Tag Archives: patient safety

Root Cause

CDC Finds that 1 in 25 Patients Acquire an Infection While in the Hospital

By Kim Smiley

A recent headline from the New York Times reads “Infections at Hospitals Are Falling, CDC Says”.  That sounds like fantastic news right?  Well, what about this one from the same day from the Washington Post: “One in 25 patients has an infection acquired during hospital stay, CDC says.”  One in 25 doesn’t seem like great odds to me.  The two headlines give very different impressions of the problem, so which one is right?

The truth is that both statements are accurate, but neither tells the complete story.  To really understand the situation, you need to read a lot more than just the headlines. This is a good analogy for what happens in meetings every day.  Something goes wrong and everybody thinks they know what THE problem is or what is THE root cause.  Many times when people argue they aren’t really in disagreement, they are just focused on different parts of the same puzzle.

Building a Cause Map, a visual format for performing a root cause analysis, can help reduce miscommunication.  The first step in the Cause Mapping process is to fill in an Outline.  The top of the Outline lists the basic background information.  At the bottom of the Outline, there is space for listing the specific impacts to the overall goals.  People may argue about what THE problem is, but it’s hard to argue when specifically listing how the problem impacts goals.  For example, most people would agree that increased cost of healthcare is an impact to the overall economic goal of a hospital.  It may sound counterintuitive, but adding detail helps clarify the situation, when defining the problem and when actually determining what went wrong.

In the case of those headlines listed above, both refer to a recent study by the Center for Disease Control and Prevention that found that about 1 in 25 patients in US hospitals in 2011 acquired at least one infection based on data from 11,282 patients treated at 183 hospitals in 10 states.   (The total number of patients who acquired at least one infection is over 700,000.) The study estimated that around 75,000 of these patients died, but didn’t provide information on whether the deaths directly resulted from the infections.  The study also didn’t include nursing homes, emergency departments, rehabilitation hospitals and outpatient treatment centers.  Previous estimates put the number of infections each year at 2.1 million in the 1970s and 1.7 million from 1990 through 2002. The rate of infections also varies widely from hospital to hospital.  There is uncertainty in the data available, but the trend seems to be going in the right direction, even though the problem of hospital-acquired infections remains significant.  Before working to reduce the risk of a problem, it’s important to lay out all the facts and understand what exactly the problem is.  That generally requires more than a simple statement, which is why the Cause Mapping uses a formal Outline to define a problem.

After the Outline is completed, the next step is to analyze the issue by building a Cause Map by asking “why” questions starting with one of the impacted goals.  Hospital acquired infections are an impact to the patient safety goal so we could begin by asking “Why are patients getting infections in hospitals?”  This occurs because they are exposed to a pathogen.  Why?  There are pathogens at the hospital because many sick people are there for treatment.  Inadequate cleanliness also plays a role.  Additionally, the pathogen is able to infect the patient.  You would continue asking questions to determine why patients are being infected until you reach the desired level of detail.  Generally, the bigger the problem, the greater level of detail is needed.

To view a completed Outline and a Cause Map of this issue, click on “Download PDF” above.

Root Cause

New Studies Shed Light on Statin Side Effect Concerns

By Kim Smiley

Usage surveys have found that the majority of people prescribed statins in the United States discontinue using them within a year. The number one reason stated by patients for stopping statin use is concern with side effects.

This issue can be analyzed by building a Cause Map, a visual method for performing a root cause analysis.  The first step in the Cause Mapping process is to define the problem by filling an Outline with the basic background information (who, what, when, where, etc.).  Additionally, the Outline is used to capture how the problem impacts the goals so that the magnitude of the problem is well understood.   Once the Outline is complete, the analysis is done by building a Cause Map by asking “why” questions to find the causes that contribute to an issue.

For this example, the fact that patients aren’t taking prescribed statins is an impact to the patient goal.  This occurs because patients were prescribed statins and they are not using them.  Looking at each cause individually, let’s first ask why patients were prescribed statins.  A physician wrote a prescription for statins because the patient was considered at risk for heart disease and statins can reduce the risk of heart disease.  Statins have been shown to reduce cholesterol levels in the blood and high cholesterol can lead to blocked arties that can contribute to heart disease.  Cholesterol is reduced because statins inhibit an enzyme in the liver that controls cholesterol production in the body and the majority of cholesterol is produced by the liver.

