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Last updated: Tue. Sep. 30, 2008 - 10:42 am EDT Bookmark and Share Subscribe RSS   E-mail

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Surgical errors may be reported inaccurately
Flawed rule could be behind low numbers at outpatient centers.
By Jennifer L. Boen

Nearly half of all surgical procedures in Indiana are done in non-hospital, free-standing outpatient, or ambulatory, surgery centers, and they report a much lower rate of surgical errors than hospitals.

Are ambulatory centers accurately reporting errors? Granted, fewer errors are expected, because ambulatory centers do less-complex surgeries than hospitals, where trauma, brain and cardiac surgery is done. But a flaw in the state's rule for reporting errors in ambulatory centers may also be a contributing factor, said Dr. Judy Monroe, state commissioner of health.

“The way the rule currently reads is that the health care facility that is responsible for reporting is the one where the error has occurred,” she said. Yet few people return to an ambulatory center for post-operative complications. Such patients go to an emergency room, the surgeon's office or to their primary-care doctor. Therein lies the rub.

“We hope that hospitals would communicate back to us,” Monroe said, but admits there is nothing in the current medical-error reporting rule that requires it.

Only four surgical errors - one per every 146,000 surgical procedures in ambulatory centers - were reported in 2007, according to the state's most recent data from the Hospital Medical Error Reporting System.

Hospitals reported 45 preventable surgical errors, or one in every 27,000 surgical procedures in 2007, including surgeries among inpatients and outpatients.

Beginning early next year, the state plans to add a new reportable error: hospital infections, specifically those that develop in a patient's intravenous or central line where medications are given, and pneumonia that develops after admission.

The Indiana State Department of Health will be taking public comments on the infection-reporting proposal soon. “We hope to have the new rule in place soon after the first of the year.”

Post-surgical infections or complications are at the center of a resolution passed this month by the Indiana State Medical Association's governing body. The group has called for a study on the need for peer reviews of all doctors in the state, including those who do not have hospital privileges. Currently, hospitals have peer-review boards where complaints or problems involving doctors are handled, but for doctors without hospital privileges, there is no tracking mechanism on surgical complications unless an individual lodges a complaint with the state medical licensing board.

That is why Fort Wayne obstetrician/gynecologist Dr. Geoffrey Cly is seeking passage of a regulation by the Allen County Commissioners that would require doctors who do surgeries involving tissue removal have hospital privileges, which would include doctors working at abortion clinics.

“A month or two ago, I had a woman come who had had an abortion at the local abortion facility. She came to me a week later with cramping, bleeding, infections. I have that documented on the pathology report there were pieces of the fetus left inside. A serious infection had developed because of the failed abortion,” Cly said.

When the woman contacted the abortion clinic to ask for her money back, Cly said, she was told, “‘You must have gotten pregnant again,'” an impossibility so soon after an abortion. “They're just denying what happened. They're not taking ownership,” he said.

Fort Wayne's only abortion clinic, 2210 Inwood Drive, is owned and operated by Dr. George Klopfer of Illinois.

Cly said he's had five or six women in the past year or so with post-abortion complications. Despite an outcry from some that the regulation would limit abortion availability in the community, Cly maintains much more is at stake than oversight of just abortion doctors.

“A lot of outpatient gynecology procedures are going on in doctor's offices,” procedures, he said, that just a year or two ago were done in surgery centers under general anesthesia. “Insurance is reimbursing extremely well. There's three times the profit for the doctor if you do it in the office rather than the hospital. But there's no regulation for all of us doing these in the office.”

One example is uterine ablation, a 10-minute laser procedure used to seal the uterine lining for controlling excessive bleeding.

An alternative to tubal ligation for permanent birth control is the Essure system. A titanium-nickel micro-device inserted into the fallopian tube encourages tissue growth around the insert, which blocks the tube. Once done mainly under general anesthesia, it is more commonly done now in the office under local anesthesia.

Although Cly does not implant the Essure system, he said, “I had one patient who had a horrible complication.” The device perforated the tube.

In the future, certain orthopedic or other laparoscopic procedures could be done in a doctor's office, and State Health Commissioner Monroe acknowledges technology is changing so quickly it is difficult for state regulations, including the error reporting system, to keep pace with patient protection needs.

“As this matures, we may need to stop and see how the rules are written,” she said. While two years of data from the reporting system is not enough to draw conclusions, “if we consistently see abortion clinics are zero” for errors, and ambulatory surgery centers' errors do not go up - which is what is expected in the next few years if they are fully disclosing - “it does beg the question of what changes need to be made. It could require legislative action.”

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