Medical Laboratory Errors

By ThinkReliability Staff

Surprisingly, many of what are considered laboratory errors do not actually occur in the lab.  But errors related to laboratory testing can negatively impact patient care.  We can look at the impacts and causes of errors related to diagnostic testing in a Cause Map, which allows us to visually diagram cause-and-effect relationships.

We begin this type of root cause analysis by determining the impacts to the organization’s goals.  In this case, because we want to consider all possible sources of diagnostic errors in a proactive analysis, we will look at the generic goals for an organization that provides healthcare.  Diagnostic errors can cause an impact to the patient safety goal because of the risk of impact to patient treatment.  Employees’ abilities to do their job is impacted because they may be receiving incorrect information from lab testing. There is a risk of impact to the patient’s treatment, which is an impact to the patient services goal.  Additionally, there is a risk of performing unnecessary treatment as a result of incorrect testing results, which could impact both the property and labor goals.

Once we have determined the impacts to the organization’s goals (and there may be more impacts for specific incidents involving diagnostic testing errors), we can ask “Why” questions to determine the causes that result in these impacts.  We will begin with the patient safety goal impact.  The patient safety goal is impacted because of the risk of an impact to a patient’s treatment.  This includes the possibilities of a risk of delayed treatment, risk of not receiving needed treatment, and a risk of unnecessary treatment.  Delayed treatment can occur from a delayed diagnosis, which could result from either delayed or incorrect testing results.

Delay of testing results can be caused by delayed reporting of results, potentially due to a lack of time requirement for reporting results and/or a lack of tracking these results.  A possible solution to delayed reporting of results can be to implement a standardized process for reporting results, which may include time limits or guidelines for reporting results.

Incorrect treatment – whether that is not getting needed treatment or receiving unneeded treatment – can result from an incorrect diagnosis.  An incorrect diagnosis can result from  an incorrect assessment of diagnostic testing.  An incorrect assessment can result from either an incorrect interpretation of laboratory test data or incorrect data from the lab testing.

Incorrect interpretation of lab testing can result from reports that are difficult to interpret, either due to a confusing layout or illegibility.  A solution to this is to have a standardized reporting form.   Other potential causes of incorrect interpretation include confusion of verbal reporting (such as over the phone) or results not being interpreted by a specialist.  Solutions that can reduce this confusion include providing reports electronically when available or repeating results when provided verbally, and making lab experts available for interpretation.

Three main reasons that incorrect data is provided as a result of lab testing is that the specimen is associated with the wrong person, possibly because a patient is misidentified, a specimen is mislabeled, or information is entered incorrectly into the computer.  Possible solutions are to use two patient identifiers and label the specimen in the presence of the patient.

Contaminated specimens can also cause incorrect testing results.  Specimens can be contaminated at collection, handling, or testing.  Any of these issues can be caused by insufficient quality control.  The risk of contamination can be minimized by a standardized quality control procedure.

Lastly, incorrect diagnostic data can result from the wrong test being performed.   This could occur due to equipment failure, an incorrect entry into the computer, or the wrong test being ordered.  More details about any specific incident can be added to the Cause Map based on evidence gathered in the course of an investigation.

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

Use of Contraindicated Clip Leads to Death of Kidney Donor

By ThinkReliability Staff

In 2011, a kidney donor in Texas bled to death after her renal artery became open.  Sadly, her death was associated with the use of clips to close the artery – rather than staples – even though the use of clips was contraindicated for this purpose.  The instructions that came with the clips said this, as did several warning letters sent from the manufacturer in previous years.

We can look at this tragic issue in a Cause Map, or visual root cause analysis.  We begin with the impacted goals.  Because of the patient death, the patient safety goal is impacted.  Emotional impacts from employees resulting from a patient death can be considered an effect to the employee impact goal.  The use of a device other than intended is a result to the patient services goal and is considered a “never event” (an event which should never happen), resulting in an impact to the compliance goal.  A lawsuit resulting from the patient death is an impact to   the organization goal.  A total of four kidney donors are known to have died as a result of using these clips.

We begin with the impacted goals and ask “Why” questions to understand the cause-and-effect relationships resulting in this tragedy.  The patient died from a massive, sudden bleed caused by the bleeding of the renal artery which was open.  The renal artery had been opened as part of the kidney donor surgery, and had been closed using clips that slid off the renal artery.  The stump remaining on the renal artery after this kind of surgery is too short to allow the clips adequate purchase, and the clips slid off.  The hospital staff was unaware that these clips were contraindicated for this use.  Although a warning was placed on the instructions for the clips, these instructions were not kept in the operating room.  Additionally, the manufacturer sent out several letters to hospitals warning them not to use these clips for kidney surgery.  However, at that time, this hospital was not using the clips, and had forgotten about the letters when the clips were purchased.

