Tag Archives: patient safety

Root Cause Analysis

Medical Laboratory Errors

By ThinkReliability Staff

Surprisingly, many of what are considered laboratory errors do not actually occur in the lab.  But errors related to laboratory testing can negatively impact patient care.  We can look at the impacts and causes of errors related to diagnostic testing in a Cause Map, which allows us to visually diagram cause-and-effect relationships.

We begin this type of root cause analysis by determining the impacts to the organization’s goals.  In this case, because we want to consider all possible sources of diagnostic errors in a proactive analysis, we will look at the generic goals for an organization that provides healthcare.  Diagnostic errors can cause an impact to the patient safety goal because of the risk of impact to patient treatment.  Employees’ abilities to do their job is impacted because they may be receiving incorrect information from lab testing. There is a risk of impact to the patient’s treatment, which is an impact to the patient services goal.  Additionally, there is a risk of performing unnecessary treatment as a result of incorrect testing results, which could impact both the property and labor goals.

Once we have determined the impacts to the organization’s goals (and there may be more impacts for specific incidents involving diagnostic testing errors), we can ask “Why” questions to determine the causes that result in these impacts.  We will begin with the patient safety goal impact.  The patient safety goal is impacted because of the risk of an impact to a patient’s treatment.  This includes the possibilities of a risk of delayed treatment, risk of not receiving needed treatment, and a risk of unnecessary treatment.  Delayed treatment can occur from a delayed diagnosis, which could result from either delayed or incorrect testing results.

Delay of testing results can be caused by delayed reporting of results, potentially due to a lack of time requirement for reporting results and/or a lack of tracking these results.  A possible solution to delayed reporting of results can be to implement a standardized process for reporting results, which may include time limits or guidelines for reporting results.

Incorrect treatment – whether that is not getting needed treatment or receiving unneeded treatment – can result from an incorrect diagnosis.  An incorrect diagnosis can result from  an incorrect assessment of diagnostic testing.  An incorrect assessment can result from either an incorrect interpretation of laboratory test data or incorrect data from the lab testing.

Incorrect interpretation of lab testing can result from reports that are difficult to interpret, either due to a confusing layout or illegibility.  A solution to this is to have a standardized reporting form.   Other potential causes of incorrect interpretation include confusion of verbal reporting (such as over the phone) or results not being interpreted by a specialist.  Solutions that can reduce this confusion include providing reports electronically when available or repeating results when provided verbally, and making lab experts available for interpretation.

Three main reasons that incorrect data is provided as a result of lab testing is that the specimen is associated with the wrong person, possibly because a patient is misidentified, a specimen is mislabeled, or information is entered incorrectly into the computer.  Possible solutions are to use two patient identifiers and label the specimen in the presence of the patient.

Contaminated specimens can also cause incorrect testing results.  Specimens can be contaminated at collection, handling, or testing.  Any of these issues can be caused by insufficient quality control.  The risk of contamination can be minimized by a standardized quality control procedure.

Lastly, incorrect diagnostic data can result from the wrong test being performed.   This could occur due to equipment failure, an incorrect entry into the computer, or the wrong test being ordered.  More details about any specific incident can be added to the Cause Map based on evidence gathered in the course of an investigation.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Never Event, Root Cause Analysis

Use of Contraindicated Clip Leads to Death of Kidney Donor

By ThinkReliability Staff

In 2011, a kidney donor in Texas bled to death after her renal artery became open.  Sadly, her death was associated with the use of clips to close the artery – rather than staples – even though the use of clips was contraindicated for this purpose.  The instructions that came with the clips said this, as did several warning letters sent from the manufacturer in previous years.

We can look at this tragic issue in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  Because of the patient death, the patient safety goal is impacted.  Emotional impacts from employees resulting from a patient death can be considered an effect to the employee impact goal.  The use of a device other than intended is a result to the patient services goal and is considered a “never event” (an event which should never happen), resulting in an impact to the compliance goal.  A lawsuit resulting from the patient death is an impact to   the organization goal.  A total of four kidney donors are known to have died as a result of using these clips.

We begin with the impacted goals and ask “Why” questions to understand the cause-and-effect relationships resulting in this tragedy.  The patient died from a massive, sudden bleed caused by the bleeding of the renal artery which was open.  The renal artery had been opened as part of the kidney donor surgery, and had been closed using clips that slid off the renal artery.  The stump remaining on the renal artery after this kind of surgery is too short to allow the clips adequate purchase, and the clips slid off.  The hospital staff was unaware that these clips were contraindicated for this use.  Although a warning was placed on the instructions for the clips, these instructions were not kept in the operating room.  Additionally, the manufacturer sent out several letters to hospitals warning them not to use these clips for kidney surgery.  However, at that time, this hospital was not using the clips, and had forgotten about the letters when the clips were purchased.

