All posts by Angela Griffith

I lead comprehensive investigations by collecting and organizing all related information into a coherent record of the issue. Let me solve a problem for you!
Hospital Acquired Condition, Root Cause Analysis

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.

Never Event

Infant Death Due to Sodium Chloride Overdose

By ThinkReliability Staff

On October 15, 2010, a 40-day old prematurely born infant died from a sodium chloride overdose at an Illinois hospital.  Because a computerized system was involved, this case has been noted as a harbinger for possible issues resulting from the use of computerized systems.  To learn more about what happened, we can look at the case in a visual root cause analysis, or Cause Map, to examine all the causes.

First we begin with the impact to the goals.  The infant’s death was an impact to the patient safety goal.  A death resulting from a medication error is a “never event“, which is an impact to the compliance goals.  There is a related wrongful death lawsuit, which is an impact to the organization’s goals.  The overdose of sodium chloride delivered to the patient is an impact to the patient services goal.

We begin the analysis with the impacts to the goals and ask why questions to fill out the Cause Map.  The infant death was caused by the sodium chloride overdose, which occurred when the infant received more than 60 times the dosage ordered by the doctor intravenously.   The infant was receiving sodium chloride intravenously to provide nutrition, as he had been born prematurely.  Although a blood test indicated abnormally high levels of sodium, it has been reported that the lab technician assumed they were inaccurate, resulting in the infant not receiving immediate care for the overdose.

When a process – in this case, the medication delivery process – does not work correctly (such as occurs when an overdose is given), it means that the checks at every level of the process were ineffective.  The final check at the patient’s bedside was ineffective because the label on the IV bag did not match the actual contents.  It’s unclear how that occurred.  The error was made at the pharmacy, when a pharmacy technician entered an incorrect number into the compounding system.  Normally entering a too-high dose would trigger an alert with an automated system, but the alerts were turned off.  Part of the reason for the error was that the pharmacy technician had to manually enter the prescription in the first place.   A  doctor enters a prescription via the automated dispensing system.  However, the automated dispensing system, and the computerized compounding system did not communicate with each other, so for orders that required compounding, a technician had to transfer the order from one system to the other, manually.

A computerized system is no better if it’s not used properly.  If parts of the system don’t communicate with each other, and safety checks are turned of, a computerized system may actually be less safe, especially if people expect the automatic checks are being performed, and so don’t perform any of their own.  Computerized systems have a lot to offer – namely, reducing the number of medication errors relating to illegible handwriting or providing automatic checks for drug interactions.  But these systems are not fail-safe and checks used to ensure that patients

Root Cause Analysis

Protein in Donated Blood Causes Life-Threatening Allergy

By ThinkReliability Staff

Blood transfusions are fairly common, with 25 million blood component transfusions occurring per year.  Blood transfusions are also very safe. The risk of health concerns from blood component transfusions is extremely low.  Until recently, it was believed that all the concerns from transfused blood were being tested for and rooted out.  However, a new case presented in the New England Journal of Medicine has presented a new concern.

A six-year-old boy in the Netherlands was receiving pooled platelets when he suffered from an allergic reaction.  The staff was able to prevent potential death or serious injury with an immediate injection of adrenaline.  As a follow-up, the staff tested the boy and ruled out many other potential causes.  The lab tests and testimony from the boy’s mother confirmed an allergy to a peptide, which is a protein that is left in the blood after ingesting peanuts. The peptide, known as Ara h2, is resistant to digestion, as evidenced by studies that have found levels in the blood 24 hours after ingestion.

Because this case demonstrates a newly discovered phenomenon, evidence to support the causes is particularly important.  Evidence supporting the placement of a cause related to a root cause analysis can be placed in a box directly below the cause box on a Cause Map.  (To see the Cause Map, click on “Download PDF” above.)  The allergy to the peanut peptide causing the allergic reaction and the peptides being present were verified by testing and interviews with the donors and the patient’s family.

The immediate solution, to inject adrenaline to prevent the patient’s death from the allergic reaction, was taken immediately but does not do anything to solve the broader problem of potential allergens in the blood supply.  One of the potential solutions is to screen the blood supply for dietary contributions, but considering the large amount of donors and recipients, this is considered to be prohibitively expensive and difficult.  Because there is not a viable alternative blood transplant source, and blood transfusions are still needed by patients with allergies, it seems that the solution must be to figure out a way to remove the proteins, at least from blood transfusions going to people with allergies.  However, another case, from 2003 resulted in a blood product recipient developing allergies when receiving a blood transfusion from a donor who had peanut allergies, so screening the blood supply prior to transfusing people with allergies may not be sufficient.

