Standard of care is a cornerstone
concept in each of the two principal professional liability risks. Civil liability exists when the physician’s
care is determined to have fallen below the standard. Professional regulation, which challenges
one’s license to practice medicine, asks the same question in order to evaluate
conduct, but usually applies an aggravated concept of negligence (such as gross
negligence.) While each liability risk
involves other issues, they both depend upon the standard. The standard of care is generally understood
as the care and treatment which may be expected of an ordinarily prudent
physician under similar circumstances. The standard of care as a concept eludes the
level of reliability which it appears to imply.
What makes sub-standard practice always debatable, is that the
“standard” includes both the personal subjective judgments of the
expert, and their unique view of “common practice.” Rarely questioned is the assumption that
their own standard of care represents or familiarizes them with “common
practice.” This is assumed upon
their qualification as an expert.
In this potential mine field of
uncertainty, we explore the ability to limit the application of standards of
care by role clarification agreements.
For reasons discussed in greater detail elsewhere, the capacity of parties to define their
relationships by mutual agreement changes
the context for applying common law notions of tort liability, of which the
accepted practice standard is one.
Private agreements change the context
for evaluating professional responsibility from the common law tort
principles defining negligence to principles of contract. Courts recognize contracts as prevailing over
tort principles because they promote collaboration and because they give
expression to the intentions and expectations of the parties.
Before analyzing strategies for
employing this opportunity, we should acknowledge that, while disputes may be
argued on the basis of standards of care, claims are rarely brought by patients
for this reason. Malpractice attorneys
look for poor medical outcomes, sufficient damages, and unfulfilled
expectations as sufficient reasons to justify undertaking a formal (litigation
based) search for evidence of substandard practice. The following analysis of role clarifying
risk management strategies is unnecessary in order to imagine the impact of
role clarification agreements on expectations and outcomes alone. In general, agreements are tools for
identifying and revising unrealistic expectations. They are also mechanisms for improving
outcomes by securing the cooperation upon which successful outcomes
depend. In short, agreements tend to
make relationships work.
boundaries for defining or limiting the application of
Let’s examine the assumption that
the scope of professional responsibility in medicine may be recognized as the
diagnosis and treatment of pathological conditions.
The distinction between treating
biological diseases as manifested in physical or biochemical symptoms on the
one hand, and on the other hand, treating the dynamics of health that are
within a patient’s control or addressing “mind-body-spirit” dynamics is a
substantive one. Physicians can determine whether their clinical purpose is to
treat pathology or manage the unique manifestation of an individual’s
constitutional disposition. If their
clinical objectives are understood and supported by their patients, role
clarification enables their intention to remain at the core of our inquiries
about professional responsibility.
Defining scope of practice roles enables physicians to make choices
known and supported by patients, and to tailor the nature and extent of their
responsibility to their values, skills and intentions.
Most scope of practice statutes are
based upon the prohibition (without a medical license) against diagnosing and
treating pathological conditions. As has
been previously stated, one also usually finds that such statutes embody the
medical model of pathology. Consider the
AND PROFESSIONS CODE
“Unlawful Practice of Medicine” Defined:
who practices or attempts to practice, or who advertises or holds himself or
herself out as practicing, any system or mode of treating the sick or afflicted
in this state, or who diagnoses, treats,
operates for, or prescribes for any ailment, blemish, deformity, disease,
disfigurement, disorder, injury, or other physical or mental condition of any person … is guilty of a
misdemeanor. (Italics are mine.)
The latter portion contains both the
prohibition against diagnosis and treatment and the medical model of
pathology. The italicized portion is
subject to both a narrow and a broad interpretation. Because it is a criminal statute, it is
constitutionally required to be interpreted narrowly. This principle would apply to our
understanding of the rather open ended phrase “or other physical or mental condition of any person,”
which might mean just about anything if it were broadly construed.
If the aforementioned conditions
(ailment, blemish, deformity, disease, disfigurement, disorder, injury)
exemplify a common principle, judicial customs of statutory interpretation
would assist us by limiting the application of “other … conditions”
to only other similar conditions. Since
it is reasonable to conclude that the enumerated conditions are all pathological conditions, it would follow that the final
phrase might be read to mean “other physical or mental (pathological) condition(s). This interpretation may also be supported by
our recognition that, historically speaking, medical education and training is
based upon the concept of pathology.
