Tag Archives: procedures

Root Cause

More Known About Why A Donated Kidney Was Trashed

By ThinkReliability Staff

In a previous blog, we wrote about a donated kidney that was accidentally thrown out rather than being transplanted.  We began the root cause analysis investigation with the information that was available, but there were still a lot of open questions.

The Centers for Medicare & Medicaid Services (CMS) has released a report on the incident, which provides additional information we can use to update our Cause Map.  We can update all areas of the investigation, including updating any additional goals that were found to be impacted.  In this case, three employees had been placed on administrative leave.  Since the time of the previous blog, four employees have had their careers impacted – one has resigned, one has been fired, one has had a title removed, and another has since returned from paid administrative leave.  Additionally, there is a risk that the hospital may be removed from the Medicare program, another impact to the compliance goal.

The report provides more specific causes, and evidence, regarding the incident.  We know now that the kidney, which was to be transplanted, was instead thrown in a hopper by the circulating nurse.  We can ask “Why” questions to add more detail.  The kidney was thrown in the hopper because the contents of the slush machine were thrown in the hopper and the kidney was in the slush machine.  It still isn’t clear why the kidney was in the slush machine in the donor’s operating room (rather than being transferred immediately to the recipient’s room), but more information regarding the disposal is now available.

The nurse disposed of the hopper because she was unaware that  the slush machine contained the kidney.  The nurse had been on lunch break when the location of the kidney was announced and was not briefed on the status of the operation upon her return.  There was no documentation on where the kidney was located, and the nurse assumed that it was in the recipient’s room.  For reasons that are unclear (as it is usually the job of the technician who is responsible for the machine), the nurse decided to empty the slush machine while the operation was still ongoing.  This appeared to be against procedure, but the procedure had “exceptions” according to staff, and was ineffective in this case.  The technician that was responsible for the slush machine was exerting inadequate control, as the staff members have stated that no one noticed the nurse empting the slush machine.  This also demonstrates inadequate control of the kidney, since there appeared to be no staff person responsible for the kidney itself.

Since the incident, the hospital has developed a procedure for intra-operative hand-off, which includes a briefing requirement for staff members who enter an operating room mid-procedure.  Additionally, clarification has been provided that nothing will leave an operating room until the patient has left, post-procedure.  Although the transplant program is still shutdown pending investigation, a recommendation that might reduce this type of problem in the future would be to ensure that a staff member is designated as responsible for any donated organs from removal to transplant.

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

Root Cause Analysis

Donated Kidney Trashed

By ThinkReliability Staff

On August 10, 2012, a living donor’s kidney was thrown out, instead of being transplanted as planned.  The incident was chalked up to “human error”, which is almost certainly part of the problem . . . but definitely not all of it.

This extremely rare, but serious, event is being analyzed by several oversight agencies, as well as a contractor hired by the medical center in Ohio where the event took place, to ensure that needed improvements are identified and put into place so this type of incident doesn’t happen again.  We can examine the currently known information in a visual root cause analysis, or Cause Map.  To do so, we begin with the impacted goals.

There are many goals that were impacted as a result of this error.  Firstly, the patient safety goal was impacted because the patient did not receive the transplanted kidney.  This can also be considered an impact to the patient services goal.  Three personnel from the hospital were placed on administrative leave as a result of the incident.  This results in an impact to employees.  The compliance goal is impacted because this event has resulted in a review by several oversight agencies.  The living kidney donor program is currently shut down for review, which can be considered an impact to the organization goal.  The kidney was disposed of improperly, which is an impact to the environmental goal.  (Medical waste has strict requirements for disposal.)   The loss of the donated kidney can be considered an impact to the property goal.  Personnel time was taken both to attempt to resuscitate the kidney and to participate in an independent review of the donor program.  These can both be considered impacts to the labor/time goal.

Once we have determined the impacts to the goals, we can ask “Why” questions to develop the cause-and-effect relationships that led to these impacts.  In this case, the patient did not receive a kidney transplant because the kidney was thrown out and because of concern about the kidney’s viability.  Part of this concern was the delay in actually finding the kidney, likely due to the fact that it was disposed of improperly.  The reason given by the medical center for the disposal of the kidney is “human error”.  However, there is ordinarily a support system involved in organ transplants that would minimize these types of errors.  Certainly the fact that the program has been stopped and three employees – at least one of whom was not directly involved in the transplant operation – were placed on administrative leave suggest that the organization is looking at more than just a screw-up by one person acting alone.

Specifically, the investigation should look at communication – was the nurse who disposed of the organ told it was destined for transplant?  Was there a surgical time-out immediately prior to the removal with the entire operating team that discussed the plan for the kidney?  Also the training and preparation of the surgical team should be investigated.  Had the team been properly trained and prepped for this type of surgery?  The fact that it was done frequently at this facility doesn’t mean that adequate training was in place.  What about the procedure for treatment and supervision of donated organs?  Donated organs have to be treated in a very particular way to ensure their viability for the transplant patient.  Who, if anyone, was responsible for ensuring that the organ was prepared in a proper way for transplant?  Were they involved in the surgical time-out?  Lastly, because an error was made with the disposal procedure, the procedure, training and communication regarding disposal of medical waste needs to be analyzed to ensure it is adequate. The hope is that by doing a thorough review – and improvement – of policies, procedures, training and communication at the facility, it will not only reduce the risk of this type of error, but provide improvement in many other aspects of the care provided as well.

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