advocate: Assemblyman Richard Gottfried.
credit: Ellen Descisciolo
you go under anesthesia if your doctor’s only backup plan
was to call 911?
and Death at the Doctor’s Office
had no means of resuscitating her at his Park Avenue office,
short of an attempt at CPR. His nurse called 911, and Wendy’s
husband was called in the room to pull down a basic emergency
kit from a high shelf only to see his wife blue on the table.
After several doctors at Lenox HillHospital couldn’t revive
her, her siblings and husband were allowed in to say goodbye.
Wendy was the firebrand of the five siblings. Sharp-witted
and strong-willed, she was not someone easily stopped from
anything. As a kid she was a champion swimmer; as an adult
she took flying lessons. Wendy ended up marrying her flight
instructor on a cold November day in a little stone church
in Sleepy Hollow. They tried to have children and experienced
difficulties, including miscarriage, most likely because
her biological clock had nearly ticked its time out. Her
husband was much younger than she and was not interested
in adopting, so they kept trying. As a result, Wendy was
under frequent examination by her longtime obstetrician/gynecologist.
December 18, 1995, my aunt Wendy went in for what she believed
was a routine procedure. What appeared to be fibroids had
been found on her uterine wall, and her doctor needed to
examine them by performing a hysteroscopy, a common office
procedure during which the uterus is inflated with carbon
dioxide or saline solution and the doctor examines the uterus
using a scope. Not far into the procedure, Wendy suffered
an air embolism from the carbon dioxide, an uncommon occurrence
in which bubbles enter the blood stream and block blood
flow at the heart. Because her doctor had no life-support
systems on hand, and wasn’t experienced in the ways to stop
an embolism, she died from this “routine” procedure.
The family was devastated, and though it was nearly 10 years
ago, the healing has been tough. Beyond the shock of her
premature death, we were in disbelief that there were no
regulations to make sure doctors’ offices meet minimum safety
When it comes to one place where people are supposed to
and deserve to be trusting—their doctor’s office—many are
finding to their dismay that basic precautions like debfibrillators
are not in place, and are not required to be.
The risks are real. The more invasive the procedure, and
especially the more time a patient has to spend under anesthesia,
the greater the risks of cardiac arrest or other trauma.
This is true even for relatively minor procedures like pulling
wisdom teeth, and certainly for more serious ones like abortion,
plastic surgery, or even having tubes put in your child’s
ears. Even procedures that don’t require anesthesia, like
colonoscopy, pose risks of embolism similar to what happened
to my aunt.
While there are dangers regardless of setting, it’s the
ability to respond to crises that is important. Wendy died
nine years ago, and it would be nice to think that New York’s
situation has improved, but it hasn’t. In New York, there
are virtually no regulations that govern what doctors can
and cannot do in their offices. No one is required
to even monitor a patient’s vital signs during procedures
involving anesthesia or to keep emergency equipment on hand,
a basic requirement in a hospital or ambulatory care center.
Many good doctors take these precautions as a matter of
principle, but they do it voluntarily. There are others
who only do what they are forced to.
For the most part, patients do not know they could be at
risk. And what’s more, patients who are hurt or families
who sue after a death are often put under gag orders by
their attorneys during malpractice suits, so news of accidents
is seldom discussed publicly.
Wendy died, the Office of Professional Medical Conduct,
the arm of the state Department of Health that deals with
physician disciplinary action and review, told my family
it couldn’t do more than issue an “administrative warning”
to the doctor for his mistakes that resulted in her death.
One board doctor said, “A guy can literally do brain surgery
in his office with a knife and a spoon from his kitchen.
There is very limited control. And that is something, once
again, we live with, we are not happy with because we would
rather see greater control, but we are not in charge here.”
So who is in charge?
Department of Health does not have the power to regulate
doctor’s offices. Only the Legislature can give the department
that power. And patient-safety advocates say that is no
small task. As of this year, there are guidelines in place
that recommend reasonable precautions doctors should bear
in mind and implement at their discretion. But even this
measure was delayed by a lawsuit brought by nurse anesthetists.
