August 11, 2014

Feds Quietly Stop Reporting Some Hospital Errors

We’ve long advised medical consumers to research hospitals they’re considering using for the kind and frequency of errors they make. But according to a story on USAToday.com, suddenly that’s more difficult than it used to be.

“The federal government this month quietly stopped publicly reporting when hospitals leave foreign objects in patients' bodies or make a host of other life-threatening mistakes,” the paper reports. That’s contrary to what the Centers for Medicare and Medicaid Services (CMS) is supposed to do, which is making available to the public data on hospital-acquired conditions (HACs).

Last year, according to USA Today, the CMS denied changing its data-reporting practice. But as of this month, the data for eight of these avoidable “conditions” no longer are being supplied.

So where is current information about hospitals with high rates of serious errors, including embolisms (obstruction of a blood vessel by blood clot or air bubble) and transfusions with the wrong blood type?

Hospital Compare is the CMS’ website for consumers to research hospital performance — you determine the nature of the search, either by location or hospital name. The site used to list how often many HACs occurred at thousands of hospitals that accepted patients with severe injuries or illnesses and/or while recovering from surgery. Now, says USA Today, CMS still reports the rate of occurrence for 13 conditions, including infections such as MRSA and sepsis after surgery, but has dropped others.

CMS told the paper that the changes are an effort to make reports "more comprehensive and most relevant to consumers," and that new measures using data from the Centers for Disease Control and Prevention (CDC) received "strong support" from a partnership of the National Quality Forum (NQF).

That’s a public-private enterprise that reviews performance measures that might be used in federal or private reporting and payment programs. Earlier this year, our blog, “Apparent Conflict of Interest Sullies Panel of Patient Safety Experts,” highlighted problems with a prominent physician in that organization.

Helen Haskell, a member of its Patient Safety Advisory Committee, told USA Today that some members of the hospital working group thought they were voting to strengthen, not drop, the measures.

"When we voted, I certainly didn't think it would result in the (hospital acquired conditions) being removed from Hospital Compare," she said. Founder of Mothers Against Medical Error, her son died in 2000 of a reaction to medication after surgery.

According to a spokeswoman for the NQF, it decided to drop the data because it wasn't "appropriate for comparing one hospital to another."

Um … isn’t that the definition of “compare”? Contrasting one thing with another of a similar type?

No reporting system is perfect, and the CMS and the American Hospital Association have questioned the reliability of the error data for things like foreign objects left inside the patient after surgery. But we wonder if the disappearance of important data has a political component — the Affordable Care Act (“Obamacare”) requires that the 25% of hospitals with the highest rates of certain HACs, including hip fractures or sepsis (severe blood infection) after surgery, receive less money from Medicare. And Medicare or Medicaid reimbursement also is withheld if treatment is related to one of the eight HACs.

According to USA Today, “CMS said it's working on new ways of measuring HACs that would represent some of the most common adverse events in hospitals; the HACs that are no longer publicly available are considered rare events that should never happen in hospitals. That makes them both harder to track — and, patient-safety experts say, more important for consumers to know about.”

The fact that they should never happen, but do, is exactly why the public should be able to find out if such events have happened.

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July 27, 2014

Senate Hears Testimony About Woeful Record of Patient Safety

Medical experts told a Senate subcommittee earlier this month that the health-care community’s efforts to monitor and prevent patient harm are insufficient. They implored Congress to do more to prevent deaths and injuries in hospitals and other health-care settings.

"Our collective action in patient safety pales in comparison to the magnitude of the problem," Dr. Peter Pronovost, senior vice president for patient safety and quality at Johns Hopkins Medicine said. "We need to say that harm is preventable and not tolerable."

"We can't continue to have unsafe medical care be a regular part of the way we do business in health care," said Dr. Ashish Jha, from the Harvard School of Public Health.

As reported by ProPublica.org, Jha claimed that patients are no better protected now than they were 15 years ago. That’s when the Institute of Medicine issued a groundbreaking report estimating that 98,000 hospital patients a year die from medical errors.

ProPublica, an investigative public interest site, supports an ongoing, interactive series on patient safety.

The hearing was called "More Than 1,000 Preventable Deaths a Day Is Too Many: The Need to Improve Patient Safety," in a nod to patient advocate John James. He also testified before the subcommittee, and recently referred to a study in his Patient Safety America newsletter that found that 440,000 patients die yearly from preventable medical errors. (see our blog, “Protecting Yourself from the Thousand-a-Day Toll of Medical Error.”)

Preventable harm, as noted by Sen. Bernie Sanders, the chairman of the subcommittee on Primary Health and Aging, is the third-leading cause of death in America. The experts said one reason why the situation isn’t improving is because medical providers and public health agencies don’t measure the harm accurately. If you don’t quantify the problem, it’s unlikely anyone will be moved to resolve it.

Pronovost and Jha want the Centers for Disease Control and Prevention (CDC), which collects data about hospital-acquired infections, to widen its perspective, and track other forms of patient harms as well. They include:


  • medication mistakes;

  • adverse reactions to and injuries from drugs; and

  • missed or delayed diagnoses.


Dr. Tejal Gandhi, president of the National Patient Safety Foundation, said medication errors and adverse events affect as many as 1 in 4 patients within 30 days of being prescribed a drug. She said outside measures are necessary to clean up this dismal reality. "We cannot just tell clinicians to try harder and think better," she said.

The National Transportation Safety Board investigates aviation accidents, and James suggested the creation of a National Patient Safety Board as a similar type agency to investigate patient harm. He also proposed a national patients' bill of rights defining protections like those defined for workers and minority groups.

Lisa McGiffert, director of the Consumers Union Safe Patient Project, advocated for greater communication about harm when it occurs. Raising consciousness of medical errors is the first step in empowering medical consumers to make informed choices about their care. And the bright light of publicity, she suggested, can only motivate providers to improve in their record of first doing no harm, which they all promise as part of their Hippocratic Oath.

We’re gratified that Congress seems to be interested in helping medicine to do far less harm than it does, and we hope the hearing is not the end but the beginning of meaningful action.

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June 30, 2014

Military Medicine: Much Malpractice, Little Oversight

The news is not surprising, but still shocking: the nation's military medicine system is rife with lapses in quality of care that hurt service members and their families, and very little is being done about it, according to a long investigative takeout in the New York Times.

I say not surprising, because attorneys like me who represent military families in medical malpractice lawsuits against the government for sub-standard care see a lot of the kinds of problems documented in the Times article.

Pregnancy and newborn care is especially vulnerable to errors that can have lifelong consequences when children are born with brain damage. The Times investigators reported that of the 50,000 babies born at military hospitals each year, they are twice as likely to be injured during delivery as the average for all newborns around the U.S.

Perhaps the most shocking thing the Times found is the lack of accountability and followup when patients are injured in the military system. In non-military hospitals, there is at least some effort made with what is called "root cause analysis" to get to the bottom of errors and try to prevent future harm.

Dr. Mary Lopez, a former staff officer under the Army surgeon general, told the Times:

"The patient-safety system is broken. It has no teeth. Reports are submitted, but patient-safety offices have no authority."

One problem the public doesn't grasp is that the military is immune from lawsuits when an active duty service member is injured by malpractice, even if the harm occurs thousands of miles from any battle front. That immunity stems from a 1950 U.S. Supreme Court case called Feres v. United States. Congress could pass a law overriding this judge-made immunity but has never done so. Meantime, there is a double-standard system: If a family member of a soldier or sailor is hurt by malpractice, they have a right to sue under the Federal Tort Claims Act. But a service member cannot sue.

That insulates the military medical system from a lot of the accountability that lawsuits could otherwise bring to the poor quality care.

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June 19, 2014

Harmed Patient Deplores Failure to Investigate Bad Surgical Outcome

Medical mistakes are a fact of life, and they’re always troubling. But the problem’s compounded when an adverse outcome has been reported and no one bothers to investigate.

That’s what happened nearly four years ago at the Cleveland Clinic when government inspectors investigating a claim threatened to sever the renowned facility’s right to receive Medicare payments because, according to a story on ModernHealthcare.com, they were stonewalled by hospital officials.

David Antoon, a retired Air Force colonel, had accused Cleveland Clinic of failing to investigate when he claimed that someone other than his authorized surgeon had performed the prostate cancer procedure that left him seriously injured.

Hospital personnel, according to reports from the Centers for Medicare & Medicaid Services (CMS), would not make available to the feds all of the notes in Antoon's complaint file, and the doctor who said he performed the surgery would not talk about how the hospital handled the case.

Before his surgery, Antoon was a commercial 747 pilot. The operation left him incontinent. He’s bewildered not only that the hospital compounded the problem of its own making, but that there’s no oversight agency in medicine similar to the one in his profession, the National Transportation Safety Board, that addresses safety failures.

“You cannot keep things concealed in aviation,” he told Modern Healthcare. In medicine, “They're just gathering data points from patient complaints. And every data point is a damaged life or a death.”

Like many hospitals, Cleveland Clinic Health System has a track record of burying patient complaints. As Modern Healthcare reports, in 2012, CMS inspectors threatened again to slam the door on nearly $1 billion in Medicare reimbursements when hospital officials acknowledged their failure to investigate a complaint that surgeons had implanted a heart stent without having the patient’s consent.

Last summer, Cleveland was threatened with suspension from participation in Medicare after its officials told a patient there was no evidence that a surgeon failed to remove a needle used in a procedure. The truth was that the hospital had an X-ray clearly depicting the needle.

Although the hospital wouldn’t make anyone available to be interviewed by Modern Healthcare, it defended itself in an email: “Cleveland Clinic sees more than 5 million outpatient visits per year, has nearly 160,000 admissions and the highest acuity [the sickest of the sick] of patients in the country. We are committed to providing the best care and safest environment for our patients.”

The clinic also blamed deficiencies in the state's inspection system for the high number of CMS deficiencies.

It’s true that pure numbers don’t give a complete picture of a hospital’s treatment and safety success; those with sicker populations necessarily will have poorer outcomes, in terms of pure numbers. But the troubling thing about this situation is the denial — of a problem, of access to information.

Modern Healthcare examined tons of federal inspection reports showing that, between 2010 and 2013, Cleveland spent 19 months on “termination track,” the term for a facility skating on thin Medicare ice because of patient complaints and insufficient follow-up.

Cleveland has lots of company; as reported in the magazine, the clinic “is far from alone in facing the only sanction the CMS can apply to hospitals when serious safety problems and violations of informed consent rules are brought to light by patient complaints. An analysis of Medicare inspection data found that between 2011 and 2014 there were at least 230 validated serious incidents … that led the agency to threaten hospitals with losing their ability to serve Medicare patients unless they immediately fixed the problems.”

During that window, at least 9,505 complaints were lodged with the CMS, involving 1,638 hospitals. Only the most serious complaints result in threats of being cut off from government funding, and only rarely do the feds make good on them.

The problem endures because of regulatory limitations: Unlike with nursing homes, the CMS doesn’t have the authority to levy fines against hospitals that violate the rules.

“The absence of meaningful sanctions,” says Modern Healthcare, “provides a loophole for officials at some hospitals to engage in prolonged negotiations with CMS inspectors when confronted with patient-safety complaints, which typically conclude with the hospital promising to revamp policies and beef up staff training. The result, safety advocates say, is a regulatory system unable to respond to problems in a manner that ensures the problems won't happen again once the inspectors have left the premises.”

One reason we have advised consumers to approach hospital ratings with a wary eye is because sometimes, serious incidents and responses to individual cases aren’t reflected in a hospital’s overall ranking. They don’t seem to have much impact on accreditation by the Joint Commission, the voluntary organization funded by hospitals and whose only enforcement power is to withdraw accreditation. “The commission, whose inspection reports are not made public,” Modern Healthcare reports, “has consistently awarded the Cleveland Clinic good quality-of-care ratings.”

Cleveland eventually corrected each problem cited by the CMS. Antoon, the former pilot, has become a vigorous patient-safety advocate who has an ongoing medical-malpractice case against the Cleveland Clinic and his physicians there. But, as he told Modern Healthcare, no amount of money can repair his physical or emotional damage.

“This stopped being about me a long time ago. This is about a fraudulent, broken medical system where patients are injured and nobody is accountable. The airplanes are still crashing. Doesn't anybody care?”

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May 4, 2014

Stemming the Tide of Misdiagnosis in Doctors' Offices

We know a lot more than we used to about diagnosis mistakes in hospitals, but a new study says that every year, at least 1 in 20 adults gets the wrong diagnosis in a doctor's office.

For more than 6 million U.S. patients a year, according to the authors of the study published in the journal BMJ Quality & Safety, these misdiagnoses can have major consequences and can amount to medical malpractice.

“The question is, can we eliminate human error, and the answer is no,” Hardeep Singh, lead author of the paper, told The Boston Globe. “We have just now begun to understand what [these errors] are and what we can do.”

Although hospital misdiagnoses aren’t news, said one Globe source, not many researchers have studied the incidence and consequences of outpatient misdiagnoses. We wrote about one such study published last year in JAMA Internal Medicine that showed essentially the same results as the new one in BMJ.

An outpatient error can be as minor as calling a cold an allergy, but it can be as major as overlooking cancer or stroke and causing a dangerous delay in treatment.

Lots of things complicate making a diagnosis, and making sure it’s correct. Doctors must find the right balance between overtesting and overtreating, and missing diagnoses that should have been given more attention and intervention.

And there isn’t even a clear, best-practice definition of diagnostic error. Different practitioners use different measures to define a mistake.

The BMJ researchers analyzed data from three earlier studies, two concerning cancer and one about diagnostic errors recorded in primary care electronic health records. They all used similar definitions of outpatient misdiagnosis.

Because misdiagnosis is complicated, it requires a multifaceted solution, the authors say. It requires the patient, the care team and the health-care system to work together to reduce mistakes. We’ve long been champions of this quality-control approach to delivering health care.

Another Globe source said patients must be involved, and assertive, and readers of this blog know we agree. Patients must tell their doctor about medications they take and problems they’re having. They must ask questions if they don’t understand something the doctor says, or if the doctor isn’t responding to them. Never leave a doctor’s office wondering what happened, what to do and what are the consequences if you don’t understand or follow instructions.

Patients should make sure all their caretakers — people they’re seeing for second opinions, specialists, physical therapists, etc. — have access to their medical data.

Doctors who aren’t completely confident in their diagnosis or treatment recommendation should ask colleagues for a second opinion. That’s often difficult for people in their position of authority, but it’s essential to prevent patient harm. And patients have the right, if not the obligation, to ask their doctor how confident they are of the diagnosis, on a scale of 1 to 10. If the confidence factor is less than 7 or 8, ask for a second opinion.

Expert analysts of the new study said systemic changes also are necessary to lower the rate of outpatient misdiagnosis. Physician support and follow-up should be standard operating procedure.

And when mistakes happen — and they will, no matter how good the care is — practitioners need to know. That’s the only way they can learn from them. According to one Globe source, “There’s a lot of learning that should be going on, that’s not.”

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March 24, 2014

Hospital Errors Remain Too Common Because of Doctor Deficiencies

The high rate of hospital medical errors has been acknowledged in all quarters of the health-care industry, and we’ve certainly done our share of blogging about it (“Why Can’t Hospitals Clean Up Their Medical Errors?”). Certain measures, such as the federal government’s error-reporting systems have been developed to address the problem.

But they’re not working, or at least not well enough, according to Dr. Philip Levitt, a retired neurosurgeon and former chief of staff of two hospitals. Writing in the Los Angeles Times, Levitt says, “American hospitals have a big problem with unnecessary deaths from medical errors. Estimates of the numbers vary widely, but extrapolating from the best studies, a conservative estimate would be that well over 100,000 people a year die unnecessarily because of errors made by their health-care teams. And the numbers have remained high despite concerted efforts to bring them down. Why? Because we've embraced a so-called solution that doesn't address the problem.”

Levitt reminds readers that the hospital error wake-up call was sounded in 1999, when the Institute of Medicine (IOM) issued a report, "To Err Is Human." It concluded that if hospitals implemented certain systems consistently, unnecessary deaths would drop by half within five years.

Since then, Levitt says, the medical profession has supported this “systems approach” that basically amounts to standardizing routine aspects of patient care. For example, no matter what hospital, no matter what patient, every heart attack victim is given an aspirin when entering the hospital; no matter what hospital, circumstance or patient, every surgical patient is given antibiotics just before the operation. Hospitals uniformly embrace checklists to ensure that all members of the treatment team follow accepted protocols.

Standardization, Levitt explains, wasn’t sufficiently tested in all medical applications. So the number of unnecessary deaths hasn't dropped significantly. He refers to a recent study in the New England Journal of Medicine that compared rates of mortality and complications in some Canadian hospitals before and after they began using surgical safety checklists. Here’s what the researchers found: "Implementation of surgical safety checklists in Ontario, Canada, was not associated with significant reductions in operative mortality or complications."

The reason, Levitt suggests, is simple: “Most preventable mishaps in hospitals are caused by the acts of individual practitioners, not flawed systems, and there was plenty of evidence of that fact available when the [IOM] wrote ‘To Err Is Human.’"

As so often is true in medicine, it comes down to people. The people who must apply art to science. The people who use the technology. The people who get paid, or not, for opting in or out of a certain procedure. Sometimes mistakes are not a human’s fault. But sometimes they are.

Levitt mentions several studies depicting human mistakes:


  • A 1991 Harvard Medical Practice Study examined more than 30,000 randomly selected records from 51 hospitals; more than 6 in 10 incidents of harm to patients were because of either errors of technique or the failure of doctors to order the correct diagnostic tests. Only 6 in 100 adverse events were due to systems problems.

  • A 2008 University of South Florida analysis of 10,000 surgical patients found that only 4 in 100 complications were attributable to flawed systems; the rest resulted from individual human shortcomings.

  • A 2013 Baylor College of Medicine study found that most failures to diagnose arose from deficient physician performance during doctor-patient interactions, including poor history-taking, inadequate physical examinations or ordering the wrong tests. The study suggested that systems remedies, such as checklists and electronic medical records programs, would not address missed diagnoses because the problem is rooted in the doctors’ thinking.

  • By 2006, more than 3,000 U.S. hospitals (more than 3 in 4 of the country’s acute care beds), had enrolled in a systems-based program called the 100,000 Lives Campaign, an outgrowth of recommendations in "To Err Is Human." In 2010, researchers from Harvard and Stanford examined patient harms in hospitals in North Carolina, which had an enrollment rate of 96%. The researchers found no reduction in preventable patient injuries between 2002 and 2007.


“The major studies of what causes preventable errors,” Levitt writes, “have mostly failed to examine whether some doctors had a disproportionate number of bad outcomes. That failure has caused researchers to miss the most significant source of patient harm: incompetent doctors.”

But the data do define the problem. A former chief statistician for the National Practitioner Data Bank (a nonpublic federal repository of information about health-care providers in the United States) examined medical malpractice suits nationwide. He found that 2 in 100 U.S. doctors were responsible for half of the payouts over a 20-year period. An Australian study of 19,000 complaints against doctors over a 10-year period found that 3 in 100 of Australia's doctors accounted for nearly half of all complaints.

“The institutions meant to protect patients from inept physicians are not doing an adequate job,” Levitt states.
Here’s why:


  • The average American hospital revokes the privileges of one doctor every 20 years.

  • Only 250, or 0.04%, of the nation's 650,000 physicians lose their licenses annually. “At that rate,” says Levitt, “it would take 50 years to remove the most dangerous 2% of doctors.”

  • Only 1 in 100 patient harms is reported by hospitals to the 26 state health departments that require such reporting. Because 6 in 10 such harms are caused by the acts of individual doctors, an essential method for identifying erring doctors is blocked.


“These things all need to be addressed,” Levitt concludes, “if we are to prevent even some of the 1 million patient deaths likely to occur in the next decade.”

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November 17, 2013

How Should a Doctor Handle Disclosure When Another Doctor Hurts a Patient?

A thoughtful analysis published last month in the New England Journal of Medicine (NEJM) grapples with the difficult position a physician is in when he or she believes a colleague has committed a mistake that hurt a patient.

It's an urgent question, and a common issue for those of us who represent patients in malpractice lawsuits. We frequently find that, as a new Pro Publica report shows, doctors who see another doctor hurt a patient turn away in silence because they don't know how to handle it.

The New England Journal article was a joint effort by several medical, legal and academic professionals representing patient safety, medical malpractice insurance and litigation, bioethics, and health policy.

They set up their discussion with this scenario:

A young neurologist practicing in a small hospital admits a woman with high blood pressure and diabetes who has had a stroke at home. In reviewing the patient’s medical record, the doctor sees that, during two electrocardiogram (ECG) tests in her primary care doctor’s office, the patient appears to have experienced atrial fibrillation.

Afib, as it’s known, is an abnormal heart rhythm that presents a risk of stroke, chest pain and heart failure, from blood clots that develop in the non-working atrium of the heart.

The primary care doc is an internist who refers many patients to the neurologist. He read both ECGs as normal and attributed the odd rhythms to “probable mitral-valve prolapse and anxiety.” The neurologist shows the internist the ECGs and expresses concern about Afib. He suggests that she is confused by noise from the old ECG machine, but two cardiologists the neurologist consults both say it’s Afib. The internist requests the neurologist to transfer the patient to his care.

The essay, “Talking with Patients about Other Clinicians' Errors,” discusses how doctors continue to struggle with the obligation to disclose errors even though the medical community agrees that there’s an ethical duty to communicate openly with patients who have been harmed by them.

“Existing guidelines emphasize the overall importance of disclosing errors, but (with the exception of the case study of the American College of Physicians Ethics and Human Rights Committee) they offer little guidance on disclosing others' mistakes; this lack of guidance heightens clinicians' uncertainty about what to do,” the authors write. “Consequently, patients may be told little about these events, and opportunities to build trust, ensure that learning occurs after errors, and avoid litigation may be lost.”

Sometimes it’s assumed that the doctor who discloses an error committed it, but health care can be delivered by many different clinicians in many different settings. Systems, as well as people, fail, and can play a role in adverse events.

When someone is trying to determine what happened, but was not directly involved in the error, one strategy is to talk with the involved colleague or colleagues about what happened, whether it was a harmful error and what, if anything, to tell the patient. In reality, though, lots of factors make this difficult: fear of how a colleague will react; cultural norms of loyalty, solidarity and “tattling”; reluctance to risk an unfavorable reputation with colleagues; power differentials associated with seniority, gender and race; dependence on colleagues for referrals…

Using the patient's medical record to raise concerns about a potential error without initiating a direct conversation can avoid awkwardness and maintain the appearance of collegiality, but it can create evidence for a malpractice suit without allowing the colleague to dispel misconceptions.

Some health-care institutions could help determine what happened and plan for disclosure, but that can be problematic for some clinicians worried that reporting a concern to the hospital will result either in punitive retribution, or no action at all.

Clinicians and institutions might have different malpractice insurers that disagree about how to handle the event. And many clinicians work in small practices without access to institutional resources to help them figure out what happened and navigate the disclosure conversation.

Sometimes, the facts surrounding harmful errors seem clear, but doctors worry about destroying patients' trust in the colleague who erred. They worry about triggering litigation. It’s one thing to subject a colleague to difficult conversations with an angry patient or family, and quite another to expose him or her to a potential malpractice suit.

Most states protect some aspects of disclosure conversations from use in litigation, but this protection is incomplete and might not extend to protecting an unrelated third party to the disclosure. And although research suggests that good communication about adverse events may reduce lawsuits (see our blogs, “Acknowledging a Mistake Made Her a Better Doctor” and “Admitting Errors Is the Right Thing to Do”), data are lacking to indicate how to disclose others' errors while minimizing the risk that a patient will initiate a claim.

The writers suggest a scientific approach to figuring how to tell patients what they need to know for maximum benefit to all. They say the preferences of patients, clinicians and institutions about how to handle such situations should be solicited, and numbers should be crunched for what disclosure strategies result in what outcomes.

Patients and their families come first. “[A] patient's right to honest information shared with compassion about what happened to him or her is paramount,” they write. “Simply put, when disclosure is ethically required, the fact that it is difficult must not stand in the way. Patients and families should not bear the burden of digging for information about problems in their care.”

The writers acknowledge that many families will need financial help after a serious error and will have a hard time getting it if they don’t have information about what happened. “Clinicians rightly perceive the current medical liability system as flawed and understandably worry that they may not be treated fairly should a patient file a claim,” the writers say, “[b]ut these concerns do not obviate clinicians' duty to be truthful with patients; as professionals, clinicians are expected to put the patient's needs above their own.”

The essay goes on to discuss how to discern the facts of an error, and that hospitals must take the leadership role to facilitate this discovery and to ensure that high-quality disclosure conversations occur with patients, regardless of which clinicians were involved in the event.

And institutions also are responsible for cultivating “atmospheres of trust in which people are encouraged, even rewarded, for providing essential safety-related information — but in which they are also clear about where the line must be drawn between acceptable and unacceptable behavior.”

The writers call these “just cultures,” which encourage clinicians to report adverse events and help address hierarchy issues involving nurses and trainees that can obstruct the free flow of information to the patient.

They say insurers also must lead the effort to do right, especially for doctors who don’t have strong institutional connections. Support also should be provided by medical societies and professional organizations. Patient-safety organizations, backed by strong legal protections for the confidentiality of information reported to them, could help bridge the gap in cases that involve multiple institutions.

So, back to our neurologist in her disclosure pickle. What should she do?

Here’s the writers’ prescription: After being rebuffed by the internist, she should tell him that she plans to request a formal cardiology consultation and, with the diagnosis in hand, communicate the findings to the internist and try to formulate a joint disclosure strategy. If the internist declines or objects to the cardiology consult, she should seek assistance from the institution's medical director or other senior administrative leader, and hope that she gets support from a disclosure coach.

Well, yeah. It’s difficult, but isn’t it common decency?

The writers think so. They conclude: “… transparent disclosure of errors is a shared professional responsibility. Only a collective approach to accountability can fully meet the needs of patients and families after harmful medical errors.”

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September 11, 2013

Suggested Reading—Weak Oversight in Texas Allowed People to Die

The incompetency and gross malpractice of Texas surgeon Dr. Christopher Duntsch raised so much attention that you wonder why his neurosurgery practice in Dallas wasn’t mistaken for a chop shop. By the time his license to practice was revoked in June, two of his patients were dead and four were left paralyzed.

People went on the record to call him out: One person told authorities that Duntsch was “the worst surgeon I’ve ever seen.” Another told a reporter that Duntsch seemed to learn things properly only in order to do the exact opposite. Another compared him to Hannibal Lecter. And these were his medical peers.

So why did it take more than a year after the Texas Medical Board was aware of Duntsch before this clearly out-of-control medical provider was stripped of his propensity to do harm? As the Texas Observer concludes, it’s “the weakness of Texas’ unregulated system of health care, a system built to protect doctors and hospitals. And a system in which there’s no way to know for sure if your doctor is dangerous.”

Read the whole sordid story here.

What adds insult to injury is that Texas "tort reform" has wiped out the ability of most victims to sue for malpractice in court. And that helps attract doctors like Duntsch to a state where they know there will be little accountability for any harm they cause.

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August 21, 2013

Surgical Errors -- When Technology Is the Problem

Surgical errors are a common cause of medical malpractice lawsuits. Sometimes it’s the result of an horrific human mistake such as operating on the wrong body part or leaving a tool inside the patient. A new study shows that a significant number of surgical mistakes are caused by problems with the equipment or technology used.

We love technology, whether it’s our mobile device, our car’s GPS or a medical tool that makes us better. But using the wrong tool in a medical setting, or using it improperly, can be deadly.

For example, we’ve discussed the ongoing problems with the Da Vinci robotics system that’s promoted for a wide range of surgeries including those for bladder, colorectal, gynecologic, kidney, prostate and throat cancers.

The new study, published in BMJ Quality and Safety, involved a review of more than 19,000 scientific studies that examined problems arising during a variety of surgeries.

As discussed on AboutLawsuits.com, nearly 1 in 4 of all surgical errors was associated with the failure of equipment or technology.

Additional analysis found that more than 4 in 10 errors had to do with how the machines were configured or calibrated; nearly 4 in 10 concerned the lack of availability of equipment, and more than 1 in 3 involved malfunctioning machines.

Sometimes, as we’ve written, mistakes are made because people aren’t trained properly in the use of the equipment.

Regarding the severity of operating room errors, 1 in 5 was classified as “major”; 13 in 100 of those were the result of technical failures, and 8 in 100 were about problems in communication.

Surgical errors are demonstrably reduced when hospitals implement certain procedures, including safety checklists, (see our blog, “Checklists for Surgery Safety Cut Death and Injuries.”) and the BMJ study bolstered this approach. In operating rooms where equipment safety checklists were followed before surgery, the number of errors was cut by half. When equipment-specific checklists were employed—that is, certain guidelines are followed for certain tools—errors dropped by nearly 61%.

As AboutLawsuits noted, medical mistakes affect as many as 16 in 100 inpatients, and nearly half of reported medical errors concern surgical procedures.

If you or a loved one is scheduled for surgery, make sure you understand the procedure—who is performing it, what are his or her credentials (how many similar procedures has he or she done; is he or she board-certified in the specialty) and whether a certain technology or tool is being employed.

If it is, investigate its safety record on the FDA’s website and ask if your caregiver has a financial stake in the equipment. Keep in mind that practitioners and hospitals that have invested heavily in new technology are especially keen to use—and charge for—it. Those financial interests might impair the providers’ objectivity when it comes to the appropriate use of technology in your situation. (See our blog, "Conflicted Care: Physicians with a Financial Stake in the Medical Devices They Use.")

Sometimes, device sales representatives are admitted to an OR to advise the surgical team on the proper use of their product. These situations are fraught with the potential for abuse. You have the right to know if this situation pertains to your case. If so, ensure that your caregivers follow guidelines for outsiders in the OR devised by the ECRI Institute, an independent, nonprofit organization that researches safety, quality and cost-effectiveness of patient care.

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August 5, 2013

New Surgical Rating Tool Gives Mediocre Grades to Major Institutions

Our "Better Health Care" newsletter focuses this month on how hospitals are rated for patient safety. Among the several ways it mentions for consumers to measure hospital performance is a new guide from Consumers Union, the outfit that publishes Consumer Reports.

As reported last week by Reuters.com, many of the 2,463 hospitals included in the Consumers Union (CU) effort are nationally renowned facilities, and some of them earned less than stellar ratings. “The Cleveland Clinic,” reported Reuters, “some Mayo Clinic hospitals in Minnesota, and Johns Hopkins Hospital in Baltimore, for instance, rated no better than midway between ‘better’ and ‘worse’ on the CU scale, worse than many small hospitals.”

The problem, as Patrick Malone’s newsletter notes, is that a rating organization has access to only some data, and many of them have an agenda; that’s why it’s best to look at several different measures, and understand the biases and variables that each brings to the task. Reuters affirms that CU had only limited access to data, so its ratings confirm the difficulty patients experience in seeking objective information on the quality of care at any given facility.

Last week’s report was the first of its kind for CU. It included hospitals in every state, and it measured only the quality of their surgical care. It analyzed the percentage of Medicare patients who died in the hospital during or after their surgery, and the percentage that stayed in the hospital longer than expected based on standards of care for their condition.

The ratings are based on Medicare claims and clinical records for 86 kinds of surgery, including back operations, knee and hip replacements and angioplasty. Adjustments were made to account for the fact that some hospitals treat older or sicker patients. Data on patients who were transferred from other hospitals were excluded because, according to CU, they are often difficult cases that shouldn’t be counted against the receiving hospital.

Specific complications such as infections, heart attacks, strokes, or other post-surgery problems aren’t teased out, but the researchers say the length-of-stay data indicates those issues.

“Some of the findings are counterintuitive,” says Reuters. “Many teaching hospitals, widely regarded as pinnacles of excellence and usually found at the top of rankings like those of U.S. News & World Report, fell in the middle of the pack.” (See our blog about the limitations of the U.S. News & World Report annual rankings.)

As Dr. Marty Makary, a surgeon at Johns Hopkins Hospital and author of "Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care," told Reuters, "For a complex procedure you're probably better off at a well-known academic hospital, but for many common operations less-known, smaller hospitals have mastered the procedures and may do even better [with post-surgical care].”

Some representatives from hospitals with disappointing ratings called into question whether the methodology reflected the full picture of quality of surgical care, saying that outcome data (how well patients undergoing a certain procedure fare in the longer term) is a better metric.

In the CU rating, several urban hospitals did well despite serving many poorer, sicker patients, whose outcomes usually skew figures downward. Rural hospitals usually outperformed more urban facilities, and some that are barely known outside their own region were stars.

Reuters observed that “hospital choice matters more for some procedures than others. Length of stay for hip and knee replacements and back surgery varied widely, for instance, while hospitals' scores for colon surgery and hysterectomy were more similar to one another.”

There’s a lot of hospital data out there you’re unable to see. According to Reuters, the American College of Surgeons collects data on things like the rate of infections at the surgical site and urinary tract infections through its National Surgical Quality Improvement Program. But it doesn’t release the data publicly because hospitals give the information to the program on a confidential basis. Still, about 1 in 5 of about 500 participating hospitals voluntarily reports some data to the federal Center for Medicare and Medicaid Services.

Some hospitals, including the Cleveland Clinic, make information about outcomes available on their websites. CU advocates for such greater "medical transparency,” and Dr. Peter Provonost of Johns Hopkins supports requiring hospitals to report patient outcomes just as the Securities and Exchange Commission requires public companies to report financial data.

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August 4, 2013

Tracking Doctor Discipline Just Got Harder

Public Citizen, a nonprofit citizen/consumer safety advocate, publishes a report each year about doctors that have been disciplined by state medical boards. But the state medical boards just made its job a lot harder.

As reported by ModernHealthcare.com, the Federation of State Medical Boards (FSMB) “has quietly killed its Annual Summary of Board Actions report.” It was the resource Public Citizen used to spread the word, ranking state medical boards by how many disciplinary actions per capita they imposed on physicians.

The federation had been compiling reports since 1985 and, according to ModernHealthcare, promised to issue a new and improved version in the autumn. But it won’t necessarily include per-state statistics.

Public Citizen, which has been interpreting the data since 1999, claims that the federation shuttered the report to stop it from giving information that might be useful and interesting to patients, but that providers hated. The organization says it will continue to rank state boards by finding data elsewhere.

As we’ve noted, the adequacy of state medical boards, which grant professional licenses as well as conduct disciplinary actions, is inconsistent. There’s little uniformity in how they operate, how much authority they have and how effective they are in ensuring that health-care practitioners are responsible and accountable for safety lapses.

Until this year, each spring the FSMB noted the number of physician licenses revoked, suspended, modified and ordered to be surrendered or retired by each medical board.

The FSMB prefaced its report by saying, “Because states operate with different financial resources, levels of autonomy, legal constraints and staffing levels, the FSMB discourages using data from this report to compare or rank states.”

Public Citizen ignored that suggestion. As explained by ModernHealthcare, it calculated a three-year average of the number of licenses revoked, suspended or modified by the state board, dividing that figure by the number of doctors in a state to create a “serious actions per thousand physicians” standard. It usually got a lot of media play.

The federation, medical board officials and physician groups claimed Public Citizen’s report was misleading because the number of board disciplinary actions is driven by the number of bad doctors in a state, not by the effectiveness of the board that oversees them; that different boards have different missions—some are punitive, others rehabilitative. They say you shouldn’t compare apples to oranges, that you can manipulate data to prove anything you want to prove.

Dr. Sidney Wolfe, founder and a senior adviser of Public Citizen's health research group, told ModernHealthcare that it's likely that states have the same ratio of misbehaving doctors—about 1 in 100, he estimates—so differences in board activity are likely to reflect variables such as board leadership and resources. He believes FSMB yanked the report to avoid trouble within the ranks. Trouble that it created.

Public Citizen contends that by airing the data in an accessible way, positive change has occurred—state legislatures have boosted funding to medical boards, and that better monitoring improves patient safety.

Helen Haskell, a member of the National Patient Safety Foundation's board of governors and founder of Mothers Against Medical Error, told ModernHealthcare that even if medical boards are constrained by their state legislatures, “Public Citizen plays a vital role, and they're the only people taking on this issue. If doctors are licensed by the state, they need to be regulated by the state, and someone needs to keep an eye on (the state boards) to make sure that happens.”

The FSMB notes that because all state boards have websites, the federation can’t just track disciplinary actions; it must describe board structure, board staffing, budget, frequency of board meetings, etc. Officials say they’re working with the Department of Health and Human Services to establish a “minimum data set” for state boards to post information on individual licensees so consumers can see “who's practicing where.”

Kevin Bohnenblust, executive director of the Wyoming Board of Medicine, agreed that the annual report should change with the times; that it should reflect the realities of, for example, physician shortages in states such as Wyoming. “If we can make a physician better—with additional training or drug and alcohol treatment—then taking a license away doesn't ultimately serve the community if you can get a doctor to practice safely again,” he told ModernHealthcare.

It’s a fair point. But we remain skeptical that closing raw data to interpretation by agencies with patient interests in mind is a positive move. When it comes to the availability of information, less is seldom more.

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June 16, 2013

Acknowledging a Mistake Made Her a Better Doctor

Time and again it has been proved that when a doctor acknowledges a mistake and engages the patient instead of ignoring or denying what happened, everyone’s interests are served. Our blog from last year, “Admitting Errors Is the Right Thing to Do,” explained why this approach creates a culture of honesty within the medical profession, is good for patients and reduces the incidence of medical malpractice lawsuits.

“My Near Miss,” an op-ed published last month in the New York Times, is a personal, poignant account of an emergency department doctor’s mistake and how it made her realize that she, and any other medical professional who errs, must step up and admit it.

Dr. Danielle Ofri, author of the book “What Doctors Feel: How Emotions Affect the Practice of Medicine,” recounts the day she neglected adequately to review a CT scan, an oversight that could have spelled death for her elderly patient had someone else not paid attention. It was the end of a long day, and the ER staff was keen to move their patients to other hospital departments.

