Category Archives: Root Cause

Root Cause

Anesthesia Without Electricity or Oxygen Tanks

By Kim Smiley

Almost 32 million surgeries are performed globally each year without a proper supply of oxygen and anesthesia, predominantly in developing nations.  Many more surgeries are canceled or delayed because anesthesia isn’t available.  One of the issues that plague hospitals in low income countries is that traditional anesthesia machines need electricity and oxygen tanks to function, both of which can be in short supply. A new design, called the Universal Anesthesia Machine (UAM), can operate without electricity or oxygen if necessary and is proving to be a practical solution to this difficult problem.

The UAM was invented by a doctor, Dr. Paul Fenton, who worked as an anesthesiologist at Queen Elizabeth Central Hospital in Blantyre, Malawi where he saw the problems with providing adequate anesthesia first-hand.  He designed his machine to use electricity when it is available, but to continue to function if power is lost by using a hand-powered pump on top. A digital display of oxygen levels switches to a 10 hour battery when power is lost so that the patient can continue to be monitored.  It also uses a compressor and air from the room so oxygen tanks aren’t required.

In an effort to make the UAM as practical to use as possible, it doesn’t use specialized parts.  Parts needed to maintain the machine should be available through a typical auto supply shop.  It’s also a flexible design that is compatible with all standard adult and pediatric breathing systems.

Honestly, this invention sounds too good to be true, but the UAM seems to be functioning as promised.   The number of UAMs in use is still relatively small (100 have been distributed to 18 countries), but they have already provided oxygen for over 30,000 surgeries.  Inadequate anesthesia is a huge issue, but this new machine may very well prove to be an important step in working towards a solution.

Click on “Download PDF” above to see a Cause Map of the problem of inadequate anesthesia.  You can also learn more about how the Universal Anesthesia Machine works by clicking here.

Root Cause

Patient Rediagnosis Lifts Death Sentence

By ThinkReliability Staff

A patient diagnosed with stage-four lung cancer and given less than a year to live was relieved to have the correct diagnosis – treatable sarcoidosis. However, he was then concerned about how the misdiagnosis occurred in the first place, risking his health had he gone along with a recommendation for chemotherapy.

After nearly a year of coughing, the patient underwent a CT scan and was diagnosed with sarcoidosis, a treatable lung disease. Shortly after that diagnosis, a lung biopsy found the presence of stage-four lung cancer. The patient was referred to an oncologist, who recommended chemotherapy. Luckily for the patient, the diagnosis didn’t seem right and he sought a second opinion. Although the tissue samples from the initial biopsy tested positive for stage-four lung cancer, additional biopsy results showed that he did not have cancer.

In order to reduce the risk of a diagnosis error like this one occurring in the future, it’s important to identify all the causes that contributed to the issue. We can capture these cause-and-effect relationships in a Cause Map, or visual root cause analysis. The first step in the Cause Mapping process is to capture the impacts to the goals. In this case, there was a potential safety impact to the patient receiving unneeded chemotherapy, which could have potentially caused a worsening of the actual disease from which he was suffering. The patient services goal was impacted by the misdiagnosis and the property and labor goals were both impacted by the potential for unneeded treatment, as can occur with any misdiagnosis.

Once the impacts to the goals have been determined, the next step is to determine the cause and effect relationships by beginning with an impacted goal and asking “Why” questions. The misdiagnosis resulted from the contamination of a biopsy sample sent to the lab to determine the pathology of the disease. The patient’s lab sample was contaminated with stage-four lung cancer from another patient. (DNA testing confirmed the presence of both the patient’s biopsy sample and tissue from a sample of the lung cancer sufferer.) The presence of DNA from both samples indicates that they were cross-contaminated, though the method is still unknown. (The patient with lung cancer was properly diagnosed.) Because the two diseases are pathologically similar, it was not immediately clear that there was a problem with the sample used to make the diagnosis.

