Root Cause

FDA Inspections Find Issues at Compounding Pharmacies

By Kim Smiley

Unsafe practices at compounding pharmacies were found during recent Federal Drug Agency (FDA) inspections.  The FDA visited about 30 pharmacies in 18 different states, focusing on the production of sterile drugs which was determined to be the highest risk to patient safety.   The inspection findings include a number of potential contamination issues such as inadequate ventilation, unidentified particles in vials of supposedly sterile medications, cleanliness issues in clean rooms such as rust and mold, and insufficient microbiological testing. Interest in compounding pharmacies was increased after the fall 2012 outbreak of fungal meningitis that killed 50 and sickened hundreds was traced back to compounded injectable steroid medication that had been shipped across the country.

A root cause analysis of the issues at compounding pharmacies can be done by building a Cause Map.  A Cause Map visually lays out the different causes that contribute to an issue and is a way to intuitively illustrate the problem.  Compounding medications are an issue because they can pose both indirect and direct risks to patient safety and patients are using them.   The indirect risk is that patients may inadvertently use an ineffective medication.  Compounded medications are not regulated by the FDA and have not gone through a formal approval process that requires extensive testing.  Medications that are compounded can also be a direct risk to patient safety if they are contaminated or sub- or super-potent.  As the fatal fungal meningitis outbreak unfortunately demonstrated, contamination of supposedly sterile drugs can have deadly consequences. Compounded drugs are receiving more attention than traditionally manufactured drugs because some of the facilities may have less oversight and the recent investigations found more issues with the work processes at the compounding pharmacies than is typically discovered at drug manufacturing facilities.

Many are asking questions about how compounding pharmacies are regulated and overseen.  Compared to drug manufacturers, the FDA’s regulatory authority over compounding pharmacies is limited.  Compounding pharmacies are not generally even required to inform the FDA what drugs they are making or register with the FDA.  State boards of pharmacy regulate the compounding pharmacies and the FDA typically becomes involved only to do for-cause inspections upon receiving reports or complaints or when states have requested assistance.

It’s worth noting that compounding pharmacies do serve an important need.  Some individuals cannot be treated with standard manufactured medication.  An example of this is when somebody is allergic to an inactive ingredient, such as a dye, in an approved medication.  The real concern is that the creation and  use of compounded medications seems to be changing from its traditional function.  According to Ilisa Bernstein, acting director of Center for Drug Evaluation and Research’s Office of Compliance, “Some aspects of these firms’ operations appear more consistent with those of drug manufacturers than with those of traditional pharmacies. Some firms make large amounts of drugs that appear to be copies of FDA-approved, commercially available drugs when it does not appear that there is a medical need for an individual patient to receive a compounded version of the drug.”

There have been a number of voluntarily recalls as a result of the recent inspections.  The FDA and state regulatory boards are working together to address the issues that were uncovered.  Additionally, the FDA is pushing for new legislative authority over the highest-risk compounding pharmacies, but there isn’t agreement on whether changes are necessary and it’s not clear what the outcome will be.

For more information about compounded medications, please visit the FDA website.

Root Cause

Successful Emergency Response to Boston Bombing

By ThinkReliability Staff

The successful activation of emergency plans allowed 8 hospitals in the Boston area to treat 144 trauma patients injured in the bombings that occurred April 15, 2013 near the finish line of the Boston Marathon.  Even with that heavy burden, these hospitals ensured the continued safety of patients and staff during a very unsure time, as well as assisting the police and Federal Bureau of Investigation (FBI) with the ongoing investigation.

While details on the bombings themselves are still being determined and disseminated, it’s apparent that emergency planning and preparedness processes within the area Boston hospitals were successful in allowing an ‘unprecedented’ response.  We can view the response to the bombings by the area hospitals in what we like to call a root cause “success” analysis.  After all, lessons can be learned not only from what didn’t go well, but also what did.  Hospitals around the country can learn from the response by the Boston area hospitals to this trauma.

