Patient advocate: Assemblyman Richard Gottfried. photo credit: Ellen Descisciolo

Would you go under anesthesia if your doctor’s only backup plan was to call 911?

Life and Death at the Doctor’s Office
By Ashley Hahn

He 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.

On 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 standards.

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.

When 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?

The 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.

‘When 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 settings.

“So 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.

“A 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.

“Lots 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.

“We 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.”

“I 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,” says 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 surgery.

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.

“The 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.

In 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 in place.

“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 killed 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 things.”

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 reporting system.

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 facilities.

Next 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.

“Clearly, 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.

“I 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.’ ”