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Could TJC's antibiotic standard get you sued?
Requirement results in 'a host of legal problems'
An elderly man comes to your ED and is admitted to the hospital with severe dehydration and fever of unknown origin. Two days later, an X-ray reveals pneumonia.
When the patient is discharged with the diagnosis of pneumonia, this triggers the person collecting core measures data to check the patient's chart. They will find that the patient did not get the antibiotics within the six-hour time frame required by The Joint Commission.
"But that wasn't the diagnosis at the time the patient was in the ED. That is one of the problems with the standard," says Angela F. Gardner, MD, FACEP, assistant professor in the division of emergency medicine at University of Texas Medical Branch, Galveston, TX, and former director of risk management for Dallas-based EmCare. "When you make the discovery is the appropriate time to start the antibiotics."
The Joint Commission expanded the required timeframe from four to six hours; the change was effective in October 2007.1
"This is, frankly, astounding," says Jesse M. Pines, MD, MBA, assistant professor of emergency medicine and epidemiology at the Hospital of the University of Pennsylvania in Philadelphia. There is even less evidence of an association between a six-hour window and survival than a four-hour or eight-hour window, he adds.
The root of the problem is that The Joint Commission's standards were developed by specialists, without the involvement of emergency physicians, according to Frank Peacock, MD, vice chief of emergency medicine at The Cleveland (OH) Clinic Foundation. "Pulmonologists don't work in the ED, and they have no clue about what goes on. You get unintended consequences when you have somebody who doesn't work in an ED making the rules," he says.
The data behind The Joint Commission's antibiotic standard are "far from definitive," according to Pines.
The standard is based on two large retrospective studies of Medicare patients, all age 65 and older, admitted with pneumonia.2,3 These studies found a link between a reduced mortality rate and patients getting antibiotics within four hours and eight hours, respectively.
However, there are a number of issues with these studies that bring their conclusions into question, says Pines. "People can sit at home for days before coming to the hospital with pneumonia. To think that giving antibiotics a few hours sooner really makes a difference does not make good sense, unless the patient comes in critically ill. There may be something else driving the difference in death rates. Some other factor that is unmeasured in these studies may be responsible."
Pines hypothesizes that the patient's presentation accounts for the differences in mortality rates; specifically, he points out that patients with an atypical presentation of pneumonia get later antibiotics.4
"When patients don't have a cough, it takes longer to diagnose the pneumonia, and thus, antibiotics are delayed," says Pines. "The clinical presentation says something about how the host is responding to the infection. I would guess that this is likely a stronger factor in the association between antibiotic timing and mortality, than anything related to delays in antibiotics."
Christopher Fee, MD, assistant clinical professor in the department of emergency medicine at University of California San Francisco, agrees that there may be other variables that were unaccounted for in the studies. For example, it may be that patients who received more rapid antibiotics were cared for in hospitals that provide better care in a number of other ways, such as better nursing care or adherence to other practice guidelines. "Thus, the time to antibiotics may be a surrogate for overall better care," says Fee. "This was not measured or controlled for."
According to Pines, "what is clear is that the group that makes recommendations to CMS [the Centers for Medicare & Medicaid Services] on these rules has a vested interest in keeping these timing guidelines in place," says Pines. "This is because people on the committee that make the recommendations to CMS on this also happen to be the authors that wrote the original papers. It seems like a classic example of academic conflict of interest."
Current pneumonia guidelines from the American Thoracic Society (ATS) and Infectious Disease Society of America (IDSA) recommend that antibiotics be administered as soon as possible after the diagnosis is confirmed, preferably while the patient remains in the ED. In other words, ED physicians should not confirm the diagnosis but then send the patient to the inpatient floor without giving the first dose of antibiotics, says Fee.
Pines says the problem is that The Joint Commission "jumped the gun" and declared that early antibiotics in pneumonia be the standard of care before there was sufficient evidence. "This may create a host of legal problems," he says.
Likely to come up during a lawsuit
"When a lawsuit happens for a patient with pneumonia who was admitted through the ED, I'm sure the lawyers are going to look at whether they got early or delayed antibiotics," says Pines.
Pines adds, however, that it would be difficult for an attorney to link any specific bad outcome to a delay in antibiotics, unless it was delayed by days or weeks. "The problem is they have certified early antibiotics in pneumonia as a care standard before the evidence was there to really support this assertion," he says. "Therefore, there may be cases that inappropriately point to delayed antibiotics as causative in a bad outcome."
