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Hospitals Are Not Reporting Errors as Required by Law

September 12, 2008

Pennsylvania and New Jersey have laws requiring medical providers to report errors.  Experts say that compliance with these error reporting statutes is spotty, at best.

By: Josh Goldstein - Philadelphia Inquirer Staff Writer

Two patients at Fox Chase Cancer Center in Philadelphia required additional surgery last summer after objects were accidentally left inside their bodies, state health investigators found.

Three patients at Mercy Fitzgerald Hospital in Darby had to be sent back to the OR last year to stop excessive postoperative bleeding.

At Abington Memorial Hospital, an elderly woman recovering from surgery for a broken hip in 2005 was left on a bedpan for at least 41/2 hours. She developed two open bedsores as a result.

None of the hospitals reported the problems, a violation of state law, according to the Pennsylvania Department of Health.

For several years now, hospitals in Pennsylvania and New Jersey have been required to report medical mistakes and serious complications to state agencies charged with reducing medical errors. But some hospitals aren't fully complying, undermining efforts to improve patient safety, experts say.

In New Jersey, five of the state's 80 hospitals failed to report a single preventable mistake last year, officials said. In Pennsylvania, some facilities didn't report any serious events or even the near misses that might have harmed patients.

""I don't know how many is enough, but zero is a bad number,"" said James Bagian, head of the Department of Veterans Affairs' National Center for Patient Safety.

""Anybody that is supposed to report close calls and has zero reports is clueless,"" he said. ""Management is asleep at the switch and just waiting until they kill someone.""

There currently is no way for consumers to know how local hospitals are doing. Agencies in both states declined requests by The Inquirer to release the number of reports from individual hospitals. So the public can only learn that a hospital isn't reporting mistakes in those rare instances when the health department cites it for failing to comply with the law.

Twenty-six states require hospitals to report mistakes, and by next year Massachusetts, California and Minnesota will make the reports public.

Hospital associations in both Pennsylvania and New Jersey say members are training more staff and working to improve treatment in everything from medication safety to fall prevention.

""We are only a few years into this process,"" said Aline Holmes of the New Jersey Hospital Association, and ""we have seen a steady increase in reporting.""

Pennsylvania's mandatory-reporting law, passed in 2002, established the Patient Safety Authority and requires hospitals to report events that result in death or an ""unanticipated"" harm. Hospitals are also required to report near misses.

New Jersey's 2004 law makes hospitals report serious incidents, based on ""never events,"" a list of 28 problems that should never happen. They include surgery on the wrong patient, an infant discharged to the incorrect person, serious injury from incompatible blood transfusions, and death or serious injury due to a medication error.

Since reporting began in February 2005, the health department has received 1,600 reports - about 20 per hospital for the 31/2-year period - and an analysis of each case.

""There is still some underreporting, and we are working directly with the hospitals to understand why,"" said Eliot Fishman, policy director of the New Jersey Department of Health and Senior Services.

Fishman said that the state had not cited any hospitals for failing to report but that it was helping them improve their internal safety systems.

Consumer advocates want more transparency so patients can make better health-care decisions.

""All the experts we have talked to have told us that there is not enough reporting going on to reflect the real number of major adverse events occurring in New Jersey hospitals,"" said Doug Johnston, chief lobbyist for AARP of New Jersey.

The senior citizens' group and Consumers Union are asking the agency to release hospitals' reports to the public, as it will do with hospital-acquired infection rates.

The New Jersey Hospital Association, which supports reporting, opposes public release of that information.

""It may present an unfair picture of what is actually going on . . . when we have some hospitals that are not reporting and other hospitals that are reporting,"" said the hospital association's Holmes.

In Pennsylvania, the authority's 2007 annual report noted reporting disparities. For example, while one large academic medical center reported one serious event for every 200 days of patient care, a similar hospital reported one every 12,500 patient days.

A few hospitals, the authority noted, submitted no reports at all.

How many should be reported? James Conway, a quality expert at the Institute for Healthcare Improvement in Cambridge, Mass., said on average a review of 100 patient medical charts reveals 40 instances of harm.

""The best we have found anywhere is 20 instances of harm and the worst is over 100,"" Conway said. ""Are all of those serious, reportable events? No, but it shows that even in the best hospitals, there is suffering and harm at a minimum, if not tragedy.""

In the five years since the Pennsylvania law went into effect, the health department has cited four hospitals in Southeastern Pennsylvania for failing to report serious events.

None was fined.

Both states could impose a $1,000-a-day penalty for each failure to report.

The foreign objects left in the patients at Fox Chase and the severe-bedsore case at Abington are considered ""never events.""

Delinda Pendleton, Fox Chase's director of quality management, said in a statement that the patients were informed of the mistakes in face-to-face conversations. She said Fox Chase recognizes that reporting such errors provides opportunities ""to learn and improve the already high quality of our patient care.""

Yashima White, a spokeswoman for Mercy Fitzgerald, said in a statement that the hospital staff didn't realize that postoperative complications rose to the level of requiring a report. All three patients bled excessively after their release from the hospital, she said, and had to have additional surgery. The hospital has now adopted the health department's approach to ensure such problems are reported.

Besides Fox Chase, Mercy Fitzgerald and Abington, Brandywine Hospital in Chester County was cited for failing to file any serious-event reports from October 2006 through March 13, 2007.

Brandywine's chief executive, Mark A. Betz, said the hospital's failure to report happened when it was between risk-management directors. Steps have been taken to correct the lapse.

John J. Kelly, Abington's chief medical officer, said the hospital acted quickly in the case of the patient left on the bedpan. It implemented training sessions for nearly 1,000 nurses and spent $2.6 million to install 250 beds designed to reduce pressure ulcers.

That's how the system is supposed to work, and why reporting mistakes and trying to fix them are critical to improving patient care.

""We apologized to the patient and her family and have taken measures to prevent something like this from happening again,"" Kelly said. ""We made a mistake. It was entirely avoidable.""

But he also noted that the state, prompted by a complaint from the patient's family, began looking into the matter so quickly that the hospital hadn't had time to determine whether or not the incident had to be reported.

Still, the numbers suggest underreporting is more than just a passing problem.

Calvin Johnson, the Pennsylvania secretary of health, said only people with their ""head in the sand"" would fail to see the problem of uneven reporting by hospitals. But he noted that with about 200 hospitals and millions of patient visits each year, it is impossible for the state to check every chart.

""It requires that something trigger the system,"" he said, such as a patient complaint.

Plaintiff lawyers said there were many cases to examine because of a large loophole in reporting requirements.

Hospitals don't report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority's board.

He said he thought one reason many hospitals don't want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn't report a problem, it doesn't have to send the patient that letter.

Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years.

Fixing this ""is not a priority,"" he added.

Others on the authority's 10-member board said the agency was working on more concrete definitions.

""We are trying to come up with a tighter interpretation,"" said Ana Pujols-McKee, chair of the authority's board and chief medical officer at Presbyterian Medical Center in Philadelphia.

McKee said the disparity in reporting just became apparent after three full years of results.

In 2007, the authority said hospitals and other health facilities reported 7,277 serious events and 204,706 near misses. Hospitals accounted for 99 percent of the reports.

While it's important to study each of those reports, it is at least as crucial to identify hospitals that are not participating at all, said Conway, of the health-care improvement institute.

""We cannot improve care unless we understand the problems,"" Conway said. ""There can't be safety without transparency.""