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New rules set up to help fight surgery mix-ups
WASHINGTON -- Starting July 1, operating rooms are supposed to be a little safer: Surgical teams must take new steps to prevent operating on the wrong body part or wrong patient.
Among the requirements: Much as airline pilots go through a safety checklist before takeoff, surgeons and nurses must take what's being dubbed a "time-out" before cutting. It's to double-check that the right patient is on the table, if he's really to lose a kidney and not a gallbladder -- and if so, on which side.
Hospital regulators hope the new rules will finally put an end to growing reports of wrong-site, wrong-procedure and wrong-patient surgeries.
"These should never happen," says Dr. Dennis O'Leary, who heads the Joint Commission on Accreditation of Healthcare Organizations. The agency can revoke the accreditation of hospital or other surgical sites that don't comply with the new safety steps.
This isn't wrong surgery because of a misdiagnosis, but mixups inside the operating room. In one infamous 1995 case a doctor amputated Willie King's wrong foot; indeed, the mixups are thought to be most frequent in orthopedic surgery.
But reports range the gamut from removing the wrong organ to drilling into the wrong side of a patient's skull to a recent case where the wrong patient was given a heart catheterization.
No one knows exactly how many such wrong surgeries occur, because the commission receives only voluntary reports, although they're a small fraction of the nation's 70 million annual surgeries.
Rushed pace of ORsStill, despite issuing two warnings to hospitals and surgical centers in recent years, the regulatory agency knows of 275 cases since 1999 -- a steady increase each year and a problem it calls undoubtedly undercounted.
Consider the rushed pace of many operating rooms, where it's easy to wheel in the wrong patient from a line of waiting stretchers, or to position X-rays backward as bustling workers ready dozens of high-tech gadgets.
"People should not underestimate the potential for confusion," O'Leary says. "The fact that you have M.D. or R.N. after your name doesn't keep you from making mistakes."
His regulatory agency is betting that if surgical teams have a mandatory system of double-checks, they can catch mixups before a patient is harmed. Among the rules:
The surgeon must literally sign the incision site, while the patient is awake and cooperating if possible, with a marker that won't wash off.
Some doctors, and patients themselves, already do that voluntarily, but regulators found a confusing hodgepodge of styles. An "X" can mean "operate here" or "not here," and writing out "not this knee" backfires if the "not" gets smudged. So, don't place any mark on a non-operative site, the new rules stress. Avoid "X" in favor of doctor initials or some other mark used hospital-wide.
The entire operating team must stop all other work just before surgery begins and go through a checklist to ensure the correct patient is on the table, and that everyone -- surgeons, nurses, anesthesiologists, technicians -- agrees what procedure is being done, on what body part. Have a system to resolve any confusion.
"My rule was you do not hand a knife to any surgeon until everything's cleared up," says Tom McLaren, surgical services administrator at Florida's Tallahassee Memorial Healthcare.
A growing awarenessThat rule averted one disaster at his previous hospital, McLaren recalls: A surgeon was ready to slice into a right kidney while a nurse argued for the left one. Technicians pulled back the scalpels as the frustrated doctor pointed to the posted X-ray -- which a radiologist later noticed was placed backward.
"Many people believe, 'this could never happen to me, that happens somewhere else,"' laments Bill Duffy, president of the Association of periOperative Registered Nurses.
But there's growing awareness that any health worker can make such a mistake, and more than 40 medical organizations, such as the American Academy of Orthopaedic Surgeons and Duffy's nursing group, now have signed on to help the accreditation commission teach the new rules.
O'Leary also has some consumer advice: speak up if you're about to be anesthetized without seeing signs that the surgical team has double-checked your identity and your surgical site.