Monitoring outside the HSC

Finding

The evidence suggests that the Chief Medical Examiner's Office failed to identify the problems with the Pediatric Cardiac Surgery Program in a timely fashion. This is in large measure a result of over-reliance on information provided by the surgeon alone and the fact that, in most cases, the CME's investigation team waited for the final autopsy report. Autopsy results were not available to the Chief Medical Examiner's Office in a timely manner.

The office of the CME did not track surgical deaths by program. As a result the CME's office was not able to identify trends in the Pediatric Cardiac Surgery Program.

The office of the Chief Medical Examiner was not informed of the changes in the Pediatric Cardiac Surgery Program in 1994, particularly the anaesthetists' withdrawal of service on May 17, the slowdown that occurred afterward and the Wiseman Committee review. Since these events were linked to concerns about mortality, it was critical to any review of surgical deaths and, as such, ought to have been communicated to the CME's office.

In these cases, while the Chief Medical Examiner's investigators read the charts and spoke with the surgeon about the patients who fell under the Chief Medical Examiner's jurisdiction, even a cursory discussion with the nurses and the anaesthetists would have revealed significant underlying concerns.

In the autopsies performed in these cases, over-reliance was clearly placed on the information that was obtained from the surgeon. If the information as to what happened during surgery is vital to the conclusions to be drawn by the pathologist, a greater attempt must be made to gather such information from as many of the people involved in the proceeding as possible. To rely exclusively on the one party who might be most responsible for the fatal outcome seems unwise.

The autopsies of the children whose deaths are under review were done in a timely manner; however, the final reports in some cases took months to complete. In none of the CME cases were final reports completed within 30 days of the autopsy as set out in the Fatality Inquiries Act. This meant that those responsible for monitoring the program, such as the CME and the Children's Hospital Standards Committee, were not able to use them effectively. The delays were due partially to staffing shortages in the Department of Pathology, as well as to the length of time that it took for all laboratory tests to be completed.

The timelines for the completion of autopsy reports ought to reflect reality as well as change it, because the length of time to obtain these reports seems far too long.

It also is not appropriate to have the autopsies in Chief Medical Examiner's cases involving surgical deaths performed by the staff of the hospital in which the operation took place. The better practice would be to have autopsies in CME cases performed by a pathologist not affiliated with the hospital in order to overcome any appearance of a potential conflict of interest.

Additionally, the HSC's practice of not informing parents that their children's hearts would be retained following autopsies was not appropriate.

Recommendations

It is recommended that: The Office of the Chief Medical Examiner develop a protocol requiring hospitals to inform that Office of significant changes in the delivery of medical services, such as program slowdowns and shutdowns, as well as any hospital-related deaths that cause the hospital to undertake a program review.

It is recommended that: The Office of the Chief Medical Examiner maintain a database of hospital deaths, which would track in-hospital deaths and causes of death on a weekly and monthly basis.

It is recommended that: As part of their investigation into a patient's death, the Chief Medical Examiner's investigators conduct preliminary interviews of nursing and medical staff who had been involved in the patient's care.

It is recommended that: For CME cases the Chief Medical Examiner arrange to have autopsies performed by a pathologist not affiliated with the hospital where the operation has been performed, unless it is unreasonable or impossible to do so due to distance, time or expertise.

It is recommended that: The Chief Medical Examiner develop guidelines for pathologists to follow in obtaining information before performing an autopsy in CME cases. These guidelines should not place over-reliance on anyone whose involvement might have contributed to the death of the patient.

It is recommended that: The Office of the Chief Medical Examiner establish reasonable timelines to complete autopsies, prepare and forward preliminary results and complete the final reports, including the completion of necessary laboratory work.

It is recommended that: The Chief Medical Examiner insist on compliance with reasonable timelines for the preparation and delivery of autopsy results.

It is recommended that: The HSC and other hospitals amend their autopsy consent forms. The forms should make it clear that the hospital might wish to retain organs and other specimens from the bodies of deceased patients. Families should have the option of withholding such consent, while still consenting to the autopsy itself.