Tag Archives: patient safety

Root Cause Analysis

Hungover Surgeons More Likely to Err

By ThinkReliability Staff

The headline probably isn’t shocking to anyone who’s woken up the next morning with a pounding headache and dry mouth.  Clearly one’s performance at work is going to be impacted by a night of unabated drinking.  However a recent Irish study, published this month in the Archives of Surgery, show surprising results regarding the lingering effect of alcohol consumption.  Their findings show that well into the day surgeons are more likely to make mistakes.

Modern surgical techniques, including laparoscopic surgery, require great manual dexterity and control as well as sustained mental focus.  It is common knowledge that both of these skills are impaired while intoxicated.  What is unknown is how these skills are impaired after one is no longer intoxicated, but obviously still affected.  In all but one test subject, their blood alcohol content (BAC) had returned to 0.00%.  Initial testing done in the morning showed no significant difference between test and control subjects, however later in the day there was a perceptible decline.  While the study was only a preliminary one, it indicates that more research is needed in this area.

A Cause Map can be especially helpful in a research environment because it helps define causal relationships.  In this case, the researchers focused on the effects of drinking the night previous.  But perhaps there are other reasons at play, such as fatigue, which contribute to the effect.  When searching for causes it is important not to focus in on one aspect, ignoring others, since all causes are required to produce an effect.

It is expected that surgeons wouldn’t actually drink while at work.  However, there are surprisingly no guidelines about when they should stop drinking beforehand.  Pilots are federally mandated not to drink at least 8 hours prior to flying or fly with a blood alcohol content (BAC) of .04% or greater.  Perhaps this study will generate an overdue discussion on the need for abstention prior to surgery.  Potential solutions, such as training or regulations, can be displayed directly on the Cause Map above the appropriate cause.

Root Cause Analysis

Tungsten Particles Remain in Patient’s Bodies After Clinical Trial

By ThinkReliability Staff

Thirty women who participated in a research clinical trial that hoped to revolutionize the treatment of breast cancer are now facing the possibility of long-term effects from tungsten particles left in their body or disfiguring surgery.  The trial involved radiation treatment that could be performed in one short session instead of over many weeks, offering obvious benefits to the patients.  However during follow-up checks after the trial, many women found particles of tungsten, a heavy metal, in their breasts and chest muscles.

Some physicians have recommended removal of the affected areas.  The choice between that, or living with the risk of tungsten particles, whose long-term effect has not been thoroughly studied, is an impact to the patient safety goal.  In addition the particles will look like calcium deposits, which can be an indication of cancer, in future mammograms, resulting in an impact to the patient services goal.  The device has since been recalled, which is an impact to the property goal, and at least one suit has been filed against the manufacturer of the device and the hospital performing the trial.  It is believed that 30 women are affected.

The health issue of leaving the tungsten within the patient’s body is caused by a particle of unknown long-term safety being deposited in the body.  The tungsten appears to have been shed by a device used during radiation treatment to prevent radiation from reaching other parts of the body.  It’s still unknown how a device that would shed particles into a patient’s body made it into a human clinical trial.  What is known is that the device went through the accelerated FDA approval process known as 510(k) for devices that are similar to devices that have already been approved.  It’s unclear which device was considered similar enough to allow for the approval of this one, but there have been many concerns that the FDA’s approval process is insufficient.

An in-depth look at the approval process of the FDA is currently underway to determine where changes in the process may result in a more thorough review and , most importantly, prevent an issue like this one from reoccurring.

Root Cause Analysis

Toddler Dies From Contaminated Wipes

By Kim Smiley

A 2 year old boy died December 1, 2010 following a routine surgery to remove a benign cyst from near his spinal cord and brain.  He appeared to be recovering well when he contracted bacterial meningitis and quickly succumbed to the infection.  Tests revealed the bacteria were a rare strain, Bacillus cerus, which is typically associated with food poisoning and not hospital infections.  How the patient was exposed to the bacteria was initially unknown, but now a potential source has been identified.