Root Cause Analysis

Reducing Stillbirth Rates Worldwide

By ThinkReliability Staff

Stillbirth is the loss of a pregnancy after 22 weeks gestation.  Around 2.6 million stillbirths occur every year around the world, primarily in developing countries.  However, the kind of attention being addressed to other issues in the developing world has not been focused on stillbirth, leading the rates of stillbirth to decrease more slowly than other death rates.  In an attempt to draw more attention to this issue – with its profound impact on the family and community – the Lancet has published a series of articles on stillbirth, addressing some of the impacts, causes, and a plan to reduce the number of stillbirths in half by 2020.

The information provided by this comprehensive series can be summarized visually within a Cause Map.  A thorough root cause analysis built as a Cause Map can capture all of the causes in a simple, intuitive format that   fits on one page.  We begin the Cause Map much as the series begins – with a focus on the impacts of stillbirth, beginning with the 2.6 million deaths per year.  We can consider this an impact to the public safety goal.  A related impact is an impact to the public safety goal – lack of access to quality care.  Starting with these two goals, we can begin an analysis of the problems contributing to stillbirth.

Although the data collection for stillbirth lacks consistency, there are five major causes of stillbirth that we’ll address here: fetal growth restriction, childbirth complications, maternal infection, maternal disorders, and congenital abnormalities.  At a very, very high level, we can discuss some of the causes of these issues, which the Lancet series hopes to address in order to halve the number of stillbirths by 2020.

Fetal growth restriction can be caused by inadequate prenatal care.  Increased fetal growth restriction detection and management is expected to reduce the number of stillbirths by 107,000 per year.  Childbirth complications can be caused by lack of quality obstetric care and/or labor past 41 weeks.  Comprehensive emergency obstetric care is expected to reduce yearly stillbirths by 696,000 and  identification/induction of women who are past 41 weeks gestation is expected to reduce another 52,000.

The main maternal infections of concern are malaria and syphilis.  Additional malaria prevention (such as insecticide treated nets) would reduce annual stillbirths by 35,000 and syphilis detection/treatment another 136,000.  Maternal disorders of concern are mainly diabetes and hypertension. Detection and management of maternal diabetes and hypertension would prevent 24,000 and 57,000 stillbirths per year, respectively.  Congenital abnormalities can be caused by insufficient folic acid intake at and after conception.  Increased access to folic acid supplementation would save 27,000 lives.

If all of these recommendations can be fully implemented, more than 1 million stillbirths could be prevented each year.   Far more detail can be added to this Cause Map, depending of the level of analysis required. As with any investigation the level of detail in the analysis is based on the impact of the incident on the organization’s overall   goals.  To see the outline, Cause Map, and solutions, please click “Download PDF” above.  To learn more about stillbirth, and the goals, please see the Lancet series.

Root Cause Analysis

Tungsten Particles Remain in Patient’s Bodies After Clinical Trial

By ThinkReliability Staff

Thirty women who participated in a research clinical trial that hoped to revolutionize the treatment of breast cancer are now facing the possibility of long-term effects from tungsten particles left in their body or disfiguring surgery.  The trial involved radiation treatment that could be performed in one short session instead of over many weeks, offering obvious benefits to the patients.  However during follow-up checks after the trial, many women found particles of tungsten, a heavy metal, in their breasts and chest muscles.

Some physicians have recommended removal of the affected areas.  The choice between that, or living with the risk of tungsten particles, whose long-term effect has not been thoroughly studied, is an impact to the patient safety goal.  In addition the particles will look like calcium deposits, which can be an indication of cancer, in future mammograms, resulting in an impact to the patient services goal.  The device has since been recalled, which is an impact to the property goal, and at least one suit has been filed against the manufacturer of the device and the hospital performing the trial.  It is believed that 30 women are affected.

