Category Archives: Hospital Acquired Condition

16 patients infected with hepatitis C; thousands potentially exposed

By Kim Smiley

At least 16 patients were infected with hepatitis C after receiving treatment at two hospitals in Utah. Additionally, officials have stated that an estimated 7,200 patients may have potentially been exposed to hepatitis C.  Investigators are working to determine exactly what happened and to test patients who were potentially exposed.

Hepatitis C is a blood-borne illness and cannot be spread by casual contact, including through saliva or sharing food and water. It is not an illness that should typically be at risk of transmission from healthcare professional to patient. A nurse who tested positive for a rare form of hepatitis C worked at the two hospitals that have each had at least one patient who tested positive for the same rare form of hepatitis C. Officials have not released detailed information on how the hepatitis C outbreak occurred, but there are some suspicious circumstances.

The nurse in question was fired in November 2014 after a hospital found evidence that she had diverted medications, which means she was tampering with syringes or other injectable equipment to steal medication.  The nurse pled guilty to the offense and her license was suspended in December of 2015.

It can be very difficult to identify medication tampering by medical personnel, but one of the most alarming facets of this case is that the nurse had been reprimanded and fined by a previous employee for similar misbehavior.  It seems like it should be possible to identify whether a prospective employee has a history of issues with medication diversion during the hiring process. Investigators have not commented on what type of background checks were done prior to her employment at the second hospital, but it seems like an area where hard questions should be asked.

The immediate risk of this particular nurse exposing more patients has been addressed since she is no longer working at a healthcare facility.  The hospitals are offering free testing to anybody who was potentially exposed and are working on a case-by-case basis to determine how to pay for any necessary treatment of those who were infected.  No longer-term solutions have been identified yet, but the investigation is still underway so it is not clear if any lessons learned will result in changes to overall work processes.

Click on “Download PDF” to view an initial Cause Map of this incident.  A Cause Map visually lays out cause-and-effect relationships and can help identify a wider range of causes that contributed to an issue.  Identifying more than a single root cause can promote a wider range of solutions to be considered and can aid in reducing the risk that a problem may reoccur.

“Desensitization” Process Improves Compatibility of Donor Kidneys

By ThinkReliability Staff

Many patients with advanced and permanent kidney failure are recommended for kidney transplants, where a donor kidney is placed into their body. Because most of us have two kidneys, donor kidneys can come from either living or deceased donors. If a compatible living donor is not found, a patient is placed on the waiting list for a deceased donor organ. Unfortunately, there are about 100,000 people on that waiting list. While waiting for a new kidney, patients must undergo dialysis, which is not only time-consuming but also expensive.

Researchers estimate that about 50,000 people on the kidney transplant waiting list have antibodies that impact their ability to find a compatible donor kidney. Of those, 20,000 are so sensitive that finding a donor kidney is “all but impossible” . . . .until now.

A study published March 9, 2016 in the New England Journal of Medicine provides promising results from a procedure that alters patients’ immune systems so they can accept previously “incompatible” donor kidneys. This procedure is called desensitization. First, antibodies are filtered out of a patient’s blood. Then the patient is given an infusion of other antibodies. The immune system then regenerates its own antibodies which are, for reasons as yet unknown, less likely to attack a donated organ. (If there’s still a concern about the remaining antibodies, the patient is treated with drugs to prevent them from making antibodies that may attack the new kidney.)

The study examined 1,025 patients with incompatible living donors at 22 medical centers and compared them to an equal number of patients on waiting lists or who received a compatible deceased donor kidney. After 8 years, 76.5% of the patients who were desensitized and received an “incompatible” living donor kidney were alive compared to only 43.9% of those who remained on the waiting list and did not receive a transplant.

The cost for desensitization is about $30,000 and a transplant costs about $100,000. However, this avoids the yearly life-long cost of $70,000 for dialysis. The procedure also takes about two weeks, so patients must have a living donor. The key is that ANY living donor will work, because the desensitization makes just about any kidney suitable, even for those patients who previously would have had significant trouble finding a compatible organ. Says Dr. Krista L. Lentin, “Desensitization may be the only realistic option for receiving a transplant.”

The study discusses only kidney transplants but there’s hope that the process will work for living-donor transplants of livers and lungs. Although the study has shown great success, the shortage of organ donations – of all kinds – is still a concern.

To view the process map for kidney failure without desensitization, and how the process map can be improved with desensitization, click on “Download PDF” above. To learn more about other methods to increase the availability of kidney donations, see our previous blog on a flushing process that can allow the use of kidneys previously considered too damaged for donation.

