Did an EP’s care result in an adverse event that triggers mandatory reporting to state or federal agencies? “If I’m that EP, I would want to make sure I understand what is, or isn’t, being communicated,” offers Michael R. Callahan, JD, a partner at Katten Muchin Rosenman in Chicago. He adds that EPs should know these two things if an adverse event is reported for an ED patient:
- Is an adverse event report, in fact, required?
- What information does the hospital have to provide?
“If I’m involved in a report, I want to know if my name is being used, and if so, whether it is really necessary,” Callahan explains. “Is the hospital providing too much information, and now I’m exposed?”
Contrary to what many believe, the EP’s name isn’t necessarily required in an adverse event report. “Typically, the hospital only provides what they are required to provide, nothing more and nothing less,” Callahan notes.
However, it’s possible that the hospital decides to include the EP’s name in the report regardless. This may be a misguided attempt to escape liability for the patient’s bad outcome. “I don’t think the hospital can completely wash its hands of responsibility when it comes to an EP, [which would be more likely if the defendant is] an independent surgeon,” Callahan adds.
An ED’s adverse event report could trigger an investigation by the state licensing board, by the Centers for Medicare & Medicaid Services (CMS), or even by an accredited body such as The Joint Commission. This is more likely to happen if there is a pattern of adverse outcomes in that ED, Callahan says.
Once an investigation occurs, it means the medical records surely will be reviewed. “They obviously can’t redact or delete the name of the EP involved, in that event, because it’s part of the medical records, which are never privileged,” Callahan explains.
CMS or state investigators are “going to want access to anything and everything, in order to determine if the hospital was or was not in compliance,” Callahan adds.
This includes what the hospital did, if anything, because of the adverse event. “That’s where it gets dicier,” Callahan warns. The question then becomes: Is the information the agency is asking for privileged or confidential, either under state law or federal law?
Typically, an adverse event in the ED triggers a comprehensive internal peer review investigation and/or a root cause analysis. If the hospital conducted these activities under the umbrella of a patient safety organization, it’s likely the material will be treated as a privileged patient safety work product. “Consequently, the hospital is not going to turn that over, at least initially,” Callahan says.
The investigating agency might want to know if the root cause analysis or peer review evaluation revealed any problems with the EP who cared for the patient. Conflict over what the hospital will or will not agree to produce often ensues.
“Obviously, the hospital doesn’t want to lose their Medicare eligibility, although that’s rare,” Callahan says. “They also don’t want their hospital to be on the ‘bad hospital’ list, because they are then going to be visited by the state or the feds every other week.”
State laws vary as to what information is privileged. If it’s the state licensing body asking questions about whether any peer review was performed on the EP because of the adverse event, Callahan says, “Our response is, ‘Sorry, under our state statute you are only entitled to medical records. We are not going to turn over our peer review files.’”
On the other hand, if a federal agency, such as the department of public health, is investigating, “they get access to everything,” Callahan notes. “The hospital, at that point, might not have a choice.”
However, if the internal review was conducted under the auspices of a patient safety organization, privilege applies to both state and federal proceedings. “Then there are the negotiations,” Callahan adds.
The hospital might agree to turn over the action plan resulting from the root cause analysis, to show how ED policies were modified to prevent the incident from happening again. Likewise, the hospital might agree to allow ED nurses to be interviewed, but without turning over any internal analyses. The amount of push-back varies. “If the hospital says, ‘We don’t think we have to turn this over in order to demonstrate compliance,’ many times the government will agree. But sometimes they don’t,” Callahan warns.
Depending on the facts of the case, investigators may not be focused on the EP at all. “It all depends on how deep the government wants to dive in terms of getting access to the information, and what the hospital is willing to produce,” Callahan offers.
The state licensing board may want to conduct its own review and ask an expert to comment on the EP’s care.
“They have that right,” Callahan says. “On the other hand, they don’t want to redo this work if the hospital has already done it.”
The government’s justification for demanding this information is that it is needed to determine if the hospital is in compliance or not. In malpractice litigation, the plaintiff doesn’t have the same argument.
In a malpractice lawsuit against an EP, Callahan explains, “Even if you have to disclose information to CMS because you’re not going to run the risk of getting kicked out of Medicare, you can do it without losing protection.”
Five EMTALA Violations
Even a single adverse event in the ED could lead to an investigation and greater scrutiny of the patient’s medical record. “Who knows where it goes from there?” Callahan asks. “EPs are independently exposed both from a regulatory and legal standpoint, as is the hospital.”
A CMS investigation of a possible violation of the Emergency Medical Treatment and Labor Act (EMTALA), for instance, has important legal implications for individual EPs. In a recent case Callahan reviewed, one EP’s complaint about the care provided by another EP triggered an onsite review by CMS.
CMS determined that the EP had violated its conditions of participation. As part of the investigation, CMS requested copies of about 20 patient records, which were sent for review by a quality improvement organization and expert EPs. Based on a review of those records, CMS decided to investigate the EP independently.
“Almost a year after the complaint was originally filed, CMS came back to the hospital and said, ‘Based on the cases that we reviewed, you now have five EMTALA violations,’” Callahan recalls.
The EMTALA violations involved patients who were not stabilized adequately, a patient who had not undergone an adequate medical screening exam, and patients for whom required tests weren’t performed before transfer. “The hospital has the obligation under EMTALA to provide these services,” Callahan notes. The EP doesn’t have an independent obligation and cannot be sued under EMTALA. “However, if found to have violated EMTALA, EPs are at risk for civil fines and penalties, and independent action as it relates to their continued participation in Medicare,” Callahan notes. Additionally, if an EMTALA violation is found to exist, this could result in the patient or family filing a separate malpractice claim against the EP.
“An EMTALA violation can open up a whole can of worms in that regard,” Callahan warns. The plaintiff attorney might allege, for instance, that the EP delayed treatment or should have consulted with a specialist, resulting in permanent harm to the patient.
“If a malpractice case against the EP does occur, the question arises as to whether the reports on any investigations by state or federal agencies are confidential,” Callahan adds. If the EP takes any notes after an adverse event occurs, these may be discoverable. “Consult risk management and hospital counsel,” Callahan advises. “You want to make sure the notes are not going to see the light of day, from a discovery standpoint.”
- Michael R. Callahan, JD, Partner, Katten Muchin Rosenman, Chicago. Phone: (312) 902-5634. Fax: (312) 902-1061. Email: email@example.com.