Tag Archives: healthcare

Root Cause

Errors in Translated Medication Instructions

By ThinkReliability Staff

It’s well known that instructions on medication (both prescription and otherwise) can be confusing and lead to potentially lethal consequences.  (See our previous blog on the topic.)  Now imagine how much more danger there is if you don’t speak the language in which the instructions are printed.

A recent study published in the American Academy of Pediatrics Journal “evaluated the accuracy of translated Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population. ”  The study found significant issues with label accuracy with a popular language in an area with a large population of speakers of that language.  You can imagine how these results could get even worse for an area that had a smaller number of Spanish speakers, or for patients who speak a less common language.

One of the most striking examples was a man who received heart medication that was to be taken once daily.  The instructions were only partially translated and “once” (which means 11 in Spanish) was left on the instructions.  The patient took 11 pills (instead of 1) a day.

The study found an overall error rate of the prescription instructions that had been translated into Spanish by computer of 50%.  (86% of the pharmacies surveyed translated their prescriptions with a computer program.)  It is likely that patients with the incorrectly translated prescription instructions took the medicine incorrectly, resulting in the potential for serious harm, or even death.  This is an impact to the patient safety goal.  The rate of errors made by the computer means more work for pharmacists and translators due to the corrections that must be (or should be) made.  (Obviously this is not always happening.)  Patients receiving instructions they do not understand can be considered an impact to the patient services, compliance, and organizational goals.  (The study was performed in the Bronx, New York.  It is a law in New York City for pharmacy chains to provide translated labels for the top seven foreign languages in the area.)

Patients do not understand the directions because the patients do not speak English and the instructions are either not translated, or are translated incorrectly.  The instructions may be translated incorrectly because the computer program translates them incorrectly and there is an inadequate verification of the computer translation, because the pharmacist does not speak the language and/or there is no translator available (likely due to lack of funds or an uncommon language).   The instructions may not be translated if the pharmacy has no translating capabilities, also likely due to cost or an uncommon language.

An obvious suggestion is to improve the accuracy of the computer programs that do the translating, perhaps standardizing the translations among the different programs that do the job.  Pharmacists could also be provided with a guidebook of translations for standard pharmacy terms (such as take orally).  Additionally, translation software could be added to the computer programs currently used by pharmacists.

I have a simpler suggestion that I borrowed from the aviation industry.  I noticed the last time I flew that instead of having translations of the safety instructions in a dozen different languages, there were practically no words at all.  Instead, the airline used picture instructions.  I suggest doing something similar with medications.  (See my example of a picture for “take orally” on the PDF.  View the root cause analysis investigation and my picture by clicking “Download PDF” above.)

Because of the risk involved, it’s clear something needs to be done.  Prescription instructions are hard enough to understand in English, much less poorly translated into another language.  I’m sure suggestions will keep coming in, and surely some smart folks out there will come up with a way to reduce the potential for confusion and injury.

Root Cause

Therapy Equipment Delivers Radiation Overdoses for Years

By ThinkReliability Staff

In September of last year, a physicist at a healthcare facility was trained on use of the BrainLAB stereotactic radiation therapy system.  During this training, the physicist realized that the system had been incorrectly calibrated, as the wrong chamber had been inserted into the machine.  The facility realized that the chamber had been incorrectly inserted at installation in 2004, and that patients who used the portion of the machine calibrated by that chamber had received radiation overdoses over those five years.

The facility is working through the impacts of these errors, the causes of the error, and what needs to be done to keep an issue like this from ever happening again.

First let’s examine the impacts to the goals resulting from this error.  There’s an impact to the patient safety goal due to potential for deaths and injuries. (Because these patients  were already sick – sometimes very sick – the facility is still determining what impact the overdoses may have had.)  There has not yet been mention of an employee impact – the physicist who set up the machine is no longer at the facility – so we’ll just put a “?” after Employee Impact.  The event was reported to The Joint Commission (no reports were required by law), which can be considered an impact to the compliance goal.   The organizational goal was impacted due to potential lawsuits against the hospital.   The patient services goal was impacted because 76 patients received an average overdose of 50% (other patients received overdoses that were considered within the acceptable range for treatment).  Because radiation was involved, there is the potential for an environmental impact.  However, there is no evidence that any radiation leaked to the environment, we’ll put a “?” by the environmental goal as well.  Lastly, the property and labor/time goals were impacted because of the additional follow-up exams, testing, support, and treatment, which the facility will provide for all those affected by the issue.

