Patient Safety Blog

That question is now on trial in a small west Texas town, where a nurse stands accused of a felony for reporting a doctor whom she thought was guilty of malpractice on patients. Even if the nurse is acquitted, the case could have a chilling effect on nurses' willingness to act as whistle blowers when they see sub-standard medical care.

The defendant, Anne Mitchell, R.N., was indicted for "misuse of official information," a felony, because she reported to the state medical board her concerns about the quality of care delivered by Dr. Rolando G. Arafiles Jr.

Nurse Mitchell worked in quality of care issues for the Winkler County Memorial Hospital where both she and Dr. Arafiles worked.

The case is being followed closely by the Texas Nurses Association, which raised money for the defense of Ms. Mitchell. Click here for case updates.

When the indictment was first reported last summer against Ms. Mitchell and a second nurse (whose charges were recently dropped by the local prosecutor), the American Nurses Association also spoke out strongly.

“ANA wants Winkler County to know the world is watching – we will be monitoring this case closely in the hope that the apparent abuse of prosecutorial discretion will be corrected,” said ANA President Rebecca M. Patton, MSN, RN, CNOR. “It is outrageous to file criminal felony charges against these nurses based on allegations that they raised concerns over a physician’s actions. This undermines one of the basic tenets of the nurse’s Code of Ethics – nurses have a duty to advocate for the health and safety of their patients, and that is what these nurses were doing.”

The New York Times detailed Ms. Mitchell's concerns with Dr. Arafiles' practices in a recent article by Kevin Sack, which also discusses the bigger picture for quality of medical care.

Nurses are traditionally seen as patient safety advocates. That role needs to be nourished, not threatened, for the sake of all patients.

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Posted In: Health Care Reform

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Once they understand what "tort reform" tries to do to victims of medical malpractice, most fair-minded people agree it's just not fair to put artificial legislative limits on the amount of money a patient can recover in a lawsuit. Such limits hurt the most devastated victims: People with spinal cord injuries, brain injuries and similar catastrophic harm are the ones who typically qualify for multi-million dollar damages to set their lives back on track. In the few cases when juries are more generous than the facts warrant -- an occurrence that is statistically rare -- the trial judge and the appeals court judges have the power to roll back the number to something reasonable.

So what does this have to do with judicial elections?

The U.S. Chamber of Commerce has poured millions of dollars into a multi-year campaign to convince the public there is an epidemic of frivolous lawsuits out there -- something no independent objective body has ever found. The reality is that the system works: the only cases that result in big damage awards are those where independent-minded judges have found plenty of evidence to support the jury's award of money, and if they don't, the jury decisions are thrown out.

The Chamber also has been busy putting money into electing judges who take a more aggressive, pro-business, anti-consumer stance. And the U.S. Supreme Court's recent decision in the Citizen United case unleashed all restraints on corporate contributions to political candidates of all kinds, including judges in those states where judges stand for election. So the Chamber can be expected to ratchet up its judicial elections campaign accordingly.

The Illinois Supreme Court this week adhered to its past precedent and ruled that that state's legislative damages cap violated the "separation of powers" between the judicial branch and the legislative branch. The case is called Lebron v. Gottlieb Memorial Hospital. Historically, it has been up to the courts to decide on a case-by-case basis how much money a particular claimant should be paid, and artificial damage caps imposed by the legislature invade that judicial power.

One of the Chamber's fair-haired judges is Illinois Supreme Court Justice Lloyd Karmeier. The Chamber paid $2.3 million to help get him elected to the high court's bench in 2004, according to the Center for Justice and Democracy.

Justice Karmeier dissented in the Lebron decision and would have let the damage cap law stand. He may have done so for reasons quite apart from politics. In fact, his dissenting opinion quoted extensively from President Obama's health care reform speech last fall, in arguing that legislatures, not judges, need to set health care policy. True enough, as far as it goes.

What's unfortunate is the continued politicization of all branches of the American government, and the Citizen United decision by the U.S. Supreme Court will make it worse, because the court gives corporations the power to put a very large thumb on one side of the judicial scales of justice-- one elected judge at a time.

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Posted In: Medical Malpractice

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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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Posted In: Medical Error , Medical Malpractice , Standard of Care--Hospitals

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The best measure for understanding what Americans spend on health care is the health care share of GDP (Gross Domestic Production). When that share crossed the 10 percent thershold in the early 1980s, plenty of economists sounded the alarm that ruin was ahead if we couldn't somehow make that share stable, so the rise in health care spending kept pace with the economy but didn't take a bigger and bigger piece of the pie.

