Joan Rivers’s death spurs new look at outpatient centers
By Sandra G. Boodman December 15 at 2:43 PM
Wendy
Salo was alarmed when she learned where her doctor had scheduled her
gynecologic operation: at an outpatient surgery center. “My first
thought was ‘Am I not important enough to go to a real hospital?’ ”
recalled Salo, 48, a supermarket department manager who said she felt
“very trepidatious” about having her ovaries removed outside a hospital.
Before the Sept. 30 procedure, Salo drove 20 miles from her home in Germantown, Md. to the
Massachusetts Avenue Surgery Center in
Bethesda for a tour. Her fears were allayed, she said, by the
facility’s cleanliness and its empathic staff. Salo later joked that the
main difference between the multi-specialty center and Shady Grove
Adventist Hospital — where she underwent breast cancer surgery last year
— was that the former had “better parking.”
Salo’s initial
concerns mirror questions about the safety of outpatient surgery centers
that have mushroomed since the highly publicized
death of Joan Rivers. The 81-year-old comedian died Sept. 4 after suffering brain damage while undergoing routine throat procedures at
Yorkville Endoscopy, a year-old free-standing center located in Manhattan.
Federal
officials who investigated Rivers’s death, which has been classified by
the medical examiner as a “therapeutic complication,” found
numerous violations at
the accredited clinic, including a failure to notice or take action to
correct Rivers’s deteriorating vital signs for 15 minutes; a discrepancy
in the medical record about the amount of anesthesia she received; an
apparent failure to weigh Rivers, a critical factor in calculating an
anesthesia dose; and the performance of a procedure to which Rivers had
not given written consent. In addition, one of the procedures was
performed by a doctor who was not credentialed by the center.
Rivers’s gastroenterologist, who was the clinic’s medical director,
has left the center. The clinic, which remains open,
faces termination from
the Medicare program in the wake of Rivers’s death; it must correct
deficiencies and pass an unannounced inspection. Yorkville officials
have said they have corrected the deficiencies and are cooperating with the investigation.
Staff quickly move a patient to recovery. (Melina Mara/The Washington Post)
“Anytime
there is a major or minor accident, people begin to question the safety
record,” said anesthesiologist David Shapiro, past president of the
Ambulatory Surgery Center Association, a national trade group and member
of the board of an organization that accredits surgery centers.
Rivers’s death, Shapiro said, is an aberration. “We have an exceptional,
exceptional success rate,” he said, adding that his industry is “very,
very tightly regulated.” Since 2006, he noted, an industry group called
the
ASC Quality Collaboration has been reporting aggregate data on complications including burns, falls and surgery on the wrong site or wrong patient.
A
2013 study
by University of Michigan researchers who analyzed 244,000 outpatient
surgeries between 2005 and 2010 found seven risk factors associated with
serious complications or death within 72 hours of surgery. Among them:
overweight, obstructive lung disease and hypertension. The overall rate
of complications and deaths was 0.1 percent — about 1 in 1,000 patients —
and involved 232 serious complications, such as kidney failure,
including 21 deaths. Comparable statistics could not be obtained for
hospitalized patients because most studies involve specific procedures.
Another
study found that about 1 in 1,000 surgery center patients develops a
complication serious enough to require transfer to a hospital during or
immediately after a procedure.
Lisa McGiffert, director of Consumers Union’s
Safe Patient Project,
has a significantly less rosy view than Shapiro. Surgery centers, she
said, largely operate under a patchwork of state laws of varying
strictness. Detailed information about outcomes and quality measures is
lacking, she said, and the Rivers case raises questions about “the
relaxed attitude that might have prevailed.”
“There’s not much
known about what happens within the walls of these places by regulators
or by the public,” McGiffert said. “Hospitals are more tightly
regulated” than outpatient surgery centers. “They have to report on many
more aspects of what they do, such as errors and certain infections.
The unusual thing about Rivers’s death, she added, is “that she was a famous person and everyone found out about it.”
Dramatic growth
The
number of ambulatory surgery centers or ASCs — which perform procedures
such as colonoscopies, cataract removal, joint repairs and spinal
injections on patients who don’t require an overnight stay in a hospital
— has increased dramatically in the past decade, for reasons both
clinical and financial. More than two-thirds of operations performed in
the United States now occur in outpatient centers, some of which are
owned by hospitals. The number of centers that qualify for Medicare
reimbursement increased by 41 percent between 2003 and 2011, from
3,779 to 5,344,
according to federal statistics. In 2006 nearly 15 million procedures
were performed in surgery centers; by 2011 the number had risen to 23
million.
Patient Joann Berkson gets help filling out forms. (Melina Mara/The Washington Post)
Advances
in surgical technique and improved anesthesia drugs have allowed many
procedures to migrate out of full-service hospitals to free-standing
centers, which offer doctors greater autonomy and increased income.
Patients say the centers are
cheaper, require less waiting and offer more personalized care.
Surgery
centers are “a much more convenient, safe place to get quality health
care,” Shapiro said, enabling patients to avoid exposure to “the
infections, chaos and delay” that he said pervade many hospitals.
Nearly
all ambulatory surgery centers are owned wholly or in part by doctors
who refer patients to them. These doctors earn money by performing
procedures and receive a share of the fee charged by the facility.