In 1982-83, California Board of
Medical Quality Assurance conducted hearings on such far reaching questions as
how medical licensure served the public interest, whether its laws were
unreasonable constraints on the grown of emerging perspectives and whether the
law should be modified. It was called
The 2052 Project because it considered the potential repeal of Cal. Bus. &
Professions Code Sec. 2052, discussed above.
The chairman concluded the inquiry stating that:
…the central issue concerning the
scope of professional responsibility was the need for doctors (and indeed all
health practitioners) to establish with patients a process for clarifying their
individual and mutual responsibilities in clinical relationships. This can best be accomplished through public
and professional education about the manner in which we allocate responsibility
in all other relationships — the making of individual agreements and contracts.
Health care agreements need not be
in writing nor need they be signed documents.
In fact, documents which purport to define questions of professional
liability (such as waivers or disclaimers) are viewed with suspicion and may be
invalidated as overbearing, unconscionable, or against public policy. They might even be argued to be evidence of
wrongful knowledge, suggesting that the author or proponent expected that by
their execution, questionable practices might be made acceptable. Actuall, all documents purporting to be
contracts are more accurately just evidence
of the meeting of the parties’ minds on the essential elements of their
agreement. That’s the contract. Today, contract law examines all writings,
material evidence, personal recollections, and the context, in order to
determine the parties’ intentions.
Writings that serve other legitimate
clinical purposes, such as gathering information, are both more reliable, more
professional, and because they are less legalistic, they are more acceptable in
general. An intake application asking
for the patient’s concerns about pathology separately from their interests in
constitutional matters or wellness concerns would serve a legitimate clinical
purpose and document a scope of practice agreement. Agreements could be simply noted
in the chart or confirmed in writing by correspondence without appearing
legalistic or projecting the defensive attitude that alienates patients.
Professional correspondence, especially when copied to the patient, is a useful
and inoffensive way to confirm verbal dialogue about roles.
II. Allocating Responsibility for Decisions
generated by informed consent.
Decisionmaking patterns were
surveyed and studied according to four models identified in a 1988 effort to explore the variety of decisionmaking
styles suggested by a 1982 President’s Commission. The Commission identified professional and
social difficulties with the judicially imposed doctrine of informed consent,
including widespread confusion about its requirements. A more recent study suggests that nine out of
ten surveyed decisions fail to inform patients sufficiently to participate
meaningfully, and less than one percent assessed patient understanding.
informed consent can generate. The
Supreme Court, however, finally clarified why a signed consent was not a
contract, and articulated the elements essential for judicial recognition of
health care contracts that would support agreements which define how consent is
understood and used. The opinion
illustrates judicial reluctance to expanding the application of common law
consent doctrines, and hints at meaningful guidelines for recognizing health care
contracts. The Court addressed two questions: Is a consent to surgery a contract? Should evidence of oral agreements contrary
to the consent be precluded by the parole evidence rule (which is a contract
Freeman, the patient, signed a consent
authorizing Dr. Lane to perform back surgery.
Dr. Lane testified to Freeman’s oral consent for Dr. Kovacs to operate
with Lane assisting, and the patient’s complaint for damages from a
post-operative spinal infection (a risk of the procedure) lost in the trial
court. The Court of Appeal reversed,
holding that the written consent was a contract, that
evidence of oral agreements contrary to the written consent, and ordered a
directed verdict against Dr. Kovacs for performing an unauthorized surgery. Dr. Kovacs appealed to the Kentucky Supreme
The Supreme Court reversed, holding
that a consent to surgery was not a contract, therefore evidence of verbal
agreements were admissible, and not precluded by the parole evidence rule. It reiterated established law that, in the
absence of statutory requirements, consent to treatment need not be written,
and may be oral or implied from conduct.
It stated that the consent form lacked the required specificity of terms
necessary for contractual recognition, and contained none of the earmarks of an
enforceable contract. It enumerated the
necessary contractual elements as including the specific obligations of
performance by each party, and the term or time frame within which performance
was expected. It added that the terms of
a contract must be sufficiently complete and definite to enable a court to
determine the measure of damages in the event of breach.
I read the Kentucky Supreme Court
opinion as suggesting two important notions.
The first is that courts are aware of the difficulties which consent
doctrines have caused, and are reluctant to further extend their
application. For this reason, I believe
the judicial trend to narrowly interpret consent doctrines will continue. The second idea is that solutions to
clarifying misunderstandings that may stem from unrealistic expectations lie in
contract, not in the norms of tort law.
