Georgia Injury Lawyer Blog

Elderly nursing home patients have been routinely receiving costly antipsychotic drugs which increase their risk of death and are not approved for their treatment.

According to a report from the Health and Human Services Department’s inspector general, 88 percent of the antipsychotic drugs administered in nursing homes were prescribed for uses that the Food and Drug Administration hasn’t approved.

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, the government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the study found, costing the program $116 million for those six months.

Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) want Medicare to explain why it wrongly paid millions of dollars in claims for drugs that were given to seniors for these unapproved uses.

Medicare provides coverage for some unapproved uses, but the senators suggested that the report’s findings might indicate a flawed decision-making system.

The Medicare agency said in its response to the inspector general’s report that it should have denied more than half the claims it paid for the use of antipsychotics in nursing homes.

The inspector general of the Department of Health and Human Services went so far as to state that “government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions.”

According to the audit, some of the drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are potentially lethal to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses.

In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

In a novel, yet sensible approach designed to reduce medical errors, increase the quality of care, and reduce costs, the Obama administration issued a final regulation to reward hospitals that provide high-quality care. This step is the first in a series of planned steps that are designed to fundamentally transform the way that the federal government pays for healthcare.

Under the initiative, one of several authorized in the new healthcare law the president signed last year, Medicare will pay more to institutions that score well on a series of measures that gauge patient care and pay less to those that don't meet quality benchmarks.

Though commonplaces in many industries, setting quality benchmarks and tying them to compensation will be new for many of the nation's hospitals. It is a strategy that Medicare has never used before on a systematic basis.

But many experts and consumer advocates said Friday that they saw these kinds of quality initiatives as crucial not only to improving medical care but also to controlling costs.

Hospitals that fall short of the new benchmarks could lose as much as 1% of what Medicare would pay them in 2013.

That's a relatively smallt penalty for an industry that receives more than $150 billion a year from Medicare, but the stakes could become significant as more quality initiatives are implemented.

Medicare provides insurance to nearly 50 million elderly and disabled Americans, paying for 12.4 million hospitalizations in 2009, according to the Centers for Medicare and Medicaid Services.

One recent study published in the journal Health Affairs estimated that 1 in 3 hospital patients experienced an "adverse event" such as being given the wrong medication, acquiring an infection or receiving the wrong surgical procedure.

The Obama administration sees improving quality as the best strategy for saving cash-strapped public healthcare programs like Medicare and Medicaid rather than requiring beneficiaries to pay more for their care.

In the first year, hospitals will be graded on 12 process measures, which track things like how quickly heart attack victims are given anti-clotting medicines and how quickly surgical patients receive antibiotics after surgery to cut down on infections

In 2014, the Obama administration plans to expand the report card to include outcome measures, including mortality rates for patients after they leave the hospital and the prevalence of hospital-acquired conditions such as infections and bedsores.

Institutions with high rates of hospital-acquired conditions, as well as those with high readmission rates, stand to be penalized a second time because of another quality initiative still under development.

Some hospital officials have criticized the imposition of two penalties for hospital-acquired conditions. The American Hospital Association raised concerns about relying too heavily on surveys of patient opinion, which they said could penalize hospitals that care for sicker patients.

Women under 50 who follow the advice of a U.S. panel to forgo annual mammograms may be at risk for more severe forms of breast cancer

Three recent studies led by radiologists suggest that failing to get regular breast screenings left women more likely to discover cancer at an advanced stage. The delay resulted in larger tumors and a worse prognosis once the cancer was uncovered, the data found.

The U.S. Preventative Services Task Force said in 2009 that most women ages 40 to 49 do not need mammograms, recommending the screening for those with a disease history or who had a greater risk due to another factor.

The American Cancer Society disputed the advice, and insurers still cover annual screenings.

However, a study in Colorado suggests 62 percent of doctors changed their advice to match the U.S. guideline and 16 percent fewer women got the test.

The three studies were presented at separate medical meetings held recently by the American Society of Breast Surgeons in Washington D.C., and the American Roentgen Ray Society in Chicago.

Breast cancer killed an estimated 40,000 women last year and is the second leading cause of death among women, exceeded only by lung cancer. The American Cancer Society estimated that about 207,090 new cases of invasive breast cancer were diagnosed in 2010.

In issuing its recommendations, the federal task force said women in their 40s are more likely to get false-positive tests that lead to unnecessary biopsies and anxiety than to discover cancer through a mammogram.

The guideline was challenged by the cancer society, which urged doctors to advise women of that age to continue routine annual screenings.