So the question that still needs to be answered is why aren’t patients taking their statins if they can reduce their risk of heart disease?  The most significant reason that patients are discontinuing statin use is because they are concerned about side effects and the concerns haven’t been adequately addressed. Patients are concerned about side effects because they believe they have experienced side effects or they are generally worried about potential side effects.

Like most other medications, statins can have serious side effects, such as liver injury, cognitive impairment and potential for muscle damage (especially when combined with certain other medications.  According to the U.S. Food and Drug Administration, the value of statins in preventing heart disease has clearly been established and the benefits outweigh the risks, but one of the reasons that patients are concerned about side effects is that there are very outspoken critics of statins that do not agree with this assessment.  For the purpose of this example, we will assume that the FDA is correct that patients would benefit from taking statins if they are prescribed and that it is in fact a problem if patients discontinue using stating when their physicians have recommended them.

The final step in the Cause Mapping process is to come up with solutions that can be implemented to help reduce the risk of a problem occurring in the future. So how can the risk that patients will discontinue statins be reduced?  One possible solution would be to give patients reliable information that shows that statins are relatively safe and are effective at reducing the risk heart disease.  If patients believe that the benefits of statins outweigh the risks, they will be significantly more likely to take them.  More information is becoming available as researchers continue to study the benefits of statins and the frequency and severity of side effects.  For example, a recent study that used 83,000 patients and randomized statin therapy and a placebo found that “only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo”.  With more data about the effectiveness of statins and the accurate information the risks associated with them patients can make decisions based on real data and better determine if they should keep taking the statins.

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

Root Cause

13-Inch Surgical Tool Left In Patient for Months

By Kim Smiley

For about two months after surgery to remove a large malignant tumor Donald Church complained of severe pain.  Initially, he was told that it was normal pain associated with recovery from a major surgery, but an x-ray was ordered after his physician felt a lump in his abdomen.  The x-ray revealed that a malleable retractor similar in size to a ruler had been left inside his body after surgery.  A second surgery was done to remove the tool.  Mr. Church is not expected to suffer long-term health consequences and received a $97,000 settlement.

A Cause Map, a visual format for performing a root cause analysis, can be built to help understand how this issue happened.  Once all the causes that contributed to an issue are found, potential solutions can be found and the most promising can be implemented to help reduce the risk of a similar issue reccurring.

So how did this happen?  How does a large surgical tool get left inside a patient?  This occurred because the patient needed surgery to remove a tumor, the malleable retractor was used during the surgery and the surgeons were unaware that the tool remained inside the patient. (These causes are vertical on the Cause Map with “and” between them because all 3 were necessary for the issue to happen.)  A malleable retractor was used while the wound was being closed to help protect the organs under the wound from possible puncture from the suturing needle.

The surgeon was unaware that the tool was inside the patient because he couldn’t see it and there wasn’t an adequate system in place to manage surgical tools.  Malleable retractors are normally held partly out of the wound, but it had slipped entirely inside the wound during the surgery.  Once the tool was out of sight, it was forgotten.  While many hospitals have requirements to formally count surgical tools as they enter and leave the operating room to ensure that all are accounted for, there wasn’t a policy in place in the facility that performed the surgery at the time.  With no formal system to track tools, there weren’t any easy indications to the operating team that there was a problem.

While this is a particularly egregious example, there are an estimated 4,000 cases of retained surgical items each year in the United States. Better solutions need to be found to reduce the risk of this preventable and potentially deadly problem from happening.  A simple solution to reduce the risk for retained surgical items is to institute a formal procedure for counting surgical supplies and tools before and after surgery.  Simple manual counts are a first step, but errors still occur, especially in the often hectic and stressful environment in an operating room.  Some hospitals use a visual inventory system where tools are brought in a special storage bag with an individual compartment for each item.  As items are done being used they are put back into their specific spot.  If all compartments are full, everything is accounted for so it’s easy to tell if something is missing.

