Independent federal safety board needed to prevent adverse events

With harsh statistics suggesting adverse events occur in as many as 30% of medical treatments and that as many as 24 000 Canadians die annually due to medical mishaps, a Health Canada-commissioned report contends the health care system must implement a new safety-conscious regime that's far more proactive in preventing death and injury caused by misdiagnosis, surgical mishaps, drug reactions and other forms of medical error.

At the core of this “safety management culture,” in which health care manages risk with the same reliability as the nuclear, aviation and railway industries, should lie an independent, arm's–length and heavily financed Canadian Patient Safety Agency whose function would be to oversee safety procedures “unhindered by political consideration or the imperative to promote the industries' economic health,” argue Dr. Sam Sheps and Karen Cardiff of the University of British Columbia in a report entitled Governance for Patient Safety: Lessons from the Non-Health Risk-Critical High-Reliability Industries.

It would be the equivalent of creating “an Auditor-General of the health care system,” said Sheps, professor of health care and epidemiology at UBC, in an interview.

He says Canada should follow the United Kingdom's lead by creating an agency that investigates mishaps and recommends “useful regulatory or process interventions” to improve safety, and reports directly to Parliament.

The report, 1 of 6 commissioned by Health Canada with an eye toward possibly holding a roundtable discussion on the issue later this year, argues that government policy changes toward deregulation, privatization and decentralization exacerbate the risk of medical mishap because they “privilege efficiency, and industry economic viability, over the more fundamentally important objective of safer health care.”

As a result, little is done to foresee potential failures or implement procedures to manage risk. The report, which was presented to Health Canada in mid-April, states: “Anticipating failure is not a preoccupation of practitioners (although anesthesiologists are certainly more aware than most physicians that failure lurks around every corner).”

Having failed to implement adequate safety measures, including a suitable reporting network and an investigatory mechanism, the system is abrogating its “duty to care,” the report states, adding that a systemic response is needed. “One-off solutions whether in post-op surgical infections, wrong site surgery, ventilator associated pneumonia, will not provide the governance structures or system processes that will significantly establish enhanced safety in health care. It is like swatting mosquitoes instead of draining the swamp.”

Adopting a governance entity that reports to Parliament like Canada's Transportation Safety Board, which oversees aviation, would also promote more training, certification and education regarding hazard identification and mitigation.

Some of the contentious aspects of adopting a more safety-conscious system — such as a diminished degree of self-regulation by professional associations, potential diminution of physician autonomy and limitations on practice, and mandatory reporting of adverse events (with guaranteed anonymity) — are either resolvable, or non sequiturs, according to the report.

Anxiety that admission of error or adverse events will lead to litigation is not evidence based: “...when there is full disclosure and apology, litigation is reduced as is the amount of compensation awarded. In general, the public realizes that health care is risky.... What enrages people is not that errors occur so much, as is denial and obfuscation.”

“Most want organizations and professionals to learn from their mistakes or flawed processes so that whatever problem was encountered will be much less likely to happen again. It is not asking too much of the health care system to take this perspective and deeply embed it in every aspect of professional and organizational activity; indeed it is part of the ethical duty to care.”

The report's authors argue that the recently established, $8-million Canadian Patient Safety Institute (CPSI) could be transformed into such an agency by being given total independence and in-house analytic capacity. But CPSI chief executive officer Philip Hassen wants no part of it. “We don't want to be a regulatory agency. That work is better done by the provinces, who have all the authority in health care, except for a few areas, such as drugs, which the federal government has responsibility.”

University of Toronto Professor of Health Policy Management and Evaluation Dr. Ross Baker, co-authored the Canadian Adverse Events Study (CMAJ 2004;170:1678-86) that estimated 9000 to 24 000 Canadian patients die annually following an adverse event in hospital and that 7.5% of patients admitted to acute care settings experienced adverse events. Baker argues that a national patient safety agency probably isn't feasible given Canada's fractured jurisdiction over health care.

“I don't think it would be workable to have one national agency that's charged with the regulatory responsibilities. We'd fight so long about what that would look like, and who would get to sit on what bodies, that it would takes years to set up and meanwhile, we have this agenda to work on, which is improving patient safety. Let's work on that.”

Federal Health Minister Tony Clement was equally lukewarm, saying the new Conservative government has other priorities that'll do more to promote safety. “The best thing we can do is to continue to pursue the Patient Wait Times Guarantee and an Electronic Health Record via Infoway. Both will enhance patient safety.”

Sheps says the jurisdictional nightmare and inertia aren't reason to ignore safety concerns, particularly if the end result is erosion of public confidence. “You want to be seen to be proactive and ahead of the game. But I have no illusions it's going to be easy.”