When Massachusetts General asked hospital staff from Israel, who unfortunately see this kind of trauma on a far more regular basis, to give emergency response training they likely did not suspect their hospital to be the site of a horrific mass trauma like that experienced in Boston.  The hospital’s experience with war-style trauma was certainly extremely helpful in dealing with the aftermath of this kind of trauma, rarely seen outside of war zones.  As Dr. Ron Walls, the chairman of the Department of Emergency Medicine at Brigham and Women’s Hospital stated, “For many, many people in emergency medicine who are practicing domestically and not in the military, these are once-in-a-lifetime events.”

For once-in-a-lifetime events, facilities have to hope that the training and education they’ve provided to their staff, and the processes that they’ve developed for dealing with emergencies, can stand up to the tragedy.  In this case, these Boston hospitals (once they have time to take a breath, which may not be for a while), should give themselves a pat on the back for their amazing handling of a tragic event.  Hospitals elsewhere should take note and ensure that their emergency procedures will allow the same sort of successful response.

A pat on the back should also go out to the staff in the medical tent at the finish line, whose quick actions and extensive equipment allowed on-scene stabilization and quick transfer of the severely injured to the area hospitals.  Lastly, the many spectators who kept their cool and assisted on scene should also be commended.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to learn more about the emergency procedures at Massachusetts General.

Root Cause

Lead Poisoning Still An Issue for US Children

by Kim Smiley

Lead poisoning has once again hit the news with scary headlines such as “Blood Lead Levels High In 535,000 Kids In The USA” and “Despite Big Progress, Many Kids Have High Lead Levels in Blood“.   But what do these articles actually mean in context?  What does “many kids” refer to and how alarmed should we be?

A tool like a Cause Map, a visual method for performing a root cause analysis, can be useful to analyze issues like this one.   The first step in the Cause Mapping process is to define the problem and that alone can help clarify an issue.   Part of defining the problem is to determine which overall organizational goals are being impacted by the problem.   In this example, it becomes clear that there are really two different, but related goals that need to be considered.  The most basic goal is the safety goal.  The safety goal is being impacted because children are still being negatively impacted by exposure to lead in the United States, despite decades of work to dramatically reduce lead in the environment.  The second issue is that 2.6% of children in the US have blood lead levels (BLLs)  higher than the levels set by the Center for Disease and Control (CDC), an impact to the regulatory goal.

It’s clear why exposure to lead remains a concern. Ingestion of lead is dangerous, especially to small children. High levels of lead in the body can have severe and immediate consequences such as coma, convulsions and even death.  Lower levels of lead have been shown to cause lower IQs, behavior issues, hearing problems and a number of problems in organs in the body.  Problems with lead exposure are well known and the use of lead has been dramatically reduced.  Use of lead in household paints, one of the most common sources of ingested lead, was banned in 1978.  However, paint is still one of the primary sources of lead contamination because many children live in houses built before 1978.  Paint chips containing lead can still be an issue, especially if an older house has loose paint or is undergoing a renovation.  Use of lead in gasoline, a common source of soil contamination, was phased out by the end of the 1980s.

The second issue of concern is that 2.6% of children have blood lead levels above the limit set by the CDC.  What does this mean?  If this problem is hitting headlines, are things getting worse?  One important piece of data is that the CDC lowered the limit for young children in 2012 to 5 µg/dL from 10 µg/dL.  Why was the limit lowered?  The limit was lowered because no amount of lead has been determined to be safe for young children and less lead is always better.  The new limit of 5 µg/dL was based on lead levels in the 2.5% of children with the highest levels.  It was a way to target the children most at risk and it marked a shift towards a more prevention-based approach.

Is it okay that 2.6% of children still have blood lead levels above the target?  Of course not.  Is there still work to do in preventing lead exposure?  Many people believe there is.  But the alarming headlines may not tell the whole story.  Here are some other facts that help put the issue of lead exposure in historical context: an estimated 88% of children aged 1 to 5 had blood lead levels at or above 10 mcg/dL from 1976 to 1980; from 1991-1994 it was 4.4% , from 1999-2002 it was 1.6% and it dropped to 0.8% in 2007-2010.    Lead exposure is a still an issue, but it’s an issue that has been drastically improved.

To view a Cause Map of this issue, click on “Download PDF” above.  For more information, click here to visit the CDC’s information page about lead.