This patient’s problem—altered mental status—didn’t seem as urgent as the department’s heart-failure and raging-infection cases. She was a nursing home resident with dementia, and, as Ofri writes, “it was hard to get worked up over a demented nonagenarian who was looking a little more demented.”

Ofri hoped to move the patient to the intermediate care unit, where patients with no active medical issues waited to be discharged. But first, they had to review lab reports, a CT scan of her head and a chest X-ray to make sure the patient didn’t need treatment. “But the docs at the intermediate ward left at 5 p.m. and it was 4:45,” Ofri writes. “I quickly scanned through the labs, called the ward’s doctor and ran through the case — demented patient, still demented, return to nursing home tomorrow.

“I remember the doctor’s voice so clearly: ‘You’re sure the labs and everything are normal?’ Yes, yes, I said, everything is fine. She hesitated, then said OK.” Ofri and the intern she was working with happily moved on to other patients.

We can all understand this mind-set—who hasn’t been eager to dispose of an annoying or uninteresting chore in order to get something more meaningful done?

But that patient, it turned out, was hardly uninteresting. A radiologist reviewing the CT scan that night had seen intracranial bleeding, and notified the intermediate care unit doctor. The next afternoon neurosurgeons were draining the blood from inside the patient’s skull.

Ofri was horrified. As she explains, “You couldn’t do much worse than miss an intracranial bleed.”

“I had failed to check the head CT! I was appalled at myself, mortified by my negligence. I stumbled through the rest of the day, an acrid mix of shame and guilt churning inside me.”

As Ofri says, no one knows how many of these “near miss” medical mistakes occur. Probably many more than the number of known errors. According to a 2006 report by the Institute of Medicine, medication errors alone affect 1.5 million patients a year.

Ofri never told anyone about her lapse—not the intern, the attending physician nor the patient’s family. She wrestled with a variety of escapes: the radiologist had caught the problem, no additional harm had come to the patient...

But if that patient had been discharged, or if Ofri had prescribed something ostensibly harmless, like aspirin, the patient could have bled to death. “The patient was simply lucky,” Ofri admits.

Ofri learned a lot that day and is a better doctor for it. She reminds readers that the attention now being paid to reducing medical errors is bearing fruit. Electronic prescriptions help to avoid penmanship mistakes. Wristband bar codes help to ensure that medications go to the right patient. Surgical checklists help to prevent common oversights.

“But we can stop only the errors we know about,” she says. “There remains a black hole of near misses, of uncharted errors—a black hole of shame that prevents caregivers from coming forward.”

That hole is the inability or unwillingness of a medical professional to acknowledge his or her mistake.

Ofri says that most medical professionals keep these “shameful mistakes” to themselves, as she did. But she never forgot how it felt, and for her book, she interviewed doctors about the emotional experiences that have molded them; nearly all remembered a medical error that they had been party to and many had never spoken about it before. “The shame of their errors—including the near misses—was potent, even decades later.”

We agree with her prescription for this malady: Leaders have to stand up and cop to what happened. “Hearing how a person in authority handled the emotional fallout and the feelings of incompetence may give others the courage to come forward,” she says. “Until we attend to the culture of shame that surrounds medical error, we will be only nipping at the edges of one of the greatest threats to our patients’ health.”

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June 9, 2013

Cancer Patient Diagnoses the Hospital’s Chemotherapy Error

The value of a patient advocate has never been proved more profoundly than in “Right Regimen, Wrong Cancer: Patient Catches Medical Error.” In this case, the advocate was the patient.

The article in the May issue of Web M&M (Morbidity and Mortality Rounds on the Web), published by the Department of Health and Human Services, detailed how a man being treated for metatastic penile cancer prevented a horrible mistake from being made. He was admitted to the hospital for his fourth round of chemotherapy. In the three previous rounds he had received the drugs paclitaxel, ifosfamide and cisplatin each of the three days he had been hospitalized, and had experienced minimal side effects.

On the fourth day of his fourth round, he was expecting, as usual, to be discharged to go home. That morning, a nurse entered his room, and explained that she would be administering his chemo that day. Because this was not the standard routine, he asked to speak with the oncology team before he got the chemo.

An oncology fellow spoke with him, reviewed the orders and realized that two additional days of chemo therapy had been ordered in error. Rather than the three-day regimen for metastatic penile cancer, the order had been given for a higher dose, five-day regimen of paclitaxel, ifosfamide, and cisplatin for germ cell cancer. After the first oncologist conferred with the attending oncologist and discussed the situation with the patient, he was discharged that day.

Close call. Smart patient. Lucky man.

The mistake was formally reviewed. It turned out that the outpatient oncologist (a specialist in penile and germ cell cancers) had recommended the appropriate three-day regimen to the oncology fellow on a paper form, despite the fact that the facility had an electronic health record (EHR) and computerized entry system. The oncology fellow inadvertently chose the wrong paper order set—he saw that the order set included the correct agents but failed to notice the higher dose and incorrect duration.

The inpatient attending oncologist, who did not know the patient and was not a penile cancer specialist, had co-signed the fellow's incorrect orders. During the patient’s hospitalization, the internal medicine team copied and pasted the original oncology outpatient note for the three-day course of chemotherapy, even though it was different from the five-day regimen that was ordered this time. None of the other safety checks—a chemotherapy pharmacist and chemotherapy nurse checking the orders against allergies, kidney function, etc.—identified the discrepancy.

As the article authors wrote, “The discovery of the error by the patient is notable and the team is to be commended for responding rapidly to prevent additional harm. This ‘intervention of last resort,’ though, cannot be depended upon. Not all patients are attentive, knowledgeable, and brave enough to voice concerns about their care.”

Amen, brother. Oncology care is complicated and risky. Treatment of the life-threatening disease often is toxic itself. Ordering and administering chemotherapy requires expertise and, as the writers say, “meticulous coordination of care.”

Conflict between electronic and paper-based systems is not acceptable in such precarious circumstances. Lack of coordination among oncology team members who specialize in different forms of the diseases is not acceptable. As the articles states, chemotherapy regimens “can involve multiple drugs administered in repetitive cycles, and are adjusted periodically to address toxicities. As the case illustrates, chemotherapy administration is among the more hazardous and challenging activities in all of medicine.”

The message this case sends should be heard by both the professionals providing the care and the patients and their advocates, who must insist on being part of the oversight of their care. For further information, see our two-part newsletter, “Protecting a Loved in the Hospital,” and “A Safer, Healthier Hospital Stay.”

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May 17, 2013

Study FInds Malpractice Suits Can Make Hospitals Safer

A new survey of hospital risk managers finds that malpractice lawsuits can give them important clues to holes in their hospitals' patient safety nets that need patching.

The study by UCLA law professor Joanna Schwartz was excerpted in the New York Times op-ed page. Professor Schwartz writes:

New evidence ... contradicts the conventional wisdom that malpractice litigation compromises the patient safety movement’s call for transparency. In fact, the opposite appears to be occurring: the openness and transparency promoted by patient safety advocates appear to be influencing hospitals’ responses to litigation risk. ...

My study also shows that malpractice suits are playing an unexpected role in patient safety efforts, as a source of valuable information about medical error. Over 95 percent of the hospitals in my study integrate information from lawsuits into patient safety efforts. And risk managers and patient-safety personnel overwhelmingly report that lawsuit data have proved useful in efforts to identify and address error.

One might think that hospitals would have little to learn from lawsuits, given other requirements that hospitals report, investigate and analyze medical error. But participants in my study said that lawsuits can reveal previously unknown incidents of medical errors — particularly diagnostic and treatment errors with delayed manifestations that other reporting systems are not designed to collect.

Lawsuits can also reveal errors that should have been reported but were not — medical providers notoriously underreport errors (although studies have shown that the threat of litigation is not responsible for this underreporting) and lawsuits may fill these gaps.

Professor Schwartz's findings, which readers can also read about here, should help the pushback against misguided "reforms" that purport to make hospitals safer by making it harder for patients to sue for accountability when they have suffered serious harm from medical errors. As she reports, even hospital risk managers are finding that lawsuits are valuable sources of information about what really goes in inside hospitals. And is that any surprise?


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May 2, 2013

Misdiagnosis Is the Most Common and Most Dangerous Medical Mistake

After reviewing 25 years’ worth of payouts for malpractice claims in the U.S., researchers determined that diagnostic errors represented the largest proportion of claims, the most serious patient harm and the highest total of penalty payouts.

As reported by ScienceDaily.com, the researchers from Johns Hopkins Hospital found that diagnostic errors accounted for 28.6% of the 350,706 paid claims they analyzed, and 35.2% of total payments. These mistakes resulted in death or disability nearly twice as often as other error categories, including surgical mistakes and medication errors.

"This is more evidence that diagnostic errors could easily be the biggest patient safety and medical malpractice problem in the United States," lead author David E. Newman-Toker, M.D., Ph.D., told ScienceDaily. “There's a lot more harm associated with diagnostic errors than we imagined."

By error category, death (as opposed to serious harm) percentages of malpractice claims were:


  • diagnosis: 40.9%

  • medication: 38.7%

  • treatment: 25.7%

  • obstetrics: 22.7%

  • surgery 13.8%.


The study examined only claims that resulted in a malpractice payout—most incidents of malpractice never see the light of litigation. Researchers estimate the number of patients suffering misdiagnosis-related, possibly preventable, significant permanent injury or death in the U.S. each year could be 80,000 to 160,000 people. Many routine diagnostic errors result in costly patient inconvenience and suffering; one estimate suggests an average diagnostic error rate of 15 in 100 when patients consult doctors for a new problem.

The study was published in BMJ Quality and Safety in Health Care. According to MedPageToday.com, the authors analyzed data from the National Practitioner Data Bank (NPDB), an electronic record of payments made on behalf of physicians with medical liability settlements or judgments. It also tracks adverse peer review actions against licenses, clinical privileges and professional society memberships.

A diagnostic error can involve a diagnosis that is missed, wrong or delayed. Harm can result from the delay or failure to treat a problem because the initial diagnosis was wrong or unknown, or from a treatment given to address a condition the patient didn’t have.

By category of diagnostic error, percentages of malpractice payouts were:


  • missed diagnosis: 54.2%

  • delayed diagnosis: 19.9%

  • misdiagnosis: 9.9%.


Much of the remaining percentage was unclassified.

The study authors said diagnostic errors are tricky to track and quantify because often there’s a big gap between when the error occurs and when it's detected. It’s easier to recognize other malpractice mistakes, such as operating on the wrong body part or giving someone the wrong dose of medicine—those harms present quickly.

Treatment errors were responsible for 27.2% of the study’s total, and surgery-related errors amounted to 24.2%.

As Newman-Toker said, the difficulty of identifying a diagnostic error is compounded by human errors of commission: Experts often minimize the scope of diagnostic errors not because they were unaware of them, but "because they were afraid to open up a can of worms they couldn't close.”

By more than double, diagnostic error claims were the result of outpatient rather than inpatient care, but inpatient errors were more likely to be lethal.

Between 1986 and 2010, diagnosis-related payments totaled $38.8 billion, and per-claim payments were highest for mistakes causing serious neurologic harm, such as quadriplegia and brain damage requiring lifelong care. Such payments were more than for errors resulting in death.

It’s difficult to pin down the complete cost of diagnostic errors. Newman-Toker told Science Daily that tens of billions are spent every year on "defensive medicine," which, as readers of this blog know, is when doctors order tests that might be unnecessary solely to protect themselves from being accused of neglecting to do something. "Yet diagnoses are still missed, with grave consequences," Newman-Toker said.

Which confirms the wealth of evidence that “defensive medicine” does nothing to immunize someone from making errors, large or small.

The public health effect of diagnostic errors, the authors said, probably is much greater than previously believed because earlier estimates were based on autopsy data. That information counts only deaths, not disability.

"Despite their significant impact, diagnostic errors have received relatively limited public and scientific attention, even from the patient safety community," the authors wrote.

As noted by MedPageToday, the diagnostic error scenario could be even bleaker than this study suggests: Practitioner data in the NPDB is incomplete, and it might grossly underestimate diagnostic errors because many lawsuits are dismissed before settlement.

"We found roughly equal numbers of lethal and nonlethal errors in our analysis, suggesting that the public health burden of diagnostic errors could be twice that previously estimated," the authors said. "Healthcare stakeholders should consider diagnostic safety a critical health policy issue."

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May 1, 2013

Hospitals Profit from Their Mistakes

If no good deed goes unpunished, does it follow that no bad deed goes punished?

It does, apparently, if you’re a hospital. As widely reported earlier this month, including by the New York Times, a new study published in the Journal of the American Medical Association [JAMA], says that errors committed by hospitals can be lucrative because insurers compensate them for patients who must remain hospitalized longer than they should as a result of preventable surgical mistakes.

According to The Times, “Changing the payment system, to stop rewarding poor care, may help to bring down surgical complication rates, the researchers say. If the system does not change, hospitals have little incentive to improve: in fact, some will wind up losing money if they take better care of patients.”

What is this, Opposite Day in Health Care?

Researchers analyzed records of 34,256 people who had surgery in 2010 at one of 12 hospitals run by Texas Health Resources, a large, nonprofit hospital system. Of those patients, 1,820 suffered at least one complication, such as blood clots, pneumonia or infected incisions that could have been prevented.

Without such complications, these patients would have been hospitalized three or four days; with them, they averaged 14 days in the hospital. The average tab was $30,500 more than for patients without complications ($49,400 versus $18,900). Private insurers paid far more for complications than did Medicare, Medicaid or patients who paid for their own care.

The researchers made clear to The Times that they weren’t suggesting that hospitals make deliberate errors in order to boost their bottom lines, nor were they refusing to address the problem. But they did say, the paper reported, “that the current payment system makes it difficult for hospitals to perform better because improvements can wind up costing them money.”

You’d think that insurers would be motivated to heal this sick financial scenario, and a spokeswoman for an insurance trade group said all the right things about moving American health care away from the fee-for-service model to one that emphasizes quality over quantity, one that rewards better care. She did note that Medicare and private insurers now use a “never list” of things they will not pay for, including leaving a sponge or instrument inside a patient, or operating on the wrong organ or wrong limb.

Still, given that, for example, Wellpoint, the corporate parent of Anthem Blue Cross Blue Shield and others, made a profit last year of more than $2.6 billion, how much farther will insurers go to fix a system that, for them, isn’t broken?

Reducing complications, said the researchers, means that insurers not only should not pay for substandard care, but should financially reward excellent care. Also, hospitals should be required to disclose their complication rates so that patients who have options can avoid those with high rates. Such facilities could either improve, or close.

To its credit, Texas Health Resources was trying to figure out how to reduce its hospitals’ surgical complication rates, which prompted the study. The outfit’s complication rate was 5.3%, about the same as those reported by similar hospitals. A Texas Health Resources consultant, according to The Times, said the they were stunned to learn that lowering the complication rates would cost the hospital money.

Dr. Mark C. Lester was one of the study’s authors and also is an executive with THR. He told The Times that its hospitals used a checklist system to help prevent complications. Harvard’s Dr. Atul A. Gawande is a pioneer of the checklist approach, and he also participated in the study. Surgical checklists, as we’ve described before, involve routine procedures, some of them quite simple, to ensure such things as the right patient is on the table, the right body part is being addressed, drug allergies are known and the right medications are being given in the right doses.

When asked if the hospital would lose money if more patients required less care, Lester said, “To us that doesn’t have an impact.”

“Reducing complications and increasing safety is why we’re there,” he told The Times. “If in doing that, some payments don’t come our way, it’s not of consequence. What’s of consequence is that people who come to us are in a safer environment.”

To learn more about hospital errors, read our backgrounder. For information about how to protect yourself and your loved ones while hospitalized, read our two-part newsletter, “Protecting a Loved One in the Hospital,” and “A Safer, Healthier Hospital Stay.”

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March 6, 2013

Diagnostic Errors in Primary Care Put Many at Risk

Most of the attention given to medical errors concerns institutional issues, such as surgical mistakes, hospital medication mishaps, lack of infection control and emergency room misdiagnoses, or individual caregivers who are woefully deficient in the practice of medicine. But a new study in JAMA Internal Medicine makes clear that primary care patients also are routinely at risk of misdiagnosis.

As reported on Reuters.com, the research shows that when it comes to analyzing and resolving medical errors, relatively little attention has been paid to what happens in your primary care doctor’s office.

And that oversight is itself a mistake.

The JAMA researchers analyzed electronic health records to track 190 diagnostic errors made during primary care visits at two health-care facilities. The misdiagnosed patients in all of those cases were hospitalized or came back to the doctor’s office or emergency room within two weeks.

There was a variety of mistakes, but pneumonia, heart failure, kidney failure and cancer each accounted for 5 to 7 out of 100 problems doctors first diagnosed as something else.

Although some of the mistakes were relatively harmless, some were lethal. Of the 190 cases, 36 patients had serious, permanent damage, and 27 died.

Dr. David Newman-Toker of Johns Hopkins University School of Medicine told Reuters “You're really talking about at least 150,000 people per year, deaths or disabilities that are resulting from this problem.”

Diagnostic challenge is part and parcel of the practice medicine, which depends on both science and art. A patient who shows up in the doctor’s office with mild shortness of breath and a routine cough with a little phlegm might lead a doctor to diagnose bronchitis. But, as one of the study authors told Reuters, “… lo and behold they would come back two days later with heart failure."

The art of diagnosis will always have its hits and misses, so what can practitioners and patients do to maximize the former and minimize the latter? As we’ve said before, a lot of errors—and their harms—can be avoided if doctors practice the basics and if the doctor-patient relationship is based on mutual respect and communication.

Most of the missed diagnoses, the study showed, were because the doctor failed to get an accurate patient history, do a full exam or order the correct tests. Patients periodically should review their files to ensure they contain a full medical history. They should ask certain questions about the purpose of each exam and test—for a list, see our blog “Inquiring Minds Want to Know: Questions Patients Should Always Ask.”

The researchers suggested that minimizing errors in primary care situations might require changes in doctor training to prepare them for patients who come to their appointments armed with all of the relevant information about the nature and timing of their symptoms.

"I do think it's important for a patient to question or observe the doctor," Newman-Toker told Reuters. "Ask pointed questions: ‘What else could this be? What things are you most concerned about?'"

And patients, he said, should "not just assume that once the diagnosis has happened the first time, that everything is said and done and that it's all over. You just can't have blind obedience to the doctor's diagnosis."

So if you develop new symptoms or your symptoms get worse after you see the doctor, don’t assume everything is fine because the initial diagnosis was not something serious. Your job as a patient is to understand that making a diagnosis involves uncertainty, because symptoms and circumstances can change, and to follow up if they do.

As one of the study authors said, "We need to get patients more engaged in the conversation with the providers. [T] he main message is: How do we effectively (make diagnoses) together?"

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January 28, 2013

Hospital Medication Errors—What the Patient Doesn’t Know

Despite efforts by the government and conscientious health-care facilities to promote the proper prescribing and administration of medicine, the incidence of hospital medication errors is more frequent than believed, according to new research published in the journal Critical Care Medicine.

Possibly even more disappointing is that patients and their families often aren’t told when such a mistake occurs.

As described in a story on AboutLawsuits.com, the study found that when an error occurred, not only weren’t the people affected notified, more than half the time no corrective action was taken after the mistake was discovered.

Researchers at Johns Hopkins University School of Medicine in Baltimore analyzed nearly 840,000 medication errors that happened in 537 hospitals across the country. Both regular care wards and intensive care units (ICUs) were studied. More than 750,000 errors were reported, and more than 9 in 10 of them occurred in wards other than intensive care. So the sheer number of mistakes doesn’t necessarily appear to be a matter of the urgency or extreme condition of the patient.

But the gravity of the errors does appear to be related to critical conditions. Mistakes that caused the most harm or resulted in the patient’s death did occur in the ICU at twice the rate of non-ICU wards.

“Consideration should be given to developing additional safeguards against ICU errors,” the study authors concluded, “particularly during drug administration, and eliminating barriers to error disclosures.”

As explained by AboutLawsuits, the data was collected for the years between 1999 and 2005 from MEDMARX, a program for anonymous, confidential reporting of medication errors. It’s a self-reported system, which makes the results of this study even more alarming. How many errors weren’t reported because they didn’t have to be?

Most of the mistakes happened when the medicine was being administered, as opposed, for example, to a contaminated or missed medicine, although failing to give a patient a scheduled medicine was common.

The most harmful errors involved problems with a dispensing device, such as an IV line. Giving someone the wrong dose also was a significant problem.

Although patients and their loved ones often weren’t told that a medication mistake had been made, neither was 1 in 3 hospital staff members who had made the mistake, at least not immediately after they’d done so.

To learn more about the types of medication errors, see our backgrounder. To learn how to protect a loved one in the hospital, see my newsletter here. To learn how to have or help someone have a safer hospital experience, see my newsletter here.

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January 15, 2013

Medical Student Gets Disappointing Lesson in Hospital Errors

Dr. Elaine Goodman had just finished her first year at Harvard Medical School when she became intimate with the consumer side of medical care. Her story, recounted on ProPublica.org, is a cautionary tale for everyone, professional or patient, and sheds yet more checkered light on patient safety in the hospital.

Goodman learned firsthand, while her mother was being treated for breast cancer, that plenty of errors and mishaps occur in the hospital, not so much from glaring medical malpractice, but from the "swiss cheese" holes everywhere in the system that too often lined up to hurt a patient.

When the daughter visited her mother one morning, she found her bloodied, hallucinating and disoriented. Mom had pulled out the staples from a recent procedure on her head. Another time, mom got a black eye from being banged in the face with a stethoscope. She fell frequently, experienced unnecessary side effects from drugs, almost had unnecessary brain surgery and was nearly given the wrong drug.

Remember, this is a person whose family member was part of the medical community. What in the world was going on?

“It was really eye opening for me to see the reality of how difficult it was to keep her safe in the hospital,” Goodman told ProPublica, the public interest investigative news outfit. “It’s not enough just to have caring, qualified people to keep the patient safe.”

Goodman’s mother died in 2008 after spending six months in the hospital. Her daughter believes the inpatient misfortune she suffered hastened her decline.

Goodman, now a second-year resident in internal medicine and primary care at Brigham and Women’s Hospital in Boston, participated in ProPublica’s coverage of patient safety by completing its Provider Questionnaire. ProPublica reporters confirmed the details of her mother’s story.

In her extended interview with ProPublica, Goodman addressed several issues about patient safety she hopes will contribute to the public good. Following are excerpts.

What did you your experience with your mom teach you about medicine?

“I hadn’t realized how hard it is to keep a complicated patient safe in the hospital. The harm is rarely caused by actual negligence. The vast majority of cases involve a lot of people doing fairly reasonable things, and somehow something just falls through the cracks.”

“One day my mom fell out of bed in the middle of the night. They had bed alarms to notify nurse if a patient starts to fall out of bed. But there’s also a chair alarm, and the nurses showed us that there were only enough electric outlets for one alarm at a time, and the alarms had identical cords – making it hard for the nurses to tell which alarm was plugged in. The day my mom fell, the wrong alarm was plugged in.”

Medication errors were frequent. My mom was on a seizure medication that needed the dose adjusted according to her nutritional status. The physicians probably knew this, but with all the handoffs, [see our recent blog about hospital shift changes] a new doctor would come in, see the drug level was low in her blood – and without carefully observing her nutrition – and then up the dose. She was being accidentally overdosed on the medication which caused her to sleep for days.”

“The biggest error related to her chemotherapy, which was administered by a device straight into the fluid of her brain. They’d give her the chemo about once a week, and it was supposed to last an entire week. One weekend … [a different] physician administered the chemo. About a week later her normal oncologist came to us in tears. …[H]er colleague had not administered the right chemotherapy drug, and the type she’d received had only lasted a day, not a week. My mom had effectively gone for a week without getting any treatment.”

How did the hospital doctors and officials respond?

“[The family] had a lot of conversations with the hospital administrators about what they were going to do about such a big medication error. We arranged to become members of the hospital’s patient safety committee. That got us involved in a way that made us feel they were addressing it.”

“... It turned out the drug that had been incorrectly administered had a name that was almost identical to the name of the correct drug, and the labels were almost identical. Plus, the hospital did not have a pharmacist who had specific expertise in chemotherapeutics. It was a case that illustrated what they call the “Swiss cheese model” for how errors occur. All the holes just line up and then the mistake is made. …”

“The hospital ended up hiring a new chemotherapy pharmacist, training the nurses and changing how the chemotherapy drugs were ordered and labeled.”

What do you see as the causes of ongoing patient safety problems?

“Complexity. There are exponentially more treatments, medications and technologies now compared to a few decades ago. We also have so many different ways patients are insured, different facilities they’re staying in and various aspects to their care. There are so many layers to manage.”

There’s also a huge problem with overbooking our physicians and medical staff. The patient volume is high, and they’re in and out of the hospital more quickly. … Physicians are constantly multitasking — being paged all the time, distracted, working long hours — with no time to sleep. …”

“And yet the emphasis is on the individual doctor taking care of all the issues. … Frankly there aren’t enough hours in the day to make sure you do all of that. You also don’t have the mental bandwidth to do it.”

How did your experience change the way you practice medicine?

“… When I was first in the hospital with my mom I tried not to ask too many questions. I didn’t want to be labeled ‘difficult,’ or as the daughter in med school who thinks she can dictate decisions. As a result, my mom’s care got worse. I realized that we family members had a lot to offer, especially in terms of handoffs between physicians. … In one case with my mom, a radiologist had picked a chemo drug he thought was best and later I saw a nurse begin to administer a different chemotherapy drug in response to his order. I questioned the nurse. The nurse was kind of annoyed, but she called the radiologist and then administered the correct drug.”

What did you learn about patient safety as a medical student?

“We had some lectures peppered throughout the curriculum. No patient safety course, but we had talks here and there. I went to med school because I was passionate about science and care, so the patient safety topics weren’t the most exciting. …”

“I would have been more attuned to this problem if the instruction had been tied to individual patients. When I came back to medical school [after caring for her mother], I did a patient safety elective – which was a new thing at the time – where students sit in on committees that are reviewing adverse events. Reviewing those cases made it easy for me to imagine myself as a physician who missed something important while caring for a patient.”

What’s one way medical providers can reduce the number of patients who suffer harm?

“Sometimes errors are not even tracked. When I returned to medical school after my mom’s death, I found that there was no way for medical students to report an error. There was an error reporting system, but the medical students did not have a login for it. …”

“And when errors are reported, the response is not always constructive. I filed an error report a few days ago about a medication event. Most people responded well, but a few emails I got showed some people were not happy being involved in an error report. … People are still prone to taking these things as personal failings instead of thinking about the system. …”

“We need to build a culture of patient safety. That means removing the stigma from patient safety and error reporting so we can collect data about errors and learn how we can fix things. That’s better than not knowing the scope of the problem because people are afraid to talk about it.”

To see the article Goodman wrote about patient safety for the American Medical Association, link here. To learn more about how to protect patients in the hospital, see my two-part newsletter on preventing common hospital errors, here and here.

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December 30, 2012

Boy’s Death from Sepsis Spurs Guidelines to Prevent Malpractice in Treatment

Earlier in 2012, we wrote about the sad, unnecessary death of Rory Staunton, a 12-year-old New Yorker who died of septic shock because he was misdiagnosed with a stomach bug. A good thing has come of that tragic event.

As the New York Times reported, New York will be the first state to require hospitals to look aggressively for sepsis, a life-threatening bacterial infection of the bloodstream or body tissues, in order to initiate treatment sooner. (See our backgrounder on sepsis and malpractice.)

The regulations currently being drafted demand that hospitals also must publicly report the results of their efforts to control and treat sepsis.New York’s action, which the governor hopes to implement in 2013, reflects the interest of a national panel that recommended the adoption of similar standards on a federal level.

Sepsis is a leading cause of death in hospitals. Dr. Mitchell M. Levy, author of a forthcoming paper on sepsis treatment, told The Times that sepsis is “the most common killer in intensive care units. It kills more people than breast cancer, lung cancer and stroke combined.”

Recent efforts by the Surviving Sepsis Campaign, a global community of medical professionals, have established guidelines on identifying and treating sepsis, and mortality rates have declined by 40 percent as a result. But because the early signs of sepsis—high pulse rate, fever—are similar to those of many other illnesses, it’s difficult to diagnose it conclusively in its early stage.

But the key is to catch it early, when it can be treated effectively with antibiotics and fluids. The problem is that many hospitals don’t follow the guidelines. One sepsis research program involves some 300 hospitals, but the global consortium would like to have 10,000 participants.

As The Times reports, in April 2012, Staunton died of severe septic shock after he became infected, apparently through a cut. He was treated in the emergency room of NYU Langone Medical Center, where the severity of his illness was not recognized as soon as it should have been, nor were the indications communicated effectively when they were known. Staunton was sent home with a diagnosis of stomach pain. When his laboratory results came back after he checked out, showing cause for alarm, his parents were not contacted. The publicity following his death prompted the medical community to pay attention.

New York’s health commissioner, Dr. Nirav R. Shah, convened a symposium on sepsis that included presentations from Staunton’s parents. Shah said the new regulations requiring hospitals to use best practices in identifying and treating sepsis were actions taken “in honor of Rory Staunton.”

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December 27, 2012

A Federal Plan to Make It Easier to Report Medical Mistakes

Accountability for preventable mistakes has now been officially recognized as an important part of the effort to make medical care safer for everyone.

The Agency for Healthcare Research and Quality (AHRQ) is the lead agency in the federal HHS department charged with improving the quality, safety, efficiency and effectiveness of health care. It supports research that helps people make more informed decisions and develops partnerships among different groups to make such improvements happen.

Accountability is part of that effort. To that end, the AHRQ is seeking approval from the Obama administration for a prototype system for patients to report medical mistakes and unsafe practices by health-care providers.

The New York Times described the plan, and said that even hospitals were receptive to the idea, despite some concerns about malpractice liability and possible financial penalties for poor performance.

Consumers have several options for reporting medical errors; last year we blogged about how to complain about unsafe medical care. The FDA’s MedWatch program is another channel for reporting adverse event about drugs and devices, but not practitioners. Individual states’ medical licensing boards field complaints, but their effectiveness and responsiveness vary widely.

And mistakes often go unreported anyway.

The AHRQ director, Dr. Carolyn M. Clancy, told The Times, “Currently there is no mechanism for consumers to report information about patient safety events.”

“Patient reports could complement and enhance reports from providers and thus produce a more complete and accurate understanding of the prevalence and characteristics [of medical errors].”

Common errors are drug mix-ups (the wrong medicine is given, or the wrong dose), surgical mistakes (surgery on the wrong body part, for example,) radiation overdoses and procedures (or the lack of them) that cause infections.

The Times story referred to research suggesting that 1 in 4 patients experiences adverse events; some were not even recorded in their medical records.

The system proposed by the AHRQ enables patients and their family members to report medical errors and near errors via a Web site and telephone interviews. The information would include:


  1. details of the medical mistake;

  2. the date and location of the adverse event, and whether it resulted in harm;

  3. the type of harm;

  4. contributing factors; and

  5. whether the adverse event was reported and to whom.


The Web and phone questionnaires would ask patients why the mistake might have happened and offer a list of possible reasons. It also would ask for permission to share the adverse event information with health-care providers so they can take steps to improve patient safety.

The information submitted in the reports would be analyzed by researchers from the RAND Corporation and the ECRI Institute, a not-for-profit organization that investigates medical errors.

The feds would like to begin collecting data in May. Questionnaires would be available in hospitals and doctors’ offices. Information about the reporting program would be distributed to pharmacies and mailed to patients’ homes.

If the plan gets the go-ahead, and if patients volunteer to describe their adverse experiences with regularity, an important new data base should contribute mightily to recognizing how mistakes happen, and to a broad-based response to preventing them.

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December 26, 2012

Surgical Mistakes That Never Should Happen Regularly Do

A couple of months ago, we posted a blog about surgical errors, specifically when the operating teams leave tools inside the patient. That’s an example of what’s known in the medical biz as a “never event.” That means it’s a mistake, a malpractice event, for which there is never any excuse and that should never happen.

Researchers from John Hopkins University School of Medicine published a story this month in the journal Surgery that disclosed that never events occur with shocking regularity. Leaving tools inside a wound, operating on the wrong body part or even the wrong body happen about 500 times a year. The researchers estimated that 80,000 never events occurred in U.S. hospitals between 1990 and 2010.

They said their estimates probably are on the low side.

The study said that malpractice claims were paid for 9,744 never events; payments totaled $1.3 billion. More than 6 in 100 never-event patients died, more than 32 in 100 suffered permanent injury and nearly 60 in 100 were temporarily injured.

According to the Washington Post, about half of those cases involved objects left inside the patient (usually sponges, as our story earlier this year noted). The other half were cases of the wrong body part being operated on, and 17 were people who weren’t supposed to have that surgery at all.

And those were only the cases for which claims were paid; if a patient didn’t experience or didn’t report harm, they weren’t represented in the study.

The Post said the study indicates which doctors are more likely to be involved with a never event—those who had been the defendant in prior malpractice claims. The data also showed that younger doctors were more likely to settle malpractice claims for never events.

Our friends at Pop Tort, the unfiltered civil justice blog sponsored by the Center for Justice & Democracy, remind us that only a tiny percentage of people injured by malpractice in this country file lawsuits, and the Johns Hopkins study assumed that 12 in 100 errors result in indemnity payments. Some people say only 3 in 100 such patients file claims. (Pop Tort refers readers to the Center’s resource, “Briefing Book, Medical Malpractice: By the Numbers.”)

As Pop Tort points out, the $1.3 billion paid out doesn’t include the additional health-care costs for the affected patients, most whom never file suit.

Although fining hospitals more severely for never events is a popular notion, Pop Tort proffers its own solution: “What if hospitals and medical societies stopped spending millions of dollars a year lobbying to limit the recovery to malpractice victims [see our post about malpractice “reform,”] and devoted that money instead to patient care? And how about a law that would double every jury award when a ‘never event’ caused the injury--a meaningful penalty where the money goes to the person actually injured (instead of a fine, where the money goes who knows where?) And stop demonizing injured patients and their attorneys. That would be a start.”

We applaud that approach, but more immediate solutions to the problem of never events, as the Washington Post noted, involve better hospital leadership and communication. “Hospitals that have implemented checklists have seen success in increasing communication between health-care providers. Others have reviewed their policies to see where patients might be slipping between the cracks, and made improvements that way.”

As the researchers wrote in Surgery, “We trail behind other high-risk industries that have used systematic approaches to successfully identify and reduce sentinel errors. Strategies used in other complex systems such as aviation may help provide a blueprint to examine both the individual and the institutional factors that contribute to these preventable and costly events.”

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December 5, 2012

Lawsuit Prompts DC Hospital to Change Policy to Improve Patient Safety

The Washington Hospital Center has agreed to change the way that patients are admitted for brain imaging procedures, in response to a lawsuit by a brain-injured patient whose family says she was left without a doctor for several hours while she was having an undetected stroke after a procedure in the hospital's radiology department.

The patient was represented by Patrick Malone & Associates in both a medical malpractice lawsuit for her brain injury and another lawsuit to enforce the policy change agreement .

When Lyn Gross underwent a procedure in June 2003 to treat an aneurysm in her brain, the radiologist who conducted the procedure listed her in the hospital record as being the patient of a neurosurgeon who had no idea who the patient was. When she showed signs of developing a stroke after the procedure, treatment for the stroke was delayed for several hours because of confusion over who was supposed to be her main doctor. Mrs. Gross ended up with severe brain damage. She lives with her husband at their home in Fairfax County, Virginia.

In settling the lawsuit brought on her behalf by her husband Paul Gross, the family asked the hospital as a condition of the settlement to agree that the interventional radiologists who do procedures on patients would not have authority to list another doctor as the "attending physician," unless that doctor knew about the patient in advance and consented to be the patient's doctor. The hospital agreed to implement a new policy.

Mr. Gross filed a new lawsuit against the hospital this year because the hospital had never confirmed its new policy, and he asked the Superior Court to enforce the settlement. That prompted confirmation from the hospital that the policy has been implemented.

Patrick Malone, the Gross family's attorney, said:

"This is good news for patients in the District of Columbia who undergo intricate and dangerous brain interventional procedures performed by radiologists. These radiologists aren't qualified to direct the care of patients after the procedure when something goes wrong. So it's important to have a clear understanding up front about who is going to be the treating doctor after the procedure."

More details about Mrs. Gross's lawsuit against Washington Hospital Center can be found on the Patrick Malone firm website, under the "True Stories" section.

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December 3, 2012

E-Record Shortcuts Threaten Integrity of Medical Records

Medical records are supposed to be a truthful repository in real time of everything that happened to a patient. Their integrity is vital to high-quality patient care and to the ability of a patient to hold providers accountable in court if things go wrong. So word of widespread abuse of shortcuts allowed by electronic record systems is important for patients, lawyers and safety advocates.

A recent op-ed piece in the New York Times by Dr. Leora Horwitz, an assistant medical professor at Yale, documented problems like copy-and-paste where one provider's error early in a patient's treatment gets replicated over and over by later providers who are supposed to be recording their own independent observations of the patient.

Another issue is the too-tempting way that an e-system can allow a single mouse click to populate every box of a fill-in-the-blank physical examination with completely normal, healthy results.

Now more doctors have weighed in with letters to the Times editor on e-record abuses. One, Madhura Pradhan, a pediatric kidney specialist in Philadelphia, wrote:

The ease of using built-in shortcuts for documentation in medical records is teaching younger physicians to be efficient at the expense of being thorough.

Time and again, I see notes in charts that have clearly been copied or have been entered from standardized templates with conflicting information cited elsewhere in the chart. This not only compromises the patient-physician interaction but also makes me question the level of engagement of the physician in that visit.