So how are we doing? Health care's share of the economic pie went up to 17.3 percent of GDP in 2009, according to a new report in the respected journal Health Affairs. It's the biggest single-year increase since 1960.

The Wall Street Journal's Health Blog crunched some numbers and reported:

The U.S. spent $2.472 trillion on health care last year, according to a paper out today in the journal Health Affairs. That’s $282 million an hour.

Health spending as a percent of GDP — a key metric that shows how much of all U.S. spending goes to health care — rose from 16.2% in 2008 to 17.3% in 2009, far higher than any other industrialized country. That’s the largest one-year increase since 1960, when the feds started closely tracking national health expenditures.

The figure went up so much because health spending continued to rise, even as the overall economy shrank. The aging population accounted for a small part of this rise, but two other factors were more important: rising prices and increasing use. Health-care prices rose by 3.2% in 2009, according to the Health Affairs paper, significantly faster than prices rose for the overall economy. Utilization, which includes both volume and intensity of health-care services, rose by 1.5%.

The share of health-care spending paid for by the government (through programs such as Medicare and Medicaid) is also rising, and is projected to cross the 50% threshold soon.

The share of the economy for health care will be close to 20 percent within the next 10 years, according to government forecasters.

These sobering numbers show the urgency of "bending the cost curve down," as the pundits like to say. Unfortunately the urgency of reforming the safety and quality of health care has taken a far back seat to the money discussion. They actually are compatible goals. One thing we've learned in the health care reform debate is the huge overspending in health care caused by widespread use of new technologies before their benefit is proven, driven in part by conflicts of interest by those pushing the new technologies.

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Posted In: Accessibility of Healthcare , Health Care Reform

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To avoid becoming a malpractice victim, and to get the highest quality care, a useful safety credential for patients to look for in researching hospitals is called NSQUIP.

NSQUIP stands for the National Surgical Quality Improvement Program, developed by the American College of Surgeons. It was adapted from an error-reduction system started by the Veterans Administration system (a pioneer in patient safety and quality in several respects).

A recent report found across-the-board safety improvements in those hospitals participating in the NSQUIP since it was started in 2005.

The problem is that only about 250 hospitals in the United States participate. The College of Surgeons is now looking for ways to lower the $35,000 annual price tag for participation, which apparently has been a barrier to smaller hospitals to adopt the program.

Here is a list of the hospitals that currently participate in the NSQUIP.

The Wall Street Journal Health Blog reports on a new program growing out of NSQUIP which will help surgeons and patients calculate the exact risks of a proposed procedure and individualize it for their own hospital, based on data collected by the NSQUIP.

The NSQUIP program marks another step forward in giving patients the information they need to make intelligent choices about their health care. Unfortunately prospective patients don't have direct access to the NSQUIP data, but some of it is available indirectly through websites that gather hospital metrics, such as the Joint Commission "Quality Check" site and the Medicare Hospital Compare site.

I discuss the pros and cons of various hospital quality ratings in my book, "The Life You Save," where I conclude that one of the best measures now available is patient satisfaction, which is a survey that appears on the Medicare site.

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Posted In: Hospitals , Medical Malpractice , Standard of Care--Hospitals

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New ethics rules that bar Harvard doctors from giving speeches paid by drug manufacturers have prompted one doctor to give up his prestigious academic position in favor of keeping the income from the speeches. The physician is Dr. Lawrence M. DuBuske, an allergy and asthma specialist who is quitting his positions at Boston's Brigham and Women’s Hospital and Harvard Medical School. According to the Boston Globe, Dr. DuBuske made about $100,000 in three months last year giving some 40 speeches for six drug makers, including GlaxoSmithKline.

The ethics rules were put in place by Partners HealthCare, the physicians' group that employs most Harvard-connected doctors.

One Globe reader put this in a good perspective:

It's a good thing that he resigned. Now, when he speaks, the information he presents will be judged by the standards of a paid speaker employed by an entity with interests, rather than a disinterested academic. Meanwhile, he remains an expert allergist, and will likely find a place to practice.

