ED observation units mean fewer missed diagnoses
ED observation units mean fewer missed diagnoses
Less risk of patients discharged inappropriately
by Staci Kusterbeck, Contributing Editor
Observation units significantly decrease an emergency department (ED) physician's liability risk, primarily because fewer patients are discharged home inappropriately, according to Michael A. Ross, MD, FACEP, director of the emergency observation unit at William Beaumont Hospital in Royal Oak, MI.
In a landmark study, Ross and other researchers compared the rate of missed myocardial infarction (MI) diagnosis in EDs with and without a chest pain observation protocol. In EDs without an observation unit, the rate was 4.5%, and in EDs with an observation unit, the rate was less than 0.5%.1
"For chest pain, observation units led to a tenfold decrease in missed MI — that is huge," says Ross. "And I am positive they do the same thing for appendicitis and stroke." Other studies have reported similar findings, showing that with observation units, missed MI incidence is less than 1%.
"The usual miss rate for MI is maybe 5% for EDs. So that is a major decrease," says Sharon E. Mace, MD, director of the observation unit at Cleveland (OH) Clinic. "If you take not just chest pain but asthma and other things and do this appropriately, you can markedly decrease liability for those conditions as well." Cleveland Clinic, which sees about 6000 patients a year, has had an ED observation unit since 1994.
Several studies have shown that patients are more satisfied in ED observation units than inpatient units. "Patient satisfaction is another thing that has an impact on liability," says Mace. "Patients are much happier in an observation unit than being in an in-house floor. And if you have happier patients, they are less apt to sue you," she says.2,3
Having an observation protocol lowers a physician's threshold to complete a diagnostic evaluation for ED patients who are at risk for a serious condition, and in doing so, captures patients who might have been missed. "Having said that, though, litigation is a fact of life. Between 5 and 10% of ED visits are eligible for observation units. So with that volume, litigation is inevitable," says Ross. "There is no system or diagnostic protocol in medicine that is 100% foolproof."
Mace says she is not aware of any lawsuits filed as a result of a patient being in an ED observation unit. "I think there is enough experience out there now that we know the pitfalls and the issues so we can avoid them," she says.
In a 2002 study, researchers looked at academic institutions with an ED residency program and found that 36.1% had observation units and 44.9% were planning to open a unit. A 2003 follow-up study that looked at all types of hospitals indicated that 18.8% of EDs had an observation unit, with 11.6% more planning to implement one.4,5 There are no more recent statistics available, though Mace says that she expects the percentage has increased significantly since the studies were done.
Reduced liability risks are one reason why EDs are opening observation units, and overcrowding is another — which in itself is a liability issue, says Mace. "It limits our ability to take care of patients in a timely fashion and because of that, there are increased risks," she says. "There is just no place to put patients, and the observation unit is a very quick way to process patients."
Select right patients
Without an observation unit in the ED, there is a "threshold" issue. "The physician has to decide to call and get somebody admitted and go through that whole process. A lot of the patients that go to the observation unit are just a little bit shy of that threshold," says Ross. The observation unit makes it easier to complete the patient's workup without having to reach that threshold, he explains.
Many of these patients may actually be fine going home, but there are clearly misdiagnoses that would also be sent home if observation were not an option, says Ross. Avoiding misdiagnosis is hard to quantify or prove, but there is plenty of anecdotal evidence of this from ED physicians, according to Ross. "When we opened our unit, several of my partners thought we shouldn't be doing this, that we should just make up our minds to admit or discharge people," he recalls. "But over the course of a year, every one of them came to me and said, 'If it wasn't for the observation unit, I would have sent this guy home and missed this diagnosis.'"
No research has been done on the rate of malpractice claims per observation case, says Ross. "Observation patients are a peculiar case mix. They are not your most straightforward group of patients in the ED," he says. "They are people that often pose a diagnostic dilemma. They fall above the threshold for discharge but below the threshold for admission." The following are principles for management of an observation unit that, if adhered to, minimize risks:
- Have a focused patient care goal with a clearly defined reason for observation. "Patient selection is a very big issue," says Ross. The main pitfall to avoid is putting an inappropriate patient in observation, warns Mace. "If somebody is an ICU type of candidate or seriously ill, they probably should not be in an observation unit," she says.
The observation unit should not be used to manage a patient that the ED physician knows should be admitted as an inpatient, but the admitting inpatient physician refuses to accept, says Ross. "That is really beyond the scope of the observation unit," he says. "When you start to do that, you take on risks because you are caring for a patient in a setting not designed for that patient."
- Limit duration and intensity of service.
- Select an appropriate hospital location.
- Provide appropriate staffing skills and equipment.
- Provide continuing care in an outpatient setting which includes appropriate transfer care from one physician to another. "This is critically important," says Ross. "There has to be a very clear delineation for who is responsible for the patient in the observation unit." There should be no question in anybody's mind at any minute of the day as to who the responsible physician is, and what their participation in the patient's care will be, he explains.