Another, an internist in New York named George Lombardi, wrote: "It is deeply disrespectful and against a physician’s canon of ethics to take shortcuts in evaluating and caring for patients."

Still another physician, Dr. Margo Cohen of New York, wrote about the errors she discovered in the records of doctors caring for her husband's cancer -- how she as the wife had supposedly had long conversations and agreed with the care plans of doctors whom she'd never met.

A patient, Lois Berkowitz, had an interesting suggestion. Before the doctor can save the e-record, the doctor should be required to get the patient's agreement that the record accurately represents their encounter.

Not practical for all patients or for all situations, still, such a practice would go a long way toward getting us back to the goal: records that are accurate enough that they can safely guide future care and provide a database for malpractice analysis if the patient gets hurt.

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November 25, 2012

Copy and Paste Medical Records: A Tempting Shortcut with Perils for Patient Safety

Electronic medical records make it easy -- too easy -- to document that a doctor or nurse has performed a model examination of a patient. One click, and the empty slots fill in the results of a normal exam from head to toe. But was that thorough exam really done?

Copy and paste is another shortcut offered by electronic records that saves a lot of typing, but that can allow errors in a record to perpetuate from shift to shift and day to day. All it takes is a single mistake in, say, the past medical history taken of a patient when admitted to the hospital, and every other provider copies the error, with sometimes terrible results, as when the initial history taker, and then everyone else, misses an important disease that the patient has had.

An op-ed in the New York TImes highlights the downsides of electronic documentation. Leora Horwitz MD, a Yale medical professor and internist, says she wouldn't go back to the bad old days of handwritten medical records, but the new electronic records carry some dangerous temptations for busy providers and also make care more expensive. Dr. Horwitz writes:

Of course, you shouldn’t click those buttons unless you have done the work. And I have many compulsively honest colleagues who wouldn’t dream of doing so. But physicians are not saints.

Hospitals received $1 billion more from Medicare in 2010 than they did in 2005. They say this is largely because electronic medical records have made it easier for doctors to document and be reimbursed for the real work that they do. That’s probably true to an extent. But I bet a lot of doctors have succumbed to the temptation of the click. Medicare thinks so too. This fall, the attorney general and secretary of health and human services warned the five major hospital associations that this kind of abuse would not be tolerated.
...
In short, reading the electronic chart has become a game of looking for a small needle of new information in a haystack of falsely comprehensive documentation and outdated, copied text. Why do we doctors do this to ourselves? Largely, it turns out, for the same reason most people do most things: money.

Doctors are paid not by how much time they spend with patients, how well they listen or how hard they think about what could be wrong, but by how much they write down.

Of course, when you have an honor system for how much a doctor is paid, the documentation requirement is a natural check-and-balance to make sure the time really was spent with the patient. Now we need a way to make sure that point-and-click medicine and copy-and-paste medicine really serve the patients' interests.

This reinforces my advice to all patients: Read your own medical records. You may be surprised what you find there. You will always be educated, and sometimes you can catch flagrant errors, whether they are due to copy-and-paste issues or other problems. Last month's newsletter has more on how to get and read your own medical records.

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November 11, 2012

Congress Will Consider Greater Oversight of Compounding Pharmacies

From the meningitis outbreak, something good may come out of something bad. Earlier this month, U.S. Rep. Edward J. Markey of Massachusetts introduced a bill in Congress to boost the federal government’s authority to regulate compounding pharmacies.

As we’ve been reporting in the last several weeks (most recently last week), compounding pharmacies have been able to operate in often sketchy ways without the kind of oversight necessary to protect patients from harm. As reported on FDA Law Blog, Markey’s bill, the Verifying Authority and Legality in Drug Compounding Act of 2012 (VALID):


  • Ensures that compounding pharmacies operating as drug manufacturers are regulated by the FDA as drug manufacturers (they do not currently fall under FDA scrutiny).

  • Preserves state regulatory authority for traditional small compounding pharmacy activities and the requirement that drugs are compounded per each patient’s prescription. The FDA may waive this requirement in the event of a drug shortage or to protect the public health or well-being, but not for longer than one year unless the Secretary of Health and Human Services deems an extension necessary.

  • Increases transparency to the public by requiring compounded drugs to include this statement: “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA at _____” (phone number and a website).


A “Do Not Compound” list of unsafe or ineffective drugs must be published within one year of enactment. State agencies responsible for regulating compounding pharmacies will receive the list, and it will be available on the FDA’s website.

Pharmacists and pharmacies compounding a drug product are required to report to the Secretary of Health and Human Services (HHS) any adverse event associated with the use of it within 10 days after becoming aware of it. If a pharmacist or pharmacy knows of any kind of contamination, chemical or physical change or deterioration of a drug that has been distributed and “could cause serious injury or death,” the pharmacist has five days to report it to the Secretary.

Some compounding operations are excused from some of the Act’s provisions, but not pharmacies required to be registered as drug manufacturers. Pharmacies or pharmacists might be waived if they: work within a hospital system compounding drug products exclusively for its patients; compound sterile drug products; compound drug products in limited quantities before receiving a valid prescription for an individual patient in their state.

As noted on FDA Law Blog, Markey, whose district is home to the New England Compounding Center (NECC) that distributed the contaminated steroid medicine that caused meningitis, said the VALID Compounding Act would close the “regulatory black hole.”

Additional developments in the NECC case were reported last week by the Boston Globe.

First, Massachusetts regulators ordered all the pharmacists and technicians employed by the NECC to stop working in the drug-compounding industry. That indicates, the paper said, that state regulators are concerned that the workers failed to follow proper procedures.

Duh. A letter from the Massachusetts Board of Registration in Pharmacy obtained by The Globe said that pharmacy staff “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”

The state board had already decided to seek surrender of NECC’s license. And the outfit shut down last month and recalled all of its products.

Later in the week, The Globe reported that the director of the state pharmacy board was fired and the board’s attorney placed on administrative leave for allegedly ignoring a complaint in the summer that NECC was distributing bulk shipments of drugs to hospitals in Colorado. That violates its state license.

NECC has long been a problem. As the Globe noted, The Colorado Board of Pharmacy issued a cease and desist order to the pharmacy in April 2011 after discovering its “unlawful distribution of prescription drugs.” This summer, when a Colorado hospital discovered a bulk shipment of a drug from NECC, Colorado authorities notified their Massachusetts counterparts.

They blew it off.

The House of Representatives’ Energy and Commerce Committee is convening public hearings Nov. 14 about the problems at NECC.

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November 5, 2012

Why Compounding Pharmacies Often Don’t Pay for Their Mistakes

As the death toll continues to rise from the meningitis outbreak after a compounding pharmacy distributed contaminated medicine a few months ago, how these facilities operate has come under increased scrutiny. A story published last week in USA Today detailed how compounding pharmacies escape regulatory punishment and end up paying for their mistakes only through lawsuits by injured patients for damages.

“In some cases,” the paper reports, “there's almost no penalty for pharmacies that break the rules, and the people who run them simply continue with business as usual, sometimes with tragic results.”

Compounding pharmacies “customize” medicine—they combine various ingredients to create products specific to individuals or discrete markets, but for regulatory purposes are not considered manufacturers. (See our recent post about how compounding drugs are made.)

According to USA Today, since 1990 the FDA has recorded about 200 adverse events associated with 71 compounded products.

In its review of state and federal legal and regulatory documents, USA Today tracked contaminated, adulterated and mismeasured products, and some that were counterfeit or illegal. Many compounding pharmacies went out of business not for their failure to uphold regulatory standards, but because they got sued for their skanky wares.

Personal injury lawsuits are an avenue for reparation by people who have been harmed by wrongdoing and malfeasance, but they’re hardly a substitute for governmental control. As Joanne Doroshow, executive director of the Center for Justice & Democracy at New York Law School told USA Today, civil lawsuits help “to make sure the most dangerous compounding pharmacies are forced out of business. Nothing else seems to be doing it … because the entire regulatory system lacks teeth."

Three such lawsuits have been filed against the Massachusetts pharmacy responsible for the current meningitis crisis. That number is decidedly preliminary.

The public hammer also fell: The Massachusetts Board of Registration in Pharmacy revoked the pharmacy’s license and those of three of its pharmacists. Among the cases reviewed by USA Today, it’s the only time a state permanently revoked a pharmacy’s license. And that’s pretty much the extent of the civil punishment the government can mete out. The Massachusetts state board is not empowered to issue fines for wrongdoing.

Criminal prosecution by the FDA and U.S. Justice Department remains a possibility, but it’s remote—it’s legally difficult to hold pharmacists accountable for deficient drugs they produce or dispense. Conflict of interest also might play a role.

Former FDA compliance officer Sarah Sellers told USA Today that she can’t recall another case in which a state closed a compounding pharmacy permanently, possibly because members of state pharmacy boards often operate or have interests in compounding pharmacies. "If there is conflict of interest at the state level, that may be a contributing factor in the lack of enforcement," Sellers said.

The paper recounts a story from 10 years ago of a meningitis outbreak in North Carolina due also to a contaminated injectable steroid produced by Urgent Care Pharmacy, a South Carolina compounding facility. After finding poor sanitation and deficient quality-control practices, state and federal investigators ordered it to cease selling the contaminated drug, and issued warnings to 11 states where they had been distributed.

The South Carolina Board of Pharmacy levied a $10,000 fine, shut it down until the pharmacy corrected its deficiencies and suspended the license of the pharmacist in charge.

Urgent Care declared bankruptcy a few months later in the wake of several lawsuits by victims who had been injured by the drug. But the pharmacist whose license was suspended was allowed to continue working on a probationary basis; he now works at another South Carolina pharmacy and his record, USA Today reports, shows him “in good standing” with “no disciplinary action.”

Forest Horne, a lawyer who represented the family of a woman who died after receiving a contaminated injection, told USA Today "The regulatory system failed. If that guy is able to go back and work in a pharmacy … I think the regulatory system is not working, because the conditions in that plant were absolutely abysmal.

"If these people aren't stopped through litigation, they're not going to be stopped."

This is no way to promote best medical practice and ensure patient safety. Litigation takes a long time and isn’t always successful. And we haven’t even touched on the topic many people find most troubling about free-wheeling compounding pharmacies: their role in producing and distributing illegal drugs.

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November 4, 2012

Scary Numbers and Sobering Questions about Diagnostic Errors

In an insightful piece published recently in the Journal of the American Medical Association (JAMA), three physicians ponder why errors in diagnosis are not represented in efforts to improve the quality of medical care and, ultimately, patient safety.

According to the authors, 40,000-80,000 people die every year from diagnostic errors; those are defined as mistakes due to delayed diagnosis, missed diagnosis and/or incorrect diagnosis. They represent from 10 to 20 out of 100 cases. They might be the result of incorrectly interpreting test results, “system-related” errors within a health-care organization or faulty clinical reasoning. Everyone makes mistakes, and the health-care profession is no different.

As the authors point out, most diagnostic errors cause little or no patient harm, or are discovered in time to fix them. Still, they’re largely preventable—the authors cite a recent survey of more than 6,000 doctors, and more than 9 in 10 said so.

One piece of the Affordable Care Act (ACA, the health-care reform act of 2010, or “Obamacare”) established the National Quality Strategy to “improve the delivery of health care services, patient health outcomes and population health.”

A primary goal of the strategy is to measure quality so that everyone—providers, patients, insurers—understands the standards, and, therefore, how to reach and maintain them across all aspects of care. Basically, it has three factors:


  • Better Care: Improve the overall quality of care, by making health care more patient-centered, reliable, accessible and safe.

  • Healthy People and Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social and environmental determinants of health in addition to delivering higher-quality care.

  • Affordable Care: Reduce the cost of quality health care for individuals, families, employers, and government.


The JAMA authors want to know “How is it … that improving diagnosis goes largely unrepresented in the current quality framework? The recently proposed National Quality Strategy focuses almost exclusively on management …” Diagnosis, they say, is overlooked in most efforts to ensure quality and safety.

Even the venerable report “To Err Is Human,” published in 1999 by the Institute of Medicine (IOM,), which we discussed in a recent post about medical error reporting, gives diagnostic mistakes short shrift. As the JAMA article notes, it mentions “medication error” 70 times, but “diagnostic error” only twice.

The JAMA authors attribute this lack of attention to a couple of things: difficulty understanding and measuring diagnostic errors; the “absence of ownership,” or the habit of medical providers not acknowledging and/or taking responsibility for mistakes. “Through malpractice suits,” they write, “physicians are well aware of diagnostic error, but there is a general tendency to perceive that such errors are made by someone else, someone less careful or skillful.”

And because certain other kinds of errors are clear—operating on the wrong body part, giving someone the wrong dose of medicine—diagnostic errors “seem intensely personal: the ‘system’ appears to be the physician, and his or her own knowledge, skills, values, and behaviors.”

But excluding these mistakes from an overall “diagnosis” of quality care has consequences the authors show can undermine patient safety. It breeds apathy within health care-organizations.

“We are unaware of any health care organization,” they write, “that is currently collecting specific data on diagnostic error or engaged in a system-wide campaign to decrease the frequency or consequences of diagnostic error.”

If you don’t have that information, they say, you can’t improve the ability to diagnose nor can you measure such progress.

They also show the relationship between diagnostic ability and the cost of care. We’ve written repeatedly about the health-care industry’s penchant for testing, testing, testing, and the consequences of such overtreatment. The JAMA article notes that costs related to such testing are “increasing faster than any other component of health care expenditures,” and acknowledges the harm it can cause when it’s wrong.

In summary, the writers call for an equal appreciation of diagnosis and treatment when it comes to defining a high quality of care. They call for medical schools to emphasize the importance of diagnosis, and teach students about the nature of human error, and how people progress from novice to expert. They call for the use of diagnostic checklists to guide clinicians toward systematic ways of diagnosing.

“For high-quality care,” they conclude, “being ‘well calibrated’—which includes physicians knowing their limits and accurately assessing their own degree of certainty with a diagnosis—may be just as important as being right.”

Medical training must be supported by policy. Oversight agencies and professional associations, the writers say, must include evaluations focused on diagnosis, establish standard standards for efficient workup of diseases, help define acceptable error rates and evaluate prevention strategies.

We all understand how “the thigh bone’s connected to the hip bone;” we need to understand how the diagnosis bone is connected to the treatment bone. To mix a metaphor…

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October 20, 2012

Starting a Dialog between Attorneys and Surgeons about Medical Malpractice (Part 2)

This is part 2 of my talk to the American College of Surgeons about medical malpractice and how attorneys for injured patients can work together with organized medicine to make for better, safer care (and fewer lawsuits as a result). (Click here for part 1.)

I want to tell some very short stories about clients of mine where we had to bring malpractice lawsuits against their surgeons. You see the view in these kinds of symposiums from 40,000 feet. Here is the view from sea level.

Mike Wood, backhoe operator:

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Mike Wood lost the median nerve controlling his left hand when a surgeon talked him into doing a procedure to open a blocked subclavian artery (under the shoulder blade) that was causing absolutely no symptoms. Instead of the standard approach through the groin or elbow, for percutaneous balloon access, the surgeon chose his own technique through the brachial plexus, cutting down through the tissue in the armpit, retracting the nerves, putting a catheter in the brachial artery and going upstream to unblock the subclavian. Mike Wood woke up in intense pain in the hand and he couldn't use first three digits. Another surgeon six weeks later found the median nerve swollen and dead in brachial area – a few millimeters from the suture that marked where the artery had been penetrated, and the area of damage matched the width of the retractor that must have pulled too hard and too long on the nerve.

Two vascular surgeons testified in defense at trial. They could cite no literature advocating the brachial plexus cut-down for what was supposed to be a non-invasive percutaneous (through the skin) balloon procedure, and they could cite no one they knew who did it this way. Nor did they unblock subclavian arteries this way. But they told the jury it was still OK.

They also testified about the indications for surgery. Despite the lack of any symptoms, and the lack of any support in the surgical literature for doing this surgery when the patient has no symptoms of pain in the arm or dizziness from the arm trying to grab blood flow from one of the arteries going up the back of the neck to the brain, they also said surgery was absolutely okay to do because of the possibility of future symptoms.

To me, Mr. Wood's case shows hows how overwhelming the case must be to win. And how the defense even defends the indefensible.

Another case: Jaime Vargas, bus mechanic:

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Gall bladder removal: The surgeon cut off the common bile duct (the connection from the liver to the intestines), failed to recognize what he had done for two days, and worse, he did his own roux-en-Y repair and made the arm going to the liver so short the patient got a series of infections in the new bile duct, eventually destroyed the liver and he died.

The surgeon had no explanation for the initial injury: Still, the case was defended by two surgeons, who said the operator had done nothing wrong in failing to convert to open surgery or failing to do x-ray of the bile ducts to make sure he was cutting in the right place. Eventually this case settled shortly before trial, but only after Mr. Vargas had died from liver failure.

One more quick example: Billy Boone, home builder:

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An ENT did surgery to clean out a benign growth behind his ear from his mastoid cavity, called cholesteatoma. Seventeen years before, another surgeon had done the same surgery, and had left a small hole in the base of his skull, but no injury. In the new surgery, the surgeon stuck an instrument through that hole into the base of his brain's temporal lobe. The operative report was silent about this. Only evidence was a CT scan two days post-op, done after patient complained of trouble reading the newspaper and retrieving names of close friends. CT scan showed a pencil diameter tract of air going from the base of the skull into the brain parenchyma, surrounded by a pool of blood.

The defense strategy was deny and defend. They couldn’t really say what had happened, but it had nothing to do with the surgery.

We won the trial, but the case went all the way to the highest court of Maryland. [Blog readers can find the decision here.]

I'm proud to say we made new law in Maryland for patients: giving them a right to know up front if their surgeon lacks experience in the type of surgery he proposes to do.

The Wood, Vargas and Boone cases had this in common – lack of experience by the surgeons.

Dr. Goldberg was a general ENT, not a neuro-otologist, no experience in revision mastoidectomies.

Wood’s surgeon was a cardiothoracic surgeon, not vascular, and had done this procedure once or twice before.

Vargas’s surgeon had been trained in the era of open gall bladder surgeries and was doing this laparascopically, which he had done maybe half a dozen before. More important, on the bile duct repair, he had done one previous in his entire life. A forty-five minute drive from this hospital was Johns Hopkins in Baltimore, which has full-time biliary surgeons who would not have made the basic error of the too-short roux-en-y arm that killed the patient.

American medicine has financial incentives that encourage inexperienced surgeons to not refer patients to better qualified surgeons. In fee for service medicine, the surgeon loses any fee if he refers the case out.

One legal reform could go a long way toward fixing this. If surgeons were employees of their hospitals, and not independent contractors, the employer would have both the muscle and the financial incentives to better supervise individual practitioners. It’s called enterprise liability.

• Enterprise liability: make the hospital (clinic, HMO, etc.) liable for everyone practicing within their institution, even “independent contractors.” This provides an incentive for meaningful peer review, meaningful institutional guidelines and enforcement. Lowers litigation expenses – one defendant, one set of attorneys. It also allows for more equitable spreading of the costs of insurance: instead of high-risk specialists being personally on the line for insurance premiums, the hospital can decide how to fairly allocate the costs of its coverage for all members of the surgical staff.

• Enterprise liability is already the rule in military and veterans’ health care. In fact, individual surgeons are immune from lawsuit. The patient must sue the federal government as the sole defendant.

Outside the government, medical practice is becoming more corporatized. Here in Washington, D.C., Johns Hopkins now owns two of our major hospitals. George Washington University has been buying up doctors’ group practices. Enterprise liability fits into a trend that’s already happening.

• A related concept is enterprise notice. Avoid patients having to sue all providers by letting them put on notice everyone, stop the statute of limitations clock, and add defendants later if discovery shows them to be culpable.

Let me turn to some of the other legal reforms you have been talking about today.

Here is one program that trial lawyers like me have no problem with, as long as it’s done in an even-handed and fair way. That is: Early offer/apology programs, or what I call "be open and honest with the patient."

Here are the essential elements I see for fairness in an early offer/apology program:

• Mandatory participation of all hospital staff, including non-employee physicians, in any apology program. Why? If not, patient who knows this is an “early offer/apology” hospital might think that failure to be approached means whatever happened to them was not a preventable compensable error.

• Right to hire own attorney: Advise patient in writing before any meeting. Encourage lawyer presence. No signing away legal rights without consult from independent counsel. Why? This is not a “full employment for lawyers” program but simply an evening of the scales concept. The hospital will have its own legal counsel, whether present in the room with patient meetings, or just behind the scene. Patients need their own counsel. Period. Any counsel must be completely independent from the hospital, not on any ‘favored attorneys’ list. This will ultimately protect hospital from later accusations of undue influence or fraud.

• Protect apologies from use in court but not facts of what went wrong.

• Stop clock on legal deadline for filing suit till end of talks between hospital and patient.

• Offer fair compensation.

• No penalties for patients who decline early offers.

This follows my simple litmus test: what would you want for a family member hurt by another medical provider that you’re not connected to.

Bottom line on early offers: Your institutions can do all of this now. You don’t need any laws passed to be open, honest and fair with your patients.

Let me speak to a couple of other reforms you have talked about today:

First, clinical practice guidelines, which you are calling "safe harbor" provisions.

• What you may not know is: We already use these in court, and the current system works well: Practice guidelines can be admitted into evidence by either side, with a sponsoring expert to explain. This is the rule under Federal Rule of Evidence 803-18 and similar rules in all states I know of except Minnesota.

• Allowing practice guidelines as “evidence” but not conclusive lets both sides explain to the fact finder why the guideline should or should not be given weight, based on:
– Relevance to this patient.
– Bias and conflicts of interest in the formulation of the guideline.
– Scientific evidence for the guideline.
– Guidelines that are conflicting, vague or otherwise wrong for this patient.

• The proposal for "safe harbor" guidelines as a One-way street – guidelines can exonerate but never implicate a doctor’s liability – is obviously unfair. You wouldn’t want that for a family member injured by medical care.

• If medicine really requires customized attention to individual patients, then guidelines will never be conclusive. If guidelines were conclusive in actual medical practice, that would turn doctors from the thinking professionals that they are now, into mere technicians. So why would you want conclusive guidelines in law that you would not want in medical practice.

• Last point on practice guidelines: I challenge people to show me a case where a doctor proved adherence to a relevant clinical guideline and still lost the case. I would not prosecute the case against that doctor and doubt if any sane colleague would.

Finally, health courts. I’ve already mentioned that having schedules of injury payments is a bureaucratic style solution that does not fit the way we typically work in America. Other problems:

First, there is no evidence of any unfair tilt in the current system toward patients. Quite the opposite.

Why does it happen over and over that indefensible cases go all the way to trial and even appeal, as in the cases of Mr. Wood and Mr. Boone.

Are juries biased? Absolutely yes. But not the way some of you might think. I wrote a book a few years ago about how patients can get better medical care so they never need the services of lawyers like me. And towards the end of the book – after I detailed a lot of common sense ways that patients can better participate in their own health care and improve its quality – I had a short passage about jury trials that I’m going to boil down here:

Seven studies over the past three decades have compared the outcome of jury trials with the private evaluations by the insurance company of their own doctors’ performance. The studies have been remarkably consistent: Even where doctor reviewers have rated the medical care “indefensible” or “poor,” plaintiffs win at trial no more than 50 percent of the time. When the doctor reviewers have rated the care “defensible,” the juries overwhelmingly agree, and vote for the defendant doctors 80 to 90 percent of the time. When different reviewers disagree about the quality of the care, and so the case is rated “unclear” or “a tossup,” the defendants still win around 70 percent of the time. Note the logical pattern in the research: As the evidence of negligence becomes more clear, the victim win rate goes up. But it almost never gets higher than 50 percent, even in the “indefensible” cases. Juries have a very heavy thumb on the scales of justice favoring the doctor defendant.

How are “indefensible” cases defended? For starters, juries never hear about the “indefensible” evaluations. Those are tucked into a very private file back at the insurance company headquarters. A skilled lawyer is hired to defend the case and is set loose to find an expert witness willing to defend the care. … the jury never hears about the turn-downs. For all the jury can see, the plaintiff has an expert, and the defense has an expert, and they’re both pretty glib, and so the benefit of the doubt goes to the doctor, who, after all, was only trying to help his patient.


So those of you who want to do away with juries and have professional fact finders or even “health courts”– just a friendly word of advice – be careful what you wish for. Any reasonably neutral decision maker will return verdicts for patients far more often than happens in our current 50 state system. You might want to look at what happens in federal courts with life-appointed judges from both political parties, who decide malpractice cases without a jury in lawsuits against government hospitals like the Veterans hospitals and military hospitals. The plantiff’s win rate before judges is considerably higher than for malpractice cases tried to juries, according to the U.S. Bureau of Justice Statistics.


More problems with health courts:

• First: Shift from negligence to preventability as the legal standard solves no problems. Fault is embedded in the idea that the harm could have been avoided. If we compensate all harms in hospitals, even non-preventable ones, the system loses all connection to accountability for doing poor job.

• Second: Who are we trying to help? Shouldn’t it be the patients who suffered the worst harms? Why would we shift to a system that in essence reduces payments to worst injured in order to fund payments for lesser injured? Patients with minor injuries can take care of themselves. It’s the crippled, maimed, paralyzed, brain-damaged patients, and family members of those killed, who need a system that tries to bring some measure of justice to what’s happened to them.

Let me wrap up:

I started this talk with the idea that both the leadership of surgeons and patient advocate attorneys want the same thing: to improve safety, reduce medical errors and have fewer injured patients knocking on my door and other attorneys.

We know that concerted safety reform efforts can have a dramatic impact on lowering malpractice payouts. Look at this slide that shows what happened at New York Presbyterian Hospital when they had a multi-year effort to reform the safety of their baby deliveries.

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This is from a study published in 2011 in the American Journal of Obstetrics and Gynecology.

They not only dramatically cut their payouts, more important, they had a lot fewer “sentinel events,” which means many more healthy babies.

This is just one program in one hospital. Safety reform is something you can do even without the cooperation of the plaintiff’s bar. If you don’t like lawyers, that could be your best revenge, by making medicine safer and cutting down on our business.

To me and attorneys who do the kind of work I do, the statistics are stunning, but numbers themselves are not really the point. (Here are a few more pictures of my clients. There are many more.)

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The point is that these are real human beings.

There are many more patients and many more stories just like these.

Their lives were broken by preventable medical events.

They need to be treated honestly and fairly by our compensation system.

They want us to pay it forward. To help make sure the same thing doesn’t happen to other people.

That’s the challenge for your and my professions.

(Click here for part 1 of my talk to the surgeons.)

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October 9, 2012

Leaving Tools Inside the Patient after Surgery

Even when surgery is necessary, it’s scary. Common patient concerns include anesthesia, operating on the wrong body part, infection, and surgical stuff left inside your body after you are closed up. All these prospects are fairly remote, except for the risk of infection. But then you read a story like the one recently published in the New York Times and you wonder if you’ll ever consent to being cut open.

Four years after undergoing a hysterectomy, Sophia Savage experienced extreme pain and vomiting. A CT scan found that a surgical sponge, an artifact of her hysterectomy, had lodged in her abdomen. She underwent another operation to remove it, but it had adhered to her bladder and other viscera, and caused an infection that required the removal of a large segment of intestine.

Savage sued the original hospital and won $2.5 million in damages. But that award has been appealed, and her health has declined seriously. Unable to work, Savage has bowel problems, anxiety and depression. It’s a sad coincidence that nursing was her own former profession.

According to The Times, 4,000 cases of so-called “retained surgical items” occur every year in the U.S. Most of the items left behind are the gauzelike sponges used to absorb blood. A long operation might require dozens of them.

Failing to remove these infectious time bombs, experts say, is the result of surgical teams using a clunky method to account for their use. Usually, a surgical nurse keeps a manual count of sponges used, but an OR can be chaotic, and it’s easy to miscount. In 4 out of 5 cases in which sponges were left behind, the surgical team had declared them all accounted for.

Despite efforts by groups such as the Association of periOperative Registered Nurses and the American College of Surgeons many hospitals, The Times says, haven’t updated their procedures.

So patients are left at risk, Dr. Verna C. Gibbs, professor of surgery at the University of California, San Francisco, told The Times.

“In most instances, the patient is completely helpless,” said Gibbs, who is also the director of NoThing Left Behind, a national surgical patient safety project. “We’ve anesthetized them, we take away their ability to think, to breathe, and we cut them open and operate on them. There’s no patient advocate standing over them saying, ‘Don’t forget that sponge in them.’ I consider it a great affront that we still manage to leave our tools inside of people.”

Although sponges account for about 2 in 3 retained items, post-surgical patients are carrying around all sorts of stuff: clamps, scalpels, even scissors. But they’re easier to spot in a surgical cavity than balled-up, blood-soaked sponges, which are more likely to be left behind during abdominal operations and in overweight patients.

Technology to the rescue! Sponges can be tracked via radio-frequency tags, which are about the size of a grain of rice. As reported on PubMed.gov, one study reviewed 2,285 cases in which sponges were tracked using a system called RF Assure Detection, which alerts the team at the end of an operation if any sponges remain inside the patient. In this study, 23 forgotten sponges were recovered from nearly 3,000 patients. The cost was about $10 per procedure.

Another tracking system employs bar code technology. Every sponge is scanned before use and again when it’s retrieved.

But as effective as electronic tracking can be fewer than 1 in 100 hospitals use it, Dr. Berto Lopez, chief of the safety committee at West Palm Hospital in West Palm Beach, Fla., told The Times. His advocacy of the technology comes from personal experience: He was sued in 2009 for leaving a sponge inside a patient. Two nurses had assured him that all sponges had been accounted for, but they weren’t. Now he won’t operate in any hospital that does not use electronic tracking.

Depressingly, Lopez believes hospitals resist electronic tracking because they don’t want to spend the 10 bucks.

But Gibbs, of NoThing Left Behind, believes technology should augment manual counting, not replace it. Some hospitals, she told The Times, use inexpensive “counter bags” in which each sponge has its own compartment. If a compartment is empty at the end of an operation, a sponge is missing. Then the electronic tracking system can help find it.

Gibbs also believes that counting sponges should not be the responsibility of only nurses: Everyone in an operating room must share accountability. “Technology is but an aid,” Gibbs told the Times. “The way that safety problems are corrected and fixed is by changing the culture of the O.R.”

If you or a loved one is scheduled for surgery, inquire about the hospital’s procedures about retained surgical items. The hospital’s patient advocate and/or your surgeon should be willing to discuss it. Ask if there is a technological tracking procedure as well as a manual count. If you are not satisfied with the response, you might consider other hospital options.

To read about some surgical mistakes that proved to be learning opportunities, see our blog “Medical Mistakes that Led to a Greater Good.”

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October 8, 2012

Why Don’t Patients Report the Harm Caused by Medical Errors?

According to ProPublica, the nonprofit investigative journalism organization, "A review of medical records by the U.S. Health and Human Services Department's inspector general found that in a single month 1 in 7 Medicare patients was harmed in the hospital, or roughly 134,000 people. … An estimated 1.5 percent of Medicare beneficiaries experienced an event that contributed to their deaths ... which projects to 15,000 patients in a single month."

So why, then, are patients so reluctant to report medical errors? In reviewing nearly 200 stories ProPublica has collected via its Patient Harm Questionnaire, the writer learned that many of the contributors—people who have suffered harm while undergoing medical care—don’t file formal complaints with regulators. The reasons range from being traumatized, disabled, unclear about the bureaucratic process of complaint and, remarkably, unaware that they’ve been a victim of a medical error.

That’s not good for them or anybody who has or will avail themselves of the U.S. health-care system—in other words, it’s bad for everybody.

When harmed people don’t complain, as ProPublica notes, there is no independent investigation, no outside accountability for providers who may have made mistakes, no public inspection report that documents the problems and, one hopes, prompts solutions and avoids repeated mistakes.

Of course, the latter point assumes that an agency receiving a complaint and pursuing it makes its report public. That isn’t always the case.

There’s no central system to tally and track adverse medical events. “There’s no way to know,” according to ProPublica, “when and where patients are being harmed or to tell if the problem is worse in one place than another.”

What’s taking so long? At the turn of this century the Institute of Medicine’s landmark “To Err Is Human” report recommended a national system to record cases of serious harm to patients or death to provide accountability, expand the body of medical knowledge and to save lives.

Even though in many states hospitals are required to file reports when patients suffer unexpected harm—called “sentinel” or “adverse” events—federal officials say such state efforts are lacking. In July, the Department of Health and Human Services found that only 12 in 100 harmful events identified by its inspector general’s office even met state requirements for reporting them. Hospitals reported only 1 in 100 harmful events.

As we reported last month, when hospitals accept responsibility for harming patients, good things happen in terms of reducing costs and improving care.

The bleak scenario of under-reporting might be redrawn in the not too distant future.

The federal Agency for Healthcare Research and Quality (AHRQ) is inviting the public to submit comments about a proposed program to encourage consumers to complain about harm suffered while undergoing medical care.

By collecting information in a common format, the agency hopes to develop ways to gather information by phone and via the Internet and to follow up with a questionnaire for medical providers. Patients will be asked what happened, who was involved and for permission to contact their medical providers involved in the event. Official public comment is due Nov. 9; you can also submit comments directly to Doris Lefkowitz, the AHRQ reports clearance officer, at doris.lefkowitz@AHRQ.hhs.gov.

One member of ProPublica’s Patient Harm Facebook group explained why so few of the people like her pursue complaints about their care. She said emotional trauma, physical disability, feeling intimidated by providers and social pressure not to complain conspire against airing grievances. She said that a passive questionnaire is unlikely to elicit responses and suggested instead that patient harm information be gathered like the national survey given to recently discharged hospital patients. Its results are publicly reported on Hospital Compare, a site composed of data collected by HHS from all Medicare-certified hospitals that’s intended to help medical consumers find hospitals and compare their quality of care.

Other ways you can report harm while undergoing medical treatment include:

October 5, 2012

A Surgeon Outs the Deficiencies in Health Care

If only Dr. Marty Makary could be everybody’s doctor. He’s a surgeon at Johns Hopkins Hospital and associate professor of Health Policy at the Johns Hopkins School of Public Health. Unlike many of his fellow professionals, he’s vocal about the deficiencies in the delivery of health care, and openly discusses the problems of medical malpractice.

Makary led the effort of the World Health Organization (WHO) to measure hospital complications and co-developed the life-saving checklist for surgeons that’s become best practice to reduce infection and mistakes and to improve patient outcomes. As author of “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Healthcare,” he’s often quoted about medical error, and his informed opinions widely reproduced.

We think highly of his work, and are sharing some excerpts from his book. Our selections come from a long story recently published on The Daily Beast.com/Newsweek, but he’s been widely quoted in other media, including The Wall Street Journal.

On Overtesting and Overdiagnosing
“A host of new studies examining the current state of health care indicates that approximately one in every five medications, tests, and procedures is likely unnecessary. What other industry misses the mark that often? Others put that number even higher. Harvey Fineberg, M.D., president of the Institute of Medicine and former dean of the Harvard School of Public Health, has said that between 30 percent and 40 percent of our entire health-care expenditure is paying for fraud and unnecessary treatment.”

“Politicians debate different ways to pay for our broken system. But if we are going to get serious about reducing health-care costs—and improving health-care outcomes—we need to address the 20 percent of medical care that is unnecessary and dangerous. The public should demand disclosure of a hospital’s patient-outcome statistics. After all, we have information on a car’s safety record to inform our decision about which car to buy. But when it comes to choosing medical care, the consumer is left to walk in blind. While we currently have a free market for health care, the competition is at the wrong level. Many patients tell me they choose their medical care based on parking. For an industry that represents one sixth of the U.S. economy, we can do better than that.”

See our blog, “Overtested, Overtreated, Overcharged.”

On Hospital Competency
“While patients are encouraged to think that the health-care system is competent and wise, it’s actually more like the Wild West. The shocking truth is that some prestigious hospitals participating in a national collaborative to measure surgical complications have four to five times more complications as other hospitals. And even within good hospitals, there are pockets of poorly performing services.”

“The wide disparity in the quality of medical care is no secret among hospital staff. In a study I conducted in 2006, we asked hospital employees, ‘Would you feel comfortable receiving medical care in the unit in which you work?’ While there were hospitals where 99 percent said yes, at more than half of the hospitals we surveyed, the majority of health-care workers said no. And to the question of whether their hospital gives priority to what’s best for the patient, again, in more than half of the hospitals surveyed, the majority of health-care workers said no.

“In other words, everyone who works in medicine knows about this problem but few talk about it. A cardiovascular anesthesiologist once described to me a colleague who was one of four heart surgeons at his well-known heart hospital. This surgeon had six consecutive deaths during routine bypass surgery. Half the operations of his last 10 surviving patients took several hours longer than the norm, often requiring the patient to be put back on the heart-lung bypass machine after having come off it. I asked my friend if he ever thought about reporting this surgeon to someone. He laughed and asked, “Like who?” The hospital administration loved this young doctor and was making a mint off his work. The senior partners were very protective of him—he covered their holiday shifts and happily tended to whatever the senior surgeons did not like to do. Whenever one of his complications was discussed at a peer-review conference, they cut him tremendous slack, attributing the death to some extenuating patient circumstance.”

See our blog, “An Insider Dishes About Hospital Ratings.”

On Hospital Transparency
“A new generation of doctors has been developing fair and simple ways to measure how well patients do at individual hospitals. In hospital-speak, we call the information “sensitive data”—data that would tell you which hospitals have much worse outcomes than others.

“It’s the kind of data that, if you had access to it, would help you know just where to find the best care. But you don’t. And that is precisely the problem with the entire system: because a hospital’s outcomes are hidden from the public, neither consumers nor payers have any way of measuring whether the medicine they provide is good, adequate, or even safe. Much as the financial crisis was incubated when bank executives turned a blind eye to the ugly details about their mortgage-backed securities, so too does medicine’s lack of accountability create an institutional culture that results in overtreatment, increased risk, and runaway costs.”

