The unexpected death of comedian Joan Rivers in 2014 at a New York City ambulatory surgical center put these centers in the spotlight, and not in a positive way. A media frenzy followed, and it was revealed Ms. Rivers had a routine and minor elective procedure. In the wake of her death, concerns were raised about the safety of ambulatory clinics. According to the medical examiner, Ms. Rivers's heart stopped following sedation with propofol, but no obvious medical errors were found to have occurred, and the manner of death was considered to be a "therapeutic complication." A Centers for Medicare and Medicaid Services investigation, however, concluded that the clinic had made several serious errors, including a failure to identify deteriorating vital signs and to provide prompt intervention.
The terms "routine" and "minor," often used to describe the endoscopic procedure that Ms. Rivers underwent, can be misconstrued to mean without risk. Yet every medical procedure, no matter how benign, carries a risk. This incident has raised several important questions: Could Ms. Rivers's death have been avoided? Would the outcome have been different if the procedure had been performed in a hospital? Are ambulatory surgical centers generally safe?
The first surgical center opened in Phoenix in 1970, according to the Ambulatory Surgery Center Association (ASCA). About a decade later, after Medicare began reimbursing for procedures performed in surgical centers, the number of these facilities across the country multiplied. More than 25 million surgeries are now performed each year in about 5,300 ambulatory surgical centers.
"Most outpatient procedures in ambulatory surgical centers are safely done," says Frank J. Overdyk, MD, MSEE, a member of the board of advisors of the Physician-Patient Alliance for Health and Safety, while also acknowledging that "the record is far from perfect."
SAFETY DATA AND OVERSIGHT
Although individual cases can have tragic endings and result in extensive media coverage, as in the Rivers case, it's been difficult to gauge overall safety at ambulatory surgery centers because comprehensive statistics are lacking. Most procedures are low risk and many, such as endoscopy, don't even require an incision. Tracking complications, such as surgical site infections, can be challenging, because patients may go for follow-up to a different setting, such as a physician's office or hospital ED.
Like hospitals, ambulatory surgical centers are subject to a range of regulatory oversight that varies by state. Forty-six states require that the centers be licensed, which generally necessitates initial and ongoing inspection and reporting. Third-party accreditation is required in 28 of these states. The three recognized accrediting organizations are the Accreditation Association for Ambulatory Health Care, the American Association for Accreditation of Ambulatory Surgery Facilities, and the Joint Commission. In 25 states, a certificate of need is required, meaning that the need for an ambulatory surgical center must be demonstrated before one is opened. The intention is to manage health care costs by preventing the overbuilding of these centers.
Facilities that want to participate in Medicare must be certified by that program, in addition to complying with state licensure laws. The centers must demonstrate compliance with Medicare standards that are meant to ensure patient safety and the quality of services provided at the facilities. Obtaining accreditation in states in which it's not required can make facilities more attractive to third-party payers. Such voluntary accreditation can be obtained from all three accrediting bodies.
A recent investigation by Kaiser Health News and the USA Today Network put a decidedly negative spin on ambulatory surgical centers. In what the investigators refer to as the "most extensive examination of these records to date," their team combed through legal filings, autopsy records, and more than 12,000 state and Medicare inspection records, in addition to interviewing dozens of stakeholders in the industry. They reported that more than 260 patients who had procedures at ambulatory surgical centers have died since 2013. They also noted that, since 2015, health inspectors working for Medicare had detected 230 lapses in rescue equipment or training regulations. Other findings included more than a dozen cases in which patients were endangered because of a lack of trained staff or emergency equipment. The investigators also found that Medicare inspectors had flagged 122 surgery centers in 2015 and 2016 for lapses in risk assessments. At least 14 patients had died after spine surgery in the two years since Medicare had begun paying for this type of surgery at ambulatory care centers in 2015.
It's important to remember that these are the findings of an investigative report, not a research study. This investigation was also heavily focused on individual cases and didn't provide important context. There is no mention of the number of procedures that have been safely performed since 2013, for example, or the percentage of procedures that resulted in death. Comparative data regarding inpatient or outpatient hospital mortality for similar procedures during the same time period were not presented. Moreover, the report mentions only the number of lapses that were flagged-not the actual number of centers where these occurred. It's not clear, for example, if there were multiple infractions at only a handful of centers or repeated lapses at the same centers.
William Prentice, chief executive officer of the ASCA, points out that the investigation misrepresented the quality of care provided by surgical centers by focusing on a small number of tragic events. The investigators "used a handful of anecdotal reports to imply there were risks associated with ASCs [ambulatory surgery centers] without providing any context," he says. "In five years' time, the period the reporters indicate they examined, ASCs would have performed more than 100 million successful procedures. The article makes no mention of that."
Prentice asserts that ambulatory surgical centers are as safe or safer than hospitals. "To determine value, you need to look at quality and cost," he says. "Multiple studies demonstrate the cost savings ASCs provide and deliver compelling evidence that ASCs offer a quality of care that is on par with, and often superior to, the care available from other outpatient surgery providers."
The article from Kaiser Health News and the USA Today Network did acknowledge that "most operations done in surgery centers go off without a hitch. And surgery carries risk, no matter where it's done. Some centers have state-of-the-art equipment and highly trained staff that are better prepared to handle emergencies."
Care is increasingly being transitioned to the community, and outpatient surgery is becoming more common, says Kathy Mertens, DNP, MPH, RN, associate chief nurse and assistant administrator at Harborview Medical Center in Seattle. "Nurses are in a key position to ensure that standards of care are met, safety protocols are followed, and centers are adequately equipped to take care of emergencies," she says. "Nurses have a large presence, not only in managing the patient's care but in making sure everything is running smoothly with the whole team."
Mertens, who is also president of the American Academy of Ambulatory Care Nursing, points out that "nurses can really help fill in some of the gaps in communication and assessment and alert the team if there are red flags. For example, pre-op assessment is so critical and can affect outcomes if something is missed, such as if the patient has diabetes," she says. "We also need to make sure that the practical things are taken care of, such as if they have a ride home after surgery, someone to take care of them after surgery, and stable housing."-Roxanne Nelson, BSN