These instances are referred to as "never" events, meaning they are never supposed to happen. But even though they are reported in a small percentage of surgeries, they occur with alarming regularity.
Surgical equipment inadvertently left inside patients after procedures and operations accounts for the second-most-common preventable adverse event in acute care, behind serious pressure ulcers, or bed sores.
In the latest fiscal year, California hospitals reported 197 cases of "retained foreign objects" for a total of 350 incidents over the past two years. They accounted for 14 percent of all preventable errors reported during those two years. That's out of 2,446 adverse events reported in California from July 1, 2007, through Dec. 31, 2009, according to the state Department of Public Health.
In 29 of the cases involving a retained foreign object, the state deemed the problems serious enough to issue fines, according to public health officials. Three years ago, a new law gave state public health officials the authority to issue administrative penalties for violations that put patients at risk of death or injury.
Reducing mistakes
The state intends to use $800,000 of the almost $3 million in such hospital fines that have been collected since 2007 to research how to help hospitals reduce their chances of leaving objects behind after a surgery or procedure. The funds have been approved, but will not be available until after a state budget is signed.
"We really want to drive change. Penalties are one way of driving this change," said Kathleen Billingsley, deputy director of the state public health department's Center for Health Care Quality.
Billingsley said that many hospitals have begun making significant improvements to their quality systems in response to their mistakes.
San Francisco General is one such hospital. This year, the hospital was hit with a $25,000 fine for a 2008 case in which a surgical sponge, the most common object left behind after any procedure, was discovered in a patient three months after she had endured more than eight hours of surgery to treat two types of cancer.
The surgery required two surgical teams to remove the patient's uterus, fallopian tubes and ovaries, to resection her bowel and colon and to reduce the size of the tumor. There were complications of massive bleeding, and the surgery had to be conducted in two stages over the course of a couple of days.
The surgical teams conducted a routine counting of equipment after the operation, but missed a 4-by-8-inch piece of surgical sponge that had been used to stanch the bleeding. It was later removed, and the patient, who the hospital will not identify because of privacy laws, continues to seek care at the hospital.
"This was a very unfortunate incident and, whether or not there was a fine involved, we would have addressed this very seriously," said Dr. Todd May, chief of the medical staff for San Francisco General.
The health implications of leaving items in patients' bodies varies widely depending on the patient and other complications.
May said the case motivated the hospital to make several key changes. For one, the hospital no longer uses sponges that small for abdominal surgeries. Now patients who undergo surgeries identified as high risk for a retained object undergo a low-dose X-ray to detect anything left behind. Sponges used in those procedures now have a special strip that will show up on the scans.
Inspection before closure
Under San Francisco General's revised policies, any member of a surgical team, including all nurses and technicians, are required to examine the incision before closure and permitted to call for an instrument recount at any time. The hospital has had no further incidents of retained foreign objects.
Other techniques being explored by hospitals include radio-frequency detection systems and bar codes on the equipment, said Dr. Niraj Sehgal, UCSF associate professor in hospital medicine and the associate chairman of quality and safety in the department of medicine.
While some solutions seem simple, no one solution works for all hospitals, Sehgal said. While some technologies can decrease the likelihood of error, medicine is practiced by humans.
"There's an element there that still relies on a human to be perfect," he said, "and humans are not perfect."
The federal government also has begun to focus on "never" events. In 2008, the Centers for Medicare and Medicaid stopped reimbursing hospitals for the cost of caring for patients who experienced "never" events such as retained foreign objects after surgery. The theory is that hospitals shouldn't be paid twice for preventable errors - once for the initial procedure, and again for the follow-up treatment to correct the error.
Since 2007, California has issued 156 administrative penalties to 108 hospitals. These penalties carry fines of $50,000 for the first violation, $75,000 for the second, and $100,000 for the third or subsequent violations at the same hospital.
So far, $4.8 million in penalties has been assessed and $2.9 million has been collected.
Hospitals can appeal the fine by requesting a hearing, but they still must submit a plan to the state explaining how they intend to correct the problem.
'It's unfair and unsettling'
An attorney who represents hospitals that have appealed penalties accused the state of "terrorizing" hospitals.
"There's no statute of limitations, no criteria. You can get a letter a year later saying we're fining you $50,000 for a retained foreign object you reported a year earlier," said Mark Kadzielski, head of the West Coast health care practice for Fulbright & Jaworski. "It's unfair and unsettling to hospitals."
Officials from the California Hospital Association, a trade group that represents more than 400 hospitals statewide, acknowledged that the public reporting of the fines is difficult for hospitals, but they generally support the state's efforts to reduce the number of preventable mistakes.
"We all share the same goals," said Debby Rogers, vice president of quality and emergency services for the hospital group. "Using those funds to focus back on hospitals and areas we can approve is a great idea."
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