On January 5, 2011, The Triad Group, one of the nation’s largest medical product suppliers, announced a massive recall of alcohol wipes, swabs and pads because of contamination from the same rare bacteria, Bacillus cerus.  Products by this manufacturer were used to care for the boy during his hospital stay.  Although, a definitive link between the death of the boy and the recalled pads has yet to be established, there is a lawsuit pending.

Since the time of the recall, other people have come forward with possible cases of infection from Bacillus cerus from using the recalled products.  The FDA has launched an investigation.

Even through the investigation is not completed, this example can be built into a Cause Map based on the information that is available.  A Cause Map is an intuitive, visual method of performing a Root Cause Analysis. Any additional information can be added to the Cause Map as it becomes available and any necessary changes made.

When beginning a Cause Map, the first step is to determine the impact to the organizational goals and document them in an Outline.  In this case, the Safety Goal was impacted because a boy died and there is potential that more people were infected by the same harmful bacteria.  Once the impact to the goals is completed, Causes are added to the map by asking “why” questions. In this case, the boy died from bacterial meningitis because he was exposed to Bacillus cerus.  Next, we would ask “why” he was exposed to the bacteria.

Because the link between the recalled wipes and the death of the patient has not been officially determined, a question mark is included with that information when it’s added.  It’s important that all evidence or lack of evidence is documented on the Cause Map so that it is clear which Causes are agreed upon, known facts and which still need to be proven. Click on the “Download PDF” button above to see a high level Cause Map of this example.

The recall is a short term solution to this problem, but at least all products known to be contaminated should be removed from shelves and hospital storerooms.  It isn’t clear yet what steps are needed at the manufacturer to ensure safety of consumers, but the affected products will not be sold again until they are tested and deemed safe.

Root Cause Analysis

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Root Cause Analysis

Pregnant Woman Receives Wrong Medication

By ThinkReliability Staff

One of the most exciting moments in a young couples’ relationship is finding out that they are about to start a family.  New moms-to-be will take extra precautions to make sure their child has the best possible start in life – a healthier diet, a regimen on prenatal vitamins, limitations on coffee and so on.  However, that excitement is sometimes tempered with worry about the new baby’s health.

Mareena Silva had just found out she was expecting.  Six weeks pregnant and a bit under the weather, her doctor prescribed Mareena antibiotics to clear up an infection.  She filled the prescription at the local Safeway, and after taking the medicine as directed, became nauseous.  Upon checking the medication label, she made the horrifying discovery that she had been given the wrong medicine.

Instead of the antibiotics she had been prescribed, Mareena had taken a dose of methotrexate.  Methotrexate is a chemotherapy drug which targets rapidly dividing cells, like cancer…or embryos.  Her doctor urged her to vomit whatever medicine she could.  Then an ambulance rushed her to the hospital where she was given charcoal to absorb any medication remaining in her stomach.  Unfortunately, at this point all she can do is wait to see if her unborn child was affected by the unintended medication.  Methotrexate can cause serious birth defects, especially during the critical formative period during the first trimester, and even miscarriage.  Reports state that the baby faces 50-50 odds of developing abnormalities.

How did Mareena end up with a drug sometimes used to abort ectopic pregnancies?  The pharmacy staff dispensing the medication accidentally handed her one intended for patient in her late 50’s with a very similar name.  According to statements released by Safeway, pharmacy staff failed to repeat Silva’s name to her twice and verify her birth date – standard company policy.  The company has said that they are conducting an investigation to see why their procedure was not followed.  They will not be the only ones looking into the incident; the Colorado Pharmacy Board will also be reviewing the case.

Unfortunately mistakes like this are far too common.  No national agency tracks how many prescriptions are incorrectly distributed, and few states track such information either.  However, a 2003 study by Auburn University indicates that the dispensing error rate could conservatively be estimated at 1%.  That’s astonishing considering billions of prescriptions are filled each year.  How might those errors be prevented?  Dispensing medication is more complex than meets the eye, and there are a number of places a mistake can happen.  In this instance, Safeway’s pharmaceutical staff did not follow proper procedures for dispensing medication.  18.3% of dispensing errors were caused by procedures not followed according to U.S. Pharmacopeia’s 2003 study of medication error reports.

