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Surgical errors rise in Mass. despite new controls

Many preventable mistakes cited, but few of them caused serious harm

Massachusetts hospitals are reporting more errors during surgery and invasive procedures, even after an intensive, decade-long campaign to reduce these mistakes — called “never events” because they’re preventable and, with reasonable precautions, simply shouldn’t happen.

Errors disclosed to state health officials since 2011 included anesthesia injected into the wrong leg, a guidewire left inside a patient’s vein, and a catheter threaded into a patient who didn’t need one, according to hospital safety leaders.

Several of them said the reported number of such incidents is rising as more care shifts to outpatient clinics, procedure rooms, and physicians’ offices, where administrators and caregivers generally have been less vigilant about implementing safety protocols of the sort required in most hospital operating rooms. Hospital leaders said they are doing a better job recognizing and reporting these errors and training staff.

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Many of the errors driving the increase are the sort which some caregivers view as less serious — improperly inserting medication tubing or administering local anesthesia, for example, and not removing the wrong kidney or cutting into the wrong side of the brain. But these less harmful mistakes still can cause pain and anxiety for patients.

“They are uncomfortable and unnecessary for patients and should never happen, even though there is not permanent harm,’’ said Dr. Kenneth Sands, chief quality officer at Beth Israel Deaconess Medical Center. “People have become more sensitized and reporting is getting better for when these events occur.’’

According to state data reviewed by the Globe, hospitals are projected to report 94 missteps during surgery and invasive procedures in 2012 when complete results are tallied, an increase of 65 percent over 2011. The 2012 projections are based on hospital reports for the first half of the year. The number of mistakes during surgery and invasive procedures is the highest since the state began collecting data five years ago, even as errors of all types, including preventable patient falls and bed sores, have declined.

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Some hospitals, including Boston Children’s and South Shore in Weymouth, did not report any surgical errors during 2011 and the first half of 2012, but nearly half of all facilities documented at least one.

The largest hospitals, including Massachusetts General and Brigham and Women’s, which do the most procedures, tended to report the greatest number of mistakes, many of them occurring outside their operating rooms. The Brigham reported 14 surgical errors during the 18-month period, 10 of them objects left inside patients, and 4 procedures on wrong body parts, including one case in which anesthesia was injected into the wrong leg of a patient. None of the patients suffered long-lasting harm, said Janet Barnes, executive director of compliance at the Brigham.

Mass. General reported nine surgical errors, including one where a wire used to guide medical staff as they inserted tubing into a vein was forgotten. Dr. Elizabeth Mort, vice president of quality and safety at the hospital, said it was removed without harm to the patient.

The case of mistaken identity that caused staff to insert a catheter into the wrong patient occurred at Beth Israel Deaconess, another large Boston hospital. Sands said new policies clarify who is responsible for making sure that the next patient brought into an exam room matches the patient on the schedule. A language barrier contributed to the error, he said. The patient, Sands added, did not suffer long-term harm.

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Some smaller hospitals, such as Jordan in Plymouth, and Cape Cod in Hyannis, also reported several surgical mishaps during the past year and a half.

The focus on reducing medical errors dates back to 1999, when the Institute of Medicine released a groundbreaking report revealing that tens of thousands of patients die each year because of preventable medical errors, including those that occur during surgery.

In 2009, an influential study published in the New England Journal of Medicine found that using simple checklists during major operations lowered deaths and complications by more than one-third. Since then, a growing number of hospitals have implemented checklists in their operating rooms, which require staff to confirm the patient’s identity and the site and type of procedure, among other steps, before giving anesthesia and again before making an incision.

Hospitals have been required since 2008 to notify the Department of Public Health about “serious reportable events,’’ including surgery on the wrong body part or the wrong patient, performing the wrong procedure, and leaving foreign objects inside a patient.

The health department — as well as the federal government — also prohibited facilities from charging insurers and government payers for services provided as the result of a serious reportable event, such as follow-up surgery to remove a clamp or sponge left inside a patient, as incentive to prevent these mistakes.

Part of the reason for the projected 2012 increase in Massachusetts may be that the list of errors that must be reported has grown. In October 2012, the state more clearly defined surgery to include invasive procedures such as biopsies, colonoscopies, and electroconvulsive therapy.

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Dr. Madeleine Biondolillo, director of Health Care Safety and Quality, said it's unclear whether actual rates of errors are going up, or whether hospitals are just recognizing and reporting them more often.

“When safety becomes a serious central concern as it should, reporting does go up,’’ said Dr. Donald Berwick, former director of the US Centers for Medicare and Medicaid Services and a national medical safety advocate who is running for governor in Massachusetts. “Hospitals will look worse before they look better. That is good news because they are noticing things that previously went below the radar.’’

Barnes said when Brigham and Women’s Hospital realized that the number of objects left inside patients was increasing in 2011, it pulled together a task force to look for common problems.

In one case, staff inserted two gauze packs into a woman to reduce bleeding after she gave birth. But because of a miscommunication among caregivers, only one pack was removed before she was sent home. Ten days later, the patient, in pain and unable to sleep, saw her obstetrician, who found the second pack and removed it. The woman wrote anonymously about her experience in a Brigham patient safety newsletter, describing the anxiety the error caused her.

Barnes said the group did not find common causes in the 10 cases of retained objects. But as a result of the case of the woman who gave birth, the hospital adopted a requirement that all women with vaginal gauze packs must have a thorough physical exam or x-ray before being discharged.

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In the wrong-site procedures that occurred at the hospital or its outpatient clinics, staff did not closely follow checklists that are standard in operating rooms, she said. The procedure wasn’t followed in these cases “because a lot of people view them as low-risk events,’’ she said.

Sands said Beth Israel Deaconess is working on the same issue, and has hired a doctor whose job is to improve safety practices in non-surgical areas of the hospital.

With checklists ubiquitous in operating rooms, surgical staff are battling another problem: fatigue.

Last year, Tufts Medical Center published a study in which medical students secretly observed operating room staff who were supposed to be implementing checklists. Researchers found that the entire surgical team was attentive just 82 percent of the time; sometimes caregivers had left the room to get equipment, were talking on the phone, or were conversing with one another.

“That was the problem — people didn’t stop what they were doing,’’ said Dr. William Mackey, head of surgery. “The more you do something, the more routine it becomes. You have to fight against the routineness.’’

The state health department reviews serious reportable events in a way that can make the underlying details of cases less transparent to the public. In other instances when a hospital harms a patient or makes a mistake that has the potential for harm, health department staff often inspect the facility and write a report describing problems, which is a public record. With serious reportable events, inspectors usually go onsite and issue a “statement of deficiencies.’’

The health department instead often uses special serious reportable event forms filed by hospitals to evaluate their improvement efforts. “We don’t have unlimited resources,’’ Biondolillo said.


Liz Kowalczyk can be reached at kowalczyk@globe.com. Follow her on twitter at @GlobeLizK