Once the causes related to the issue have been captured, possible solutions can be brainstormed.  In this case, there are solutions for all the stakeholders in the event.  The operating team should use staples instead of these clips to close the renal artery.  The FDA has issued a safety notification to attempt to provide additional warnings against using these clips after kidney donation.  The hospital has implemented a system to track and document warnings and recalls related to medical equipment.  Some personnel in the medical community have requested that the warning not to use the clips after kidney surgery are printed directly on the clips, rather than on the operating instructions.  Dr. Amy Friedman, the Director of Transplant Services at Upstate Medical University in New York, who had raised concerns about using clips in kidney donors starting in 2004, would also like the warnings to include information that donors have died as a result of using these clips.  Although the FDA believes that the warnings up to this point have been sufficient, hopefully the additional actions will prevent another death from the use of these clips.

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

Abuse of “Good Grade” Pills

By Kim Smiley

A recent New York Times article, “Risky Rise of the Good-Grade Pill” talked about the dangers associated with abuse of prescription stimulants.  These stimulants are prescribed to treat attention deficit hyperactivity disorder (ADHD), but they cause individuals without the disorder to become hyper focused and better able to concentrate for long periods of time.  There isn’t good data on how many high school students are abusing the stimulants, but anecdotal evidence implies that a significant number of students, especially those at highly competitive high schools, use the prescription stimulants to help improve test score and grades.

This issue can be analyzed by building a Cause Map, a visual root cause analysis.  The first step when beginning a Cause Map is to determine the impact to the overall organizational goals.  In this example, the Safety Goal is impacted because there are risks to the students abusing the prescription stimulants.  Once the impact is defined, “why” questions are asked and causes are added to the Cause Map.

Why are there risks to students abusing prescription stimulants?  Students are at risk because students without medical need are using the stimulants, the stimulants can be dangerous and illegal sale or procession of these drugs can have severe consequences.

Students are using the stimulants because they are available and they can aid in earning good grades.  The stimulants are available because some people sell them and there is anecdotal evidence that some students fake the symptoms to get prescriptions for them.

Many of the students using these stimulants don’t realize that there can be serious health issues with using them.  First off, these drugs are one of the most addictive substances that have a medical use.  There is little known about the potential long term health issues of abusing prescription stimulants.  There is also a concern that these drugs may act as a gateway drug which has the potential to open the door to more drug abuse as students get more comfortable with the idea of taking pills. In the short term, there are a number of health issues to consider including heart irregularities, exhaustion and even psychosis during withdrawal.

Another important fact many students are unaware of is that giving these drugs to a friend can have heavy legal consequences.  Distribution of prescription stimulants is considered a felony.  Adderall, Ritalin and other name brand stimulants used to treat ADHD are controlled as Class 2 substances, the same as cocaine and morphine, and the sale of them carries severe penalties.

This issue is just beginning to come to light and more information is needed to fully understand how many students are involved and the best way to stop the abuse of the prescription stimulants.  As more information is available it can easily be added to the Cause Map.

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

Four Patients Contracted Hepatitis C

By Kim Smiley

A cardiac catheterization lab was temporarily shutdown after four patients tested positive for hepatitis C.  All four patients have the same strain of hepatitis C which means they contracted the virus from the same source.  The investigation into this incident is ongoing, but no other connection other than the cardiac lab has been found between the four patients.

This issue can be analyzed by building a Cause Map, an intuitive root cause analysis that visually lays out the cause-and-effect relationships between the factors that contribute to an incident. The first step in building a Cause Map is to determine the impact to the overall organizational goals.  The basic information about an incident and the impacts to the goals are documented in an Outline.  In this example, the safety goal was impacted because four patients contracted hepatitis C and there is potential that more people were also infected.  The customer service goal is also impacted because hundreds of people need to be tested to ensure that they are not also infected.  Once the impact to the goals are determined, “why” questions are asked to find the causes that belong on the Cause Map.

Testing is necessarily because hepatitis C is often asymptomatic for many years so many infected individuals will not know unless they are tested.  Hepatitis C can be treated with medication and cured in 50–80% of cases, but there cases that cause severe liver issues. Hepatitis C is the leading cause of liver transplants.

651 patients had used the cardiac catheterization lab since August 2011 and all are being tested along with 30 staff members.  Test results take up to 10 days to process so the final results on how many people were infected aren’t available yet.

New Hampshire Division of Public Health and hospital officials are still investigating to determine the source of the hepatitis C.  It was likely medical equipment of some type since hepatitis C is spread through blood to blood contact.  Once the investigation is complete, any additional information can be easily added to the Cause Map so that it documents all relevant information for the issue.

Once the investigation is completed, the lab will be able to make whatever changes are necessary to ensure that all equipment is properly sterilized and this type of event doesn’t occur again.