Monthly Archives: August 2013

Root Cause

Patient Dies After Fall During Transfer

By ThinkReliability Staff

A medical center in California received a fine for an adverse event in which a patient’s fall at the facility resulted in his death.  As a part of the investigation into these types of events, a plan of action to mitigate the risk of similar events occurring in the future.  In order to best determine which events will be helpful in decreasing future risk, a full accounting of the cause-and-effect relationships that led to the incident being investigated can be helpful.  We can develop a visual map of the causes that resulted in this incident in a Cause Map, a visual form of root cause analysis which determines all relevant causes in order to offer the most possible solutions.

We begin our analysis with a summary of the “what, when and where” of the event, as well as determining which of the organization’s goals were impacted.  In this case, the patient safety goal was impacted due to the patient death.  The compliance goal is impacted because the facility was found to be noncompliant with requirements for licensure as a result of this event.  The fine from the state health department can be considered an impact to the organizational goal.  The patient services goal was impacted due to the improper transport of a patient.  Lastly, it was found that equipment was missing necessary safety features.  This can be considered an impact to the property/ equipment goal.

Once we have determined the impacts to the goals, we can begin with one impacted goal and ask “Why” questions to  determine the cause-and-effect relationship that led to the impacted goals.  In this case, we begin with the patient safety goal.  Why was the patient safety goal impacted? Because of a patient’s death.  Why did the patient die? His death was due to rib fractures and internal bleeding.  Why? Because of blunt force trauma.  Why? Because the patient fell out of a geri/bed chair (a device that can be used as a stretcher semi recliner or chair).

To ensure that the causes we include in our analysis are accurate, we include evidence wherever possible.  Evidence allows validation of the inclusion of causes on the Cause Map.  In this case, the evidence for the cause of death is provided by the autopsy report.

In addition to continuing to ask “Why” questions to add more detail to the Cause Map, we can also add additional impacted goals to the Cause Map.  For example, the patient fall out of the geri/bed chair was what caused the noncompliance with licensure that is an impact to the compliance goal.  This noncompliance caused the fine to the facility.   The patient fell out of the geri/bed chair due to inadequate transport, which impacted the patient services goal.

In some cases, more than one cause is necessary to result in the effect.  The inadequate transport was caused by the patient – who had been assessed as a high fall risk – being both left unattended and not secured in the geri/bed chair.  The patient was not secured on the geri/bed chair because it did not have straps.  It’s also possible he was not secured, and was left unattended, because the transport team, who took him to the radiology department to get an X-ray, was not aware of his high fall risk.  Although a transfer form is used to turn the care of a patient over to another team in cases such as this, there was no record on the transfer form that indicated a report being made to the transfer team that would have included information about the patient, including his fall risk.

As part of the investigation, corrective actions are required.  As is typical in these cases, many of the solutions included additional training and education to staff to reduce the risk of these events happening again.  Although usually included as part of the corrective actions for adverse events, training (or re-training) and continued education are some of the least effective solutions in terms of error recurrence.  (After all, presumably the staff had already been trained on the policies and requirements that were already in place at the time of the accident.)  More effective solutions include changes in policy that result in increased patient safety.  For example, in this case the transport policy has been updated to ensure that patients are left in locations where they can easily be monitored.  This of course will not prevent all falls, but may prevent some, and will certainly lead to staff noticing falls quickly.  Even more effective are changes in equipment to make following policies easier.  In this case, the geri/bed chair that was used for patient transport did not have a strap, even though its use was required.  It is unreasonable to expect busy staff to spend their time searching for equipment that has the proper safety equipment.  Rather, ensure that all geri/bed chairs or other transport devices have the required safety devices.  I’m sure you can imagine that it is much more likely for staff to comply with a policy requiring use of safety devices when the devices are available and by doing so, will reduce the risk of patient falls, and patient deaths.

To view the Outline, Cause Map, and recommended solutions please click “Download PDF” above.  Or click here to read the state department of health report.

Root Cause

Patient Receives Unneeded Mastectomy

By ThinkReliability Staff

Information about a lab mix-up that resulted in a patient receiving an unnecessary mastectomy was recently released by a health authority in Nova Scotia, Canada.  The authority has conducted an investigation into the error and how it occurred.  We can look at some of the information that will need to be considered in order to reduce the risk of a similar issue recurring.

First, we capture the “What”, “When”, and “Where” of the incident.  In this case, a switch of pathology results occurred in late April, 2013 at a cancer center in Nova Scotia.  The error was caught as a result of oversight analysis of tissue samples.