Once we’ve determined the impact of the event, we can begin an analysis of how it happened.  Or, what were the causes?  The goals were impacted due to the overdose to several patients.  The overdose occurred because the radiation therapy machine was miscalibrated and the miscalibration was not discovered for five years.  The machine was miscalibrated because the incorrect chamber was installed and the chamber installation was not verified.  The physicist chose the wrong chamber and the equipment representative (who was on hand for the installation) did not notice the error.  At this point, it’s unclear why the physicist chose the wrong chamber and why the equipment representative did not notice the error.

The miscalibration was not noticed for five years because any re-calibration of the machine depended on the chamber which was incorrectly installed.  So although the machine was not delivering the correct amount of  radiation, the problem was with the calibration itself, resulting in a propagating error.  According to the facility, none of the patients showed any unusual side effects that would indicate they were getting too much radiation. However, some of the symptoms may take years to develop.  Additionally, no other staff members were trained on the equipment for five years.  It was a second staff member who was trained on the equipment who finally noticed the error.

Even though there are some questions still remaining in our Cause Map, we can develop some solutions, as the facility in question (as well as other stakeholders) is doing.   One suggestion is to do an external calibration of the machine – i.e., use a calibration method that is completely separate from the machine to determine if the correct amount of radiation is being delivered.  Also, have an independent verification that each piece of the equipment was installed correctly.   Require the equipment representative to sign off on the installation.  Last but not least, train other staff members to operate the equipment as backup.   The facility is working with the FDA to assist in its efforts to increase the safety of radiation use in healthcare settings.  (See our previous blog about this topic.)

Step 4 to avoid radiation therapy errors: verify HOW MUCH – how much radiation therapy is required, and how much is the patient actually getting.

Root Cause Analysis

Wrong Body Part Irradiated

By ThinkReliability Staff

In October of 2005 a therapist was preparing a patient for radiation therapy.  The therapist used a tattoo on the patient’s body to guide the radiation therapy.  Additionally the therapist brought up a photo of the area to be irradiated.  Unfortunately in this instance the tattoo and the photographs both indicated the patient’s esophagus – which was the site of previously delivered radiation therapy – instead of his upper spine, where the new radiation treatments were to be delivered.

Although there was no damage to the patient’s health, this incident impacted the facility’s patient safety goal, because of the potential for injury to a patient when radiation is delivered unnecessarily.  Additionally, it impacted the patient service goal because the radiation treatment was misdirected to the wrong body part.  The organization and compliance goals were impacted because of this reportable error.  Lastly, there are impact to the materials and labor goals due to the additional treatments that were required to deliver radiation to the upper spine.

The situation was complicated by the software error that brought up an old picture, indicating that the therapy should treat the esophagus.  To add to the confusion, there was a tattoo on the esophagus designating it as the site of the therapy.  There was nothing in the set-up notes to indicate that the patient had had a previous round of radiation therapy.  It is unclear whether the therapist had access to the patient’s chart, which would have designated the area to be irradiated and would mention the previous therapy.

The facility involved introduced measures to solve the software problems which resulted in the old photograph being downloaded.  Second therapy sites are now marked with double tattoos.  Information such as the therapy location and any previous radiation therapy sites are now included in the set-up notes.  Additionally, ensuring that the therapist has access to a patient’s medical chart will help allow the therapist to ensure a patient’s therapy is delivered properly.

