Shortage of Life Saving Cancer Drug

By Kim Smiley

Shortage of a lifesaving cancer drug, methotrexate, has hospitals scrambling to find enough drugs to treat patients. Methotrexate has long been a treatment for acute lymphoblastic leukemia, or ALL, and a type of bone cancer called osteogenic sarcoma.  A particular form of methotrexate without alcohol-based preservatives is needed to treat ALL because a high dose must be injected directly into the spines of patients and preservatives can be toxic and cause paralysi at such a high dose.  With treatment, ALL can be cured more than 90 percent of the time.  What makes this drug storage particularly heart breaking is that ALL most often strikes between ages 2 to 5.  If hospitals don’t have adequate supplies of preservative free methotrexate, children will die from a disease that is largely curable.

This issue can be analyzed by building a Cause Map, an intuitive, visual root cause analysis.  A Cause Map is built by determining the impact to the overall goals and then asking “why” questions to add causes that contributed to the issue and show the cause-and-effect relationships between the causes.  In this example, the safety goal is clearly impacted because there is a risk of patient death.

To begin adding causes to the Cause Map, we could ask why that is true.  Patients may die because they have cancer, the doctors may not be able to treat the cancer and the cancer is fatal if untreated.  Why might the doctors be unable to treat the cancer?  There is a shortage of the required medication because the plant that was the primary supplier for US is shut down.  The plant is voluntarily shut down so that significant manufacturing and quality issues can be addressed.  In order to understand the issues, it is also worth asking why one plant manufactured so much of the supply of methotrexate.  As much detail as necessary can be added to the Cause Map.  Once the Cause Map is built, the information can be used to brain storm solutions and determine which should be implemented.  To view a high level Cause Map of this issue, click on “Download PDF” above.

In this example, the FDA is currently negotiating with five plants that are approved to manufacture methotrexate to increase their production of the drug.  In the meantime, the plant that was shut down has worked with the FDA to allow distribution of some of the methotrexate that was manufactured, but not shipped prior to the shutdown.  Hospitals still have a smaller supply of methotrexate than would be desired, but all patients’ needs are currently being met.


Patient Brain Damaged Due to Malpractice and Surgeon Inexperience

By ThinkReliability Staff

When complications occur during surgery, an experienced surgeon and surgical team can help ensure a positive outcome for the patient.  Inexperience can lead to problems – in this case, brain damage.  A special concern in this case is that hospital documentation advertised that the surgeon was accredited when he did not meet the requirements.  They were convicted of fraud.

When a patient suffers brain damage, the patient safety goal is impacted.  Any time the patient safety goal is impacted, an investigation  should be performed.  In this case, we can look at the issue in a Cause Map, or visual root cause analysis.

With the Cause Mapping approach, we begin with the impacts to the organization’s goals.  In addition to the brain damage, the patient also suffered from  loss of eyesight, another impact to the patient safety goal.   The  doctor was convicted of malpractice, which is an impact to the employee.   Additionally, the hospital was convicted of fraud, which can be considered an impact to the compliance goal.  The hospital was assigned $178 million in compensatory damage and $10 million in punitive damages.    Last but not least, the patient services goal was impacted due to the uncorrected leakage in the patient’s abdomen.

We can begin with the first patient safety goal and ask “why” questions to add more detail to the map.   In this case, the patient suffered brain damage as a result of a stroke.  The patient suffered a stroke because of uncorrected leakage in the abdomen.  The leakage occurred as a result of bariatric surgery, potentially due to the inexperience of the surgeon.  In addition,  the leakage was not treated for 8 days.  Again, it is believed that the inexperience of the surgeon contributed to insufficient patient care.

The fact that the leakage was untreated for 8 days was considered reason for malpractice.  While the patient was on a respirator due to his stroke, he was not treated with eye drops, resulting in a retinal burn that left him blind.  The hospital was convicted of fraud because it used documentation with the accreditation seal from the American Society Bariatric Surgery’s Center of Excellence referencing the surgeon who performed this surgery.  However, the surgeon did not meet the requirements for accreditation.  He had performed an insufficient number of surgeries and had not taken an adequate number of bariatric education courses to meet accreditation  requirements.  The use of the seal in hospital documentation was determined to be fraud.

