Monthly Archives: December 2012

Root Cause

Bed Rail Death

By ThinkReliability Staff

A patient’s death in 2006 at an assisted living facility in Vancouver, Washington has helped spurred a review of the safety of bed rails.  The patient’s death was due to strangulation when her neck got caught in side rails on her bed.  The side rails had been provided by her family at the suggestion of the assisted living facility.

A recent Consumer Product Safety Commission (CPSC) review of bed rail fatalities indicates that there have been 155 deaths due to the use of bed rails between 2003 and May 2012 but until now, regulation of the use and design of bed rails has been somewhat haphazard.  We can examine the issues that led to the 2006 death – and have likely contributed in many of the other bed rail-related deaths, in a Cause Map, or visual root cause analysis.

We begin by considering the impacts to the goals.  The patient safety goal is impacted due to the patient strangulation and death.  The patient services goal is impacted because of the patient getting stuck in the bed rail.  Indeed, injuries resulting from bed rails are far more common than deaths, with about 36,000 injuries requiring emergency room treatment reported since 2003.  There is a concern about potentially inappropriate use of bed rails, which can be considered a property goal and the ensuing review of bed rail deaths can be considered a labor impact.

We begin with the patient safety goal and ask “Why” questions to determine the cause-and-effect relationships that resulted in the impacted goals.  The patient death was due to being trapped in bed rails.  This occurred due to her illness – about half of patients who die in bed rail incidents have medical problems, a gap between the bed rail and mattress, and the use of bed rails.  The gap can be attributed to the design of the bed rail and/or the incompatibility between the mattress and bed rail.  In this case, the bed rail was purchased by the family and the mattress provided by the facility.  ASTM standards for bed rails are voluntary and regulations governing bed rails are insufficient in their current state.

Bed rails are used primarily to keep patients from falling out of bed and to assist patients in getting in and out of bed.  However, hospitals and nursing home use has decreased since dangers have become more well known.    Most deaths (61%) attributed to bed rails occur at home.  It is suggested that a decrease in availability of caregivers may increase the use of bed rails.

When the FDA issued a safety alert regarding bed rails in 1995, it adopted voluntary guidelines and did not require safety labels or recall of any types of bed rails.  At the time, there was political support for less regulation, industry was concerned about legal issues and resistant to any tougher regulation and there was – and still is – confusion over which regulatory agency is actually responsible for bed rails.  The CPSC maintains that bed rails are medical devices and not under their authority.  However, the FDA claims that if no medical claims are made associated with the bed rails, they are not within their regulatory authority either.  Additionally, because deaths and injuries related to bed rails are not necessarily reported, and problems not highlighted to consumers, the issues are not well known.  Some are hoping to change that.

Representative Edward J. Markey has called for the formation of a task force to address the issue.  The CPSC completed a report on deaths, which has been provided to the FDA.  And, manufacturers say that newer designs and safety straps will reduce the risk of patient death.

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

Root Cause

Baby Breastfed by Wrong Mom

By ThinkReliability Staff

After a newborn baby at a Minneapolis hospital was placed in the wrong bassinette, he was delivered to the wrong mother and breastfed.  Because breastfeeding can carry risks of transmission of communicable diseases the CDC recommends HIV and hepatitis testing after such events.

We can examine this incident – and what went wrong – in a visual root cause analysis, or Cause Map.  The Cause Mapping procedure begins by determining the impact to the organization’s goals.  In this case, the patient safety goal is impacted due to the risk of transmissible disease.  The hospital involved has stated there will be consequences to staff for not following hospital procedure.  This is an impact to the hospital’s employee impact goal.  The patient services goal is impacted because babies were switched (and apparently misplaced for some period of time) and because of the testing that the baby who was breastfed by the wrong mother will require.  The hospital will pay for the testing, which can be considered an organizational goal impact.