Another solution that is gaining in popularity is use of an electronic tracking system.  The most common use of electronic systems is to track sponges, which are by far the most common object left inside patients.  Each sponge has an electronic tag and the patient is scanned after surgery to verify that none were left behind.  Sponge tracking systems add about $8 to $12 to the cost of each surgery and have dramatically reduced the number of retained sponges when used.

To view a high level Cause Map, click on “Download PDF” above.

Root Cause

New Study Finds that Dirty Stethoscopes May Spread Germs

By Kim Smiley

It’s been well documented that washing hands can prevent infections and in the same vein some researchers are now asking questions about potential contamination risks posed by stethoscopes and other small medical equipment used to examine multiple patients. In a recent study, stethoscopes were tested after they were used to examine patients and most were found to have bacteria on them.  Unlike the guidance provided for hand washing, there are currently no guidelines that require physicians to disinfect their stethoscopes between patients.

This issue can be analyzed by building a Cause Map, a visual format for performing a root cause analysis.  In a Cause Map, the causes that contribute to an issue are laid out to show the cause-and-effect relationships to aid in understanding the role the causes played.  The first step in the Cause Mapping process is to fill in an Outline with the basic background information for a problem such as the location and time it occurred.  Additionally, how the issue impacted the organizational goals is documented on the Outline.  The possibility of patient exposure to bacteria is an impact to the safety goal in this example.  Once the impact to the organizational goals is defined, the Cause Map is built by asking “why” questions.

Why is there a risk of patient exposure to bacteria?  This is happening because a contaminated stethoscope may be placed on a patient’s skin.  Stethoscopes are commonly used to listen to a patient’s heart and lungs and they work best when placed directly onto the skin.  Stethoscopes may get contaminated from being used on a person with bacteria on their skin and stethoscopes are not necessarily cleaned between uses.  Stethoscopes aren’t always cleaned between uses because there are currently no guidelines requiring it.  There aren’t any guidelines because it hasn’t been clear if they are needed.  There has been limited research done to understand the issue and determine how much of a risk of illness a contaminated stethoscope may pose, especially if used on healthy skin.

The new study is a good early step in understanding the issue, but it was a relatively small study and a larger scale study may be needed in the future.  The study “Contamination of Stethoscopes and Physicians’ Hands after a Physical Examination” looked at the stethoscopes used by three physicians as they examined a total of 83 patients in a Swiss hospital.  The researchers found bacteria on the stethoscope after 71 of the patient examinations.  It’s also difficult to determine whether bacteria on stethoscopes is responsible for spreading bacteria and whether it has actually caused illness.

The final step in the Cause Mapping process is to come up with solutions that can reduce the risk of the problem recurring in the future.  One good thing about this particular issue is that the solutions are relatively easy and cheap.  Physicians who are concerned about the cleanliness of their stethoscopes can either give them a give clean with disinfectant between patients or use disposable covers that are already commercially available.  Guidelines about cleaning stethoscopes are likely years in the future, but you can always ask your physician about the issue or to clean the stethoscope if you are concerned.

Root Cause

Failure to Read Back Physician Order Causes Patient Death

By ThinkReliability Staff

A patient suffering from pneumonia required a bedside bronchoscopy in a California hospital.  In order to provide sedation for the procedure, the physician performing the procedure requested a dose of Versed.  Although the actual dosage requested was not recorded, the nurse gave the patient 2 milligrams via IV and, a minute later, another 2 milligrams.  The maximum published dose for Versed is 1.5 milligrams over no less than 2 minutes.

Because of the bedside scenario and the verbal order for medication, the nurse was required by hospital policy to repeat back the order.  He did not, so there was no opportunity for the physician to realize the error.  Within a few minutes, the patient stopped breathing and was administered CPR.  However, the patient never regained consciousness and died nine days later.

We can look at this issue within a Cause Map, a visual root cause analysis that addresses all the cause-and-effect relationships that resulted in the issue being investigated.  The analysis begins with the impacted goals.  In this case, the patient safety goal is impacted due to the patient death.  The failure to follow hospital policy regarding repeat back of verbal orders is an impact to the compliance goal.  The patient services goal is impacted by the overdose that was administered.  The overdose resulted in extra care required for the patient, an impact to the labor goal.  As a result of the issue, the hospital was fined $50,000 by the California Department of Public Health.  (Click here to read the report, which was used to create this blog.)

