Mary McClinton, 69, arrived at Virginia Mason Medical Center one day in November 2004 for a complex but routine procedure. She had been diagnosed with a brain aneurysm, and doctors planned to place a stent in an artery and then inject dye into her bloodstream for an imaging test. The procedure appeared to go according to plan, but she awoke in terrible pain. The team worked feverishly to determine what had happened and how they could help her, but she never recovered. Mrs. McClinton never left the hospital. Nineteen days after the procedure, she died.
At first, the team was mystified as to what had happened to cause her death. After carefully reviewing every step along the way they finally found the culprit. A topical disinfectant solution, chlorhexedine, had been mistaken for the injectable dye. In fact, the disinfectant, injectable dye, and a saline solution - three visually identical clear liquids - were all placed in unlabeled stainless steel bowls in the procedure room. At some point, the disinfectant - highly toxic if used internally - was drawn up into the syringe meant for the dye. A tragic, fatal, and wholly preventable mistake.
Building a Culture of Safety
At that moment in time, late 2004, Virginia Mason was a couple of years into its journey to apply the Toyota Production System to its own work through the Virginia Mason Production System. This approach is all about constantly examining and improving processes - and the system is intended to prevent dangerous errors completely.
In the months after Mary McClinton’s death, Virginia Mason decided to make patient safety the organization’s singular goal.
But organizational culture does not change overnight. And the first steps towards building a culture at Virginia Mason that put patient safety at the very top of the pyramid, felt to some, well, unsafe. Staff were deeply committed to patient safety, but hesitant to report errors. Some felt that nothing would come from making a report. Others were concerned that it would take too much time, or that they would get in trouble, or be shunned by colleagues. And this fear was by no means confined to Virginia Mason. For generations, it has been a cultural norm in medicine to avoid public communication about medical errors. Even private conversations within a hospital or practice were not the norm.
The leadership team who had traveled to Japan a few years earlier had been deeply impressed when they witnessed a ‘stop-the-line’ moment in a manufacturing facility. Any employee can slow or stop the line at any time, and managers rush to the staffer immediately. Not to punish them for slowing things down, but to aid them in solving a problem and ensuring that no error makes it into the next stage of production. They had to find a way to translate this to a medical setting.
Executive leaders were tasked with transforming the error reporting system into one that was safe - there would be no negative repercussions on staff for reporting a safety problem - and responsive. Execs would immediately respond to a safety alert and ensure that action was taken immediately. It is not immediately obvious how to classify safety errors in a medical setting, but eventually the hospital created a color-coded system for Patient Safety Alerts: red for anything life threatening or that could pose serious harm; orange for less severe but often complex issues, and yellow for everything else, such as something that could have the potential for error but is not immediately life threatening.
Even with a renewed system in place, it took months of practice - executives truly responding to calls and supporting staff who called alerts, and staff having the opportunity to see the focus remain firmly on patient safety and identifying problems with the system - not on blaming individuals - for the culture to start to shift.
Mistake-Proofing
The staff at Virginia Mason was devastated by the accidental death of Mary McClinton. They knew they had to ensure that the error that caused it could never be repeated. As they dove deep into every step of the procedure she had undergone that day one thing became painfully obvious: there should never have been three unlabeled stainless steel bowls of clear fluid on the prep table. It would be far too easy to repeat the same mistake. One simple fix seems quite obvious in retrospect: there is no need for chlorhexidine to be placed in a bowl at all, since it should not be drawn up into a syringe. The hospital immediately adjusted its setup so that chlorhexidine would be placed on a swab, never again to be confused with an injectable fluid.
But the examination revealed further issues with the typical setup of prep tables for anesthesia. There was no standard system for exactly which items to place on the table, and where to put them. Each person might set their tray up in a slightly different way. A provider coming in to use a table set up by someone else might not find exactly the supplies they were used to encountering. The team decided to standardize the setup. They created a ‘shadow board’ - images of each item and the desired layout printed out and laid atop the tray under a clear plexiglass sheet. Each piece of equipment could be placed on top of its image, and it would be immediately obvious if an item was missing or out of place.
Continuing the Legacy
Nearly twenty years after her death, the Mary McClinton Patient Safety Award has become one of the most important honors at Virginia Mason. It is awarded each year to a team that has made outstanding progress toward a safer patient environment. Her death was a tragic accident, and it was a catalyst that has transformed Virginia Mason and saved countless lives every year since.