See our blog, “Rating Hospitals by Readmission Is Not Simple.”

On Dangerous Doctors
“Years ago, one of my favorite public-health professors, Harvard surgeon Dr. Lucian Leape, opened the keynote speech at a national surgeons’ conference by asking the thousands of doctors there to ‘raise your hand if you know of a physician you work with who should not be practicing because he or she is too dangerous.’ Every hand went up. Doing the math, I figured that each one of these dangerous doctors probably sees hundreds of patients each year, which would put the total number of patients who encounter the dangerous doctors known to this audience alone in the hundreds of thousands. If, say, only 2 percent of the nation’s 1 million doctors are seriously impaired or fraudulent (and most experts agree that 2 percent is a low estimate), that would mean 20,000 impaired or fraudulent doctors are practicing medicine. If each one of these doctors typically sees 500 patients each year, then 10 million people are seeing impaired or fraudulent doctors annually. Incredulous at the numbers, I took to asking the same question whenever I spoke at conferences. And the response was always the same.”

“[T]he National Practitioner Data Bank collected by the U.S. Department of Health and Human Services … is also known as the national “blacklist” of doctors. The public has absolutely no access to it. When I requested the list, I was given a version with the doctors’ names deleted; the only groups that can query the list are state medical boards or human-resources departments doing background checks. Ironically, sex offenders’ names are broadcast to the community when they move into town, but doctors who lose their license in one state because of sexual misconduct with a patient are shielded by name in the database if their license is later restored or if they continue to practice medicine in another state.”

See our blog, “Minnesota Tells Dangerous Doctors: We Won’t Punish You.”

On Preventable Medical Errors
A 2010 New England Journal of Medicine study concluded that as many as 25 percent of all hospitalized patients will experience a preventable medical error of some kind, and 100,000 will die annually because of errors. If medical error were a disease, it would be the sixth-leading cause of death in the country. My research partner lost his father due to a medical error. My medical partner lost his younger sister due to a medication error. My best friend’s mom had her breast removed unnecessarily because she was mistakenly told she had stage-III breast cancer. My grandfather died at age 60 from a preventable infection following a surgery he didn’t need. Andy Warhol died prematurely of a mistreated gallstone at 54; “Saturday Night Live’s” Dana Carvey had open-heart bypass surgery on the wrong vessel; and the singer Kanye West’s mother recently went to a surgery center for a routine plastic surgery, developed a rare complication, and died.”

See our blog, “Medical Mistakes That Led to a Greater Good.”

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September 25, 2012

ProPublica Expands Patient Safety Services Site

All year, ProPublica, the public-interest investigative journalism organization, has been beefing up its service information for medical consumers. In recent months, we’ve covered its nursing home inspection reports, and its Facebook page for patients reporting medical harms.

Last week, ProPublica introduced a new site where medical consumers and medical providers can participate in ongoing conversations about patient safety, get updates and share opinions and personal stories.

It’s promoted as a central clearing house for information ranging from highlights of the Facebook patient harm group to links to reporting on health care quality to tools consumers can use to research health-care providers.

Among the offerings:

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August 26, 2012

Six Ways to Rate Your Ob/Gyn

Like reviews of restaurants and plumbers, these days doctors can be rated six Internet ways from Sunday. Some sites are fair, useful and worth your time; some provide more opportunities to vent than to advise. We looked at the doc-rating phenomenon in “The Ups and Downs of Patient Ratings of Doctors.”

When it comes to medical provider reviews, there’s an undeniable cred-boost if the info provider is a member of the class under scrutiny. Writing on KevinMd.com, Dr. Jennifer Gunter, who practices obstetrics and gynecology, offers guidance on how to rate your ob/gyn and, if he or she is found wanting, to find a better provider.

In general, she looks for communication skills: “how a doctor discusses options if the care seems valid or if a second option is in order,” and the ability to explain a treatment plan as it relates to recommended guidelines. She also looks for board certification.

When patients come to her with tales of medical misadventure, sometimes, she writes, “they make me want to shout, ‘Your doctor did/said what?!’ These are red flags, because not only are these recommendations potentially harmful, but if your doctor recommends one thing that is so flagrantly bad, well, uh, um, how can you trust the rest of their care?”

Precisely. So here are her six red flags that should prompt you to seek ob/gyn care from someone else.

1. Giving you a prescription for estrogen-containing birth control (pills, patch or ring) without inquiring about migraines. Migraines with aura are an absolute contraindication to estrogen-containing birth control because of an increased risk of stroke. A doctor’s failure to inquire about migraines indicates unfamiliarity with guidelines from the Centers for Disease Control and Prevention (CDC).

2. Blaming pelvic pain on pelvic organ prolapse. Prolapse is not a cause of pelvic pain. It causes a bulge and a feeling that something is coming out of the vagina, but it does not cause pain. A doctor who thinks the two are related knows nothing about prolapse and even less about pain. Or just wants to operate.

3. Booking you for incontinence surgery without a bladder diary (a log that measures input and outgo for 48 hours) and a post-void residual (a test to ensure you empty your bladder correctly). This simple diary and test can distinguish people who can (and can’t) be helped by surgery, as well as indicate some people who could be even worse after surgery.

4. Dismissing your concerns about pain with sex. Painful sex, called dyspareunia, is not normal: Sex should not hurt. If it does, taking a complete history and conducting an appropriate exam are in order. Many medical conditions can cause painful intercourse and not one of them is “It’s all in your head.”

5. Giving you a prescription for fluconazole (Diflucan) if you also take a statin drug for high cholesterol. These two medications can interact with fatal results and should not be given together, especially for a routine yeast infection.

6. Blaming pelvic pain on pressure from fibroids. Fibroids are benign tumors of the uterine muscle that can cause irregular or heavy bleeding, but they do not cause chronic pain. Sometimes, when they outgrow their blood supply, they degenerate into an acutely painful condition, but that can be diagnosed with imaging studies, and is not chronic pain. A large fibroid uterus would weigh 1 pound, so if a 1-pound uterine resident caused severe daily pain, how could pregnancy ever be endured?

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July 31, 2012

Why Can’t Hospitals Clean Up Their Medical Errors?

Earlier this month, we mentioned a column by Maureen Dowd in The New York Times concerning the unnecessary death of 12-year-old Rory Staunton from septic shock, who was misdiagnosed as having a stomach bug.

The sad story has legs not only because we’ve learned more about what happened that day at New York University Langone Medical Center, but also because medical errors remain an intractable problem in the U.S., as reported last week by ProPublica, a nonprofit investigative news organization.

Rory had been taken to the hospital’s emergency room in March. He was diagnosed with a gastrointestinal problem and sent home. Three hours later, his lab results showed that his white blood cell count was nearly five times higher than normal. The hospital notified neither his doctor nor his family of the lab results. As reported by The New York Times, the incident prompted the hospital to revise certain procedures, including that ER doctors should be notified immediately of certain abnormal lab results and that the patient and his or her doctor also be notified when results are reported after the patient is released.

Excuse me? Isn’t it plain to anyone with even a shred of common sense that lab results should be reviewed, interpreted and communicated promptly?

Rory suffered septic crisis—when a treatable infection becomes life-threatening—a few days after cutting his arm while playing basketball. That’s probably when the bacteria entered his bloodstream. A common medical problem turned into a fatality because nobody was paying attention.

Dr. Joshua Needleman, a specialist in pediatric pulmonology at Weill Cornell Medical Center in New York, told The Times:

“The big questions are about how to integrate new information that doesn’t fit with the perception you have formed. How to listen to the patient when they are telling you something that doesn’t fit with your internal narrative of the case. These are the hardest things to do in medicine and yet the most important.”

Another expert, Dr. Robert E. Lynch, director of pediatric critical care at Mercy Children’s Hospital in St. Louis, said that Rory’s lab results were “virtually incompatible with a diagnosis of viral gastroenteritis,” which is what he was diagnosed with.

Even with assurances by NYU Langone that the problem has been addressed, ProPublica isn’t optimistic. Medicine does not have a good record in this regard. “[W]e wish we could tell you that this case will spur changes in emergency rooms across the nation, that never again will a hospital make such an avoidable mistake,” wrote its reporters. “But, sadly, decades of experience covering such incidents suggest the medical system may prove resistant to change. Forget about every hospital rewriting its procedures. History suggests it would be a victory if NYU Langone manages to follow its own new rules as we all hope they will.”

According to ProPublica, nearly 100,000 people die annually in the U.S. from medical errors in hospitals. “Despite the resulting national focus on patient safety, patients continue to be harmed and killed by medical shortcuts, inadequate training and breakdowns in communication.

“Unlike the airline industry, which relies on a safety net of checklists, the medical community has been slow to adopt them in all areas and often puts its faith in the outdated idea that doctors are infallible.”

Here are some of the horrific but common errors enumerated in its story:


  • Between 2002 and 2008, NYU Langone repeatedly was penalized by the New York State Department of Health for errors that led to patient deaths, including one delay in diagnosing an infant's herniated bowel and deteriorating condition in the emergency room. The hospital also has a record of operating on the wrong body part.

  • Three times in 2007, surgeons at Rhode Island Hospital, the main teaching hospital of Brown University's medical school, drilled into the wrong side of patients' heads

  • In 2009 at the same hospital, a surgeon operated on the wrong side of the patient's mouth during cleft palate surgery.

  • Also in 2009 at Rhode Island Hospital, a surgeon operated on the wrong finger of a patient.


After each of those incidents, the hospital said it was committed to patient care and would make needed changes. It was fined repeatedly, and has not performed a wrong-site surgery since. But in 2010, the state health department fined the hospital another $300,000 for leaving a broken drill bit inside a patient’s skull.

Remember Martin Luther King Jr./Drew Medical Center, another chronically deficient hospital in Los Angeles? Starting in 2003, stories began to emerge about how a nurse in the cardiac monitoring unit failed to notice that her patient's heart had slowed and stopped for more than 45 minutes. On the patient’s chart, she wrote that she was not in distress. Two weeks later another patient on a monitor died after her failing condition also went unnoticed.

Health officials demanded that nurses and technicians in monitoring units be retrained and new procedures established. In the next two years, however, five more King/Drew patients died in similar circumstances. Some nurses not only neglected patients as they lay dying, but purposely turned down the alarms on the monitors or lied about their actions on patient charts.

In Las Vegas, the nation’s largest clinically based outbreak of hepatitis C occurred in 2008. Nurses at a colonoscopy clinic were reusing syringes and single-use medicine vials, infecting more than 100 people with the deadly disease. Last month we wrote about the widespread misuse of injectable drugs, four years after the high-profile crisis in Nevada.
When inspectors in Las Vegas investigated other facilities, they found the same problems.

And despite a campaign by the Centers for Disease Control and Prevention to raise awareness by providers of the need to use only one needle and syringe per patient, earlier this month, the Colorado Department of Public Health and Environment said thousands of patients may have been put at risk of HIV and hepatitis because a local dentist had used needles and syringes repeatedly for days at a time.

If you or a loved one has been harmed while undergoing medical care, ProPublica invites you to share your story here.

In concluding its report, ProPublica said that medical errors don’t usually occur because medical providers are malicious. They occur because of the culture of an institution. “Administrators need to empower front line staff,” advises ProPublica, “no matter their rank, to speak out when they see safety lapses before they cause harm — which is difficult in a system that reveres doctors above others.

“Addressing the types of failures that led to Rory Staunton's death depends on redirecting resources at a time when they are scarce and accountability amid the chaos of busy hospitals.”

It’s difficult to rewire institutional thinking. But it’s a matter, literally, of life and death.

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July 15, 2012

"Lessons Learned in Blood:" Capt. Sullenberger on Preventing Medical Malpractice

Readers should check out a powerful NYT column by Maureen Dowd on the unnecessary death of a 12-year-old boy from an undiagnosed but easily treatable strep infection.

Rory Staunton's hero was Captain Sully Sullenberger, who safely landed the airliner in the Hudson. As Sullenberger told Ms. Dowd:

“If something good comes from Rory’s death, it will be that we realize we have a broken system. Patient care is so fragmented. For the most part, medical professionals aren’t taught these human skills that some deride as ‘soft skills.’ So there’s insufficient sharing of information and ineffective communication.

“Some in the medical field look upon these deaths as an unavoidable consequence of giving care. But they’re inexcusable and unthinkable.”

Our firm represented a family in a similar case a few years ago, where the doctor assumed his patient had a benign condition but she actually had a strep infection brewing that would have been easily treated with penicillin. I discuss lessons from that case about communicating with your doctor in my book, "The Life You Save."

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July 4, 2012

When a Medical Device Warning Was Ignored, the Patient Died

Last month, we wrote about the danger of drug and medical device warnings and recalls that go unnoticed by hospitals and doctors, much less patients. A recent story reported by CNN demonstrates the tragic consequences of such ignorance.

When Florinda Gotcher entered the hospital to donate one of her kidneys to her brother, recalled her daughter, Melinda Williams, "She was so happy. She was overwhelmed that she was able to save her brother's life."

Kidney donor surgery is relative safe: According to CNN, in 2010, the year before Gotcher's surgery, 6,276 people donated a kidney. Thirty days later, they were all still alive. Mere hours after her surgery, Gotcher was dead.

Williams said that surgeons from University Medical Center in Lubbock, Texas told her Gotcher experienced massive, sudden internal bleeding after her laparoscopic procedure, and that they’d done everything possible, but that nothing could save her.

Really?

Kidney donation surgery requires cutting the renal artery. If it’s not properly closed, patients bleed to death. Staples or clips typically are used to close the artery, and both methods are considered safe. Except for laparoscopic kidney donation.

Clips are not indicated for the arterial stump because they can slip off. Four people are known to have died from exactly this circumstance, and 12 others suffered injuries. When Gotcher was taken back into the operating room after her collapse, her clips were found floating in the pool of blood that had collected in her abdomen.

This should have surprised no one, as the clips’ manufacturer, Teleflex, in 2006 began sending warning letters to hospitals that the clips were unsafe for use in laparoscopic kidney donor surgeries. Hospitals received at least three and as many as six such letters.

In addition, the product package bears a warning symbol directing doctors to review the instructions accompanying a separate tool used to apply the clips, which make clear that the clips should not be used on kidney donors.

Officials at University Medical Center acknowledged receiving the letters in 2006, but said they hadn’t purchased those clips that year. By the time they did, the letters had been forgotten, simply one more of the dozens the hospital received every year concerning safety issues.

Many medical professionals believe warning letters don’t go far enough, and that warnings should be posted directly on the devices themselves. The FDA disagrees, stating that the letters are “effective,” never mind that only about half the hospitals mentioned in documents obtained by one researcher acknowledged receipt of the warning notifications.

And the agency appears to have undercut its initial analysis, given that after Gotcher’s death it issued another notice reminding surgeons of the clips’ unsuitability for kidney donor surgeries.

As the FDA told CNN, "despite repeated efforts to communicate this important safety information, some transplant surgeons continue to improperly use these clips. While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine."

University Medical Center settled a lawsuit over this tragedy, and acknowledged that its process to track warnings failed. Now it uses an outside contractor to document and track warnings and recalls.

But it’s too late for Florinda Gotcher.

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June 24, 2012

We Know More About Medical Error and the Harm It Creates … But Not Enough

Twelve years ago, Helen Haskell’s son died because of a series of medical errors. That sad episode prompted her to found Mothers Against Medical Error (MAME), which offers support and advice for people who share such tragedy.

Haskell’s ongoing effort to quantify medical errors and the harm they can cause are detailed in her story on Reporting on Health, an online community for people to share information that fosters better media coverage of health and medicine.

You can’t head off medical harm, Haskell contends, until you can identify its reach. Until 2010, she writes, the primary source cited for the frequency of medical harm in the U.S. was a 1999 report by the Institute of Medicine (IOM). As venerable an institution as it is, the IOM collected data for the report from the 1980s and 1990s--old numbers that didn’t fully offer even a sense of what was happening at the end of that decade, much less more than a decade later.

In addition, the IOM reported only on hospital admissions (see our article, “Hospital Errors” ); but medical harm, of course, occurs in outpatient clinics and surgery centers, in physicians’ offices and nursing home, in dialysis clinics and chemotherapy centers -- wherever medical care is rendered.

In short, while the IOM metrics were solid, they gave an incomplete picture of the impact of medical harm in the U.S.

In 2010 and 2011, Haskell says, new studies were published by the Health and Human Services Department in the New England Journal of Medicine (NEJM) and Health Affairs that advanced the body of harm knowledge.

Employing a system called the Global Trigger Tool developed by the IOM, the studies probe medical records for evidence of potential adverse events. To no one’s surprise, Haskell writes, the newer research found “exponentially greater levels of harm than had been reported earlier by the IOM.

Specifically:


  • more than 1 in 4 hospitalized Medicare patients had suffered an adverse medical event resulting in harm;

  • approximately 180,000 Medicare beneficiaries died every year from their medical care;

  • 1 in 3 patients admitted to three large teaching hospitals suffered medical harm, often more than once;

  • nearly 1 in 5 patients in 10 North Carolina hospitals experienced at least one adverse medical event;

  • a commonly used adverse event detection method—voluntary reporting and the Agency for Healthcare Research and Quality’s Patient Safety Indicators--was poor; it missed 9 in 10 of the events (Global Trigger Tool found at least 10 times as many confirmed, serious events).


The 1999 report, Haskell reminds, was considered a wake-up call for the health-care system to come to grips with the extent and repercussions of medical errors, but the newer studies showed that from 2002 to 2007 there was no significant change in the rate of harm.

The researchers concluded, “Though disappointing, the absence of apparent improvement is not entirely surprising. Despite substantial resource allocation and efforts to draw attention to the patient-safety epidemic on the part of government agencies, health-care regulators and private organizations, the penetration of evidence-based safety practices has been quite modest.”

This “modesty” was quantified:


  • only slightly more than 1 in 100 U.S. hospitals have implemented a comprehensive system of electronic medical records;

  • only 9 in 100 have even basic electronic record-keeping;

  • physicians-in-training and nurses routinely work hours in excess of what’s proved to be safe;

  • compliance with even simple interventions such as hand washing is poor in many centers.


That’s bad, but, as Haskell notes, we still don’t know how bad—or even if it’s less bad—because the most recent numbers crunched in the newest studies date from 2008; the least current numbers come from 2004. That’s better than numbers from the 1980s, but it’s not the most revealing information. Much has changed since the 1990s, but the tired data don’t tell us what changes increase estimates of harm, and what changes decrease them.

In the intervening years, medicine has become more corporate and more consolidated. Bottom-line pressure has intensified. The incidence of medical encounters has increased, but most occur outside of hospitals, where safety isn’t tracked.

In summary, our collective attention about medical errors and the harm they do has been piqued. But that’s only half the job of actually addressing and minimizing them.

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April 2, 2012

Admitting Errors Is the Right Thing to Do

Early in life most of us are taught to tell the truth. Its corollary is to admit when you’ve made a mistake.

In the world of medical malpractice, however, these simple life lessons are complicated. One reason is because confidence—and, often, its uglier relation, arrogance—is characteristic of many good doctors. Arrogant doctors don’t want to admit when they’re wrong; indeed, many don’t even recognize it.

But a big reason for a medical professional’s inability to admit making a mistake is concern over being sued. Patients, that thinking goes, have a stronger lawsuit if you’ve admitted that you erred instead of remaining silent and forcing them to prove it.

There’s lots of evidence to suggest that attitude is more bone-headed than wise; we reported a study that concluded that patients are less likely to sue when hospitals are honest in copping to their mistakes. A recent post on the KevinMD blog speaks to that situation.

Former hospital CEO Dr. Paul Levy addresses the issue as a matter of leadership. He talks about a creating a culture of honesty that is good not only for the medical professionals who work there, but good for the patients who depend on their care.

Medical leaders, Levy says, “must do everything [they] can to encourage people to admit mistakes they have made and to call out problems they have found in the organization. If people think they will get in trouble for having erred, or for having brought up a systemic problem in the organization, those errors and problems will go unreported. The person and the organization will thereby lose an opportunity to grow and improve. Accordingly, a strong commitment not only to transparency but to a just culture is essential to achieve continuous improvement.”

A patient was admitted to his former hospital for surgery on her left ankle. When she woke up in the recovery room, imagine her surprise at finding her right ankle bandaged.

The surgeon had operated on the wrong limb.

He immediately notified his superiors, including Levy. The quality assurance staff reviewed the mistake, and decided unanimously to publicize it throughout the hospital. The point was to teach lessons about pre-operative procedures, and to ensure that such grievous harm would not happen to any future patients.

Levy also blogged about the incident, he says, “in the hope that our experience might be of value to workers in other hospitals.”

Many hospital staffers, Levy reported, wanted to know if the surgeon would be punished, and were surprised when he said “no.”

The surgeon had been punished enough, Levy believed. The surgical team, he said, was “devastated by their error and by the realization that they had participated in an event that unnecessarily hurt a patient.”

It was sufficient, Levy believed, that the responsible parties had reported the error promptly, had disclosed it to the patient and apologized and had participated honestly in the case review.

Comments following Levy’s blog were less charitable than he was. Most commenters believed there should have been consequences beyond a deep sense of regret. One person wanted to know:


  • Did the patient’s insurance company pay the erring surgeon?

  • Who paid the anesthesiologist, hospital facilities/supplies and support staff's bills incurred during the incorrect surgery?

  • Who paid the co-payments for office visits before and following the incorrect surgery?


These are fair concerns, but no one in Levy’s story necessarily is absolved from taking responsibility for the cost of the error. We’re looking at the bigger picture here, at the establishment of a cultural default of admitting errors promptly and accepting responsibility for them.

Like the commenters, hospital trustees grappled with the notion of punishment. One supported Levy’s actions, another said that the surgeon should have known better. “Wouldn’t someone in another field be disciplined for an equivalent error?” he had asked.

Levy says he initially over-emphasized the wrong point, the doctor’s sense of regret. “The head of our faculty practice,” he wrote, “put it better than I had, ‘If our goal is to reduce the likelihood of this kind of error in the future, the probability of achieving that is much greater if these staff members are not punished than if they are.’”

The goal of patients, advocates and caregivers should be the same: learn from an error, and reduce its incidence going forward. A kindergartner understands that.

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March 14, 2012

Pill Doctor Busted for Murder

A report recently published by the Centers for Disease Control and Prevention (CDC) drew a scary picture of prescription drug problems in the U.S. “The epidemic of prescription drug overdoses in the United States has worsened over the last decade, and by 2008, drug overdose deaths (36,450) were approaching the number of deaths from motor vehicle crashes (39,973), the leading cause of injury death in the United States.”

“These increases occurred,” the report read, “despite numerous warnings and recommendations over the past decade for voluntary education of providers about more cautious use of OPRs [opioid pain relievers].”

Some doctors just aren’t getting the message: One study showed that only about 3 in 100 physicians account for more than 60 in 100 OPR prescriptions. One of them, it appears, might be Hsiu-Ying "Lisa" Tseng, an osteopath practicing in a Los Angeles suburb. Last month, authorities finally said “enough” to Tseng, and charged her with murder in connection with three fatal overdoses.

Narcotic drugs—OPRs—are at the heart of this grim reality. We’ve looked at their dicey history before, and efforts to make them safer. By 2010, the report said, OPR sales were sufficient to medicate every American adult with a standard dose of hydrocodone (Vicodin) every four hours for month. Is it any wonder that sales of these morphine-like drugs such as Oxycontin, Percocet and Dilaudid paralleled the OD death trend?

As recounted by the Los Angeles Times, Tseng also stands accused of recklessly prescribing narcotic painkillers and other addictive drugs, but the murder charge is, according to The Times, “a rare attempt to hold a physician criminally liable for patients' deaths.”

Tseng told The Times in 2010 that she had been confronted about her prescribing habits by her patients' loved ones. At the time, she absolved herself of any problem they might be having. “‘They call me all sorts of names — drug doctor, drug-dealing doctor.… I tell parents a lot of times it's their problem."

The three dead patients named in the district attorney’s complaint died in 2009 after traveling long distances to see Tseng, a general practitioner. One came all the way from Arizona.

According to The Times, the Drug Enforcement Administration had been investigating Tseng for years even as her patients continued to overdose. The feds were considering charging her under a drug-dealing statute.

In addition to the deaths, the L.A. district attorney has charged Tseng with 20 counts of prescribing painkillers and anti-anxiety drugs to people who had no legitimate need for the medications. She was nabbed by investigators working under cover as "patients." The drugs she allegedly prescribed included the common black-market drugs oxycodone and alprazolam. Some of Tseng’s patients had been charged with dealing drugs, and family members told The Times that they suspected their loved ones of selling some of their prescriptions to finance their habit.

Tseng was in deep trouble even before her murder rap. She had agreed previously to surrender her medical license in settlement of gross negligence charges related to more than a dozen patients (three of whom died) to whom she allegedly prescribed excessive amounts of drugs without taking the standard-care precautions of checking a state-run prescription database to see if they were already being prescribed similar drugs from other doctors.

Cases like Tseng’s and that of Michael Jackson’s doctor, Conrad Murray, who was convicted of involuntary manslaughter, are highly unusual. Brian Liang, director of the Institute of Health Law Studies at the California Western School of Law, told The Times, “We don't generally criminalize negative medical outcomes. It is very rare for a physician to get hit with gross negligence to the point of criminality. That's a very difficult standard."

Said Tseng to The Times a couple of years ago: "I never intended to kill anybody."

But it looks like she did. And it looks like she was given plenty of time to do it. Yes, it’s nice that somebody is bringing down the hammer on a supposed “caregiver” who’s really a dangerous threat. But we want to know what took you so long?

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February 13, 2012

Electronic Health Records Make Doctors Accountable -- and Some Don't Like That

Electronic health records (EHRs) hold much promise for reducing medical errors and improving quality of care, but the prospect that patient advocates can use EHRs to do an autopsy of where a patient's care went wrong has some in the medical industry sounding an alarm.

Last week a story (actually a press release, on closer scrutiny) in the Wall Street Journal's Market Watch talked about "Crippling Access to Physician's Actions" allowed by tattle-tale Electronic Health Records. Among the horrors described by IT consultant Dr. Sam Bierbock:

EHRs ... can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

And this is a bad thing?

Fortunately there are patient advocates in the medical informatics industry. One is Scot Silverstein, MD, of Drexel University, who trained as a doctor in intensive care units, which have heavy demands for up-to-the-second monitoring information on the desperately ill patients they care for. Dr. Silverstein wrote a well-informed blog post on the real problems with EHRs and why it won't wash to make plaintiff attorneys and malpractice lawsuits the whipping boy for the industry's troubles.

Our firm represented a patient's family last year in a particularly tragic malpractice case where we used the hospital's "audit trial" of EHR records to show that a nurse was claiming to be in two places at one time. Her neglect led to the stillbirth of our family's child.

The alarm of IT consultants like Dr. Bierbock over the ease of auditing health care brought about by EHR's is really a false alarm. Yes, there will be closer scrutiny of medical decisions. But audit trails will lead to more accurate understanding of what happened in any tragic injury, and that should lead to better care for all.

First published on Technorati.

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February 6, 2012

Minnesota Tells Dangerous Doctors: We Won't Punish You

It's been known for a while that Minnesota ranks dead last in the nation in the frequency with which its doctors are disciplined by the state licensing board for harming patients. Now we know why.

A new investigative series by the Minneapolis Star Tribune has some dizzying quotes from state officials who are charged with protecting the public.

For example, when asked why Minnesota so seldom took action against a doctor's license when authorities in another state had already done so, Ruth Martinez, supervisor of the board's complaint review unit, replied:

"What's the point of piling on?"

(Earth to Ms. Martinez: If your state is the only one that hasn't restricted a doctor's license to practice after some horrendous harm to patients, where do you think that doctor is going to end up practicing?)

Perhaps even more revealing are the words of the board's executive director, Robert Leach, who is quoted as follows by the Star Tribune:

"I'm satisfied the public is protected in Minnesota -- very satisfied. And remember that part of public protection is ensuring an adequate supply of health care practitioners to the public. You can't take everybody out of practice just because they had a problem. That's why we're not in the business of removing credentials unless absolutely necessary. We want to be remedial."

When the board declines to act against a doctor, patients have no way of finding out that that doctor might be a problem -- because by law in Minnesota, only public discipline is disclosable. So there's a real Catch 22 for patients trying to make sure they are seeing a top notch doctor.

Kudos to Public Citizen's Health Research Group for its compilation of the discipline statistics state by state, on which the Minneapolis newspaper report was based.

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January 9, 2012

Two Steps Forward, One Step Back for Patient Safety in Hospitals

There’s been a lot of good news lately about what hospitals are doing to protect patients: Many have improved their infection control practices, many are looking at the value of “hospitalists” (doctors who practice exclusively with inpatients) and many have embraced palliative care.

Yet for every two steps forward for patient safety, it appears as though many hospitals are taking at least one step back. As reported last week in The New York Times, a federal report concluded that hospital employees recognize and report only 1 in 7 errors, accidents and other events that harm Medicare patients.

An even more shocking revelation in the report by Department of Health and Human Services investigators is that once hospitals do investigate preventable injuries and infections, they seldom change their practices to thwart them from recurring. This despite the fact, as HHS Inspector General Daniel R. Levinson pointed out, that Medicare reimbursements to hospitals are contingent on them tracking such errors and adverse events, analyzing and addressing them.

“Adverse events” are those that cause significant harm experienced by patients as a result of medical care.

As the Times reported, “Despite the existence of incident reporting systems,” Levinson said, “hospital staff did not report most events that harmed Medicare beneficiaries.” And, he said, some of the most serious problems, including some that caused patients to die, were not reported.

The report found that “hospitals made few changes to policies or practices” even after employees reported harm to patients. In many cases, hospital executives told federal investigators that the events did not signify any “systemic quality problems.”

Among the problems enumerated were:


  • medication errors;

  • severe bedsores;

  • hospital-acquired infections;

  • delirium caused by overuse of painkillers; and

  • excessive bleeding linked to improper use of blood thinners.


Levinson estimated that more than 130,000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month, and that many hospital administrators knew that hospital staff were underreporting them.

Whereas once hospital employees were afraid to admit mistakes for fear of reprisal, that doesn’t seem to be the problem here. Rather, Levinson said, it’s that hospital employees don’t recognize “what constitutes patient harm,” nor do they realize that certain events harm patients and should be reported. And sometimes they just assume someone else will report the episode, they believe it to be so common as to be insignificant or they assume it is an isolated event unlikely to be repeated.

For more information about hospital errors, and what you can do about them, see this page on our website.

In response to the confusion described by the HHS report, Medicare officials said they would develop a list of “reportable events” hospital employees could use to eliminate questions about what’s required and what isn’t. In addition, the Medicare agency said, hospitals should give employees “detailed, unambiguous instructions on the types of events that should be reported.”

You mean they haven’t already done so?

Article first published as Two Steps Forward, One Step Back in Hospital Patient Safety on Technorati.

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December 26, 2011

Our Nation's Hidden Elderly Deaths Scandal

Last week we reported about the shockingly deficient numbers of hospitals that do not conduct autopsies, and, as a result, miss important diagnostic and/or treatment lessons from the results.

In a related and equally disturbing reality, when elderly people die under suspicious circumstances, the reasons often remain unknown because autopsies are seldom performed on people older than 65. The investigative report by ProPublica and PBS Frontline says that no one knows how many of these suspicious deaths have been ascribed to “natural” fatalities, and how many, in fact, were the result of elder abuse or mistreatment. The report quotes a U.S. Department of Justice researcher describing the situation as “a hidden national scandal.”

The system of investigating the cause of suspicious deaths is compromised by insufficient funds, a shortage of trained medical personnel and lack of national standards that, the writers conclude, sometimes have “helped to send innocent people to prison and allowed killers to walk free. When it comes to the elderly, the system errs by omission.”

Specifically, here’s how the system discourages appropriate scrutiny of senior citizen deaths:


  • When treating physicians report that a death is natural, coroners and medical examiners almost never investigate. But doctors often get it wrong: Nearly half the doctors in one study failed to identify the correct cause of death for an elderly patient with a brain injury caused by a fall.

  • In most states, doctors can write out a death certificate without ever seeing the body.

  • Autopsies of seniors have become increasingly rare. People older than 65 represented about 6 in 10 U.S. deaths and 3.5 in 10 autopsied deaths in 1972. A generation later, seniors accounted for 7 in 10 deaths, but fewer than 2 in 10 autopsied deaths. Of the 1.8 million seniors who died in 2008, post-mortem exams were performed on only 36,000.


The ProPublica/Frontline story reports about one death a doctor attributed to clogged arteries and heart failure, but which, thanks to a tip by a nursing home worker, prompted state officials to re-examine. They concluded that the death was due to a combination of ailments often related to poor care—an infected ulcer, pneumonia, dehydration and sepsis. They said the patient’s demise was hastened by the inappropriate administration of powerful antipsychotic drugs, which can have potentially lethal side effects for seniors.

Prosecutors ended up charging the physician and two former colleagues with killing the patient and two other elderly residents.

In another case, the death was attributed to "failure to thrive" due to "dementia." The physician who signed the death certificate hadn't seen the patient for 13 days before he died. She never saw his corpse.

Only when the director of the funeral home that was preparing his body for burial spoke up was it discovered how wrong was the official cause of death. "I'm no CSI expert, but I've been doing this for 25 years, and I've seen a lot of dead people," the funeral home official said. "He was all bruised up and purple, and his ribs were all broken."

He contacted the coroner's office, and an autopsy showed that some kind of violent impact had snapped five ribs. One of the broken bones had pierced the patient’s left lung, flooding his chest with blood. The damage was fatal. His case, too, resulted in criminal prosecution of a nursing home employee.

The reporters identified more than three-dozen cases “in which the alleged neglect, abuse or even murder of seniors eluded authorities. But for the intervention of whistleblowers, concerned relatives and others, the truth about these deaths might never have come to light.”

State laws rely on doctors to separate extraordinary fatalities from routine ones, principally by what they record on death certificates. When a doctor encounters an unusual fatality—a death that might have been caused by homicide, suicide or accident—the physician must report it to the coroner or medical examiner for further investigation.

But death certificates are frequently erroneous or incomplete; one study published last year found that nearly half of 371 Florida death certificates surveyed had errors in them. Doctors without training in forensics often have trouble determining which cases should be referred to a coroner or medical examiner.

Robert Anderson, chief of mortality statistics for the Centers for Disease Control and Prevention, said some doctors don't grasp the significance of death certificates. "I've had instances where the physician just doesn't understand the importance of what they're writing down," he told ProPublica/Frontline. "I'm appalled when I hear that."

Part of the problem is age bias—the death of an older person is accepted much more readily than someone younger—and part of the problem is a lack of resources. Coroners and medical examiners can’t keep up with the number of bodies to be autopsied as it is. Bringing in more seniors exacerbates the problem.

Article first published as Our Nation's Hidden Elderly Deaths Scandal on Technorati.

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December 11, 2011

Finally, Accurate Report Cards Will Be Released on Doctors' Safety and Quality of Care

Knowledge, they say, is power. It’s also a necessary tool for crafting cost-effective medical practices and protecting patient safety.

Medicare has an enormous claims database from which valuable knowledge can be mined. Finally, within about one year, employers, insurance companies and consumer groups will be able to unearth its information to produce “report cards” on doctors and hospitals.

This blog has championed this access to information, and the subject also figures mightily in “The Life You Save: Nine Steps to Finding the Best Medical Care and Avoiding the Worst,” my book about patient advocacy and medical mistakes.

As described in an Associated Press story, researching a health-care provider’s history in the Medicare database has not been possible before, thanks to a decades-old court decision. Releasing such information, the ruling read, violates the privacy of doctors. The medical establishment was vigorous and vocal in not wanting the people who pay for and receive its ministrations to know how its members rate.

Congress and the executive branch disagreed. For once, both parties were unified on this issue, and federal law has been revised to authorize access to the Medicare database.

What does this mean to the average patient? Suppose you need a knee replacement. Wouldn’t it be nice to compare potential surgeons by how many such procedures they’ve performed, if there were preventable complications and how many?

Experts who analyze Medicare’s billing records glean critical information that not only promotes quality care, it reduces cost and waste by promoting practitioners who are skilled and responsive. The delivery of health care is more efficient and outcomes improve when complications, readmissions and legal adventures are kept to a minimum.

"This is a giant step forward in making our health care system more transparent," said Marilyn Tavenner, Medicare's acting administrator of the newly accessible Medicare mother lode.

Performance reports could be available to consumers by the end of next year. Although individual doctors will be identified in the files, patient names and personal information will not.

Companies are keen to identify the economies of scale that will emerge from analyzing Medicare’s data as it applies to their insurance coverage. But some employer groups also want their workers to know how well their health-care providers are doing their jobs. An executive with the Business Roundtable, which represents CEOs of major corporations, told AP, "We want to make it understandable and usable by our employees. That has always been the goal."

The American Medical Association, which represents doctors, claimed that this data could be misleading or misunderstood by the average consumer. A surgeon with many patients who develop complications, for example, actually might be a top practitioner. He or she just might be willing to accept difficult cases others reject.

There are accommodations to the medical community—providers have the right to see their information before it is released publicly, and they will have 60 days to challenge it.

And Medicare promises to screen the analytical methods of groups requesting access to the data, which isn’t free—access to the files comes at a cost.

The price for transparency is worth it.

First published on Technorati as Finally, Accurate Report Cards on Doctors' Safety and Quality of Care.

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November 6, 2011

How to Complain Effectively about Unsafe Medical Care

If you believe your care provider has caused serious harm by negligence or malpractice, consult an attorney about legal relief. But that’s using a machete, and sometimes the job requires a butter knife.