While the investigation will unearth further information about what happened behind the counter that day, a detailed Cause Map pictorially lays out how the incident occurred and why.  As the investigation unfolds, more information can be added and solutions can be developed to prevent future incidents like this one from happening.

Root Cause

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.

Root Cause Analysis

ER Wait Leads to Amputation

By ThinkReliability Staff

In some cases, it’s easy to equate “cause” with “blame”.  Sadly that seems to be the case for the family of a 2-year old triple amputee from Sacramento, where a near-certain malpractice suit looms.  The fundamental question in this story is whether or not Malyia Jeffers would have come so close to death had she been diagnosed and treated sooner, upon arriving at the emergency room.

Malyia, bruised, feverish and weak, waited with her family in her local hospital’s emergency room for five hours.  Originally assessed as sick with only a virus and a rash, her parents suspected something more.  Once again a triage nurse reassessed Malyia as non-urgent, with just a virus and rash.  Finally as her small body went limp, her frantic father barged past the ER nurses’ station to demand a second opinion.  That move is probably what saved her life, as blood tests soon confirmed liver failure due to group A streptococcus (GAS).  Two hospital transfers later, Malyia was on life support and blood pressure medication which kept her heart beating and ultimately saved her life.  The lack of oxygen to her limbs however forced doctors to amputate her left hand, fingers on her right hand and both of her lower legs three weeks after her initial infection.

According to the Center for Disease Control, “severe, sometimes life-threatening, GAS disease may occur when bacteria get into parts of the body where bacteria usually are not found, such as the blood, muscle, or the lungs…Streptococcal toxic shock syndrome (STSS) results in a rapid drop in blood pressure and organs (e.g., kidney, liver, lungs) to fail. While 10%-15% of patients with invasive group A streptococcal disease die from their infection, more than 35% with STSS die.”  Doctors know that early diagnosis and treatment are critical with aggressive bacteria such as GAS.  Would Malyia have fared better had she been seen sooner?

Emergency room waiting times have exploded in recent years.  If you were to ask someone on the street why, you might guess that the biggest contributing factor is the growing number of uninsured patients.  Not so, according to an extensive 2009 government report.  Long wait times are actually a symptom of a complex problem.  Vacant hospital beds, specialist availability and access to primary care all play a part in why emergency rooms, especially metropolitan ones, are constantly full.  Using a Cause Map, it is easier to see exactly why.

While Cause Mapping might help us see why ER wait times are a complex issue, it doesn’t alleviate the suffering the Jeffers family has and will face in the months and years to come.   Unfortunately it is tempting to point fingers and place blame.  Yet the reasons behind this tragic cause are not so simple.  Hopefully, process improvements will alleviate the suffering of those stuck waiting in the ER.

More information on the story can be found in the Sacramento Bee.  A 2009 GAO report also provided helpful information on the nation-wide issue of emergency room waiting times.

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 1)

By ThinkReliability Staff

A case study of an incident where the wrong surgery was performed on a patient was recently published in the New England Journal of Medicine.  Surprisingly, the study was published by the surgeon who performed the operation, because, in his words, ” hope that none of you ever have to go through what my patient and I went through.”  The surgeon also provided full disclosure to the patient – who requested that he also perform the correct surgery.

We will be analyzing this issue in two parts.  This week, we’ll be looking at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  (The timeline and process map can be seen by clicking “Download PDF” above.)  Next week, we’ll perform a root cause analysis of the issue.

The timeline of events shows a harried day where the surgeon in question performed a carpal tunnel release surgery with a patient who became upset about the use of anesthetic, then briefed the patient who would later receive the wrong surgery, then performed another carpal tunnel release surgery on a second patient.  Then the first patient became very agitated, resulting in an emotional conversation for the surgeon.  Delays resulted in a change of operating room and operating staff for the third patient, so the nurse who had performed the pre-procedure assessment was no longer participating in the procedure.

The  procedure was further delayed when the circulating nurse had to leave to find a tourniquet, since there wasn’t one in the operating room.  The surgeon spoke to the patient in Spanish (she did not speak English), which the nurse took as the time-out, so a real surgical time-out did not occur.  As per hospital protocol, the patient’s arm, but not the specific surgical site, was marked, but it washed off while her arm was being prepped for surgery.