These guidelines gain a little power because whether or
not a physician had met them could be a factor in a malpractice
investigation. They remain, however, nonbinding and optional.
The Legislature has floated bills that would require a reporting
system for medical errors in the state and establish a database
of doctors. But nonbinding guidelines and reporting provide
little solace to a family who believes a loved one’s death
could have been prevented.
I tell people that the Health Department does not regulate
physicians offices or inspect them on a regular basis, they’re
. . . they’re shocked,” says Assemblyman Richard Gottfried
(D-Manhattan), who chairs the Assembly’s health committee.
“I think the average citizen assumes that there must be
Health Department regulations governing physicians’ offices
and believes that they are periodically inspected like restaurants.”
In part, he says, this is because we very much want to believe
we are safe. And most of the time we are safe in our doctor’s
hands. The reality is, however, that invasive procedures
and surgery are increasingly happening within the confines
of private practices, making the lack of regulation of these
procedures a much more serious problem.
Office-based procedures are on the rise for several reasons,
including improved technology, lower cost, and patient convenience.
The practice of medicine became standardized in the wake
of a critical report about the field issued in 1910. As
a result of the report, reforms were enacted requiring that
doctors graduate from accredited medical schools, and states
were put in control of issuing licenses to qualified doctors.
Throughout the 20th century, the practice of medicine got
dramatically more complex, and much of it moved into hospital
we have increasing technology, increasing risky procedures,
and the wisdom was that those belong in places like hospitals,”
says Arthur Levin, director of the Center for Medical Consumers,
a nonprofit group that advocates for better quality health
care statewide and nationally. Part of that trend came with
the use of different types of sedation and anesthesia, as
well as operative improvements.
But hospital care was resource-intensive. The development
of short-acting anesthetics helped lead to the rise of day
surgery. This in turn led to the rise of ambulatory surgery
centers, licensed outpatient facilities that are required
to meet safety standards similar to the ones hospitals meet.
Many are even on the same property as a hospital.
huge amount—and we’re talking about 40 percent—of what was
done in inpatient moved to an ambulatory basis,” says Levin.
As technology improved, “and as it became clear that some
things weren’t so complex after all,” he says he believes
some doctors figured out that they could safely perform
the same procedures even in an office.
of procedures that might have previously required not only
the backup facilities of a hospital but a two- or three-day
stay, can now be quite appropriately be done on an outpatient
basis,” says Gottfried. “From the patients’ viewpoint, that’s
vastly more convenient, plus there are economic pressures
for outpatient surgery.”
For example, elective surgery, such as cosmetic surgery
that bears no medical necessity, is not covered by insurance
companies, and therefore can have a hefty price tag if it
is performed in hospitals. So plastic surgeons have moved
many of these procedures into their offices in order to
accommodate more patients at lower prices.
Beyond plastic surgery, many other disciplines have begun
performing invasive procedures and surgeries in their offices
that were once reserved for outpatient surgery centers and
hospitals. The only trouble is that when the procedures
moved to offices, the regulations that previously covered
them in hospitals and centers didn’t follow.
sort of have regulation and attitudes that go back to early-20th-century
medicine,” says Levin. It has been collective wisdom that
the state should license hospitals and ambulatory surgery
centers and make those places meet particular standards
of care, which includes having procedures, equipment and
staff in place for emergencies. If that’s the prudent and
intelligent way to patient safety, Levin charges, “how does
it make sense that when we do the same thing with the same
risk in an office we don’t make the same requirement? Either
we have been overcautious and have held hospitals and other
facilities to a ridiculous standard, or we’re simply dropping
the ball on office-based procedures. It makes no sense at
all [if you require these things] in a place where you have
lots of highly trained personnel, lots of equipment, lots
of experience with dealing with patients who are in trouble,
who have a bad reaction to anesthesia or go into cardiac
arrest, that you then allow the same risk to occur in an
office-based setting where you might have a physician and
a receptionist. [There], when a patient goes into cardiac
arrest, it’s call 911 and wait for an ambulance.”
think that notion of the physician’s office being unregulated
is a totally out-of-date concept, and has its roots in an
era when there was very little public health regulation
at all,” says Gottfried.