The independent task force under the U.S. Agency for Healthcare Research and Quality, was first formed in the 1980s to give advice on screening, counseling and preventive medicines based on an assessment of scientific

Academic and practicing doctors and nurses make up the group. They have published guidelines on more than 100 topics and are reviewing 30 more, involving cervical cancer tests, dementia and glaucoma screening and the use of electrocardiographs for detection of coronary heart disease.

One of the studies analyzed breast cancer cases in women younger than 50 from 1998 to 2008. The study showed that 94 percent of the women ages 40 to 49 diagnosed through a mammogram were considered disease free after five years compared with 78 percent of those who didn’t receive the screening exams.

Another study studied biopsy results from Jan. 1, 2008, to Dec. 31, 2009. Seventy-one of 108 diagnosed breast cancer cases were detected by a mammogram and 37 resulted from discovery of a lump or other symptom. Twenty-two cases were non-invasive cancer in the tested group compared with one among those who were not.

None of the cancers in the mammogram group had progressed to latest stage form of the disease compared with 17 among those who weren’t screened.
More than half of the women who had a mammogram showed no evidence of cancer in their lymph nodes compared with 39 percent in the group that hadn’t been screened, The study also showed the size of the tumors to be on average smaller among the women whose cancer was discovered in a mammogram.

Infections are now the number one cause of deaths in nursing homes, causing nearly 400,000 deaths annually.

A study published in the May issue of The America Journal of Infection Control reports that 15% of American nursing homes each year receive deficiency citations for infection control.

The study, conducted by researchers at the University of Pittsburgh's Graduate School of Public Health, looked at deficiency data collected from about 16,000 nursing homes per year between 2000 to 2007 as part of Medicare/Medicaid certification.

The researchers reported that there appeared to be a strong correlation between low staffing levels at nursing homes and infection control deficiency citations.

A major cause of these infection rates is Clostridium difficile infection (CDI, also known as C. diff), particularly if the residents are elderly and taking antibiotics for another infection. CDI is an infection that causes diarrhea and more serious intestinal conditions It can even be fatal. CDI is most commonly seen in nursing home residents and hospital patients.

Clostridium difficile bacteria are found in the feces of an infected person. Other people can become infected if they touch items or surfaces that are contaminated with the bacteria and then touch their mouth.

CDI can be treated by a healthcare provider with a 10-day course of antibiotics that specifically treats CDI. More serious cases of CDI may require hospitalization or surgery.

CDI can be prevented by washing hands with soap and warm water. Patients in hospitals and residents in nursing homes should wash their hands very often and try to avoid touching surfaces, especially in bathrooms.

This simple preventative measure can prevent pain, suffering and even death among nursing home residents.

Preventable medical errors kill thousands of Americans every year.

A recent study found that nearly one out of three hospital patients is harmed by the care they receive. The Institute of Medicine, an independent nonprofit organization within the National Academy of Sciences which works to provide unbiased advice to decision makers within the medical community, estimates that as many as 100,000 Americans die each year from preventable medical errors in hospitals. This is approximately the same number of annual deaths caused by auto accidents, AIDS, and breast cancer combined.

In the United States which has the world's most skilled doctors and nurses and the finest hospitals, this statistic is unacceptable. These mistakes don't just cause pain and anguish, but also add to skyrocketing health insurance bills for families, businesses, and government.

The Obama administration has begun partnering with health care systems and hospitals in an effort to reduce these costly often caused by fragmented delivery of care, missing data, and poor communication between providers.

In one example, the Seton Family of Hospitals in Texas has reduced serious complications during birth by 93 percent over the last decade by following best practices. And by making sure one group of asthma patients consistently gets the right follow-up care and appropriate preventive treatment, Seton reduced those patients' emergency room visits by 37 percent and hospital stays by 63 percent.

This collaborative program between government and the health care industry is the Partnership for Patients. The Obama administration has joined with more than 1,200 other hospitals nationwide, along with hundreds of employers, health insurers, provider organizations, and patient advocates, to launch the unprecedented alliance that will promote innovations to improve hospital care and reduce wasteful spending.

The goals are ambitious -- to reduce preventable injuries in hospitals by 40 percent and cut readmissions by 20 percent. Achieving these goals would save 60,000 lives and protect more than 1.6 million patients from complications that would put them back in the hospital.

Reducing preventable errors and unnecessary hospital readmissions would also save at least $50 billion over 10 years in Medicare costs alone. At a time when Medicare costs are expected to rise 91 percent over the next decade, this is a significant step in cost reduction.