Beginning with an impacted goal and asking “Why” questions adds more detail to the analysis.  In this case, the overdose occurred due to the need for Versed and the larger than ordered dose.  The larger than ordered dose resulted from a miscommunication between the physician, who ordered the Versed, and the nurse, who administered it.  The nurse did not repeat back the order as required, and the physician did not request a repeat back.  Although the requirement was apparently for the person receiving the order to repeat back, patient safety is everyone’s responsibility.  Pausing the procedure to ask for a repeat back would have likely saved the life of this patient.

Not mentioned in the analysis was the conditions under which the order and procedure were performed.  Clearly ability to hear was a concern.  A study published in May of 2013 determined that background noise in the operating room can result in difficulty in communication between team members, not only by affecting team members’ ability to hear each other, but could also impair an individual’s ability to process auditory information.  Other studies have found that other environmental factors can impact medical errors.  Specifically, one study found that most medication errors were more likely to occur when the previous 30 minutes were hectic and involved staff member distraction.  It is unclear how much of a role the environment played in this case.

The hospital involved in the issue focused efforts on ensuring hospital policies were re-emphasized.  While this is a typical response in this type of situation, the training efforts must ensure that the importance of the policies is emphasized, possibly by using lessons learned from actual cases to demonstrate the risk of these policies not being followed.  Additionally, all staff must take responsibility for patient safety.  Even though the policy required repeat back by the nurse, other staff members involved with the procedure should have played a role in ensuring that the communication between members was adequate to ensure patient protection.

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

 

Root Cause

Stroke Treatment Inadequate in Many Cases

By ThinkReliability Staff

Research presented at the American Stroke Association’s International Stroke Conference 2014 showed that although 81% of people in the United States lives within an hour’s drive of a hospital equipped to treat acute stroke, only 4% received tPA, a drug which can reduce disability if given within 3-4 hours of the first stroke symptom, and the only drug approved by the FDA to treat stroke.

Researchers reviewed the records of 370,000 Medicare stroke claims from 2011.  (Annually in the United States, 800,000 people suffer from stroke.)  The low percentage of patients receiving the recommended (and only) treatment for stroke is a significant impact to both the patient safety goal (because of the disability that could be avoided with proper treatment) and the patient services goal, because so many patients are not getting adequate treatment after a stroke.

There are many challenges involved in administering tPA within the recommended time frame.  Administration is ideally done within 3-4 hours of the first stroke symptoms, but faster is better.  As the study‘s lead author, Dr. Opeolu Adeoye, M.D., M.S. states, “Every 15-minute delay in getting treatment increases the odds of that patient not being able to go home.”

Although 4 out of 5 patients live within an hour’s drive of a designated stroke center, a hospital which is equipped to treat stroke (and not all hospitals are), that still leaves almost 20% who aren’t.  The drug tPA can’t be administered before imaging confirms the stroke and that it is a non-bleeding-type stroke as administering tPA to patients suffering from a bleeding-type stroke can cause harm.  Even after a patient arrives at a stroke center, delays in imaging and treatment could increase the time before tPA is administered to outside the window.  The study also found that 60% of hospitals did not administer tPA to stroke victims, though it is the only recommended treatment for acute stroke.

Many potential solutions are being studied and implemented to reduce the risk of stroke after disability.

For patients: the best way to reduce the risk of disability from stroke is to prevent having a stroke in the first place.  About 80% of strokes are preventable and due to risk factors, such as smoking or obesity.  Maintaining a healthy lifestyle can reduce the risk of stroke.  If you or a loved one suffers from a stroke, contact an ambulance, as the ambulance will be able to direct you to a designated stroke center.  If you are driving yourself, it’s worth it to go to a designated stroke center, even if that means “bypassing another hospital that isn’t set up to deliver the necessary therapy, ” says Dr. Adeoye.

For paramedics: because paramedics tend to see most stroke patients before they get to a medical center, the search is on for a drug that could be administered prior to imaging (unlike tPA) so that stroke treatment could begin prior to arriving at a medical center.  A study looked at administering intravenous magnesium in the ambulance, but found that it did not improve stroke-related disability.  However, if another drug can be found that would, researchers are hopeful, as the median time for receiving the stroke treatment by ambulance was 45 minutes after symptoms began, and 74% of patients began treatment within an hour.