If you have a medical procedure – surgery, a screening test – whose outcome is not what you were led to expect, or has made you worse off, there are several ways to lodge complaints. Many of these options recently were spelled out in an article in the Los Angeles Times.

Often, as simple a gesture as writing a letter can have the desired effect, especially if your primary objective is to have your problem acknowledged. If you’ve expressed concern, for example, about enduring, post-procedure pain that hasn’t been addressed, a letter to your doctor seeking the name of another practitioner who can evaluate your symptoms, review the procedure that caused them and suggest how to treat it can be a wake-up call.

As The Times reported, a doctor no longer interested in treating a patient is legally required to notify him or her in writing. The doctor also is obliged to provide references to another physician, and instruct the patient or new provider how to access the records relevant to your treatment.

If you’re trying to get, say, a surgeon, to accept responsibility for an adverse outcome, Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen in Washington, D.C., outlines what to do. “Failure to do so,” he said in The Times, “amounts to patient abandonment, an infraction that would justify an investigation by the state medical board.”

Most state medical boards – the agencies responsible for licensing medical practitioners, monitoring their behavior and imposing discipline – have similar provider requirements. Jennifer Simoes of California’s Medical Board said that a patient should file a complaint if he or she “believes the quality of care that they received was poor or not the standard of care they should have received."

Other state agencies also are appropriate places to report medical mistreatment and misadventure, such as state insurance commissions, which monitor health-care coverage by private insurers. Complain to your insurance company via letter, and copy your state insurance commission.

Medical societies, which range from all-encompassing organizations such as the American Medical Association (AMA) to groups whose membership is limited to certain medical specialties, such as the American Academy of Orthopedic Surgeons (AAOS), are concerned about their reputations. It’s in their best interest to ensure their members are responsive to patient needs and complaints.

To find a state medical society, visit the AMA’s website and click on the “Patients” tab to link to the Medical Societies Directories.

If your problem relates to a surgery or procedure performed in a hospital, file a complaint with that facility’s patient advocate and, if it has one, the ombudsman. Many hospitals are accredited by the Joint Commission, about which we recently wrote. It’s an independent, nonprofit organization that accredits and certifies U.S. health-care organizations and programs.

The Joint Commission also accepts patient complaints, and its Office of Quality Monitoring uses consumer complaints to help assess if a hospital meets its accreditation standards. In The Times’ story, Michael Kulczycki, executive director of the Joint Commission's Ambulatory Care Accreditation Program, said of patient complaints, "We would focus on the continuity of care and appropriate follow-up to the patient."

File complaints at http://www.jointcommission.org. Click on Report a Complaint About a Health Care Organization in the Action Center box on the home page. After reviewing a complaint, the Joint Commission can present your issue to the hospital and ask it to review the doctor’s actions to see if additional action is necessary.

Medicare patients have additional avenues to voice complaints. Contact your regional Medicare Quality Improvement Organization (QIO), which reviews medical care and helps consumers who complain about the quality of their care. Locate a QIO near you at http://www.ahqa.org. Click on QIO Locator.

As always, you have legal rights to safe and responsible medical care. Don’t be reluctant to exercise them if you’re not getting the attention, professional courtesy and resolution you believe you deserve. As Carome said in The Times, "Ultimately another way physicians are held accountable is through litigation."

You can find out more about non-lawsuit options for making a complaint about a doctor, nurse, hospital or other health care provider by reading the Health Care Advocates' Power Kit on Patrick Malone's law firm website. It contains addresses of all the relevant agencies and tips on how to make an effective complaint.

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August 12, 2011

Why Aren't Hospitals Any Safer with Fewer Sleep-Deprived Trainee Doctors?

No one wants to be treated in a hospital by a doctor at the tail end of a 36-hour shift who is falling asleep on his or her feet. So the organization that supervises training programs for resident doctors mandated an 80-hour work week limit.

A provocative piece in the New York Times Magazine makes the case that shorter hours for residents hasn't made hospitals any safer. Why?

  • Handoff errors -- poor communications about patients between the doctor leaving a shift and the new doctor arriving -- are still rampant in hospitals, because of lack of systematic training in how to do a proper handoff.
  • Lack of supervision, leaving residents to make decisions with little experience and no guidance.
  • Many hospitals flout the new rules, and residents work longer than they should.

It's an issue that resists easy answers, as shown by the many comments to the article, which you can click here to read.

We have a good discussion of how handoff errors can lead to malpractice and preventable harm to patients on our firm's website.

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July 22, 2011

Malpractice in the Operating Room: Who Is Responsible?

It was supposed to be a routine hernia operation. But then the surgeon ordered the anesthesiologist to give the patient a blood-thinning drug. The anesthesiologist, who wasn't familiar with the drug, injected the drug directly into the patient's i.v. line, as soon as the surgeon ordered it. That was a double mistake, and it started a cascade of consequences for the patient, who later became our law firm's client.

The legal issue in the medical malpractice lawsuit we filed was: Who was responsible for the misuse of the drug? Just the anesthesiologist, who should have known better than to inject the drug intravenously, and so soon? Or the surgeon too?

That issue was finally resolved this week in our client's favor. Here is what happened.

The too-quick use of the drug Lovenox, which was intended to prevent blood clots in the legs after the surgery, caused bleeding in the spinal cord, with permanent nerve damage for our client. The use of the drug was against the "black box warning" on the drug's official labeling, which said doctors should wait after a spinal anesthetic at least several hours, and also against the official policy of the Washington, DC hospital where the surgery happened.

The anesthesiologist settled out of court on the eve of trial and turned over to the injured patient the anesthesiologist's cross-claim for "contribution" against the surgeon.

The trial court then ruled, after a hard-fought trial, that the surgeon was jointly responsible with the anesthesiologist for the injury.

After a long battle, the District of Columbia Court of Appeals affirmed the trial court's ruling in all respects. You can read the decision on our firm's website here.

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July 12, 2011

Testing for Life-Saving Communications Skills in Young Doctors

Want to go to medical school? How well do you listen? How well do you work in a team? Those issues are now being tested by the nation's newest medical school in screening applicants.

This is not just a matter of touchy-feely. Preventable deaths and malpractice have been proven to happen all too often when arrogance trumps smooth teamwork and easy communication among members of medical teams.

But testing communication skills is not so easy. So in the new testing regime created by the leaders of Virginia Tech Carilion medical school, medical school applicants are given a series of quick, speed-dating type interviews where they have to show how they respond to real world scenarios that require good communication and teamwork skills.

Gardiner Harris has a fascinating account in the New York Times about the new program. A key quote from the article brings home its importance:

A pleasant bedside manner and an attentive ear have always been desirable traits in doctors, of course, but two trends have led school administrators to make the hunt for these qualities a priority. The first is a growing catalog of studies that pin the blame for an appalling share of preventable deaths on poor communication among doctors, patients and nurses that often results because some doctors, while technically competent, are socially inept.

The second and related trend is that medicine is evolving from an individual to a team sport. Solo medical practices are disappearing. In their place, large health systems — encouraged by new government policies — are creating teams to provide care coordinated across disciplines. The strength of such teams often has more to do with communication than the technical competence of any one member.

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July 12, 2011

Prescription Medicine: The Argument for Letting Generics Look Like the Brand Name Original

You fill a prescription with a brand-name medication. The pills are light-blue ovals that come in a plastic bottle. When the generic version becomes available, your insurance company insists that you purchase only that, and your doctor agrees.

This time, the pills are round, white and come in a carboard blister pack. If the medicine works the same, who cares?

Two physicians writing in the New England Journal of Medicine, argue that we all should.

They say letting generics look like the brand name original makes for safer and even more effective medicine.

The doctors argue against a practice called "trade dress." The term refers to federal laws that protect the unique appearance of brand-name drugs by prohibiting generic pharmaceutical manufacturers from making similar-looking pills or designing similar packaging.

The researchers accept that trade dress has played a meaningful role in keeping drugs safe. It can prevent different medications from being mistaken for each other, thwart counterfeiting and prevent shady pharmacists from making unauthorized substitutions of generic for brand-name drugs and skimming the extra profit for themselves.

But drugs that are supposed to perform one way but look different every time you refill the prescription, suggest researchers Jeremy Greene and Aaron Kesselheim, can lead to medication errors, can be unnecessarily more expensive and can diminish the generic drugs' effectiveness, thanks to the placebo effect not kicking in for the generic drug.

A placebo, or "fake" drug, is a sugar pill or other inert substance used in medical trials to test different treatments among trial subjects who are unaware if they are being given medicine or something that just looks like it. Often, however, patients receiving the placebo respond positively, sometimes strongly so.

As reported on MedPage Today, The NEJM researchers note that "A resurgence of research on the placebo effect suggests that drug appearance can have a distinct functionality." They say a medication's packaging and the perceived dollar value of products can influence a product's effectiveness as well.

So because one medicine that always looks different can be confusing, because generics make up about 70% of all U.S. prescriptions but less than 20% of prescription-drug costs and because a patient's mind is a powerful player in his or her ability to heal an ailing body, the researchers support amending regulations to permit generic drugs to resemble their brand-name counterparts.

Such changes would codify a consistent, organized system of pill appearance that would:


  • simplify the complexity of certain medical regimens;

  • encourage the use of generic drugs when appropriate; and

  • increase a patient's ability to take the medication as directed.


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July 4, 2011

Expanding the List of Medical Misadventures that Should Never Happen

Nearly 10 years ago, the National Quality Forum (NQF) published a report, Serious Reportable Events (SREs) in Healthcare. It identified 27 really horrible mistakes occurring in hospitals deemed largely preventable and of concern to both the public and health-care providers. Thanks to their extreme nature, these "adverse events" have come to be known colloquially as "never events." They include such medical misadventures as surgery on the wrong body part, festering bedsores acquired after admission, patient falls and life-threatening medication errors.

Establishing consensus of what constitutes preventable errors among everyone vested in the satisfactory delivery of health care--consumers, providers, researchers, etc.--facilitates clear accounting and resolution of them.

The report was revised in 2006, and once again the program is updating the list of SREs.

The take-home message this time is that SREs are an equal-opportunity aspect of practicing medicine that go beyond the confines of a hospital. The mission is expanding to collect data also from:


  • ambulatory and office-based surgery centers;

  • long-term care settings (including skilled nursing facilities); and

  • physicians' offices.

The uniform approach to measurement helps to drive national improvement in patient safety through shared learning and prevention. More than half of the states use the NQF-endorsed list of SREs in their public reporting programs.

This update adds these "never events":


  • death or serious injury of a newborn associated with labor or delivery in a low-risk pregnancy;

  • patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen;

  • patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology or radiology test results; and

  • death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area.

The NQF report is widely embraced as what health-care monitor Bob Wachter calls "a dominant force in the patient safety field." It has, he notes, a real and measurable impact: Medicare, for example, has stopped paying hospitals the extra costs associated with SREs. "While the money being withheld is relatively small...," Wachter says, "the policy has captured the attention of administrators and providers everywhere."

Still, Wachter sees room for improvement, noting that:


  • many events on the list lack standard definitions, leaving them subject to interpretation;

  • unintended consequences can occur, such as preventing a fall by tethering a patient to the bed who otherwise would benefit from walking;

  • the "no pay for errors" policy might prompt private insurers to suspend all payments after a facility reports an SRE;

  • the list doesn't capture some mistakes, such as diagnostic errors and errors of overuse; and

  • some serious adverse events are not known to be fully preventable.

Greater accountability can only encourage sustained efforts to protect patients from sloppy, incompetent and witless medical behavior. Efforts to refine the process are good for both the providers and those of us who receive medical care.

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June 15, 2011

Time of surgery doesn’t affect heart/lung transplant outcomes

A study examining outcomes of heart and lung transplant surgery has concluded that patients fare essentially the same whether the transplants are performed during the day or at night. Two smaller previous studies – one on kidney transplants and the other on liver transplants – had indicated that patients tended to fare worse if the operations took place in the middle of the night.

The new study, published in the Journal of the American Medical Association, took into account all of the nearly 30,000 heart and lung transplants performed in the United States over 10 years. Researchers were surprised by the results, which indicated that, contrary to conventional wisdom, patient outcomes had little to do with the time of the operation or the fatigue of the surgeon. Rather, they seemed to hinge on the reliability of the surgical team.

Unlike surgeons in other specialties, cardiothoracic surgeons almost always work in the operating room with the same team of highly specialized anesthesiologists, nurses, physician assistants and technicians. The team’s familiarity with and constant repetition of the same complex steps — placing patients on bypass machines, performing certain intraoperative studies, even executing specific suture sequences — may be the key to ensuring consistent performance, whatever the time of day.

When performing a transplant, “the surgeon isn’t doing a complicated operation in the middle of the night with an anesthesiologist who usually staffs gynecology procedures and a nurse who works in the orthopedic operating rooms during the day,” says Dr. Ashish Shah, a co-author of the study and assistant professor of surgery at the Johns Hopkins University School of Medicine. “We need to think about doctors less like airline pilots and more like a part of a special forces military team. Those teams carry out complex tasks at a very high level and under less than ideal physiologic or environmental conditions.”

Source: The New York Times

You can read an abstract of the study here.

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May 30, 2011

Physician learns about hospital errors the hard way

Doctors who aren't directly involved in patient safety issues often sail through their careers without much awareness of how commonly errors and malpractice infect hospitals, clinics and medical offices. Then they become patients, and suddenly their world is turned upside down.

Itzhak Brook, M.D., has been a doctor for more than 40 years. He is an infectious disease pediatrician at Georgetown University Hospital in Washington, D.C. Then he got throat cancer a few years ago.

His cancer was successfully removed, but then it came back. He had to have his voice box -- the larynx -- removed, and the throat was reconstructed.

It was then that the errors began to pile up, or, as he puts it, “mistakes occurred at all levels of my care.”

Dr. Brook recorded these incidents before, during and after his surgery:

* Surgeons had failed to timely diagnose the recurrence of his cancer. It was finally observed by an astute resident via a basic procedure that allowed visualization of the pyriform sinus, which was where his tumor was located. Had his experienced surgeons done the same basic procedure, his tumor most likely would have been observed and removed much earlier.

* Surgeons mistakenly removed scar tissue instead of the cancerous lesion. A week after the surgery, pathological studies revealed that the tumor was actually farther down in the pyriform sinus. This error could have been avoided if frozen sections of the lesion itself, not just its margins, had been analyzed in the operating room. As a result, he had to undergo additional surgery to remove the tumor, which was more difficult because of swelling and changes to the surgical site due to the original operation.

* While still in the ICU one day after surgery, he experienced an airway obstruction and couldn’t find his call button, which had fallen on the floor. Though he was only a few feet away from the nurses station, he was unable to get the attention of staff but was ignored. (He couldn’t call out because he no longer had a larynx).

* In what was probably the most serious error, he was fed soft food by mouth far too early, which, following laryngectomy with flap reconstruction, can lead to failure of integration by the flap. It took 16 hours before the feeding was stopped, and only after Dr. Brook brought this to the attention of a senior surgeon. The error occurred because the order to start feeding was in fact intended for another patient.

In addition, nurses and other staff:

Did not clean or wash their hands.

Did not use gloves.

Took oral temperature without placing the thermometer in a plastic sheath.

Used an inappropriately sized blood pressure cuff (which produced alarming readings).

Attempted to administer medications by mouth intended to be given by nasogastric tube.

Dissolved pills in hot water and fed them through the feeding tube (thus irritating the esophagus).

Delivered an incorrect dose of a medication.

Connected a suction machine directly to the port in the wall without a bottle of water.

Forgot to rinse the hydrogen peroxide used for cleaning the tracheal breathing tube (causing
severe irritation).

Did not write down verbal orders.

Fortunately, despite all these errors, Dr. Brook did not suffer any long-term consequences. Still, his experience made him realize that a hospital is the least safe place for patients, and that all hospitalized patients should have a dedicated patient advocate such as a family member or a friend at their bedside.

Dr. Brook writes extensively about his experiences as a throat cancer patient on his blog. He also lectures to medical groups to try to get doctors and nurses to understand the human costs of the epidemic of medical error.

You can also read Dr. Brook’s account of his hospital experiences in the Journal of Participatory Medicine.

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May 17, 2011

Doctor Superiority Is Dangerous to Patient Health

Ask any nurse for stories about dealing with doctors, and you will hear that American hospitals and other health care institutions have a long way to go before civility and teamwork rule the day. Why is that a malpractice prevention issue?

Nurses have a vital role as a check and balance to catch mistakes and oversights by doctors that could lead to tragic malpractice injuries. But a typical example, when a nurse quietly questions a doctor's order for a medication that the nurse doesn't think appropriate, is to hear the doctor say: "When you get an MD after your name, you can question what I order."

Stamping out the attitude of doctor superiority is important for everyone in the health care system, especially patients. That message came through loud and clear in letters to the editor of the New York Times responding to a nurse's frustrated column about being humiliated one too many times by a doctor in front of a patient.

The CEO of one of New York City's top hospitals: Herbert Pardes of New York-Presbyterian Hospital, wrote:

The best doctors I know consider themselves part of a team and use the team’s knowledge to the advantage of the patient. They think “patient first” and draw on the experience of nurses, laboratory technicians and other medical professionals. The patient receives the doctor’s best treatment advice based on the collective knowledge of the team.

Doctors who accept only their own counsel are putting ego before medicine, possibly at the expense of the patient. Hospital care should be based on collective wisdom to reach the best treatment plan. Nurses, doctors and all highly trained medical professionals each have a role to play, each of which is invaluable to the patient.

And another letter writer, Donna Nickitas, a nursing professor at Hunter College, said:

As a nurse, I would not want my family member or my nursing students in a hospital where physicians demean and insult their nurse colleagues, thus hampering their ability to care. A culture of civility and a climate of respect and dignity not only win the day but also ensure patient safety and quality care.

So when you're in a hospital and you see doctors acting arrogantly, know that it's not just a personality quirk, but something that could be bad for the health of any patient, including you and your loved ones.

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May 2, 2011

New York creates fund for infants with neurologic damage due to medical errors

As reported in more detail on our child safety blog, New York state has created a new fund to pay medical expenses for infants who suffer brain and nerve damage because of medical malpractice and other medical errors.

The fund, which is due to go into effect on Oct. 1, 2011, allows medical costs to be provided on a yearly basis to injured children. Parents can still pursue medical malpractice actions on the basis of emotional distress and other harms.

Fortunately for the babies, a part of the proposal that would have put an arbitrary and low ceiling of $250,000 on the amount recoverable for intangible injuries was dropped from the final legislation.

Source: New York Law Journal

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April 29, 2011

Plugging the "Black Hole" in Medical Licensing Boards

Too often, patients and families with a serious complaint about an incompetent or unethical medical doctor will write their concerns to the state licensing board and then see their case drop into a black hole. But now, thanks to the work of one crusading family, the state of Washington has a new law to make its board more responsive.


Consumers shuld hope that more of these disciplinary bodies around the country sign on for the basic changes in board conduct now required by the state of Washington. For instance, the new law requires the board to give families a report of the final disposition of any complaint, with reasons for the board's action.

These bodies are important upholders of patient safety because they have the legal power to pull or place restrictions on a doctor's or nurse's license to practice -- yet they seldom do.

In malpractice actions brought by the Patrick Malone law firm, we have often experienced the black hole first hand when we have tried to bring dangerous practitioners to the attention of state licensing authorities.

In one case, we sent a thick pile of medical records to a state licensing board about a plastic surgeon who overdosed a patient with so much local anesthetic that her heart stopped, causing her to go into a vegetative state.

The board responded a year later with a notice that the surgeon had been given a "private reprimand." When we asked them to explain what that meant, they said it was "private."

Oh.

In another case, we sent records, expert reports and other data to a state board demonstrating how a nurse had mishandled Pitocin, causing a woman's uterus to rupture with tragic consequences for her unborn baby. Two years later, we received a one-sentence notice that the board had decided not to do anything. The board advised us with pro forma language that we could send them more information. We pointed out in response that not knowing what else they might need, we felt stymied. The board said that was our problem.

Washington state has acted thanks to the efforts of Yanling Yu and Rex Johnson. Three years ago, Yu's father, Xingxun Yu, 81, died after being given a drug his daughter says triggered a fatal allergic reaction. They filed a complaint with the state's Medical Quality Assurance Commission about the doctor. When the board proved non-responsive, they enlisted the help of two state senators.

The new Washington law, which was signed by the governor a week ago, requires a disciplinary authority to promptly respond to inquiries about a complaint's status and provide the person complaining with a report on its final disposition. The law also gives family members the right to tell boards how a medical injury has affected them or their loved ones.

Yu told the Seattle Times: "I think it will make a difference, at least make them more responsive. I think it is a great step forward from what I call the dark ages in the process."

Lisa McGiffert, campaign manager for Consumer Union's Safe Patient Project, said she hoped the new Washington law would become a national model.

Article first published as Plugging the "Black Hole" in Medical Licensing Boards on Technorati.

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April 26, 2011

Accurate quality measures needed to improve health care quality and safety

The push to make hospitals and doctors more accountable for health care quality means more attention must be paid to the accuracy and reliability of measures used to evaluate caregivers, according to Johns Hopkins patient safety expert Peter Pronovost.

There is little consensus as to which measures are scientifically valid and accurate assessments of quality, and this risks misinforming patients who may make decisions based on metrics that poorly reflect the state of health care, Pronovost wrote in the April issue of Health Affairs.

Pronovost supports the bipartisan effort to pay for value rather than volume with health care, but says serious work needs to be done to create a “whole library of outcome measures” such efforts require. Failure to create such measures “could ultimately lead to a failure to make improvements in hospitals where quality is judged to be better than it is,” he says.

Pronovost maintains that despite the substantial, persistent shortcomings in the quality of care that causes needless patient harm and increases health care costs, fixes can’t be put in place until rigorous scientific data show exactly where systems are broken, and until hard comparative evidence points to what types of repairs work best.

In the absence of such safety and efficacy science, he says, there will remain little consensus among hospitals and physicians about the best methods to judge quality or improvement. He points to overall hospital death rates as an example of an imperfect reflection of quality of care that in many cases is the only measure used.

Pronovost notes that physicians typically support the use of outcome measures if they are valid and reliable enough to enable conclusions to be drawn about the quality of care. Unfortunately, too often they aren’t.

For example, he says, some states penalize institutions for what they deem are preventable complications contracted by patients during their hospital stays, even though the hospitals don’t know exactly what they are being judged on because those states use a proprietary algorithm (commonly referred to as a "black box") created by a private company to determine which hospitals are “successful” and which ones should be sanctioned. Clinicians and the public end up not knowing how accurate the measures are or how they were calculated.

Source: The Johns Hopkins University Gazette

You can read the abstract of the article in Health Affairs here.

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April 20, 2011

Washington state bill seeks consumer accountability for medical licensing board

Washington state lawmakers have proposed a bill that would give more rights to people who file licensing complaints alleging medical mistakes. Up to now, when something terrible happens to a patient in a hospital or under a doctor's care, families often file complaints with the Medical Quality Assurance Commission (MQAC) - the state's medical disciplinary board - but hear nothing for months or even years, only to finally be told that the official finding is "insufficient evidence" or "no cause for action." Not surprisingly, this leaves many families wondering if the physician and/or hospital have covered up what really happened to the patient.

Last year, nearly 1,400 Washington families filed complaints with the MQAC. Like most state medical boards, the MQAC typically closes most without action - of the 1,400 complaints, 950 were investigated and disciplinary action taken in only 94 cases, says its legal manager, Michael Farrell. Current Washington state law doesn’t require MQAC to divulge evidence during investigations or to detail its reasoning, Farrell says, and for the most part, it doesn’t.

But Lisa McGiffert, director of Consumers Union's Safe Patient Project, a national patient-safety effort, says that “many patients who file complaints end up getting frustrated because they feel like their report disappears into a bureaucratic black hole." Under the proposed law, which has already been passed by the House and is currently before a Senate committee, patients would have a "better opportunity to be heard."

The proposed law, which is being touted as model legislation for other states, would require a health profession's disciplinary board to promptly respond to complainants' queries about the status of an investigation, provide copies of files on request once a case is closed and, when deciding whether to reconsider its original finding because of new evidence, provide an explanation of its reasoning. For the first time, families would be given the right to tell board members how they've been affected - in writing or in person and before a case is closed - and recommend sanctions.

Source: The Seattle Times

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April 12, 2011

Government Gets Serious about Patient Safety

The new federal "Partnership for Patients" safety initiative has drawn enthusiastic early endorsement from safety mavens like Dr. Bob Wachter of UCSF. It should: By his own insider's account, Wachter helped inspire HHS leaders to finally take seriously the national scandal of preventable harm in hospitals and clinics. Here's his story.

The official government announcement with details is here.

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April 12, 2011

As much as 45% of all U.S. health care costs due to medical errors, studies show

Medical mistakes account for between 18 and 45 cents of every health care dollar spent in the U.S., and a medical error or adverse effect occurs in one out of every three hospital admissions, researchers say.

According to studies published in the journal Health Affairs, the single most expensive cause of harm is infection after surgery, with more than 252,000 infections costing $3.36 billion reported in 2008, while pressure ulcers (bedsores) are the most common preventable event, with with nearly 375,000 cases in 2008 costing $3.27 billion.

Following a shocking 1999 report that showed that as many as 98,000 people die annually due to medical mistakes, hospitals have tried to reduce such adverse effects, but serious mistakes persist. In 2006, for instance, medical mistakes contributed to as many as 187,135 deaths and 6.1 million injuries that cost between $393 billion and $958 billion.

“There are some examples of excellence; we have many [intensive-care units] that have eradicated central line infections. But surrounding those examples of excellence we have serious adverse events going on,” said Dr. Mark Chassin, president of the Joint Commission, a nonprofit organization that accredits health care programs. “Every week in the United States, up to 40 patients undergo a procedure meant for somebody else or the wrong body part,” he said.

The costliest medical errors were:

1. Infections after surgery (252,695 in 2008, cost $3.36 billion)

2. Pressure ulcers - Bedsores (374,964 in 2008, cost $3.27 billion)

3. Complications from noncardiac implants and grafts (60,380, cost $1.07 billion)

4. Complications from lower back surgery (113,823, cost $1 billion)

5. Excessive bleeding complicating a procedure (78,216, cost $680 million)


Source: National Journal

You’ll find more information about the Health Affairs studies here.

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April 5, 2011

Oregon bill would extend whistleblower protection to non-nursing hospital staff

A bill before Oregon’s state Senate would give non-nursing hospital staff members workplace protection when reporting health care practices that endanger patient safety.

Currently, Oregon nurses are legally protected against retaliation in hospitals when reporting practices that jeopardize patient health or safety. If it becomes law, Senate bill 237 would extend the same protections to Oregon’s non-nursing hospital staff, including lab and X-ray technicians, certified nursing assistants, licensed practical nurses and others.

Advocates of the bill say it is necessary because workplace retaliation against healthcare workers who report patient safety issues is common, and filing a complaint with a regulatory agency or speaking truthfully to an on-site regulatory inspector can pose significant career risks. The bill would improve patient care and safety by legally prohibiting retaliation against staff by their hospital employers.

The Senate committee studying the bill also heard testimony that because of the “warm and fuzzy” relationship between hospitals and state and federal legislators, hospital health care workers also need protection from retaliation from state and federal regulatory agency employees. In addition, state Senators were urged to prohibit the disclosure of any personal identifiers of any complainant to any other person or entity.

Source: Salem Statesman Journal

You can read the draft legislation here.

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March 29, 2011

Two simple ways to cut medication errors

Medication errors in a hospital’s psychiatric unit were cut drastically with two techniques: an electronic prescription drug ordering system and a computerized method to report adverse events, according to new research from Johns Hopkins University.

The leader of the study, Geetha Jayaram, MD, MBA, an associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, says that “with the use of electronic ordering, training of personnel and standardized information technology systems, it is possible to eliminate dangerous medication errors” altogether.

The findings published in the March issue of the Journal of Psychiatric Practice illustrate how the psychiatric unit at The Johns Hopkins Hospital in Baltimore went from a medication error rate of 27.89 per 1,000 patient days in 2003 to 3.43 per 1,000 patient days in 2007. And none of the medication errors during the study period caused death or serious, permanent harm, Javaram notes.

“Having something typed eliminates bad writing — and most errors — immediately,” she says. “It’s a good reason for going electronic.” Medication errors, which can be lethal, are known to be caused by illegible handwriting, misinterpretation of orders, fatigue on the part of medical personnel, pharmacy dispensing errors and administration mistakes. A pharmacy may misread what a physician has written or give the wrong medication or the wrong drug dose to a patient.

The computer program used in the psychiatric department also includes integrated decision support for drug dosage selection, drug allergy alerts, drug interactions, patient identifiers and monitoring — things that can be lost with a manual system that relies on layers of human beings to ensure the correct decisions are made, Jayaram says. The more the number of steps involved in the process, the greater the likelihood of mistakes.

Source: Scienceblog

You can read the complete study here.

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March 23, 2011

“Alarm fatigue” endangers hospital patients

“Alarm fatigue” caused by the rising use of monitors is distracting and numbing hospital personnel with deadly results, the Boston Globe reports.

An investigation by the newspaper reveals that more than 200 hospital patient deaths in the U.S. between January 2005 and June 2010 are linked to problems with alarms on patient monitors that track heart function, breathing, and other vital signs.

Typically, the problem isn’t the equipment, but rather the failure by medical personnel to react with urgency or notice the alarm. As monitor use continues to increase, the audible beeps from the machines can become so relentless that nurses become desensitized. How relentless? At a 15-bed unit at Johns Hopkins Hospital in Baltimore, staff documented an average of 942 alarms per day — about 1 critical alarm every 90 seconds.

Nurses said the number of alarms can be so overwhelming that they turn into background noise — although a dozen nurses interviewed by the Globe said they have never seen a nurse purposely ignore an alarm. The problem, says one nurse, is that “everyone who walks in the door gets a monitor. We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

In addition, the devices themselves have flaws that contribute to alarm fatigue. For example, monitors can be so sensitive that alarms go off when patients sit up, turn over or cough. Some studies have found more than 85 percent of alarms are false (i.e. they go off when the patient isn't in danger. Over time this can make nurses less and less likely to respond urgently to the sound.

In many cases, of course, nurses miss alarms warning of problems that aren’t life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, also may go unheeded.

In one extreme case, a cardiac monitor blared 19 dangerous arrhythmia alarms for nearly 2 hours before staff silenced the alarms temporarily without treating the patient, who died. In other instances, staff have misprogrammed complicated monitors or forgotten to turn them on.

Hospitals that have experienced alarm-related deaths have aggressively addressed the issue, hiring nurses and technicians whose sole job is to monitor the monitors and modifying monitors to make them less sensitive to unimportant changes and less prone to false alarms. But overall, hospitals and the medical device industry have yet to seriously tackle the issue.

Source: The Boston Globe

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March 19, 2011

George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group

If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group?

"Protect Patients Now!" It has a nice ring, doesn't it?

However, the people behind this campaign, which was launched in Washington to advocate for the H.R. 5 "tort reform" bill in Congress, are anything but patient advocates.

The campaign comes from a group called the Health Coalition on Liability and Access. A list of the coalition's members can be found on its website, and includes:

* Major medical malpractice insurance carriers (Pro Assurance, The Doctors' Company, Medical Protective);

* Doctors' lobbying organizations, especially those who have been active in political efforts to curb lawsuits (the AMA, plus neurosurgeons' and orthopedic surgeons' societies and others);

* Long-time "players" in the legal "reform" space, particularly the American Tort Reform Association, which got much of its seed money from the tobacco industry.

The coalition calls itself a "grassroots advocacy organization" but conspicuously absent from its membership are any of the consumer groups — Consumers Union and Public Citizen, to name two — who have been pushing the medical industry to make health care safer (and thereby solve its lawsuit problem).

H.R. 5 was sent to the floor of the U.S. House of Representatives this week by a party line vote of the House Judiciary Committee. The bill gives special breaks in the form of damage "caps" and other special treatment not only to all physicians, nurses and other individual caregivers, but also to drug manufacturers, nursing homes and hospitals.

The idea of H.R. 5 is that by making the medical industry less legally accountable for the harms it causes, Congress will free up the industry to become safer and provide cheaper care to more Americans.

I did not make that up.

The American Association for Justice (of which I am a member) has an online petition for concerned consumers to send a message to their Member of Congress about this bill.

Article first published as George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group on Technorati.

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March 10, 2011

Hospital’s comprehensive obstetrics program cuts malpractice claims by 99%

Anyone who believes it's inevitable that some babies will get injured during childbirth may have a change of heart after reading how a New York City hospital dramatically cut staff errors and reduced medical malpractice payouts by 99%.

In a report published in the American Journal of Obstetrics & Gynecology, the head of the obstetrics team at New York Weill Cornell Medical Center describes how the safety initiatives they introduced reduced avoidable deaths and serious injuries to zero in 2008-2009, down from five in 2000.

“Any hospital could do it — it's not about money, it's about changing the culture to make it safer to deliver babies,” says team leader Dr. Amos Grunebaum. The new measures introduced by the team reduced errors and helped ward off lawsuits by clearly documenting everything doctors did right in cases where a bad outcome was not their fault.

Consumer advocates are hailing the report as a breakthrough in patient safety and a better way to curb malpractice costs than so-called tort reform.

Patient safety advocates like me, who represent patients in medical malpractice lawsuits, have said over and over that we would like to see lawyers get less business by making the medical system safer for patients.

The reforms at Weill Cornell resulted in annual medical malpractice payouts dropping from an average of $28 million from 2003 to 2006 to $2.6 million a year from 2007 to 2009. And since there were no sentinel events reported in 2008 and 2009, those numbers are expected to drop even more.

Among the changes were:

* Doing away with the labor and delivery unit's dry-erase whiteboard, which staff used to communicate patients' progress, and replacing it with a new electronic application.

* Not allowing any paper charting.

* Hiring a full-time patient safety nurse to educate staff on new protocols the doctors wanted and to conduct emergency drills.

* Hiring three physician assistants and a “laborist” (an obstetrician who works at the hospital full-time) who works nights and weekends, reducing on-call time for other obstetricians, in order to avoid errors due to sleep deprivation.

Though many aspects of the plan were costly, the authors concluded that the savings in medical malpractice payments "dwarf the incremental cost of the patient safety program.”

Source: Crain’s New York Business.com

You can read the article in the American Journal of Obstetrics and Gynecology here.

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March 3, 2011

New "Physician Compare" Website Doesn't Impress

Patient safety advocates like me have long dreamed of cracking open for the public the vast trove of data the government collects on doctors, so patients could figure out who gets the best outcomes and guide their doctor choices accordingly. Medicare was supposed to start down that path with its new "Physician Compare" website, but alas, it has a long way to go.

One critic says the new site "is confusing and unfriendly to consumers, painfully slow and, worst of all, factually unreliable. Put bluntly, the agency ... has produced a consumer tool that practically shouts, 'We couldn't care less whether any consumer ever uses this.'"

The quotation is from Michael L. Millenson, President of Health Quality Advisors LLC, writing on the Kaiser Health News website.

The Medicare site has basic information about doctors, like their practice address, but misses out on many tidbits that consumers want to know:

* Hospitals they practice at

* Malpractice history

* Where they trained

* Board certification.

Those kinds of things can be found at commercial sites like healthgrades.com for a small fee. Or you can search one of the sites that lists doctors' board certifications, like
the American Board of Internal Medicine, which certifies internists.

The quality information that consumers really crave, such as surgeons' complication rates or incidence of wound infections, lies off in the future somewhere. Medicare says it will begin adding quality data to the site in 2012, with a formal launch date in 2013. Don't hold your breath.

Meantime one surgical specialty group, the Society of Thoracic Surgeons, has collaborated with Consumers Reports to publish quality data on heart and chest surgeons. Read our blog entry on this here.

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March 1, 2011

Doctor who botched prostate cancer brachytherapy procedures at VA hospital sanctioned

A physician who gave nearly 100 veterans with prostate cancer incorrect doses of radiation has been sanctioned by the Nuclear Regulatory Commission (NRC). The errors involved the incorrect placement of iodine-125 seeds in patients to treat prostate cancer.

Out of 116 such brachytherapy procedures performed at the facility between 2002 and 2008, the VA reported that 97 were carried out incorrectly. The NRC investigation found that Dr. Gary Kao, a radiation oncologist at the VA Medical Center in Philadelphia, took part in 91 of the 97 incorrect procedures. In several cases, the incorrect doses were caused by Kao having implanted the seeds in nearby organs or surrounding tissue.

As a result, the NRC ruled that Kao cannot take part in agency-related activities without undergoing more training. The NRC also issued a separate order requiring Gregory Desobry, a medical physicist who worked at the same facility, to notify the agency if he accepts employment in that capacity involving NRC-regulated activities within 20 days of beginning such work. Last year, the NRC fined the Philadelphia VA hospital $227,500 over the incidents.

Source: Philadelphia Inquirer

To view a copy of the NRC decision, click here.

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February 22, 2011

Kidney transplanted into the wrong patient -- luckily without apparent harm

After transplanting a kidney into the wrong patient, the University of Southern California University Hospital has shut down its kidney transplant program pending an investigation.

While this may be a unique event at USC, mixups in transplants unfortunately pop up around the country on a regular basis, because of the lack of rigorous safeguards to check and double-check to avoid tragedies. In this case, luck prevailed.

The patient escaped harm apparently because the mistake involved a kidney that happened to have universal blood type “O,” making it a close enough match to avoid harming its unintended recipient.

Kidney transplants are often performed on short notice and outside of normal hours, and the number of people involved -- surgeons, anesthesiologists, nurses, transporters and patients (donor and recipient) -- make them a challenge to coordinate.

Although safeguards are in place to prevent such occurrences, there is never a direct one-on-one relationship between any two individuals involved, which means miscommunications remain possible. Ultimately, the surgeon is responsible for making sure that the patient who's now in the operating room is indeed a patient on this list and is the patient that they wanted to be calling in from this list.