 

Root Cause

Reuse of Insulin Pens May Have Spread Hepatitis

By ThinkReliability Staff

After a similar incident at a Veterans hospital, a hospital in New York reviewed its insulin injection procedures and discovered that insulin pens may have been used for more than one patient.  Re-use of insulin pens for more than a single patient carries a small risk of cross-contamination, which can result in a patient being infected with a communicable disease, such as hepatitis B, hepatitis C, or HIV.

The hospital notified 1,915 patients who had received injections between November  2009 and January 2013 of the possibility for contamination and recommended testing.  Twelve patients have tested positive for Hepatitis C, and one has tested positive for Hepatitis B, though an investigation is ongoing to determine if this is related to the injections.

The use of insulin pens resulted in 30 outbreaks from syringe or needle reuse over ten years, from 2001-2010. So, although the possibility for cross-contamination is considered low, the risk for the spreading of communicable diseases is unacceptably high.

The potential for spreading communicable diseases is an important impact to the patient safety and environmental goals.  We can examine these impacted goals and the cause-and-effect relationships that led to these impacts, in a Cause Map, or visual root cause analysis.

We begin by defining the impacts to the goals.  In addition to the patient safety goal, the compliance goal is impacted because re-using insulin pens is against recommendations by the FDA and CDC.  The organizational goal is  impacted due to a lawsuit from the patients who have tested positive for Hepatitis B and Hepatitis C.  Patient services are impacted due to the improper reuse of the insulin pens, and the labor and property goals are impacted by the additional follow-up, testing and potential treatment for the almost 2,000 patients affected.  Once we have determined the impacts to an organization’s goals, we can ask “Why” questions, which helps develop cause-and-effect relationships that resulted in these impacts.

Insulin pens are designed for multiple injections, meaning that there is stored insulin within the cartridge after a single injection is given.  Backflow of blood into the pen can result in the remaining insulin being contaminated.  This can result in the spread of communicable disease if the pen is then used on a different patient for subsequent injections.

Because it is known that insulin pens should not be used on multiple patients, it is evident that there was an issue with the procedure or policy regarding use of insulin pens.  It is unclear what the specific issues were relating to this incident, but the hospital involved has reviewed and reinforced policies and procedures related to insulin injection.

Many facilities, including the hospital discussed here, which discovered the potential for re-use during a review after a similar incident at a Veteran’s hospital, have discontinued the use of insulin pens due to the potential for cross-contamination.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read the hospital’s press release.

Click here to visit our previous blog about about hepatitis B and C.

Click here to visit our previous blog about a different contamination issue involving hepatitis C.

 

Root Cause

Rabies From Donated Kidney Kills Recipient

By ThinkReliability Staff

A kidney donation recipient died in February, 2013.  It was determined that his death was due to rabies – specifically rabies that had been transferred with the donated kidney during the transplant in September 2011.  Although infectious disease transmission through transplant – especially rabies – is rare, there is benefit in visually diagramming a root cause analysis of this event in a Cause Map.   A Cause Map begins with the specific impacts to an organization’s goals resulting from an incident, and shows the cause-and-effect relationships that led to those impacts.

In this case, the patient safety goal was impacted due to the recipient death.  The receipt of organs infected with a disease such as rabies is an impact to the patient services goal.  Three other recipients also received organs from the same donor but have not shown symptoms of rabies.    Their treatment is an impact to the property and labor goals, due to the cost, time and inconvenience of those treatments.

The impacted goals form the first cause-and-effect relationship in our Cause Map.  We ask “Why” questions to determine other cause-and-effect relationships.  In this case, the donor death was due to rabies.  The donor was infected with rabies from an infected transplanted organ, and was not treated for rabies.  The recipient was not treated for rabies as the symptoms did not emerge until a year after the transplant (rabies can have a long incubation period).  The donor organs were infected with rabies from an unknown cause, though rabies usually results from contact with wild animals (specifically, this strain of rabies appears to be from a raccoon).   The transplant medical team was unaware that the donor had rabies.

Though the donor had encephalitis, it was thought that it was due to a food-borne illness.  (Detail on how the diagnosis was obtained has not been released.)  While there is testing for certain diseases performed on donor organs, due to the time constraints on the viability of the organ, testing for rabies is not generally performed.  However, new guidance from the Disease Transmission Advisory Committee (put out after this donation occurred) urges caution in use of organs from donors with encephalitis, perhaps including more robust testing for specific illnesses, or using only certain organs.