The contacts between drug companies and academic medicine are extensive. They should be. You want the best, smartest, most creative docs involved in drug (and device) production. But the money involved is huge, and some will get seduced by the Green Side of the Force. Full disclosure of interests is a step, but only a step.

For patients, it helps to know if the prescription the doctor is writing for you has even a hint of a special interest from the drug maker. The many blandishments that drug makers lavish on doctors -- even small things like pens and scratch pads, plus free meals and "fees" for speaking at seminars -- are known to do their job of creating subtle influence on the prescription writer.

That's why I recommend that patients look for doctors who have the "no free lunch" philosophy: they accept nothing whatsoever, including samples, from the drug makers. That leaves their judgment completely independent.

You can read more about the "no free lunch" movement in medicine at this website.

I have a whole chapter in my book, "The Life You Save," on how to become a smart consumer of medicines.

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Posted In: Conflicts of Interest , Medications

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It ought to be so easy. Congress waves its magic wand, makes it illegal for health insurers to discriminate against sick people by charging them higher premiums or excluding their "pre-existing conditions," and voila, there you have it -- reform that everyone wants. But here's the downside, and here is why health insurance reform is not easy without tough and unpopular mandates on healthy people.

If insurance discrimination against the sick was outlawed without any requirement that everyone buy health insurance, then many people would take a chance and "go bare" of insurance while they're in good health. After all, they couldn't be punished financially once they got sick and really needed the coverage. More and more, the only people buying insurance would be the ones with big medical bills. And without the premium money from the healthy to subsidize the bills for the sick, the insurance companies would have to raise rates, and this would discourage more people from buying insurance, and soon we would have what economists call "the death spiral" of ever higher premiums and ever fewer insureds.

So no health reform has ever succeeded without a wide base of financing where the healthy and the sick alike contribute to the money pool, whether through insurance premiums or taxes.

Uwe Reinhardt, the Princeton health economist, explains this in a recent "economix" blog post in the New York Times.

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Posted In: Insurance

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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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Posted In: Medical Device Safety , Medical Error , Medical Malpractice , Radiation Therapy , Standard of Care--Hospitals

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Measured by results -- preventable deaths and injuries due to malpractice, medical errors, preventable infections, misdiagnosis and other events that shouldn't happen -- American health care has a lot of problems. Millions of patients are injured every year, and upwards of 200,000 patients die annually from preventable errors and hospital-acquired infections. The United States also lags far behind other developed countries in basic health outcome measures like life expectancy and infant death rates.

But when U.S. hospitals measure themselves with a different yardstick -- the "process" measures of how often certain important things get done for commonly treated diseases -- the results are astoundingly good. An annual report from the Joint Commission, the agency that inspects and accredits hospitals, finds steady improvement in the "process" quality measures that it looks at -- with most hospitals now performing in the 99% range on things like how often heart attack patients get standard treatments in the ER like aspirin and beta-blocker drugs.

The Joint Commission now measures 31 quality indicators. They cover the most common hospitalizable conditions: heart attack, heart failure (when the pump isn't pumping effectively), pneumonia, surgical care, and children's asthma. You can go to this website to look up information about a particular hospital.

The problems with the report are:

* Data is reported voluntarily by the hospitals, with no independent audit from anyone other than the Joint Commission. The Joint Commission says it's independent from the hospital industry but is often seen by critics as a cheerleader.

* Outcome measures -- deaths and injuries -- are not included in the report. Even infection rates, which could have required reports if Congress ever passes health care reform, are not yet reported.

Consumers Union has a Safe Patients Project. CU says it's high time for the U.S. health care industry to be required to report its results. Patient advocates like me agree wholeheartedly.

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Posted In: Health Care Reform , Hospitals , Medical Malpractice , Standard of Care--Hospitals

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What can cancer patients do to protect themselves from malpractice in radiation therapy? This urgent question arises from a lengthy series of investigative reports in the New York Times. The articles exposed serious patient injuries that stem from therapists who are overwhelmed and inexperienced, lax regulation and indifference by hospital administrators.

A key part of the problem is that technological sophistication has outrun the ability of the humans running the radiation machines to monitor the safety of the radiation beams they train on patients' bodies.

Another issue is that no central agency is responsible for inspecting the machines and credentialing the people who run them. Depending on the type of radiation involved, the Food and Drug Administration, the Nuclear Regulatory Commission and various state health agencies could have jurisdiction. Or worse, each could claim that someone else has the jurisdiction, and the patient can slip through the cracks.