To regulate anything about physicians’ offices, the government
has had to jump through flaming hoops. The only three things
regulated thus far are radiology, clinical laboratory work,
and infection-control measures. Gottfried points out that
when the Health Department adopted regulations regarding
notifying pregnant patients about HIV, the regulation could
apply only to private practices that were “involved with
health-department-licensed HMOs.” The department had to
use the hook of regulating HMOs in order to regulate something
minor in a doctor’s office.
Blair Horner, legislative director of the New York Public
Interest Research Group, sees evidence that patients are
at risk in both regulated settings (hospital and surgery
centers) and unregulated settings. He says, “Because it’s
more well-documented, we know there’s a huge amount of people
that get injured or killed due to medical mistakes in the
hospital. It’s got to be worse in an unregulated setting.
The only silver lining is they don’t typically do open-heart
surgery in an office, or brain surgery.”
There isn’t good data on the rate and scope of medical errors
during office-based procedures, which makes the job of advocating
for regulation difficult. In part this is because physicians
in New York are not required to report medical errors in
offices. Levin, however, cites a study from Florida (a state
that actually regulates office-based procedures and has
error reporting), published in the Archives of Surgery
in 2003. That article indicated that doctors can’t respond
to emergencies, like cardiac arrest or anaphylactic drug
reactions, in an office setting as well as in hospitals
or centers. The study also found that a patient was 10 times
more likely to be hurt due to a mistake in an office. Florida
was one of the first states to require the reporting of
medical errors in offices by physicians, something New York
legislators have tried in vain to pass for years.
Along with Florida, New Jersey, Rhode Island and Texas all
have some regulations in place governing office standards
of care. The unfortunate truth is that states with regulations
in place have usually put them there after experiencing
some highly public horror stories.
“As the evidence—meaning bodies—pile up on this, I think
it becomes more compelling that government has to act,”
Horner. “The problem, though, is political.”
The state Department of Health did not return Metroland’s
repeated calls for comment on this story.
Guidelines “basically set a floor, not a ceiling, for the
standard of care,” says Barbara Ellman, assistant director
for policy at the Medical Society of the State of New York.
The Medical Society, the statewide advocacy group for physicians,
worked with the Department of Health to develop the optional
guidelines currently in place and opposes further regulation
at this time. The society wants to see first if the guidelines
work, and then reassess. The society opposes reporting of
what it calls “non-risk-adjusted data,” which it says would
compare doctors who take high-risk patients with those who
don’t. In her experience, Ellman says physicians have been
eager to meet the standards suggested by the guidelines.
While work was being done on drafting the guidelines, a
serious push to regulate office-based procedures was made
by now-former state Sen. Roy Goodman (R-Manhattan) and Gottfried.
Goodman chaired the Senate Committee on Investigations,
Taxation, and Government Operations, which issued a report
in February 1999 called “Problems of Office Surgery.” It
decried the lack of reporting and therefore lack of adequate
data on errors. Among its disturbing findings were examples
of doctors performing procedures in their offices that they
are underqualified to do (such as an ophthalmologist performing
breast enhancements), and that doctors commonly buy outdated
anesthesia equipment from hospitals that are getting rid
of them precisely because they are too old. The report also
said that even if the optional guidelines go into effect,
“there will be no way for the public to know which physicians
are following them and which are not.” As a result, the
report recommended that the state move to regulate office-based
At the time of this report, bills were introduced in the
Legislature that would have regulated office-based procedures
and required doctors to report medical errors that occur
in offices. Neither was adopted.
reality is that we don’t know the extent of the risk,” says
Levin. Because there is no requirement that doctors report
errors that occur in offices, New York suffers from a lack
of data. Previously it has been incumbent upon the patient
to report errors and file claims.
order to convince legislators that regulations are in the
best interest of New Yorkers, advocates believe that better
data is needed to prove that medical errors occurring in
offices are frequent and diverse, and often do not end well.