Once the patient sought another opinion, it was verified that the first biopsy sample did contain cancer cells. However, another biopsy and blood tests showed he did not have cancer. The original hospital confirmed their diagnosis of cancer even after this information until another biopsy was performed at that facility. Five months after the initial cancer diagnosis was the diagnosis updated to sarcoidosis. The patient filed a complaint with that hospital, as well as the hospital where chemotherapy was recommended, on October 23, 2014.

Once all the causes are determined, solutions can be determined that address the various causes. Because it’s still not clear how the cross-contamination at the lab occurred, an investigation specifically addressing that issue should occur, looking in detail at the specimen handling procedures and adding improvements where necessary to reduce the risk of cross-contamination. (The risk is already very low; the lab has said that it generally handles 70,000 specimens a year and this is the first contamination issue known.)

Additionally, the method for reconsidering diagnoses based on additional testing from alternate providers must be examined. Though the initial misdiagnosis in this case, based on a lab sample that clearly showed the presence of cancer cells, is understandable enough, the ensuing delay in updating the diagnosis despite heavy pushback from the patient is not. Ideally the lessons learned from this case will provide safer and more effective healthcare for everyone.

Root Cause

Deaths and Arrests Leave Many Questioning Mass Sterilizations

By ThinkReliability Staff

The deaths of 13 women after they underwent tubal ligation (female sterilization surgery) at a government- run clinic in India have resulted in outrage and arrests, but few answers. It is known that shortly after one of these mass sterilizations on November 8th at a mobile clinic, the women became ill and died.  The doctor was arrested for performing 83 sterilizations in 6 hours when government regulations permit only 30 in a day.  (The doctor says that pressure and incentives from the government encourage more sterilization surgeries despite guidelines.)  The cleanliness of the tools used for the surgeries as well as of the clinic itself are believed to have caused infections that led to severe septic shock that resulted in these deaths.

However, patients from different clinics who had taken antibiotics from the same batch used at the sterilization clinic also became ill, raising the question of contaminated – or outright counterfeit – drugs.  The owner and son of the manufacturing clinic that provided the antibiotics were also arrested.  It’s now believe that the women exhibited signs of potential poisoning and that trace amounts of a chemical used in rat poison were found in tests of the batch of antibiotics.  The signs of poisoning and septic shock can be similar, so additional testing is needed.

Either way, it’s clear that the care these women received was substandard.  Not only is the condition of the clinics and medication in question, but also the use of these surgeries as a form of family planning, which is common in the area.  In a survey, 34% of households indicated that female sterilization was their main method of family planning. Availability of less permanent birth control and medical care are limited, and population is booming.  The government has encouraged female sterilization, not only by running the mobile clinics but also paying the women who are sterilized.  The women who died from the procedure were given 1,400 rupees, or about $23 US.

Although there is currently limited information on what exactly lead to the death of these women, an analysis of those things that went wrong can still be useful to look for solutions.  (Click “Download PDF” above to view the one-page overview of a Cause Map, or visual root cause analysis, of what is known so far.)  Each possible cause (which indicates that more evidence is needed) can be developed with additional detail when more information is available.

Post-mortem inspection of the women who were killed indicated that their deaths were due to septic shock from severe infections.  The infections were believed to have been obtained during the surgery due to dirty tools or poor conditions.  (It’s not surprising that a clinic with limited resources known for having substandard cleanliness would struggle to ensure clean equipment for 83 surgeries in 6 hours.)  If the antibiotic they were given in order to fight potential infection was adulterated (and not providing the desired active ingredients, or too little of them to be effective), it would decrease the women’s ability to fight off the infection.

The potential poisoning (supported by sickness of others who received medication from the same batch) is believed to be due to counterfeit or adulterated medication.  Preliminary testing showed the presence of a chemical used in rat poison within the medication.  Counterfeit and adulterated drugs are both a problem in India; the World Health Organization (WHO) estimates that as many of 1 in 5 drugs made in India are fake.  The US FDA prevents the importation of the antibiotic used at the clinic from India.  Drug inspectors in the area indicate that about 25% are of substandard quality due to poor manufacturing practices.  Enforcement of drug quality is limited in the area, and issues with medication are seen frequently.

