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Despite Washington State Law, Medical Errors Will Likely Go Unreported

The Seattle Post-Intelligencer recently ran an important story about the reporting of hospital errors, and the reasons why the Washington law requiring this reporting is inadequate. Even though the story is specific to Washington state, it has implications for any other states considering a reporting law. The article states the most serious problems with the Washington law are:

  • No enforcement: There’s no penalty for those who ignore or violate the law.
  • It’s easy to dodge the intent of the law: The rules laying out which incidents must be reported make it easy for hospitals to determine that an error isn’t a “reportable error.” The definitions used in Washington are being rewritten to eliminate loopholes.
  • Hands-off oversight: The nurse who runs the state medical error reporting program receives and reviews reports, but said she takes no steps to investigate non-reporting. A lawmaker who co-sponsored the law says the program is supposed to do more to track down missing reports.
  • Underfunding: Washington has one of the worst-funded error reporting programs in the country.
  • Underreporting: Hospitals in Washington appear to be reporting less than a tenth of the events the law requires them to submit.

The article is lengthy, but worth reading. Here are the opening paragraphs:

Gary William Clezie told his daughter there was nothing to worry about before he entered Yakima Regional Medical & Cardiac Center for a simple outpatient arthroscopic shoulder surgery. She never saw him alive again.

Hours after the operation he was brain damaged, a result of nursing errors including a misadministration of pain medication, according to state investigation records.

He died two days later in February 2009, after family members agreed the 47-year-old construction worker could be removed from life support.

Clezie was one of thousands who are harmed each year by medical care in Washington hospitals, some fatally and some suffering serious disabilities.

Health care workers, facilities and regulators have been working for years to reduce the astronomical number of medical errors that occur annually.

But despite their efforts, the country has taken only baby steps toward reducing medical errors that injure and kill hospital patients.

One of the reasons mistakes continue to plague health care is that many facilities are not reporting their mistakes, despite state laws requiring that they do so. Experts say error reporting and analysis leads to improved care over time and ultimately saves lives.

Though Washington is one of 27 states that require hospitals and other facilities to report serious medical errors, just a fraction the errors that likely happen here are reported.

Washington’s medical error reporting program isn’t able to enforce the reporting law because it’s underfunded and lacks enforcement powers — and because the rules laying out which incidents must be reported make it easy for hospitals to rule that an error isn’t a “reportable error.”

Though Clezie was otherwise healthy when he went in for routine surgery, and died because of medical errors, Yakima Regional officials decided that the circumstances of his death didn’t fit any of the state’s 28 definitions of “serious reportable events.”

After the family filed a complaint about Clezie’s death with the state Department of Health’s licensing division, the Department of Health “determined that there was cause for corrective action against [the hospital,]” a letter from the DOH stated. The department required the hospital to make changes to improve care, health department documents show.

But state Department of Health officials agreed with Yakima Regional officials’ determination that they were not required to report the case. They agreed the circumstances of Clezie’s death didn’t exactly fit any of the 28 available categories, they said.

If Clezie had died within 24 hours of surgery, his death would have qualified as reportable under the category “intraoperative or immediately postoperative death” in a normal, healthy patient.

But he didn’t. Clezie stopped breathing for a long time. The staff revived him. He was brain damaged, but lived for another two days, so his death wasn’t considered an “immediately postoperative death.”

Another of the 28 categories, medication error, was also rejected as a reason to report the case.

According to state investigation records, Clezie was given a continuous “drip” of Dilaudid, a potent opioid pain medication, and he was outfitted with a device that allowed him to self-administer additional pain medication as needed.

The doctor ordered the Yakima Regional nursing staff to attach a device to Clezie that would monitor his blood oxygen level and would alert staff if the amount of oxygen in his blood fell below a certain level. If that happened, staff were instructed to call a doctor, take Clezie off the self-administered drug device, and give him oxygen.