This case reinforces the necessity for patients to be active in their own care in selecting their physicians.  Specifically, patients should perform  their own investigation of their surgeon’s qualifications.  However, in this case accurately determining those qualifications would have been difficult due to the associated fraud.  If the patient had asked how many surgeries the surgeon had performed, he may have decided to go elsewhere.

To view the Outline and Cause Map, please click “Download PDF” above.

Patient Death over the Holidays

By ThinkReliability Staff

On December 31, 2010, a patient entered St. James’s Hospital in Leeds for a urinary tract infection.  Unfortunately for the patient, the hospital was experiencing nursing shortages due to the holiday and the patient died 3 days later.  The death of the patient is an impact to the patient safety goal.  We can look at this incident in more detail, based on the information available, in a root cause analysis presented in a visual Cause Map format.

Besides the impact to the patient safety goal, there was an employee impact due to the staffing shortage.  The patient’s son noted mistakes in the patient notes and charts (an impact to the compliance goal) and received a settlement from the National Health Service (NHS).  Last but certainly not least, the patient services goal was impacted due to the delay in appropriate treatment that the patient experienced.

To add more detail to the Cause Map, we can ask “why” questions.  The patient’s death was due to the combination of a urinary tract infection and the delay in appropriate treatment.  The urinary tract infection was caused by a catheter in place as the patient was bed-bound due to a previous stroke.   The delay in treatment was two-fold: first, the patient was not given another dose of antibiotics for 24 hours after the initial dose administered in the emergency room.  Second, the medication that was eventually given was not effective as the infection was resistant to that particular antibiotic.  The junior doctor who prescribed the medication failed to notice the antibiotic resistance and there was no over check of the prescription, likely due to the staffing shortage.

The patient was not monitored for 15 hours during the first 24 hours she was in the hospital.  Neither the nurses (again, likely due to the shortage) nor the consultant who performed morning rounds monitored her during this time.  This likely also led to mistakes in the patient’s notes and chart (which her son says number 140) and contributed to the patient’s death.  The NHS and hospital involved have developed an action plan to ensure that lessons are learned from this incident.

To view the Outline and Cause Map, please click “Download PDF” above.

High Heels May Increase Risk of Strains

By Kim Smiley

A new study found that habitually wearing high heels changes the biomechanics of how a woman walks and may increase the likelihood of strains, even when the heels are off.  The research compared young women who had worn high heels at least 40 hours a week for a minimum of two years with women who never or rarely wore heels.  Their walks were studied by using motion-capture reflective markers and electrodes to track leg-muscle activity.  The lengths of the muscle fibers in their legs were measured by ultrasound probes.

This example can be built into a Cause Map, an intuitive root cause analysis format.  A Cause Map lays out cause and effect relationships and helps illustrate how all factors that contribute to an issue relate to one another and to the overall problem.  To view a high level Cause Map of this issue, click “Download PDF” above.

After scrutinizing the walks of both those who favored heels and those who didn’t, the researchers determined that habitually wearing heels changed how the women walked, even when their feet were bare.  The high heel wearers took shorter, more forceful strides and kept their feet perpetually in a flexed position with their toes pointed.

Why does this matter?  The change in walking biomechanics means that the high heel wearers primarily engaged their muscles while walking.  The control group who rarely wore heels used a combination of tendons and muscles to walk.  The use of the tendons is important because they act as springs in the body and have the capacity to store energy.  Engaging tendons while walking is more efficient.  The high heel wearers had to use more energy to cover the same amount of ground as the control group and this can cause muscle fatigue. So this means that wearing high heels causes the muscles to be engaged more while walking, greater use of the muscles increases everyday strain on muscles and this may in turn increase the chance of strain injuries.

One of the more interesting findings was that frequently wearing high heels caused shortened fibers in calf muscles so that the changes in walking biomechanics remained even after high heels were removed.   It’s also interesting to note that the volunteers who participated in the study were young (the average age was 25) meaning that the changes the researchers found are not something that takes decades to occur.

The researchers recommend limiting high heel wear to a couple of times a week if possible and removing shoes when it’s an option, such as when seated at a desk.