If such a case were to go to trial, Pines says that ED experts would need to argue that there is no definitive link between early antibiotics and survival rates in pneumonia patients. "Juries might have a hard time understanding the subtleties of why the studies are not definitive."
Fee says he is not aware of any lawsuits that have occurred for failing to meet this standard. "Even The Joint Commission and CMS acknowledge that it is unrealistic, and likely harmful, to expect that 100% of pneumonia patients will receive antibiotics within the window, since doing so means that many other non-pneumonia patients would have been given antibiotics to achieve such a goal," he says.
Regardless of that, if a lawsuit occurs and antibiotics weren't given within six hours, the ED physician would have to explain this to a jury. "The jury may or may not decide that it was a good reason. Many of these cases are not black and white. It is going to be very difficult for people to understand," says Gardner.
A few years ago, Gardner cared for an 82-year-old man who had broken his hip falling out of his wheelchair. After examining him, she sent him for a chest X-ray — a routine practice for any patient with a broken hip because they may have to go to the OR.
When the X-ray came back two hours later, it showed pneumonia. Gardner wrote the order for antibiotics, which were given at four hours and 45 minutes — at the time, outside the timeframe required by The Joint Commission.
"It was not the diagnosis that he came with. There was nothing I could have done differently; he had no symptoms whatsoever to lead you to believe he had pneumonia," says Gardner. While no lawsuit ensued, Gardner says if one had occurred, she would have been in a position of having to defend why she hadn't followed the guidelines.
In addition to the six-hour timeframe, The Joint Commission is allowing EDs to document "diagnostic uncertainty" to indicate that the diagnosis of pneumonia was not clear at the time of the patient's arrival to the ED. If a physician documents "suspected pneumonia," this would fall outside of the reporting requirement because there was not a definitive diagnosis in the ED.
"The infuriating part of this is that these new guidelines have added new administrative hassles like this, and they really do nothing to help improve the actual quality of ED care," says Pines. "And the guidelines might actually be hurting people by providing incentives to physicians to give antibiotics when they are not sure."
If the ED physician suspects pneumonia after the evaluation, he/she should give the antibiotics, advises Fee. However, if their suspicion is relatively low and they have no objective data to support the diagnosis — the patient has a normal or unchanged chest X-ray, normal labs, normal lung exam, and no hypoxia or fever — then they should simply not include pneumonia as a final diagnosis. "They can include it in their differential or medical decision making, but the case will be excluded from The Joint Commission/CMS reporting if pneumonia is not one of the final ED diagnoses," says Fee. "You also cannot include 'consolidation,' 'infiltrate,' or 'possible pneumonia' there, or it will be eligible for core measures reporting."
Risk of inappropriate antibiotics
Clearly, The Joint Commission standard has changed the practice of ED physicians; across the country, rates of early antibiotics in pneumonia are on the rise.5
"The problem is that there is no clear evidence that this benefits patients," says Pines.
Pines points to an unintended consequence of the requirement — that ED patients with pneumonia-like illnesses such as congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) are getting antibiotics when they don't need them.
No one would argue that giving antibiotics to a patient with pneumonia is the right thing to do, as soon as the diagnosis is confirmed, says Fee. "The problem is with identifying these patients within the given time window, and the lack of convincing evidence that receiving antibiotics within that window really impacts mortality," he says.
Establishing an artificial time window creates pressure to give antibiotics to a patient who may have pneumonia, but in whom the diagnosis remains uncertain and is pending further evaluation, such as a chest computerized tomography scan. "This has the potential to cause ED physicians to administer unnecessary antibiotics," Fee says.
The problem, says Peacock, is that now, "everybody who might have pneumonia gets antibiotics."
"It's not good medicine, but that's what we do in the United States," says Peacock. "We are in an epidemic of C. diff infections now, which is very rare to get without an antibiotic-associated event. And here we are, putting patients at risk for diseases to comply with a rule that is really poorly thought out. Patients can get an allergic reaction or diarrhea from antibiotics for a pneumonia they don't even have."
Fee adds that he doesn't think that lawsuits involving ED physicians failing to meet the six-hour timeframe are likely to increase. In fact, he envisions the opposite scenario. What if a non-pneumonia patient, such as a CHF patient, is given antibiotics purely out of pressures about time?
"If the patient suffers an adverse event because of it — an allergic reaction, volume overload exacerbating the CHF, or interaction with their Coumadin — this could lead to a lawsuit," says Fee.