After the hospital realized its mistake, the organ procurement organization performed a cross-match test using blood samples they already had to determine the transplant's compatibility. The hospital then began looking for a suitable recipient for the other kidney, which was later transplanted at a local hospital. The intended recipient of the misplaced kidney received another organ a few days later.

The mixup reportedly occurred after two kidneys from separate donors arrived at the transplant center simultaneously on Saturday, Jan. 29. According to an official with the One Legacy kidney transplant program, the kidney’s packaging and documentation was accurate, suggesting the mistake was the result of human error.

In a statement, the hospital confirmed that it had temporarily and voluntarily halted transplants and said no patients were harmed as a result of the mistake. But it did not provide any details as to the nature of the error and declined to answer questions. The state Department of Public Health is investigating the incident.

“The hospital inactivated the program while clinical protocols are assessed and additional safeguards to the kidney transplant program are developed," the hospital said in statement. The hospital also notified United Network for Organ Sharing (UNOS), a federal program that organizes the distribution of organs for transplant, that the kidney program had been halted. As of Feb. 11, USC had 508 patients waiting for kidneys, including 313 men and 195 women, according to UNOS.

Source: ABC News

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January 12, 2011

Couple challenges West Virginia malpractice award caps

A West Virginia couple who had been awarded more than $1.5 million in damages in a medical malpractice case only to have the award cut by two-thirds is challenging the state law that caps medical malpractice payouts to victims.

The husband developed rhabdomyolysis after being given a combination of medications at a West Virginia hospital. A jury awarded the couple $1.5 million for pain and suffering and $129,000 for medical expenses and lost wages, greatly exceeding West Virginia’s malpractice damages cap.

The cap, originally $1 million when enacted in 1986, has been cut repeatedly and now stands at $250,000 for most cases and $500,000 for the most severe. The cap applies no matter how many plaintiffs there are, so multiple plaintiffs have to split the award, which can be no more than $500,000.

In the rhabdomyolysis case, the man was awarded $1 million for his pain and suffering and his wife $500,000, but their claim was reduced to $500,000 in total for both of them. The couple is arguing that the damages cap is unconstitutional because it interferes with the right to a trial by jury and prevents the jury from making the ultimate decision in the case.

Lobbyists representing physicians and insurance groups have filed a brief in the case arguing that the caps should remain in place in order to keep malpractice insurance rates affordable and to prevent physicians from leaving the state. The case has been appealed to the West Virginia Supreme Court.

Source: Renal and Urology News December 2010

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January 10, 2011

Surgeons' Sleep Deprivation and Patient Safety

Research shows that a surgeon who has been working for 24 hours is impaired as much as a drunk person in thinking and motor function. So should patients have a right to know if their doctor has been up all night?

Yes, say a group of sleep researchers, who argued for full disclosure of sleep deprivation in a recent article in the prestigious New England Journal of Medicine.

No, responded the American College of Surgeons, whose leaders say it should be up to the individual surgeon to decide if he or she is too tired to operate -- or if the surgeon needs to tell the patient before heading to the OR.

The debate shows that surgeons and hospital administrators are just beginning to consider some basic issues of fatigue and patient safety that in other contexts -- piloting airliners and driving large trucks on interstate highways -- have long been settled.

Surgeons understandably don't want to be subject to the welter of bureaucratic rules that truck drivers and pilots deal with. And patients might not like it either if a surgeon was required to announce that he would be starting their surgery but another doctor would come into finish it because the time would stretch beyond the first doctor's hour limit.

But some sensible limits could easily be put in place. For one, the opportunity for a surgeon to work inhuman hours is created by hospitals who let a surgeon sign up for overnight call, which often results in working all night in the OR, and let the same surgeon schedule elective non-urgent cases for the next day.

Why would a surgeon do this in the first place? The lure of money, as a number of commenters on the New England Journal of Medicine website candidly admitted. Which raises a problem with the American College of Surgeons' idea that surgeons should be left to their good judgment on when and when not to operate. Anyone who schedules back-to-back call nights with elective cases is not showing good judgment in the first place.

Another issue for patient safety is the surgeon who is well rested but inexperienced, for not having gone through sleepless nights filled with surgical cases. Residency training programs are now starting to limit young surgeons to 16-hour days, which many surgeons say is going to result in a generation of rested but green doctors.

The right of informed consent gives at least one answer to the conundrum. Every patient has a right to know what any reasonable patient would want to know going into a surgery. And since we would all pause before submitting to the knife with a surgeon smelling of alcohol, the same right should apply to the less obvious danger of the sleep-deprived surgeon. If a doctor wouldn't want a family member to undergo surgery with that glassy-eyed doctor, then the same right should apply to all patients.

This means patients should be told, and should be given the option of rescheduling or bringing in a fresh replacement to operate. This will be inconvenient for hospital schedulers and may cause some surgeons to lose income. But patients will ultimately be safer for it.

And if hospitals want to minimize patients getting upset for having their plans upended at the last minute, all they have to do is adjust their call schedules to make these up-all-night dilemmas a rare event.

Article first published as Should Patients Have a Right to Know When Their Surgeon Has Been Up All Night? on Technorati.

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January 7, 2011

One hospital: Three wrong-site surgeries in four months

Federal and Massachusetts state health investigators have cited a Boston teaching hospital for making at least three surgical errors in the last four months of 2010, all of which involved surgeons operating on the wrong vertebrae during spinal surgery. Two of the surgeries were performed by the same surgeon, whose name has not been released.

The spike in spinal surgical errors at the Beth Israel Deaconess Medical Center -- one of Harvard's teaching hospitals -- was notable, because hospitals across Massachusetts had reported only 11 similar incidents from 2006 through 2008. Officials noted that the incidents were unrelated and attributable to human error on the part of the surgeons.

Wrong-site surgical errors are considered to be “never” events (i.e. events that should not happen if the surgeon and medical staff follow the appropriate standards of medical care). The hospital said it had procedures in place to prevent such errors, and said it could not explain how the incidents happened if those procedures were being followed.

In a recent study, U.S. researchers found that errors in judgment were involved in 85% of wrong-site surgical errors and that in 72% of the medical mistakes in the operating room, the surgical team failed to take a “time out” to assess the situation and make sure their surgical plan was correct.

In all three cases at the Beth Israel Deaconess, the doctors completed the surgery without realizing that the vertebrae they were working on was undamaged and just below or above the part of the spine that was actually injured. Two of the errors were discovered during post-surgical X-rays, when patients continued to suffer back pains, and the third was discovered in a routine postoperative X-ray.

Source: About Lawsuits.com

You can view an abstract of the study in Archives of Surgery here.

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December 30, 2010

State Licensing Boards Fail to Protect the Public from Dangerous Health Care Providers

Without a license to practice medicine or surgery or nursing or whatever, no health care practitioner can touch a patient. So the state licensing boards that issue -- and are authorized by law to take away -- licenses are important watchdogs for patient safety and accountability.

Which is why a year-long investigation by reporter William Heisel makes you want to cry.

He found ... well, let's borrow the introduction to his new article:

Medical boards from coast to coast are inconsistent, inefficient and ill equipped to monitor the hundreds of thousands of doctors licensed under their watch, Antidote’s investigation of every state board has found. There are some standouts, but, overall, they do a terrible job protecting patients and informing the public.

It bears repeating that most doctors do a great job and are focused on one thing: helping their patients heal and lead healthier lives. The mission of this tour was to explore what happens to that minority of doctors who don’t follow the rules.

One example in the story: Licensing boards that think they're doing a good thing when they restrict a doctor convicted of sexual molestation from seeing a certain age group of patients, naively failing to realize that the doctor will just "pivot his practice" to prey on a different age group.

Another issue: So many malpracticing doctors getting shunted to places where the patients are already vulnerable: poor towns, prisons, and addiction treatment centers.

Read the rest of his piece here.

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November 17, 2010

Wrong operation teaches surgeon the value of pre-procedure protocols

An orthopedic surgeon who performed the wrong operation on a patient now says he no longer sees any burden in The Joint Commission’s (TJC) Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery. And he's gone on the record in a prominent medical journal to confess error and try to help other surgeons do it right.

TJC’s universal protocol recommends that surgeons:

1. Conduct a pre-procedure verification process.

2. Mark the procedure site before the procedure is performed.

3. Perform a time out.

The surgeon, David C. Ring, M.D., was treating a 65-year-old woman whom he had diagnosed 3 months earlier with trigger finger, a common disorder in late adulthood in which a finger or thumb snaps or locks before unlocking (like a trigger), caused by a swollen flexor tendon.

According to Dr. Ring’s own account, the correct arm had been marked at the wrist by the nurse but the planned incision site on the hand was not marked. Dr. Ring performed three other carpal tunnel procedures that day, one of which was performed on a patient who became extremely agitated before and after the procedure, causing the surgeon to vow that the next procedure would be the best carpal tunnel release he’d ever performed. In addition, the patient was moved to another operating room, resulting in a change of personnel which meant the nurse who had had performed the preoperative assessment would not be in the room during the procedure.

About 15 minutes after performing the carpal tunnel procedure, Dr. Ring realized he had performed the wrong surgery. After informing staff, he told the patient about the error, apologized and offered to perform the correct procedure. The patient agreed, and the trigger finger release was performed. Later, the patient’s son informed Dr. Ring that the patient had lost faith in him and would not return for followup care. A financial settlement was negotiated shortly after the event.

Dr. Ring asked that the case be published in the Case Records of the Massachusetts General Hospital to encourage the development and following of procedures that would minimize the risk of such events occurring again.

Source: New England Journal of Medicine

You can view and download a poster of the Universal Protocol here.

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November 16, 2010

Checklists for surgery safety cut death and injuries, new Dutch study shows

Any lingering doubts about the positive effects of comprehensive surgical checklist intervention should vanish following the release of a study conducted in the Netherlands and published in the New England Journal of Medicine.

The Dutch study evaluated the effects of a comprehensive surgical checklist intervention in six regional and tertiary care centers in the Netherlands and involved 11 distinct checklists applied
during different phases of preoperative, intraoperative, and postoperative care completed by
surgeons, anesthesiologists, nurses and other staff.

The checklists included nearly 100 items that address the availability of imaging information, equipment and materials, patient and operative site verification, communication of postoperative instructions between caregivers and discharge instructions. Outcomes improved substantially as a result of this intervention. The proportion of patients with one or more complications fell from 15.4 to 10.6%, while mortality dropped from 1.5 to 0.8%.

A large international study supported by the World Health Organization (WHO) released last year reported similar results, showing that checklists cut surgical morbidity and mortality almost in half. However, not everybody was convinced by the findings of the WHO study, because:

1. The pre-intervention/post-intervention study failed to control for confounding factors, such as the the “surgical Hawthorne effect,” which states that outcomes tend to improve rapidly when surgeons know they are being evaluated.

2. The study’s operating room checklist consisted primarily of common-sense items and processes of care that seemed unrelated to the most common serious complications of surgery, making it implausible for some that improved compliance with these practices could lead to such drastic reductions in morbidity and mortality.

3. Compliance of the eight study hospitals with the checklists had no bearing on the extent of improvement in outcomes. Overall compliance with processes of care on the checklists improved negligibly even in the two hospitals with the greatest reductions in morbidity and mortality, while conversely, the two hospitals with the greatest increase in compliance showed no change in outcomes.

The Dutch study avoided these pitfalls by including hospitals that had already been tracking their surgical outcomes with the same detailed registry for many years, so the results cannot be attributed to the effects of performance feedback.

It also documented a strongly positive relationship between checklist compliance and outcomes, in that patients with incomplete checklists had significantly more complications than those for whom checklists were more fully completed.

Finally, the study included a control group. At five similar hospitals that did not implement the checklist intervention, morbidity and mortality were unchanged during the study period.

An editorial published with the article concluded that surgery checklists now have advanced from a good idea to "standard of care."

Source: New England Journal of Medicine

You can view an abstract of the Dutch study here.

You can view an abstract of an editorial about the Dutch study here.

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November 11, 2010

Rampant Malpractice and Safety Hazards Found in Kidney Dialysis Centers

ProPublica, the investigative reporting group, is publishing a series on the quality of care the nation's 400,000 dialysis patients get, and it's not pretty. The basic conclusion:

"Taxpayers spend more than $20 billion a year to care for those on dialysis -- about $77,000 per patient, more, by some accounts, than any other nation. Yet the United States continues to have one of the industrialized world's highest mortality rates for dialysis care. ...

"At clinics from coast to coast, patients commonly receive treatment in settings that are unsanitary and prone to perilous lapses in care. Regulators have few tools and little will to enforce quality standards. Industry consolidation has left patients with fewer choices of provider. The government has withheld critical data about clinics' performance from patients, the very people who need it most. Meanwhile, the two corporate chains that dominate the dialysis-care system are consistently profitable, together making about $2 billion in operating profits a year."

The ProPublica reporters go on to say that: "One reason the system's problems have evolved out of the health care spotlight is that kidney failure disproportionately afflicts minorities and the dispossessed."

Read more about this emerging malpractice and safety scandal here.

And here is part 2 of the series, which opens with a horrifying story about a woman who lost a quarter of her blood because the dialysis tube delivering the cleansed blood back to her body became dislodged and the technicians didn't notice until it was too late.

Here is one more piece of it, an important footnote about how the ProPublica reporters got the hard data on patient deaths that the government keeps hidden from the public.

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November 10, 2010

Fatigue Wears at Doctors' Work Performance Too

The headline is not exactly shocking, so the real news may be why the issue of how long work days can cause doctors to make errors is so rarely studied.

For nurses and residents (doctors in training), plenty of studies have found that when work days stretch beyond twelve hours, more mistakes are made, and patients become vulnerable to malpractice and even smaller errors.

But a new study of radiologists is one of the first to examine the effect of long work days on the performance of attending level physicians. The researchers gave a set of bone X-rays to radiologists at the beginning of their work day, and again at the end. Then they measured their accuracy at finding fractures. By the end of the day, the radiologists were making around one in twenty more errors -- both missing fractures and seeing ones that weren't there -- than at the start of the day. It's a small but significant difference.

The study in the radiology journal concluded:

"After a day of clinical reading, radiologists have reduced ability to focus, increased symptoms of fatigue and oculomotor strain, and reduced ability to detect fractures."

Dr. Bob Wachter, a UCSF patient safety guru, has a thoughtful piece on this in his own blog, which he titled: Tugging on Superman's Cape. Read it here.

Dr. Wachter riffed off a story he heard about legendary heart surgeon Michael Debakey performing sixteen open heart surgeries in a single day, even in his eighties. While the Baylor staffer who told Wachter this story was awestruck at Debakey's stamina, Wachter wondered what it would be like to be patient No. 16.

For the rest of us, there's a lesson when facing elective surgery. Surgeons love to stack up patients back to back and operate from the early morning to late in the day. If we have any choice, we should opt for a place early in the queue. Why tempt the gods of fatigue?

Article first published as Fatigue Wears at Doctors' Work Performance Too on Technorati.

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September 30, 2010

Some good resources for patient safety advocates

A group of patient safety advocates has put together two outstanding web sites chock full of information about how to navigate the health care system safely for you and your loved ones.

The Empowered Patient Coalition (click here for the web site) is educating patients on how to become informed and involved in their own health care -- which makes for better, safer outcomes. One of their first projects is a blueprint for managing a stay in the hospital. The web site has many more valuable resources, including this directory of non-profit patient safety groups, helpful books and other resources. Many of these groups were started by lay people who had terrible experiences with medical malpractice in the health care system and want to make a difference by helping others to avoid injury.

A related web site has a broader directory of patient safety advocates who serve the public. The directory includes patient safety professionals, radio shows, blogs and other links. Click here for the link. Mothers Against Medical Error (MAME), through its founder Helen Haskell, put together this directory.

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September 19, 2010

OSHA to consider limiting medical residents’ time on the job to 80 hours per week

The Occupational Safety and Health Administration (OSHA), the main federal agency charged with the enforcement of workplace safety and health, is looking at limiting the number of hours medical residents can work to 80 hours a week.

The decision to consider such limits came after OSHA received a petition filed by Public Citizen; the Committee of Interns and Residents/SEIU Healthcare; the American Medical Student Association; Dr. Charles Czeisler, Baldino professor of sleep medicine and director of the division of sleep medicine at Harvard Medical School; Dr. Christopher Landrigan, assistant professor of pediatrics and medicine at Harvard Medical School; and Dr. Bertrand Bell, professor of medicine at Albert Einstein College of Medicine.

Petition signatories noted their concerns about medical residents working extremely long hours,” anc cited evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors, and motor vehicle accidents.

In agreeing to consider the petition, assistant secretary of Labor for Occupational Safety and Health David Michaels, who heads OSHA, noted that “the relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error. In its investigation of the root causes of the BP Texas City oil refinery explosion in 2005, in which 15 workers were killed and approximately 170 injured, the U.S. Chemical Safety Board identified worker fatigue and long work hours as a likely contributing factor to the explosion."

In addition to seeking a limit of 80 hours of work in each and every week for hospital residents, the petition also seeks:

A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;
At least one 24-hour period of time off work per week and one 48-hour period of time off work per month, for a total of five days off work per month, without averaging;
In-hospital on-call frequency no more than once every three nights, no averaging;
A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;
A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

Source: Occupational Health and Safety Magazine

You can view Dr. Michaels' full response to the petition here.

Also, here's one surgeon's entertaining take on the issue, in the Psychology Today blog. You can guess his point of view by his title: "Training surgeons not sissies."


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September 15, 2010

Detailed heart surgery ratings now available

Until now, it’s been easier to rate appliances and restaurants than surgeons in most parts of the country, but that should change now that surgeons who perform cardiac bypass surgery are being rated on objective quality measures in Consumer Reports magazine.

The consumer magazine recently published ratings of 221 surgical groups in 42 states online. The same ratings will be available in the October print issue. To date, only a few states, such as New York, compile data-based ratings of physicians.

The data Consumer Reports used to rate the physicians was collected the Society of Thoracic Surgeons, which includes more than 90% of cardiothoracic surgeons in the U.S. in its membership. Physician groups, not individual surgeons, were rated either above average, average or below average based on (a) complication and survival rates; (b) the surgical technique used; and (c) the type of medication(s) the patient was sent home with after surgery.

An article in the New England Journal of Medicine called the move to make this data public “a watershed event in health care accountability.”

The 221 groups rated in Consumer Report represent less than a quarter of physician groups that perform bypass surgery in the U.S., as only surgical groups that allowed their information to be published were rated. Of these, only five were rated below average, which is fortunate, because the gap in treatment between a below-average and an above-average surgical group can be extremely wide; for instance, at an above-average hospital, patients had a 92% chance of receiving the recommended medications when leaving the hospital; at one of the below-average hospitals, patients had only a 24% chance of getting the recommended drug.

For now, the information is available only to people who subscribe to Consumer Reports online and print subscribers. However, STS says it will make the ratings freely available on its web site in a few months.

Source: New York Times
Visit the web site of the Society of Thoracic Surgeons (STS) here.

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September 6, 2010

Patient safety authority finds frequent dosing errors with a narcotic drug

Healthcare providers need to know more about the efficacy and potency of hydromorphone, a pain killer frequently used as a morphine substitute in post-operative patients, to avoid medication errors and adverse drug reactions (ADR), says an advisory from the Pennsylvania Patient Safety Authority (PPSA).

Researchers hired by PPSA reviewed 1,694 medication error and 937 adverse event reports involving hydromorphone from January 2008 to October 2009. They identified lack of knowledge about hydromorphone potency and the difference in potency between morphine and hydromorphone as the most significant factors causing serious medication errors, particularly when a patient is switched from morphine to hydromorphone.

Hydromorphone is administered in doses that range from 0.4 mg to 2 mg, whereas patients may receive as much as 7-10 mg of morphine. Incorrect dosing may occur when prescribing, dispensing or administering hydromorphone when a physician, pharmacist or nurse confuses hydromorphone and morphine. Other medical errors noted in the study were giving patients the wrong drug and not noting a documented allergy.

Some adverse drug reactions to hydromorphone also may be preventable. The study found that of the 447 reported ADRs involving central nervous system or respiratory effects, 292 (65%) were preventable, and, of these, 205 (70%) resulted from dosing errors.

To reduce the number of medical errors and ADRs involving hydromorphone, the study recommended implementing risk reduction strategies such as constraints and standardization, which focus on system improvement. It also recommended writing hydromorphone with the first five letters capitalized (i.e. HYDROmorphone) to further distinguish it from morphine.

Source: Pennsylvania Patient Safety Authority
You can view the report here.

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August 27, 2010

The Price Tag of Medical Errors: $19.5 Billion per Year in the U.S.

Medical errors and malpractice events cost the U.S. economy $19.5 billion in 2008, according to a recently released study commissioned by the Society of Actuaries.

Of the approximately $80 billion in costs associated with medical injuries, about 25% were the result of avoidable medical errors, the study says.

Lost productivity due to related short-term disability claims cost $1.1 billion, while $1.4 billion was lost due to increased death rates among individuals who experienced medical mistakes.

The study also found that:

• There were 6.3 million measureable medical injuries in the U.S. in 2008; of the 6.3 million injuries, the SOA and Milliman estimate that 1.5 million were associated with a medical error.

• The average total cost per error was approximately $13,000.

• In an inpatient setting, seven percent of admissions are estimated to result in some type of medical injury.

• The measurable medical errors resulted in more than 2,500 avoidable deaths and more than 10 million excess days missed from work due to short-term disability.

The study also identifies the 10 medical errors that are most costly to the U.S. economy each year. Approximately 55 percent of the total error costs were the result of five common errors:

• Pressure ulcers • Postoperative infections • Mechanical complications of devices, implants, or grafts • Postlaminectomy syndrome -- back surgery • Excessive bleeding complicating a procedure

Source: Fierce Healthcare

To view the complete report, click here.

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August 21, 2010

Easily Mixed-Up Medication Tubes Cause Patient Deaths and Injuries

For years, patient safety experts have known that medical devices, like tubes that deliver food and drugs to hospitalized patients, need to be designed so that predictable mix-ups don't hurt patients. If a tube is safe if it goes through the nose to deliver food to the stomach, it should not be possible to hook up the same tube to a line that delivers medication to a blood vessel, since that could kill the patient.

But this basic safety philosophy -- which permeates other high-risk industries like aviation and nuclear power -- still hasn't penetrated the medical industry, as a new report in the New York Times documents in distressing detail.

Partly to blame is the U.S. Food and Drug Administration, which could set up uniform rules that would bar as unsafe any medical devices where fatal mix-ups could be easily made by hurried nurses or other caregivers.

The way the agency does its work is the problem. When the FDA has tried to act on a case-by-case basis with an application from a manufacturer for a new product, efforts by FDA safety reviewers to solve the problem have been met with cries from the new manufacturer that it is being unfairly singled out.

Efforts to have industry-wide regulations have met with years of bureaucratic delay and industry resistance.

Here's a quotable quote from former FDA official Dr. Robert Smith:


“F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die.”

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July 7, 2010

Inexperienced Resident Doctors to Receive More Supervision in Malpractice Prevention Effort

A newly minted M.D. doctor wandering the halls of a hospital, working long hours with little sleep as he or she begins years of residency training, can be a potential disaster waiting to happen. That's the source of the old bromide about July being the most dangerous month to get sick, since that's when residency programs start their new year.

In theory, all junior doctors receive careful supervision from senior doctors in training and from full-fledged "attending" physicians. But in practice, in busy institutions junior doctors can work long hours with little supervision, and mistakes that cause injuries to patients can result.

In 2003, residency programs accredited by the official supervisory body, the ACGME, were required to cut resident work weeks from 120 to 80 hours. But in December 2008, the Institute of Medicine, part of the National Academies of Sciences, recommended more changes to improve patient safety in residency programs.

One of them was to end the practice of 24-hour shifts.

The ACGME is now following that advice, but only in part. As of July 2011, first-year residents will be limited to 16-hour shifts, but after the first year, residents will still be able to work a 24-hour shift. Many experts believe the longer shifts are dangerous for patient safety because of sleep deprivation.

The 16-hour limit for first-years is part of a series of recommendations being submitted to the ACGME board for final approval in a few months.

Sidney Wolfe, MD., head of Public Citizen Health Research Group, is critical of the failure of the ACGME to propose a 16-hour limit across the board. He says: "The improvements in the new ACGME guidelines are largely swamped by the failure to cover the majority of medical residents with the protection of not having to work more than 16 hours continuously."

In the new proposal, first-year residents would also be barred from moonlighting at other jobs and from being "on call" in hospitals.

See the article in American Medical News for more details.

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June 19, 2010

A Life-Saving Number: The Nurse-to-Patient Ratio

The greatest fear for any patient in the hospital, and the biggest nightmare for their families, is that something will go wrong suddenly and no one will respond until it's too late. Beeping monitors are no help if their alarms go unheeded. Patient safety experts know that one basic way to keep patients safe and prevent death or injury from malpractice is to have enough nurses on hand.

How many is enough? Nursing leaders got the state of California, after a 10-year fight with the hospital industry, to mandate minimum nurse-to-patient ratios: one nurse for every five post-surgery patients, one nurse for every two intensive care patients, one nurse for every four children in the pediatrics ward.

If you have a family member in the hospital, these numbers are worth keeping in mind. Ask the bedside nurse how many patients he or she is in charge of. And don't let hospital management confuse the issue by pointing out how many aides they have. Aides can plump pillows and give other comfort measures. But only a nurse can recognize when a patient is in peril and give lifesaving treatment.

A new study by a nursing professor at the University of Pennsylvania, Linda Aiken, asserts that mandatory minimum nurse-to-patient ratios like California's could prevent as many as 14 percent of post-surgery deaths in New Jersey hospitals and 11 percent in Pennsylvania.

Another important outcome of ensuring that nurses aren't overwhelmed by too many patients is that nurse burnout and job turnover go down, and overall quality of care improves, according to the study.

Theresa Brown, an oncology nurse in Pittsburgh, has an op-ed piece in the New York TImes asking why bills in Congress to mandate minimums nationally haven't gone anywhere.

Saving money, of course, is the issue. But that's a penny-wise answer. Saving lives can be a lot cheaper in the long run.

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April 13, 2010

Malpractice Lawsuit Ends with Safety Improvements by Hospital

A tragic death in Albany, New York proves the power of the civil justice system to spur safety improvements to prevent injury to other patients.

In settling out of court a lawsuit for the death of 32-year-old Diane McCabe, who bled to death after a Cesarean section delivery, the Albany Medical Center agreed to fund for the next 20 years a Diane McCabe Memorial Quality Lecture series focusing on enhancing patient safety. The settlement also requires the hospital to buy a maternal and neonatal simulator to be used in staff training on the labor and delivery unit and to change procedures on the use of a machine that monitors a patient's vital signs during childbirth.

The attorney for Ms. McCabe's family, John Powers, said:

"It was never about the money with the family. It came down to the non-monetary aspects involved with the settlement. They wanted to do something to make certain this doesn't happen to someone else and to create a memorial to Diane for the children as they grow up that they'll know that their mother is being remembered in this way."

Read more in the Albany Times Union here.

Unfortunately the medical industry continues to push for "reforms" that would curb the right of patients and their families to seek legal redress for tragic incidents of malpractice. The industry actually argues that hospitals would work harder to improve patient safety if they were freed from the risk of lawsuits when they fail to live up to their promises. Joanne Doroshow, the author of the Pop Tort blog, has a one word response to this notion: "Pul-leze!" Read more from her column here.

Deaths of mothers in childbirth are fortunately rare. But injuries to the newborn baby are not so uncommon. My law firm's website has more about birth injuries here and here.

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March 26, 2010

Safer Health Care, But at a Cost

American medicine is moving rapidly from small doctor-owned medical practices to large corporate-run clinics, a trend that will likely mean safer care for patients, but with a loss of close relationships with personal doctors.

Just since 2005, the percentage of doctor-owned practices has declined from over two-thirds to less than half, as doctors face a myriad of financial pressures, according to an article by Gardiner Harris in the New York Times.

Patients typically get better coordinated care in the large group practices now emerging as the model for medical practice. When doctors work together under one umbrella, it's easier to pass the patient from primary care to specialist to hospital without the communication gaps that cause so many tragedies and give rise to malpractice lawsuits. The larger practices also can better afford the electronic medical record systems that help this coordination.

Big practices also spell loosening of the intimate bond between doctor and patient, just like Costco and Walmart spelled the end of close relationships that many of us had growing up with our neighborhood merchants. But closeness and a sense of trust are much more important to the healing process than buying groceries. So the challenge for medical leaders will be to find ways to keep big medical practices from becoming too impersonal.

Whether this trend will slow rising medical costs is another question. Many of the large companies gobbling up doctors' practices are monopolies in the towns where they operate, making them more able to resist reimbursement cuts by insurance companies.

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March 18, 2010

How to Speak Up When Health Care Goes Wrong

A new website has tools for learning how to speak up effectively when you've had a bad health care experience. That can be anything from being on the wrong end of someone's rudeness to being the victim of a serious malpractice event. The website is called The Assertive Patient. Click here for the link. It comes out of Massachusetts but has good resources for patients everywhere.

The website has a good diagram here that shows the steps involved in getting resolution to a bad experience, especially if it's in a hospital. You start with talking with the providers involved and if they are non-responsive, the hospital will have some sort of patient advocate or ombudsman or quality assurance officer or "risk manager" (many different terms cover the same thing). If this doesn't work, formal complaints to regulatory bodies are the next step, or talking to a lawyer.

The final chapter in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, also gives a step-by-step approach to getting to the bottom of poor quality care. And you can get the same information at my law firm's website, by filling out the form to download our free Injury Fact Kit.

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March 12, 2010

Malpractice Patterns in Long-Term Care Hospitals Under Federal Investigation

The U.S. Senate Finance Committee is investigating deaths of patients at long-term care hospitals, in follow-up to a report in the New York Times last month. That report showed that the profit-making chains who run these hospitals, which cater to chronically ill patients, sometimes skimp on staffing and training, and disasters have resulted.

More on the original report in the Times can be found in our blog entry on the subject here.

These long-term care hospitals occupy a niche between large general hospitals and nursing homes. They do not treat specific kinds of patients but are defined only by the fact that patients tend to stay longer than at a regular acute-care hospital, but less time than at a nursing home. They are typically small, with around 60 beds. Many times they lease space from a regular hospital and will occupy a floor or wing in a larger facility.

The New York Times reports that it has received new information about disturbing events at hospitals run by the Select Medical chain. One example from the Times:


According to a doctor’s deposition in a lawsuit, nurses at a Select hospital in Tulsa, Okla., injected a relatively healthy 79-year-old woman with 10 times the amount of insulin she was supposed to receive back in January 2009. They then failed to notify her doctor for at least 90 minutes after they discovered that she had fallen into a coma. The woman, Ruth Tanner, died a month later without fully regaining consciousness, according to medical records and the lawsuit.

Select Medical generally does not comment on pending lawsuits, so out of respect for the legal process and the parties involved, it will not do so in the Tanner case, the company spokeswoman, Ms. Curnane, said.

Dan Graves, an attorney for Ms. Tanner’s family, said that family members agonized after the overdose. “Now their grief and loss has been multiplied by the knowledge that other families have suffered similar tragedies because of Select’s practices.”

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March 10, 2010

Medical Malpractice Is a Leading Cause of Preventable Death in District of Columbia

Deaths from preventable medical error kill as many people in the nation's capital as guns, and far more than motor vehicle crashes, according to a new report from the D.C. Department of Health.

The report, the first of its kind in the District of Columbia, analyzed the 5,168 total deaths reported to health officials in 2007. It determined that fully half of the deaths could have been prevented. Among the leading causes of preventable death:

1. Tobacco: 860 deaths
2. Poor diet and physical inactivity: 780 deaths
3. Infections (not counting HIV): 240
4. Alcohol abuse: 150
5. Firearms: 140
6. Medical errors: 140
7. Poisons (and pollution): 110 deaths

DC Motor vehicle deaths were a distant 10th place on the list of leading preventable causes of death, with 30 deaths in 2007, according to the Health Department.

Another interesting number: The Department estimates that as many people died from lack of health insurance -- which discourages access to medical care -- as motor vehicles -- 30 people in 2007.

The estimate of deaths from lack of health insurance is based on the number of uninsured people in D.C. and uses methodology from a report by the Kaiser Family Foundation. The estimate of deaths from medical error was made by applying D.C. population numbers to estimates that were made in 2000 by the Institute of Medicine, part of the National Academy of Sciences.

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March 10, 2010

Is Sexism Dangerous to Patient Safety?

It sure is. Work by Peter Pronovost and other pioneers in the patient safety movement has shown over and over that medicine's culture of "doctor knows best" can be dangerous to patient safety and can cause episodes of medical malpractice. That's because nurses (still mostly female) often see errors in the making and yet feel it is not their place to criticize or correct the (usually male) physician.

Pronovost, a Johns Hopkins critical care doctor, has a new book: Safe Patients, Smart Hospitals: How One Doctor's Checklist Can Help Us Change Health Care from the Inside Out.

Changing the culture of medicine, to encourage nurses to speak up as valued members of the medical team, is critical to improving patient safety, Dr. Pronovost says.

I interviewed Peter Pronovost last year for my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst. One of the things I wrote about then was how the simple culture change of having all members of the surgical team introduce themselves by name at the beginning of the operation has been found to have a big impact on improving safety. Why? Because when people know each other by name, and not just by "nurse," or "doctor," they communicate better with each other, and good communications are vital in preventing hospital errors.

Patient Safety And Sexism In Medicine

I've been thinking about sexism in medicine since the news last month about the west Texas nurse who was brought up on criminal charges for having the gumption to report a doctor she thought was endangering patients to the state licensing board. The nurse was ultimately acquitted, as reported on this blog, but of course the outrage was that she was investigated and indicted in the first place (and fired from her job at the hospital where she had watched this doctor).

It's no surprise that the nurse was female, the doctor was male, and the nurse's accusers in the sheriff's office and the local prosecutor were male too.

Of course, it's not just the gender of the people involved, but their power. Doctors admit patients to hospitals and thus are "cash cows" who are often coddled by hospital administrators for fear the doctor will take his business elsewhere.

After the Texas "not guilty" verdict, there were some interesting comments from nurses about their experiences. One posted on the San Antonio Express newspaper web site was revealing:

I am from the east coast. There, the relationship between doctors and nurses is collegial. We respect one another as licensed professionals. I was amazed that the difference here in Tx. One simple example - if a patient being admitted for chest pain, and their blood test that shows they probably had a heart attack is positive, then standard of care is that they should be admitted to a unit that can do constant heart monitoring (telemetry). Where I am from, if the doctor gave written or telephone orders for a standard unit (without telemetry), it is the DUTY of the nurse to remind him/her that the patient has a positive Troponin and needs a telemetry bed. If you did not do that, and the patient had a poor outcome, the review committee would point the finger to the nurse that took the telephone orders for admission on not taking it up the chain of command until that patient had a telemetry bed. She or he would then face a peer review and be potentially turned into their state licensing agency to determine if their license should be suspended or revoked for failure to follow appropriate patient standards of care.

I heard a nurse very politely say "doctor, would you like a telemetry bed for this patient with a high troponin level"?

His response? "Can you put a nurse on the phone that knows how to take orders"?

The issue was dropped, right then and there, and the decision to let it drop was supported by the ER and hospital nursing supervisor, because they didn't want to upset the physician. Now I have met very nice physicians here, but for the most part, this is the attitude of many physicians towards the nurses. Nurses hold a license, and have a duty to ensure quality and safety of care, in addition to taking care of the patient.This includes reporting even the SUSPICION of unsafe care. It is a shame when our ability to do so is threatened by situations like this.

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February 5, 2010

Medical Malpractice: Too Many Lawsuits or Too Much Preventable Harm?

This question can be answered -- perhaps unscientifically but with arresting examples nonetheless -- by just one week's worth of news. Joanne Doroshow of the Center for Justice and Democracy did a roundup of the evidence and posted her findings on the Huffington Post.

Ms. Doroshow found lots of reports of terrible injuries to patients and little accountability for the wayward practitioners except through the painful but necessary process of lawsuits in court. As she concluded:

Fixing our health care insurance system is no easy job. But this is the wrong time to consider weakening the legal liability and accountability of incompetent or reckless health care providers.

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January 31, 2010

Better Care with the Tried and True, or the Seduction of the New?

Time and again in U.S. health care, new technologies are hurried into wide use with little testing, scant training of their human operators, and lack of solid evidence that newer really is better. After the flush of optimism has faded, billions of dollars later, we learn how to judiciously use the new equipment, but only after patients have been hurt or killed by the rush to the new.

The latest example is the deployment of new radiation therapy machines on cancer patients with operators who are not properly trained or credentialed and equipment that has not been tested or calibrated. The New York Times' recent investigative series on the subject prompted one knowledgeable reader, Dr. Joseph Imperato, medical director of the Center for Advanced Radiation Medicine at Lake Forest (Ill.) Hospital. to write this:

To the Editor:

As a radiation oncologist practicing for 25 years, I believe that there is a crucial part of the story of radiation mishaps that has not been mentioned: the “nuclear arms race,” in which people want the newest technologies, without stopping to think about who is operating them.

In the past, academic medical centers were typically the first to obtain and use new technologies. The equipment would be thoroughly vetted and reported on in peer review articles before being accepted and used by the smaller community hospitals.

Now the reverse is true. Small community hospitals often far outpace academic medical centers. One example is the proliferation of proton centers run by for-profit companies. Often the staff has limited knowledge and experience with this extraordinarily complex equipment. And new technologies are often assumed by the public to be better, even though there is often little firm clinical data to support that.

As we struggle as a country to come to grips with health care costs, this is one area where there is great opportunity for savings. Clinical reviews can prevent the proliferation of needlessly expensive technology. What the public must come to grips with is that “new” is not automatically “better.”

