An extremely rare but tragic case has been recently brought to light. On October 16, 2009, a patient was brought to a hospital center in Syracuse, New York after suffering a drug overdose. Over the next several days, the patient was in a deep coma, though she did not meet the requirements for brain death based on scans performed at the hospital. The family was notified and agreed to donate her organs. The patient, after being sedated, was prepped for donation after cardiac death (DCD). The organ harvesting stopped prior to any organs being removed when the patient opened her eyes on the operating table.
The hospital was cited not only for the error, but for the inadequate response and investigation after the error was made by the state Department of Health and the Centers for Medicare & Medicaid Services (CMS). Specifically, the CMS report states “The hospital’s Quality Assurance Performance Improvement program did not conduct thorough reviews of an adverse occurrence involving a patient who was being considered for withdrawal of life-sustaining treatment when she regained consciousness.”
We can examine the error using a Cause Map, or visual root cause analysis, to determine the issues related to the incident. This provides a starting point for developing solutions to reduce the risk of such an incident recurring, and improving healthcare reliability at this site.
It’s important to frame the issue with respect to an organization’s goals. In this case, the patient safety goal was impacted due to the risk of patient death from having organs removed. The accidental removal of organs can also be considered an impact to the patient services goal. The compliance goal is impacted because of the sanction and fine (though a minimal $6,000) from the Health Department. Negative press and public opinion as a result of this incident – which was uncovered and reported to the Health Department by the press – is an impact to the Organizational goal.
Beginning with an impacted goal – in this case the Patient Safety goal – asking “Why” questions allows us to develop the cause-and-effect relationships that led to the issue. In this case, the risk for patient death was due to risk of removing her organs. The risk for removing organs is because the organ harvesting process had begun. (The investigation did find that there were no concerns with the organ donation process itself, indicating that errors were prior to the donation prep process.) The process began because the family agreed to donate organs after the patient was (incorrectly) determined to have suffered cardiac death.
There were a combination of errors that resulted in the patient being incorrectly declared “dead”. Because all of these factors acted together to result in the impact to the goals, it is important to capture and fully investigate all of them to be able to improve processes at the organization. In this case, the patient was injected with a sedative, which was not recorded in the doctor’s notes. It is unclear who ordered the sedative and why. (It’s also unclear why you would sedate a dead patient, as another doctor stated “If you have to sedate them . . .they’re not brain dead.”) The patient had previously been in a deep coma due to the drug overdose. It is possible the coma went on longer than usual because the patient was not given activated charcoal to inhibit absorption of the drugs by the body after the staff was unable to unable to place a tube. There appears to have been no additional effort – another area that should be investigated to ensure that protocol is sufficient for patient safety.
The hospital’s evaluation of the patient’s condition before a diagnosis of cardiac death was insufficient. Specifically, it has been noted that the staff performed an inadequate number of brain scans, inadequate testing to determine the drug levels remaining in the body, and ignored signs that the patient was regaining consciousness prior to preparing her for organ donation. Because details of these issues were not thoroughly investigated, it’s impossible to know whether the protocols in place at the organization were inadequate for determining cardiac death or whether the protocols were adequate and weren’t followed by staff.
Determining if changes need to be made to protocols as a result of this tragic (though I do want to emphasize rare – the state was unable to find any similar cases in its records) incident is of utmost importance to reduce the risk of an incident like this happening again. Hopefully the additional scrutiny from the state and CMS will ensure improved patient safety in the future.
To view the Timeline, Outline and Cause Map of this issue, please click “Download PDF” above. Or click here to read more.