PHILIPPINE HEART CENTER

3RD VIRTUAL GOVERNANCE IN HEALTHCARE SUMMIT

IMPLEMENTING A SAFE HOSPITAL CULTURE IN THE NEW

NORMAL September 14-17, 2021

September 16, 2021

ROBIN AUGUSTINE Q. FLORES, MD, FPATACSI, FPCC, MSc
Day 3 : Important Patient Safety Documentation Forms
 DISCLOSURE
• Adapted from Canadian Medical PA
 Informed Consent

Learning Objectives

1. Describe the 3 key elements of a

valid informed consent
2. Recognize your legal obligation to
communicate relevant information
to patients
3. Explain the importance of
discussing and documenting risks
related to procedures & treatment
 Informed Consent

Introduction

Why do we need consent?

• Patient autonomy
• The right to make one’s own health decisions
• Treatment is more than surgery; may also be medical
or investigative
• The doctor’s role is to give advice — it is the patient’s
RIGHT to accept or reject that advice.
Informed Consent

Case Study
Informed Consent

Case Study

Meet Jenna
Jenna presents to an emergency
room with a 2-day history of an
extremely pruritic rash that is
spreading all over the body.
Informed Consent

Case Study

Dr. Jones
Dr. Jones is the emergency room
physician working that evening.

She performs a thorough history

and physical exam, and diagnoses
a severe reaction to poison ivy.
Informed Consent

Case Study

Management/Discharge Plan
Dr. Jones Prescribes a 7-day course
of prednisone 40 mg PO daily,
tapering over a month.

She tells Janna the medication may

increase her appetite and cause
trouble sleeping, but does not
elaborate further (see note ↗️ ).
Informed Consent

Case Study

8 months later…
Jenna ‘s rash resolves but she
subsequently develops persistent
pain in her left hip and groin area.

She is diagnosed with avascular

necrosis (AVN) of her left femoral
head and ultimately requires a
total hip replacement.
 Informed Consent

Case Study

What happens next…

A legal action is initiated by Jenna, alleging that Dr. Jones
failed to disclose the risk of avascular necrosis from steroid
use and ill-advised her regarding the use of prednisone.
 Informed Consent

Case Study

The experts’ opinion

The medical experts review Dr. Jones’ chart. They express
concern over the lack of documentation about any
discussion with Jenna pertaining to informed consent for
the steroids prescribed, specifically with respect to the
potential for AVN.
 Informed Consent

Case Study

The experts’ opinion

In their opinion, Dr. Jones did not inform Jenna of the
potential side effects of steroid use, nor did she have a
discussion to obtain Jenna’s consent for using steroids.

In addition, they feel tat the failure to provide this

information represents care that was below the
standard of care.
 Informed Consent

Case Study

Legal outcome
On behalf of Dr. Jones, a settlement is paid to Jenna
Informed Consent

Elements of a Valid Informed Consent

Three Key Elements

 Informed Consent

Key Element - Voluntariness

Voluntariness
Patients must be free to consent to
or refuse treatment.
• Consent should be obtained
without duress or coercion.
• Be aware of situations with
potential for coercion, which
may influence a patient’s
choice.
 Informed Consent

Key Element - Information

It is important to
• Inform patients of the diagnosis.
If some uncertainty exists about
the diagnosis, mention the
uncertainty, the reason for it, and
what other possibilities are being
considered.
 Informed Consent

Key Element - Information

It is important to
• Explain the proposed investigation(s)
or treatment(s).
• Detail the chances of success.
• Discuss available alternative
treatments and their risks, including
not doing anything, which is always an
option, e.g. choosing a less invasive
option
• Explain the consequences of leaving
the medical condition untreated.
 Informed Consent

Key Element - Capacity

Capacity
Patients are considered to have the
capacity to consent if they understand
the:
• Nature of the proposed investigation
or treatment.
• Anticipated effect of the proposed
treatment and alternatives.
• Consequences of refusing
treatment.
 Informed Consent

Key Element - Capacity

Read back: it is important to verify patients’

understanding. Take reasonable steps to
ensure that patients comprehend the
information being given, particularly if there
are language difficulties, emotional issues or
concerns regarding mental function. Asking
patients to repeat the salient elements in
their own words can serve this purpose.

When appropriate, you may wish to

encourage patients to invite a family member
or friend to attend the discussion.
 Informed Consent
Key Element - Capacity to Consent,
Minors

Minors: In most centers, the consent for

minors rest with the parents.
Young people are considered capable of
consenting or refusing treatment (ex.
mature minor) if their physical, mental an
emotional development allows for a full
appreciation of the nature and
consequences of their decision, specific
to the suggested investigation or
treatment. It is up to you to decide if the
patient is mature enough to give consent.
 Informed Consent
Key Element - Capacity to Consent,
Minors

Minors: Depending on the nature of the

medical condition and the complexity of
a proposed treatment, it is often
prudent to discuss the importance of
involving the parents, and to obtain
permission to do so from the minor.