For medical centers:  The American Heart Association/ American Stroke Association’s national quality initiative Target: Stroke℠ aims to reduce the time between stroke symptoms and treatment.  Since its initiation in 2010, the percentage of patients treated within 60 minutes or less from hospital arrival has increased from less than one-third to more than one-half.  Additionally, the average time from arrival to treatment dropped from 74 to 59 minutes. These faster treatment times have reduced the percentage of stroke patients who died in the hospital from 9.9% to 8.3%.  The improvements were seen in patients regardless of age, sex, or race.

Ideally, the implementation of these solutions – and many more that are in the works – will continue to reduce the risk of, and from, stroke.

To view the Outline, Cause Map and solutions related to inadequate treatment for stroke patients, please click “Download PDF” above.  Or click here to read more.

Root Cause

Man Found Dead After Waiting 8 Hours for Emergency Treatment

By ThinkReliability Staff

A man seeking treatment for a rash at a Bronx hospital emergency room (ER) was found dead eight hours later, still in the waiting room, of as-yet unknown cause.  The incident is currently under investigation by the New York State Department of Health and the cause of death will be determined by a medical examiner.

When performing an investigation of a case like this one, it’s important to focus on the goals that were impacted by the incident and determine all the causes that resulted in the goals being impacted, not just finding one “root” cause.  In this case, the impact to the patient safety goal has clearly been impacted because of the death of a patient within the hospital itself waiting to be seen.  The patient service goal was clearly impacted because the patient did not see a doctor in the six hours – or more – between arrival and his death.  The schedule goal is impacted by the significantly higher-than-average wait at this particular ER.  Lastly, the labor goal appears to be impacted by insufficient staffing levels.

According to the hospital, the cause of the patient’s death is simple.  Per the Hospital spokesperson: “His name was called several times on several occasions, and he did not respond… People have personal responsibility when your name is called, you have to get up and see the doctor.”  The hospital says that all guidelines were met and, even goes so far to add that “probably this scenario in this shape and form has happened in any big hospital in New York City.”

Many don’t find that answer acceptable. Although hospital guidelines may have been followed, there’s no discussion of whether the guidelines were adequate.  It is apparent that the hospital guidelines do not include any sort of care or supervisor for patients prior to being called in to the waiting room.  However, there’s no discussion of whether that meets the standard of care expected of these hospitals.  As this lack of oversight resulted in the death of a patient going unnoticed – potentially for hours – in a hospital waiting room.

In addition, the incident has brought up questions about the impact of the long wait time.  The wait at the emergency room for this hospital is an average of 306 minutes – more than 5 hours.  The national average is 137 minutes and the average in the state of New York is 155 minutes.  When the patient was called, starting at 2 and a half hours after entry, he may have well been asleep, given that the next interaction he had was with a security guard who woke everyone in the waiting room at 2 a.m.  This periodic waking of people in the waiting room – meant to ensure that nobody was using the waiting room as a shelter – next happened at 6:40 AM, and is when the patient was found dead.  Unofficial reports suggest the patient may have been dead for hours.  The patient was last seen moving at 3:45 AM on security cameras.

These questions demonstrate the fallacy of the one “root” cause approach.  The hospital’s assessment begins – and ends – with placing blame on the patient for not responding to a call in the ER.  But this expectation may not be appropriate in all cases.  Although a shorter ER wait time may or may not have saved the life of the patient in this case, it would certainly ease the strain of an ER visit for most patients and potentially save a life.  There have been several publicized cases of deaths or significant disabilities resulting from waiting too long in the ER.  Certainly an incident like this occurring at a hospital merits a review of policies that allowed a man to die unnoticed by staff.

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

Root Cause

Inappropriate Antibiotic Risk Not Decreasing for Adults

by ThinkReliability Staff

Infections caused by bacteria (such as sinusitis and tonsillitis) respond to antibiotics; those caused by viruses (such as bronchitis and influenza) do not.  Prescribing antibiotics for viral infections will not treat the infection and contributes to the rise of antibiotic-resistant bacteria. This is known as inappropriate antibiotic use.   A recent study showed that efforts to reduce inappropriate antibiotic use have been effective in pediatric, but not adult, patients with acute respiratory tract infections.