More than 20% of patients who received an implantable cardioverter-defibrillator -- a high-tech device that produces electrical impulses to regulate heartbeats and prevent life-threatening arrhythmias -- in recent years were not good candidates to receive the device, a new study suggests.

Researchers at Duke University looked at more than 111,000 patients who received ICD implants between 2006 and 2009. More than 25,000 of those patients did not meet evidence-based criteria for receiving the device, according to the study.

The risk of dying in the hospital was significantly higher for patients who received the ICD but did not meet the criteria, and 1 out of 121 patients in this category experienced complications following the implant, the study found.

According to the study published Tuesday in the Journal of the American Medical Assocaition,, ICDs often are recommended as a primary prevention tactic for patients who are at high risk for a cardiac arrest or life-threatening arrhythmia, but who have not yet suffered from these symptoms.

However, the Centers for Medicare and Medicaid Services, CMS, in the U.S. Department of Health and Human Services, has issued a "decision memo" stating that only people having certain serious heart conditions or cardiac histories are suitable candidates for ICDs.

The memo further states that patients must meet numerous other qualifications relating to clinical trials and not have certain serious diseases or conditions that would lower the implant's efficacy or the patient's likelihood of long-term survival.

Dr. Ralph Brindis, president of the American College of Cardiology, said in a statement that the Duke University findings will have "major implications."

Dr. Robert Michler, chairman of Cardiovascular and Thoracic Surgery at Montefiore-Einstein Heart Center, said the data should act as a "wake-up call" for physicians, surgeons and patients.

He says that in this case electophysiologists should be making the final determination if the patient needs the device.

These specialists have additional training in the diagnosis and treatment of abnormal heart rhythms and were less likely to implant an ICD in a patient who did not meet evidence-based criteria, the study found

The study’s authors reported that even with the current guidelines some patients may fall into a gray zone and that each physician needs to use clinical judgment to make recommendations.

According to the authors , deviating from the guideline are acceptable in various circumstances, but 20% is a significant amount of deviation.

A disturbing Inspector General report from the shows that medical errors are harming and killing our senior citizens at alarming rates.

An estimated 15,000 Medicare patients die each month, and many more are injured, because of usually preventable medical mistakes in hospitals and other facilities.

The report focused on “adverse events,” defined as "harm to a patient as a result of medical care, such as infection associated with use of a catheter," and “never events,” which are specific "serious events, such as surgery on the wrong patient, that the National Quality Forum (NQF) deemed 'should never occur in a health care setting.'”

The Inspector General of the Department of Health and Human Services found:

--An estimated 13.5 percent of hospitalized Medicare beneficiaries experienced adverse events during their hospital stays.

--An additional 13.5 percent of Medicare beneficiaries experienced events during their hospital stays that resulted in temporary harm.

--Physician reviewers determined that 44 percent of adverse and temporary harm events were clearly or likely preventable.

--Hospital care associated with adverse and temporary harm events cost Medicare an estimated $324 million in October 2008.

Significantly, the 2009 loss to taxpayers was "$4.4 billion spent on care associated with events"--which did not even include the cost of followup care.

The cost in lives, health, and taxpayer dollars of preventable medical errors is far too high. Respect for life of our senior citizens requires accountability when harm occurs, and preventive steps to ensure patient safety.

A portion of the Inpsector General's report is reprinted below:

Continue reading "Medical Errors Kill 15,000 Medicare Patients Each Month, According to Inspector General" »

Outrageous surgical "errors" continue to maim and kill patients throughout Georgia and the United states despite requirements that hospitals and doctors abide by a standard set of procedures to prevent surgical mistakes.

These errors include operating on the wrong patient or the wrong body part.
This inexcusable problem is highlighted in a new study in the Archives of Surgery. The data was drawn from an insurance database in Colorado that included 27,370 self-reported incidents from 6,000 physicians from 2002 to mid-2008. Doctors in the insurance plan receive incentives for early reporting of adverse events.

In one case reported, a chest tube was inserted into the wrong lung, the healthy one, causing it to collapse, killing the patient. In other cases, surgeons removed a healthy ovary, operated on the wrong side of the brain, fused the wrong vertebrae and did procedures on the wrong eye, knee, foot, elbow and hand.

Surgeons reported performing 25 operations, including three prostatectomies, on the wrong patient, as well as 107 procedures on the wrong body part. The mix-ups often started in the internist’s office.