We can capture the goals impacted as the result of the issue.  In this case, the patient safety goal was impacted because a patient (Patient 1) received an unnecessary surgery (mastectomy).  In addition, the patient safety goal was impacted because another patient (Patient 2) did not receive a necessary surgery.  The staff employees are impacted because they are reportedly devastated, as frequently happens in cases like these.  The organization goal is impacted due to the apology given to the public as a result of this issue.  The patient services goal is impacted due to a switch of the tissue samples.  The property goal is impacted because an unnecessary procedure was performed, and the labor goal is impacted due to the extensive investigation that is taking place.

Asking “Why” questions can help determine the cause-and-effect relationships that led to the impacted goals.  In this case, the patient safety impacts are due to the switching of the patient’s sampling.  This occurred due to the results being recorded into the wrong records.

While trying to solve a problem, it can be helpful to examine the related processes.  In this case, we look at the tissue sampling process.  Any process is meant to get from point A to point B. In this case, the process ideally takes us from a tissue sample being taken (point A) to a diagnosis (point B).  We know that we did not get to point B in this case (i.e. the diagnosis was incorrect).  Looking at the steps in more detail can help us determine which specific part of the process did not go as intended, which will allow us to identify process-specific solutions.

A sample is taken from a patient, labeled, and sent to the lab.  The lab tests the sample, obtains the results, then delivers them to the patient’s physician or care center.  At that point, the results are recorded in the patient’s records and then used to make a diagnosis.  The error reportedly occurred at the point where the results were entered into the patients’ records.

Once we’ve identified the specific point where the error occurred, we can identify potential solutions.  In this case, the facility involved is implementing bar-coding and moving towards an automated system.  Although there is still the potential for error, it is reduced with automated systems and bar codes because the data has to be transcribed fewer times. As the Premier of Nova Scotia stated, “Human error is always a possibility. But one of the things we strive for is to ensure there are appropriate controls in place to ensure that the risk of these things is absolutely minimized.”

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

Root Cause

Heart-Lung Transplant Blood Type Mismatch

By ThinkReliability Staff

On February 22nd, 2003, a patient at Duke University Medical Center died after receiving her second heart-lung transplant.  The first transplant she received was rejected by her body due to a blood type incompatibility (she was Type O, the organs were Type A).  The loss of her life was tragic enough, but it was compounded by the fact that the two rare heart-lung block donations she received could have saved the lives of others as well.

We can perform a thorough root cause analysis built as a Cause Map that can capture all of the causes in a simple, intuitive format that fits on one page.  First we determine the impacts on the organization’s goals as a result of this incident.  The death of a patient was an impact to the hospital’s patient safety goal.   The surgeon, who knew the patient well, was devastated. The loss of the organs was an impact to the patient services goal.  The compliance goal is impacted because patient death due to blood incompatibility is considered a “Never Event” and a “Hospital-Acquired Condition”.  These types of events may require reporting by the accrediting agency and also may impact reimbursement to the hospital for costs incurred as a result of these errors.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that resulted in those impacts.  The patient died because her health condition deteriorated after a second transplant surgery was performed.  Her body rejected the first set of organs because the blood type of the first transplanted organs was incompatible with the patient’s blood type.

The mismatched blood type organs were transplanted because the procuring surgeon (sent to pick up the organs) was not told of the blood type, so he could not perform an effective blood matching.  Donor services offered organs with the incorrect blood type because they didn’t ask what that was, possibly because the surgeon had specifically asked for the organs for this patient, and they assumed that a surgeon wouldn’t ask unless the blood type was correct.  The surgeon didn’t verify the blood type of the organs because he assumed that donor services wouldn’t offer an organ of the wrong blood type (which is normally the case, per their regulations).  The mismatch was discovered in the laboratory, but not until too late in the procedure, because the surgery must begin while the organs are en-route, due to limited viability of the organs.

In a previous blog, we discussed the process that is generally used to ensure appropriate blood type matching for blood transfusions.  A similar process to ensure that organ donations are also blood-type compatible.

This tragic incident demonstrates the problem in making assumptions, and it shows us some areas where transplant safety can be improved.  Although this was a very rare case, both hospitals and the donor services are making improvements to their systems to ensure this never happens again.

Root Cause

Adult Dose of Heparin Delivered to Premature Infants

By ThinkReliability Staff

On September 16, 2006 6 premature newborns in Indianapolis were given adult doses of the blood thinner heparin, used to prevent blood clots that could clog intravenous (IV) tubes.  Adult doses are 1000x more concentrated than infant doses.  Three of the babies died and the other three were in critical condition.  In 2007, in Los Angeles, an overdose was given to three more babies due to the same error.  Luckily none of those babies died.  (Up to 17 babies in Texas also received heparin overdoses in 2008, but these were caused by a mixing error at the hospital pharmacy.)

