February 1999, 204.168.97.3/Docs/surgery.htm (29 November 2001).
40. Twersky interview with Lapetina, 2 January 2001.
41. Moss interview with Lapetina, 5 January 2001.
42. Twersky, "Standards for Office Anesthesia Vary Widely or Do Not Exist."
43. Florida Department of Health Board of Medicine, "Specific Reason for Finding an Immediate Danger."
44. Prager, "Florida Bans Some Office-Based Surgeries."
45. Florida Department of Health Board of Medicine, "Specific Reason for Finding an Immediate Danger."
46. Florida Medical Association, "FMA Opposes the Board of Medicine’s Moratorium on Office Surgery," 9 August 2000, www.fmaonline.org/printpage.cfm?page=/about/legal_office_press.cfm (29 November 2001).
47. T. Williams, "Update on Board of Medicine August 23, 2000 Emergency Meeting to Consider FMA Proposal to Modify the Moratorium on Level III Office Surgery," 23 August 2000, www.dameprac.com/Members-only/Archive-News/htm/mora_upheld.htm (17 May 2001).
48. L.O. Prager, "Florida Lifts Ban on In-Office Surgery with New Safeguards," American Medical News, 27 November 2000.
49. Ibid. Level I office surgery is that in which minor procedures are performed under topical or local anesthesia not involving drug-induced alteration of consciousness other than minimal preoperative tranquilization of the patient. Level II is that in which perioperative medication and sedation are used intravenously, intramuscularly, or rectally, thus making intraoperative and postoperative monitoring necessary.
50. Twersky, "Standards for Office Anesthesia Vary Widely or Do Not Exist."
51. Ibid.
52. Moss interview with Lapetina, 5 January 2001.

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