As mentioned above, both the surgeon and the owners of the pharmaceutical manufacturing facility have been arrested.  Both sterilizations and the use of certain drugs have been limited in the area until the causes resulting in the women’s deaths have been determined.  What hasn’t happened (yet) is a serious look at the country’s method of family planning in hopes that these types of tragedies never happen again.

Root Cause

Chronic Obstructive Pulmonary Disease (COPD) is Strangling Nation’s Health

By ThinkReliability Staff

The facts about chronic obstructive pulmonary disease (COPD) aren’t pretty.  COPD is not one but a group of diseases that impact airflow and breathing.  Included in the group are emphysema and chronic bronchitis.  (These diseases are grouped together because they are commonly diagnosed together.) COPD is the third leading cause of death.  In 2010, it was the cause of death of 135,000 Americans.  Every year, COPD results in millions of visits to the doctor’s office or emergency room and hundreds of thousands of hospitalizations, which last an average of almost five days.

All that medical care doesn’t come cheap.  COPD is the fifth most expensive disease in the US, with $32.1 billion in direct medical costs.  (In addition, billions of dollars are attributed to absenteeism and mortality costs as a result of COPD.)  An additional concern is that many COPD sufferers are rehospitalized soon after release.  COPD is the third most common cause of 30-day rehospitalization.  Under the Hospital Readmissions Reduction Program (HRRP), penalties or loss of benefits are applied to hospitals with greater than average rehospitalization.  The penalty for readmission of COPD patients beyond average is $33,000.  Of US hospitals, 44.5% received readmissions penalty in 2013.

Because there is no cure for COPD, limiting rehospitalizations primarily involves ensuring appropriate treatment to limit symptoms, and exacerbations, which account for 50-75% of medical costs.  However, there are actions that can slow the progression of COPD.  By diagramming the cause-and-effect relationships resulting in progression of COPD in a Cause Map, we can visually show how solutions act on these causes.  As discussed above, impacts to goals associated with COPD include patient safety (deaths), environmental (exposure to air pollutants), compliance (potential for penalties/ loss of benefits), patient services (high levels of rehospitalization), operations (absenteeism) and property/labor (direct medical costs).  These impacts are primarily caused by exacerbation of COPD.

Exacerbation of COPD results from the progression of the disease and delayed treatment.  COPD develops due to exposure to air pollutants (primarily tobacco smoke or industrial chemicals), genetic factors (which are just beginning to be understood), and respiratory infections or untreated asthma.  Because there is no cure for COPD, time without treatment is the primary way that symptoms increase.  (82% of COPD sufferers are over age 65.)  Inadequate treatment typically results from the underdiagnosis of COPD (experts predict 10-12 million sufferers have not yet been diagnosed) and insufficient adherence to a medication regime.  Based on self-reported values and pharmacy claims, adherence to prescribed medication regime is 32-50%, meaning less than half of COPD sufferers are following doctor’s orders with regards to their COPD, even though studies have also found that optimized medications can reduce exacerbations of COPD by 20%.

Along with underdiagnosis, a cause of exacerbations is delayed treatment.  Part of this is also caused by insufficient adherence to a prescribed medication regime, but also to delayed reporting.  Symptoms of an exacerbation generally occur about a week prior to a discernible reduction in lung function, but all too often that week is spent without medical care because patients tend to delay reporting symptoms until their lung function is affected.

To reduce the impact of COPD as well as the potential for rehospitalization, the following is recommended:  First, the biggest impact an individual can have on COPD is to stop smoking.  Individuals should also reduce their exposure to air pollutants, including cigarette smoke and industrial chemicals (whether at the work place or in home cleaning products).  Those experiencing an exacerbation of symptoms should report it immediately and should follow all medication guidelines given by their doctor.  For doctors, guidelines for the use of spirometry (a breathing test to measure lung function) can provide a more accurate diagnosis of COPD.  Presenting information to patients about the importance of the above measures can also help reduce COPD exacerbations and potential for rehospitalization.