This means an important first step is getting incident reporting
“We developed a bill that would have merely required the
hospitals to report to the Health Department—not even the
doctors—if a patient came into the ER . . . based on what
they thought was the result of a surgical procedure at the
doctor’s office, they’d have to report that,” Horner says.
“The Medical Society
that at last second.” Horner is also quick to point out
that the Medical Society “has one of the largest PACs in
the state and an army of lobbyists and their clout to stop
The hospitals, however, were for providing this information.
Hospitals have to file patient discharge information, including
where the patient came from when he or she entered the hospital.
For hospitals to track patients arriving from doctor’s offices,
they would simply have to enter a new code in their preexisting
Hospitals do have a vested interest in seeing offices regulated
and errors reported. “Right now, almost half of surgeries
are done out of a hospital and maybe nearly half of those
are in an office,” notes Horner. “As that percentage rose,
hospitals have to view that as an economic disadvantage.”
Hospitals are concerned about the quality of care, but also
about making the playing field more economically level,
according to Matt Cox, a spokesman for the Healthcare Association
of New York State, which represents hundreds of health-care
year, health care will be on the state’s legislative agenda
because the Health Care Reform Act, which governs all health
policy for the state, expires in December 2005 and must
be renewed. This provides an important opportunity for advocates
interested in improving the quality of care. The Healthcare
Association and health-care-quality advocates indicate that
regulating and reporting requirements for office-based procedure
is on their radar for the coming year.
While legislators indicate that full regulations are many
steps down the legislative path, smaller steps can be attempted
in the meantime, such as passing reporting requirements.
Levin suggests that the state could also make it professional
misconduct for a physician to perform a procedure in an
office that he or she couldn’t perform in a hospital. “That’s
not a guarantee of anything, but at least it says that the
physician has privileges at a hospital and that the hospital
privileging process has decided this physician is capable
of doing this procedure,” says Levin. He adds that these
steps seem “so reasonable that it becomes embarrassing for
people to fight against it—not that they won’t.”
It is not that patients trust their doctors too much; it
is rather that they should be able to be so trusting. Until
there are standards of care in place for offices, however,
patients need to better educate themselves.
consumers should be as aggressive shoppers for health care
as they are for cars,” says Horner. He encourages people
to do their research. Medical consumers in New York can
look their physicians up online in the Department of Health’s
database and to check their credentials and if they have
disciplinary or malpractice histories. It’s also important
to verify that a doctor is board certified in the field
for procedures he or she is performing. “You don’t want
your ophthalmologist doing foot surgery,” Horner adds. Patients
should strive to have as much information as possible, not
only about the risks involved in certain procedures, but
about their doctors too.
Presuming safety does not make anyone safer. Patients’ care
relies on informed consent. If you don’t know enough about
a procedure, you should ask questions. It is important to
find out about a doctor’s emergency response training, how
long it takes to get to the closest hospital, and whether
they keep a “crash cart” containing emergency drugs, a defibrillator,
oxygen and an endotracheal tube, as well as other equipment.
Ask if you will be monitored during the procedure and/or
while under anesthesia. If you’re at all uncomfortable about
having an invasive procedure—no matter how minor—you can
ask if it can be done somewhere with emergency backup. This
is especially important for higher-risk patients including
children, elderly and obese people. Learning if your doctor
is credentialed to perform the same types of procedures
in a hospital is useful because it provides evidence of
advanced training and confidence in the doctor’s competence.
think [some doctors] view it as, they get the license, ‘Don’t
bother us unless we do something wrong,’” says Horner. “The
license is not divinely given, they get it from the public.
So the public has every right in the world to say, ‘OK,
we’ll give you a license, but we want you to do certain
things in addition to going to school.’ ”