Step 3 to avoid radiation therapy errors: verify the WHERE – which body part requires the radiation therapy

Root Cause Analysis

Wrong Radiation Treatment Delivered to Patient

by ThinkReliability Staff

A cancer patient was scheduled to receive two radiation therapy treatments – radiation to her upper lung every day, and radiation to her mediastinum on alternating days.  However, a mix-up resulted in her receiving the program for her lungs to her mediastinum (which resulted in ten times the prescribed dose) and receiving the program for her mediastinum to her lungs (which resulted in one-tenth the prescribed dose).  The patient died of cancer later in the year.

This incident impacted the facility’s patient safety goal, because the patient died of cancer, possibly because the radiation dose to her lungs was too low to effectively fight the cancer.  Additionally, it impacted the patient service goal because the patient received the wrong radiation treatment.  The organization and compliance goals were also impacted because of this reportable error.

How did this happen?  The patient had a complex radiation therapy program, involving two different treatments to two different parts of her body simultaneously (radiation was delivered to different body parts on alternating days). Obviously some confusion on the part of the staff was involved, and because only one therapist was present for administering the therapy, there was no oversight, or anyone else to catch the error.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Unless it is medically necessary, avoiding administering two different therapies at one time would reduce the risk of this type of confusion.  The treatment a patient is receiving should always be verified before the treatment is administered.  Also, because of the high level of risk to patients, more than one therapist should be present.  (The facility involved in this particular incident has implemented a rule that more than one therapist be present for complex treatments.  Although it’s not clear exactly what’s meant by complex, surely this would qualify.)   Hopefully these steps, when taken by facilities who deliver radiation therapy to patients, will reduce the risk of radiation errors.

Step 2 to avoid radiation therapy errors: verify the WHAT – the type of treatment the patient is receiving.

Root Cause Analysis

Radiation Therapy Delivered to Wrong Patient

By ThinkReliability Staff

In March 2006 a patient (who we’ll call Patient A) reached an exciting milestone. She had just completed radiation treatment for a brain tumor.  However, she was not told that her radiation therapy was complete.  Instead, the therapist opened the medical chart of another patient (Patient B) and left.  Another therapist came in, saw the chart for Patient B, and noticed that Patient B required radiation treatment for breast cancer.  The therapist then delivered that radiation to Patient A.

This incident impacted the facility’s patient safety goal, because of the risk of injury to Patient A.  Additionally, it  impacted the patient service goal, because Patient A received unnecessary radiation.  The organization and compliance goals were also impacted because of this reportable error.

How did this happen?  Patient A was at risk for injury because of the delivery of unnecessary radiation.  She was given radiation meant for another patient because the therapist delivered the radiation and Patient A, not knowing that her own treatment was complete, didn’t know to stop it.  The therapist did not effectively verify the identity of Patient A, instead going off the chart that had been opened by the previous therapist, for unknown reasons.  Had the first therapist told Patient A that her therapy was complete, or had the first therapist not opened another patient’s chart, or had the second therapist verified the identity of Patient A, this error would probably not have occurred.

Based on the causes of this incident, we can develop action items to be taken by the facility to reduce the risk of this type of incident happening again.  Therapists should not open charts until they have verified the identity of a patient.  They should verify a patient’s identity before treatment, and they should review the outcome of a treatment with the patient.  After all, had any of these steps occurred, Patient A would have been able to properly celebrate the end of her radiation therapy, rather than worry about a risk to her health.

Step 1 to avoid radiation therapy errors: verify the WHO – the identity of the patient.

Root Cause

Hospital-Acquired Infections Sepsis and Pneumonia

By ThinkReliability Staff

Infections of any kind acquired in a hospital are undesirable from the perspective of both the hospital and the patient.  After all, patients go to a hospital to get better, not sicker.  Until recently, the incidence of these sorts of infections has been difficult to determine, with inconsistent reporting requirements across the country and difficulty determining the sources of such infections.  However, a recent study in the Archives of Internal Medicine has determined some staggering numbers related to two hospital-acquired infections, sepsis and pneumonia.  Together, these two infections result in 48,000 deaths and $8.1 billion in additional costs per year.  A total of 1.7 million patients contract infections at hospitals every year.