To view a one-page PDF with an overview of the cause-and-effect relationships, and recommended solutions for minimizing the impact of COPD, please click “Download PDF” above.    Or, visit the COPD Foundation to learn more.  You can also view a Cause Map of America’s Smoking Epidemic, here.

Root Cause

Re-engineered connectors may prevent tubing mix-ups

By ThinkReliability Staff

Patients being treated at healthcare facilities may have multiple tubing connections designed to provide different medical treatment products.  Disaster can occur when tubing is connected incorrectly.  The most well-studied example is when enteral feeding solutions are accidentally directed into intravenous (IV) lines.  The Joint Commission (TJC) found 116 case studies, including 21 that resulted in deaths, due to this type of misconnection, discussed in a recent Sentinel Event Alert.  In 2006, this happened to a pregnant woman, resulting in the death of both her and her fetus.  (See our previous blog on this topic.)

Issues involving tubing misconnections have been reported since the 1970s and are not limited to feeding tube/ IV mix-ups.  Many types of tubing for medical product delivery are susceptible to misconnection due to the use of luer connectors, which allow a high degree of connection compatibility.  Concern is growing over these types of connections, and it’s become clear that training is not adequate to prevent these types of connections.  According to the Joint Commission, “The basic lesson from these cases is that if it can happen, it will happen.  Luer connectors are implicated in or contributed to many of these errors because they enable functionally dissimilar tubes or catheters to be connected.”

Action is being taken that would prevent these misconnections by ensuring that each type of tubing has its own, non-compatible connector.  The Association for the Advancement of Medical Instrumentation (AAMI) is leading an international initiative to develop small-bore connectors standards.  Public review of the standards is now available (along with other helpful information including case studies) on the AAMI website.  The State of California has passed legislation requiring manufacturers of intravenous, epidural or enteral feeding devices to implement the new standards that aim to prevent misconnection, though it does not take effect until January 1, 2016.

Connectors meeting the new, non-compatible standards are becoming available but compatible connectors may still be in use and in inventory systems.  To limit risk of patient death or serious impairment while the new connectors are phased in, TJC recommends that tubing is traced from the patient to its point of origin every time it is connected, disconnected, or during a patient hand-off.  Labeling high-risk tubing and routing tubes and catheters in specific directions (towards the head for IVs; towards the feet for enteric feeding tubes) has also been recommended to reduce the risk of misconnection.

Going forward, only equipment that is incompatible with female luer connections on IVs should be purchased for all non-IV equipment and acceptance testing should be performed on new purchases to ensure it is not compatible with IV tubing connections.

The cause-and-effect relationships leading to the patient safety risks, and the solutions that are being recommended can be visually diagrammed in a Cause Map, or visual root cause analysis.  To view a one-page overview of the issue, please click on “Download PDF” above.

Root Cause

The Race to Develop an Ebola Vaccine

By Kim Smiley

Traditional public health methods have not been able to stop the Ebola epidemic raging in West Africa and some experts are speculating that a vaccine may be necessary to quash the outbreak.  The only problem is an approved vaccine against Ebola doesn’t exist.

A Cause Map, a visual root cause analysis, can be built to analyze this issue by intuitively laying out the causes that contribute to the problem.  A Cause Map is built by asking “why” questions and documenting the answers on the Cause Map to show the cause-and-effect relationships.

So why isn’t there an approved Ebola vaccine?  There are several promising vaccines in development, but some of them are newer efforts that haven’t had time to go through the lengthy approval process.  A few potential vaccines have been around for years, but development stalled prior to the necessary human trials.  Prior to this year, there was limited potential revenue from an Ebola vaccine because of the limited demand so it has never been a high-priority product. Demand for, and interest in, producing an Ebola vaccine, has of course skyrocketed as a result of the ongoing epidemic in West Africa and Ebola cases popping up in other countries.

Now that companies are putting significant resources in the race to produce an Ebola vaccine there are still huge logistical obstacles that must be overcome.  At least two different vaccines should be ready for large-scale human trials early next year, but actually distributing the vaccine and tracking volunteers will require significant resources.  The vaccine must be kept at a constant temperature which can be difficult in regions of West Africa without reliability electricity.  Keeping track of thousands of volunteers is always a massive undertaking, but will be even more challenging in the middle of an epidemic in a region where the medical systems are overtaxed.  There is also a chance for significant political fallout if the vaccine created by Western countries and given to poor African nations turns out to have harmful side effects.