Once the causes related to the issue have been captured, possible solutions can be brainstormed.  In this case, there are solutions for all the stakeholders in the event.  The operating team should use staples instead of these clips to close the renal artery.  The FDA has issued a safety notification to attempt to provide additional warnings against using these clips after kidney donation.  The hospital has implemented a system to track and document warnings and recalls related to medical equipment.  Some personnel in the medical community have requested that the warning not to use the clips after kidney surgery are printed directly on the clips, rather than on the operating instructions.  Dr. Amy Friedman, the Director of Transplant Services at Upstate Medical University in New York, who had raised concerns about using clips in kidney donors starting in 2004, would also like the warnings to include information that donors have died as a result of using these clips.  Although the FDA believes that the warnings up to this point have been sufficient, hopefully the additional actions will prevent another death from the use of these clips.

To view the Outline, Cause Map, and Solutions, please click “Download PDF” above.  Or click here to read more.

Root Cause Analysis

Four Patients Contracted Hepatitis C

By Kim Smiley

A cardiac catheterization lab was temporarily shutdown after four patients tested positive for hepatitis C.  All four patients have the same strain of hepatitis C which means they contracted the virus from the same source.  The investigation into this incident is ongoing, but no other connection other than the cardiac lab has been found between the four patients.

This issue can be analyzed by building a Cause Map, an intuitive root cause analysis that visually lays out the cause-and-effect relationships between the factors that contribute to an incident. The first step in building a Cause Map is to determine the impact to the overall organizational goals.  The basic information about an incident and the impacts to the goals are documented in an Outline.  In this example, the safety goal was impacted because four patients contracted hepatitis C and there is potential that more people were also infected.  The customer service goal is also impacted because hundreds of people need to be tested to ensure that they are not also infected.  Once the impact to the goals are determined, “why” questions are asked to find the causes that belong on the Cause Map.

Testing is necessarily because hepatitis C is often asymptomatic for many years so many infected individuals will not know unless they are tested.  Hepatitis C can be treated with medication and cured in 50–80% of cases, but there cases that cause severe liver issues. Hepatitis C is the leading cause of liver transplants.

651 patients had used the cardiac catheterization lab since August 2011 and all are being tested along with 30 staff members.  Test results take up to 10 days to process so the final results on how many people were infected aren’t available yet.

New Hampshire Division of Public Health and hospital officials are still investigating to determine the source of the hepatitis C.  It was likely medical equipment of some type since hepatitis C is spread through blood to blood contact.  Once the investigation is complete, any additional information can be easily added to the Cause Map so that it documents all relevant information for the issue.

Once the investigation is completed, the lab will be able to make whatever changes are necessary to ensure that all equipment is properly sterilized and this type of event doesn’t occur again.

Root Cause Analysis

Study Finds that Diabetics are at Risk of Medication Errors

By Kim Smiley

A new study found that nearly a third of diabetic hospital patients experienced a medication error in a one week period.  The study examined bedside data for 12,800 patients and 6,600 patient questionnaires for hospitals in England and Wales.  Medication errors when treating diabetics can have severe consequences because many diabetics require medication to maintain healthy blood sugar levels.  Blood sugar levels that are either too high or too low can result in significant illness and even death if untreated.

The two most common errors found by the study were failing to properly adjust medication when a patient’s blood sugar level was high (23.9%) and failing to sign off on the patient’s bedside information chart when insulin was given (11.1%).

This issue can be examined by building a Cause Map, an intuitive, visual root cause analysis format.  The first step to building a Cause Map is to determine the impact to the overall organizational goals.  In this example, the risk to diabetic patients is an impact to the safety goal.  The next step is to ask “why” questions and add the cause boxes to the Cause Map to illustrate the cause and effect relationships between all the factors that contributed to the issue.

In this example, the risk to the diabetic patients occurred because medication errors occurred and the patients required medication to maintain healthy blood sugar levels.  The study did not provide details on why the medication errors were made by hospital staff, but that information could be added to the Cause Map if it becomes known.  A Cause Map can be still be useful when only a high level map can be built because it can help identify an at risk population and a common problem, the diabetic patients and the medication errors, which could help identify where more research is needed or where resources could be directed.  To view a high level Cause Map of this issue, click on “Download PDF” above.

A potential solution that has been suggested for this problem is to improve training for hospital staff on how to properly treat diabetic patients.  A more detailed look at understanding exactly why the staff is making errors could help direct the training plan to the most needed areas.