It’s easy to see how this sets the scene for mistakes. Unfortunately, these kind of things happen, and so it is important that there are procedures in place to minimize errors.  The procedures here are the universal protocol, which are shown on the PDF.  Additionally, the parts of the process that were not performed, or were performed improperly, are noted in red.

Root Cause Analysis

Drug Shortages

By ThinkReliability Staff

Shortages of commonly used medications are beginning to impact patient safety.  The Institute for Safe Medicine  Practices (ISMP)recently asked healthcare workers to participate in a survey regarding drug shortages.  One out of three respondents said that shortages caused medication errors that could have caused harm to patients.  One out of four respondents said mistakes with medication reached patients, and one in five said that patients were harmed by the medication errors.  In addition, patient care has been impacted by the unavailability of some commonly used medications.  There have been reports of patients who woke up during surgery because sedative was being conserved.

Although the U.S. Food and Drug Administration (FDA) requires manufacturers to notify them when there are drug shortages that have no alternatives, there are no sanctions if they do not.  Because many of these drugs have alternatives, the manufacturers are not required to notify the FDA, and healthcare providers are oftentimes not aware of shortages until they run out of needed medication, causing last-minute scrambles and potentially leading to medication errors, such as when an alternative drug has a lower dosage than the drug being replaced.  Because healthcare providers are so accustomed to the dose of the replaced drug, medication errors can result amidst the confusion.

The FDA estimates that approximately 40% of the shortages are due to manufacturing problems, including safety issues identified in inspections, 20% of the shortages are due to production delays, and another 20% occur when manufacturers stop making drugs.  Although drug manufacturers will not confirm, it is assumed that as insurance companies start covering fewer and fewer brand names and generic prices continue to undercut brand-name prices, it isn’t profitable to make some medications.  The FDA does not have authority to require manufacturers to make medication.  Also contributing to the shortages are increased demand, and shortages of parts and raw materials required to manufacture the medications.

Trying to address these issues and come up with some solutions to the drug shortages is going to take more work than just identifying the issues.  To that end, groups representing doctors, anesthesiologists, pharmacists and safety advocates have invited the FDA, health experts, supply chain representatives and drug manufacturers to attempt to work through a solution earlier this month.  Hopefully they’re able to come up with some actions that will prevent further deaths and medication errors due to this shortage

Root Cause Analysis

Hospital Working Hard to Prevent Recurrence of Medication Errors

By ThinkReliability Staff

Experts believe that most medical errors go unreported, due to a combination of lax reporting laws, strict patient privacy laws, and ambiguous definitions of these medical errors.  However, Seattle Children’s Hospital is making an attempt to be forthright and accountable with not only its mistakes, but its plan for improvements.  Seattle Children’s made the news recently when it published the serious reportable events that had occurred there from 2004-2010, including two deaths resulting from medication errors.

Additionally, a third child died after a medication error in September 2010, but it has not been determined if the medication error contributed to the death and an adult patient was given the wrong medication but recovered at around the same time.

In response to these errors, Seattle Children’s is performing a root cause analysis by independent experts to determine the causes.  In the meantime, Seattle Children’s is making specific process improvements, such as allowing only pharmacists and anesthesiologists to administer calcium chloride (an overdose of which led to one of the deaths), as well as general training and reminders for staff.  The hospital held a patient safety day on Saturday, October 30th, 2010, where over 550 staff members participated in training and simulations designed to improve patient safety, with a focus on medication safety.

Although the root cause analysis of the various medication errors has not been completed, Seattle Children’s has identified some specific causes that may contribute to medication errors and is launching improvements to try and reduce the impact of these causes.  For example, interruptions to nurses when they are in the process of ordering, preparing or administering medications can lead to medication errors.  During the training, the staff discussed the types of interruptions that occur and what can be done to reduce them.

Medication errors are estimated to kill 1.5 million people per year, so Seattle Children’s is not the only medical facility that will find itself reeling after the deaths of several patients.  These other facilities should take Seattle Children’s lead and begin a serious attempt to reduce these errors, and deaths.

Want to learn more?  See our webpage about medication errors in medical facilities or watch the video.