Due to an acute shortage of viable donated organs, some believe that organs from disease-positive donors should be used, and treatment started immediately.  With many in need of transplants dying on the waiting list, this may be a more practical approach, though there are certainly concerns about transmitting diseased organs to those who are already very ill, and who will be taking immune suppressing drugs to prevent rejection of transplanted organs, making them more susceptible to such diseases.

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

Read our previous blog about a recipient who died of lung cancer after receiving the lungs of a heavy smoker

Root Cause

US Stockpiles Smallpox Medicine, Fear of Bioterrorism

By Kim Smiley

The last case of smallpox in the United States occurred in 1949, but the government recently made headlines for spending $463 million on enough medicine to treat two million people infected with the disease.  It is feared that the deadly and disfiguring disease could be used by bioterrorists and the government wanted to be prepared in the event of an attack.

The concern that smallpox could be used for bioterrorism can be analyzed by building a Cause Map, a visual root cause analysis.  The first step is to fill in an Outline with the background information for the problem and determine which goals are impacted.  In this example, the safety goal is impacted because there is a chance of many deaths if smallpox is released, the financial goal is impacted because hundreds of millions of dollars were spent on treatment for smallpox and the customer service goal is impacted because people are nervous about the potential for smallpox bioterrorism.  Once the impacts to the goals are determined, the Cause Map is built by asking “why” questions.

Why is there a potential for many deaths?  This is true because there is the potential that a smallpox outbreak could happen, many are unprotected against smallpox, and smallpox is a very deadly, highly contagious disease.  An outbreak could occur if bioterrorists released smallpox because the virus still exists in research labs in the US and Russia.  Advances in the genetic field have also opened the possibility that the smallpox virus could be  re-engineered and essentially created in a lab anywhere in the world.   Many people are unprotected against smallpox because the vaccination program ended in 1980 when it was eradicated.  People vaccinated prior to 1980 likely maintain some level of protection from smallpox, but the effectiveness of the vaccine degrades over time and they are no longer fully protected.  Smallpox is a very dangerous disease because it has fatality rate of about 30% and many survivors are left blind or disfigured.  It’s also very contagious and can be spread without direct contact because it can be transmitted via aerosolized droplets from saliva and other body fluids.

The financial goal is also worth considering.  Hundreds of millions of dollars have been spent to prepare for a potential smallpox attack.  The government has long stockpiled smallpox vaccines in the event they were needed, but the move to buy medicine to treat the disease is fairly recent and substantially more expensive than just buying vaccines.  This option has only recently been a possibility because there was no treatment for smallpox until now.  A private company developed antiviral medicine to treat smallpox in the hope that it would be profitable.

Developing solutions to problems that might occur is always tricky and likely to cause debate.  There are many reasons why a smallpox bioterrorism attack is frightening, but how much money should the US government spend to prepare for an attack?    How much preparation is enough?  There is no simple answer, but it’s important to understand these types of problems to the best of our ability to help make well thought out and reasonable decisions.

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

 

 

 

Root Cause

Cases of Deadly ‘Superbugs’ on the Rise in US

By Kim Smiley

A new antibiotic resistant strain of bacteria is causing deaths and raising flags in US healthcare facilities. The bacteria is called Carbapenem-Resistant Enterobacteriaceae, often shortened to CRE, and is named for its ability to resist carbapenem antibiotics, the last resort treatment for antibiotic resistant bacteria. The fatality rate for those infected may be as high as 50 percent. In 2012, 4 percent of hospitals reported cases of CRE, up from about 1 percent a decade ago. The situation at long-term care hospitals is significantly worse, with 18 percent reporting cases last year.

The issue of CRE can be analyzed by building a Cause Map, a visual method for performing a root cause analysis. The first step is to create an Outline that documents all the background information for an issue. How the problem impacts the overall organization goals is also listed on the bottom of the Outline. In this example, the safety goal is obviously impacted since there have been patient deaths. After the Outline is completed, the second step is to build the Cause Map. The Cause Map is built by asking “why” questions to determine what causes contributed to the issue and then arranging the causes visually to show cause-and-effect relationships. Why have there been patient deaths?  This has occurred because they were infected with CRE and CRE infections are dangerous.