The analysis step of the Cause Mapping process begins with the impacted goals.  To continue the analysis, we ask “why” questions.  The patient safety goal is impacted because of the risk of disease.  The risk of disease is caused by being breastfed by the wrong mother.  This occurred because the wrong baby was brought to the mother,  the mother was breastfeeding, and the infant’s bands were not matched to the mother’s bands, although this was hospital procedure.  According to the hospital’s statement, “While hospital procedures require staff to match codes on the infant’s and mother’s identification bands in   order to prevent incidents like this, it appears these procedures were not followed in this case.”

The wrong baby was brought to the mother because multiple babies were kept in bassinettes in the nursery, and the baby had been placed in the wrong bassinette.  It is unclear what procedure was used to determine which bassinette the baby should be placed in, but the procedure was obviously ineffective.

The hospital has stated that its procedures will be reviewed.  Certainly the procedure to verify a baby’s wristband to a mother’s will be emphasized and retrained.  Additionally, matching of the baby’s wristband with a tag on the bassinette would reduce these types of issues.  Some hospitals have gone so far as to stop using nurseries where multiple babies are placed and instead keep the newborn in the mother’s room.  This also would reduce the risk of baby switching incidents.

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

Root Cause

A Tongue Tie Release Wrongly Performed in Case of Tongue Lesion Resection

By ThinkReliability Staff

A California hospital has been fined $50,000 – its fifth administrative penalty from the State since 2009 – for performing the wrong procedure on a 6-year-old boy.  The boy was supposed to receive a tongue lesion resection, but instead a tongue tie release was performed.

We can examine the issues that resulted in this incident within a Cause Map, or visual root cause analysis.  The first step in any analysis is to define what you are analyzing.  We begin with impacts to the organization’s goals.  In this case, we look at the impacted goals from the respect of the hospital.  First, the patient safety goal  was impacted due to an increased risk of bleeding, infection, and complications from anesthesia.  The compliance goal is impacted because performing the wrong surgical procedure on a patient is a “Never Event” (events that should never happen).  The organizational goal is impacted because of the $50,000 fine levied by the State of California.  The patient services goal is impacted because the wrong procedure was performed and the labor goal was impacted due to the additional procedure that was required to be performed.

The second step of our analysis is to develop the cause-and-effect relationships that describe how the incident occurred.  We can develop these relationships by beginning with the Impacted Goals and asking “why” questions.  For example, the patient safety goal was impacted because of the additional risk to the patient. The patient received additional risk because of the performance of an additional procedure.  An additional procedure was necessary because the wrong procedure was initially performed.

There are many causes that contributed to the wrong surgery being performed.  These causes are outlined in the  report provided by the California Department of Public Health.  In this case, there were several causes that likely resulted in the wrong procedure.  The Operative Report had the incorrect diagnosis – tongue tie – which would suggest that a release would be the appropriate procedure.  Additionally, the Anesthesia Record contained the wrong procedure (tongue tie release), possibly because the Pre-Anesthesia Evaluation originally noted that a tongue tie release was to be performed and was later corrected (by crossing out the incorrect procedure and writing in the actual procedure).

The type and site of surgery was not verified.  The surgeon who performed the surgery could not remember if a time-out had been performed, although there was a record of a time-out performed immediately prior to the surgical procedure.  Since the time-out was performed immediately prior to the procedure and the surgeon was unable to remember the proper procedure, the time-out was obviously ineffective.

The surgeon stated after the surgery that he believed that the tongue tie release surgery which was performed was indicated based on scar tissue that was found under the tongue.  The surgeon did not notice the lesion on the tongue during the surgery and no pre-surgical exam was performed by the surgeon.  Additionally, the surgical site was not marked (as the site of the correct, as well as the incorrect, surgeries were both within the patient’s mouth).

During the procedure, none of the other staff stopped the surgery as it was occurring.  However, given the proximity of the “correct” site to the “incorrect” site, it may have been difficult for the other staff to see what was going on.  The surgeon did note that the lesion removal should have created a sample, the lack of which was not noted by staff.

The surgeon involved in this case has indicated that he will be examining his patients prior to surgery in the future. Hopefully this incident will also serve as a reminder to all medical staff that in the case of a site that cannot be marked as per procedure, extra care should be taken to ensure the correct site is operated on and the correct procedure is performed.

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