The Kentucky Court is suggesting that agreements containing the elements
of contract, including complementary responsibilities and term, will be seen as
valid contracts. As such, they have the
capacity to modify how common law norms (such as informed consent requirements)
The President’s Commission concluded
that “shared decisionmaking is the appropriate ideal that a sound doctrine
of informed consent should support.” After doubting that this will occur “if
primary reliance is placed on the courts,” it encouraged patients and
health care professionals to “vary the style and extent of discussion from
that mandated by the general presumption (informed consent.)” Fifteen years before the Kovacs case, a
President’s Commission was calling for contractual clarification of how consent
is understood and used.
Three common styles or models of
making decisions, familiar to us in in other relationships, are compared here:
collaboration, patient choice and the traditional professional assumption of
responsibility. We can summarize these
four decisionmaking models in the following manner:
1. Traditional- Physician decides. Patient’s trust and confidence replaces the need for consent.
2. Informed consent – Physician decides with the patient’s consent based on disclosure of risks & alternatives.
3. Collaboration – Physician and patient discuss and decide jointly.
4. Patient choice – Patient decides with physician’s counsel.
Physicians assuming traditional
responsibility (Model 1) or informed consent (Model 2) will initiate
conversation aimed at obtaining compliance and may generate adversity with
patients who wish to collaborate or decide.
Knowing which patients would rather trust the physician’s judgment than
make decisions themselves will ideally lead to more relevant and productive
decisions with all patients. Knowing
which patients prefer to collaborate or make their own decisions could avoid
unnecessary adversity occasioned by divergent expectation about decisionmaking
styles, and will enable parties to build true partnerships which may grow and
change, and enjoy greater clinical success.
preferences and patient education and referral.
Physicians surveyed were asked to
assess the relative frequency in which they believed the four decisionmaking
models should be employed. They also
estimated the relative preferences for decisionmaking styles among their
patients. This permitted a subjective
comparison of physicians and their own patient population regarding values and
preferences for allocating responsibility for making medical decisions. They were asked to indicate which kinds of
medical decisions were most appropriate for each decisionmaking style. They were also asked to identify the most
frustrating or troublesome aspect of their patient relations, and the most
common misunderstandings which threatened clinical efficacy or led to disputes
and grievances in their specialty. Most
misunderstandings were about treatment expectations and risks of
Physicians differ in their values
and preferences for decisionmaking styles, and so do their patients. Only a few
physicians inquired expressly about the values and preferences of patients for
assuming responsibility in making decisions.
Just how a physician uses these proposed models of making decisions is a
function of his or her personality and style of communication. Some physicians indicated that they intuited
or guessed about their patient’s preferences, based upon the kinds of questions
patients asked. Sometime after being
surveyed, physicians reported increased satisfaction about being able to be
more “pro-active” in asking relevant questions themselves, and in
identifying patient preferences. They had
learned to differentiate levels of participation, and had
learned to elicit patient values, or to articulate their own preferences. One physician said, “this makes the practice
of medicine more interesting and more fun.”
Three patterns of decisionmaking
preferences among physicians are predictable and were identifiable. Some felt that the largest percentage of
decisions should be made by professionals; some thought by patients, and some
identified collaboration. Not surprisingly,
none identified informed consent for the most preferred category. Most reserved this preference to surgical
procedures and high risk medications. Of
greater interest however, was that this inquiry revealed that most physicians
were unsatisfied with how their decisionmaking values comported with those of
their patients. This was commonly
identified as the most frustrating or troublesome aspect of their patient
While physicians saw the potential
for identifying the particular values and preferences of individual patients,
most physicians wanted the bulk of their patients either to be more compliant
with their judgment, or to assume more responsibility than they were accustomed
to taking. Most of those surveyed had a
clearer impression of the values of their patients as a whole than of segments
of their patient population that possessed a variety of values and preferences.
Patient decisionmaking values reflected geographic and demographic dimension of
practices. Age and plan affiliations
were also factors.
Role clarification agreements
identify potential misunderstandings and unrealistic expectations. They establish general parameters that give
more structure to relationships, but even more importantly, they introduce a
new tool for revising plans in the future.
Contracts are often thought of as static or rigid obligations that limit
one’s behavior and, I suspect, are commonly avoided for this reason. If instead, we think and speak of collaborative planning, we will
emphasize the dynamic nature of role clarification agreements that may be
modified as personal desires and circumstances require. By making a verbal agreement that clarifies
any assumption which may not be shared, one introduces contract as a working
tool that can be used again as needed.
Physicians can inquire of patients’
general decisionmaking preferences in the early stages of their relationship,
when tensions arise, or can elect to address all of their patients on the
subject with general educational material.
