Articles Posted in Patient Safety

young surgery team in the operating room .As The Boston Globe continues to report on the unsafe practice of concurrent surgeries, we want to remind patients and health care consumers that you have legal rights when you seek medical treatment.

In 2015, The Boston Globe Spotlight Team reported on the practice of concurrent, overlapping surgeries at hospitals in Massachusetts and across the country. Concurrent surgery occurs when a surgeon has one patient still in surgery and starts a procedure on another patient. Patients were not informed of the practice.

This month, the U.S. Senate Finance Committee urged hospitals to clearly prohibit the practice.

doctor-patient-2014.jpgDespite years of patient safety initiatives, reports of serious medical errors at Massachusetts hospitals are rising rapidly.

In 2013, Massachusetts acute-care hospitals reported 753 serious medical errors and other patient injuries, according to The Boston Globe. This was an alarming 70 percent increase from the previous year. Other hospitals, including those providing psychiatric and rehabilitative care, saw a 60 percent increase from 2012.

Some say the reason may be broader reporting requirements from the state. Since 2008, hospitals have been required to notify the state Department of Public Health about serious reportable events. In addition, the Department of Public Health now has a computerized system for reporting, a change from when medical errors were reported by fax.

In the past, hospitals had to report incidents which left a patient with a “serious disability.”
In 2012, the term became “serious injury” and it has new categories, including if a patient dies or suffers serious injury if a medical professional fails to communicate test results.

State officials say the new requirements have been fully implemented. That means the conversation should move on to safety and preventing medical malpractice.

There were very serious injuries reported in 2013 and these are the areas which saw the largest increases:

  • Patients who underwent a procedure on the wrong body part
  • Patients who were burned in an operative room fire or by a heating pack
  • Patients who were exposed to contaminated drugs or improperly sterilized equipment

Massachusetts is working to reform medical malpractice along with many other states and the federal government. In 2012, the state passed a health care cost containment bill. The goal of the bill was to save the state $200 billion in health care costs over the next 15 years. Measures included $135 million in grants to help community hospitals adopt electronic medical records and a 182-day cooling off period for injured patients to negotiate out-of-court with hospitals and physicians.

A few months earlier, some Massachusetts hospitals had also joined a plan which would allow doctors to apologize to patients for medical errors and work to settle malpractice claims out of court. It was based on a model developed by the University of Michigan Health System which was credited with reducing the number of lawsuits.

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medicalerrors.jpg
In 1999, the Institute of Medicine reported a stunning figure: Each year, up to 98,000 people were dying in U.S. hospitals. These people were not dying from the illness that brought them to a hospital, but from medical mistakes which happened during treatment there.

Over the years, there have been signs the number may be greater. One came in 2010, when the Office of Inspector General for Health and Human Services reported that hospital mistakes contributed to the deaths of 180,000 Medicare patients in just one year.

Now, a new study published in the Journal of Patient Safety reports between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These harms may include patients getting the wrong medicine, surgical errors, or infections resulting when safety procedures are not followed. That makes medical malpractice the third leading cause of deaths in the U.S., following heart disease and cancer.

ambulance-200.jpgA Boston paramedic believed to have been tampering with painkillers may have exposed 57 people to blood-borne illnesses in 2011. The city began notifying the potential victims this weekend, the Boston Globe reported.

The paramedic was relieved from his duties at Boston Emergency Medical Services on Sept. 6, 2011, when the alleged tampering with vials of both painkillers and sedatives was discovered. A total of 64 patients may have been exposed, but seven died after being transported to local hospitals. Their deaths are not believed to be have been related to the alleged medical negligence and drug tampering.

The city will follow up with letters to the potential victims and offers for free medical tests to determine if they were exposed to any infectious diseases. The drugs were allegedly tampered with during a six-week period in the summer of 2011.

The city continues to investigate the paramedic’s alleged actions. At this point, city officials say they do not know how the individual may have tampered with the medications, which are in a liquid form and injected. No criminal charges have been filed against the paramedic.

The news follows another case of alleged medical malpractice involving drug abuse by a medical professional in New Hampshire. In July, a medical technician named David Kwiatkowski was arrested. Kwiatkowski has been infected with hepatitis C since at least 2010 and is accused of exposing 30 patients, some at Exeter Hospital in New Hampshire, with the illness.

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medical-A copy.jpgSeven Massachusetts hospitals have announced a plan to start a new initiative to increase reporting of medical mistakes and cut down on medical malpractice lawsuits.

The “Road Map to Reform” plan for the test hospitals calls for doctors and nurses to take the unusual step of fully disclosing medical mistakes to patients and apologize. Three large insurers and a medical group have donated about $1 million to underwrite the initial work. The plan was developed by a coalition of physician, hospital and patient groups, which included the Massachusetts Medical Society, the state’s largest physician group. Legislation has also been proposed to assist the effort.