Sepsis is a bloodstream infection.  The study found that nearly 20% of patients who contract sepsis after invasive surgery at a hospital will die from it.  On average, a patient who contracts sepsis can expect 11 additional days at the hospital, at a cost of $32,900.  Sepsis contracted in hospitals is generally a bacterial infection, caused by bacteria in the bloodstream (known as bacteremia).  A patient must be exposed to bacteria in order for the bacteria to access the bloodstream.  Bacterial access to a patient can be caused by ineffective infectious control procedures.

Nosocomia (or hospital-acquired) pneumonia is an infection of the lungs.  Like sepsis, in a hospital setting it is generally caused by a bacterial infection when bacteria enter the lungs.  Also like sepsis, this requires bacterial access to the patient.  More than 11% of patients who contract nosocomial pneumonia after invasive surgery will die.  On average, a patient with nosocomial pneumonia will spend 14 extra days in the hospital, at a cost of $46,400.

To prevent these types of bacterial infections, every employee in a hospital must practice effective infectious disease control.  Each hospital must develop infection control procedures to aid in preventing the spread of disease.  As an example, here we’ll look at the infection control procedure for  pre-surgery.  This extremely simple procedure was developed based on the CDC’s Surgical Site Infection FAQs.  If a patient has hair in the surgical area, it should be clipped, not shaved, to avoid infection.  If a patient is high risk, he or she may receive antibiotics before the surgery.  The patient’s skin will be cleaned at the surgical site to avoid introducing the patient’s skin bacteria into the surgical wound.  Before the providers begin surgery, they will wash their hands and arms up to the elbows thoroughly and don protective wear.  This helps prevent bacteria carried by the providers (including bacteria from the providers’ previous patients) from infecting the patient.

This is just one example of a process that demonstrates infection control to protect patients from hospital-acquired infections.  More can be developed, based on a hospital’s best practices.  What’s important is the focus on infection control to protect patients.

Root Cause Analysis

Applying the Proposed FDA Initiatives to Fatal Radiation Overdose

By ThinkReliability Staff

Recently, we posted two blogs about medical radiation overdoses resulting from cancer overdoses –  a patient who overdosed on radiation therapy for breast cancer, and a second patient who overdosed on intensity modulated radiation therapy for tongue cancer.  Because of the risk of these types of incidents, proper control of radiation in medical settings has become a high priority for several investigations.  Recently, the U.S. Food and Drug Administration (FDA) released an initiative to control unnecessary radiation exposure from medical imaging.  Many of the initiatives to reduce exposure from medical imaging can also be applied to reduce exposure from
radiation therapy.

We will look at one of our previous blogs – the intensity modulated radiation therapy overdose – and discuss how the initiatives proposed by the FDA may have prevented the death of Scott Jerome-Parks.  There are two radiation protection concepts for the initiatives – justification for use of radiation-related procedures, and optimization of the dose during the procedures.

The justification portion of the initiative aims to ensure medical justification and informed decision-making by patients and their doctors.  In order for the decisions to be informed, the FDA notes that patients must have comprehensive understanding of both the risks and benefits of the use of radiation.  If patients were more aware of the risks of the use of radiation, it’s possible that Jerome-Parks and others would have chosen alternative approaches or would have selected facilities based on their experience or safety rating.  Currently, because reporting requirements for errors involving radiation are inconsistent (or there are none at all), it’s nearly impossible for patients to make these sorts of comparisons.

Another issue raised by the Jerome-Parks case is the lack of safeguards on the radiation equipment itself.  Jerome-Parks received seven times the radiation dose on three occasions, and nobody noticed.  The FDA proposes that equipment designed to deliver radiation be equipped with safeguards that optimize radiation doses and/or provide alerts when radiation exceeds a reference level or range.  These safeguards would alert providers when radiation doses are higher than expected, giving them another chance to verify that the settings are correct.  Hopefully this will prevent many occurrences of radiation overdose.