Past estimates suggested that such mistakes occurred once in every 110,000 procedures, but the paper’s lead author said the incidence might not be so rare, and might even have increased.

The lead author, a surgeon , described the findings as “shocking” and "unacceptable."

It is interesting that this finding, by a panel of surgeons, comes at a time during which doctors groups, hospitals, large insurers, and some politicians, are attempting to curb the rights of citizens to recover damages for even these outrageous events.

Medical malpractice lawsuits in Georgia have long been the target of doctors’ groups and big insurance companies. Using advertising, political contributions, and misinformation, they have been successful in fostering the notion that these lawsuits are frivolous. Many people have bought into this misconception, that is, until it happens to them or a loved one.

A recent story in the Miami newspaper illustrates this well. A Belle Glade, Florida judge plans to sue two radiologists and a surgeon after a foot long by foot wide sponge was left in him after surgery and went undiagnosed for five months, even as he developed serious health issues from it.

Late last year 67-year old Nelson Bailey checked into Good Samaritan Medical Center for surgery to treat his diverticulitis which was causing him abdominal pain. After the surgery the pain not only continued, but got worse.

When the judge complained to his doctor, he was sent for a CT scan but the metal marker on the sponge was reportedly misidentified in the test results. The judge was subjected to even more CT scans, and again the marker was misidentified.

Finally doctors identified the sponge and in March he underwent another surgery during which doctors removed the foot long by foot wide sponge which had begun to fester and was full of pus. Doctors also had to remove a part of Bailey's intestine which had been severely damaged by the sponge.

As part of the settlement he reached with hospital and its owner, Tenet Healthcare System, the judge is allowed to talk publicly about his experience in hopes that hospitals will make changes so something like this never happens again.

Now the judge would also like damage award caps placed on medical malpractice lawsuits brought in Florida repealed. Recently, the Georgia Supreme Court declared similar caps enacted by the legislature in Georgia unconstitutional.

The judge was quoted as saying , “But what I would like to see is when you have malpractice per se, something this egregious, the damages should be between the parties, a judge and jury without the state legislature dictating limits."

Preventable medical errors add extremely high costs to the healthcare provided in Georgia and across the United States. The Society of Actuaries, the largest professional organization dedicated to supporting 21,000 members in the United States and Canada, recently commissioned a study to assign a cost to these medical errors.

The study defined measureable costs of medical errors to include increased medical costs, costs related to an increased mortality rate, and costs related to lost productivity after the occurrence of an error. Most other costs of medical errors, such as pain and suffering, which are not measureable from medical claim databases, were not included. Neither were malpractice costs or insurance payments.

An error was defined as a preventable adverse outcome of medical care that is a result of improper medical management (a mistake of commission) rather than a progression of an illness due to lack of care (a mistake of omission).

Using medical claim data, the study identified costs of medical errors in the United States of $19.5 billion during the year 2008. Of this amount, the vast majority identified (about 87% or $17 billion) was a direct increase in the medical costs of providing inpatient, outpatient, and prescription drug services to individuals who are affected by medical errors.

The study also identified increases in indirect costs of approximately $1.4 billion related to increased mortality rates among individuals who experience medical errors and approximately $1.1 billion related to lost productivity due to related short-term disability claims.

Using medical claim data the study estimated that 6.3 million measurable medical injuries occurred in the United States in 2008. In an inpatient setting, seven percent of the admissions in the claim database resulted in some type of medical injury. Of the 6.3 million injuries, it was estimated that 1.5 million were associated with a medical error.

Measuring the total cost per error as approximately $13,000, the resulting total cost to the United States economy was $19.5 billion. Additionally, these errors resulted in over 2,500 excess deaths and over 10 million excess days missed from work due to short-term disability.

The estimates of mortality costs and lost productivity were based on limited data and the authors of the study stressed that they were likely underestimated. Both were limited to a one-year period following an error, and deaths are further limited to those which occurred in the hospital.

Not only is this data stunning in the total dollar figures, but it becomes even more so when it is remembered that these errors were all defined as preventable.

Acts of medical malpractice are often hidden by the secrecy afforded hospitals and health care providers by various state laws which make these matters confidential and immune from discovery by the public.

In an effort to reduce these sometimes deadly errors, the state of Indiana initiated a method of publicly tracking preventable medical errors. In just the fourth year of reporting, Indiana hospitals and surgery centers reported more than a 10 percent decrease in errors between 2008 and 2009.

