The Basics of Informed Consent:
Past, Present & Future
DPH RAP Session
September 15, 2011
Presented by
Elizabeth Plott Tyler
TYLER & WILSON
5455 Wilshire Boulevard, Suite 1925
Los Angeles, California 90036
Phone (323) 655-7180
Fax (323) 655-7122
Copyright © 2011 Tyler & Wilson
Consent: The Primary Issue
Consent to Treatment
▪ Guiding Principle: The fundamental right of
self-determination (to make decisions for
one’s own self)
▪ The right to self-determination continues even
if a patient is no longer able to advocate for
himself
▪ The right to self-determination exists even if a
health care professional disagrees with the
patient’s decision
Where It All Began
Cobbs v Grant, (1972) 8 Cal. 3d 229
▪ A patient can only effectively exercise the right of
self-determination if the patient possesses adequate
information to make an intelligent choice
▪ Physician must disclose whatever information is
material to the patient’s decision
▪ Specifically, Physicians must disclose:
▸ Risk of death or serious harm
▸ Complications that might possibly occur
▸ Such additional information as a skilled practitioner
of good standing would provide under similar
circumstances
What is Not New
The Definition of Informed Consent for California SNFs
▪ 22 CCR Section 72052
▸ Informed consent means the voluntary agreement
of a patient or a representative of an
incapacitated patient to accept a treatment or
procedure after receiving information in
accordance with Tittle 22 Sections 72527(a)(5)
and 72528
What is Not New
The Informed Consent Rights of California SNF Patients
▪ 22 CCR Section 72527(a)(5)
▸ Patients have the right
– to receive all information that is material
– to an individual patient’s decision
– concerning whether to accept or refuse any
proposed treatment
What is Not New
The Duties of an Attending Physician in a California SNF
▪ 22 CCR Section72528(a)
▸ It is the responsibility of the attending licenced
healthcare practitioner
▸ To determine what information a reasonable
person
▸ In the patient’s condition and circumstances
▸ Would consider material
▸ To a decision to accept or refuse a proposed
treatment or procedure
What is Not New
The Duties of the SNF and its Nurses
▪ 22 CCR Section 72528(c) -▸ To verify that the patient’s health record contains
documentation that the patient has given informed
consent
▸ Before initiating the administration of:
--psychotherapeutic drugs, or
--physical restraints, or
--the prolonged use of a devise that may lead to the -inability to regain use of a normal bodily function
What is Not New
Policies SNFs are Required to Have
▪22 CCR Section 72527(a)(5)
The facility shall establish and implement
written patients’ rights policies and procedures
▪22 CCR section 72527(e)(1)
Those concerning informed consent shall
include
– How the facility will verify that informed consent was
obtained
What is Not New
Documentation of Informed Consent
▪ It is up to each SNF to decide what type of
documentation it will allow
▪ Physicians are not required to do the actual
documentation in the SNF chart
(their job is to have the discussion)
▪ Documents requiring signatures of patients or
responsible parties are not required
▪ Informed Consent is “not simply” about
documentation
What is Not New
Every Order Does Not Require New Informed Consent
▪ Informed consent is required only when:
▸ A new order is made, or
▸ The dose on an existing order is increased
--Out of the original dosage range
What is Not New
The Exceptions
▪22 CCR Section 72528(e)
▸ In cases of emergency
▪22 CCR Section 72528(f)
▸ When the patient has specifically waived the right
to information about risk
▸ When the physician feels that full information would
“unhinge” the patient
– (but only if a patient’s “representative” gives informed
consent)
What is New
The Handling of Preexisting Orders
▪ AFL 11-08 dated 1/7/11 (See also DOM 11- 03)
“Change in the Guidance regarding Title 22
Section 72528 (c)”
▪ Now
▸ Surveyors must confirm that health records contain
documentation that the patient gave informed
consent” for applicable drugs and restraints
▸ “Including those admitted with preexisting orders”
What is New
DPH ‘Suggestions’ for Compliance
▪ “In order to be in full compliance, the
