AHS Clinical Policy
Consent to
Treatment/Procedure
Overview
•
•
•
•
•
•
Purpose of Consent Policy
Consent to Treatment/Procedures
Forms
Resources
Case Scenarios
Questions
2
Consent Policy Suite
AHS CONSENT POLICY
(Broad Principles)
Suite of Associated Procedures
Adults with
Capacity
Adults with
Impaired / Lack of
Capacity
Mature Minors
& Minors
Mental Health
Formal Patients
& Community
Treatment
Orders
Consent Form(s)
(limited # of forms: needs-based)
Human Tissue
& Organ
Donation
Consent Form(s)
As per national
& international
requirements
RESOURCES e.g.
patient guides, clinical algorithm etc.
3
Introduction
Purpose of a new consent policy:
• Consistency of consent process within AHS
• Legislative compliance
• Informed consent
4
Legislative Compliance
• Adult Guardianship and Trustee Act
• Human Tissue and Organ Donation Act
• Mental Health Act
• Family Law Act
5
Informed Consent
• Reflects good practice
• Contributes to Patient safety
• Enhances patient experience
6
Give Consent
Voluntary
Withdraw Consent
Informed
Refuse Treatment
Specific
Shared
Decision-Making
& Accountability
Capacity
PRINCIPLES
Patients / Partners
Practitioners
Substitute
Decision-Maker
Emergency
7
Consent Process
The consent process, when clinically safe to do so,
consists of adhering to the following five steps:
1. Determine capacity: as per continuum
2. Commence dialogue: as per rights & principles
3. Verify understanding: address barriers
4. Decision-making: patient/alternate & provider
5. Document process & outcome: verbal or written as
required, or noted in health record.
8
When Consent is Required
• Before a procedure or treatment is provided there
must be express or implied consent
– Unless a valid exception applies
e.g. in an emergency
9
Most Responsible Health Practitioner
• Means the Health Practitioner who has
responsibility and accountability for the specific
Treatment/Procedure(s) provided to a Patient and
who is authorized by Alberta Health Services to
perform the duties required to fulfill the delivery of
such a Treatment/Procedure(s) within the scope of
his/her practice.
• Only the Most Responsible Health Practitioner may
now obtain informed consent from the patient
10
Informed Consent
• Duty of Most Responsible Health Practitioner to
inform the Patient:
–
–
–
–
–
Nature of Treatment/Procedure
Risks
Benefits
Alternatives
Consequences
11
Implied Consent
• Consent inferred from the Patient
– or Alternate Decision-Maker (if applicable)
• Presumed by actions and surrounding
circumstances
• Example:
– Presents voluntarily for an examination
– Minor or less invasive treatment/procedure
12
New Criteria for Consent
“The Most Responsible Health Practitioner is
responsible for ensuring that there is valid and
informed consent for any given Treatment/
Procedure(s) …… Informed Consent may be
expressed verbally or in writing, or be implied.”
13
New Criteria for Consent
“Express written consent shall be obtained for the
transfusion of blood and blood products.” (PRR-01,
Section 1.3)
14
Documenting Consent Outcomes
• The MRHP is responsible for ensuring appropriate
documentation of the consent process and
outcomes on the patient health record.
• Specifically, the following outcomes shall be
recorded:
a. Agreement to treatment/procedures
b. Refusal of treatment/procedures
c. Withdrawal of consent previously given
(PRR-01 7.1)
15
Adults with Capacity
• An Adult Patient is presumed to have
Capacity and is able to make decisions until
the contrary is determined
16
Adults with Capacity
Scenario:
The patient arrives at the office of Dr. X and needs a
bowel resection.
“I generally obtain written consent for surgical
procedures from patients in my office
– In some cases a blood transfusion is needed and
I generally discuss the possibility with the patient
– Typically in the past where I work I would witness
the patient’s signature.
– What do I do now?”
17
Obtaining the Consent Form
• Form Name:
– Consent to Specific Treatment/Procedure
– Form #09741
• Where do I get the form?
– Obtain the form the way previously obtained or
on Insite
• Access on Insite:
http://insite.albertahealthservices.ca/frm-09741.pdf
18
19
Consent Policy: Blood
• The MRHP is responsible for obtaining the consent
for blood and blood products.
• Per Consent Policy:
“Express written consent shall be obtained for the
transfusion of blood and blood products.”
20
Patient
Witness
MRHP
21
Witnessing a Consent
• Written Consent should be witnessed:
• a) Any person, other than a relative of the Patient,
the Most Responsible Health Practitioner or the
interpreter for the Patient, may witness the signing
of a Consent Form.
22
Witnessing a Consent
• Written Consent should be witnessed:
• c) In the event that the Patient expresses doubt
about the Consent Process and requests further
explanation, the witness shall not sign the Consent
Form and the Most Responsible Health Practitioner
shall be notified.
• PRR-01-01 Section 5.6
23
Procedure: Adults with Capacity
• Scenario:
• Dr. X is now proceeding with surgery on a patient
and consent was obtained over a year ago on the
old consent form.
– Do I need to do the consent process again?
24
Duration of Consent
• New consent is needed if:
• a) The Patient’s condition has materially changed;
• b) The medical knowledge about the Patient’s
condition or the Treatment available has materially
changed; or
• c) There has been a refusal to a portion of the
Treatment/Procedure(s) originally planned or a
refusal regarding the involvement of particular
individuals in the Treatment/Procedure(s) (e.g.
medical trainees).
25
Duration of Consent
• Dr. X determines that he does not need to obtain a
new consent.
• Does Dr. X need to complete the new form?
No, the old form should be honoured.