This topic raises some really difficult ethical issues.  How much do you fast-track a vaccine?  People are dying and an effective vaccine would save lives, but distributing a vaccine prior to the normally required testing could also result in significant human suffering if there is an unexpected side effect.  When has a vaccine been tested “enough” to justify giving it to people in a high-risk environment?  Even designing the human trials requires some hard decisions.  Do you conduct a blind study with a control group, knowing that some of that group is statistically likely to be infected with a deadly disease? There is a lot of gray area and it’s difficult to know what the right answer is.  Thousands of lives may hang in the balance and there isn’t a lot precedence in how best to respond to the challenge of this Ebola outbreak.

If you’d like to learn more about this epidemic, you can read our previous blogs:

Patient With Ebola Sent Home From ER

Ebola Outbreak Claiming Lives of Medical Staff

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

 

Root Cause

Humidity May Cause Loss of Hospital Accreditation

By ThinkReliability Staff

A hospital in California has received a preliminary denial of accreditation from The Joint Commission, which may lead to a loss of Medicare and Medicaid funding.  This move is rare – less than 1% of hospitals are denied accreditation.  The ruling was made during an onsite survey after reports that four patients had developed surgical-site infections after hip replacement surgery within a month.  (The patients all recovered after administration of antibiotics.)

Says the hospital’s Associate Director of Emergency Services, “Surgical infections are extremely rare. When we saw the cluster we stood up and took notice. We stabbed every corner and every crevice.”

However, that may not be entirely true.  First of all, surgical infections are probably not what’s considered “extremely rare”.  In a recent study, the Centers for Disease Control and Prevention (CDC) found that 1 in 25 patients acquires an infection while in the hospital  and infections are among the leading cause of death worldwide.  (See our previous blog for more details.)  Only slightly more than 20% of those infections were found to be surgical site infections from inpatient surgery, but that still results in about 157,500 surgical site infections a year.

There’s also a question about how quickly action was taken to address the issues identified by The Joint Commission, specifically high humidity.  After the four patients were infected with enterobacter (a bacteria that is harmless in the gut but can cause illness in a wound), the hospital cultured equipment and instruments and found no contamination.  However, three of the surgeries which resulted in the surgical site infections took place in an operating room that had been identified in February or March to have high humidity due to issues with the heating and ventilation system.  Although a new system would not be installed for several months, surgeries continued to take place in that operating room until The Joint Commission identified problems with heat and humidity.

The germs that caused these infections can also be introduced to a surgical site by medical staff – usually due to improper hand washing or surgical prep procedures.  It’s unclear if this may have been the case here – there has been no discussion of this possibility – but handwashing issues are a constant source of infections at healthcare facilities.  According to studies, more than 50% of infections are largely preventable with good hygiene and technique.

The hospital has 23 days from the October 8th preliminary denial of accreditation to meet federal standards.  The hospital is installing new heating and air conditioning equipment and is reviewing its procedures for “hospital documentation and staff communication”.   Hopefully other processes will be reviewed as well.  The hospital expects to reopen its operating rooms soon.

To view an overview of the investigation of this issue, please click “Download PDF” above. The downloadable PDF shows the goals impacted by this issue, a visual layout of the cause-and-effect relationships that led to the impacted goals, and the solutions being discussed by the hospital to improve patient safety regain their accreditation.

Root Cause

FDA To Device Maker: Complaints Not Properly Investigated

By ThinkReliability Staff

The Food and Drug Administration (FDA) issued a warning letter – a possible precursor to regulatory action – to a manufacturer of pulse oximeters challenging its response to violations identified during a facility inspection in 2013.  Specifically it found that:

1) Complaints of device failures were not adequately investigated,

2) Investigation records did not include required information,

3) Procedures did not identify all potentially affected product, and

4) Causes of failures were not investigated.

