Bone-Chilling Mistakes Hospitals Make And Why They Don't Want You To Know

Claire* was detained by security at the airport when the metal detector went off. Guards couldn’t figure out why. Eventually, they let her board the flight, but when she arrived home she immediately asked her doctor to order an X-Ray. The result: There in Claire’s abdomen, clear as day, was a retractor, a surgical instrument the size of a crowbar, somehow left behind from her recent surgery.

This story is not as unusual as we would all hope. Indeed, the story is instructive enough that it appears in the leading textbook on patient safety, “Understanding Patient Safety” by Bob Wachter. There’s even a well-vetted medical term for this kind of error: “foreign objects retained after surgery,” one among many scary mishaps labeled as “serious adverse events.” The Leapfrog Group, my nonprofit which represents employers and other purchasers of healthcare, has another name for these outrageous errors: “never events” – mistakes that should never happen, no excuses. Surgical never events – Claire’s experience, plus some other errors you don’t want to hear about during lunch, occur about 11 times a day, according to a study from Johns Hopkins. There is a host of grisly mishaps known to happen beyond the surgical suite in the walls of a hospital, from excruciating and fully preventable Stage 3 or 4 bedsores to collapsed lungs. When you count all the non-surgical and surgical never events, they happen about 200 times a day to Medicare beneficiaries alone.

Here’s the kicker: Though I don’t know Claire, I bet the offending hospital billed her for the surgery to remove the crowbar. They probably weren’t brazen enough to bill her to replace the missing retractor in the operating room, but stranger things have shown up on hospital bills.

Employers and other purchasers have long been outraged by these astonishing misadventures in hospitals, and they are tired of paying for them. In recent years, they’ve adopted a set of purchasing principles that include refusing to pay for never events and demanding an apology to the patient. It’s amazing that we even needed to establish such guidelines in the first place. But according to the Leapfrog Hospital Survey, while the majority of reporting hospitals committed to adhere to our guidelines, hundreds more refused.

A few years ago, after many battles, Medicare finally started requiring hospitals to publicly report on some of them, including the following nine events:

Foreign object retained after surgery

Air embolism

Pressure ulcers, Stage 3 and 4

Trauma and falls

Collapsed lung due to medical treatment

Breathing failure after surgery

Postoperative PE/DVT (a preventable and often deadly blood clot)

Wound split open after surgery

Accidental cuts or tears from medical treatment

We used these nine measures in our Hospital Safety Scores – letter grades assigned to more than 2,500 general hospitals warning consumers of their propensity for deadly mistakes. We found that some hospitals have many more of these never events than others. And the public deserves to know which hospitals protect patients best.

But the American Hospital Association (AHA) and its lobbyists disagree. They did not want hospital data on these never events, as well as some other terrible measures, publicly reported. They acknowledge these events happen, but they say the government wasn’t measuring them in a way that’s perfectly fair to hospitals.

Purchasers continually fight this effort to suppress reporting. The best-known and most well-respected national coalition of employers, unions and consumer advocates, the Consumer-Purchaser Disclosure Project, pleaded in a letter last year to Secretary of Health and Human Services Kathleen Sebelius, “When it comes to patient safety, we simply cannot afford – in either human or financial terms – to delay or derail progress toward greater transparency and accountability. Nor can we wait until the arrival of perfect measures before addressing patient safety gaps in our health care system.”

The hospital lobbyists nearly won suppression of never events. Last fall, the Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, announced they would stop reporting the never events listed above, plus other key measures. However, the agency recently told us they do, indeed, plan to continue reporting these measures, at least through 2013, so we’ll keep working with them to continue the level of transparency the public deserves.

The good news is that the administration has taken steps to identify other measures of patient safety for public reporting and pledges to tie Medicare payment to performance on those measures in the future. These are new measures of infection, errors and accidents. Just last month, CMS put out for public comment a proposed rule to make a number of important new safety measures public.

Last week, the hospital lobby submitted a 58-page comment letter complaining (among other things) that these measures aren’t perfect enough, but consumer and purchaser organizations responded, saying the measures, in fact, meet the requirements of good science and give the public the information we need to protect ourselves and our families.