See the Times' letters section for more.

In my book, "The Life You Save," I have several chapters that speak to this issue, particularly with new drugs. What patients need to understand is that whatever the technology, the early years of use are in essence a continuation of the testing phase. If you are comfortable with being a guinea pig, that's fine, but very often you can get better, safer care with the tried and true. And if the new technology looks enticing, go with an operator who has the most experience using it, because practice does make perfect.

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January 24, 2010

Malpractice in Radiation Therapy: Hideous Injuries from Lack of Simple Checklists

More evidence of the urgent need for "checklists" to protect patient safety in complex medical treatments comes with a long article in the New York Times about terrible injuries from malpractice episodes during radiation therapy. Yet readers have to dive deep into the article to find this key point.

Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions. Why did it happen? The hospital, St. Vincent's in New York, blamed a confluence of tragic coincidences. But I reached a different conclusion, as I wrote in a blog post to the Times' "Well" blog:

Deep in this tragic article is the following paragraph that exposes the reforms that are needed before medical care can become safe for all patients:

"It was customary — though not mandatory — that the physicist would run a test before the first treatment to make sure that the computer had been programmed correctly. Yet that was not done until after the third overdose."

So there you have it. If the physicist had been required to run the test -- better yet, if the equipment had been set so that it wouldn't work until the final test had been run -- Scott Jerome-Parks would not have suffered the hideous injuries so eloquently described in the article.

Medicine needs to adopt standard and mandatory - not merely "customary" -- checklist routines to ensure the safety of patients. This is the thesis of Atul Gawande's new book, "The Checklist Manifesto," and I have a chapter on how patients can enforce checklist protocols before surgery in my own book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

Many medical commenters on the New York Times "Well" blog defensively say, "We're only human," to excuse these kinds of errors. Yes! That's exactly the point of the checklist. It recognizes that we're all only human and that when we are deploying potentially deadly treatments, a final check and double-check is needed, every time, before pressing the button.

The Times also found that the manufacturer of the software that ran the linear accelerator, which delivered the radiation, did not have in place until after the injury a simple "fail-safe" mechanism to prevent the kind of error that occurred.

The entire article by the brilliant reporter, Walt Bogdanich, is worth reading. Here is the Times' own summary of the article:

The Times found that while this new technology allows doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error — through software flaws, faulty programming, poor safety procedures or inadequate staffing and training. When those errors occur, they can be crippling.

I also recommend that readers interested in patient safety issues go through some of the NYT "Well" blog posts on this article.

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December 29, 2009

Medical Malpractice Lawsuits in Washington D.C.: An Unusual Venue for a Patient Safety Message

A subway station might seem an unusual place to try to educate the public about protecting the rights of injured patients -- but maybe not so much when that station is the nearest to the Capitol building in Washington, D.C., and is traveled by thousands of staffers who work on Capitol Hill.

"Tell Congress to put patients first," the ads say. "There are 98,000 reasons why you should. 98000reasons.org."

The number refers to an oft-quoted report from the National Academies issued ten years ago that estimated that 98,000 patients died unnecessarily each year from medical errors.

Since then, as this blog has reported, the estimates of preventable deaths have climbed, despite a spate of efforts to make medical care safer.

The new ads are sponsored by the American Association for Justice, the lawyers' group that includes attorneys like me who represent patients in malpractice lawsuits. The ads are discussed in an article by Elizabeth Olson in the New York Times.

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December 29, 2009

Different Points of View on Medical Malpractice Lawsuits

A physician writes in the New York Times about her own emotionally trying experience being sued for malpractice by a patient's family, and seeing the case dropped after four long years of litigation. The case happened to be against an internist for colon cancer, something where I have fresh experience. Here is the text of my comment on the Times' website:

In Dr. Savitsky’s account, it’s hard to understand how an internist would be sued for a patient’s colon cancer, and many commenters railed that this was an example of “frivolous” lawsuits or patients suing their doctors for being guilty of mere human error.

I know nothing of the facts of Dr. Savitsky’s case. But I do know how an internist can come to be sued for colon cancer. I just mailed a settlement check today to my client, a widow who lost her husband at age 59 from an entirely curable colon cancer. We successfully sued her husband’s internist for egregiously failing on multiple occasions to follow basic rules of medical practice in treating middle-aged men. I wrote more about this case a few months ago on Huffington Post.

Yes, there are occasions when our litigation system bruises people who don’t deserve it. Far more often, it is the only way that ordinary folks have to call to account those who have broken the rules and caused serious harm.

There are many other thoughtful responses to the doctor's column on the Times' site. Here is just one:

I have very mixed feelings about all of this.

It’s easy for outsiders to pass judgment on how the patient/family is supposed to feel after a bad outcome. It’s easy to apply cheap armchair psychology and decide the family is angry, or in denial, or looking for someone to blame, or that they have a lottery mentality or that they don’t know how to constructively handle their grief. The attitude seems to be that they should just shut up and be grateful for the health care they received.

Unless it’s happened to you, you really have no idea of how you’re “supposed” to feel. Take it from someone who’s been there: I was truly shocked at the level of rage and depression I experienced. I never, ever thought I would say this, but I now understand a lot better why some people sue… and I am a lot less likely to judge them harshly for it.

That said, I appreciate Dr. Savitsky’s story and I’m glad she shared it. If only we could have heard the family’s side of the story as well. Maybe then we would all have a better understanding of what the experience is like on both sides of the fence. Because right now, judging from the conversation here, most of us don’t understand.
— Perrin

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December 18, 2009

A Patient Safety Leader Speaks Out

An interview with patient safety leader Dr. Robert Wachter in the New York Times was both encouraging and dismaying. Encouraging because Dr. Wachter gets it right about what the medical system needs to do to make health care safer. Dismaying for some of the shrill and hysterical comments from physicians posted on the NYT blog in response.

Dr. Wachter, a hospitalist at UC-San Francisco, made a number of sensible points, including:

* Financial incentives need to be better aligned with safety. Instead, the incentives are mostly focused on getting paid by insurance companies. Quote:

"For instance, I can lose my hospital privileges if I fail to sign a dictated discharge summary or operative note. But if I don’t clean my hands for the next 10 years, nothing will happen to me."

* More honesty is needed when confronting errors. Quote:

"The only way we are going to fix this problem is to become much more open and transparent. That transparency will drive us to improve and allows us to educate each other."

* Standardizing safety routines is urgently needed. Quote:

"The chaos of everyone doing things their own way is incredibly dangerous, and it is that chaos which gets in the way of the [doctor-patient] relationship. You can make health care better, safer and less expensive while strengthening the core of the patient-doctor relationship. You can standardize certain parts of care based on clear evidence, which will free up doctors to focus on those pieces of the health care puzzle where there is no data — those issues that are uniquely human and that require judgment, expertise and empathy."

Now for the dismaying part. If you scroll through the "Well" blog comments on Dr. Pauline Chen's interview with Dr. Wachter, the ones with "MD" behind their name jump out for their ... well, judge for yourself:

A reader who identified himself as Dr. Mark Johnson: "Wachter is attention-craving sensationist, apparently employed by NYT on their anti-doctor crusade. Is he even practicing medicine? Has he ever worked outside of academia?"

Another reader who signed as Anonymous: "It’s simple. If you don’t trust the medical system, just don’t use it. Don’t come see me when you’re in a trauma. Don’t come see me when you want an elective procedure. Just don’t come see me. It saves me the energy that I waste catering to people who hate me and distrust everything I do."

Another one, who identified himself as Mark Davis, M.D., had a similar suggestion that patients should just move out of the country if they don't like it.

Back to a more encouraging take:

It was good to see many, many other readers writing in with thoughtful comments and ideas about how we can improve health care for everyone. The only ones that made me wince were those that demonized lawyers who represent injured patients. Some of them have the naive idea that if lawsuits were lessened, everyone in health care would come forward with more honest confessions about their errors, which would lead to vast improvement. The fact is that even countries with very little malpractice litigation, like England, have the same problem with the culture of secrecy in medicine.

Killing the messenger who delivers the bad news won't solve the problem.

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November 18, 2009

Mammograms: Understanding the Risks and Benefits

The new breast cancer screening guidelines demonstrate yet again why savvy patients need to understand the numbers behind risk/benefit studies before making the very personal decision about whether and how often to get a cancer screening test.

The recommendations of the U.S. Preventive Services Task Force that women hold off on routine mammograms until age 50, and then get one every couple of years instead of every year, are based on sophisticated statistical modeling that aimed to get the most benefit at the least harm. The benefit is saving lives. The harm is overdiagnosing, overtreating, and needlessly frightening women who receive "false alarms" with mammograms.

The key fact that women -- and all patients -- need to understand is that your risk of a "false alarm" depends on your risk for the disease. The lower your natural risk of disease, the higher the risk of a false alarm, and vice versa. The reason the task force said that women between ages 40 and 49 don't need screening is that with the low risk of disease in that age group, the chance of needless false alarm is much higher, and the benefit of discovering the occasional cancer is much lower.

For example, one statistical model, called the Stanford model, which the task force looked at, concluded that if women between ages 40 and 69 got mammograms every year, there would be on average 2,250 false alarms -- "false positive" results -- in every 1,000 women -- an average of two per woman tested over ten years. On the other hand, there would be a total of 164 years of life gained among these 1,000 women. When the mammograms were reduced to every other year, and only given between ages 50 and 69, the years of life gained were 99 and the false alarm rate went down to 780 per 1,000. That is the tradeoff.

Those extra 65 years (164 versus 99) of life gained among the 1,000 women also come at an economic cost: if 1,000 women have to get 10 mammograms each over 10 years, that cost is around $10 million (assuming $1,000 per mammogram).

We don't like to think about "rationing" medical care, but sensible decisions on both a personal and societal level have to take into account how much we're spending for how much gain, and what else the same amount of money could be spent on.

In my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," I have an extensive chapter on the risks and benefits of breast cancer screening at different ages. Here is an excerpt:

What about saving lives with screening tests intended to catch early cancers? Here is how that statistic of a 25 percent reduction in deaths translates in the real world. If you thought that means that of every 100 women screened, 25 of them would be saved by mammograms, you would be making a natural assumption that many others have made, but you would be very far off the mark. The actual numbers come from a series of studies in Sweden involving some 280,000 women. Of those over age forty who did not undergo mammograms, 4 in 1,000 died of breast cancer over the ten years of the study. Of those over age forty who did have mammograms, 3 in 1,000 died of breast cancer over the same ten years. The reduction from 4 to 3 per 1,000 is where the 25 percent number comes from. Put another way, for every 1,000 women who participate in mammogram screening for ten years, 1 of them will be saved from dying of breast cancer.7 The odds of saving 1 life are a little improved if screening begins only at age fifty instead of forty. Of every 270 women who start screening mammograms at age fifty and undergo one every other year for the next twenty years, 1 life will be saved—or about 4 in 1,000, which is a lot more than the 1 in 1,000 lives saved for starting mammograms at age forty.

The new statistics from the Preventive Services Task Force concluded that the benefit from mammograms in women aged 40-49 was even lower than the Swedish estimates -- more on the order of one life saved for every 1,900 women screened, instead of one in 1,000.

Here's the bottom line, as I put it in my book:

Are those kinds of odds worth it to undergo the trouble of regular screening? That is a personal decision. My only point is that to make that decision rationally and realistically, you need to look at the numbers with eyes wide open.

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October 29, 2009

Where Are the Firing Offenses in Medicine?

The recent news about the two Northwest Airlines pilots whose licenses were revoked, less than a week after they let their plane wander 150 miles off course, raises the question: Where are the firing offenses in medicine?

The pilots injured no passengers, and the event didn't even qualify as a "near miss." But because they egregiously violated safety rules by working on their flight schedules on a laptop in the cockpit, the aviation authorities did not hesitate to pull their licenses.

In the medical industry, by contrast, it is well known that a doctor will lose his or her license for only flagrant patterns of drug or alcohol abuse or other criminal behavior, with a trail of dead and injured patients usually lasting years before the practitioner is finally put out of business.

Read my entire post on this in the Huffington Post here.

One of the HuffPost comments on my blog post raised the fair point about what should be firing offenses for attorneys. Here's what I said in response:

A firing offense for an attorney should be any conduct that is unethical or negligent and hurts a client. (That's a short and probably incomplete answer to a complicated question.)

In most states, the highest court of appeals of the state has power to revoke attorney licenses. Some do a better job than others. But unlike medicine, everything happens out in the open, for the public to observe.

For patient advocates like me, the frustrating part of the medical discipline system is its secrecy and unresponsiveness. I filed a formal licensing complaint about a Maryland plastic surgeon who put a healthy patient into a permanent coma with a gross overdose of local anesthetic; two years later, I received a one-paragraph response from the state board that he had received a "private reprimand." No details available, because, after all, it's "private."

In another recent case, I complained to the Florida nursing board about a nurse-midwife whose overuse of the uterine-stimulating drug oxytocin caused the uterus to rupture and the baby to suffer terrible cerebral palsy. More than a year later, I received a one-sentence reply that the board had "failed to find probable cause."

In the law world, comparable incidents would have received at least a detailed explanation of why the licensing body was or was not taking action. That's what we should demand of any professional disciplinary system that respects the public's right to know.

The current sorry state of medical discipline is one reason I warn readers of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," that patients need to go way beyond looking up medical licensing discipline to make sure they are picking the right doctor for themselves.

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October 6, 2009

Another Quiet Hero of the Patient Safety Movement

Dale Ann Micalizzi took her 11-year-old son Justin to a hospital in upstate New York one evening because his ankle had an infection that needed to be drained. It was supposed to be a 10-minute procedure. Justin never woke up.

That happened in 2001. Today, Dale and her husband Gary head up a non-profit group called Justin's HOPE, which is dedicated to improving health care for children. She speaks often to medical staff in hospitals. One important message she gives to hospital administrators: When a mistake has happened, deal openly and honestly with the parents.

Any parent who can turn their grief into something positive is a real hero. Especially when that child has died an unnecessary, preventable death due to medical errors, the easier thing would be to retreat into numbness and bitterness. So I salute Dale Micalizzi.

I celebrate a number of heroes of the patient safety movement in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

You can read more about Dale's advocacy in an article in the Schenectady Gazette.

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October 5, 2009

"Defensive Medicine" -- A Mom's Moving Response

A North Carolina mother who lost her 6-year-old son to preventable medical errors writes a moving response to talk of "malpractice reform" and "defensive medicine." Laurie Sanders opens her story in the Charlotte Observer with these lines:

Medical negligence isn't a topic I gave much thought to until my 6-year-old son went to the hospital sick for the first time in his life and died of oxygen deprivation. A happy little boy, with no history of breathing problems, no allergies ... never sick. Christopher was my only son. His daddy, my husband, had died of cancer a few years earlier.

In experiencing the death of my husband and son, I have seen the best medical professionals and the worst. I have seen the most caring, and the least.

I buried my husband knowing that medical professionals did everything they could. I buried my son knowing that medical professionals failed him at the most basic level.

Ms. Sanders tells what happened to her son, including the legal investigation she launched to get at the truth, and then offers these thoughts:

One of the lessons of Christopher's unnecessary death - and my necessary lawsuit - is not that health care providers need to engage in cost-inflating "defensive medicine." Instead, it is that doctors and nurses must pay attention, communicate with their colleagues and adhere to well-recognized standards of practice.

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October 5, 2009

People's Pharmacy: Radio interview on patient safety

Patrick Malone was interviewed on the People's Pharmacy radio show on how to avoid medical injuries and get the best care for you and your loved ones. You can listen to a podcast of the show by clicking here.

The hosts of this syndicated public radio show are an interesting couple. Joe Graedon is a pharmacist, and Terry Graedon is a medical anthropologist.

In their interview with Patrick Malone, Joe Graedon shares his own story about a medical tragedy that happened to his mother. The lesson: Any time you have a loved one in the hospital, you need to arrange for 24/7 presence there by a family member or close friend. It's very important to have an advocate with you at all times. Patrick Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, has an entire chapter on all the ways that an advocate can help prevent injury and get you home safely from a hospital stay.

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September 16, 2009

A Virginia Child's Story Shows Why Every Patient Needs an Advocate in the Hospital

Every hospital patient needs someone with them at all times to help prevent medical errors and keep them safe. That's a mantra I have advocated for years, and another example of why it's good advice comes with a riveting story in the Washington Post by health writer Sandra Boodman.

Ms. Boodman's article tells how a Washington area woman's advocacy in the emergency room and hospital helped lead to a correct diagnosis of baffling symptoms, and likely saved her sick daughter from harm. The article interviews Patricia Dawn about her 4-year-old daughter Brooke's illness, that was eventually discovered to be Kawasaki disease, an unusual heart condition.

Brooke got the right treatment in time, but only because of her mother's persistence. Mrs. Dawn refused the recommendation of the emergency room doctors to take her daughter home at 2 a.m. when she wasn't feeling any better but they had run out of things to do. At her insistence, her daughter was hospitalized, and an infectious disease specialist eventually figured out that the red lips, red eyes, fever longer than five days, and swollen lymph node in the neck all were signs of Kawasaki, which affects about 2,000 American children a year.

It was also at the family's suggestion that the infectious disease doctor was brought in who made the correct diagnosis.

The story underlines the importance of having a good advocate present at all times with a patient in the hospital. Even a lay advocate can see when symptoms aren't improving and can insist on action.

I discuss this subject in depth in Chapter 12 of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

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September 15, 2009

New Patient Safety Report Cards in Pennsylvania

Pennsylvania continues to lead the nation in showing how public health authorities can cast a little disinfecting sunshine onto the patient safety practices of hospitals.

In its latest report, the Pennsylvania Patient Safety Authority says that in 2008, a total of 194 surgery patients were sewed up with a foreign object still inside them. They have a term for it: RFO, for Retained Foreign Object.

To avoid leaving behind a sponge, needle or other instrument, the nurses and doctors involved in any surgery are supposed to go through a counting ritual. The problem is that the count doesn't always end correctly. In fact, the same Authority reported that last year, there were over 2,000 instances of incorrect counts, which doesn't always mean an object has actually been left behind.

One technique to follow up when there has been a discrepancy in the count is to do an x-ray of the affected area. That should show up any hidden objects.

The RFO problem is expensive for patients and hospitals. According to the Consumer Union Safe Patient Project, the average cost of a hospital stay for the corrective surgery and other problems that come from a retained object is $62,631.

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August 11, 2009

"Dead by Mistake" -- the Staggering Death Toll of Medical Error

A new series of investigative articles by the Hearst newspapers concludes that errors in medical facilities are still taking some 100,000 lives per year -- a decade after a national report first focused wide attention on the problem. Worse, the reforms that started after that report have been piecemeal and ineffective, according to the authors.

The series concudes:

[T]he federal government and most states have made little or no progress in improving patient safety through accountability mechanisms or other measures. According to the Hearst investigation, special interests worked to ensure that the key recommendations in the report -- most notably a mandatory national reporting system for medical errors -- were never implemented.

Among the key findings of the Hearst investigation:

• 20 states have no medical error reporting at all, five states have voluntary reporting systems and five are developing reporting systems;
• Of the 20 states that require medical error reporting, hospitals report only a tiny percentage of their mistakes, standards vary wildly and enforcement is often nonexistent;
• In terms of public disclosure, 45 states currently do not release hospital-specific information;
• Only 17 states have systematic adverse-event reporting systems that are transparent enough to be useful to consumers;
• The national patient-safety center is underfunded and has fallen far short of expectations;
• Congress approved legislation for "Patient Safety Organizations" as a voluntary system for hospitals to report and learn from errors, but the new organizations are devoid of meaningful oversight and further exclude the public;
• Hearst journalists interviewed 20 of the 21 living authors of "To Err is Human" -- 16 believe that the U.S. hasn't come close to reducing medical errors by half, the primary stated goal of the report;
• New York's reporting system has run out of money and staff -- its last public report is four years old;
• The law mandating reporting in Texas expired in 2007, and funding ran out -- a new reporting law has been passed, but no funds have been allocated;
• Washington State requires reporting, but doesn't enforce that requirement -- and the legislature failed to provide funds to analyze the results.

If there is a silver lining in this cloud, it is that safety experts now know a lot more about how patients can keep themselves safe and secure in the health care system. I report their recommendations in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

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August 7, 2009

Saving Lives -- and Money Too -- With Patient Safety Reform

A new report from Public Citizen proposes 10 cost-cutting, patient safety measures that would save an estimated 85,000 lives and $35 billion a year. The report, "Back to Basics," analyzed the results of scientific studies of treatment protocols for chronically recurring, avoidable medical errors.

In contrast to the high-tech tests and procedures that many experts blame for staggering increases in the nation’s health care costs, most of the reforms in Public Citizen’s report involve fundamentals as simple as practitioners consistently washing their hands, sufficiently tending to patients to prevent bed sores, and following simple safety checklists to prevent infections and complications stemming from operations.

Many of the proposals on Public Citizen's list are the same that I discuss in my book, "The Life You Save." The only difference is that I believe patients and families can do their own health care reform at home to implement many of these safety measures. I discuss examples of things patient advocates can do at the bedside to help prevent pressure ulcers (bed sores), injuries from falls, blood clots, infections and medication errors. See Chapter 12: "Your Personal Advocate, in the Hospital and Out," and Chapter 13: "The Scandal of Infections in Hospitals and Other Health-Care Facilities, and What You Can Do."

Here is more from Public Citizen's news release announcing their new report.

Aside from the tragedy of needless deaths and injuries, the financial toll of failing to follow accepted safety procedures is astounding. Severe pressure ulcers cost an average of $70,000 apiece to treat. A catheter infection costs $45,000. Each instance of ventilator-associated pneumonia costs $5,800. Collectively, avoidable surgical errors cost an estimated $20 billion a year, bed sores $11 billion and preventable adverse drug reactions $3.5 billion.

"There are many incentives to order expensive tests and procedures and too few rewards for providing basic, sensible care," said David Arkush, director of Public Citizen’s Congress Watch division. "As the largest investor in the nation’s health care system, the federal government should ensure that fulfilling basic patient safety standards is a condition of receiving federal reimbursements. And the government should pay providers for doing the right thing. It will save money in the long run."

Public Citizen proposes that health care providers:

• Use a checklist to reduce avoidable deaths and injuries resulting from surgical procedures (saves $20 billion a year);

• Use best practices to prevent ventilator-associated pneumonia (saves 32,000 lives and $900 million a year);

• Use best practices to prevent pressure ulcers (saves 14,071 lives and $5.5 billion a year);

• Implement safeguards and quality control measures to reduce medication errors (saves 4,620 lives and $2.3 billion a year);

• Use best practices to prevent patient falls in health care facilities (saves $1.5 billion a year);

• Use a checklist to prevent catheter infections (saves 15,680 lives and $1.3 billion a year);

• Modestly improve nurse staffing ratios (saves 5,000 lives and $242 million a year);

• Permit standing orders to increase flu and pneumococcal vaccinations in the elderly (saves 9,250 lives and $545 million a year);

• Use beta-blockers after heart attacks (saves 3,600 lives and $900,000 a year); and

• Increase use of advanced care planning (saves $3.2 billion a year).

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August 6, 2009

Broken Alarms and False Alarms in Medical Testing -- the Swine Flu Problem

Swine flu testing is the latest example of an important issue for informed patients. Patients need to understand that some medical tests are valuable if there is a "positive" finding, but not much good at all if they are "negative." The problem is that the test is "insensitive," which means a negative result can miss the disease that's really there -- a "broken alarm."

For swine flu, in every 100 patients who actually have flu, the various brands of "rapid flu" tests will have a "positive" result (meaning the patient has the flu bug) for as few as ten of the 100 patients, or as many as 69 of the 100 patients. Even with the higher accuracy, that means that a lot of patients are being missed by these "rapid flu" tests. These statistics come from a New York Times article quoting newly published studies and experts in the field including the Centers for Disease Control and Prevention.

A CDC official told the Times:

“We’re saying you need to understand the limitations of these tests,” Dr. Timothy M. Uyeki, an author of the C.D.C. guidance, said in an interview. “The clinician should not base a decision to treat or not treat on the basis of a negative result.”

Another classic example of an "insensitive" test is the "hemoccult" test for hidden blood in the stool. If it's positive, you need further workup. If it's negative, it doesn't give you a clean bill of health for colon cancer. That's why the standard screening test for colon cancer is a colonoscopy, which looks at the entire length of the colon with a video camera.

My book "The Life You Save" has a chapter about understanding medical testing and why you cannot necessarily rely on a negative test result.

The point is: A negative result doesn't mean you have a clean bill of health. Sometimes you have to pay attention to other signs and symptoms.

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July 31, 2009

Patient Injuries and Deaths in Hospitals Are Under-Reported and Covered Up

One hundred thousand preventable deaths from medical errors in hospitals each year: That is the usual statistic cited by patient safety advocates. It comes from a 10-year-old report issued by the Institute of Medicine of the National Academy of Sciences. The fact is, though, that the death and injury rate could be substantially higher. No one is sure, because no one is counting "adverse events" in a rigorous, systematic way, and evidence keeps piling up that hospitals under-report these events to health authorities and worse, cover them up.

An investigation by the New York Daily News of the city's municipal hospital system -- with eleven hospitals and 1.1 million patients treated last year, the nation's busiest city-run system -- found dozens of examples of failures to report egregious errors, and subsequent cover-ups including alteration of medical records to make it look like nothing had gone wrong.

The Daily News reported:

The coverups hid a trail of human suffering among patients who were maimed and relatives who were never told the truth about how their loved ones died or were injured unnecessarily.

The newspaper found a pattern of failures by state health authorities to act on evidence of fraudulent behavior in covering up the injuries. Moreover, it found that the state reporting agency itself was dysfuctional. According to the article:

The state is supposed to track and analyze all medical incidents and implement improvements. The problem is this oversight system — the New York Patient Occurrence Reporting and Tracking System (NYPORTS) — is a disaster.

Since 1999, all New York hospitals have been required to self-report a long list of medical incidents to NYPORTS, which in turn analyzes the incidents and implements patient safety reform.

Sunday NYPORTS barely functions. The Statewide Council that oversees it hasn't met in more than two years. Though NYPORTS is supposed to release "annual" reports, the last one filed is dated 2004.

To avoid needless injury, patients have to be vigilant about their own health care. That is why I wrote my book, "The Life You Save," which lays out a system of nine simple steps for patients to follow to get the best medical care and avoid the too-frequent disasters that happen in our fragmented care system.

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July 20, 2009

Breast Cancer Screening: A Provocative Balance Sheet

Imagine if every 50-year-old woman thinking about whether to have a mammogram received the following "balance sheet" showing the "credits" and "debits" as understood by the latest research:

For every 1,000 women who have a yearly mammogram over the next ten years: Credits

1 woman will avoid dying from breast cancer

Debits
2-10 women will be overdiagnosed and treated needlessly

10-15 women will be told they have breast cancer earlier than they would otherwise have been told, but this will not affect their prognosis

100-500 women will have at least one "false alarm" (about half of these women will undergo a biopsy)

These numbers appear in an editorial in the British Medical Journal in July 2009, written by Dartmouth researcher H. Gilbert Welch, M.D., in response to news that the British National Health Service had scrapped a proposed pamphlet that would have described the benefits of mammograms, but failed to talk about their downside.

The key comparison in the above balance sheet is the ratio of one woman's life saved for every two to ten lives harmed by overdiagnosis. The one-to-two ratio comes from a study three years ago by Zackrisson and colleagues. The one-to-ten ratio is from a more recent study by Gotzsche. The tipping point for women in deciding whether to undergo annual mammogram screening is probably somewhere on this sliding scale. The test might not feel worthwhile if ten women are hurt for every one helped, but might seem worth it if only two were hurt for every one helped.

As the author writes:

Mammography is one of medicine’s "close calls"—a delicate balance between benefits and harms—where different people in the same situation might reasonably make different choices. Mammography undoubtedly helps some women but hurts others. No right answer exists, instead it is a personal choice.
To inform that choice, women need a simple tabular display of benefit and harms—a balance sheet of credits and debits.

Unfortunately, medicine hasn't yet pinned down the precise numbers on the balance sheet. For now, women need to be informed that there are varying estimates, and they need to make their own decisions.

Readers should note that this discussion applies only to cancer screening in low-risk women who have no noticeable lumps; women who can feel a lump in their breast are in a different risk category and need to see a doctor promptly.

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July 10, 2009

How to Learn from Medical Mistakes

A column in the New York Times by Pauline Chen, M.D., relates how a colleague of hers named "Ed" crashed and burned on his way to becoming a general surgeon, seemingly because of his difficulty in learning from his own mistakes.

The blog comments by both doctors and patients are revealing. Many make the point that physicians can deal with the stresses of medical practice, and become better at their craft, by being less obsessed with perfection and more open to working with others in a supportive, teamwork environment. I particularly enjoyed a comment (No. 121) from "Susan," that linked the issue to the recent story by Jane Gross in the Times about the Sisters of St. Joseph near Rochester, New York, who have figured out that putting the patient's wishes at the heart of the enterprise makes for more humane and better health care.

Here is the comment I posted on the Times' site:

Susan’s comment is right on target. A team ethic, and the recognition that “we’re all in this together” — patients included, goes a long way toward making the inevitable small mistakes a teaching moment rather than one step toward a disaster for the patient. And when disaster does happen, honesty is always the best policy. I represent patients in lawsuits against hospitals and doctors, and can say emphatically that the medical industry could greatly reduce its exposure to legal actions if hospitals and doctors would just respond with maturity and complete candor when mistakes happen.

One more change in philosophy could help reduce the toll of medical error. If patients were more involved at every step of the process, we could help nip a lot of disasters in the bud and get better care for ourselves and loved ones. There is much that we can do, starting with reading our own medical records. I just wrote a book about this called “The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.” Chapter One can be read at http://www.lifeyousave.com.

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July 6, 2009

Malpractice Payments Are Far Under 1% of U.S. Medical Costs

Malpractice payouts to injured patients and families declined for the third year in a row and amount to somewhere between 0.18% and 0.6% of U.S. medical costs, according to a new study from Public Citizen.

It would be great if improved patient safety was responsible for the decline, but that is highly unlikely, according to the consumer group's analysis, which said that the reduced payouts appear to be because fewer injured patients are being compensated.

The study also undercuts the idea that the system is glutted with large numbers of "frivolous" lawsuits. According to a press release from Public Citizen:

More than 80 percent of the money paid out for medical malpractice in 2008 was for cases involving "significant permanent injuries"; "major permanent injuries"; injuries resulting in quadriplegia, brain damage or the need for permanent care; or death, according to NPDB [National Practitioner Data Bank] reporting.

Despite the hysteria surrounding debates over medical malpractice litigation, experts have repeatedly concluded that several times as many patients suffer avoidable injuries as those who sue. The best known such finding was included in the Institute of Medicine’s (IOM) seminal 1999 study, "To Err Is Human," which concluded that between 44,000 and 98,000 Americans die every year because of avoidable medical errors. Fewer than 15,000 people (including those with non-fatal outcomes) received compensation for medical malpractice that year, and in 2008, the number receiving compensation fell to just over 11,000.

As an advocate for patient safety and author of a new book on how we can all improve the quality and safety of the health care we receive, I agree that the only humane way to reform medical malpractice is to take seriously patient safety and implement systematic improvements to cut the numbers of injuries.

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July 5, 2009

Geriatric Doctors Are Valuable Aids for Any Elderly Patient

Elderly patients are different. They are more sensitive to some drugs, less to others, have unusual presentations of common conditions, and otherwise are not that easy to diagnose and treat when the doctor is used to dealing with younger patients.

Bemoaning the lack of required geriatric training in medical schools, geriatrician Dr. Rosanne Leipzig gave this example in a recent op-ed piece she wrote in the New York Times:


Often even experienced doctors are unaware that 80-year-olds are not the same as 50-year-olds. Pneumonia in a 50-year-old causes fever, cough and difficulty breathing; an 80-year-old with the same illness may have none of these symptoms, but just seem “not herself” — confused and unsteady, unable to get out of bed.

She may end up in a hospital, where a doctor prescribes a dose of antibiotic that would be right for a woman in her 50s, but is twice as much as an 80-year-old patient should get, and so she develops kidney failure, and grows weaker and more confused. In her confusion, she pulls the tube from her arm and the catheter from her bladder.

Instead of re-evaluating whether the tubes are needed, her doctor then asks the nurses to tie her arms to the bed so she won’t hurt herself. This only increases her agitation and keeps her bed-bound, causing her to lose muscle and bone mass. Eventually, she recovers from the pneumonia and her mind is clearer, so she’s considered ready for discharge — but she is no longer the woman she was before her illness. She’s more frail, and needs help with walking, bathing and daily chores.

This shouldn’t happen.

Dr. Leipzig co-authored an article for medical educators listing 26 areas of competency in treating elderly patients that medical students should have to demonstrate before getting out of school; the list is nicknamed the "Don't Kill Granny" list.

For the rest of us, the takeaway lesson is that when we're advocating for an elderly relative with a new doctor, we need to find out if the doctor has deep experience in treating elderly folks, and if not, ask for a second opinion from a doctor who does. This can make a huge difference in quality of medical care -- and quality of health for our relatives' twilight years.

More tips on being a patient advocate can be found in Patrick Malone's new book, "The Life You Save."

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June 24, 2009

More Evidence for a Good Health Habit: Reading Your Medical Record

Evidence continues to pile up for why patients need to read their own medical records. A new study finds it is distressingly common for primary care practices, especially big ones, to fail to inform patients about abnormal test results.

The study was published in the Archives of Internal Medicine and was reported by Nicholas Bakalar in the New York Times. The study was also featured in Tara Parker-Pope's "Well" blog at the Times, which features a number of horror story comments by readers.

Overall, the study found seven times out of 100, abnormal test results were not conveyed to patients. In two large primary care practices, one in four abnormal test results were never mentioned to the patient.

Bottom line: Patients who don't hear back the results of their testing can never assume that no news is good news. People need to ask for a copy of their test results from either the doctor's office or the lab where the test was done.

Getting and reading your own medical records is Step One in the nine-step system I recommend for getting the best medical care, in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

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June 22, 2009

Who Pays for Medical Mistakes?

Several thought-provoking letters to the editor in the New York Times address this issue in the context of the current health care reform battle. One of the letters is from Patrick Malone and says:

To the Editor:

The reason malpractice is expensive and burdensome is not any unfairness in the system, but because too many patients are being hurt every day in a system that has failed to use basic safety checklists that have made injuries rare in other high-risk industries.

When the hospital industry’s own two-year pilot project to improve safety is called the Five Million Lives Campaign, we can see that the true urgency of reform lies in safety and quality.

“When the right care is delivered to the right patient at the right time, every time” is how Elizabeth A. McGlynn, a RAND Corporation researcher, defined quality care. And when we achieve that, malpractice lawsuits will no longer be the “burden” that some doctors perceive. Patrick Malone

Chevy Chase, Md., June 17, 2009

The writer is a lawyer and the author of “The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.”

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Another Times letter writer makes the point that we should have public report cards on hospitals and doctors that would give patients basic safety and quality information so we could make intelligent choices about who cares for us. That's an idea worth doing.

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June 19, 2009

The Role of Lawsuits in Enforcing Patient Safety

Patrick Malone had a recent blog post on the Huffington Post that discusses the "medical hit-and-run" -- preventable injuries that happen to patients where the doctors and nurses pretend nothing happened. The comments below his blog post are interesting.

All responsible attorneys would like nothing better than to reduce the number of lawsuits that have to be filed seeking accountability on behalf of injured patients. But the way to do that is with comprehensive safety programs that reduce the number of injuries.

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May 22, 2009

Is Our Health Care System Safer Today than 10 Years Ago?

A new report from Consumers Union says too many patients are still dying every year from needless errors. The report makes a number of proposals for how reforms could be instituted to improve patient safety. A starting point will be to change the health reform debate in Washington from one of just access and money to one focusing on quality and safety.

Nearly 10 years ago, the Institute of Medicine estimated that nearly 100,000 people died each year from preventable medical error. Has there been any substantial improvement in the last decade? The Consumers Union report says the frustrating answer is "We don't know" -- because systems to methodically measure and report harm are still not widely in place.

What should consumers push for?

* A national system with mandatory reporting of all infections acquired in health care facilities and other harms from preventable errors.

* More widespread adoption by hospitals of computerized systems for ordering and dispensing drugs to cut medication errors.

Those are the key steps called for by the Consumers Union report. Here's one more that I advocate in my new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst -- a "single payer" system. How would having a government-paid health care system help with safety? For starters, it would allow much easier monitoring of quality and errors. Instead of cobbling together data from dozens of insurance companies about how patients did at a particular hospital, all the data would be centralized and could be easily analyzed and compared. That way, problems with care could be more easily identified before tragedies occur.


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May 19, 2009

Military Families Discover How Lack of Accountability Is Dangerous to Health

Families of active duty military service members sometimes learn too late a shocking fact about the military medical care system: lack of accountability when someone has been injured or killed by malpractice. The latest victim is Cindy Wilson, an Air Force technical sergeant who bled to death after a cesarean section delivery due to an artery that was cut during the operation and not found until she had lost an entire body's volume of blood.

As described in an article by Bill Sizemore in The Virginian-Pilot, after the death of their 37-year-old daughter at Langley Air Force Base, Tommy and Connie Wilson learned about the "Feres doctrine." That is the name of the U.S. Supreme Court decision from 1950 in which the Court ruled that the military was immune from lawsuits concerning injuries to active duty service members caused by negligence of other service personnel, even if that malpractice was egregious.

George Washington University law professor Jonathan Turley was quoted in the article as calling the Feres doctrine "one of the most grotesque rules created in the history of this republic" - because it encourages lack of safety practices in military hospitals.