 

Hospital pays hackers ransom of 40 bitcoins to release medical records

By Kim Smiley

In February 2016, Hollywood Presbyterian Medical Center’s computer network was hit with a cyberattack.  The hackers took over the computer system, blocking access to medical records and email, and demanded ransom in return for restoring the system.  After days without access to their computer system, the hospital paid the hackers 40 bitcoins, worth about $17,000, in ransom and regained control of the network.

A Cause Map, an intuitive visual format for performing a root cause analysis, can be built to analyze this incident.  Not all of the information from the investigation has been released to the public, but an initial Cause Map can be created to capture what is now known.  As more information is available, the Cause Map can easily be expanded to incorporate it.

The first step in the Cause Mapping process is to fill in an Outline with the basic background information.  The bottom portion of the Outline has a place to list the impacts to the goals.  In this incident, as with most, more than one goal was impacted.  The patient safety goal was impacted because patient care was potentially disrupted because the hospital was unable to access medical records.  The economic goal was also impacted because the hospital paid about $17,000 to the hackers.  The fact that the hackers got away with the crime could be considered an impact to the compliance goal.  To view a filled-in Outline as well as a high level Cause Map, click on “Download PDF” above.

Once the Outline is completed, defining the problem, the next step is to build the Cause Map to analyze the issue. The Cause Map is built by asking “why” questions and laying out the answers to show all the cause-and-effect relationships that contributed to an issue.  In this example, the hospital paid ransom to hackers because they were unable to access their medical records.  This occurred because the hospital used electronic medical records, hackers blocked access to them and there was no back-up of the information.  (When more than one cause contributed to an effect, the causes are listed vertically on the Cause Map and separated with an “and”.)

How the hackers were able to gain access to the network hasn’t been released, but generally these types of ransomware attacks start by the hacker sending what seems to be routine email with an attached file such as a Word document. If somebody enables content on the attachment, the virus can access the system. Once the system is infected, the data on it is encrypted and the user is told that they need to pay the hackers to gain access to the encryption key that will unlock the system. Once the system has been locked up by ransomware, it can be very difficult to gain access of the data again unless the ransom is paid.  Unless a system is designed with robust back-ups, the only choices are likely to be to pay the ransom or lose the data.

The best way to deal with these types of attacks is to prevent them. Do not click on unknown links or attachments.  Good firewalls and anti-virus software may help if a person does click on something suspicious, but it can’t always prevent infection.  Many experts are concerned about the precedent set by businesses choosing to pay the ransom and fear these attacks may become increasingly common as they prove effective.

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.

Facial Burns from Surgical Fires

By ThinkReliability Staff

At least two patients received burns to the face from surgical fires in early December 2011.  Surgical fires are becoming an increasing risk to patients (and staff) in the operating room.  Although the 550-650 surgical fires a year that are estimated to occur by the ECRI Institute is a small percentage of patients undergoing surgery, this doesn’t make surgical fires seem “rare” to those who are affected.

A surgical fire, like any fire, requires the presence of three elements: a heat (or ignition) source, fuel, and an oxidizing agent.  Oxygen is necessarily present for breathing; however, additional oxygen supplied to the patient increases the risk of a fire.  Additionally, nitrous oxide produces oxygen from thermal decomposition.  An increased level of oxygen increases the risk of a surgical fire.  Like oxygen, fuel will always be present in a surgical room.  Prep agents, drapes, and even a patient’s hair are fuel sources.  Vapors from insufficiently dry prep agents are extremely flammable.  Although some drapes are advertised as flame-resistant, the ECRI has determined that all types of drapes burn in oxygen.

Surgical equipment, such as electro-cautery devices and lasers, are believed to provide the ignition source for many surgical fires.  The increased use of such devices is believed to contribute to the increase in surgical fires.  Although these devices can provide benefits during surgery, a non-ignition source tool should be considered for surgery performed near the oxygen supply of a patient requiring oxygen.

The best way to protect patients from surgical fires is to prevent them by reducing the use of oxygen, decreasing the flammability of potential fuel sources in the operating room (by allowing prep agents to dry and coating hair or other flammable objects with water-based lubricant) and ensuring that heat sources are monitored carefully to reduce the risk of ignition.  In addition, operating teams should be prepared in the case of fire to minimize effects on patient and staff safety by taking steps to extinguish the fire and evacuate if necessary.

The effects and causes of surgical fires, as well as some recommended solutions, can be diagrammed in a Cause Map, a visual form of root cause analysis.  To view the Cause Map for surgical fires, please click “Download PDF” above.  Or click here to read a more detailed write-up about patient burns.

Additional resources on surgical fires:

ECRI Institute

FDA

The Joint Commission

Anesthesia Patient Safety Foundation (APSF)

Teenager Paralyzed After Epidural Not Removed

By ThinkReliability Staff

In May 2008, a fourteen-year-old entered an English Children’s Hospital for a routine surgery to remove gallstones.  The recovery, however, was anything but routine.  The patient was given a spinal epidural to reduce pain during the operation; however, the epidural was not removed until two days later. By then, permanent damage of the spinal cord caused the patient to be paralyzed from the waist down.