“This program appears to be a first step towards fair compensation of injured patients. However, the devil is in the details, and the foremost concern is that patient’s rights must be preserved,” said Massachusetts medical malpractice lawyer Marc Breakstone.

The test hospitals include Beth Israel Deaconess Medical Center in Boston, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Milton, Baystate Medical Center in Springfield, Baystate Franklin Medical Center in Greenfield, Baystate Mary Lane Hospital in Ware, and Massachusetts General Hospital. The plan is expected to be implemented statewide over the next several years.

Here is how the program will work: any medical professional can report a suspected medical error. The hospital will conduct a “root cause analysis” to determine if caregivers or hospital policy or systems were fault. If caregivers are to blame, they will apologize and the hospital and medical malpractice insurers will determine the amount of compensation.

Patients will be encouraged to hire a medical malpractice lawyer during negotiations with the hospital to evaluate whether a compensation offer is fair.

The Massachusetts coalition developed the plan with a $300,000 federal grant. It is based on a plan adopted by the University of Michigan Health System 10 years ago. The Michigan plan reduced the number of medical malpractice lawsuits in half each month and the time to resolve all claims fell from one year and four months to less than a year, according to a 2010 study published in the Annals of Internal Medicine.

The coalition is pushing for legislation to help implement the changes. Changes include a six-month mandatory “cooling-off period” after a medical error occurs before a patient can file a medical malpractice lawsuit. The coalition also wants to make physician apologies inadmissible in the event of a medical malpractice lawsuit.

Attorney Marc Breakstone noted that apologies are already inadmissible in court, so legislation must be carefully crafted to avoid limiting relevant evidence. “A doctor should not be permitted to say that he or she made a mistake, explain the mistake, then immunize the confession with an ‘I’m sorry’ at the end of the discussion.” He added, “Other changes in the legislation need to be studied carefully.”

Currently, settlements which involve a physician mistake attributed to hospital policy become part of the physician’s public record. One part of the proposed legislation would shield doctors from blame on their public records for medical mistakes attributed to hospital policy, though the medical mistake would remain public through the Department of Public Health.

But in cases where a physician is at fault, settlements would become part of the physician’s public record with the Massachusetts Board of Registration in Medicine and the National Practitioner Data Bank.

In addition to the Massachusetts Medical Society, the coalition involved in Baystate Health in Springfield, the Massachusetts Coalition for the Prevention of Medical Errors, and the Massachusetts Hospital Association.

Related:
Massachusetts Hospitals Promise Openness, Apologies, The Boston Globe

Check Your Doctor’s Safety Record Online
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patientalarms_web.jpgThe Food and Drug Administration (FDA) and the Joint Commission are looking to prevent cases of alarm fatigue, a type of medical negligence in which doctors, nurses and staff fail to respond to medical alarms, reported The Boston Globe.

In September 2011, the Globe reported that between January 2005 and June 2010, at least 216 deaths nationwide were linked to alarms on patient monitors that track heart function, breathing and other vital signs. At least 119 other patients have died since 2005 in cases involving warning signs on ventilators.

In many cases, doctors, nurses and other medical professionals failed to respond because of so-called “alarm fatigue,” a state where they had grown desensitized to the numerous alarms they heard on a hourly and daily basis, many often false. In some cases, nurses and staff have turned the medical alarm off or the volume down.

The FDA, which is responsible for reviewing medical devices, is now providing its reviewers training on alarm standards and safety, the Globe reported today. The reviewers evaluate 4,000 applications per year from manufacturers. An FDA official told the Globe he wants to make sure new products which are approved are fundamental to patient care and track what a company claims.

The Joint Commission, the national organization that accredits hospitals, has also made preventing this form of medical negligence a top priority. The commission drafted a national patient safety goal on alarm management last year. The commission’s advisers want more specific recommendations. The organization plans to survey 4,500 hospitals and 1,000 long-term facilities to develop those more detailed recommendations to prevent this medical negligence.

Several Massachusetts hospitals are attempting to implement patient safety changes on their own after being subject to medical malpractice lawsuits in alarm fatigue cases.

After settling a medical malpractice lawsuit in April 2011, Massachusetts General Hospital in Boston disabled the off switches on 1,100 cardiac monitors, installed alarm speakers and educated nurses about alarm fatigue.

UMass Memorial Medical Center in Worcester saw two wrongful deaths over four years due to failure to respond to patient alarms, according to the Globe in September 2011. The hospital responded by holding monthly drills for medical staff, arranging for seminars for hospital nurses and started sending low-battery warnings to nurses’ cell phones and pagers for life-threatening changes in patient conditions.

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A recent Supreme Court ruling is limiting court actions by injured patients who have filed claims against manufacturers of generic drugs.

