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

Elizabeth M. Lapetina and Elizabeth M. Armstrong

Disclosures

Health Affairs. 2002;21(4) 

In This Article

Abstract and Introduction

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 im prove 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.

Since the institute of medicine (IOM) released its explosive report, To Err Is Human, two years ago, attention to the problem of medical mistakes has waxed and waned. In the popular press, riveting accounts of egregious errors such as wrong-limb amputations and gross chemotherapeutic overdoses have dominated the discourse. In the policy arena, attention so far has focused on errors in the hospital setting and on finding ways to improve inpatient safety.

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.

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]

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.

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.

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 Amercan 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]

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