Relocation of offices, changes in associates, or acquision of new
practices are ideal opportunities to introduce general education on the subject
to all patients. Phyisicians interested
in developing the subject more slowly might design material intended for new
patients only. These materials could
then be used with patients who present challenging relationship difficulties,
or when potentially discomforting tensions arise in otherwise satisfactory
relationships. Some may wish initially
to explore the concepts in conversations with patients so that the subsequent
design of education material reflects one’s individual values and interests as
they are identified by experience.
wanting patients to assume more responsibility.
Physicians can indicate their own
decision-making preferences in general terms, or indicate which kinds of
decisions they prefer to address in a particular manner. Patients can be encouraged to consider
different levels of responsibility for different kinds of decisions, and to
understand that their preferences may change over time as circumstances change
and as options become more familiar.
Some of those surveyed who recognized that their ideals favored
collaboration and patient choice complained of frustrations with patients who
wanted to be told what to do. A healthy
reluctance to accept professional responsibility for decisions was often
compromised by fears of losing patients, which can lead to physicians taking
more responsibility than their science justifies. This may in turn cultivate a lack of patient
responsibility. When there is a poor
outcome, this dynamic is fodder for disputes and litigation.
A healthy alternative to attempting
to persuade patients to take responsibility is simply to identify different
decisionmaking styles that may be appropriate for a variety of situations or
personal values, and allow the patient to reflect on where they may be along
the continuum. Greater precision may be
achieved by expressing one’s own values and preferences, and then suggesting
the kinds of decisions which you
believe might warrant patient choice or collaboration as compared with those
calling for more professional judgment.
Whether to have surgery is more appropriate, in most cases, for patient
choice or collaboration. Physicians will
differ on whether to share decisions about surgical technique or operative
route. Whether to medicate or modify
behavior is a different kind of decision than which medication to choose or
what dosage to use.
Remember that decisionmaking values
vary among professionals and know your boundaries. Identify your options. Allow for growth and change, perhaps by
agreeing to play a decisive role initially, the condition that the patient
contemplate the spectrum of options for future decisions. A decision to defer to defer a decision may
lead to a better style of decisionmaking.
Refer a patient to a colleague who prefers a different role and see if
it is reciprocated to your mutual satisfaction.
Such referrals build confidence for respecting your own practice
seeking more patient compliance.
A comparable number of physicians
expressed concerns about lack of patient compliance and frustration with
patients who wanted more information than was thought necessary to cooperate in
medical treatment plans. These
physicians identified themselves as being more traditional in their
decisionmaking values and preferences, and believed their understanding of
medicine warranted greater trust and confidence from their patients than they
were accustomed to receiving. They
frequently approached the obligations of informed consent resentfully, and felt
the doctrine as an imposition on physicians by lawyers and courts.
Defiant or uncooperative patients
take more time and are higher liability risks.
They struggle for their “right to decide” and may leave your
practice as an expression of their non-compliance. Even when a patient has disappeared, the
failure to follow diagnostic studies by contacting patients whose test results
warrant further exploration may be alleged as negligence. Staying in touch with assertive patients in
the decision making process is a key to understanding and preventing
These situations call for
understanding the middle ground between traditional professional
responsibility, patient choice, and informed consent, which collaboration
represents. Struggles over “who
decides” can be reduced by proposing that some decisions must be made by
patients, some are best made by professionals, and others may be made
jointly. Realizing that physicians and
patients will differ among themselves in
how they might allocate responsibility can open an inquiry into your respective
values and preferences. Identify those
decisions you won’t delegate, or those you feel bound by standards of care to
make, and distinguish them from those which might be made jointly by
collaboration. This may help patients
see an alternative to the struggle for control.
With time and experience, you will
both see the spectrum of decisionmaking responsibility and be able to consider
more options. While collaborative
planning teaches new forms of sharing decisions, recognize your own boundaries,
and give yourself the gift of knowing when a referral to a more collaborative
colleague may be saving yourself trouble in the future. Patients who lose the “battle for
control” with their physician or managed care provider will likely look
back to the experience in order to find someone to blame for a bad clinical
outcome. A working referral relationship
with a colleague in your specialty who may be more interested in collaborating
with patients, may also be a resource for learning to function more
collaboratively yourself. However, the
ideas of collaborative planning need not result in greater shared decision
making. They are tools for discovering
misunderstandings and unrealistic expectations.
They may be used as well for appropriate patient selection.
how consent is understood and used.
