DC Medical Malpractice & Patient Safety Blog

The state of Maryland is putting some financial sting in its efforts to get hospitals to lower the number of patients who contract deadly infections while hospitalized.

Nine hospitals are being fined a total of $2.1 million for having higher than usual infection rates.

The hospitals are: in the Washington, DC area: Prince George's Hospital Center, Shady Grove Adventist, Montgomery General, Doctors Community and Washington Adventist, plus University of Maryland Medical Center in Baltimore, St. Joseph Medical Center in Towson, Civista Medical Center in La Plata and Memorial Hospital in Cumberland (now part of the Western Maryland Health System).

Twenty-three hospitals - including Holy Cross, Howard County General, Suburban Hospital and Johns Hopkins in Baltimore - did better than the state average and will receive small bonuses.

The list of all hospitals included in the survey and their infection rates for fiscal year 2010 can be found by clicking here and then click on this line on the web page: Hospital Infection Related PPC Rates, FY 2010.

The state's effort is more ambitious than just infections. It follows a set of 49 PPCs: Potentially Preventable Complications. It sets up payment incentives and fines to encourage hospitals to reach goals of making patient care safer.

A bill currently awaiting action in the Arizona state Senate would prevent patients injured by medical students from being able to sue them. If the bill passes, students under the supervision of a licensed health care professional would not be liable for malpractice unless there was clear and convincing evidence that the student acted with gross negligence.

As with many proposed legislative bills, the proposal sounds like a solution in search of a problem. It's not clear that medical students EVER get sued for malpractice, and even if they were, the logical person to hold accountable would be the supervising physician who failed to oversee the student's conduct. But legal immunity is always a slippery concept, because one ambiguity in this bill is whether ANYONE would be liable if the student hurt someone.

Critics of the proposed bill maintain that there is no reason to grant immunity to someone actually providing health care (as opposed to just studying) and that such immunity could provoke irresponsibility.

But proponents of the bill argue that victims would not be without recourse, noting that the supervising physician, his/her employer and/or the student’s university would likely incur the costs of defending such malpractice suits. They also point out that being named a defendant in a malpractice lawsuit will follow the student around, potentially making it harder to find work and increasing malpractice insurance rates.

One Democratic Senator is demanding specific language in the final version of the bill that would clearly spell out that the supervising physician would be liable for any malpractice attributable to a medical student.

Source: Arizona Daily Sun

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

One thing you won't see mentioned much in the new U.S. Dietary Guidelines: red meat.

Nutrition experts know that to fight back against our national epidemic of obesity, it's important that we eat red meat only sparingly. But the guidelines, a product of the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, show the heavy hand of the food industry in what they say, and more importantly, what they leave out.

That's the criticism from the Harvard School of Public Health, which has a new article on the subject in its latest newsletter.

Other criticisms of the dietary guidelines from the Harvard folks:

* Too lax on refined grains -- white bread, white pasta, white rice.

* Too much dairy.

* Too little Vitamin D. Most Americans need 1,000 milligrams a day, which is hard to get from food alone.

* Too easy on sodium. Most Americans should only consume 1,500 milligrams -- a teaspoon and a half -- per day, but the guidelines allow 2,300 milligrams for everyone but "high risk" groups.

You can read the full dietary guidelines here, and the Harvard critique here.

Go here to see the Healthy Eating Pyramid, Harvard's alternative advice on good diet.

An excerpt of the key advice from the Harvard School of Public Health:

Go with plants. Eating a plant-based diet is healthiest. Choose plenty of vegetables, fruits, whole grains, and healthy fats, like olive and canola oil.

Cut way back on American staples. Red meat and processed meat, refined grains, potatoes, sugary drinks, and salty snacks are part of American culture, but they’re also really unhealthy. Go for a plant-based diet rich in non-starchy vegetables, fruits, and whole grains. And if you eat meat, fish and poultry are the best choices.

Article first published as New Dietary Guidelines May Be Overly Influenced by Agribusiness on Technorati.

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk. Only 21 devices (19%) had been approved through the more rigorous premarket approval (PMA) process, which requires clinical testing and inspections. (Eight other devices were exempt from any FDA regulation.)

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Originally, the 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids. It did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. Instead, it only required proof that the device was substantially equivalent in materials, purpose, and mechanism of action to another device that was already on the market, with the previous device serving as the “predicate” device with which the new device would be compared.

This approach was justified as a way to give manufacturers the opportunity to make small improvements on the devices already on the market and to allow companies with new products to compete with very similar devices without using the more extensive PMA process. If the FDA determined that the product was reasonably safe and effective according to the 510(k) review, it was said to be cleared for market rather than approved.

However, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which shifted the regulatory standard to "the least burdensome approach in all areas of medical device regulation." This had the practical effect of making 501(k) the dominant mechanism for new device clearance, with the FDA now reviewing only 1% of medical devices using the more rigorous PMA process.

To decrease the number of high-risk recalls, the study recommends:

1. The FDA fully implements current law that subjects "life-saving and life sustaining" (Class III) devices to the PMA process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

Source: The Los Angeles Times

You can read the complete study here.

Many women with early breast cancer do not need to have their armpit lymph nodes removed, according to a new study. Currently, this painful procedure has long been routine, as physicians believed it would prolong women’s lives by keeping the cancer from spreading or coming back. However, the study shows that removing the cancerous lymph nodes is unnecessary when women receive chemotherapy and radiation, which wipes out most of the disease in the nodes.

The study indicates that for about 20% of women (40,000 women a year in the U.S.), the removal of the cancerous lymph nodes doesn’t (a) alter the treatment plan for the patient; (b) improve survival rates; or (c) make the cancer less likely to recur. And it has a downside, since it can cause complications like infection and lymphedema, a chronic swelling in the arm.

Experts say that the new findings, combined with similar ones from earlier studies, should change medical practice for many patients. However, they warn that change may come slowly because the notion that the nodes must be removed is very deeply ingrained.

The current approach to surgical treatment of breast cancer is to cut out obvious tumors — because lumps big enough to detect may be too dense for drugs and radiation to destroy — and to use radiation and chemotherapy to wipe out microscopic disease in other places. Until now, physicians believed that even microscopic disease in the lymph nodes should be cut out to improve the odds of survival.

The new results do not apply to all patients, only to women whose disease and treatment meet the criteria in the study, which were:

Early tumors at clinical stage T1 or T2 (i.e. less than two inches across).

Biopsies of one or two armpit nodes found cancer, but the nodes were not enlarged enough to be felt during an exam, and the cancer had not spread anywhere else.

The women had lumpectomies, and most also had radiation to the entire breast, and chemotherapy or hormone-blocking drugs, or both.

The study included 891 patients with their median age in the mid-50s. After an initial "sentinel" node biopsy, the women were assigned at random to have 10 or more additional nodes removed, or to leave the nodes alone. In 27 percent of the women who had additional nodes removed, those nodes were cancerous. But over time, the two groups had no difference in survival: more than 90 percent survived at least five years. Recurrence rates in the armpit were also similar, less than 1 percent.

Dr. Grant W. Carlson, a professor of surgery at the Winship Cancer Institute at Emory University, who authored an editorial that accompanied the study, said that by routinely taking out many nodes, “I have a feeling we’ve been doing a lot of harm.”

Source: The New York Times

You can read an abstract of the study here.

More than two dozen hospitals in Ohio that collaborated to reduce hospital infections and drug mix-ups saved $12.8 million in health care expenses by doing so, according to a recently released report. The Solutions for Patient Safety initiative, launched by a coalition of business and hospital groups in January 2009, included 17 hospitals acute care hospitals and eight children’s hospitals.

The report said hospitals were able to achieve the changes by sharing successful data-collection techniques and best preventive medical practices with one another.

Seventeen central Ohio hospitals cut methicillin-resistant Staphylococcus aureus (MRSA) infections by 42% and catheter-related central line associated bloodstream infections (CLABSI) by 37%, thereby avoiding an estimated 918 patient days in the hospital and preventing 14 deaths. Meanwhile, the eight children's hospitals cut surgical infections by 60% and adverse drug events by 35%, preventing more than 3,500 children from being harmed while in the hospital and saving $5.3 million in medical costs.

Two processes - hand hygiene and "scrubbing the hub" - emerged as critical to significantly reducing infection rates for MRSA and CLABSI. Hand hygiene was the primary area of focus for the collaborative’s efforts to reduce MRSA infections, and an inverse relationship between hand hygiene and incidence of MRSA was observed. Since the beginning of hand hygiene data collection by specially hired observers in September, the rate of compliance with washing hands upon entering and leaving a patient’s room, even while wearing gloves, has improved by more than 20 percent. For CLABSI related infections, the observers identified a critical point of infection transmission related to the length of time the “hub” (the access point in a catheter where fluids and medications are administered) is cleaned.

Source: American Medical Association News

You can read the report here.

Last spring, we reported in this blog about an obscure medical journal study that punctured the balloon of the U.S. News "Best Hospitals" rankings.

The study by Dr. Ashwini Sehgal found that the rankings were based almost purely on the subjective reputation of the hospitals among similarly situated health care institutions, a self-fulfilling prophecy. More important, the rankings have almost nothing to do with a hospital's core job of keeping patients safe, which is something for which objective measures do exist.