Root Cause

Airman Loses Both Legs After Gallbladder Surgery

By ThinkReliability Staff

A former member of the US Air Force lost both legs after a routine gallbladder surgery and was medically retired.  During the surgery, his aorta was lacerated.  Subsequent delays meant his legs were without blood flow for hours.

After the damage to the aortic laceration was repaired, still more time passed before the patient was transferred to a civilian hospital for treatment.  The Air Force Medical Center did not have a vascular surgeon on-site.  By the time the legs were removed, the patient had lost more than 2/3 of his blood volume.

Multiple issues contributed to the injuries received by the airman.  We can examine these issues in a visual root cause analysis presented as a Cause Map.  First we determine the impacts to the goals.  The patient safety goal was impacted due to the potential for patient death during the surgery and aftermath.  Although there was no disciplinary action taken by the Air Force, a $54.8 million lawsuit has been filed that claims negligence.  Last but certainly not least, the loss of both of the patient’s legs can be considered an impact to the patient services goal.

We begin with the impacted goals and ask “Why” questions to determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient’s legs had to be removed after they were without blood flow for several hours.  The blood loss was caused by a laceration to the aorta, made during the gallbladder surgery, and the subsequent accidental suturing of the aorta during the repair.  The repair to the aorta was delayed as it was not immediately recognized.  A surgical resident was performing the operation, and it is likely inexperience and lack of supervisor from the supervising surgeon contributed to this delay.  Additionally, although the operating room staff was unable to get a blood pressure reading from the patient, it was assumed that the machine was malfunctioning. After the aorta repair, there was further delay in recognizing and treating the loss of blood flow to the legs.  As there was no vascular surgeon on-site, the patient was eventually transferred to a civilian facility, where both legs were amputated.

The facility has not commented on the case and so it is unclear what actions might be taken to protect patients.  There have been several charges of negligence at the facility in recent years.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Hospital Acquired Condition, Root Cause Analysis

New Research on the Impact of Hospital-Acquired Infections

By ThinkReliability Staff

Recent research has shown that in-hospital mortality for patients who acquire an infection in the hospital increases from 4.5% to 18.5%.  Hospital-acquired infections are infections obtained while a patient is hospitalized.  The three main hospital-acquired infections (or HAIs) are bloodstream infections (28% of HAIs), pneumonia (21%) and urinary tract infections (15%).

Not only does an HAI increase the mortality rate, it has other impacts as well.  We can look at these impacts, and their causes, in a root cause analysis demonstrated visually as a Cause Map.  For the purpose of this root cause analysis, we will limit our investigation to HAIs that occur during hospitalization in an intensive care unit (ICU).  We begin with determining the other impacts to the goals.  The patient safety goal is impacted due to the increase in mortality.  The organization goal is impacted because many insurers (including Medicare and Medicaid) will not reimburse for some infections obtained during hospitalization.   Additional treatment is required to treat the infection, resulting in an impact to the patient services goal.  The treatment for these infections normally results in an increased stay in the ICU (from an average of 8.1 days to 15.8 days), at a cost of $16,000.  It is estimated that 26.7% of all ICU stays result in at least one HAI.

Beginning with the impacted patient safety goal, we can ask “Why” questions to demonstrate the cause-and-effect relationships leading to the increase in mortality.  Increased mortality is due to the acquiring of an HAI.  HAIs result from the exposure to a pathogen and frequently occur in the ICU partially due to the increased risk of infection due to the underlying condition for which the patient is in the ICU.  There are two types of pathogens to which patients can be exposed: endogenous (essentially, from the patient’s own body) and exogenous (from visitors, healthcare providers, equipment, the environment, etc).  HAIs are highly related to the use of invasive support measures, which provide a path for either kind of pathogen directly into the patient’s body.  Specifically, the use of a central intravenous line is cited in 91% of bloodstream infections, mechanical ventilation is cited in 95% of hospital-acquired pneumonias, and urinary catheters are cited in 77% of urinary tract infection.

Because these invasive support measures are generally required for patient care, it’s difficult to see how these infections can be reduced.  However, some programs have been shown to substantially reduce HAIs – and the cost associated with them – by improving the culture of safety and compliance with preventive methods.  One such program in Michigan has reduced the rate of bloodstream infections associated with central lines from 7.7 to 1.3 per 1,000 catheter days.  Even without a dedicated safety program, insisting on hand washing and proper cleanliness procedures during the insertion, checking, and removal of invasive support measures can reduce the risk of HAIs.  Additionally, because the use of invasive support measures is so strongly correlated to HAIs, removal of these measures as soon as possible can also reduce the risk.