Does shared decisionmaking replace
the need for obtaining informed consent?
many people think that the patient’s signature on a well drafted consent
satisfies legal requirements, remember that there is widespread recognition
that the legal doctrine isn’t working well, and that physicians, risk managers,
lawyers and courts differ on what it requires. Consent is when the patient shows up for
treatment, not when he/she signs the paper.
Shared decisionmaking clarifies how
consent is understood and used. It
established the context for understanding appropriate dialogue about risks and
alternatives. I suspect that courts will
not permit shared decisionmaking to undermine the basic fairness which they
believe the current judicial doctrine attempts to require. A more useful question might be whether
shared decisionmaking, even when it results in a patient deferring to
professional judgment, involves greater representation of a patient’s interest
and a more meaningful participation in decisions than informed consent. If the answer is “yes,”
collaborative planning will bring more cooperation, increased clinical
efficacy, reduced risks of unfulfilled expectations, and fewer disputes: in
other words, cases that courts will never see.
Since informed consent is thought of as a defensive risk management
strategy, physicians often end up seeking compliance, and are therefore likely
to cultivate adversity. Seeking informed
consent generates misunderstandings and adversity. When we think contractually, instead of
thinking defensively, we can identify the basic terms that are necessary for
the relationship to work. Defensive
thinking misses this step. Agreements
tend to identify the basic terms which are necessary to make a relationship
work. The substantive interests which
informed consent seeks to protect will be guarded as well by collaborative
Every doctor practices with a
combination of implied and express agreements which allocate responsibility in
their clinical relationships. One’s
pattern of agreements reflects one’s skills and preferences for sharing
responsibility with patients. When roles are implied by conduct rather than
defined by agreement, they are often misunderstood by both parties. Although many malpractice cases involve negligence,
I believe that more originate in common misunderstandings about the scope of
professional responsibility assumed and the allocation of responsibility for
The remedy for these
misunderstandings is shared decisionmaking and role clarification. The scope of professional responsibility can
be defined according to customary scope of practice boundaries, reserving the
application of traditional standards of care to conventional treatments.
Employed together, shared
decisionmaking and role clarification can transform adversity in clinical
relationships and clarify the context within which informed consent is
understood and used. With collaborative
planning, doctors need not share decisions in all situations. They can identify and refer patients with contrary decisionmaking interests,
or elect decisionmaking strategies which accommodate the values and preferences
of individuals, while allocating responsibility according to their own
interests and desires. As our health
care system transforms itself, those practices which are built upon the
foundations of collaborative planning will have more lasting value.
 The standard of care is usually specialty
specific, however if a general physician undertakes a specialized function, he
will be held to the standard of care expected of the specialty. The same principle applies to one practicing
a function of a specialty different than his own.
 Epstein, Richard, LLB, Medical malpractice:
the case for contract. Am. Bar Found.
Res. J. 1976:87,
Green, Jerry A., J.D., Minimizing malpractice risks by
role clarification: the confusing transition from tort to contract, Annals of
Internal Medicine, 8/1/88, p.234
 Ben Winters,
Assurance 2052 Committee Memorandum, 5/20/83.
 Jerry A. Green, JD, note 2, supra.
 President’s Commission for The Study of
Ethical Problems in Medicine and Biomedical Research. Making Health Care Decisions: The Ethical And
Legal Implications Of Informed Consent In The Patient-Practitioner
Relationship. USGPO ;1:105 (1982.)
 Clarence H. Braddock, et al., Informed
Decision Making in Outpatient Practice,
JAMA, Vol.282, No.24, p.2313-2320, 12/22/99.
 Commission, supra, note 7, at p.38
 Id at p. 30
 Consider identifying three patients: a) usually
“wants you to decide,” b) usually just wants “your expertice and advice,” and
c) a joint decision maker. What do you
like/dislike about each? What is the
scope of your professional responsibility in each case? What verbal agreement might clarify roles or
consider changing them?
 One physician reports that he conducts an
informal survey of colleagues following their informed consent discussions,
asking simply, whether they gave or got informed consent. The tally of responses appears to remain a
 Quite different from express choices are the
situations in which deferring to professional may be implied from the
necessities of emergency, unconsciousness, or infirmity. Once we learn collaborative planning in the
easy cases, we will feel more comfortable applying the principles to surrogate
decision makers or the challenges of social contract. For example, preferences and values regarding
decisions during incapacity may be learned beforehand, communicated to
surrogates, or incorporated into medical plans.