But the blood-oxygen monitoring device was not attached to Clezie. And when his blood oxygen level was measured below the defined level — at 12:01 a.m. of the day he stopped breathing — the staff did not call the doctor or take him off the self-administering drug device.

Not long afterwards, still early that morning, he was found not breathing. His heart was re-started, but he suffered “degeneration of brain function due to lack of oxygen due to respiratory arrest” according to the complaint intake form.

Based on these errors, the Department of Health ‘determined that there was cause for corrective action against [the hospital].”

But while “medication error” is one of the state’s 28 reportable errors, the hospital decided — and the health department agreed — the errors in Clezie’s case did not meet the definition of a reportable medication error.

“The patient’s death was the result of improper oxygen saturation,” explained Karen Jensen, assistant health department secretary for health systems quality assurance. “And yet we don’t have any information that the patient — upstream — died of any overdose.”

And so, there’s no mention of the Clezie case on the state website that publishes reported medical errors. Instead, the website says Yakima Regional has a spotless record going back four years — zero mistakes.

Kathy Whitener, Yakima Regional’s vice president for risk/quality management, said in an email: “The Department of Health law related to reporting adverse events is very clear, and Yakima Regional complies with all reporting guidelines.”

The flaws in the medical error-reporting program are nothing new. A year ago, a nationwide investigation by Hearst exposed serious problems with medical-error reporting programs in Washington and in other states.

Efforts in the past year to correct those problems have fallen short, a follow-up Hearst investigation has found. The most serious problems with the program include:

  • No enforcement: There’s no penalty for those who ignore or violate the law.
  • It’s easy to dodge the intent of the law: The rules laying out which incidents must be reported make it easy for hospitals to determine that an error isn’t a “reportable error.” The definitions used in Washington are being rewritten to eliminate loopholes.
  • Hands-off oversight: The nurse who runs the state medical error reporting program receives and reviews reports, but said she takes no steps to investigate non-reporting. A lawmaker who co-sponsored the law says the program is supposed to do more to track down missing reports.
  • Underfunding: Washington has one of the worst-funded error reporting programs in the country.
  • Underreporting: Hospitals in Washington appear to be reporting less than a tenth of the events the law requires them to submit.

According to a federal study released in March, underreporting is the norm: the Heath and Human Services Inspector General reported that 93 percent of serious adverse events in hospitals went undetected by the hospitals’ own internal reporting systems.

Dr. Brent James, chief quality officer at the Intermountain Healthcare hospital chain in Utah and one of the nation’s top experts on medical errors, said nurses and doctors at his hospitals routinely review patient records looking for medical errors, with an eye toward figuring out what’s going wrong so they can fix problems and improve care over time.

Based on those reviews, James and another scientist concluded that “serious reportable events” as defined by Washington happen at a rate of about 1 per 1,000 to 1,200 “patient days.”

According to that measure, there are likely at least 2,200 reportable incidents a year in Washington. Last year, facilities reported only 198 to the Washington health department.

“They are very clearly missing the vast majority of events,” said James. “The evidence of that is overwhelming if you look closely, not just in Washington but all over the country.”

James said in his view the Clezie incident “unquestionably” should have been reported to the state’s medical-errors reporting office, at least as a medication error. Maybe there is no absolute proof that a Dilaudid overdose killed Clezie, James said, but it is “so high on the list of causes there is no other credible candidate.”

Bryan Smith, the Yakima attorney who represents the Clezie family, declined to comment on the status of the family’s legal claim against the hospital.

Dr. Peter Angood — senior advisor for patient safety at the National Quality Forum, the organization that wrote the “serious reportable events” definitions used in Washington and other states — acknowledged problems in the wording of current definitions allow hospitals to find loopholes and avoid reporting events.

He said the National Quality Forum is rewriting the “serious reportable events” definitions in part to close the loopholes and eliminate ambiguities.