Department suggests a few methods that are
permitted under the current regulations and/or
statutes”
▸ “1. Obtain documentation that informed consent
had been obtained from the patient for the proposed
therapy and is in the patient’s medical record”
▸ “2. Obtain new informed consent as described in
Section 72528(c) and place the informed consent
documentation in the patient’s medical record”
What is New (sort of)
Complicating Factors
▪ Bedhold and Readmission Rights
▪ Following Physician’s Orders
▪ Not Accepting or Retaining Patients for whom
care cannot be provided
▪ Administering Drugs or Applying Restraints
Without Proof of Informed Consent in the
Medical Record
What Else is New
Prolonged Use of Devices that
Permanently Impact Normal Body Function
▪ None exist now but,
“With the advancement of medical technology,
there may be future devices which fit this
description”
In Summary
Informed Consent
▪ Must be Obtained by the Attending Physician
▸It is outside the scope of practice for RN or LVN
▪ Physician must explain “material” risks,
complications, benefits and alternatives in the
context of the patients co-morbidities
▪ But there are Exceptions
▪ The role of the SNF and its Nurse is to verify
informed consent was obtained and make sure
evidence of it is in the Medical Record
Capacity
An Adult With Capacity to Give Informed Consent
▪ May consent to or refuse medical treatment
▪ All persons are presumed to have capacity
▪ A patient with decision making capacity has
the right to make a “bad decision” in the
opinion of others
Capacity
Determinations
▪ Capacity: ability to understand nature and
consequences of proposed health care, including
significant risks, benefits and alternatives
▪ Patient presumed to have capacity
▪ Determination made by the attending physician
▪ Attending physician must record in medical record
▪ Above applies generally to health care decision
making; law regarding conservatorship is more
detailed and specific
Capacity
A Conserved Adult
▪ Not all conservatees lack capacity to make
health care decisions
▪ Actual conservatorship papers must be
reviewed
▪ There is usually not an issue if both
conservator and conservatee agree
▪ Public Guardian may or may not be a legal
conservator; a court proceeding is required
▪ Legal counsel may be needed if there is
disagreement
Lack of Capacity
Power of Attorney for Health Care
▪ Appointment of friend or family member as
agent
▪ Chosen by the patient so most likely more
aware of values, opinions and wishes
▪ Agent required must follow patient’s wishes, if
known, otherwise best interests in
consideration of patient’s personal values
Lack of Capacity
Surrogate decision maker
▪ Appointed by patient “personally informing” the
primary physician or, if unavailable, the health
care provider
▪ Effective only for “course of treatment or
illness” or stay in facility to a maximum of 60
days
▪ Does not replace Power of Attorney for Health
Care unless revoked
Lack of Capacity
Family members
▪ “Closest available relative” doctrine
(Cobbs v. Grant)
▪ “Relative” not defined
▪ Registered domestic partner legally same as
spouse under California law
Lack of Capacity
Family Disagreements
▪ No statutory priority placing one family
member over another
▪ Maintain life/status quo and suggest to all
family members they seek conservatorship
Lack of Capacity
Resolution of Family Disagreements
▪ Education regarding contested medical issues
▪ Social services and nursing support
▪ “Bio Ethics Mediation”
▪ Physician contact with family
▪ Court as last resort
Lack of Capacity
And Lack of a Responsible Party
▪ Health & Safety Code Section 1418.8
▪ Allows for IDT to Authorize without Informed
Consent
▸ If done in accordance with acceptable
standards of practice
Informed Consent
Thank you for your time and attention!
Elizabeth Plott Tyler
TYLER & WILSON
5455 Wilshire Boulevard, Suite 1925
Los Angeles, California 90036
Phone (323) 655-7180
Fax (323) 655-7122
Note: This class is intended to provide general information only.
For specific legal advice applicable to your personal situation, please consult an attorney.
No attorney-client relationship with the firm Tyler & Wilson or any of its attorneys created by this presentation.