People are being exposed to CRE primarily in healthcare settings. CRE is being passed between patients within the same facility and between healthcare facilities as infected patients are transferred to different healthcare settings. Exposure is occurring between patients because infected patients may not be identified or adequately isolated. Many healthcare facilities do not have the capability to test for CRE and it’s also difficult to identify who should be tested since some patients who carry the bacteria are not symptomatic. CRE also tends to infect individuals who have other health issues and weakened immune systems. Treatment of the other issues may involve invasive medical devices, such as catheters, that can provide a pathway for infection into the body.

CRE infections are dangerous because they have a high rate of fatality, up to 50 percent according to the CDC, and they are difficult to treat. CRE are resistant to virtually all antibiotics. This strain of bacteria is also particularly worrying because they can transfer their resistance to other bacteria within their family, compounding the problem. Antibiotic resistant bacteria have developed over the years because of the wide use of antibiotics. Each time antibiotics are used, bacteria have a chance to evolve and they have over the years.

The final step in the Cause Mapping process is to find solutions that would reduce the risk of the problem in the future. In this example, there isn’t an easy solution. There are no promising new antibiotics in development at this time that would likely be able to treat CRE infections so the best hope is to prevent the bacteria from spreading. The CDC has recommended steps such as identifying and isolating infected patients.

This example also show important it is to track the effectiveness of solutions after they are implemented because there can be unintended consequences that show up later on. Antibiotics have saved thousands of lives, but they are becoming less effective as bacteria develop resistance to them. New solutions will be needed to prevent or fight these types of infections in the future. Cause Mapping is a useful tool to document evolving issues because they can easily be adjusted and added to as new information is available.

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

Root Cause

Are Medical Residents Dangerously Fatigued?

By Kim Smiley

Medical residents work extremely long, tiring schedules on their arduous path to becoming physicians.  Possible consequences of this demanding schedule have long been debated.  Many wonder if it’s safe to have someone who has been on duty for 24 hours straight treating patients.

This issue can be explored by building a Cause Map, or visual root cause analysis.  A Cause Map is built by asking “why” questions and laying out the different causes that contributed to an issue to the cause-and-effect relationships.  In this example, there is potential risk to patients and to the medical residents themselves.  Patients may be at risk because fatigued medical residents are treating patients and fatigued people are more likely to make mistakes, increasing the chance of a medical error that affects patient safety.  Residents are fatigued because they work long hours and the current regulations allow 80 hour work weeks.

Additionally, the health of the residents themselves may be at risk.  A poll by the Mayo clinic found that 11 percent of medical residents had been in an auto accident.  The poll also found that 8 percent of residents reported having at least one blood or body fluid exposure due to fatigue or stress, potentially exposing them to any number of diseases.  Sleep deprivation itself can also have long term health consequences increasing the likelihood of a number of illness including heart disease and gastrointestinal problems.

While there is ongoing debate on whether residents are still working too many hours, there have been changes made to reduce resident fatigue. In 2003, residents were limited to 80 hours per week by the Accreditation Council for Graduate Medical Education.  Prior to this move, there was essentially no limit to the hours a resident could log.  This issue isn’t black and white and there are also many who argue that the limits have had negative unintended consequences.  Fewer hours in the hospital mean that residents see fewer patients and have less experience when they become independent physicians.  Limiting shifts also increases the potential for each patient to be seen by more doctors and for essential information to be lost during turnovers.  This isn’t an issue with a clear answer and any additional restrictions in the hours a resident is allowed to work will need to be mitigated with effective methods of turning over patient care and assurances that residents are getting adequate training.

This is a good example to demonstrate the important of taking an investigation past determining that the problem is caused by “human error”.  Medical errors are caused by human errors, but the most useful part of the investigation usually comes from asking why the error was made.  Was the person overly fatigued?  Was the procedure confusing?  Would the process go smoother with a phase to verify information or a checklist?  An investigation shouldn’t be stopped at “human error”; it should be taken a few steps farther to see what may have contributed to the error and what changes may help prevent a similar error in the future.

