avoiding-liability by chenshu


									Avoiding Liability Through Good
      Communication and

     By:   Lisa Wilson, JD
           University Legal Counsel
             Today’s Focus

• What does it mean to obtain informed
• What is the best evidence of informed
• How to disclose unanticipated outcomes and
  medical errors
Informed Consent
            Reasons for Informed Consent
•       Respect individuality, self-determination,
        autonomy - patient has a right to know and participate in
        plan of care
•       Structure and establish the relationship with the patient /
•       Enhance outcome – improve cooperation
•       Comply with the law, accreditation standards and avoid
        Required by common law, state statute, medical licensing
         standards, and CMS Conditions of Participation
        The Joint Commission (TJC) requires that charts contain evidence
         of informed consent
        Leapfrog and other patient safety organizations
 Informed Consent Process Includes:
• Appropriate person with decision-making capacity
• Required information
    Risks, benefits, alternatives
• Use of understandable language
• Awareness of cultural differences, literacy, beliefs,
  language barriers
    Contact Interpreter Services / Patient Relations
• Apply “teach-back” method to confirm
 Who is Responsible for Obtaining
       Informed Consent?
• The physician performing the procedure is
  responsible party
    Statutory
    Licensure requirements
    Hospital policy – UWHC Policy #4.17
• Physician may designate others (i.e. nurse,
  resident) to assist in giving information and
  obtaining signature
 Informed Consent Standard
Generally, what a reasonable patient
would want to know under same or
similar circumstances present to
make an educated and informed
      What Information Should Be
•   Details of the procedure
•   Risks and benefits of the procedure
•   Consequences of non-treatment
•   Alternative, viable medical modes of
    treatment and the risks/benefits of each
        Risk Communication
• Major emphasis on patient choice
• Provide information that aids the decision-
  making process
  Use of decision aids
• Patient values and preferences vary
  widely…difficult to predict
• Patients who are more engaged and
  informed are more compliant and have
  better outcomes
          Discussing Risks
• Display competence, a caring approach,
  willingness to discuss patient’s own
  expectations and fears…builds trust
• When discussing rates of risk it is
  suggested to use:
  absolute rather than relative risk
  a common denominator
  information that reflects the individual’s risks
• Positive versus negative percentages
Johnson v. Kokemoor, 199 Wis. 2d
        615 (S.Ct. 1999)
 Plaintiff diagnosed with basilar bifurcation
 aneurysm. Defendant clipped aneurysm but
 Plaintiff rendered an incomplete quadriplegic.
 B/4 surgery, Plaintiff had asked Defendant
 whether he had performed same surgery before
 and he said “several” times. When questioned
 further, he stated “dozens” and “lots of times.” In
 fact, Defendant had performed aneurysm
 surgery on six patients, only twice on basilar
 bifurcation aneurysm, and never one as large as
Johnson v. Kokemoor (cont.)
Wisconsin Supreme Court held that
Defendant’s relative lack of experience in
performing basilar bifurcation aneurysm
surgery and fact that other physicians
would have substantially different success
rate in performing same procedure was
something a reasonable person would
have wanted to know – choice between
alternate, viable medical modes of
 What Information Generally Need
        Not Be Provided?

• Information beyond what a reasonably-well
  qualified physician in a similar medical
  classification would know
• Detailed technical information in all probability
  the patient would not understand
• Risks apparent or known to the patient
 What Information Generally Need
    Not Be Provided? (con’t)

• Extremely remote possibilities that might
  falsely or detrimentally alarm the patient
  Must weigh the seriousness of the risk against
   likelihood it will happen
• Information in an emergency where failure
  to treat more harmful than treatment
• Information in cases where patient is
  incapable of consenting (surrogate?)
  Documenting Informed Consent
• TJC, CMS, etc require that medical charts
  contain evidence of informed consent
• Two common methods:
   Signed consent document (v. implied consent)
   Dictated chart note
Signed Consent v. Implied Consent
• Signed Consent
  • Procedures that are more than minimal risk such as
    those performed in OR; radiotherapy; chemotherapy;
    dialysis; transfusions; other invasive procedures
    (such as puncture or incision of the skin or insertion of
    instrument or foreign material into the body)
  • List of procedures requiring signed consent form
    (UWHC Policy #4.17 attachment)