Indiana’s Medical Error Reporting System requires hospitals, surgery centers, abortion clinics and birthing centers to report “never events.” These are medical errors that should never occur. The errors cover 28 serious events, from surgery performed on the wrong patient to an infant discharged to the wrong person to patient suicide.
Indiana was just the second state after Minnesota to require reporting of the errors, which are defined by the National Quality Forum, a nonprofit group seeking improvements in health-care quality. Gov. Mitch Daniels of Indiana issued an executive order in 2005 requiring the Indiana State Department of Health to implement the system.

According to press reports, some goals of the program already have been met. The reporting system has made citizens more aware of the incidence of medical errors.

The goal of analyzing data to learn where errors are being made was realized in the health department’s new initiative to reduce pressure ulcers, also known as bedsores. The state sought to improve systems for assessing risk factors for patients and in training hospital personnel. Just 22 bedsores were reported in Indiana in 2009. That is an amazingly small number.

Of the 94 preventable errors reported in Indiana in 2009, one health system, by far the state’s largest reported 18, the highest reported. That health system had 56,022 inpatient discharges and 168,689 outpatient visits during 2009.

Tracking and preventing errors is a key to reining in health-care costs. The Society of Actuaries reported this month that medical errors cost hospitals $19.5 billion in 2008.

Medicare is currently refusing to reimburse providers for treatment caused by preventable errors. The federal health-care reform lawincludes measures to cut these costs by requiring Medicare to track a hospital’s error rates. In 2014, the federal government will cut payment by 1 percent to hospitals with the highest rates of patient safety issues.

These measures reduce medical costs, and more importantly, save lives.

Incompetent nurses working in Georgia may have a history of malpractice which is unknown to the institutions and people employing them. A recent investigation reported in USA Today has disclosed the fact that communication among state licensing agencies which supposedly protect patients from dangerous nurses is frighteningly lacking and in many cases, nonexistent.

The article gives as an example the matter of Nurse Craig Peske who was fired from a hospital in Wausau, Wis., in 2007 after stealing the powerful painkiller Dilaudid.

Hospital officials reported him to Wisconsin nursing regulators and alerted police.
Six months later, Peske was charged with six felony counts of narcotics possession. But by that time, he had used a special "multistate" license to get a job as a traveling nurse at a hospital 1,200 miles away in North Carolina.

Peske was later convicted of two felony drug charges.

The ease of Peske's move demonstrates the gaps in regulatory efforts nationwide to keep nurses from avoiding the consequences of misconduct by simply moving across state lines.

The two states in which Peske worked are part of a 24-state compact created to help get good nurses to areas where they are needed most. Under the decade-old partnership, a license obtained in a nurse's home state allows access to work in the other compact states. Georgia is not a member of the compact.

The Georgia Secretary of State, like may others, maintains a database of nurses licensed to practice in this sate with disciplinary actions noted. However, in order to check the complete background of a nurse one would have to search all 50 states.

An investigation by the non-profit news organization ProPublica found that the pact also has allowed nurses with records of misconduct to put patients in jeopardy. In some cases, nurses have retained clean multistate licenses after at least one compact state had banned them. They have ignored their patients' needs, stolen their pain medication, forgotten crucial tests or missed changes in their condition, records show.

Critics say the compact may actually multiply the risk to patients. There is no central licensing for the compact, so policing nurses is left to the vigilance of member states.

With the advent of modern technology it should be a rather simple task to establish a centralized registry to which each state’s nursing licensing board could post information regarding findings of misconduct or malpractice by nurses. The existence of such a database made available to hospitals, nursing homes, and other health care organizations could potentially prevent harm to many innocent persons.

Weaknesses in the state-based system for disciplining problem nurses have surfaced as a public health issue during the past year. California, for example, revamped its nursing board and its executive officer resigned after reports of ineffective oversight that put patients at risk.

The state recently discovered that 3,500 of its nurses had been disciplined by other states but had kept clean California licenses.

Nationwide, nursing shortages have forced hospitals to rely on traveling or temporary nurses. Nurses working in one state now take medical-advice phone calls or use teleconferencing

Georgia citizens face some of the most restrictive medical malpractice laws in the country. One of the justifications used by politicians and medical groups to support these restrictions on injured patients right of recovery is that medical professionals can police their own and eliminate incompetent practitioners.

This bogus contention has finally been exposed by a doctor survey published Tuesday in of all places, the Journal of the American Medical Association.

Conducted by a team from Massachusetts General Hospital in Boston, the study used data from a 2009 national survey of close to 3,000 physicians practicing in anesthesiology, cardiology, family practice, general surgery, internal medicine, pediatrics and psychiatry.