Angood said instead of looking for loopholes, hospitals should hunt for problems and uniformly report them and fix them in the interest of saving lives. But experts say, it’s difficult to convince facilities that public error reporting is in their interest.

Prospective patients, looking up a hospital’s record on the state website, could see those error reports and decide to take their business elsewhere.

And, the fear of malpractice lawsuits or harm to reputation makes hospital officials doubly cautious about reporting errors, James said.

Whitener said in her email that Yakima Regional “has implemented rigorous clinical processes to prevent, to the best of our ability, adverse events and achieve the best possible clinical outcomes.”

But James said, in his opinion, even with the best safety program, Yakima Regional’s spotless record would be “almost impossible” in a hospital setting that large. Nearly 7,000 patients spent 29,000 days at Yakima Regional last year; it is one of the largest facilities in the state that hasn’t filed any adverse event reports since the law went into effect in June 2006.

Washington’s 162 walk-in surgery centers were added to the list of facilities required to report this year. In the first two quarters of 2010 only four of them have reported a total of five adverse events.

Experts say that number is also incredibly low based on the volume of work being done in these facilities, which do more than 340,000 surgical procedures each year.

Responding to last year’s Hearst investigation of preventable medical errors, Democratic State Sen. Karen Keiser, the chair of the Health & Longterm Care Committee, introduced legislation in January to impose a $1,000-a-day fine on any hospital failing to report an adverse event.

The Washington State Hospital Association vehemently opposed the bill. As a result, it went nowhere, she said.

“We have found no evidence that fines change organizational behavior,” explained Cassie Sauer, hospital association vice president for communications.

“Our interest is in creating a culture of patient safety, reporting, and learning, not a culture of punishment where people would be disincentivized to report.”

Some experts agree fines might not be the answer. Monetary penalties can be counter-productive, driving information underground, they say.

However, under current law, the only action the state health department can take against a hospital for a law violation is shutting it down, or suspending its license, steps no one feels are realistic.

Keiser said she wants to make changes in the program, but she’s not sure how. The state is broke and hospitals resist higher fees. And punishment isn’t the best answer.

“I’d say we have more work to do,” she said.

According to the 2008 HHS report, four states impose fines for not reporting a medical error, including California.

Republican State Rep. Tom Campbell, chair of the House Environmental Health Committee, said it’s ironic the state can fine doctors and nurses for their medical misdeeds but not facilities.

Hospitals need more oversight, said the Pierce County chiropractor who has long championed patient safety.

“They feel they can do better when they are not under public scrutiny,” he said. “I don’t think history bears that out.”

Of the 27 states with medical error reporting programs, one in five, including Washington, don’t analyze medical error data and report the results, according to the HHS inspector general report.

Analysis of medical error reports is the most important aspect of any medical error-reporting program, said Dr. John Clarke, clinical director of Pennsylvania’s medical-errors reporting program. Without it, what’s the point?

Pennsylvania found that when it properly financed its state-run program, hospitals increased their reporting.

Washington’s 2006 reporting law required the department to hire a contractor to analyze medical error data, using money from the state general fund. But the Legislature authorized an amount far lower than what was needed. When bids were sought, the lowest proffer was far higher than the money the Legislature authorized. So a contractor was never hired.

Washington’s budget for the error-reporting program is $127,000 a year, with a small cutback planned for next year. That funds one full-time staffer.

States like Minnesota and Pennsylvania assess a fee on hospitals to pay for patient safety programs. Minnesota has a relatively well-respected feedback program with an annual budget of $410,000 a year. Pennsylvania does the best studies, with a $5 million annual budget.

Selecky said Keiser and others in the Legislature “might want to revisit” the law that created the reporting program, providing more money for analysis of adverse-event reports and more enforcement.

“Clearly at the beginning of this law there was a desire and intent by the Legislature to do a lot more but there were never enough funds,” the head of the health department said.

