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By Stanley J. Geyer
10/09/07
Reasonable Caution As a Prudent Man
Stanley J. Geyer, M.D.
The Association for Molecular Pathology
(AMP) operates a Web-based listserv as a medium for member subscribers to communicate
rapidly by e-mail. In mid-July 2007, a member asked what factors determine
whether a test represents the “standard
of care.” Respondents noted that professional organizations, skillful
attorneys during litigation, and payers contribute to the determination of
standard of care.
Professional organizations play an important role in the development of recommendations
for the delivery of care, and payers affect healthcare practices based on their
decisions to fund various aspects of care. But the legal system, through malpractice
litigations, sometimes becomes the final arbiter of deciding whether a breach
in standard of care occurred in a specific case. In malpractice litigation,
standard of care is often determined by asking, “What would a reasonable
and prudent provider do in these circumstances?”
The concept of “reasonable and prudent” arose from the British
tort case, Vaughn v. Menlove (1837). The defendant built a hay rick,
a rectangular-shaped structure for storing the hay, with a chimney to prevent
the hay from igniting. In spite of the defendant’s efforts, the hay caught
fire and spread to the plaintiff’s property where the fire ruined two
of the plaintiff’s cottages. During the trial, the judge instructed the
jury to consider “whether the fire had been occasioned by gross negligence
on the part of the defendant, adding that he was bound with such reasonable
caution as a prudent man would have exercised under such circumstances.” (Source:
Wikipedia, Vaughan v. Menlove)
Reasonable caution, prudence, and such circumstances represent key elements
in determining standard of care. The guidelines of professional societies,
medical literature, and data from clinical trials offer important information
and insights about reasonable practices and, therefore, reasonable caution.
However, professional societies and organizations provide well-defined standards
of care for only a limited number of procedures or tests. The final decision
on the application or use of a test or the selection of a test method rests
with the individual practitioner or laboratory.
Prudence supposes the value of the outcome and, therefore, refers only to
the choice of the means—that is, the selection of the right process to
achieve the desired end. The evaluation of quality in the delivery of healthcare
often considers “best practices,” a notion much like prudence because
both terms refer to means, methods, processes, practices, or procedures. The
use of best practices (prudence) assumes a best outcome in the circumstances
in which the best practice is applied.
The judge in the Vaughn v. Menlove case also used the term “such
circumstances.” The rapid expansion and dissemination of medical and
laboratory knowledge need to be considered in judging standard of care. When
the AMP member asked what factors should be considered in determining if a
test represents a standard of care, she applied her question to a list of specific
tests. What may be a standard of care today may be obsolete tomorrow. A Google
search performed on August 9 2007, using the terms cystic fibrosis, standard
of care, molecular, and testing, yielded more than 26,000 hits, offering differing
opinions and test menus for cystic fibrosis screening. With the ability to
detect up to 98 percent of the 1,200 mutations in the CFTR gene, would a prudent
physician exercise reasonable caution by screening patients for all testable
mutations in the CFTR gene?
In the United States, the courtroom frequently serves as the source of determining
reasonable and prudent practices in specific cases. Likewise, payers influence
the judgments about practice by funding or withholding payment for testing.
The wise laboratorian recognizes the important role of the courts and the payers,
but will not abdicate prudence and the leadership roles required to create
and advance ever-improving of standards of care in pathology and laboratory
medicine based on sound science, clinical trials, technology development and
assessment, and the application of high quality testing in daily practice.
Neither the courts nor the payers can replace the sound judgments of the professional
men and women who lead clinical laboratories and who, in the end must create
and deliver the standards of care.
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