Recently
some centers, including the Massachusetts Avenue facility, which is
owned by 30 doctors, a third of whom are orthopedists, have begun
performing total hip and knee replacements on selected patients, sending
them home the same day. Such operations typically require several days
in the hospital. Center officials say that a new drug they use to
control postoperative pain has made expedited discharges possible.
Baltimore
internist Matthew DeCamp said that as a result of Rivers’s death,
patients have asked him whether they should avoid surgery centers.
“I
don’t think there’s necessarily one answer for all patients,” said
DeCamp, an assistant professor of bioethics and internal medicine at
Johns Hopkins. “There is no doubt that these facilities can be more
convenient and valuable for patients [and offer] a pleasant experience
of care.” But DeCamp said he has advised prospective patients to ask
about safety equipment. “I would say you would want to have what is
colloquially known as a crash cart,” a wheeled cart containing a
defibrillator, medicines and other lifesaving supplies that is standard
in hospitals.
How prepared?
Located in
a boxy brick building in a leafy section of Bethesda, the Massachusetts
Avenue center has ample free parking and is tastefully decorated with
blond wood, ergonomic chairs and sleek counters. About 4,000 procedures
are performed annually at the 10-year-old facility, which employs two
full-time anesthesiologists and a nurse anesthetist.
Each year,
about two or three patients develop complications serious enough to
require transfer to a hospital, said the center’s executive director,
Randall Gross. Most are taken by ambulance to Sibley Hospital, a mile
away, where the center has a transfer agreement and the 50 doctors who
practice at the center have admitting privileges. The closest rescue
squad is also about a mile away.
“We’ve never had a Joan Rivers incident,” Gross said. “That’s not representative of what we do.”
Louis
Levitt, an orthopedic surgeon who is chairman of the facility’s board,
said that all procedures involving general anesthesia are performed with
an anesthesiologist present. Pre-screening is designed to weed out
unhealthier patients — such as those with obesity, sleep apnea and
breathing problems — who might require a hospital.
“Patient
selection and preoperative evaluation are really important,” said
anesthesiologist Peter Shimm, who recently joined the staff after nearly
two decades at Holy Cross Hospital. And while there is no absolute age
cut-off — Gross said the center’s oldest patient was 90 — Shimm said
that elderly patients require special consideration even though “many
octogenarians are super-healthy and a lot of 40-year-olds are train
wrecks.”
But Kenneth Rothfield, chairman of anesthesiology at St.
Agnes Hospital in Baltimore, said that the staffs of surgery centers
may not be as prepared as they think they are.
“I don’t think it’s the venue that’s the most important thing,” said Rothfield, a member of the board of the
Physician-Patient Alliance for Health & Safety,
a nonprofit group. “ASCs traditionally have done simpler procedures in
healthy patients,” while hospitals have routinely dealt with a broader —
and sicker — mix of people. Hospitals, he said, are more likely to be
fully equipped and to have staff members with greater experience
handling emergencies. “Unless you have drilled for it, and trained for
it, it can be hard to pull off.”
Rothfield said that when one of
his children underwent surgery in an ambulatory center several years
ago, he brought his own resuscitation equipment and, as a precaution,
sat in a corner during the uneventful procedure, which he declined to
describe. “Just having the equipment doesn’t guarantee they know how to
use it. I worried that if something happened, the staff would have been
quickly overwhelmed.”
Infections after surgery
Postoperative
infections in hospitals have been a source of concern for years, but
little is known about the rates in surgery centers.
A
2010 report by
CDC researchers examined 68 centers in three states, including 32 in
Maryland, and found that two-thirds had one or more lapses in infection
control. These included improper cleaning and sterilization of surgical
equipment and the failure to wear gloves. The following year, the
federal agency issued infection control guidelines for outpatient
settings similar to those that apply to hospitals. Researchers estimate
that on any given day about
1 in 25 hospitalized patients has one health-care-associated infection.
Although
Maryland is among the states that does not require reporting of
postoperative infections by surgery centers, Gross said that doctors who
practice at the Massachusetts Avenue center are required to submit
monthly reports to him. The rate, he said, is “under 1 percent.” But
this number may not capture all infections: If a patient develops an
infection that is treated elsewhere and does not tell the doctor who
performed the procedure, it would not be part of the tally, according to
Gross.
McGiffert of Consumers Union recommends that surgery
center patients ask open-ended questions such as “How are you going to
make sure I don’t get an infection?”
Sharon Sprague, an assistant
U.S. attorney who lives in the District, said that neither she, her
daughter nor her husband, who have undergone a total of five orthopedic
operations at the Massachusetts Avenue center, has experienced an
infection or any other complication.
“I was convinced about the
merits of the surgery center from the beginning,” said Sprague, whose
soccer-playing daughter had a torn knee ligament repaired there in 2007.
Sprague
said she liked the fact that there was less activity than in a hospital
outpatient department. “It was a really good experience,” she said. “I
never felt any hesitation about safety.”
This
article was produced by Kaiser Health News. KHN, an editorially
independent news service, is a program of the Kaiser Family Foundation, a
nonpartisan health-care-policy organization.