The company’s response to the initial violations found during the FDA inspection was found to be unacceptable.  Some of the comments to the FDA regarding the violations were: “The reported event poses no risk to user or patient safety, therefore, no Corrective and Preventive Action required”, “The cable and sensor that were returned with the instrument were also investigated and no problem was found”, “Through the investigation process, it was determined that Masimo’s product did not malfunction”. To each of the violations, the company claimed that either no problem was found, or that the problem did not involve any failures of the pulse oximeters identified in the complaints.

This doesn’t ring true to Diana Zuckerman, the president of the National Center for Health Research.  She says, “It may well be that it’s a user error. But you have to investigate that and show that it’s a user error and not a device error… When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible.  Especially when users made complaints that the company’s product put patients at risk.”

Included in the complaints are that the manufacturer’s pulse oximeters failed to alarm in a patient that died and that they resulted in burns on both an 11-month old and 33-year-old and a skin tear on another patient.  Complaints also indicated issues with consistency of readings and exposed wires at the connection points.  The failures are getting attention not only because FDA warning letters are fairly rare – this is the first such letter to the company in its 25-year history – but also because of the company head’s views on medical errors and funding of the nonprofit Patient Safety Movement Foundation.

Pulse oximeters are used to monitor a patient’s pulse and blood oxygen.  Abnormal readings can indicate a change in a patient’s condition which may require medical intervention.  If the device fails to function, it can lead to patient injury or even death.  Because the devices are intended for use in diagnosis, they are regulated by the FDA and have to conform with FDA practices.  If the violations identified by the FDA in the warning letter are not corrected, the company may face regulatory action.

For now, the company has not released its plans to ensure compliance with the FDA requirements.  The FDA is clearly looking at updates to the investigation process used to respond to customer complaints and ensuring that causes identified as part of those reviews result in changes to other processes, such as manufacturing and quality control.

To view an outline and analysis (in the form of a Cause Map, a visual form of root cause analysis) of the FDA’s findings, click on “Download PDF” above.

Root Cause

Patient With Ebola Sent Home From ER

By Kim Smiley

If you have been paying any attention to the news lately you have heard that a patient was diagnosed with Ebola in the United States for the first time.  The fact that the patient sought treatment at an emergency room (ER) and was sent home is particularly alarming and people are naturally very interested in how such a thing could happen.

The media has been flooded with breaking news about this case. In situations like this, keeping track of what information is current and reliable and what is already outdated or has been determined to be inaccurate can be a moving target.  A Cause Map, a visual format for performing a root cause analysis, can be useful in these situations as a way to document the available information.  A Cause Map visually lays out the causes that contributed to an issue in an intuitive format.  It is relatively easy to quickly expand a Cause Map as more information becomes available.

Generally, a Cause Map is built in an Excel workbook so old versions of the Cause Map can be easily saved as different tabs and that the evolution of the investigation isn’t lost.  Additionally, it’s easy to add evidence supporting each individual cause onto the Cause Map itself so that all relevant information is documented in one location and easily referenced.  There are often things that are being considered that may have played a role in a problem, but lack evidence to determine whether or not they are actually relevant to the investigation.  This situation can be documented on a Cause Map by listing the potential cause and adding a question mark to show that a cause is being considered, but that it needs more evidence.  If that cause is later determined to not have been a factor it can be crossed out to document that it has been considered so that no work is duplicated.

So what information is known at this point about the patient with Ebola who was sent home from the ER?  A man has been diagnosed with Ebola in Dallas, Texas.  Statements by friends and family indicate that he helped transport a sick woman prior to traveling to the US.  It’s not clear whether he knew that she had Ebola or not.  After being exposed to Ebola, he passed through the airport screening because he did not have a fever at that time and he did not indicate possible exposure on the required questionnaire.   He arrived in Dallas, Texas on September 20, 2014.