There is one simple way that patients can take some measure of self-protection. That is to make sure that the radiation therapy center treating you has significant experience, in years not months, with the specific machine being used on you. Too often, hospital administrators buy a fancy new machine, advertise it heavily in glossy brochures, but don't take the time to make sure the machine is properly calibrated and that the medical physicists who operate the machine are fully trained.

You should also ask if the machine treating you has been inspected recently by an independent agency. One federally funded inspection and testing service is the Radiological Physics Center, operated out of MD Anderson Hospital in Houston. It does inspections for any radiation center that wants to receive federal funding for clinical trials. The Center found in 2008 that nearly three in ten hospitals it inspected failed to accurately irradiate a test dummy using IMRT technology.

The Times also found rampant problems with fake credentials among medical physicists, who are in charge of making sure patients get the right dose of radiation. The American Board of Radiology certifies medical physicists in one of three sub-specialties. You can check if a physicist is certified at the umbrella website for all medical board certifications, the American Board of Medical Specialties. Click here to go to the login page to search for a medical physicist's certification. The same page will let you search for whether a doctor is board-certified in any of the ABMS specialties or sub-specialties.

Also, the American Board of Medical Physics runs some certification programs. Its website has lists of diplomates but lacks any searchable database of qualified physicists. So the ABMS website is a better choice.

I recommend that patients ask questions to find out the qualifications of the persons running your radiation treatment program. If they lack certification, why take a chance?

I discuss the certification issue in detail in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." Many of the most egregious cases of malpractice that I have prosecuted for victims' families have involved doctors who lacked basic board certifications. Click here for more information on the kinds of malpractice cases we work on.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Medical Device Safety , Medical Malpractice , Radiation Therapy

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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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Posted In: Medical Error , Medical Malpractice , Radiation Therapy , Standard of Care--Hospitals

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An effort to overturn Maryland's unfair malpractice damages "cap" has been scotched by Maryland's highest court. The case involved Richard Semsker, a deceased Rockville attorney whose family was represented in a wrongful death lawsuit by Patrick Malone & Associates. The Maryland Court of Appeals has ruled that the jury's verdict must be reduced to account for the damages ceiling imposed by the state legislature.

An article in the Montgomery County Gazette discusses the decision and quotes the Semskers' attorney, Patrick Malone, who said:

"We had the entire Maryland medical establishment against us. While we have the better of the issue on the moral ground — damage caps are a terrible imposition upon victims of proven malpractice — on the other hand the establishment was against us on that."

While little understood by the general public, which often responds to vaguely worded public opinion polls by favoring some forms of "tort reform," including damage "caps," these arbitrary limits on damage awards impose a tax on the most severely injured victims of provable malpractice. Victims who have lesser injuries are not affected by the damage caps.

In the Semsker case, for example, no one challenged as unreasonable the jury's decision to pay Mr. Semsker's widow $1 million for loss of the husband to whom she had been married 21 years, and to pay each of his twin teenaged daughters $500,000 for the loss of their father. The jury heard evidence about how close the Semsker family was and how devoted Mr. Semsker was to his daughters and wife. The jury also ruled that the defendants should have to pay $1 million for Mr. Semsker's suffering in the last year of his life, which included multiple surgeries, radiation, and highly toxic chemotherapy -- all to treat a skin cancer that, according to the undisputed testimony, would have been 100% curable if his dermatologists had caught it in time.

But while the jury acted reasonably based on the evidence, the statutory damage cap required a rollback of the verdict for these "non-economic" damages from a total of $3 million to a total of $812,500. That is the "one size fits all" number that the legislature came up with in 2005 as a limit on all non-economic damages in all wrongful death lawsuits for malpractice.

Even worse, the damage cap discriminates against malpractice victims specifically, as compared to victims of other types of injuries. If the same physicians had run over Mr. Semsker with their car, that would have been a non-malpractice case and the damage cap would have been around $1.6 million instead of $812,500.

The Semsker case is also discussed in Mr. Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, an excerpt of which can be read here.

The Semskers had persuaded the judge who presided over the trial that the damage cap statute was written in such a way that its language excluded their case from imposition of the cap. But this week, the Court of Appeals reversed that decision and imposed the cap.

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Posted In: Medical Malpractice

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