To thoroughly understand the issue, we consider both the effects and causes of inappropriate antibiotic use.  A cause-and-effect diagram, or Cause Map, visually lays out these cause-and-effect relationships.

The effects of the issue are captured in a problem outline.  Effects are captured with respect to an organization’s goals.  In this case, the impacted goals are wide-ranging, so we look at them from a general health industry perspective.  Unnecessary antibiotic use can impact the person to whom they are prescribed, which impacts the patient safety goal. Unnecessary antibiotic use also increases antibiotic resistance, a growing public health problem with no easy answers.  This can be considered an impact to the public safety goal.  (For more information, please see our previous blog about antibiotic resistant bacteria and fungus.)

Besides patient and public health safety concerns, unnecessary use of antibiotics can result in unnecessary cost.  A program at a University of Maryland hospital that monitored antibiotic use resulted in $3 million in annual savings with no impact to care quality.  However, when the program ended, so did the savings.

In addition to capturing the impact to the goals in the problem outline, we can capture general information about the issue being analyzed, including important differences.  These differences can provide valuable information about potential causes to be evaluated.  An interesting difference noted in the study is that efforts to reduce unnecessary antibiotic use were effective for pediatric patients but not adults.  So far, the reason for the difference in pediatric and adult use has not been determined, but a decrease in inappropriate antibiotic use for children is a positive step forward.  (And not just because of antibiotic resistance.  A 2012 study found that antibiotic use in infants can lead to obesity.  Click here to learn more.)

After the effects of an issue are determined, cause-and-effect relationships that will lead to the causes of an issue can be developed by asking “why” questions.  In this case, several possible causes for inappropriate antibiotic use have been suggested.  Identifying causes allows more opportunities for solutions to address these causes.

Perceived pressure from patients to receive an antibiotic when presenting to the emergency room for an acute respiratory infection and difficulty making a definitive diagnosis to determine whether the infection is viral or bacterial are two of the reasons given for the continued inappropriate use of antibiotics.  Patient education can help.  A review of 89 studies in 19 countries found that prescriber access to education and advice or restrictions on prescribing antibiotics have been effective in reducing inappropriate antibiotic use.

A surprising increase in the use of antibiotics appears to be due to a reduced out-of-pocket cost borne by patients.  After Medicare Part D went into effect, reducing drug costs for some patients, a study found increases in antibiotic use for acute respiratory infections.  The study suggested that changes in patient cost-sharing may be effective in reducing unnecessary antibiotic use.

It’s likely that a combination of causes will be needed in order to reduce the prescribing of unnecessary antibiotics to a minimal level that can aid in the fight against antibiotic resistance.  Ideally, further studies will be able to develop lessons learned from the successful pediatric programs that have reduced inappropriate antibiotic use so they can be implemented for adult patients as well.

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

Root Cause

Patient Dumping Has Dangerous Results

By ThinkReliability Staff

“Patient dumping”, when hospital patients are improperly discharged, sometimes to dangerous areas, or even out of state, and sometimes without proper instructions for care, is a serious risk to patient safety and health and can result in serious costs for the hospitals and people involved.  In a recent case, a California hospital made a settlement for $250,000 in civil penalties and legal fees for leaving a patient at skid row without making any arrangements for her.

This case – and others like it – lead to obvious concerns for the health and safety of these patients.  That’s led city attorneys and homeless advocates to crack down.  Operators of homeless shelters and rescue missions in the area have installed “dump cams”, which allow them to identify cases where patients are being “dumped”.  In Los Angeles, the police department has stated they will arrest anyone who leaves patients outside a shelter.  And Mike Feuer, a city attorney, says, “Patient dumping is intolerable to me. I do have it in my mind to send a message to other hospitals that this won’t be tolerated.”

Although patient dumping appears to have lessened in recent years, it’s still a real problem.  In other newsworthy cases, another Los Angeles hospital settled a group of charges in 2011 when it discharged a disoriented patient – still in her hospital gown – by taxi and she was left in the street.  Yet another area hospital was sued for negligence in 2012 when it left a patient being treated for schizophrenia outside a rehabilitation center without notifying the patient’s family.  In 2013, the city of San Francisco filed suit against the state of Nevada, saying that a psychiatric hospital had issued bus tickets to California cities for mentally ill patients without making arrangements for them.