Physicians were questioned in three areas: about their responsibility to report physicians who were incompetent or impaired by drugs or alcohol, about their preparedness and comfort level in doing so, and about their experiences with colleagues with these issues.

According to the report, about 70% of physicians said they feel prepared to report impaired physicians, and 64% said they were prepared to report incompetent ones. But more than one-third, 36%, said they do not feel obligated by professional commitment to do so.

Physicians with less experience, 10 years or fewer, were most willing to report impaired or incompetent colleagues. Those with greater experience, 20 years or more, were less likely to feel that it was their responsibility to do so.

Pediatricians and family practice doctors were the least likely to say they felt prepared to deal with impaired or incompetent colleagues; anesthesiologist and psychologists apparently felt most prepared.

The survey also found that 17% of respondents had direct knowledge of an impaired or incompetent physician colleague in their hospital, group or practice in the last three years. Of these physicians, 67% had reported that person to a hospital, clinic, professional society or other authority.

Among physicians who had encountered impaired or incompetent colleagues and had chosen not to report them, the two most frequently cited reasons for not doing so were the belief that someone else was taking care of the issue and the belief that nothing would happen as a result of the report.

It is frightening that a large portion of physicians do not honor the commitment to report another physician even when they have direct personal knowledge of a colleague that is incapacitated by drugs or alcohol or otherwise incompetent to be rendering care to innocent human beings.

Many Georgia veterans receive care at VA hospitals throughout the state. We have previously written about the lapses in safety at VA hospitals across the country which have negligently exposed these brave men and women to life threatening diseases.

Yesterday, a former medical supply technician at the St. Louis VA Medical Center told a congressional hearing that she warned more than a year ago that dental equipment sterilization was inadequate, but she was ignored.

Earlene Johnson testified before a hearing in St. Louis called by the House Committee on Veterans' Affairs. The committee met after the VA sent letters two week ago, warning 1,812 veterans treated at the St. Louis dental clinic that lapses in sterilization of dental equipment potentially exposed them to viruses including hepatitis B, hepatitis C and HIV.

A VA official revealed yesterday that some veterans have tested positive for the viruses but it was too soon to tell if the dental equipment was the cause.

Johnson began working at the St. Louis VA in December 2008 in the sterilization division. She did not work directly for the dental division but said she saw flaws in dental sterilization. She testified that starting in March 2009, she tried to alert VA officials at the St. Louis center and in Washington about the inadequacies, to no avail.

It was a full year later that the VA notified veterans of the sterilization problem and urged them to get blood tests. Meanwhile, Johnson was fired for what she believes was retaliation for the concerns she raised.

The VA determined in March 2010 that lapses in dental sterilization had occurred from Feb. 1, 2009, through March, 11, 2010. According to the VA,
the problem arose because workers prewashing dental equipment failed to use a detergent before the equipment was sterilized.

Veterans Affairs Committee chairman Bob Filner, D-California, said his concerns extend beyond the inadequate sterilization. He wondered why problems were substantiated in March, but no one was told until the June 28 letter and news release.

VA officials have said the delay was because officials were evaluating the risk posed to veterans.

Other VA centers around the country have had problems in recent years.
In 2007, Walter Reed Army Medical Center in Washington came under fire over concerns about conditions at the hospital and treatment of veterans. That same year, a surgeon at the VA hospital in Marion, Ill., resigned after a patient bled to death following gall bladder surgery. The VA found at least nine deaths between October 2006 and March 2007 resulted from substandard care at the Marion hospital.

In 2008, inadequate sterilization of endoscopy equipment at VA centers in Florida, Georgia and Tennessee potentially exposed 10,000 veterans to viruse

Georgia medical malpractice cases have become increasingly difficult to bring as the legislature enacts more and more restrictive laws. A fact which many do not know is that patients injured by highly negligent actions in Georgia emergency departments have no right of recovery. This is due legislation which established a gross negligence standard which governing the actions of emergency room personnel.

This standard has been interpreted by the Georgia courts as requiring almost intentional conduct.

The extreme unfairness of this law is illustrated by a recent incident occurring at a VA hospital in Missouri. The VA hospital is under fire because it may have exposed more than 1,800 veterans to life-threatening diseases such as hepatitis and HIV.

The John Cochran VA Medical Center in St. Louis recently mailed letters to 1,812 veterans telling them they could contract hepatitis B, hepatitis C and human immunodeficiency virus (HIV) after visiting the medical center for dental work.