If military doctors injure someone who is not active duty military (such as a military family member or a veteran retired from service), the government is not immune from accountability. So if Ms. Wilson's baby boy had been hurt during the delivery in which she was killed, the family could have sued for his injuries. But because she was active duty, the government was immune from suit under the Feres doctrine. Because that difference doesn't make sense, a bill is now before Congress to lift the government's immunity from malpractice cases no matter who the victim is.

You can read more about legal issues surrounding military malpractice at a special section of Patrick Malone's law firm web site.

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April 27, 2009

"Back in the Hospital Again" -- A Result of Fragmented, Uncoordinated Care

Getting a loved one home from the hospital is always a relief for both patient and family, but the weeks immediately after hospital discharge are fraught with peril, as many families don't discover until the patient has to be readmitted for a new problem. This is especially common with Medicare patients: an alarming one in five Medicare patients are back in the hospital within thirty days, and one in three are readmitted within ninety days. Fully half of the non-surgical patients who have to be readmitted in the first month after going home had no followup visit with any doctor during that same month. That means the patients were basically set adrift to fend for themselves. These numbers come from an analysis published in the New England Journal of Medicine, as reported in an editorial in the New York Times.

Leaders in the health care field freely admit that hospital readmissions come about from poor discharge planning and inadequate communication with family members about what they need to do to keep the patient healthy. The president of the American Hospital Association said in a letter to The Times about the editorial: "Most unplanned readmissions can be traced back to our fragmented delivery system, and to the lack of social support programs for many elderly and sick patients."

What is the answer?

Family members who are assigned by hospitals to take care of a loved one at home need to be very clear on what they are supposed to do. Do not let a family member be dumped on your lap without a clear, written list of everything they need, including medications, therapies, and appointments for return visits. Family members need a lifeline they can call on when things don't seem to be going right.

The leaders of our health care system are talking about extending Medicare benefits so that nurse managers can coordinate the transition from hospital to home, or teams of caregivers can conduct house calls on recently discharged patients. These are promising ideas, but what is needed right now is for anyone who has a family member coming home from the hospital to speak up and insist on clear instructions and advice. Being forceful and clear can help the caregivers help you to make sure there is a well thought out plan and that you can realistically carry it out.

Patrick Malone's new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, has a chapter on how family members can become effective patient advocates when they have someone in the hospital. The chapter includes a list of key checkoff points that you need to understand when a loved one is discharged to your care. You need to have at a minimum:

* A written set of discharge instructions.

* A specific appointment with the doctor in charge for a followup visit.

* A list of bad things to watch out for, and the contact person to relay this information to.

* Written lists of all medications that need to be taken, when and how; plus all therapies that need to be done with similar detailed instructions.

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April 24, 2009

Three Things All Patients Need to Know

One of the true pioneers of modern medicine is Dr. Thomas Sarzl, who performed the first liver transplant and who developed many of the procedures that have made transplantation a safe lifesaving treatment for thousands of people.

Dr. Sarzl is still active at age 83. He was interviewed recently by another transplant surgeon, Dr. Pauline Chen, for her column in the New York Times.

From his many years of experience, Dr. Starzl gave three nuggets of advice to patients, which I am reprinting because I think he is right on target:

"As for the patients," he told Dr. Chen, "I would give this advice — I followed it myself. That is to get a practitioner of general medicine to take care of you, somebody who is not a narrow specialist. And have that person take care of yourself and the people you care for most, your family. The second is to be constantly learning so you can be informed and have some judgment about advice you are given. And then the third item would be to get a second opinion if some really significant thing happens that requires drastic therapy. Those decisions are so important that I think you should get a second opinion if you come to a point where you need the treatment required for cancer or transplantation or catastrophic indications."

My new book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," makes some of these same points. For example, Step Three of my "nine steps" says: "Team up with the best primary care doctor you can find." And Chapter 9 is titled: "The Second Opinion: Always Your First Choice."

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April 22, 2009

Legal Win for Maryland Victims of Malpractice

Victims of medical malpractice won a big victory in a Maryland court this week when a judge refused to reduce a jury's verdict in a wrongful death case to the artificial "cap" on damages set by the legislature.

The case is Semsker vs. Lockshin, in which Patrick Malone and Associates represents the family of a Montgomery County, Maryland attorney who died at age 47 from a highly curable skin cancer. Treatment of the cancer was delayed for years because of the combined negligence of Mr. Semsker's doctors. Click here for more case details and a link to Mr. Malone's closing argument in the trial, which was held in November 2008.

Four years ago, the Maryland General Assembly passed a statute under pressure from the medical lobby which cut in half the amount of money that a malpractice victim could recover in a wrongful death lawsuit from a doctor or hospital in "non-economic" damages. Those are general damages for the victim's suffering and the family's loss of companionship with their deceased loved one.

Now the judge who presided at the Semsker vs. Lockshin trial has ruled that the "plain meaning" of the statute as worded eliminated the cap from all cases except those in which the parties had arbitrated the case before suit was filed. Read more about the judge's decision in the Maryland Daily Record article.

This case is very significant for Maryland victims of medical malpractice, who are freed by this ruling from the onerous and unfair damage “cap” that acts as a regressive tax on the most injured patients.

Patrick Malone commented: “On the same day as the judge’s ruling, a report was released that shows Maryland ranks 45th among the 50 states in its rate of disciplining doctors who harm patients. Rather than trying to win special protection from the legislature to shield doctors and hospitals from accountability for the injuries they cause, the medical leaders of Maryland should clean up the disciplinary process so that the truly dangerous doctors are weeded out.”

The report Malone referred to was the annual ranking published by Public Citizen of physician license disciplinary boards. It can be accessed here.

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March 5, 2009

Patients Win, Drug Industry Loses, in Safety Case before Supreme Court

The U.S. Supreme Court has rejected a strong push by the pharmaceutical industry to win immunity from lawsuits filed by injured plaintiffs. In a 6-3 decision in the case of Wyeth v. Levine, the Supreme Court ruled that the Food and Drug Administration's approval of a drug's label does not mean that the manufacturer has no obligation to improve the warnings on the label if new information comes to the attention of the manufacturer.

This is a big victory for patient safety. The case will help doctors too, by keeping the pressure on the drug manufacturers to keep their product labels up-to-date so that doctors can be educated about the safest way to use drugs. Medical leaders, such as a group of editors of the New England Journal of Medicine, had filed "friends of the court" briefs urging the Supreme Court to take the side of the injured patient.

The heroic patient who pushed this case was Diana Levine, a Vermont musician who lost her arm and her career after being injected too rapidly with an anti-nausea drug called Phenergan. The drug is well known to cause terrible injuries if it gets into an artery. She contended, and the jury and the Vermont Supreme Court agreed, that the drug's manufacturer, Wyeth, knew about this risk and should have warned doctors on the label to avoid the "i.v. push" technique that carried a high risk of inadvertent injection into an artery.

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March 3, 2009

Questions Patients Must Ask Before an MRI or CT Scan

It's always intimidating to undergo an MRI scan or CT scan. The machines are loud and enormous and seem to swallow your body. For all the trouble and expense, patients deserve the very latest scanning equipment and should have their images read by only the most highly qualified doctors. Alas, there is a quiet scandal in the $100 billion/year medical imaging industry. Patients cannot count on the best unless they insist on it.

As quoted by Gina Kolata in the New York Times, radiology leaders say, in the words of one: "The system is just totally, totally broken." That from Dr. Vijay Rao, chair of radiology at Thomas Jefferson University Hospital in Philadelphia. One big problem is that insurers pay standard rates for scans, even if a scan on a 10-year-old machine produces a blurry image and results in patients undergoing unnecessary surgery or missing a diagnosis. There is also no financial incentive for scanning facilities to have the images interpreted by sub-specialists with more expertise in the body part being studied. But there is a big financial incentive for doctors to own their own scanning equipment, and that results in many unnecessary referrals for scans when the doctor's judgment about the patient's needs is clouded by financial conflicts of interest.

Wise patients should ask pointed questions before submitting to any imaging scan. Here is a list, adapted from Patrick Malone's new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

1. Is the scanning machine the latest generational available? If not, is there another facility nearby that has the latest generation? (In MRI scans for example, the stronger magnets on newer machines make for crisper images.)

2. Does the doctor who wants me to have this scan own the scanning equipment or the scanning facility? (If so, get an opinion from another doctor with no financial interest about whether you need the scan at this facility.)

3. Who will interpret the images? Is that doctor a sub-specialist in what's being studied? (Examples of radiology sub-specialties include musculo-skeletal, neuroradiology (brain and spine), abdominal and chest.) If not, can we get a second reading from a sub-specialist?

4. Is the scanning facility accredited by the American College of Radiology? (This ensures that basic standards are met, such as the technologist who runs the scanning machine being certified and the machine being regularly inspected for proper functioning.)

Involved patients will also want to sit down with the doctor and look at the images together. You will notice how much more detail comes out when the scan has been done on an up-to-date machine by well-trained personnel. In the New York Times article, you can see in a knee scan how the ligament is blurry on the left-side image but comes out clearly in the image on the right -- a slanting striated structure that connects the middle of the top of the tibia to the back of the femur.

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January 11, 2009

Patients Benefit from Getting Second Opinions

When a doctor knows that his patient would receive better care elsewhere, should he inform the patient and send him to another provider? While this question is yet to be settled among bioethicists and physicians themselves, authors of an article published recently in the journal, Public Library of Science Medicine, think doctors have an ethical obligation to tell patients that better care is available to them, according to the New York Times’ Denise Grady.

Research has shown that facilities that perform high volumes of a certain procedure do it better than those that perform the procedure less frequently. The difference is substantial, especially in surgeries of pancreatic and esophageal cancer, although “the experience of the surgeon and the whole medical team [is] important in any major cancer surgery.”

Only a few courts around the country have decided whether doctors have a legal duty to inform patients that another doctor might have more skill and experience performing a planned surgery. One of them is Maryland's highest court, the Court of Appeals, thanks to a client of Patrick Malone named Billy Boone who suffered brain damage after an ear surgeon punched a hole into Mr. Boone's brain.

Mr. Boone's case shows that surgeons' skills make a difference in much more than cancer surgeries. The Maryland Court of Appeals decided that Boone had a legal right to know that his surgeon did not have extensive experience doing the ear surgery that Mr. Boone underwent.

Mr. Boone had an outpatient surgery in January 2000, to remove a benign growth from the mastoid cavity behind his left ear. Dr. Seth Goldberg, an ear nose throat surgeon, performed this surgery, called a mastoidectomy. Seventeen years before, Mr. Boone underwent the same procedure, in which another surgeon drilled out the same mastoid to remove a cheesy growth of skin debris called a cholesteatoma. Unknown to Boone, the surgeon had become lost at one point during the procedure and drilled a hole in the skull just above the mastoid, near the bottom of the brain's temporal lobe. But nothing happened to his brain, which was protected by the tough fibrous shell below the skull called the dura. Years later, when Dr. Goldberg prepared for the new surgery, he took some CT scan pictures of the bone anatomy and saw the pencil-sized hole in the side of the skull.

Dr. Goldberg's surgery seemed uneventful, but after Boone went home, he developed a short-term memory problem that ruined his ability to do carpentry; worse, he developed a problem controlling his temper that unleashed itself at stressful moments on whoever happened to be nearby. Later, his neurologist explained to the jury that Boone's outbursts could be traced to injury in the limbic system that modulates emotional response.

A CT scan showed that a hole had been poked from the pre-existing skull defect into Boone's brain. A small pocket of air could be seen in the temporal lobe, surrounded by a pool of blood. But it wasn't just air in the brain – it was something slightly denser than air, likely surgical gelfoam which could have made its way there only if Dr. Goldberg had pushed it in to try to stop bleeding after he punched the first hole.

The key moment for Mr. Boone came not in the surgery but a month before, when he sat down with Dr. Goldberg to go over the planned operation. Goldberg never volunteered the key information: that with the hole in the skull from the prior surgery, his surgery would be that much more difficult, could even result in an injury to the brain, and Mr. Boone might benefit from consulting with someone who regularly did "revision mastoidectomies," the technical term for this second go-round. A general ENT doctor who advertised his specialty in facial cosmetic work like nose jobs – he named his professional corporation the "Aesthetic Facial Surgery Center of Rockville" – Goldberg only had done occasional revision mastoid surgeries. His operation on Boone proved he wasn't up to the job. On the witness stand, Goldberg admitted he hadn't discussed with Boone the hole in the skull, the chance of brain damage, or the availability of sub-specialists called neurotologists. For Billy Boone, the jury's vote in his favor, and the Court of Appeals' affirmance of the award, gave him some vindication. For other patients, his win makes it easier to demand the information you need to make a sensible selection among surgeons. Of course, if you asked Billy Boone, he would trade in legal vindication for a healthy brain any day. It's too late for him, but not for the rest of us.

(Click here for more information on the Boone case, and follow this link to Mr. Patrick Malone's closing argument.)

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December 19, 2008

Error Rates Mean Patients Should Carefully Select Colonoscopists

Colonoscopy is widely known as a powerful screening/early detection test for colorectal cancer, capable of preventing, or so it was thought, up to 90% of cancers. However, recent studies show that colonoscopy misses many cancers, according to the New York Times in an article by Gina Kolata.

A newly published Canadian study documents the low success rate of colonoscopy in picking up cancer in the right side of the colon, an area where 40 percent of cancers occur. In the left side of the colon, the area directly above the rectum, where cancers should be easier to detect, colonoscopy missed a third of occurrences.

Does that mean patients should dismiss colonoscopy as an ineffective test? Quite the contrary. Although colonoscopy is now found to prevent only 60% of colon cancer deaths, it’s still “a good test,” said Dr. Ransohoff, gastroenterologist at the University of North Carolina. In the Times article, Kolata points out that colonoscopy works relatively well, in contrast with other screening tests: Mammograms prevent 25 percent of breast cancer deaths and the Prostate-Specific Antigen (PSA) test has not been proven to prevent prostate cancer deaths.

In addition, patients can help maximize colonoscopy’s effectiveness by doing their homework. Dr. Douglas Rex, Indiana University’s director of endoscopy and professor of medicine, said that polyps in the colons may be obscured if patients did not thoroughly cleanse the bowels. Taking half of the laxative the night before the test and the other half in the morning – a procedure not always done – can help clear out patients’ systems and improve the visibility of the inner wall of the colon.

Researchers also urge patients to seek out the best colonoscopists who are skilled in performing the test consistently. Patients should ask how many colonoscopies the doctor does each year (a good volume would be three to four colonoscopies a day), what percent of those turn up polyps (it should be around 25% in men and 15% in women; much lower suggests that the doctor is missing some), and how long the scope is in the colon (colonoscopists should take at least eight minutes to withdraw the endoscope; too short a time suggests a hurried look).

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December 18, 2008

Abnormalities in Scans Can Be Misleading

A torn meniscus that shows up on the MRI scan may not be the reason why your knee is hurting. For Cheryl Westein, who demanded an MRI and saw a torn cartilage on the scan, the culprit behind her painful knee was actually arthritis. Gina Kolata in a New York Times article reports recent scientific findings that further support what many physicians already believe: radiological imaging is a presurgical tool and “does not help with a diagnosis.”

Dr. Felson and Dr. Modic, in their separate studies, found that abnormalities in scans are common and are not conclusive evidence of a diagnosis. For example, 60 percent of healthy people who do not complain of back pain will turn out to have degenerative changes in their spines. Many abnormalities go away on their own in a few months, requiring no medical intervention.

Relying on scans for diagnoses can lead referring physicians to recommend “unnecessary or sometimes even harmful treatments, including surgery.” If the root cause of the knee pain is arthritis and not the torn meniscus, the pain will return even after a surgery repairing the meniscus, as the arthritic bones continue to wear down the cartilage.

It is important for patients to know that getting radiological imaging is often not the best way to find out what is causing their discomfort. More importantly, since scans reveal abnormalities that may not be “catastrophic findings”, doctors could be misled to recommend harmful regimens that result in extra expenses.

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December 2, 2008

Tired Resident Doctors Prone to Error

Despite reforms in medical training, many resident doctors are still sleep-deprived and therefore more likely to make mistakes than well-rested doctors in training, according to an Institute of Medicine study, as reported by Tara Parker-Pope of the New York Times.

In 2003, the Accreditation Council for Graduate Medical Education capped resident doctors’ working hours at 80 per week. Before that, young medical school graduates could average 110 hours a week. But even now, with the hours capped at 80 hours a week, the Institute of Medicine report reveals that there are common violations of the 80-hour cap, although residents rarely complain. Eighty hours itself is a demanding routine even without the excess hours.

Consequences of sleep deprivation are many – including irritability, impaired judgment, and inability to concentrate – and each of these can debilitate the doctors in performing and thinking through their tasks. For better patient care and the health of the resident doctors, the Institute of Medicine recommends allowing an uninterrupted nap time for up to five hours.

It's not clear from this latest study how reform will be instituted and who will pay for it. Leaders in the field acknowledge that it will be expensive to put in place the same kind of mandatory rest periods that workers in other industries, like truck drivers, have.

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November 17, 2008

Legal Case Highlights Need for Annual Skin Checks to Prevent Deadly Cancer

A recent medical malpractice lawsuit prosecuted by Patrick Malone & Associates for the victim of a delayed diagnosis of skin cancer highlights the need for annual skin checks by a qualified doctor. Anyone who is fair-skinned, sunburns easily, or has a lot of moles on their skin should see a dermatologist or a good primary care doctor for annual skin checks. These can be part of a routine physical exam. The doctor should measure and do sketches of the moles' location and appearance on your skin, or should take good photographs. A change in a mole is one of the key indicators of potential for malignant melanoma, a skin cancer which is deadly once it gets into the bloodstream but is 100% curable when still confined to the skin. Patients and their families often don't notice subtle changes in a mole -- getting bigger, changing color, etc. -- that health care providers can pick up.

In the legal case of Semsker v. Lockshin, a benign mole on the patient's lower back turned into a deadly melanoma over an eight-year period, during which time the mole's presence and change in size was documented by the dermatologist. The lawsuit alleged the dermatologist should have removed the mole two years before it finally was removed, when it had already invaded the patient's lymph nodes. Mr. Semsker died 14 months after the diagnosis.

In their defense of the malpractice lawsuit, the dermatology practice of Norman Lockshin, M.D., P.A., contended that they would have told the patient to get skin checks even more often than he was (every few years from either his primary doctor or his dermatologist), although this recommendation was not documented in their records.

Regardless, every patient needs to know about the dangers of melanoma and the need for regular skin exams. Exams should focus on the ABCDE's of skin cancer: A for Asymmetry of the mole; B for irregular Borders; C for variegated Color or unusual color in the mole; D for diameter greater than 6 millimeters, and E for Evolution or changes in the mole's size, shape or color.

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October 30, 2008

Image Quality of Scans: A Mystery?

Patients who go in for MRIs are often told nothing is wrong, when in fact the scan is of poor quality and so misses the problem, as Gina Kolata's story demonstrates.

Doctors all agree that it is a good idea to get MRIs and other scans done at centers accredited by the American College of Radiology. But, they caution, there is a wide range of quality among those centers. Quality depends on the quality of the imaging coils put around the body part being scanned, the skill of the technicians and the expertise of the doctor reading the image:

At Massachusetts General Hospital, for example, Dr. Gazelle said, “musculoskeletal M.R.I.’s are read by someone who does musculoskeletal imaging every day” — and not “by someone who reads chest M.R.I.’s one day and musculoskeletal M.R.I.’s the next.”

Dr. Forman says it pays to check the credentials of a center’s radiologists.

“If you say, ‘Who will be reading my scan?’ and they say, ‘One of our radiologists,’ you don’t go to a place like that,” he said. (I checked the Web site of the first center I went to. The radiologist who read my scan was a generalist with no special training.)

It also pays to ask the radiology center whether it has the latest generation of scanners. The stronger the magnet in the MRI machine (the "M" in MRI stands for Magnetic), the higher quality the image it produces.

Misreadings of MRI scans can cause tragic, preventable injuries to patients, as our firm's experience has shown.

The other piece of advice we can extract from the article is not to place absolute faith in a first-time scan that turns out negative. If the scan is negative and you feel that something is still wrong--like there is still severe pain--it is worthwhile to get a second opinion.

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September 28, 2008

Hospital Patients: Know The Color of Your Bracelet

Hospitals have long used color-coded bracelets as shorthand to communicate patients' needs to doctors and nurses. For instance, a purple bracelet might indicate that a terminally ill patient does not wish to be resuscitated in the event of heart failure.

Now there is a movement to standardize bracelets, preventing confusion when a health care worker moves from one hospital where (for instance) yellow bracelets mean "do not resuscitate" to another where they indicate an allergy to peanuts.

Bracelets have other pitfalls--for instance, a patient might not wish to advertise a certain desire or condition to visiting loved ones. And children have a tendency to take them off and trade them with each other.

The important thing, if you or a loved one is staying in a hospital, is to know what the colors of your bracelets mean and be prepared to tell doctors and nurses about it. If a doctor or nurse comes up to you or your loved one and begins doing something you don't understand, do not hesitate to ask about it--not only is it good for you to know these things in general, but they may be acting on a misinterpretation of the colored bracelet.

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September 8, 2008

The Biggest Risks You Face in the Hospital

Forbes Magazine has an informative article on the frequency of hospitals making mistakes while caring for patients, pointing out that 1.5 million Americans fall victim to such errors every single year.

Some of these errors occur through sheer carelessness: for example, 100,000 people a year die from "superbugs," bacteria that are resistant to available antibiotics. Infections from these superbugs can frequently be prevented by hand-washing. Yet other errors are the system's fault and not the fault of any individual. They occur because of overcrowding and the consequent inability of doctors and nurses to spend sufficient time with each patient.

The article also cites an Auburn University study showing that hospitals administer the wrong drug one time out of five. The dosage of the drug is another common source of error. A famous recent example of a drug error is from last November when actor Dennis Quaid's newborn twins were given 1,000 times the intended dose of the blood-thinner heparin. Luckily the hospital detected the error before permanent damage was done.

What is the bottom line? There are no magical solutions, especially since most of these problems are systemic. As a doctor quoted in the article says: "If you're sick, the best way to avoid getting sicker is to take charge of your care." Asking questions and being unafraid to make demands is the most any individual patient, or their loved ones, can do to reduce risk of error.

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August 31, 2008

Hospital Death Rates Available Online

USA Today has published the government's best estimates of death rates due to heart attack, heart failure and pneumonia for every American hospital for the past two years. The article has links to the pages where the death rates are published. As USA Today points out, this information was previously inaccessible to most patients.

From the article:

Now anyone with access to a computer can directly compare a local hospital with the one across town to see how it stacks up against the biggest medical institutions nationwide.

Death rates from heart attack, heart failure and pneumonia are widely viewed as yardsticks of a hospital's overall performance.

Using this resource is one good way that people can get the information they need to make sure their health is in the best hands.

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August 16, 2008

Common Testing Mistakes at the Family Doctor's Office

A new study from the journal Quality and Safety in Health Care, and discussed in the NY Times Well blog, reveals common testing mistakes by primary-care doctors. Of course, the same kinds of errors can happen in hospitals and other health care settings.

Out of close to the 1,000 mistakes experienced by 590 patients, the following testing mistakes were the most common:

-13% involved ordering the wrong test or failing to order a test

-18% involved performing the right test, but doing it improperly

-25% involved delays in getting tests back from the laboratory, failure to get the tests back at all, or errors on the results report

-7% involved failing to follow up with patients after receiving results from the laboratory

-75% of the mistakes caused the patient to suffer (through delays in proper treatment, greater expense, physical pain or worsened overall health).

What can a patient do about this? A possible solution would be to carefully ask and write down what specific test your doctor has ordered for you. Ask when the results of the test are expected from the lab. Then make sure you call to follow up after the doctor's office should have received the results. Read the results report, if you can get hold of it, to see the name of the test and make sure that the results are for the same test that was ordered and performed. All of these things might help reduce your risk. Calling the doctor to follow up is probably the most important item on the list, as Dr. Lamberts says in his quotation in the linked NY Times blog post.

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July 19, 2008

Medicare Won't Pay for Injuries Caused by Hospital Neglect

Starting October 1, 2008, Medicare will no longer pay for eight hospital-acquired conditions that could be prevented if hospitals followed the proper guidelines.

Those eight conditions are bed sores, objects left inside the patient during surgery, falls that occur when the patient is in the hospital, blood incompatibility, air embolism, mediastinitis (infection of the area between the lungs, which can happen after a heart bypass surgery), catheter-associated urinary tract infections, and certain bloodstream infections. In addition, several other conditions have been proposed as additions to the list.

The purpose of this change is to provide an incentive for hospitals and health care providers to avoid errors and prevent neglect of patients. If both Medicare and the patient refuse to pay for treatment of a hospital-acquired condition, then the hospital is stuck with the costs, and most hospitals would obviously wish to avoid that.

This is a long-overdue incentive for hospitals to reduce the incidence of these events and injuries which should never happen.

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July 15, 2008

Adults Slack on Vaccinations

Laura Landro, in her column "The Informed Patient," discusses the problem of adults neglecting to get vaccinated for new illnesses. Not only that, but adults forget or are unaware that some childhood vaccinations lose efficacy after some time and need to be re-done. Skipping pre-travel vaccinations is also a common error.

Part of the problem is insurance: not only is vaccination for the very young more likely to be encouraged, but it is also more likely to be covered by insurance providers.

The whole column is worth a read, but here are some disturbing statistics Landro cites:

-only 2.1% of adults are vaccinated for tetanus, diphtheria and whooping cough, despite the existence of a combination vaccine for all three.

-only 1.9% of adults have been vaccinated for shingles. The shingles vaccine is recommended for all adults over 60.

-only 10% of women from 18 to 26 have received the vaccine for human papillomavirus, which can lead to cervical cancer, and which most insurance providers will cover.

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May 23, 2008

Disclosure Means Fewer Lawsuits

A recent New York Times article discusses how doctors, patients and lawyers are discovering that apologizing for medical errors often helps both doctor and patient. The patient gets closure and a sense of acknowledgment, and will receive a settlement more quickly. The doctor does not have to suffer the psychological pressure of denying any wrongdoing or cutting off contact with the patient and can avoid a lawsuit.

As the article notes, conventional wisdom has long held that a doctor should say absolutely nothing in the event of a medical error. Disclosure, it was believed, would only make the doctor and the hospital liable. But empirical evidence suggests otherwise:

Despite some projections that disclosure would prompt a flood of lawsuits, hospitals are reporting decreases in their caseloads and savings in legal costs. Malpractice premiums have declined in some instances, though market forces may be partly responsible.

At the University of Michigan Health System, one of the first to experiment with full disclosure, existing claims and lawsuits dropped to 83 in August 2007 from 262 in August 2001, said Richard C. Boothman, the medical center’s chief risk officer.

“Improving patient safety and patient communication is more likely to cure the malpractice crisis than defensiveness and denial,” Mr. Boothman said.

What most patients want in these cases is not the largest settlement possible but some sort of acknowledgment, honesty and respect. And doctors, hospitals and patients all want to settle these matters quickly without long, drawn-out courtroom battles. Full disclosure policies are a promising new way of achieving these goals.

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April 25, 2008

Protecting Yourself from Medical Error

Christina Laun at RN Central has made a helpful list: 25 Tips to Help Protect Yourself from Medical Errors.

Reading the entire list is a good idea. But many of the items on the list can be boiled down to two principles: 1) be an active participant, and 2) don't be afraid to seem entitled or pushy in demanding knowledge of what is going on. Don't be afraid you're annoying your doctor by asking questions, for instance. Speak to every member of your surgery team and make sure they know what they're doing--do not simply trust, and remember that there is no reason to feel ashamed or embarrassed about asking questions.

Furthermore, bring family or friends to support you, if you can. If you're ill, you may not be able to do the things on the list yourself. Having someone to ask the questions you don't think of and notice the things that you don't notice is an invaluable asset.

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March 28, 2008

Potential Dangers of Arbitration Agreements

Vesna Jaksic has an interesting article on Law.com on potential problems with binding arbitration agreements between doctors and patients, wherein patients sign away their right to a jury trial.

From the article:

Binding arbitration agreements between doctors and patients -- in which patients waive their right to a jury trial -- are becoming more common, a trend that could put patients at a disadvantage if medical malpractice disputes surface, attorneys warn.

A growing number of physicians, nursing homes and health care institutions are asking consumers to sign these agreements before offering services, said Stuart Ratzan of Miami's Ratzan & Rubio.

Some states have passed or are trying to pass legislation that would limit how these agreements are used. For instance, an act waiting for congressional approval in Washington D.C. would require (among other things) that the costs associated with arbitration be disclosed in the arbitration agreement. This is important because the patient must pay for arbitrators to do their job, whereas they do not have to pay for judges and juries.

It would be particularly disturbing if these agreements became common enough that people cannot get medical care without signing one.

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March 27, 2008

Medical Mistakes: A Doctor's Point of View

Tara Parker-Pope has an interesting interview with Dr. Gary Brandeland about how doctors deal with medical mistakes. Dr. Brandeland's obstetrical patient died due to someone else's error, but Dr. Brandeland still suffered from guilt over it. In addition to the interview with Ms. Parker-Pope, he has an essay describing the incident.

One of Dr. Brandeland's insightful comments is that mistakes tend to be more systemic than individual: nursing shortages and hospitals cutting back on staff to cut costs are factors that lead to overworked or confused nurses, which in turn lead to medical errors.

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February 8, 2008

Depressed Doctors More Likely to Make Mistakes

A depressed medical resident is six times more likely to make a medication error than one who is not depressed, according to a new study published in the British Medical Journal.

The study's findings are not absolutely conclusive, as the authors note. But the common problem of medication errors is often correctly attributed to the brutal schedule imposed on most medical residents. The authors advocate further study of doctors' working conditions with an eye to improving them.

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January 16, 2008

Another Study Confirms Lack of Reporting of Medical Error

Doctors are unwilling to report colleagues for making medical mistakes, as we have discussed before. A new study from the University of Iowa shows that a significant number do not report their own, either, even though they believe they should.

Lauris Kaldijan, lead researcher for the study, had this to say about it:


Kaldjian said in an interview that he was encouraged that most of the doctors believed reporting errors was an important way to improve health care quality. But he said he was troubled by the fact that fewer than half of them would have reported the hypothetical error if it didn't cause problems. He said doctors and other medical workers should take their cue from the airline industry, which encourages pilots to report every error so it can be analyzed for possible systemic flaws.

As the linked article notes, there are several positive aspects to this study. For instance, awareness of the problems caused by medical error has increased, and belief that errors should be reported is strong.

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January 11, 2008

U.S.A. Has the Most Preventable Deaths

Out of nineteen industrialized nations, the U.S. has the most deaths that could have been prevented by access to timely, effective medical care.

Ellen Nolte and Martin McKee of the London School of Hygiene and Tropical Medicine performed the study, looking at deaths before the age of seventy-five caused by numerous diseases and complications. They found that France performed the best by this measure--though France, and other countries that ranked higher than the U.S., spends less money on health care than the U.S. does.

Not only was the U.S. the worst in these rankings, but we Americans are also ranked four places lower than we were in the last study (which covered 1997 and 1998). We are getting worse and spending more money.

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January 4, 2008

The Pain of Medical Error: Not Just Physical

Guilt, fear, and further isolation plague families of victims of medical error, says the New England Journal of Medicine.

Why guilt? Because families feel like they should have kept a closer watch on their loved one, and regret the trust they placed in the health care institution or its workers. This guilt persists even if the family took reasonable precautions--for instance, the authors of the article discuss a case where a patient was given morphine and died of kidney failure despite the fact that his family repeatedly told doctors and nurses that he had sickle cell anemia. The family often feels inadequate for being unable to watch the patient twenty-four hours a day.

They also feel fear: fear of retribution, fear that health care workers will neglect or compromise their loved one's care if they make some sort of formal complaint. This is particularly true of people in disadvantaged and disempowered sections of society.

Their emotional turmoil is often compounded by the reactions of the health care workers, who will often isolate the patient's family after realizing their error. This leads to further pain and may even lead to further medical mistakes:

Guilt persists in the daughter of a woman who died after a series of errors culminating in a missed case of pneumonia. Although the daughter is a nurse, she could not gain entry into her mother's circle of clinicians, who closed ranks after the errors occurred. "The nurses were ruder to me than you can ever imagine, and the doctors wouldn't tell me anything," she said. "They looked at me like I was a dumb little girl. I became so addled that I couldn't act decisively and get her out of there to another hospital. I'll never get over my guilt."

This isolation comes at a time when, as the authors point out, patients most need someone to communicate with them on a personal and human level. They suggest that honest, direct communication--without condescension, buck-passing or hedging around to avoid lawsuits--is the best way to keep the patient safe as well as feeling satisfied with the care he or she has received.

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December 5, 2007

New Study: Doctors Reluctant to Report Errors

A new study shows that although an overwhelming majority of doctors believe they should report colleagues who make serious medical errors or otherwise violate professional standards, most do not actually do so.

This hesitance to report colleagues is understandable. But it makes detecting, tracking and studying medical error very difficult.

The senior author of the study, Dr. David Blumenthal, says that he is optimistic because most doctors support existing standards and the lack of report is not due to disagreement over ethical obligations. He also notes that doctors who practice in groups of three or more are more likely to report than other doctors.

Another interesting result of the study is that one-third of doctors admit that they would order an unnecessary MRI. Given the costs and the possible side-effects of unnecessary testing, this fact may have consequences.

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November 28, 2007

Hospital Commits 3rd Brain Surgery on the Wrong Side of the Head

Rhode Island Hospital has, for the third time this year, done a brain surgery on the wrong side of the patient's head.

The hospital has been fined $50,000 and has received a reprimand from the state Department of Health. In this most recent instance, the patient was 82 years old. Fortunately, the patient was unhurt by the mistake. However, in one of the previous instances of this mistake at this hospital, the patient died as a result.

Rhode Island Hospital has said that it will be conducting a review of its procedures and implementing reforms. One such reform would be to allow nurses greater power in ensuring that procedures are followed correctly. Another would be to mandate better verification of surgery plans, which would require better communication between surgeons and other doctors. These reforms highlight a major factor in averting medical errors: teamwork. The multiple healthcare professionals involved in taking care of a patient need to be empowered to speak up if they see something going wrong. They also need to know what the others are doing, and to make sure that they are not acting contrary to the recommendations and instructions of other healthcare providers. Performing a surgery on the wrong side of the head is only one possible thing that could go wrong in the absence of communication. Another example would be giving a patient medications that, combined with medicine the patient is already taking, could cause problems. Such errors can be minimized through proper communication between healthcare professionals.

For more information: When Surgeons Cut the Wrong Body Part

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September 10, 2007

Helen Haskell Interview

Imagine having to go to the hospital tomorrow for a procedure that the doctors tell you is simple and practically risk-free. You’re not worried. Your loved ones are not worried.

The trouble is, the procedure ends up killing you. Through some mistake or miscommunication or broken link in the healthcare system, you die while receiving what ought to be a low-risk medical treatment.

This scenario is not nearly as uncommon as it should be. However, there is a rising tide of activism and reform coming from those who suffer such incidents. Consumers Advancing Patient Safety (CAPS) is one of the many groups involved in such work. Among their other activities, they invite those who have suffered through breakdowns in the healthcare system to share their stories with CAPS so they can reach a wider audience and help each other to understand that what happened to them was not a fluke but an indication of systemic flaws.

The most recent such story CAPS has published is an interview with Helen Haskell, who in 2000 lost her 15-year-old son Lewis Blackman to a medical error caused by an inappropriate medication given during a relatively routine surgery.

The chief point to take away from Helen Haskell’s story is that there are multiple levels of doctors in a hospital. Lewis was mostly treated by residents, who are fully trained doctors in the sense that they have graduated from medical school, but are still considered in training for whatever specialty they have chosen. Care by residents is standard and safe—but when Helen wanted to speak to a more senior doctor, she was unable to do so. Hospital bureaucracy can get in the way of patients getting the information they need. In addition, patients can often get confused about who is treating them and at what level of training that person is: is he or she a nurse, or a medical student, or a resident, or an intern, or a fellow? It is not always easy to tell.

Another key point is the concept of “rapid response teams” that can be called in if a patient or family member believes that something seriously wrong is happening. Helen Haskell believes such a team would certainly have saved her son’s life. In any case, it would give patients recourse if their concerns are ignored.

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August 10, 2007

Protecting Yourself from Medical Errors

Patients often want to know what they can do for themselves to prevent medical errors. Often they feel helpless, ignorant and confused when they are seeking health care.

Thanks in part to the Internet, there are now sources that remedy this situation by providing information and helpful suggestions. Many of these various suggestions boil down to certain basic principles.

One crucial thing is to make sure each of your healthcare providers knows what you've told the other ones and what they are doing to you. Your primary care physician should know what you've told your specialists and what those specialists are prescribing for you. Each specialist should know what every other specialist is prescribing for you, and the reasons for this, and what your state of health is in general. This way, the doctor prescribing something for your leg won't accidentally give you something that could harm your heart or that you might be allergic to.

Another important general principle to keep in mind is not to be afraid to ask questions. Ask about what exactly your medications will do, if there are any alternative treatments, if there are any side effects, or about anything else that strikes you as important to know. Ask if anything confuses you about how long you should be taking a certain medication, or how often, or what activities might or might not be acceptable while you are taking it.

Do not worry about annoying your doctor or sounding stupid. Your doctor is there to look after your health and to help you understand what you should be doing, not simply to give you orders. Asking questions becomes doubly important when you are staying in a hospital. Do not hesitate to question nurses and other caregivers about what exactly is happening with regards to your care.

Another good thing to do is take advantage of all the information that is available to you in books, in magazines and on the Internet. Through these sources you can find expert answers to many questions--though these do not substitute for the attention of a medical professional.

Other places to find information on this: The Family Doctor, Medical Errors: Tips to Help Prevent Them.

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