The hospital has admitted liability, possibly leaving them responsible for some or all of the patient’s specialist care and support.  Because the anesthetic needle was not removed until the patient’s body until far later than it should have been – and more than a day after the patient’s first complaints of leg numbness – it begs the question whether the procedure for administering an epidural included follow-up care, including removal.  Procedures – whether they are written down or not – exist for most complex tasks, especially medical tasks that involve risks to patient safety.  If use of the procedure results in an error, it should be re-examined.  However, many procedures only include the first part of a procedure, or the administration, ignoring follow-up that must be completed to ensure the process is a complete success.  In this case, that follow-up should have included checks to ensure that the patient was recovering from the epidural (which would have noted something amiss when she continued to feel numbness in her legs) and a schedule to remove the epidural.  Because neither of these things happened, a plan for follow-up after administering epidurals must be developed and put into practice.

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

Preventing Central Line Infections

By ThinkReliability Staff

Central line infections, also called central line-associated bloodstream infections (CLASBI), can occur when a large tube is placed in a large vein in the neck, chest, groin or arms to give fluids, blood, or medications or to do certain medical tests quickly.  While they allow exceptional access to internal systems, Central Venous Catheters (CVC) also can cause thousands of patient deaths a year and add billions of dollars in healthcare costs.  However, these infections are entirely preventable.

In this health care scenario, patient safety is the foremost concern.  So the most basic Cause Map would show that the Patient Safety Goal is impacted by preventable bloodstream infections, and that those infections come from pathogens introduced by a central line.  The next step is to elaborate on how pathogens enter the bloodstream, and then determine what appropriate solutions might be.

Preventable bloodstream infections happen because pathogens access the bloodstream and also because the infections aren’t treated early on.  This suggests that by treating infections early on, and vigilantly watching for signs of infection, more serious infections can be prevented.

Pathogens can access the bloodstream because a central line provides a direct conduit to the bloodstream and because pathogens are present.  Again, while these are obvious statements, they allow the opportunity to develop potential solutions.  First, the CDC recommends not using a CVC unless absolutely necessary.  Additionally, CVCs shouldn’t be placed in the femoral artery in adults because it is associated with greater infection rates and secondary problems such as deep venous thrombosis.

Assuming a central line is necessary; more analysis leads to further solutions that might reduce the presence of pathogens.  Pathogens generally come from two sources – the line was improperly put in or somehow the line became contaminated during use.  Using antimicrobial materials is one potential way of minimizing contamination.

Looking closer at the uppermost branch , how the line was put in, leads to some insightful solutions.  One simple solution recommended by the CDC is to use a checklist and follow their guidance.  Checklists are a simple but highly effective way of reducing errors in repetitive processes.  There are two major causes in this branch, dirty hands/gloves from the nurse or doctor putting the CVC in the patient and the patient having dirty skin at the site of the CVC.  CDC guidance also recommends using maximal barriers such as masks and gloves and washing your hands.  Cleaning the patient’s skin with a chlorhexidine-based solution is another important step that can reduce these infections.

With so many possible solutions, it is important to identify where changes need to occur in your own processes.  This is fairly simplistic Cause Map and there are many other solutions suggested by the CDC and other government health agencies.  For more information on steps to reduce CLASBIs, see the U.S. Department of Health and Human Services Guideline.

Tackling a Seemingly Insurmountable Problem

By ThinkReliability Staff

The goal of any root cause analysis is to uncover causes and, most importantly, solutions that will reduce the risk or mitigate the effects of the problem being studied. However, sometimes a problem seems insurmountable. Take rising health care costs. There are myriad causes that contribute to increasing health care costs. Many of the solutions that have been identified are costly, difficult, or both. Additionally, some solutions place the onus on patients, which can limit the effectiveness. Although patients presumably would love to reduce their health care costs, most don’t have the resources to do so.

Although rising healthcare costs is a national issue, some of the problems you face at an organization may seem just as insurmountable. What can be done when an issue appears too big to fix?

First, ensure that you limit your analysis and potential solutions to your own sphere of influence. Although patients individually reducing obesity and taking their medications properly and on time would certainly reduce healthcare risks, those steps must be taken by the individuals. As a healthcare organization though, it is possible to take steps to increase the probability that individuals will take these steps. Generally patient education, automated reminders, and making it easier to do the right thing – by including clearer instructions on prescriptions or offering more fresh fruit in the hospital cafeteria – are steps that can be taken that are within the realm of an organization’s sphere of influence. Attempting to control solutions outside your sphere of influence is an exercise in frustration!