Selecky said she would “definitely be open to” a fee on hospitals to finance the analysis of medical error reports. She said as it stands — with the state’s budget crisis — it is possible the department’s medical-errors reporting program could be cut altogether.

Sauer said that Washington hospitals would be more aggressive about participating in the state’s program if they got feedback in return. The hospital association has asked the state’s largest hospitals to submit their state reports to the hospital association so it can do its own private analysis.

Washington’s program also is among the worst in the nation for enforcing its reporting requirements. At least 16 of 27 states with mandatory error reporting programs investigate hospital compliance by comparing medical-error reporting rates with other data like patient complaints and medical malpractice settlements, according to the HHS inspector general report. Four states conduct onsite audits.

But Linda Furkay, a nurse who single-handedly runs Washington’s adverse-event reporting office, said she has no idea whether facilities are complying with the reporting requirement — and she doesn’t do any detective work to find out.

She said the law calls for a “non-punitive” approach — she interprets that to mean her program should not track down and investigate missing reports.

She said she doesn’t even want investigators from other Department of Health programs to refer unreported cases to her, because it’s not her job to investigate missing reports.

“There’s a wall between the programs (in the health department),” she said.

Keiser, who co-sponsored the reporting law, said the department is supposed to investigate missing reports.

The non-punitive clause in the statute was intended to assure hospitals that they would not be punished for reporting the errors, she said.

Selecky and Jensen said they are aware of Furkay’s interpretation of the law and they authorized it. Jensen said when the program was designed, they kept the licensing and medical-errors reporting programs separate to honor the non-punitive nature of the program. Another reason, though, was the lack of funding.

Not a lot can be done with a one-person office, Selecky said.

“If we had a more robust staff, we may be able to design a deeper system,” Selecky said.

Asked for her assessment of the health department’s medical error reporting program, Selecky said “given the limitation of funding that we have, given how the law was written, I am very pleased we have an adverse event reporting law in the state.”

Jensen admitted that with the current approach she, too, has no idea whether hospitals are complying with the law.

“We can’t know what we don’t know,” she said.

To her credit, Furkay diligently contacts hospitals, urging their participation in her program. She reviews the accident information sent to her office to assure that the mandatory root-cause analysis reports answer all the required questions. She participates in hospital-association medical error discussions.

She said because of the workload she has a sizable backlog of reports to check.

She has assembled a statewide advisory committee. Her website contains consumer tips and reporting guidance for hospitals, including a decent frequently-asked-questions section.

Her office took another small step last year to improve reporting of adverse events. It asked hospitals to affirmatively state each quarter — yea or nay — whether they have experienced any “adverse events.”

Previously, some hospitals had never even communicated with the adverse-event reporting office. Reports from hospitals have increased during the first two quarters of 2010, perhaps as a result.

But are consumers getting good data?

While Yakima Regional appears to have a clean slate, the competing hospital in town, Yakima Valley Memorial Hospital, has reported 10 of them.

Does that mean Yakima Valley Memorial is less safe? No, said James, it more likely means the hospital is studying its mistakes and is working to improve.

Nicole Donegan, spokesman for Yakima Memorial, said her facility tends to “err on the side of reporting events” even if, in the end, their submissions to the state don’t turn out to be reportable errors.

She said her hospital learns from every mistake, makes changes and feels “transparency is best for the hospital.”

“The risk in this whole game” for health-care providers is that they will look bad compared to their competitors if they report all their errors, said Judith Hibbard, a University of Oregon professor of health policy who conducted a study in Wisconsin six years ago showing that publishing the numbers encourages hospitals to make safety changes.

Hibbard said the benefits of public reporting of medical errors far outweigh the risks. Her study showed that when medical errors were discovered in hospital records, the facilities whose problems were publicized did far more to fix them than facilities whose problems were kept private.

Moreover, she said, when consumers don’t have information on the safety of their hospitals they are forced to make “a risky blind choice.”

“The issue is getting the regulatory bodies to make sure this information is valid,” she said.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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