The alert was caused by the failure to clean dental instruments properly. According to reports, dental technicians broke protocol by handwashing tools before putting them in cleaning machines.

The instruments were supposed to only be put in the cleaning machines. The handwashing started in February 2009 and went on until March of this year.

A similar event occurred recently at a California hospital which was forced to send letters to 3,400 patients who underwent colonoscopy and other similar procedures, informing the patients that there may be a potential of infection from items used and reused in the procedures.

This misconduct is totally unacceptable, yet in Georgia, patients exposed to these deadly diseases in an emergency room setting have no recourse.

Atlanta, and other metropolitan areas in the state of Georgia have seen a rapid expansion in the numbers of same-day surgery centers. Yesterday, the Journal of the American Medical Association published an article suggesting that lack of infection practices are common in the nations more than 5000 outpatient surgery centers.

The study was prompted by a hepatitis C outbreak in Las Vegas. This outbreak was caused by unsafe injection practices at two outpatient surgery centers.

Failure to wash hands, wear gloves and clean blood glucose meters were among the reported problems found by the study. The study also found that many outpatient centers reuse devices meant to be used only by one person or dipped into single dose medicine vials for multiple patients.

In the study, state inspectors visited 68 outpatient surgery centers in Maryland, North Carolina and Oklahoma. At each site, the inspectors followed at least one patient through the entire stay. The inspections were not announced ahead of time.

The study revealed that 67% of the centers have at least one lapse in infection control and 57% were cited for deficiencies. A few of the centers in the study had not been inspected in 12 years. Under current regulations, state agencies have the main responsibility for making sure the centers comply with federal standards.

In the Nevada outbreak, 63,000 patients were notified that they may have been exposed to blood borne diseases. Nine cases of hepatitis C were linked to the clinics and it is suspected that another hundred cases may also be related.

As a result of the study, United States Health and Human Services Secretary Kathleen Sebelius announced that her department will be expanding its hospital infection control action plan to include ambulatory surgical centers and dialysis centers.

Our military service members stand ready to put their lives on the line to protect the freedoms upon which our country is based. Yet, they are not provided the basic remedies available to other citizens who are victims of medical malpractice.
Under a 60-year-old Supreme Court ruling known as the Feres doctrine, service members are banned from suing the federal government for even the most egregious medical errors.

Pending before Congress is a bill that would remove that inequity. Rep. Maurice Hinchey, D-N.Y., is the lead sponsor of the bill, the Carmelo Rodriguez Military Medical Accountability Act, which would amend federal law to “allow members of the Armed Forces to sue the United States for damages for certain injuries caused by improper medical care, and for other purposes.”

Rodriguez was a Marine Corps platoon leader and Iraq war veteran who died at age 29 from a melanoma that military doctors at first correctly diagnosed but failed to refer for treatment and then later misdiagnosed as a birthmark.

“The 7-year old son and family he left behind currently have no legal recourse for this tragic case of malpractice,” Hinchey said in a statement. “Those who were at fault have not been held accountable.”

The bill recently gained the support of the 370,000-member Military Officers Association of America. The Association’s president, retired Vice Adm. Norb Ryan, wrote a letter of support to Rep. Hichey in which he noted, that legal recourse for medical negligence is available to all other citizens, including military dependents, military retirees and survivors and their dependents, and even federal prisoners and wartime detainees. He stated that MOAA agrees that it is inconsistent to treat service members differently.

The bill has also been endorsed by the American Association for Justice, the American Bar Association, Veterans Equal Rights Protection Advocacy, the Alliance for Justice, and Protecting Our Guardians.

The bill recently was approved by the full House Judiciary Committee and awaits a House floor vote.

Medical errors kill and maim thousands of citizens every year. Now, under the new health care reform legislation, something is finally being done to protect innocent potential victims of medical errors.

The new healthcare legislation, which was so vehemently opposed by many as being the destruction of healthcare, puts hospitals on notice that they must improve the safety and quality of care for patients or risk large fines.

The health care reform statute contains dozens of provisions designed to protect patients. These include including fining hospitals in an effort to reduce medical errors, hospital-borne infections and costly preventable readmissions. It is estimated that these three problems alone cost billions of dollars annually.

When considered individually the costs and extent of these problems is staggering.
Preventable readmissions cost the health care system about $25 billion every year, according to accounting firm PricewaterhouseCoopers.