Even though the risks to patients are apparent (and financial costs to hospitals are possible), these problems continue to occur.  In cases where organizations don’t seem successful at ensuring the safety of its patients (or employees), the government will step in.  In this case, Los Angeles in particular has implemented a “patient safety zone” which encompasses most of the city’s downtown, where it is illegal to leave patients unless they are in the care of a family member.  Additionally, hospitals must obtain written consent from patients to take them to a place other than their home.

This of course can be tricky when dealing with homeless, mentally ill, or patients without relatives living nearby.  Although patient resources when dealing with these cases are limited – making proper discharge difficult in some cases – leaving a patient alone in an unfamiliar, dangerous area is never the right answer.

The impacted goals resulting from patient dumping, some potential causes, and the solutions that have been implemented by the city of Los Angeles are shown in a Cause Map, or visual root cause analysis.  To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause

27 Patients to be Tested After Ultrasound Probe Sterilization Error

By ThinkReliability Staff

On December 21, 2013, 27 men were notified that, due to improper sterilization of equipment used for their prostate procedures, they should be tested for HIV and hepatitis B and C.   Both the medical center and patients involved are understandably concerned about how they got to this point.

In order to better understand the issues involved, we can put together an investigation file using Cause Mapping, a visual form of root cause analysis.  First, we capture the basic information about the issue.

The procedures were performed from September 19 to December 10 of this year at a Seattle medical center and involved ultrasound probes used for prostate procedures.  Because more than one date is involved, we can use a timeline to add more detail to the investigation.  In this case, patients were found to have been affected beginning September 19 and ending December 10, though it’s not clear if the incorrect sterilization began on that date, or if that was the first date that a probe was used on a patient with a communicable disease.  The improper sterilization was reported to hospital officials December 17 and affected patients were notified beginning December 21st.  As a result of information released by the medical center, we know that one step in the sterilization process for the probes was not completed.  We capture this as an important “difference” that may aid in the analysis.

Next, we determine the goals that were impacted as a result of the issue.

The patient safety and patient services goals were impacted due to the risk of disease transmission for the 27 patients (the probability of which is estimated to be very low).  The compliance goal is impacted because of equipment that was not sterilized as required.  The labor goal is impacted because the medical center is paying for two rounds of HIV and hepatitis testing for the affected patients.  If it is determined over the course of the investigation that other goals were impacted as well, these can be captured in the Problem Outline as well.

Once we have determined the impacted goals, we use these goals as the first “effect” to determine the cause-and-effect relationships that resulted in the issue.  In this case, the patient safety and services goals were impacted due to the risk of disease.  The disease risk resulted from the reuse of prostate probes that had the possibility to spread disease.  The disease risk occurred because the probes may have been used on a patient that had a communicable disease and the probes were not properly sterilized before their reuse.

We can show the steps that should have occurred in the sterilization process of these probes, as well as where the specific issue in the process occurred, in a Process Map.  This map shows the steps involved in a procedure, in this case the ultrasound probe sterilization procedure.  After a probe is used, it goes through a three-step process, involving cleaning, disinfecting or decontaminating with a disinfectant spray, then sterilization by being doused with sterilization fluid.  Then the sterilized equipment is placed in a protective sheath before re-use.  (Because of the use of this protective sheath, the probe, when properly used, does not contact the patient, decreasing the risk of disease transmission.)  In this case, the sterilization step was not performed.

We include the fact that the procedure was not performed properly in the Cause Map.  The Chief Medical Officer reports that their investigation found that the cause was “human error” and no more information has been released.

In order to determine effective solutions to prevent the issue from recurring, more detail needs to be obtained about the expectations for the process being performed, as well as the verification (if any) that took place to ensure that the procedure was being performed correctly.  Once it’s possible to determine what allowed the process to break down, safeguards that will reduce the risk of it happening again can be implemented.

To view the initial investigation file, including the Outline, Cause Map, Timeline and Process Map, please click “Download PDF” above.