Now I'm delighted to report that this study has been spotted by the New Yorker's Malcolm Gladwell. As part of a long takedown of the silliness of rating systems in general -- he skewers everything from the "Best Colleges" ratings of U.S. News to the top cars rankings of Car and Driver, he had this to say about the medical study:

You can read the whole thing on the New Yorker's site here.

As I said in my piece last spring, one radical idea would be to ask patients what they think of hospitals where they've recently stayed. There actually are some very good correlations between quality of care and patient satisfaction: Clear communications, clean rooms, and good pain control are all important elements of going home safe and sound.

Medicare's "Hospital Compare" website publishes patient satisfaction reports for each hospital in the country. Check them out here.

One of the main arguments made by proponents of malpractice reform is that physicians would order fewer medical tests if patients could receive only a limited amount of money in a potential lawsuit. But that assumption may not be true, according to a recent study published in the journal Health Affairs. In that study, researchers from the University of Iowa found that not only does reducing malpractice costs not make physicians less concerned about being sued, it also doesn't necessarily result in them ordering fewer tests.

The study evaluated physicians’ perceptions about malpractice claims in states where more objective indicators of malpractice risk, such as malpractice premiums, varied considerably. It found high levels of malpractice concern among both generalists and specialists in states where objective measures of malpractice risk were low. The study also found relatively modest differences in physicians’ concerns across states with and without common tort reforms. These results suggest that many policies aimed at controlling malpractice costs may have a limited effect on physicians’ malpractice concerns.

Proponents of malpractice reform, including lawmakers, assume that physicians order unnecessary tests because they fear being sued, and this so-called "defensive medicine" is one of the main factors driving up health care spending.

However, opponents of malpractice reform argue that although some physicians request unneeded tests to avoid potential lawsuits, in many cases, physicians order tests because they're trying to do a thorough job with patients, while others order tests to exploit the “fee-for-service” system, which allows physicians to bill more when they perform more services or provide more care.

Source: Des Moines Register editorial

You can read the abstract of the University of Iowa study here.

The news this week from the Centers for Disease Control and Prevention that as many as 48 million U.S. adults have high levels of bad cholesterol, and aren’t doing enough to control it, left out one conspicuous controversy: Should lots more Americans be taking statin drugs, or would it be a huge waste of money?

Statins like Crestor and Lipitor lower cholesterol in the blood by decreasing cholesterol synthesis in the liver. Since plaques in coronary arteries are mostly composed of cholesterol, lowering cholesterol cuts the rate of formation of plaque, and in some cases, even shrinks it.

For people with diagnosed heart disease, statins are mainstream, non-controversial medical treatment. But for patients who just have high cholesterol, but no known heart disease yet, the drugs have modest if any benefit. And this is the group that is the main target of drug manufacturers for expanding sales of statins.

A cautionary statement about the questionable role of statin drugs in "primary prevention" of heart disease was recently released by the British-based Cochrane Collaboration, which conducts rigorous reviews of medical studies to see how the evidence measures up.

The authors of the new Cochrane review criticized much of the studies sponsored by drug manufacturers for leaving out key data. They concluded:

Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

Doctors who are slow to turn healthy people into medical patients are careful about whom they prescribe statins for. For example, Dr. Robert Lemmon, a South Carolina family practice doctor and medical blogger, wrote an analysis of the published studies and concluded that statins were "overrated" and did not much help people who don't have heart disease. Noting that other cautious reviewers had reached the same conclusion, even though it cuts against drug manufacturer hype, he wrote: "This post is blasphemy. Fortunately I am in good company."

The CDC report also talks about improving diet and exercise habits as strategies to cut cholesterol. That can work in individuals very well, but as a public health strategy, education campaigns also fall short in making any notable impact. That's why public health advocates reach for systemic changes that would expose people to less temptation by strategies such as bans on use of certain bad fats in restaurants and fast food manufacturers. A provocative article on this topic was published in PLoS Medicine.

Article first published as Government Reports Millions of Americans Have Untreated High Cholesterol — But What Treatment Works? on Technorati.

Hospitals say they are barring parents from taking videos of the birth of their children strictly out of concern for privacy of the health care workers and to prevent doctors and nurses from being distracted. But a New York Times article on the subject makes clear the hidden agenda: Hospitals really want to avoid the creation of graphic video evidence in the event that something goes wrong with the birth and they are sued for medical malpractice.

As a patient safety advocate, it seems to me that any hospital that concerned about legal liability is one that parents would want to avoid giving their business to. Any hospital oriented to safety would be proud of its work and would want to have the videos to exonerate their doctors and nurses, if it came to a lawsuit.

The fact is that cellphone cameras are so unobtrusive now that it is hard to imagine a real safety issue with their being in "record" mode for the moments of birth, which some parents want to capture for posterity.

I explained my concerns in an interview on a local television news show, which you can watch here.