Our advocates ask for reporting on more critical measures, faster and with more detail. AHA asks for fewer measures, reported later instead of now, and reported in generalities so you can’t discern among hospitals using the data. For instance, Leapfrog wants to end the exemption of Maryland, Puerto Rico and Guam from public reporting. We ask for data to be reported for each and every facility that calls itself a hospital; currently, CMS only reports data by hospital system, and a system can have several hospitals in a wide geographical area. (Patients care about their individual hospital, not what corporate system it belongs to. And we have found major differences among hospitals in the same network).

Meanwhile, before the ink was dry on its letter to CMS complaining about the imperfection of measures and requesting delays, AHA was quick to submit testimony to the Senate about its commitment to public reporting — as long as it’s on its own terms. AHA’s testimony asks for fewer measures to be publicly reported, and although the lack of progress nationally on patient safety is well established, the testimony reports glowing achievements by some of its member hospitals in improving on several important measures of performance. Ironically, the important measures it touts to Congress are among the same ones it tells CMS aren’t good enough for public reporting.

We can only hope for bipartisan common sense to prevail when hospitals ask to suppress information from the public that they themselves use to improve their performance. While we’re hoping for the right response from Congress, consumer and purchaser advocates will need all the support we can get to protect patients — and protect our right to know.

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Source: Forbes (Binder, 7/15)

FDA reconsiders generic drug warning labels

In a recent post, I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.

The Food and Drug Administration has been considering changes to its labeling rules aimed at giving generic drug users more protection. And last week, the Obama administration filed notice that the FDA's efforts are coming closer to bearing fruit.

According to the notice, the FDA is working on a rule that would "revise and clarify procedures for changes to the labeling" of approved drugs, whether they be name brand names, generics or biologics. The change would either enable or require -- it's not clear from the limited information released by the FDA -- drug makers to make public possible changes to their warnings while the FDA was considering them. And it would make clear that both the brand-name and the generic versions of the drug would have to change their warning labels in the event that the FDA acted on a proposed change emanating from either camp.

The FDA is expected to formally propose its new rule sometime in September.

At issue is something called a "changes being effected" supplement. When drug makers learn of adverse reactions to their products or have new reasons to doubt the adequacy of their warning labels, they're obligated to inform the FDA. The makers of brand-name drugs can seek approval for new warnings and are allowed to alert the public about such developments through a "changes being effected" supplement before the FDA acts.

Generic drug makers aren't allowed to do that, however, even though they are required to tell the FDA about new evidence that might demand a change in their warning labels. They have to wait until the FDA formally decides that the warning label for that drug -- and its brand-name counterparts -- must be changed. If the brand-name version is no longer being marketed, the FDA has some flexibility to work with the makers of generic versions to update their labels, a spokeswoman for the FDA said.

The notice filed Wednesday says the FDA's new rules "would create parity" between brand-name and generic drug makers "with respect to submission of [changes being effected] labeling supplements." That strongly suggests generic drug makers would be able to make unilateral changes to their warning labels too.

The implication of the new rule is that it would reopen the door to lawsuits by such victims as Karen Bartlett, who was disfigured and nearly blinded by an adverse reaction to a generic anti-inflammatory drug. The Supreme Court overturned a New Hampshire jury's decision to award Bartlett $21 million, saying that as long as the drug manufacturer complied with federal requirements to use the same formulation and warning label as the brand-name product, it could not be held liable under New Hampshire law for selling an unreasonably dangerous drug. Justice Samuel A. Alito Jr. said the state law put generic drug makers in an impossible bind because the only way they could avoid liability for products that prove to be unreasonably dangerous would be to change the warning labels that federal law forbids them to alter.

The FDA's new approach, however, may permit generic drug makers to give supplemental warnings about new or heightened risks before the agency formally approves changes to the label for the brand-name and generic versions of the drug. That, in turn, would invite lawyers for injured patients to argue in court that generic drugs were unreasonably dangerous if they could have carried such an extra warning but didn't.

The trade association for generic drug makers sounded a cautious note about the FDA's minimally detailed proposal. "Our members have a long history of working closely with FDA to ensure that Americans have access to safe, affordable generic medicines, and we look forward to working with FDA on this important issue," said Ralph G. Neas, head of the Generic Pharmaceutical Assn.

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Source: Opinio L.A. (Healey, 7/08)

Daughters say patient safety compromised at Dallas VA Hospital

Patient safety at the Dallas Veterans Administration Hospital is again being called into question.

Considered to be the agency's worst facility in 2004, the Dallas VA Hospital has received more than 30 certification agency complaints in the last three years.

