Standards of Care and Medical Malpractice

Standards of care are a set of guidelines generally agreed upon by professional bodies representing medical specialties, designed to help physicians practice safe and effective medicine. According to Donna Vanderpool, MVA, JD: “The standard of care is the benchmark that determines whether professional obligations to patients have been met. Failure to meet the standard of care is negligence, which can carry significant consequences for clinicians.”

These guidelines vary in strength depending on the quality of the underlying research. The more rigorous the research supporting a guideline, the more authoritative it becomes. However, there isn’t a single, centralized source where these standards can be found. Instead, they are derived from a wide array of sources, including clinical practice guidelines, state and federal regulatory agencies, court rulings, accreditation bodies, and the policies and procedures of healthcare institutions.

Establishing Medical Malpractice
In medical malpractice cases, the plaintiff must demonstrate four key elements:

Duty: The physician (defendant) owed a duty of care to the patient (plaintiff).
Negligence: The physician breached that duty by failing to meet the accepted standard of care.
Harm: The patient suffered harm as a result of the physician’s negligence.
Causation: A direct link between the physician’s negligence and the harm suffered must be established.
Negligence is identified by determining how a physician’s actions deviated from the accepted standard of care, which, in many cases, is grounded in clinical practice guidelines.

The Complexity of Clinical Practice Guidelines
Clinical practice guidelines are the most complex and sometimes confusing contributor to determining the standard of care. These guidelines are developed by professional organizations such as the American Academy of Family Physicians and are defined by the U.S. Institute of Medicine as “statements that include recommendations intended to optimize patient care, informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”

However, different professional organizations may offer conflicting guidelines for similar medical conditions, making it challenging to determine which set of recommendations should define the standard of care in a specific case. Additionally, the power of these guidelines varies based on the strength of the research they are built on. Guidelines backed by robust studies such as randomized controlled trials or meta-analyses carry more weight than those based on expert opinion or limited research.

Conclusion
The lack of a unified source for standards of care, the variability of clinical guidelines, and the differing levels of research backing them make establishing medical negligence in malpractice cases a nuanced process. Physicians are expected to practice within these guidelines while exercising their clinical judgment, and when they deviate from these standards, negligence may be found. In such cases, the strength and appropriateness of the clinical practice guidelines, as well as causation analysis, become critical in determining whether the standard of care was breached.