26
Consent Policy
• Dr. X requests clarification:
“In my facility written consent is required for some
procedures yet in other facilities my colleagues tell
me that verbal consent is obtained.
Does AHS have a list of procedures that require
written consent?”
27
Procedure: Adults with Capacity
• Scenario:
• The patient was admitted to hospital for treatment
of a medical condition but now requires surgery.
The resident from the service usually completes the
consent form with the patient.
• Is this permitted now?
28
Adults with Capacity
• Dr X sees 2 people are waiting for him in his office.
He is surprised when the person accompanying the
patient requests to see the lab work.
– Does this person have the right to see the health
record?
• The patient identifies this person as a supportive
decision maker.
– How do I know that this person is the supportive
decision maker?
– Can he/she sign the consent form?
29
Supported Decision Maker
• Means a trusted person that the capable adult
appoints pursuant to the Adult Guardianship and
Trusteeship Act to:
•
Assist him/her with accessing, collecting or
obtaining information, making decision(s) and
communicating his/her decision(s).
• Form obtained from the Office of the Public
Guardian website
30
31
Adults with Impaired Capacity
• Scenario: Dr. X walks into his office and sees 2
people sitting there. The person with the patient
says he is the co-decision maker.
• Dr X asks: What do I do?
32
Co-Decision-Maker
A Patient who is assessed as having significant
capacity impairment, but who is able to make
decisions with appropriate guidance, or an
interested party, may apply to the court for an order
appointing a Co-Decision-Maker to be a partner with
the Patient in decision-making for personal matters,
including health care.
33
Co-decision Maker
• Decisions are made jointly by the patient and the
Co-decision Maker, and both individuals sign the
consent form.
• What do I do if they disagree on whether to go
ahead with the proposed procedure?
• The adult patient’s decision takes precedence and
he/she can sign without the co-decision maker.
34
Print names of both
Patient and Co-decision
Maker
Check Co-decision
Maker
Patient
Co-decision Maker
Patient
and Codecision
Maker
both sign
35
Adults who Lack Capacity
• Who may give consent for an adult patient who
lacks capacity?
– An Agent named in a Personal Directive
– A Guardian appointed by the Court
– A Specific Decision-Maker under the Adult
Guardianship and Trusteeship Act
36
Adults who Lack Capacity
• Scenario:
• Mrs. B., a 60 year old woman presents to the
Emergency department with acute stroke and has
had a bleed requiring emergency surgery.
• How do we obtain consent for surgery?
37
38
Adults who Lack Capacity
• Scenario:
• Mrs. B goes to ICU post surgery and over the next
few days will require a variety of invasive
procedures that are typical in the ICU setting
• How do we obtain consent now?
39
Specific Decision Maker
• Mrs B has no designated agent or guardian
• Dr X knows that
– A physician, nurse practitioner, or dentist (for
dental care only) may choose the nearest
relative* to act as a specific decision maker for a
time sensitive health care decision or temporary
admission/discharge for a residential facility
• Dr X meets Mrs. B’s eldest daughter
40
Specific Decision Maker List
Ranked order:
• spouse or adult interdependent partner
• adult son or daughter
• father or mother
• adult brother or sister
• Grandfather or grandmother
• adult grandson or granddaughter
• adult uncle or aunt; or adult nephew or niece
• Office of the Public Guardian
Contact the Office of the Public Guardian if there is a dispute
as to who should be selected or when no person meets the
criteria.
41
Specific
Decision
Maker is
chosen in
the ranked
order
42
42
Specific Decision Maker
• May not:
– Make health care decisions where a decision
respecting the provision of, withdrawal of or
withholding of health care would be likely to
result in the imminent death of the Adult
(PRR-01, Section 8.2)
43
Adults who Lack Capacity
• Scenario:
• Mrs. B. recuperates from the surgery and goes to
rehab. Despite her physical progression she
appears to lack capacity. A formal capacity
assessment is planned.
• Who can do a formal capacity assessment?
• In addition, Mrs. B needs to go to a long term care
facility. What happens now?
44
45
Minors / Mature Minors
• Who may give consent
• Who may not give consent
• Mature minor assessment
• Emergency health care
46
47
Mature Minor Patient
Scenario:
• A 13 year old teen comes to an STD clinic
requesting care. How do we confirm this 13 year
old is a mature minor?
48
Minor Patient
Scenario:
A 6-year old girl needs surgery but neither of her
parents is in town but the mother is available by
telephone. How should I complete the consent
form?
49
50
Forms Questions
• Our previous form included consent for admission
and assessment. Should we still use it?
• When do we need to replace our old forms?
• What do we do with the old forms?
51
Patient OR
alternate
decision
maker as
described in
PRR 01-01
1.2,1.3
Witness is
over 18,
and not a
relative,
interpreter
or MRHP
The MRHP explains the
benefits, risks,
consequences and
alternatives to the patient
before signing the consent
Patient
Witness
MRHP
MRHP
should be
capable of
performing
procedure
and sign
prior to the
patient
52
Specific
decision
makers are
chosen in
the ranked
order
Double Dr
consent
now only
permitted if
Alternate
Decision
Maker not
available
AND
situation is
an
emergency
procedure
as
described
53
53
Consent Policy Resources
• Resources on Insite:
–
–
–
–
–
Summary Sheets
Algorithms
FAQs
Forms
Scenarios
54
Add webpage link
55
55
56
56
56
57
58
59
59
59
60
60
Contact Us
• Further Questions:
consent.policy@albertahealthservices.ca
• Suggest revisions:
clinicalpolicy@albertahealthservices.ca
• Professional Practice Consultation Service:
practice.consultation@albertahealthservices.ca
61