To view the Outline and Cause Map, please click “Download PDF” above.  Click here to read more about hospital-acquired conditions.  Or click here to read more about the latest research.

Root Cause Analysis

Living Donor Dies During Liver Transplant

by ThinkReliability Staff

In May 2010, a living liver donor died on the operating table.  Investigation showed that there were multiple issues related to the patient’s death.  The clinic was cleared of any wrongdoing in the death – and the surgeons there don’t believe that the surgical issues contributed to the death – but the clinic was cited for  violating rules designed to inform and protect donors.

We can look at all the related issues and see the cause-and-effect relationships in a Cause Map, or visual root cause analysis.  We begin with the impacts to the goals.  The patient death is an impact to the patient safety goal.  Patient deaths also cause impacts to related employees, which is an impact to the goals.  The citation for the violation of donor protection rules can be considered an impact to the compliance goals.  As a result of this incident, the clinic voluntarily stopped operations on living donors for 4 months, which can be considered impacts to the schedule and customer service goals.  Once the impacts to the goals are determined, we can begin with an impact and ask “why” questions to add detail to the Cause Map.

The patient death was determined to be due to a combination of cardiac arrest and excessive bleeding.  The cardiac arrest occurred because the patient’s heart was too weak to withstand surgery, and the patient was undergoing surgery.  The patient was donating a portion of his liver as a “living donor”.  Because the patient was not properly informed prior to his surgery, it’s unclear whether he would have continued if proper processes had been followed.  Donors are required to be given outcomes from both the site performing the surgery and national results.  The information the donor received was not up-to-date, as the paperwork had not been updated.   Additionally, because the donor’s needs may be opposite of the recipient’s needs, the donor’s advocate is required to be involved only in the donor’s care.  In this case, the advocate was also involved in the recipient’s care. Lastly, the patient received an abnormal EKG (which indicated that he may have had a prior heart attack) during his operation prep.  Although later testing showed that there was no reduction in blood flow to the heart, it’s unclear whether the patient was aware of these results or in a cardiologist was consulted.  The patient did not request a second opinion to determine whether or not he was healthy enough to handle the surgery.

Excessive bleeding occurred during the surgery and was thought to also have contributed to the patient’s death.  Bleeding occurred because the patient was in surgery.  Because the type of surgery the patient was doing is relatively new, it’s also possible that the surgeon’s lack of familiarity with the surgery may have contributed to the bleeding.  The bleeding wasn’t able to be stopped because it was difficult to find the multiple sources.  The patient was having laparasopically assisted surgery, which results in a quicker recovery time for the patient but also means that the bleeding source needs to be found through small holes, rather than one large incision.  Although the surgeons say it was not related to the patient death, a high speed blood pump was not used, though it was available, and the procedure for massive bleeding was not followed.

Whether or not these issues contributed directly to the patient’s death, they should still be reviewed as sources of improvement for the facility.  Other facilities as well can use this incident to examiner their own procedures and look for opportunities to increase patient safety.

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

Never Event, Root Cause Analysis

Patient Deaths Caused by Defective Defibrillator Wires

By Kim Smiley

A recent study determined that at least 20 patients have died as a result of defective defibrillator wires.  The wires, also called leads, connect the defibrillator to the heart to both monitor heart rhythms and deliver electric shock if needed.  Defective defibrillator wires have the potential to affect many people since more than 79,000 in the United States and 49,000 abroad have the implants.

This issue can be explored by building a Cause Map, an intuitive, visual root cause analysis method.  To begin a Cause Map, the first step is to determine what the impacts have been on the overall organizational goals.  In this example, the safety goal will be focused on since the study determined at least 20 patients have died as a result of this issue.  Once the impact to goals is found, the Cause Map is built by asking “why” questions and adding the information.

In this case, the patients died because their heart stopped.  The heart stopped because the patients were at risk of heart issues, had defibrillators implanted and the defibrillators malfunctioned.  Implanting defibrillators is a common treatment for certain heart conditions and many people have them.

The defibrillators malfunctioned because the wires used to connect the defibrillator to the hearts weren’t properly insulated and a short circuit developed, preventing the defibrillator from shocking the heart when it was needed.  The wires aren’t properly insulated because the silicone coating on the wires is breaking down over time.  The defibrillators are also malfunctioning because the issue with the wires isn’t one that can be found by routine monitoring so the problem isn’t identified until it’s too late.

The company that makes the wires is questioning the findings of the study and says that the information used was incomplete.

It’s also not clear at this time what the best course of action is at this time beyond continuing to monitor patients.  Removing the wires is considered to be a risky operation.

To view a high level Cause Map of this issue, click “Download PDF”.