His family has stated that he started feeling ill on the 24th and he sought treatment at a hospital on September 26.  He was released with a prescription for antibiotics.  Ebola can be difficult to diagnose because the early symptoms, such as fever and muscle pains, are very nonspecific.  The only information the hospital would have had to indicate that patient might have Ebola is his travel history.  Statements by the hospital indicate that the patient told the nurse he had recently been in Liberia.  The travel history information doesn’t seem to have been known by physicians that treated the patient.  Initial statements by the hospital indicated that issues with electronic health records may have played a role in the confusion, but later released more information that modified their position.  Exactly how the risk of Ebola was missed isn’t clear and this portion of the Cause Map will need to be expanded as more information is available.

It is not shocking that an Ebola case would be diagnosed in the US with travelers still arriving from West Africa and the long incubation period.  As long as Ebola is still a problem in Africa, US hospitals could see more patients with Ebola and need to be prepared for the possibility.  But it is concerning that someone who had recently traveled from West Africa with a fever wouldn’t trigger any alarms at an ER.   Individuals with Ebola must be quickly identified and isolated In order to prevent the spread of the deadly disease and hospitals in the US need to ensure that no other potential Ebola patients fall through the cracks.

Click on “Download PDF” above to see an initial intermediate level Cause Map for this example.

Root Cause

Healthcare Worker with Active TB May Have Infected Infants

By ThinkReliability Staff

A healthcare worker may have exposed more than 751 infants and 55 coworkers to tuberculosis (TB), a potentially deadly disease, during the 11.5 months she worked with newborns in the nursery and post-partum unit.  The employee was found to have symptoms of active TB (the only kind that is contagious) in July 2014 and was tested on August 21, 2014.  Infants and coworkers who were in those units between September 1, 2013 and August 16, 2014 are potentially affected.

The impacts of the potential exposure are significant.  The goal of ensuring patient safety has been impacted because of the potential exposure of 751 infants (so far identified).  Additionally, the goal of ensuring employee safety has also been impacted as 55 coworkers are also potentially impacted (those already screened have not shown any signs of infectious tuberculosis).  Because of the close contact required to spread TB, the issue has not been identified as a public health threat.  Regulatory agencies are still interested – the hospital has been cited by the Department of State Health Services for issues relating at least in part to infection control that are “an immediate jeopardy to patient safety”.  (It wasn’t clear how or if these issues are directly related to the TB exposure but were found in an inspection that occurred as a result of it.) All the patients who have been exposed may potentially require a course of antibiotics, typically six to nine months.  Infants under six months are being given the course as a preventive measure.  This impacts the patient services goal.  All the screening and treatment is being provided by the hospital free of charge, which is an impact to the hospital’s labor and time goal.

Developing the cause-and-effect relationships that led to the goals that were impacted can provide clarity to the investigation and potential solutions.  Exposure to TB occurred when an employee with an active infection came to work and was potentially aided by the hospital’s infection control policies or procedures, which may not have been effective in preventing the spread of the disease.  It’s unclear how the employee contracted tuberculosis, but she was likely not vaccinated. Although a vaccine against tuberculosis exists, it’s rarely used in US.

A question raised by this issue is why the long period of time during which there was a potential exposure?  Tuberculosis can remain latent in the body for months or even years before turning into an active case.  (It is only contagious when active.)  The employee appears to have passed a routine annual health screening in July 2013 and started showing symptoms at or near her next annual health screening in July 2014.  However, she was not tested for the disease until August 21st and appears to have continued work until August 16th.  It’s unclear why the delay occurred, and the hospital will surely be looking to ways to minimize patient exposure to workers who may be sick.

The hospital is working with the Texas Department of State Health Services and the Centers for Disease Control and Prevention to screen and treat patients and other healthcare workers that came into contact with the infected worker based on employment and medical records in an extensive outreach campaign.  The employee has been placed on leave and is being treated.  The hospital is required to submit a corrective action plan to the Texas Department of State Health Services, which should identify corrective actions to issues raised as a result of the state’s inspection and by the Centers for Medicare & Medicaid Services.

To view the impacted goals, cause-and-effect relationships and potential solutions in a Cause Map, or visual root cause analysis, please click “Download PDF” above.  Or, click here to learn more.