We can examine this issue in a visual root cause analysis, or Cause Map.  Fully investigating the errors that occurred for these overdoses to happen can lead us to solutions to increase healthcare reliability by decreasing the risk of the same situation recurring.

We begin with the outline, where we capture the what, when and where of the incident, as well as the impact to the organization’s goals.  These medication overdoses impacted the patient safety goal because they resulted in fatalities and serious injury to the babies who received the medications.  Additionally, employees involved in the issue can be affected as a second victim.  Death or serious disability due to a medication error is a “Never Event“, which is an impact to the organization’s compliance goals.  Patient services are impacted due to the incorrect drug dose delivery.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that led to the incident.  In this case, 5 opportunities for double-checking the dosage were missed.  The wrong dosage was missed as 1) the bottle was removed from the pharmacy, 2) the bottle was placed in the cabinet, 3) the bottle remained in the cabinet, 4) the bottle was taken from the cabinet, and 5) the drug was administered to the babies.  Some of the reasons that it was missed: there was no effective double check by another staff member, there was no check by a computer and of course due to human error, which was aided by the issue that the adult dosage bottle and the infant dosage bottle looked practically identical (this has since been remedied).

An article in The Journal of Pediatric Pharmacology and Therapeutics states, “As frequently occurs, all of these heparin-associated medication errors happened when a number of system failures occurred simultaneously. System failures included: 1) failure to carefully and accurately read the label on the medication vial prior to administering the drug to the patient; 2) inaccurate filling of automated drug-dispensing cabinets; 3) non-distinct “look-alike” labels on the heparin vials; 4) similar size of the heparin vials as both were 1-mL vials; and 5) “factor of ten” dosing errors.”

Many solutions to this type of error (such as requiring double checks by staff members and using a computerized prescription dispensation system) were suggested as a result of this and other heparin overdoses over the past several years and are already being implemented at hospitals across the nation.

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

Root Cause

Woman Dies After Neck Trapped Between Mattress and Bed Rail

By ThinkReliability Staff

On January 26, 2013, a nursing home resident died of positional asphyxiation after her neck became trapped between her bed’s mattress and a bed rail.  The nursing home was cited for neglect by the state for not evaluating whether or not the use of a bed rail is appropriate.

The cause-and-effect relationships that led to the resident’s death can be diagrammed in a Cause Map, or visual root cause analysis.  This allows all the issues related to the incident to be examined so that as many potential solutions as possible can be considered, increasing healthcare reliability.

The first step in the Cause Mapping method is to capture the what, when, and where of the incident, as well as the impacts to the organization’s goals.  A nursing home’s goals include ensuring residents’ safety,  employees’ safety, residents’ quality of life, and compliance with regulatory and other accrediting agencies.  In this case, the resident safety goal was impacted because of the resident death.  The resident quality of life was impacted because there was no assessment performed to ensure the use of bed rails was appropriate.  Because that assessment was not performed, the facility was fined by the state Health Department.  Additionally, the compliance goal was impacted because both the Centers for Medicare and Medicaid (CMS) and The Joint Commission prohibit the use of bed rails when used as restraints.  CMS also will not reimburse for treatment for injuries related to the use of bed rails.

Beginning with an impacted goal, asking “Why” questions aids in developing the cause-and-effect relationships that resulted in the impact to the goal.  In this case, the resident death was caused by positional asphyxiation because the resident’s neck was caught between her bed rail and mattress.  The asphyxiation also resulted from the resident not being found immediately.  In this case, there were forty minutes between the last nursing check and when the resident was discovered.

The resident’s neck was caught because she was unable to free herself due to limited mobility and dementia and the use of bed rails.  In this case, as previously noted, an assessment to determine whether the use of the bed rail was appropriate had not been performed.   Presumably the bed rail was used because of the resident’s history of falls. Despite research that the risks outweigh the benefits when using bed rails as restraints (as opposed to mobility aids for residents who are cognitively and physically able), the FDA has stopped short of requiring a safety label on bed rails.

The nursing home involved in this incident has provided an approved plan to reduce the risks of this type of incident recurring.  Beyond that particular facility, states Minnesota Commissioner of Health Dr. Ed Ehlinger,  “As a result of this death, we want all health settings where bed rails are used to take immediate steps to make sure they are following the correct guidelines around bed rails, grab bars and other devices.”

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more about the use of bed rails and associated risks.