• Implied Consent
  • Generally only for routine, noninvasive or minimally
    invasive procedures with no more than minimal risk
    (chart note strongly recommended)
        Signed Consent Document
• Standard forms used by hospital
    Flexibility in altering forms
    Procedure specific forms
• Form must have date and time when patient or patient’s
  representative signed and when physician signed
• Witness must sign and include professional designation
• Must have witness if obtaining telephone consent
• Form must be signed by patient or representative and
  physician prior to surgery / procedure
• RNs, NPs & PAs are only allowed to be sole
  authenticator on form IF they are performing the
  procedure alone (sign on witness blank)
          Dictated Chart Note
• Use in conjunction with signed consent
  document, and especially when consent implied
• Your best protection against assertion of failure
  to obtain informed consent
• Memories fade over time leaving chart note as
  only evidence of actual conversation
• Document chart note same day as discussion
  with patient noting general discussion
• Signed consent form without chart note may
  result in contest between patient and physician
               Ideal Chart Note
• Patient’s existing condition
• Nature of proposed medical care, its risks and side
• Benefits of proposed medical care and its outlook for
• Alternative, viable modes of treatment discussed and
  risks/benefits of each
• Significant questions asked by patient and answers
• Patient consented to planned care
• Any refusal to receive information
• Any refusal to receive recommended care
• To recover damages for a failure to obtain
  informed consent, patient need not show that
  physician performed below standard of care
   No hiring of expert witnesses
   May be easier to prove failure to obtain informed
    consent than to prove negligence
• Patient need only show:
   A reasonable person would have wanted to know
    omitted information
   A reasonable person would have chosen differently
    based on that information
   Failure to disclose was cause of injury
           Lawsuits (cont.)
Studies show that patients are less likely to
sue, even when there is a bad outcome, if
they have had good communication with
their physician, leading to a feeling that they
received all of the information and that their
physician truly cares about their condition
          Tips to Remember
• Ideally, time to obtain informed consent is
  not on day of procedure
• Consent is a process and good consent
  process reduces risk of claims
• Never go back and change a record. If
  error exists, use appropriate hospital
  procedures to amend
• Never put anything in a chart note that you
  would not want a judge or jury to see
Disclosing Unanticipated
      Outcomes &
     Medical Errors
 Why Disclose Medical Errors?
• Ethical to do so when error significantly affects
  the care of patient (1992 American College of
  Physicians’ Ethics Manual)
• Required by TJC: Patient must be informed
  about outcomes of care, including unanticipated
  outcomes (Standard Rl.1.1.2)
• Required by UWHC Policy: Physician or
  designee must clearly explain outcome of
  treatment or procedures whenever outcome
  differs significantly from what was anticipated
  (Policy #4.45).
          Goals of Disclosure
• To support the patient’s right to information
  about the outcomes of diagnostic tests, medical
  treatment and surgical intervention.
• To acknowledge, identify, reduce and prevent
  medical errors and improve patient safety.
• To create an environment in which patient safety
  is paramount; in which caregivers feel
  comfortable bringing unanticipated outcomes to
  light in order to learn from them and participate
  in process improvement.
• Unanticipated Outcomes: Result that
  differs significantly from what was
  anticipated. May or may not include error.
• Medical Errors: Failure of a planned
  action to be completed as intended or the
  use of the wrong plan to achieve an aim.
  Does not include intentional or reckless
  actions that result in harm to the patient.
       Known Complications
• Known complications are not
  unanticipated outcomes
• Patients should still be informed that a
  known complication occurred and the
• Use same techniques for disclosing
  unanticipated outcomes and medical
  Experiences with Disclosure
• Lexington Kentucky VA Hospital:
  systematic disclosure since 1987 of
  accidents and incidents has resulted in
  reduction of malpractice claims
• University of Michigan Health System
   2002-2004: annual attorney fees dropped
   from $3M to $1M
  2001-2004: lawsuits and notice of intent to
   sue fell from 262 to 130
 Patient Perceptions/Behaviors
• Most patients want their physicians to alert
  them to even the smallest of errors
• Patients’ motivations to sue include anger
  over feeling they have not been told all
  needed facts
• May resort to use of legal process to find
  out what happened
Provider Perceptions/Behaviors
• Fear of litigation prevents many providers
  from disclosing medical errors
• 1991 JAMA article: Wu, et al reported the
  following rates of disclosure of mistakes by
  To attending MD 54%
  To patient/family 24%
  Who Should Disclose Errors?
• Attending physician; other members of
  care team; patient relations representative;
  nurse manager
• Never make disclosure alone (witness)
• Never make disclosure of event that
  involved someone else without including
  that person in discussion
When Should Disclosure Be Made?
• As close to time of event as possible
• May not have all facts yet
• May only be able to say that it appears an
  unanticipated event occurred, with brief
  description of the event, and that an
  investigation is taking place
• Maintain regular follow up with patient / family to
  keep them informed of progress and provide
  when will be in contact until investigation is
  completed and results have been shared.
     How Should a Disclosure Be
• Try to pick a time/place where you won’t be
  disturbed by phones, pager, etc.
• Sit down!
• Make eye contact and talk slowly
• Don’t be too technical
• Pause to allow the patient to process or ask
• Ask patient if he/she understands
• Don’t be intimidated by silence or feel the need
  to fill it
        Content of Disclosure
• “There is no easy way to say this…” or “I’m sorry
  to have to tell you this…”
• Describe the event truthfully
• Discuss what, when, how, consequences
• Apologize/Sympathize: “I’m sorry that this
  happened” and “I understand this must be very
  difficult for you to hear”
• Don’t blame yourself or others!
   Events are often multi-factorial, involving many
    mistakes or break downs in process
    Discussing Consequences
• Tell patient what this means in terms of
  follow up/additional care; quality of life
  issues; etc.
• Tell patient if processes have been
  changed as a result of the event
• If patient asks about bills/compensation,
  refer to patient relations to deal with
  Never tell patient he/she will not be
   responsible for charges!
• Carefully document your discussion with
  the patient
• Include people present (later witnesses)
• Include facts you told patient about the
• Include significant questions by the patient
  and how they were addressed
• Do not reference peer or QA review or
  discussions with risk management/legal
               Legal Risks
• Negligence versus bad outcomes or
• Standard of care
• Availability of evidence
• Protection of peer review processes
• Financial liability
• Admitting liability
        Theories of Liability
• Violation of AMA Code of Medical Ethics
    Not a law, but would discredit physician
• Breach of fiduciary duty
    Failure to disclose may be fraud (failure to act in patient’s
     best interest)
• Fraudulent concealment (misrepresentation)
    Intentional injury to the patient’s best interest
    Extends statute of limitations and involves punitive damages
    Settlement likely to be more difficult and costly

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