Johns Hopkins physician-researcher Nauder Faraday, MD, this week said out loud what I bet many quality chiefs have been saying about surgical site infections, perhaps in between muttered curses, for quite some time.
He said there's little chance hospitals can consistently drive down infection rates to that elusive zerono matter how hard they try—and many are trying very, very hard. That's because, he says, there are other factors in play beyond a hospital's control, and scientists and doctors are so far clueless as to what those might be.
Some patients get infected, and some patients don't.
Therefore, he says, it's inappropriate for the Centers for Medicare & Medicaid Services to impose financial penalties, as it now does, by refusing to pay for additional care required when certain surgical procedures transmit a bug into a surgical cavity.
I don't agree with Faraday that the penalty, which has been in effect since October 1, is misguided. On the contrary, it has succeeded in putting fire under the feet of hospital teams and the surgeons who work there to take a hard look at their surgical processes, and even at how the patient is cared for at home.
Observations demand inquiry
But Faraday's report, which was published this week in the Annals of Surgery, makes some observations that should provoke more inquiry.
The paper shows that patients who incurred a wound infection requiring antibiotic treatment in the past were three times more likely to develop a painful, costly infection related to a subsequent surgery than surgical patients who hadn't had a prior infection.
That was true after Faraday adjusted for all sorts of confounders, such as age, co-morbidities, and medications, he says.
"One of the reasons we are so concerned about the potential for punitive action is that we controlled for all the things that CMS wants us to do to prevent infections," says Faraday, an associate professor of anesthesiology and critical care medicine.
"We controlled for how you prep the skin, how you administer the antibiotics, and make sure antibiotics are given on time. And we still found that there was a much higher risk if a patient had a prior infection."
Additionally, he says, the CMS policy is not designed to penalize those hospitals that have higher rates of surgical site infections, "but to penalize any hospital, regardless of what the rate is, because if (any patient) develops one of these infections where you are, you're going to suffer some financial penalty."
Genetic predisposition?
Faraday and colleagues propose that there's an underlying genetic predisposition to surgical infections in some people, which is why these patients contracted their first infection and why they are much more likely to suffer one again when they have surgery.
"If you've had a spontaneous infection in the past, that might be a clue that the immune system in your skin, or some other cells that go to your skin to treat infection so that it doesn't become a problem for you—that somewhere along the line your mechanism may be different," Faraday says.
"We all get a cut sometimes in our daily lives, and we're all exposed to bacteria, but most of us will never experience a clinical infection of our skin."
Therefore, he says, federal policy should not punish hospitals when these infections occur until:
- We know a heck of a lot more about the underlying process by which an infection takes hold in a surgical site.
- We understand which genomic sequences in certain populations make them more susceptible to an infection.
- We spend money to conduct much more basic science research into the epidemiology and risk factors linked to site surgical infections, such as unknown environmental factors in the hospital.
I agree that we need more research on why some people will get surgical site infections under the exact same circumstances that others don't. I know first hand that these infections can hit without any apparent logic, even in a brand new hospital where an otherwise healthy friend was infected late last year.
It will be interesting to see if there are genetic subtypes.
But I don't think the CMS policy to not pay for surgical site infections is wrong-headed. Those now on the list include infections incurred during certain orthopedic procedures, such as mediastinitis following coronary artery bypass graft operations and bariatric procedures.
And I wonder what we would do if we discovered such vulnerable DNA sequences. Would we do more prep work than we do now? Keep these patients in the hospital longer? Not allow them to have surgery?
Here's where I have trouble with Faraday's logic.
First, many hospitals around the country have, in fact, gotten their surgical site infection rates down to zero and held them there, through extreme diligence and monitored protocols. For example, this 2010 New York State Department of Health report shows a number of hospitals with zero colon, hip replacement, and coronary bypass graft surgical site infections.
Second, these penalties don't cost hospitals very much, in part because the severity of the patients' underlying illness puts them into a higher payment code already. According to a May, 2010 paper in the American Public Health Association Journal Medical Care, CMS estimated avoided spending of a mere $20 million to $50 million a year, or no more than $12,500 per hospital, for all and any hospital-acquired adverse events.
Third, patients were identified as having a prior infection not from their medical record or physician report, but by self-report, which is prone to error. They simply answered a question about whether they recalled ever having a history of a skin infection, such as cellulitis, a skin abscess, or wound infection that required antibiotic treatment.
I'm not sure most patients could remember that. And as for treatment, the question wasn't specific enough to distinguish an over-the-counter antibiotic product like Neosporin from one that required a physician's prescription. That masked any degree of severity the patients might recall.
Fourth, the sample size, culled from patients undergoing surgery at the University of Maryland Medical Center and Johns Hopkins Hospital, was only 613, and of those, 135 reported a prior skin infection requiring antibiotic treatment and 24 developed a surgical site infection or died of infection within six months. Not a very big sample.
'Challenging to understand'
However, Faraday makes an extremely important point that we need to know much more about the pathophysiology of infectious disease in surgical settings. And whether some people's genetic profiles are just unlucky.
"The thing that's challenging to understand, what makes it difficult for me, is that we see these cases all the time where it looks like everything has gone the same way, every (protocol) was followed, and yet why did this one in 20 or one in 100 patients get infected? It's very disturbing. And just saying something went wrong at the time of surgery clearly isn't the full answer."
Surgical site infections are terrible, I am well aware, indeed from witnessing horrifying experiences among a few friends. Nationally, researchers estimate there are 1.7 million healthcare-associated infections and 99,000 deaths each year, and 17% of those are due to surgical site infections.
Surgical site infections alone are estimated to cost $3.5 billion to $10 billion a year in healthcare costs. So it seems this would certainly be a place where research dollars would be well spent.