Root Cause

Helping the Blind See

By ThinkReliability Staff

Retinitis pigmentosa is an eye disease which results in the degeneration of photoreceptor cells in the retina.  Although it is uncommon, it is estimated that 100,000 Americans suffer from it, but a new device may be able to help them.

In normal sight, the light from a signal enters the eye and contacts photoreceptor cells in the retina.  The photoreceptor cells generate electrical impulses, which are sent to the brain by the optic nerve, allowing the vision to be interpreted by the brain.  In retinitis pigmentosa, their photoreceptor cells deteriorate, short-circuiting the vision process, eventually to the point where there is no vision at all.

To assist in our understanding of the normal vision process, and the problems with it resulting from retinitis pigmentosa, we can use a process map, or a visual step by step diagramming of any process that is examined as part of a root cause analysis.  Although in this case the process is a biological one, diagramming any process that is not producing the desired results can provide important information to develop solutions that allow the process to  again provide the desired results.

With advanced retinitis pigmentosa, all vision can be lost.   Although researchers continue to attempt to discover ways to restore as much vision as possible, any improvement can improve quality of life.  A device called the Argus II, which was approved by the FDA for use in the US on February 14, 2013, aims to help those with retinitis pigmentosa – and possibly in the future those who are blind from macular degeneration.  The device was approved in Europe in 2011 for any type of outer retinal degeneration.

The device uses a camera, video process and electrodes which do the processing work normally performed by photoreceptor cells and the optic nerve.  The electrode provides a pixelized light/dark pattern to the brain, which can allow sufferers to  see outlines and differentiate between light and dark.  Again, a process map can help demonstrate how the device works to bypass the normal vision process.

To view a process map of normal vision, and partial vision provided by the Argus II device, please click “Download PDF” above.  Or click here to read more.

Root Cause

Hiding in Plain Sight

By ThinkReliability Staff

Before you read the rest of this blog, click here and take a look at the radiograph. Did you notice anything  . . . odd?  If not, you’re in good company.  The image shown was used in a study with trained radiologists.  A vast majority – 83% – did not notice the gorilla in the upper right hand corner of the lung.

Yep, that’s right.  There’s a gorilla in that scan.  Did you miss it too?

This study was based off a study performed in 1999 that drew attention to the “inattentional blindness” effect.  Essentially, it means if you’re busy doing something that requires a lot of concentration, there’s a lot you can miss.  This new study attempted to determine whether people who were “trained for looking” – i.e. radiologists – would be better at noticing something “off”.  Actually, they were worse, based on the percent of people who missed the gorilla in the original study – 50% – being far less than the percent of radiologists – 83% – that missed the gorilla in the radiograph.  What’s particularly disturbing is that what the radiologists were looking at was a radiograph, something they’ve been specifically trained to evaluate.  To be fair, they were specifically asked to look for cancerous nodules . . . not large, hairy animals.

What are the broader implications of this study?  Well, the first is acknowledgement of the possibility of missing the seemingly obvious.  This is not, of course, limited to radiologists.  Examples of this happening are seen all over healthcare – when alarms are assumed to be malfunctioning, rather than actually indicating an issue that needs to be dealt with.  Or when sponges are left inside a patient.  It’s certainly not because the surgical staff isn’t concentrating.  Or when you have a patient seemingly ready for surgery . . . only it’s not for him.  When you have a patient who’s ready to go, and a staff who’s ready to go, it is only to easy to assume that – because everything LOOKS right, it is.

The next question, of course, is what can be done to deal with “inattentional blindness”, now that we know it exists for anyone, regardless of specialized training?  Strategies that have been developed to deal with all kinds of medical errors can also help with inattentional blindness.  Taking time to catch your breath, then going back to look again – such as occurs when using a time-out prior to surgery – can give you a fresh look that is more likely to catch those gorillas.  It can also help to use more sets of eyes, by bringing in different staff members from different areas of expertise.  Checklists can also help to focus on the obvious – forcing a check on a patient’s identity, for example.

Much like in the gorilla studies – where people overestimated their ability to notice outlying events – medical personnel who have effectively incorporated time-outs and/or checklists have been surprised at the number of potential events that have been caught by these aids.  Obviously, they’re not a panacea, or a replacement for a well-trained, caring staff.  So, the next time something seems “off”, take another look.  Maybe it’s a gorilla.