It is impossible, in large institutions, to anticipate every potential liability, as H. Lee Moffitt Cancer Center recently learned when a renegade employee was found to have improperly enrolled as many as 492 patients in a cancer research study by forging their signatures on consent forms. But it is refreshing to see an institution's leadership immediately take responsibility for the mistake, work to correct it and strive to prevent a recurrence, not only within its walls but across its industry. To ensure patient trust, Moffitt and every other agency involved — including law enforcement — now need to finish what has begun.
Dr. William Dalton, Moffitt's president and CEO, said this week that within 24 hours of the July 29 discovery of one forgery by an employee, the center had fired the worker, hired an outside auditor to investigate and informed appropriate regulatory research agencies. Dalton said law enforcement was also alerted to investigate whether the fired employee was guilty of a crime.
After all of the potentially compromised patients had been identified — and the audit showed the problems were limited to just the files assigned to the fired employee — Moffitt began notifying patients this week of the breach and ascertaining if they were improperly enrolled in Total Cancer Care.
The study, Moffitt's largest, is a longitudinal effort aimed at tracking cancer patients from their arrival at the center onward. The goal is to learn more about how specific individuals respond to cancer treatments. The database is considered the first step toward the next generation of cancer treatment, where genetics and other factors will play a role in what kind of treatment individuals receive.
Fortunately for patients and Moffitt, the forged consent forms did not involve direct treatment decisions. They merely gave the center the authority to track patients' medical care and retain tumor samples. But Dalton said Moffitt is committed to developing new protocols to ensure that all kinds of consent forms are properly acquired. He plans to share Moffitt's experience and reaction plan in a national research journal. Law enforcement also needs to follow through with an investigation.
Dalton said he was "nauseated" when he learned patients' trust and privacy had been violated. Such humility from a CEO sets the right tone for an institution whose clients arrive when they are incredibly vulnerable. Patients must be confident they can trust Moffitt's doctors and staff to be honest with them. Dalton's leadership and Moffitt's response suggest that trust remains well founded.