The dirty duodenoscope scandal is ugly and troubling, and there is a lot of blame to go around.
Much of it should be laid at the feet of the Japanese electronics giant Olympus, which decided the medical instrument might be a great replacement for its faltering consumer camera business. But in the rush to get to market, Olympus wound up distributing a product that could not be properly sterilized between uses.
Design deficiencies in the Olympus scope, and, to a lesser extent, products designed by Pentax and Fujifilm and a kit to clean the instruments, led to 250 patients developing antibiotic-resistant infections that killed at least 14 of them. Olympus only recently agreed to recall the devices after obtaining approval from the U.S. Food and Drug Administration for a redesign.
That was troubling enough, but a recent U.S. Senate investigation disclosed that there were more infections than had been previously reported, and that hospitals had played a role in delaying their reporting to federal and state authorities.
Despite at least 16 hospitals tracing the outbreaks directly to duodenoscopes, "it appears that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers," the Senate report said.
I'd like to say this is an isolated incident, but there are many indications hospitals are either lackadaisical about transparency or actively working to ensure the public is not fully informed on medical mishaps that endanger or even kill patients.
That's the case in California.
Nine years ago, it became one of the first states to mandate penalties and fines for hospitals that are found to commit medical errors that could harm or kill patients. Lisa McGiffert, director of Consumers Union's Safe Patient Project, recently told me the California law is a national model.
But those penalties and fines have dropped off steeply in recent years. In 2015, they were levied at about half the rate they were just two years before and less than one third the 2009 rate.
"I don't suspect that is a reflection of hospitals being more than twice as safe today," McGiffert said.
The agency responsible for investigating hospital mishaps, the California Department of Public Health (CDPH), hasn't announced a penalty or fine in the past eight months. The CDPH has so stonewalled my questions as to what is going on I wouldn't be surprised to hear the Great Wall of China has been moved to Sacramento.
My sources tell me a variety of factors are playing into the dropoff in penalties and fines. Among them is a manpower shortage at CDPH. I am told that is being addressed due to bigger state budget allocations that will allow the agency to hire some six-dozen new investigators.
But one of the biggest factors may be the hospitals themselves. According to the CDPH, there are only about 375 self-reported patient safety incidents per year for more than 400 acute care hospitals statewide. More than half of the state's hospitals have yet to be penalized or fined for a dangerous medical error at all. That sounds perilously like the cases of hospitals that failed to report issues with the duodenoscopes.
Presumptuous perhaps, but given Mission Hospital Regional Medical in Southern California had to shut down all 14 of its ERs due to a rampage of infections among orthopedic patients--and that the feds kept the inspection report secret for the better part of a year--does little to dispute my notion. No announcement yet from CDPH whether Mission is going to be penalized or fined for that incident. Mission has previously racked up seven penalties and fines; among the leaders in California.
Even more vexing than such secrecy is that many hospitals are appealing fines and penalties using California's already clogged administrative law courts. Often they are using the legal principal of laches--essentially, claiming CDPH waited too long to penalize them under statute. That the agency may be short-staffed is irrelevant. Nor is the fact that it is often taking years for a hearing on an appeal to occur.
That strategy is working--reports on many penalties and fines that were once publicly posted on the CDPH website have disappeared, apparently the end result of a successful appeal.
From a financial standpoint, dangerous medical errors are a financial black hole for hospitals. They often lead to much longer hospitalizations for the patient and loss of payments from both Medicare and private payers.
The intent of disclosing serious medical errors or other issues that can harm patients is to create a dialogue that would help avoid future errors--and therefore more financial stability for hospitals. There has even been a notion that apologizing to patients for errors can reduce the likelihood of lawsuits and therefore save money.
But instead, many hospital executives see disclosure of a serious error as a bad PR move. And keeping a culture of secrecy can make it more difficult for patients to pursue malpractice suits.
This is fairly typical of the short-term goals many institutions in the United States embrace. Really, when was the last time an American enterprise said they were pursuing a 10-year plan?
Instead, the impulse is to be quiet and hunker down. Given the thicket of litigation hospitals will find themselves stuck in for years to come due to the duodenoscope scandal, is this really the fiscally responsible way to proceed? What might be the consensus of patients and their families? - Ron (@FierceHealth)