The FDA has also noted the lack of training and quality assurance practices for some radiation delivery practitioners.  Several medical organizations are attempting to create standardized training and quality assurance methods to provide practitioners with the information they need to properly use radiation delivery equipment.  The FDA is also planning to partner with the Center for Medicare and Medicaid Services (CMS) to incorporate appropriate quality assurance practices into accreditation and participation criteria for medical facilities, further
supporting the safe use of radiation delivery equipment.

Looking at the two previous radiation overdose cases, we can see the detrimental effect of radiation therapy when not used properly.  Because of the great potential impact to patient safety, all involved parties MUST work together to ensure less patient risk from radiation therapy.

Root Cause Analysis

Childhood Obesity – A Community Problem

By Kim Smiley

It takes a village to raise a child . . .and to keep one from becoming obese. Childhood obesity is now being recognized as, at least partially, a community problem with community-based solutions. At the peak of the “obesity epidemic”, 32% of children in the U.S. were classified as overweight and 16% were classified as obese.

Obesity can result in a greater risk of disease (more than 90% of overweight children have at least one avoidable factor for heart disease.) This is an impact to the health goal of a community, and the nation. Obesity is the result of sustained weight gain. Weight gain is a simple balance problem. If calories consumed are greater than calories expended, as a result of too many calories consumed, too few expended, or both, weight gain will result. Usually obesity is caused by both.

First we’ll look at the causes of consuming too many calories. Too many calories are consumed when children eat high-calorie, low-satisfaction foods. In many cases, this is because a child has access to these types of foods and because healthy choices are not available. This is true with family, and at school, which generally contribute equally to caloric intake. A high proportion of foods consumed at school may be unhealthy; schools must offer healthier choices. Some schools have done away with soda and candy, but more healthy choices must also be offered. Students bringing their own lunches may suffer doubly from healthy food not being available at home, due to a lack of access or affordability. The all-too-many areas in the country that do not have access to healthy food at supermarkets or farmer’s markets are known as “nutritional deserts”, most frequently found in low-income and/or rural areas. Communities must improve access to healthy food, at school and at home.

The other part of the equation is calories consumed, otherwise known as exercise. However, children don’t need time on the treadmill; they need safe places to play outdoors or a safe route to walk or bike to school in order to get exercise. They also need physical education (PE) at school, and they need to see the importance of physical activity (something their parents may not be modeling at home, based on adult obesity rates, which are extremely high as well). Low-income and/or rural areas are less likely to have safe places to play outdoors, or a safe way for children to bike/walk to school, so these children are disproportionately affected by obesity. Communities must provide an outlet for physical activity for children.

On the downloadable PDF (download by clicking “Download PDF” above), we show the causes and solutions in a Cause Map, a simple intuitive format that fits on one page. The causes are solutions shown here are from the perspective of the community – causes and solutions that can be controlled by a community. If communities began implementing these solutions, the childhood obesity epidemic would be a thing of the past.

Want to learn more? See the Institute of Medicine report, issued in 2007.

Never Event, Root Cause Analysis

We Regret to Inform You We’ve Removed the Wrong Leg . . .

By ThinkReliability Staff

Performing surgery on the wrong body part or wrong-site surgery is a “never event” as defined by the National Qualify Forum (NQF), and can have serious health consequences for a patient.

We can use a Cause Map to determine some ways to prevent wrong-site surgery. Some of the common errors leading to wrong site surgeries are presented in the Cause Map found on the downloadable PDF. They include: time pressure, lack of paperwork, misreading radiography, not marking or incorrectly marking the surgical site, and marking the wrong site.

Once the root cause analysis is complete, solutions are brainstormed and placed with the cause they control. In this example, we use the solutions to create a basic Process Map for the surgical preparation procedure to prevent wrong site surgeries. The solutions are numbered based on the order they appear on the Process Map. It’s clear that consistent adherence to this Process Map would result in fewer wrong-site surgeries.

Click on “Download PDF” above to download a PDF showing the Cause Map and Process Map.

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