- Provide intensive managerial review. There needs to be a clear definition for how to deal with indeterminate results, such as equivocal stress test results, cardiac markers, and electrocardiogram changes for chest pain patients, says Ross. A system must be in place to ensure timely recognition of changes in a patient's condition. For example, if a transient ischemic attack patient goes on to develop a stroke, that has to be recognized within the three-hour time frame during which thrombolytics can be given.
- Use predefined protocols outlining physician, nursing, and consultant responsibilities. Between 20 to 30% of observation patients will be admitted to the hospital, because they will either fail treatment or have a serious medical condition recognized, says Ross. "That is the intent of observation," he adds.
It is important to have clear follow-up for observation patients who are discharged, in the rare event that everything was done right but an emergency condition exists and the patient is discharged, says Ross.
Observation units come in many different designs, including open units where a physician anywhere in the hospital can admit the patient to the unit. "The nurses often have a hard time identifying when patients can be discharged, or even who to contact," says Ross. "That is a high-risk situation, as opposed to a well-defined unit with clear protocols."
Not a 'dumping ground'
ED physicians typically get sued for failure to diagnose and failure to treat, with 25% of malpractice dollars paid for missing the diagnosis of acute MI, says Louis G. Graff, MD, FACEP, FACP, associate chief of emergency medicine at New Britain (CT) General Hospital, CT. "If you go down the list of other things, missing the diagnoses of epidural abscess, appendicitis, ectopic pregnancy, that's what we get sued for — when we falsely reassure the patient and discharge them home," he says.
Most lawsuits occur with atypical presentation, adds Graff. "Nobody misses an acute MI that presents classically," he says. "With ED observation units, you are taking patients that are atypical and saying, I don't have enough evidence to get you admitted to the hospital, but I'm going to continue doing tests for 12 to 16 hours." After that period of time watching the evolution of disease and changes on physical exam, the odds are you will be able to discriminate better, he says.
Observation units with defined protocols and good leadership are hardly a "dumping ground" for patients, emphasizes Graff. "Those arguments were debated 25 years ago and evidence and logic has proven them to be untrue," he says. New Britain's ED has had an observation unit since 1967.
"All the evidence shows that EDs with observation units have lowered their risks by having them," says Graff. "When we started [the American College of Emergency Physician's] observation section 20 years ago, this was much more theoretical, but now it's really been proven. That is why we've fought for this over the years."
He gives the example of an elderly woman who is weak and short of breath, but initial tests don't show anything. Only half of acute MI patients have a positive blood test or electrocardiogram when they come in, and with unstable angina, only about 5% do, notes Graff. "So your tests are normal, and then you've got to tell somebody the patient might have a heart attack and they should be in the hospital, and they're going to laugh at you," he says. "But even if it's a 5% chance of having an MI, then 5 out of 100 patients will have an MI. And if you send them home, their chance of dying doubles."
There is no way you can make a definitive decision for patients with an indeterminate risk, so the observation unit gives you a "third pathway," says Graff.
If you have a patient with chest pain, and serial cardiac markers and electrocardiograms are still negative 12 to 16 hours later, then they haven't had damage to the heart, and if you do a stress test or CT angiogram, then they don't have coronary artery disease, and you have proved this in a short amount of time, says Graff.
The observation unit reduces legal risks as "more than an ED visit but less than a hospital admission," Graff concludes. "What we are trying to do is set up this third pathway so you can have your cake and eat it too," he says.
References
1. Graff LG, Dallara J, Ross MA. Impact on the care of the emergency department chest pain patient from the chest pain evaluation registry (CHEPER) study. Am J Cardiol 1997:80(5):563-568.
2. Rydman RJ, Roberts RR, Albrecht GL. Patient satisfaction with an emergency department asthma observation unit. Acad Emerg Med 1999:6(3);178-183.
3. Rydman RJ, Zalenski R, Roberts G, et al. Patient satisfaction with an emergency department chest pain observation unit. Ann Emerg Med 1997:29;109-115.
4. Mace SE, Graff L, Mikhail M, et al. A national survey of observation units in the United States. Am J Emerg Med 2003:21:529-533.
5. Mace SE, Shah J. Observation medicine in emergency medicine residency programs Acad Emerg Med 2002:9(2);169-171.
Sources
- Louis G. Graff, MD, FACEP, FACP, Associate Chief, Emergency Medicine, New Britain General Hospital, 100 Grand St., New Britain, CT 06050. Fax: (860) 224-5774. E-mail: [email protected].
- Sharon E. Mace, MD, Department of Emergency Medicine, Cleveland Clinic, 9500 Euclid Ave., E-19, Cleveland, OH 44195. Fax: (216) 444-1703. E-mail: [email protected].
- Michael A. Ross, MD, FACEP, Chair, Short Term Observation Services Section, American College of Emergency Physicians; Director, Emergency Observation Unit, William Beaumont Hospital, 3601 W. Thirteen Mile Road, Royal Oak, MI 48073-6769. Phone: (248) 898-3080. Fax: (248) 898-2017. E-mail: [email protected].
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