A Self-Assessment Guide for Health Care Organizations - IFC

Standard EPR.3 [Informed consent]
Patients’ informed consent is obtained through a process defined by the organization and is carried out by trained staff.
Intent of EPR.3
One of the main ways that patients are involved in their care decisions is by granting informed consent. To consent, a patient must be informed
of those factors related to the planned care required for an informed decision. Informed consent may be obtained at several points in the care
process, e.g. when a patient is admitted for inpatient care, and before undertaking certain procedures or treatments for which the risks may be
high. The consent process is clearly defined by the organization in policies and procedures. Relevant laws and regulations are incorporated into
the policies and procedures. Patients and families are informed as to what tests, procedures, and treatments require consent and how they can
give consent (e.g. verbally, by signing a consent form, or through some other means). Patients and families understand who may, in addition to
the patient, give consent. Designated staff members are trained in how to inform patients and in how to obtain and document their consent.
Measurable Element Look for Score Observations
What is required
1) The organization has a
clearly defined informed
consent process described
in policies and procedures.
How is this element
assessed
Policies and procedures define the
process for obtaining informed
consent.
0 5 10 Why did you give this score
........................................................
........................................................
2) Designated staff are
trained to implement the
policies and procedures.
Staff training for implementing the
informed consent policy is
documented. This may be part of
staff orientation.
........................................................
........................................................
3) Patients give informed
consent consistent with the
policies and procedures.
Patients are informed of:
a. their condition,
b. the proposed
procedure(s) and
treatment(s) and who
is authorized to
perform them,
c. potential benefits and
drawbacks to the
proposed treatment(s)
and possible problems
related to recovery,
d. possible alternatives to
the proposed
treatment(s) and
possible results of
non-treatment,
e. the likelihood of
successful treatment(s),
and
f. the identity of the
physician or other
practitioner
responsible for care.
Consent forms are completed and
located on the patient’s medical
record. Interviews with patients
indicate that they have received all
of the information required for
informed consent.
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
........................................................
IFC Self-Assessment Guide for Health Care Organizations 27