The health issue of leaving the tungsten within the patient’s body is caused by a particle of unknown long-term safety being deposited in the body.  The tungsten appears to have been shed by a device used during radiation treatment to prevent radiation from reaching other parts of the body.  It’s still unknown how a device that would shed particles into a patient’s body made it into a human clinical trial.  What is known is that the device went through the accelerated FDA approval process known as 510(k) for devices that are similar to devices that have already been approved.  It’s unclear which device was considered similar enough to allow for the approval of this one, but there have been many concerns that the FDA’s approval process is insufficient.

An in-depth look at the approval process of the FDA is currently underway to determine where changes in the process may result in a more thorough review and , most importantly, prevent an issue like this one from reoccurring.

Root Cause Analysis

Kidney Transplant Mix-up

By ThinkReliability Staff

On January 29, 2011, a kidney was transplanted into the wrong patient.  No one was injured, but this was known as a “near miss” – had things gone slightly differently, it could have resulted in severe consequences.  Namely, the patient who received the incorrect kidney could have been killed or seriously injured, had the kidney not happened to be compatible with that patient also.  (The kidney donor had Type O blood, known as the universal donor, which aided in the compatibility.)  The patient who was supposed to receive the kidney could have had a long wait back  on the transplant list.  Luckily, a new donor was found for the second kidney and a new kidney was found for the second donor fairly quickly.  Although there were no injuries, the high potential for injury results in an impact to the patient safety goal.

To try and help figure out what went wrong, we begin with the impacted goal and ask “Why” questions to fill out the analysis. We discover that there were two kidneys that arrived at the hospital simultaneously.  In order for the kidneys to be switched, the kidneys must have been mislabeled, or miss-identified once at the hospital.  The coordinating agency for transplants states that the packaging and labeling of the organs was correct.  We then turn our focus to the identification steps of the organ once at the transplant center.

To aid in determining where process improvements can be made, first we need to define the process.  We can do this with a process map – a step by step instruction of how a process is performed.  In this case, the steps for transplants have been developed by an outside agency – the United Network for Organ Sharing (UNOS).  We can outline these steps in our Process Map.  Because of the high risk for consequence should an error occur, the process is well-defined and consists of checks to ensure that mismatches do not occur.  The last highly publicized incident of a transplant error was in 2003 (see more about that incident here).

The hospital involved has not released details about what might have occurred in the process; however, it’s certain that they’re looking at the process with a fine-tooth comb and trying to implement improvements.  The transplant program has closed down while they’re doing so.

Root Cause

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 2)

By ThinkReliability Staff

This week, we will continue our discussion of an incident where the wrong surgery was performed on a patient.  Last week, we looked at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  This week, we’ll perform a root cause analysis of the issue.

The specific steps identified that didn’t go well, or weren’t performed, from the process map now become causes on our Cause Map.  Instead of the causes or errors being grouped chronologically or by type (as they are on a fishbone diagram), the causes are grouped by their contribution to the incident.  The Cause Map reads from left to right by asking “Why” questions, beginning with the impacts to the goals.

For example, the patient safety goal was impacted because a patient received the wrong surgery.  Why?  Because the physician performed the wrong type of surgery. Why? Because the surgical site was not clearly marked.  Why? It was marked on the correct arm, though not the correct site (the wrong surgery was performed on the correct hand) and the mark was washed off during patient preparations.  These are both issues identified in the process map that did not follow the universal protocol for surgical preparations.  Both of these issues contributed to the wrong surgery.  In addition, the surgeon was thinking about carpal tunnel surgery, since most of his day, especially just prior to the surgery, had been spent on carpal tunnel surgery, either performing it, or doing pre- or post-surgery briefs with other patients.

Neither the patient nor the operating room staff stopped the surgeon from performing the incorrect surgery.  The patient spoke only Spanish, which may have contributed to her not speaking up.  The operating room staff did not include the nurse that had done the patient assessment, due to a last-minute operating room and staff switch due to other delays.  There was no time-out prior to the procedure, which may have alerted the staff about the wrong  procedure, or may have helped the surgeon switch from thinking about carpal tunnel surgery.

Once the analysis is complete, possible solutions are identified on the Cause Map.  Many of the solutions in this case are to ensure that the universal protocol procedures are being followed.  Had they been followed in this case, the risk of performing the wrong surgery would have been reduced.  Many facilities are already using the universal protocol; however, this case study shouldn’t be ignored by them.  The operating surgeon made this case public and added the following comment: “I hope that none of you ever have to go through what my patient and I went through. I no longer see these protocols as a burden. That is the lesson.”