Next, focus on a single piece of the pie. Not all the causes identified during a root cause analysis have to be tackled at once. A great way to get started: find a solution that is nearly free and can be implemented fairly transparently to staff. For example, ask providers to hand out a healthy eating brochure to patients as they leave their appointment. Is this going to make a big impact? Probably not, but it’s somewhere to start. And even a little impact can help.

Or, take a note from Camden, New Jersey. In Camden, 1% of patients are responsible for 30% of medical costs. Jeffrey Brenner, a local physician, is making a difference reducing costs by focusing on those few patients. This is the big “bang for your buck” solution. And, the solutions that work for this 1% will probably help reduce costs for the other 99% as well. By focusing on a small number of patients – determining the causes specific to them and tailor-making solutions – headway is being made against an extremely difficult problem. (Read more at: http://www.newyorker.com/online/blogs/newsdesk/2011/01/atul-gawande-super-utilizers.html)

If you’re feeling overwhelmed, try taking one step at a time. If healthcare costs can be tackled by looking at a small part of the problem, what can your organization do with a focused look at solutions?

Reduced central line infections? Check.

By ThinkReliability Staff

Sinai-Grace Hospital in Detroit has achieved remarkable reductions in bloodstream infections associated with central lines. They’ve reduced the rate of infections significantly by implementing a simple procedure and checklist. We will perform a root cause analysis that shows how these gains were achieved.

First, the hospital needed to determine what was at stake. Over 18 months, it was estimated that more than 1500 patients would die from infections. This is an impact to the patient safety goal. There was non-compliance with procedures, which is an impact to the compliance and organization goals. Infections result in a longer intensive care unit (ICU) stay, which is an impact to the patient services goal. Lastly, the hospital estimated that, over the 18 months, it would spend $175 million in additional costs from these infections.

Next, the stakeholders in the central line insertion process (doctors and nurses) were asked to help determine why these infections were occurring. Bloodstream infections resulting from intravenous catheters result when a catheter is inserted (for vascular access) with bacteria on it. Generally, the bacteria is on the catheter from a missed step in the catheter process which prevents contamination. The steps that were not always being followed were: doctors washing their hands and donning protective wear, patients not being washed with antiseptic or fully draped, and insertion sites not being covered with sterile dressing after the catheter is inserted.

As a solution, a checklist was created that outlined the six steps of catheter insertion. (The outline, Cause Map, process map, solutions, and checklist are shown on the downloadable PDF. To view it, click on “Download PDF” above.) The six steps included the cleanliness steps discussed above. Additionally, the medical professionals noticed that sometimes the procedures weren’t being followed because the necessary equipment was not available in the ICUs. Senior executives from the hospital were assigned to each unit, and were able to properly stock the ICUs. Additionally, the executives got Arrow International to manufacture central line kits that contained the necessary antiseptic and patient drapes.

The progress at Sinai-Grace has been remarkable, by joining all the necessary parties to an effective root cause analysis. Click on “Download PDF” to see what they did. (Read more in The New Yorker Annals of Medicine.)

UTIs: Painful for the Patient AND the Hospital, too!

By ThinkReliability Staff

According to Medicare data, there were 12,185 cases of Catheter-Associated Urinary Tract Infections (UTIs) in the year 2007, which resulted in an average $44,043 hospital stay. These cases represent more than $500 million in this preventable, hospital-acquired condition. As a result, Medicare and Medicaid will no longer cover costs associated with UTIs if they were not present at admission to a medical facility.

In order to work at preventing these conditions, first we must examine how they occur. We’ll do this by looking at Catheter-Associated Urinary Tract Infections in a visual root cause analysis (or Cause Map).

A UTI is an impact to our patient safety goal. A UTI is caused by pathogens accessing the urinary tract and not being removed. We will look at each of these causes in more detail. Pathogens access the urinary tract when a urinary catheter is inserted. The catheter may be used for obtaining urine, because a patient is incontinent, or to permit urinary drainage.

In order for pathogens to access the urinary tract on a catheter, there must be pathogens on or in the catheter. These can be pathogens already in the body, contamination from the drainage system, or pathogens transferred on the hands of medical personnel, or by a non-sterile insertion.

The pathogens are not removed from the body either because of an insufficient immune response caused by damage to the urinary tract by improper insertion or improper securing of the catheter. Or, the pathogens are not excreted due to an obstructed urinary flow.

Once we have determined the basic causes of a UTI from our simple root cause analysis, we can consider solutions associated with the causes. For example, if a cause is “Pathogens on hands of medical personnel”, a solution may be to require “Handwashing before and after manipulation of catheter site or apparatus.”

Click on “Download PDF” below to see the Cause Map and possible solutions. If facilities began implementing some or all of these solutions, the incidence of Catheter-Associated UTIs would decrease, and patient health and satisfaction would increase.