The ruling was issued last year and said generic drugmakers do not have control over their labels and therefore cannot be sued for failing to alert the public. Under the 1984 Hatch-Waxman Act, generic drugmakers were not required to undergo the Food and Drug Administration’s (FDA) lengthy approval process if they could prove the generic drug was equivalent to the brand-name medicine.

In most cases, the Henry-Waxman Act requires generic manufacturers use the same labels as brand-name drugs, with dosing instructions and risks for injury. For this reason, judges have started to dismiss many product liability lawsuits against generic manufacturers while allowing those against brand-name drugs to move ahead.

In a March 20, 2012 article, The New York Times reported that a woman who had received the brand name for an anti-nausea medication had suffered gangrene – or a condition that results in dead or weakening body tissue. She sued the manufacturer Wyeth and won $6.8 million.

Another woman took the generic version of the defective drug, known as promethazine, and had to have her arm and forearm amputated because of complications from gangrene. Her case was dismissed last fall following the Supreme Court ruling.

The Supreme Court ruling comes as Americans are increasingly turning to generic medicines. As prices skyrocket and the economy struggles, many health insurance companies are requiring generics be filled before brand-name drugs. Doctors are required to show medical needs for the brand name over generic.

As a result, nearly 80 percent of prescriptions in the United States are filled generic and most states permit pharmacists to dispense a generic in place of a brand name.

What Can Consumers Do:
Support efforts to change the law. Public Citizen, a consumer advocacy group, has petitioned the FDA to give generic companies greater control over their labels. The move may allow generic drug users to sue. U.S. Rep. Henry A. Waxman, D-California, is also exploring ways to address the issue.

Talk to your doctor. Ask your doctor about the medicine being prescribed, the generic and potential side effects. If you are still concerned about potential injuries, ask your doctor to call your insurance company and request a brand-name.

Research any medication you use. Write down the name of the medicine you are prescribed, the medicine you receive at the pharmacy and research both drugs. Discuss any side effects with your physician.

Consider foregoing insurance. If you are really concerned and can afford the brand-name prescription, consider purchasing it. There are many discount drug programs which may help you reduce your costs. Check with any groups you are affiliated with, including AAA and AARP.

Contact your health insurance company. If the company has required you to use generic medications, ask if it has changed its policy and is now allowing use of brand-name medications.

Related:
Massachusetts Patients’ Bill of Rights and Preventing Medical Errors.

If You Are Injured by a Defective Drug.
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stethescope.jpgThe National Patient Safety Foundation (NPSF) is sponsoring its annual Patient Safety Awareness Week from March 4 to March 10. This year, the non-profit Boston organization is focused on increasing awareness about ongoing industry safety efforts and ways both health care professionals and patients can advance them to prevent injuries from medical errors.

The medical community will introduce a new professional certification this week, the Certified Professional in Patient Safety credential. Medical professionals from all disciplines can seek the certification. The NPSF is also focusing on patient engagement and calling on patients and families to communicate and partner with providers on safety efforts. It has released a new Ask Me 3 video, in which it advises patients to ask doctors:

  • What is my main problem?
  • What do I need to do?
  • Why is it important for me to do this?

Patients are advised to carry a notebook and pen and write down the answers to each question. Massachusetts patients can also take these additional measures to protect themselves from medical mistakes:

Physician Profiles Database. You can search for a doctor’s safety record in the state’s Physician Profiles database. The database provides information on criminal convictions, medical malpractice payments and board disciplinary actions during the past 10 years. Click here for the Physician Profiles database.

Online Research. There are many reputable websites which provide information on medical conditions, procedures and hospitals. One database is Medicare’s Hospital Compare, which compiles of a wide range of data, including patient surveys and hospital death rates compared to the national average. Click here for the Hospital Compare database.

Patient’s Advocate. Massachusetts law affords you the right to have a patient’s advocate with you at medical appointments. Having a patient’s advocate allows you to focus on communicating with the medical professional, while your advocate writes down important treatment instructions, the doctor’s response to your questions or ask their own questions when they observe unusual things.

Medical Records. You have an absolute right to obtain your medical records in Massachusetts. You do not have to disclose your reason for seeking your medical records. But you can expect to be charged for photocopies so ask for an estimated fee in advance.

Ask Questions Before Surgery. Talk to your surgeon before the day of the surgery and ask questions at the hospital. Questions may include how does the hospital sterilize its equipment and does the medical staff utilize a written patient safety checklist to make sure they do not miss a step.

Avoiding Medication Errors. Medication errors can happen at the hospital or your regular pharmacy. Before you leave the pharmacy, check the drug name, dose and open the bottle to make sure the medications are imprinted with the drug name and strength. If not, ask the pharmacist to show you the bottle from which medication was dispensed.

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