# Safely Improving Emergency Diagnostic Testing through Clinical Safe Harbors

> **NIH AHRQ R18** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2020 · $349,619

## Abstract

Overutilization of healthcare resources often has negative implications. The Choosing Wisely campaign, an
initiative of the American Board of Internal Medicine, was proposed to help patients and caregivers engage in
shared conversations to reduce overuse of potentially harmful tests and procedures. However, the Choosing
Wisely campaign’s lack of linkage to medical liability considerations has substantially reduced its impact.
For instance, excessive medical imaging and its associated radiation exposure inflicts a measurably real and
significant risk of carcinogenesis, drives costs, and therefore is a significant Choosing Wisely target. This is a
particularly important consideration in the emergency care setting, frequently cited as an extremely utilization
rich environment due to the higher inherent risk of missed pathology and the isolation of clinical care.
We hypothesize a special type of predetermined standard of care (a “safe harbor”) can be defined based upon
medical evidence, and upon consultation among multiple experts and advisors, for a selected number of
clinical conditions within the specialty of emergency medicine (EM). Furthermore, a state-based, federally-
contracted and legally-recognized Quality Improvement Organization (QIO) could adopt the “safe harbor” and,
in doing so, 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.
Ultimately, defining provider liability through this predetermined, or ex ante, standard of care, may result in a
significant reduction in healthcare resource utilization within EM. Through this reduction, the quality of care
would not decrease, adverse event reporting would improve, and a measurable reduction in radiation exposure
would occur. Moreover, these predefined standards of care would improve communication between patient
and provider during the clinical transaction.
A diverse and experienced team of Vanderbilt University medicine, law, economics, and clinical faculty will
undertake this. Phase one will summon a broad group of technical experts and advisors to define safe harbors
for a narrow set of distinct clinical conditions within EM. These safe harbors would be presented for review and
approval by the appropriate QIO. Phase two will advance the safe harbor demonstration to EM practitioners
within Vanderbilt University Medical Center. Phase three will evaluate the demonstration and determine the
effects of the safe harbor on clinical decision making, adverse reporting, utilization, radiation exposure, patient
satisfaction and clinical outcomes.

## Key facts

- **NIH application ID:** 9913435
- **Project number:** 5R18HS025931-02
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** James F Blumstein
- **Activity code:** R18 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $349,619
- **Award type:** 5
- **Project period:** 2019-04-11 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9913435

## Citation

> US National Institutes of Health, RePORTER application 9913435, Safely Improving Emergency Diagnostic Testing through Clinical Safe Harbors (5R18HS025931-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9913435. Licensed CC0.

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