This surgeon has learned his lesson and will likely be more diligent about following these protocols in the future.  However, there’s no need to wait until you, or your staff members, have their own incidents to learn from.  Use this case study to emphasize the needs for these protocols, in hopes that your facility can reduce its own risk.

(Details of this incident were recently published in the New England Journal of Medicine.)

Root Cause Analysis

Wrong Surgery Performed on Patient (Part 1)

By ThinkReliability Staff

A case study of an incident where the wrong surgery was performed on a patient was recently published in the New England Journal of Medicine.  Surprisingly, the study was published by the surgeon who performed the operation, because, in his words, ” hope that none of you ever have to go through what my patient and I went through.”  The surgeon also provided full disclosure to the patient – who requested that he also perform the correct surgery.

We will be analyzing this issue in two parts.  This week, we’ll be looking at the timeline of events and a process map of the universal protocol developed to reduce the incidence of surgical errors.  (The timeline and process map can be seen by clicking “Download PDF” above.)  Next week, we’ll perform a root cause analysis of the issue.

The timeline of events shows a harried day where the surgeon in question performed a carpal tunnel release surgery with a patient who became upset about the use of anesthetic, then briefed the patient who would later receive the wrong surgery, then performed another carpal tunnel release surgery on a second patient.  Then the first patient became very agitated, resulting in an emotional conversation for the surgeon.  Delays resulted in a change of operating room and operating staff for the third patient, so the nurse who had performed the pre-procedure assessment was no longer participating in the procedure.

The  procedure was further delayed when the circulating nurse had to leave to find a tourniquet, since there wasn’t one in the operating room.  The surgeon spoke to the patient in Spanish (she did not speak English), which the nurse took as the time-out, so a real surgical time-out did not occur.  As per hospital protocol, the patient’s arm, but not the specific surgical site, was marked, but it washed off while her arm was being prepped for surgery.

It’s easy to see how this sets the scene for mistakes. Unfortunately, these kind of things happen, and so it is important that there are procedures in place to minimize errors.  The procedures here are the universal protocol, which are shown on the PDF.  Additionally, the parts of the process that were not performed, or were performed improperly, are noted in red.

Root Cause Analysis

Drug Shortages

By ThinkReliability Staff

Shortages of commonly used medications are beginning to impact patient safety.  The Institute for Safe Medicine  Practices (ISMP)recently asked healthcare workers to participate in a survey regarding drug shortages.  One out of three respondents said that shortages caused medication errors that could have caused harm to patients.  One out of four respondents said mistakes with medication reached patients, and one in five said that patients were harmed by the medication errors.  In addition, patient care has been impacted by the unavailability of some commonly used medications.  There have been reports of patients who woke up during surgery because sedative was being conserved.

Although the U.S. Food and Drug Administration (FDA) requires manufacturers to notify them when there are drug shortages that have no alternatives, there are no sanctions if they do not.  Because many of these drugs have alternatives, the manufacturers are not required to notify the FDA, and healthcare providers are oftentimes not aware of shortages until they run out of needed medication, causing last-minute scrambles and potentially leading to medication errors, such as when an alternative drug has a lower dosage than the drug being replaced.  Because healthcare providers are so accustomed to the dose of the replaced drug, medication errors can result amidst the confusion.

The FDA estimates that approximately 40% of the shortages are due to manufacturing problems, including safety issues identified in inspections, 20% of the shortages are due to production delays, and another 20% occur when manufacturers stop making drugs.  Although drug manufacturers will not confirm, it is assumed that as insurance companies start covering fewer and fewer brand names and generic prices continue to undercut brand-name prices, it isn’t profitable to make some medications.  The FDA does not have authority to require manufacturers to make medication.  Also contributing to the shortages are increased demand, and shortages of parts and raw materials required to manufacture the medications.

Trying to address these issues and come up with some solutions to the drug shortages is going to take more work than just identifying the issues.  To that end, groups representing doctors, anesthesiologists, pharmacists and safety advocates have invited the FDA, health experts, supply chain representatives and drug manufacturers to attempt to work through a solution earlier this month.  Hopefully they’re able to come up with some actions that will prevent further deaths and medication errors due to this shortage