‘Safe Harbors’ Can Address ED Providers’ Malpractice Fears
March 1, 2024 4 minutes read
By Stacey Kusterbeck
Many emergency physicians (EPs) want to follow evidence-based guidelines to reduce unnecessary testing — but worry about liability if they do not order a diagnostic test and a patient sues. “CT scans are considered frequently, or even expected by patients, for conditions like acute low back pain, uncomplicated headache, minor head injury, and pulmonary embolus,” says Alan B. Storrow, MD, an associate professor and associate director of research in the department of emergency medicine at Vanderbilt University Medical Center.
The Choosing Wisely campaign, an initiative of the American Board of Internal Medicine Foundation, aims to reduce the overuse of potentially harmful tests and procedures. For example, excessive medical imaging exposes patients to radiation. “This is a particularly important consideration in the emergency care setting due to the higher inherent risk of missed pathology and the isolation of clinical care,” Storrow says.
The fact that the Choosing Wisely initiative does not address medical liability considerations has “substantially reduced its impact,” according to Storrow. Some EPs still order unnecessary tests specifically because they fear lawsuits.
Medical malpractice liability hinges on whether the provider has met the legal standard of care. Both sides try to establish the standard of care the EP should be held to, through discovery or expert witness testimony in court. A plaintiff attorney might argue that the legal standard of care required the EP to order a CT scan or X-ray; the defense attorney might counter that the legal standard of care did not require this diagnostic testing. The jury then decides what legal standard of care the provider will be held to, and whether it was breached.
“This all occurs after the provider has diagnosed or treated the patient, and after an injury has occurred,” Storrow observes. At the time of the patient-provider encounter, an EP will not know the standard of care to which they would be held in the event of litigation. “They must, in effect, make an educated guess at what the standard of practice is,” Storrow says. “This promotes defensive medicine. The risk of this practice pattern is overtesting.”
In a recent paper, Storrow and colleagues argued that a special type of predetermined standard of care — a “safe harbor” — could establish the legal standard of care to which a healthcare provider will be held.1 The idea was initially generated in an article published by James F. Blumstein, University Distinguished Professor of Constitutional Law and Health Law and Policy at Vanderbilt Law School/Vanderbilt Medical School, a co-principal investigator on the project with Storrow.2
Attorneys often point to clinical practice guidelines as evidence of the standard of care to which an EP should be held. A safe harbor is a special type of clinical practice guideline which, under existing federal law, constitutes the legal standard of care. “This distinction is of critical importance in encouraging adoption of a medical liability safe harbor and making it effective,” Storrow adds.
Since the safe harbor is established before the patient encounter, the treating provider understands their medicolegal obligation at the time of diagnostic test ordering. By adopting the safe harbor, a state-based, federally contracted, and legally recognized Quality Improvement Organization (QIO) would establish the standard of care in the context of a legal liability claim. “Practitioners who meet such a standard, and implement it appropriately, satisfy their obligation under the law of medical malpractice,” Storrow explains.
This is based on a provision of a 1972 federal law establishing QIOs, which specifies that when providers comply with professionally developed norms of care and treatment approved by QIOs, the law provides immunity for those providers.3 Thus, if QIOs adopt professionally developed standards of care for medical practice, those standards become the standards for medical liability. In turn, compliance with the standards would protect the EP from a medical malpractice lawsuit, Storrow says.
Storrow and colleagues developed safe harbors for three conditions commonly seen in EDs: lower back pain, minor head injury, and uncomplicated headache. The guidelines give clinicians specific directions for when they can avoid medical imaging for patients presenting with these conditions and are in use at Vanderbilt University Medical Center’s ED. (The guidelines can be found at: https://www.vanderbiltem.com/s....)
“There may be some degree of protection if pathways are adopted by local clinical practice committees, but ultimately, we are seeking state-level QIO approval,” Storrow reports.
Defining provider liability through a predetermined standard of care could result in a significant decrease in unnecessary tests and procedures in emergency medicine, the authors concluded. “The quality of care would not decrease, adverse event reporting would improve, and a measurable reduction in radiation exposure would occur,” Storrow adds.
REFERENCES
- Blumstein JF, McMichael BJ, Storrow AB. Developing safe harbors to address malpractice liability and wasteful health care spending. JAMA Health Forum 2023;4:e233899.
- Blumstein J. Medical malpractice standard-setting: Developing malpractice “safe harbors” as a new role for QIOs? Vanderbilt Law Review 2006;59:1017.
- Office of the Assistant Secretary for Planning and Evaluation. Toward an Evaluation of the Quality Improvement Organization Program: Beyond the 8th Scope of Work. Jan. 28, 2007. https://aspe.hhs.gov/reports/t...
Many emergency physicians want to follow evidence-based guidelines to reduce unnecessary testing — but worry about liability if they do not order a diagnostic test and a patient sues. The Choosing Wisely campaign, an initiative of the American Board of Internal Medicine Foundation, aims to reduce the overuse of potentially harmful tests and procedures.
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