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Tribune News Service
Tribune News Service
National
Christina Jewett and Mark Alesia

Lax oversight leaves surgery center regulators and patients in the dark

The first man died in April 2014. Another died later that month. Then on July 18 of that year, a woman was rushed to a hospital where she was told she was lucky to be alive.

They all went to the same Little Rock, Ark., surgery center for a colonoscopy, among the safest procedures a patient can have. And each stopped breathing soon afterward, court records say, sustaining the same type of brain damage seen in a drowning victim.

What happened at Kanis Endoscopy Center prompted no review by officials in Arkansas, which, like 16 other states, has no mandate to report patient deaths after surgery center care. So no facility oversight authority has examined whether the deaths were a statistical anomaly or cause for alarm.

A Kaiser Health News and USA Today Network and investigation found that surgery centers operate under such an uneven mix of rules across U.S. states that fatalities or serious injuries can result in no warning to government officials, much less to potential patients. The gaps in oversight enable centers hit with federal regulators' toughest sanctions to keep operating, according to interviews, a review of hundreds of pages of court filings and government records obtained under open records laws. No rule stops a doctor exiled by a hospital for misconduct from opening a surgery center down the street.

Even the high-profile death of comedian Joan Rivers _ who passed away in 2014 following a routine procedure at a Manhattan surgery center _ failed to appear in Medicare's public tally of patients rushed to a hospital.

When Faye Watkins, 63, walked into Kanis Endoscopy in Arkansas, she was unaware that there had been two deaths after care there within the previous three months, she said. She was in the fog of anesthesia when it struck her that something was amiss. She said she heard men say her blood pressure was falling.

"I said (to myself), 'Lord, if it's time for me to go, take me. But I'm not ready,'" Watkins recalled. Her next memory was waking up in a hospital with her chest sore from CPR.

The KHN/USA Today examination raises questions about the need for more robust oversight of surgery centers, where public access to important information, such as surgical outcome data, tends to be more limited than what's available about hospitals. The gap persists even as the nation's 5,600 surgery centers have surpassed hospitals in number and taken on increasingly complex procedures.

"It's disgraceful that there's so little information" about what happens in surgery centers, said Leah Binder, chief executive of the Leapfrog Group, an employer consortium that surveys more than 2,000 hospitals a year.

Scrutinizing unexpected deaths is the norm for U.S. hospitals. The Joint Commission, their leading accreditation body, recommends that members send the accreditor reports of unexpected deaths so that lessons from one tragedy might prevent another. The top surgery center accreditation body has no similar guideline.

Bill Prentice, executive director of the Ambulatory Surgery Center Association, an organization that represents the centers in policymaking discussions, said the centers safely perform millions of procedures, from tonsillectomies to knee replacements, each year.

Prentice said he supports giving patients access to data that could compare surgery centers with hospital outpatient departments.

"We shouldn't have a patchwork system where one state asks for one thing and others ask for others," Prentice said. "What consumers want is consistency."

Colorado requires surgery centers to report deaths and some major injuries to the state health department, and the agency posts summaries of incidents online for consumers. Several other states _ including Pennsylvania, Florida and New Jersey _ require incident reports but don't reveal to the public where they happened.

In at least 17 states, health facility officials confirmed they have no way to know that a patient died because surgery centers have no duty to report. So just as in Arkansas, surgery centers had no mandate to notify an official over cases outlined in lawsuits, including a 33-year-old Missouri man who died after finger surgery, a 66-year-old Georgia woman who died after an eye procedure or a 60-year-old in Oklahoma who died soon after a total hip replacement.

Even in Colorado, a leader in transparency, the outcome of a 2017 jury trial raised questions about the depth of the oversight. Robbin Smith was paralyzed from the waist down after an epidural pain injection at the Surgery Center at Lone Tree in 2013, according to her lawsuit against the center.

Smith's attorneys cited Medicare rules that say the center's own governing body has a duty to keep patients safe. Each center must appoint a body that is legally responsible for the center's operations.

Smith's legal team argued that the center should have upheld its duty by ensuring that its doctors did not use the drug Kenalog _ an injectable steroid _ for epidural injections. The drugmaker had changed the label in 2011 to warn against using it that way due to the risk of paralysis.

The center's governing body never discussed proper usage of the drug prior to Smith's care, trial testimony shows, and there's no sign that state or private facility overseers examined the board's actions before Smith's injury.

The surgery center's lawyer argued that the doctor _ not the facility _ was responsible for choosing Kenalog for Smith's treatment. The doctor denied wrongdoing and reached a confidential settlement with Smith before her case against the center went to trial.

Jurors ultimately ruled against the center, awarding Smith $14.9 million. The center has filed a motion for a new trial.

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