Statement by Capital Health - Adverse Events

Monday, August 12, 2013 - 11:30am

Capital Health wishes to inform the public of two recent serious adverse events affecting a total of four patients.

In the first case, due to a recording error, the pathology results related to two patient tissue samples were switched in the patients’ charts. This meant that the results of one patient’s tissue analysis were reflected on the other patient’s record and vice versa. One patient received a mastectomy when it was not required and the other patient required surgery and was not scheduled for it at that point in time.

In the second case, tissue samples from two patients were switched prior to pathology analysis. As a result, one patient received a diagnostic biopsy when it was not required and the other patient required follow-up but did not receive it at that point in time.

To those patients directly affected by this event, we give our most sincere apology. Capital Health believes the trust our patients and our community place in us is fundamental to our providing the best care. Our commitment to transparency is integral to that relationship of trust and so, with the knowledge of the affected patients, we share these regrettable circumstances with the general public.

Both adverse events affected patients with cancer, but occurred in different stages in the process of preparing and analyzing tissue. The two events are not related.

The adverse events affecting these patients were discovered as a result of quality assurance mechanisms which are in place for surgical samples. All tissue removed during surgery is reviewed and in these cases the result of the pathology for the surgical samples did not match the reported results for the original tissue biopsy analysis.

There was no error in the interpretation of the tissue analyses themselves. Other tissue samples from the same periods have been reviewed and we are certain that these are the only affected patients. We are not aware of any other instances of similar adverse events having occurred in Nova Scotia in the past. The same quality assurance processes would have identified any similar events if they had occurred.

One quality review has been completed and in an abundance of caution another is in progress to determine what we can learn from these events in order to take action to prevent this from occurring in the future. Capital Health is already in the process of implementing a bar coding system for laboratory specimens that, once operational in late 2013, will significantly decrease the possibility of a similar event occurring. In addition, an automated laboratory system expected to be operational in 2014 will enhance quality and safety by reducing the need for handling and movement of specimens.

In the interest of patient confidentiality, we will not be releasing the names of the affected patients or other information about their care.

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