Root Cause Analysis

Counterfeit Drugs Bought by US Oncology Practices

By Kim Smiley

Counterfeit Avastin, a cancer treatment drug, was purchased by as many as 19 U.S. oncology practices last year.  The counterfeit drug did not contain anything that would harm patients, but there were no active cancer fighting ingredients in it. There have been no reported cases of patients being given the fake drug, but there was a very real risk that this could happen.

How did this happen?  How could so many medical facilities fall for a counterfeit drug?

This example can be analyzed by building a Cause Map, a visual root cause analysis format that intuitively shows the cause-and-effect relationships between the many Causes that contribute to an issue.   In this case, many factors led to the oncology practices purchasing the fake Avastin.  The supplier offered the lowest price for the drug, about $400 less than the manufacturer’s price.  Additionally, the supplier appeared to be legitimate and had a very convincing salesman working for them.  The supplier appeared to have both US phone number and offices in the US.  In reality, the US number phones were being automatically routed to an overseas number, but this process was transparent to the medical practices.  The counterfeit drugs themselves also appeared to be authentic.  As technology improves it is becoming more difficult to spot the fakes.

At this point in the investigation it’s not clear whether the supplier knew the drugs were fakes.  The company claims it had no knowledge that the counterfeit product.  One thing that is clear is why counterfeit drugs appear in the supply.  There is a lot of money to be made. Some prescription drugs are extremely expensive and selling fakes can be very profitable.  The drug in this case, Avastin, sells for more than $2,000 for a 400-milligram vial.  There are also generally less severe punishments for crimes associated with prescription drugs compared with the illegal drug trade.

It is estimated that less than one percent of the drug supply is counterfeit in developed nations, but counterfeit drugs are a huge issue in developing countries.  Even a small amount of counterfeit prescription drugs  has the potential for a large impact on peoples’ health.  There are a number of solutions to this issue that have been suggested.  The US Senate has recently passed a bill that pushes for stronger punishments for counterfeit drug trafficking and calls for a universal system to track prescription drugs, but it’s unclear how this might be adopted into law.

To view a high level Cause Map of this issue, click “Download PDF” above.

Root Cause Analysis

Potential Dangers of Unpasteurized Dairy Products

By Kim Smiley

A new study by the Centers for Disease Control and Prevention (CDC) found that unpasteurized milk is 150 times more likely to cause food-borne illness outbreaks than pasteurized dairy.  The CDC found that there were 73 disease outbreaks, two deaths and many permanent disabilities caused by the consumption of unpasteurized dairy products from 1993 to 2006.  Pasteurized dairy products aren’t perfect either.  According to the same report there were 48 disease outbreaks from contaminated pasteurized milk and cheese resulting in thousands of illnesses and one death during the same time period.  But the CDC determined that unpasteurized milk is a far greater risk since more illnesses were caused by it and it is estimated that only about one percent of the population consumed unpasteurized dairy products.

This issue can be analyzed by building a Cause Map, an intuitive, visual format for performing a root cause analysis.  In this example, the safety goal was obviously impacted since hundreds got sick from consuming unpasteurized milk.  The Cause Map is built by asking “why” questions and adding the information onto the Cause Map in order to show the cause and effect relationships between all the factors that contributed to the issue.  In this example, people got sick because they were exposed to harmful microorganisms.  This occurred because unpasteurized milk is more likely to be contaminated with harmful microorganisms and consumers drank unpasteurized milk.

Unpasteurized milk is more likely to be contaminated because by definition it isn’t heated to kill microorganisms.  During the pasteurization process, milk is heated to 161 degrees and held there for about 20 seconds to kill anything harmful that might be in the milk.  There is the potential for all milk to get contaminated because cow manure is a potential source of contamination and it’s a constant in the environment where milk is produced.

People drink unpasteurized milk because they prefer it and it’s legal to buy in many states.  Some consumers prefer unpasteurized milk for a number of reasons.  Unpasteurized milk has a distinct taste some people like.  There is also a general trend of people moving towards less processed foods.  The pasteurization processes decreases the amount of a few nutrients in milk so some people think that unpasteurized milk is healthier for them.  There are also a number of people who believe that unpasteurized milk has healing properties.  There are testimonies that unpasteurized dairy products have reversed a number of health issues, including allergies, asthma, digestive disorders, arthritis and behavior problems in children.

There are some who believe the sale of all unpasteurized diary should be banned because of the risk of contamination and the resulting illnesses, but unpasteurized dairy has very active, vocal advocates that believe strongly that its sale and consumption should be legal.  Both the CDC and the Food and Drug Administration urge consumers to avoid unpasteurized dairy products because of the potential health risks.