Accidents will happen. Even in the most prestigious of clinical settings.
That was the lesson learned at Dana-Farber Cancer Institute in Boston two years ago. One patient died there after receiving four times the proper dose of an extremely toxic cancer-fighting drug, and another suffered permanent heart damage.
How could such a thing happen at an institution renowned for cutting-edge cancer research in the best medical town in the U.S.?
"There is nothing more sobering than to be put on conditional accreditation by the Joint Commission and to be told by the Department of Public Health that you're in violation of some of the conditions of certification," says James Conway, Dana-Farber's chief operating officer.
In addition to being put on the defensive in public, Dana-Farber launched an intensive internal investigation of what went wrong and how to fix it.
"This institution had a systems death," and no one took responsibility for it when it happened, says Stephen Sallan, M.D., chief of staff and a pediatric oncologist.
Dana-Farber has spent the intervening two years analyzing where its systems failed and creating more foolproof ways to prevent medical errors. At the invitation of the Joint Commission on Accreditation of Healthcare Organizations, Sallan, Conway and Nursing Director Susan Grant have even gone on the road, giving speeches around the country on error reduction.
Sallan says recent studies indicate approximately 180,000 people die because of medication errors in the U.S. every year. That's the equivalent of two Boeing 747s crashing every day for six months.
The public wouldn't stand for that, of course. That's why industries like the airlines and nuclear power plants have fail-safe procedures built into their operating systems.
But not in healthcare. "In medicine we've had very little redundancy. It drives me crazy," Sallan says. "Think of prescriptions. Every medicine you've ever taken is a first draft."
At Dana-Farber now, all chemotherapy written by a medical trainee is countersigned by a staff doctor. That had not been the case before. Also, the computer now double-checks for adverse drug interactions and allergies.
The overdoses occurred in November 1994. Dana-Farber learned of them in February 1995. The Boston Globe exposed the accidents in March 1995. That same month, the Massachusetts Department of Public Health and the JCAHO conducted surprise visits, arriving on the same day.
From May to September 1995 the top leadership at Dana-Farber underwent a complete transformation. The president and chief executive officer, the chief of staff, the general counsel and the COO were replaced.
The new leadership, with advice from the board, carried out a vigorous campaign of reform. Out of 900 professional staffers, 100 were involved in the internal revolution.
"We looked at absolutely every part of our organization," Sallan says. Dana-Farber invited speakers to discuss initiatives to reduce medical errors. It sent doctors, nurses, trustees and pharmacists to outside seminars on systems improvement.
In addition to shifting the organization's priorities toward detection and reduction of errors, Dana-Farber officials set up numerous backstops to make sure specific patients get the right medications in the right dosages.
For instance, "two eyes of a doctor, two eyes of a nurse, two eyes of a pharmacist" must check and pre-approve all high-dose chemotherapy, Sallan says.
All clinical staff members have direct access to protocols. For all research protocols there is an interdisciplinary comprehensive education program. The hospital created a central repository for all patient orders. Bound black books in five locations are the only authorized versions of orders, and all orders must be stamped with a time and date.
To make sure the order books are correct and consistent, a special team goes around updating them.
Computer capabilities are being upgraded to check dosages and to link protocols with the pharmacy computer system.
Patient charts have been redesigned so there is a consistent location to note allergies. They're in the computer, too.
Also, nurses and pharmacists participate in reviewing and approving protocols. Historically, nurses and pharmacists had been involved in this, but in practice the standards had lapsed.
Sallan notes this was typical of the systems failures at Dana-Farber. A lot of formal checks and balances that had been set up long ago had fallen into disuse as personnel changed and people adapted procedures to their own needs.
"This center of gifted and autonomous physicians had developed their own gypsy solutions to everything," Sallan says. "Because they were gifted, (the solutions) usually worked."
But over time no one noticed there was no longer any fail-safe procedure in place and that the hospital had fallen out of compliance with Joint Commission, state and federal patient-care standards.
Predictably, resistance to these new safeguards has come from staff physicians. They say it deprives them of autonomy and makes them slaves to rigid protocols.
Sallan has little patience with this view. Every bit of redundancy is essential, he feels, to prevent institutional entropy from again endangering patients. You have to backstop and measure everything you do if you're going to improve quality, he insists.
For that reason Dana-Farber has brought patients into the measurement matrix. While they're waiting for an appointment, patients fill out questionnaires on hand-held computers. The physician can read a patient's views and comments when he or she pulls up a computerized medical chart.
At this point, clinical treatment, patient quality of life and clinical research can all be done in real time in the same database.