In an effort to alleviate this problem, beginning in 2012, the Department of Health and Human Services will publish each hospital's readmission track record. A “readmission” is defined as a patient returning within 30 days of discharge. High readmission rates tend to indicate hospitals are ignoring patient issues or engaging in premature discharges.

In an effort to stem this issue, beginning in 2012, Medicare will stop paying hospitals for preventable readmissions tied to certain health conditions such as heart failure or pneumonia. In 2014, the policy will be expanded even farther.

The second penalty for hospitals addresses hospital-acquired conditions stemming from medical errors or infections.

The government currently gives hospitals an incentive payment for reporting their performance in areas such as patient satisfaction and care tied to treatment of conditions such as heart failure, pneumonia and hospital-borne infections.

Under the new statute, beginning in 2012, hospitals will be reimbursed according to their score. Higher scoring hospitals will receive higher payment and vice versa.
In 2015, the government will start reporting each hospital's record for medical errors and infections relating to Medicare patients.

About 15 million injuries result every year in the United States due to inferior medical treatment. These include more than than 30,000 people who die annually from catheter-related blood stream infections.

In 2015, Medicare will reduce its payments by 1% to hospitals with the highest rate of medical errors and infections. The government will also no longer pay hospitals for treatment when a Medicaid patient is harmed during a hospital stay.

It is anticipated that these financial incentives and penalties will greatly reduce injuries to patients and save millions of dollars at the same time.

From a consumer, patient and taxpayer perspective, these new common sense provisions are a big win.

We have recently written about the defective heart defibrillators sold by the Guidant Corporation and the dangers they present. Last week a federal judge in Minnesota rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable.

The plea agreement worked out between federal prosecutors and Guidant requires Guidant to plead guilty to two misdemeanors and pay a $296 million fine.

But, the judge held that the agreement was not in the best interest of justice and failed to adequately serve the public’s interest. He found that it did not adequately address the seriousness of the offenses.

The judge found that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have allowed the court to maintain control over Guidant to ensure that agreed upon remedial steps were implemented.
The judge also suggested other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.

After a hearing last month, several doctors and patients wrote to the judge urging him to reject the deal and arguing that former Guidant executives should be criminally charged in the case.

The case results from disclosures in 2005 that Guidant did not alert doctors and patients that some of its defibrillators had a defect that might cause them to fail. At least six patients died.

Recently, prosecutors charged in court papers that Guidant had knowingly sold potentially flawed defibrillators. But that issue was not addressed in the plea agreement. Instead, the company agreed to plead guilty to two misdemeanor charges that related to the completeness and accuracy of its filings with the FDA.

Defective medical devices have been a major source of injury and death for years. During previous administrations device makers have been basically unregulated due to lax enforcement by the Food and Drug Administration. This abdication of responsibility may soon end.

Federal regulators say they are moving to tighten their oversight of medical devices. Specifically included are infusion pumps, one of the most commonly used pieces of medical equipment. These pumps intravenously deliver drugs, food and other solutions to patients, and have been the subject of many failures for years.

Last Friday, the FDA issued preliminary guidelines that will require producers of infusion pumps to supply the agency with more test data on them before they can be approved for sale.

The FDA reports that over the last five years it has received reports of 710 patient deaths linked to problems with infusion pumps. FDA officials say they think the number may be significantly higher. Some of the reported deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.

The FDA estimates that two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes.
The new initiative by the FDA is the result of the Obama administration trying to reestablish the role of the FDA after years of criticism by lawmakers and others that it was a rubber stamp for medical device industry.

A few years ago several top FDA scientists complained that their superiors had ignored both their recommendations and policy guidelines in approving the sale of infusion pumps. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009.

A senior FDA official announced that new approach that the agency was taking toward infusion pumps might soon be extended to other types of medical devices.
The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Ill.; Hospira of Lake Forest, Ill.; and CareFusion of San Diego.

Under the infusion pump proposal, which could be completed by the end of the year, producers would be required to provide additional data to support the procedures they used to determine the effectiveness and safety of their devices. In addition, companies would have to conduct limited clinical trials to ensure their pumps were not susceptible to misuse or had design elements that could create errors.

The pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong software data accidentally. FDA officials found that not to be the case. In the FDA review of pump complaints many more deaths and injuries related to the devices were the result of defective product design and engineering.

Under current FDA rules, life-sustaining devices like heart defibrillators must be subjected to clinical trials before they are approved for sale. But the FDA clears the sale of many other critical devices like pumps without clinical testing based on a manufacturer’s claim that a new device is similar to a product already on the market.