And now, there are two more.

Two daughters agreed to discuss the deaths of their fathers and the conditions they say no veteran should have to endure.

The Veterans Administration is the largest health care system in the nation, serving more than eight million veterans a year. VA officials in Washington D.C. pledge “to never compromise the safety, security or well-being of veterans."

Sydney Schoellman says the government has shattered that pledge.

Her father, Korean War veteran Gary Willingham, trusted his care to doctors at the Dallas VA hospital. In November 2010, Willingham went to the VA for what his daughter believed would be a short operation to remove a tumor from his neck.

But six hours after surgery began, Schoellman said two doctors finally emerged. "They never really admitted that anything went terribly wrong,” she said. "They kind of just padded around that."

Schoellman said what they did tell her is that her father had lost a lot of blood, and that they had accidentally clamped off his carotid artery for six minutes.

When she and her family were allowed to see Willingham, she said she was in shock.

"What we saw wasn't the man we grew up with," Schoellman said. "That wasn't the man that we'd seen how many hours earlier." With his carotid artery clamped and his brain starved of oxygen, Willingham had, in effect, suffered a debilitating stroke. Schoellman's once-energetic father was now bedridden and would spend the next year before he died unable to eat or drink on his own. Outraged, Schoellman started to dig, asking for the detailed surgical notes from the day of the operation.

"I was informed by one of the employees at the Dallas VA that I should get those records before they disappeared," she said. Deep in the surgical notes Schoellman said she found a disturbing revelation: The carotid artery had been clamped not for six minutes — as she said she was told — but for 15 minutes.

"If we had known it was 15 minutes, we wouldn't have allowed the things that went on. We would have let him end his life with dignity and the grace he lived it with before the surgery," Schoellman said.

Willingham's family has since filed a formal complaint and a legal claim against the Dallas VA for improper care. Tammie Wilson has also filed a complaint with the Dallas VA, saying her father — decorated Vietnam vet Gary McGrew — was stripped of his dignity as well.

Admitted to the Dallas VA this past February with two broken arms, Wilson said her father agonized for hours without pain medicine. "They just dawdled and dawdled, and it might have been six hours in-between," Wilson said. "I would just keep going out to the nurses' station saying, "Please, please!' They would respond slowly, if at all."

Wilson said no one seemed to be aware that her father was in his final stages in a fight with cancer. She said nurses were still trying to feed him in the minutes he was taking his last breaths.

"Here comes this nurse, stirring up the same pills and the same apple sauce he had spit out the night before because he couldn't even take a drink of water," Wilson said.

Administrators at the Dallas VA have declined to discuss either of the complaints with News 8, saying they either can't due to pending legal action or to lack of proper authorization.

They also say the complaints filed against them with the Joint Commission, the hospital accreditation agency, have been investigated and closed. They said the VA "maintains a safe and sanitary environment" and "invite families to discuss their concerns and complaints ... through several means available to them."

Schoellman said the only means left for her family is the courts, along with her ability to speak out for the veterans who cannot. "These are some of the greatest national treasures that we have, and they walk in every day, and these families are blindsided by the pain and the agony of losing someone at the hands of people who are never held accountable," Schoellman said.

Last fall, News 8 investigated complaints about quality of care at the Dallas VA. The Inspector General with the Veterans Administration last fall also found excessive wait times and irregularities with referrals and appointments.

Rep. Eddie Bernice Johnson (D-Dallas) said her office has also received complaints.

"While I am unable to comment directly on any information I have received from my constituents, many of these complaints pertain directly to the quality and timeliness of patient care," Johnson said. "The VA’s own Inspector General reports — which are public record — bear out the delays and shortcomings in patient care."

“I have repeatedly expressed my concerns to the VA in Dallas and in Washington D.C., in direct response to those complaints," the congresswoman added. "The single most important responsibility of the VA is to meet the health challenges that our veterans face. While I have worked directly with [VA] Secretary [Eric] Shinseki's office on numerous occasions within the past year, the VA at the local and federal levels have not responded impartially to these complaints. It has always been my hope that the leadership at the VA would have taken their own initiative to address these issues. I will do everything necessary to address the concerns of my constituents and patients of the VA North Texas Healthcare System. So long as the VA’s ability to meet those challenges remains in question, I will not rest until these issues are resolved.”

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Source: WFAA (AP, 6/10)