Capacity is situation-dependent, ex. A

12-year-old may be capable of
consenting to a vaccine, but not
necessarily to receiving chemotherapy.
 Informed Consent

Key Element - Capacity to Consent, Age of Consent

Age of consent: Age of majority is a legal

term reflecting the age at which
individuals can manage their own
affairs. The age of majority is
determined by provincial or territorial
statutes and is not pertinent to consent
for healthcare. It has been largely
replaced by the concept of mature
minor.
Documentation Tip:
It is not enough to decide that a minor is mature enough. Document your decision-making
process regarding the minor’s capacity to understand the proposed treatment plan, as
well as risks and benefits.
 Informed Consent
Key Element - Capacity to Consent,
Life-threatening Presentations

Age of consent
If life or limb are in danger, and the patient
is unable to consent (and the substitute
decision-maker is not immediately
available), a doctor may proceed to do
what is immediately necessary to save life
or limb, however
• Respect any known previous wishes of
the patient
• Obtain consent as soon as reasonably
possible
 Informed Consent

Talking to Your Patient About Risk

Material Risks
Material risks include risks that occur frequently as well as
those that are very serious, such as death or permanent
disability.
Communication Tip:
Ask the patient: “What is important to you?”
This helps you explore unmet patient expectations and discuss any of the patient’s fears or
concerns.
 Informed Consent

Talking to Your Patient About Risk

Special Risks
A patient’s special circumstances might require
discussion of potential, but normally uncommon risks of
the investigation or treatment, when typically these
might not be seen as material.
 Informed Consent

Talking to Your Patient About Risk

Special Risks
The courts have been clear that the consent discussions
extends to what the physician knows or should know a
particular patient would deem relevant to making a
decision about whether or not to undergo treatment,
️ E.g. The impact of a rare ulnar nerve injury during
carpal tunnel release would likely be greater on a
concert pianist versus a jackhammer operator.
 Informed Consent

Delegation of Consent

The trainee or medical student can have a consent

discussion with a patient instead of the attending
physician. However, the physician performing the
treatment or investigation remains ultimately
responsible for the quality of the discussion in obtaining
consent.
 Informed Consent

Delegation of Consent

The attending physician may delegate the duty, but

should be confident the delegate has the knowledge
and experience to provide adequate explanations to the
patient and to answer the patient’s questions, including
special risks for the specific patient based on their
circumstances.
 Informed Consent

Documenting Consent

Informed consent is a process. A signed consent form is

generally required by hospital policy, but is not
adequate evidence of the consent discussion.
To that effect, it is important to document the consent
discussion contemporaneously in the patient’s medical
record.
 Informed Consent

Documenting Consent

The documentation should include:

• A general statement regarding the risks, benefits,
indications, and alternatives discussed
• A statement about the patient’s apparent
understanding (especially if they are a minor or where
there are concerns regarding capacity to consent)
• Special risks discussed
 Informed Consent

Documenting Consent

The documentation should include:

• Questions or concerns addressed with the patient;
this helps personalize the documentation
• Documentation of handout materials provided to the
patient to support the consent discussion
 Informed Consent
Speaking of Consent…
When documenting your
consent, consider the
acronym P-A-R-Q:
P - Procedure
A - Alternatives
R - Risks; material & special
Q- Questions asked by the
patient
Documentation Tip:
Note the particular questions asked by the
patient, as it personalizes the consent discussion
and demonstrates that a fulsome informed
consent discussion occurred.
As well, keep copies of any patient handouts or
drawings, or additional information that are
shared with the patient as part of the medical
record.
 Informed Consent

Speaking of Consent…

A 17 y/o male, varsity football player with exertion all

dyspnea diagnosed with Atrial Septal Defect, secundum
type with septations.

P - Procedure
Interventional closure VS. Surgical
Pros and cons of each approach
Possible complications and success rate of each
 Informed Consent

Speaking of Consent…

A 17 y/o male, varsity football player with exertion all

dyspnea diagnosed with Atrial Septal Defect, secundum
type with septations.

A - Alternatives
Minimally invasive atrial septal defect closure
Comparison of conventional VS minimal access
Suitability of procedure to patient’s characteristics
 Informed Consent

Speaking of Consent…

A 17 y/o male, varsity football player with exertion all

dyspnea diagnosed with Atrial Septal Defect, secundum
type with septations.

R - Risks; material & special

Overall risk stratification (EUROScore II/STS)
Institution’s capability for such procedure/s
Availability of specialists and/or devices
 Informed Consent

Speaking of Consent…

A 17 y/o male, varsity football player with exertion all

dyspnea diagnosed with Atrial Septal Defect, secundum
type with septations.

Q- Questions asked by the patient

Factor in cost and length of hospitalization
Recovery time and return to activities of daily living (ADLs)
Psychological impact of intervention to the patient
 Informed Consent

Speaking of Consent…

The patient underwent minimally invasive atrial septal

defect closure, totally endoscopic, non rib-spreading
with a total hospital stay of 5 days.
He was able to join practice for his team 2 weeks after
discharge and had no limitation of activity whatsoever.
 Informed Consent

Summary

The three KEY ELEMENTS include:

• Voluntariness

• Capacity

• Information
 Informed Consent

Summary

Physicians have an obligation to communicate relevant

information to patients, with the goal of providing what
information a reasonable person would like to know.
This includes discussion of material and special risks
related to a proposed procedure or treatment, as well
as alternatives to treatment or no treatment.
 Informed Consent

Summary

Informed consent is a process that provides an

opportunity for patients to make their own healthcare
decisions, based on discussions with their physician
regarding the proposed procedure or treatment,
whether medical, surgical or investigative.
 Informed Consent

Summary

Although it is a legal requirement in many healthcare

institutions to have a signed consent form before any
procedure, the form itself only serves as documentary
evidence that the patient accepted the treatment and
does not replace documentation of the consent
discussion with the patient.
Informed Consent

THANK YOU!