ATMC SLOGAN

Do nothing out of selfish ambition or vain conceit.

 Rather, in humility value others

above yourselves, not looking to your own interests but each of you to the interests of

the others.

MAYA 5YRS 1ST DECEMBER

CONSENT AND PATIENT’S RIGHTS

ATMC10 – KUWAIT; 29TH NOV. -1ST DEC.

WHICH COMES FIRST!Before considering the issue of consent in clinical transfusion practice, it is necessary to highlight the basic foundations of patients’ rights as part of the overarching broad principles of Universal Human Rights.

This presentation will consist of 3 main sections:

Universal Human Rights, Patients’ Rights and

empowering of the community Good medical practice and duty of care Consent in transfusion practice

PATIENT’S RIGHTS

THE UNIVERSAL DECLARATION OF HUMAN RIGHTS -1948

THE UNIVERSAL DECLARATION OF HUMAN RIGHTS -1948

It recognized:

“the inherent dignity” of the person

“the equal and undeniable rights of all members of the human family”.

It provided the basis of patient rights

What is owed to the patient as a human being, by physicians and by the state, took shape in large part thanks to this understanding of the basic rights of the person.

THE UNIVERSAL DECLARATION OF HUMAN RIGHTS -1948

It has been instrumental in:

Enshrining the notion of human dignity in international law,

Providing legal and moral grounding for improved standards of care for the “human family”

Giving important guidance on critical social, legal and ethical issues.

MODELS OF PATIENTS’ RIGHTS

Patients' rights vary in different countries, often depending upon prevailing cultural and social norms.

Resulting in different models that reflect in general the “Patient-Physician” relationship.

These models usually mirror the “Citizen-State” relationship and the spectrum of rights to which patients are entitled.

PATIENT/PHYSICIAN RELATIONSHIPS

There are at least four models which reflect this relationship:

The paternalistic model

The informative model

The interpretive model (Patient’s advocate)

The deliberative model (Consensus in decision making)

Each of these suggests different professional obligations of the physician toward the patient

PATIENTS’ RIGHTS - MODELS

In the paternalistic model, the best interests of the patient are valued above the decision-making power of the patient.

The informative model sees the patient as the best judge of his or her own interest

“There is growing international consensus that all patients have a fundamental right to consent to or to refuse treatment, and to be informed about relevant risk to them of medical procedures”.

EMPOWERING PATIENTS & COMMUNITY

The relationship between human rights and right to health, including patient rights poses challenges

More than just educating policy makers and health providers

Make citizens aware of what they should expect from their governments and their health care providers and about the kind of treatment and respect they are owed

DOES THIS APPLY TO TRANSFUSION PRACTICE ?

Our countries need to acknowledge and recognize that there is basic societal ground work that needs to be done to raise the awareness of the community

Citizens, then, can have an important part to play in elevating the standards of care when their own expectations of that care are raised.

Many countries have already recognized this, and have advanced the knowledge of the role and challenges of Blood transfusion in the public, academic and scientific spheres.

DUTY OF CARE

&ETHICS

GMP & GCTPIt is all about:

DUTY OF CARE,

GMP (Good Medical Practice),

GCTP (Good Clinical Transfusion Practice),

Now a requirement in many countries

AUTONOMY ( Right of individuals for self-determination}

Whether patient asks or not.

Patients have the right to self-determination.

This should be respected

CONSENT & GOOD MEDICAL PRACTICE

General Medical Council, UK

You must be satisfied that you have consent or other valid authority before you undertake any examination, investigation or provide treatment …..

Usually this will involve providing information to patients in a way they can understand, before asking for their consent.

You must follow the guidance in seeking patients’ consent,

And the ethical considerations, which includes advice on children and patients who are not able to give consent

PATIENTS AND DOCTORS MAKING DECISIONS TOGETHERGeneral Medical Council, UK

You must work in partnership with your patients.

You should discuss with them their condition and treatment options in a way they can understand,

You should respect their right to make decisions about their care.

You should see getting their consent as an important part of the process of discussion and decision-making, rather than as something that happens in isolation.

PATIENTS & DOCTORS MAKING DECISIONS TOGETHER

IS CONSENT FOR BLOOD

TRANSFUSION REQUIRED?

THE NEED FOR PATIENT’S CONSENT

How did the need for patient’s consent for transfusion develop?

Originally implied consent in emergency.

Incidence of reactions and serious infections.

The onset of the AIDS epidemic.

Auto transfusion

Alternatives

THE NEED FOR PATIENT’S CONSENT

Why the fuss?

Are we ready in our countries?

Is it compatible with our health delivery systems?

Is it implementable with our current blood services?

Is it needed to reduce infection?

Is it needed to promote the use of alternatives?

What are the organizational and operational challenges?

CONSENT

Should it be written?

Would verbal consent do?

Implied consent, is it valid?

Consent depends on:

The nature of the health delivery system

The nature and quality of blood transfusion services

The Patient/Physician relationship

WHAT INFORMATION ?

Degree of necessity of transfusion

Range of hazards

Extent of possible risk

Available alternatives

Misinformation and false reassurance

Avoid misleading information

COMMUNICATING INFORMATION ?

The information should be in proportion to the nature of their condition,

The information adequate in order maximise patients’ opportunities to make decisions for themselves

Respect patients’ decisions”.

“Effective relationship should be a based on partnership, openness, trust and good communication”.

COMMUNICATING INFORMATION ?

Explain the options to the patient, in a balanced way.

Recommend a particular option believed to be best for the patient, without pressure to accept the advice.

Ensure that patients have understood the information.

Answer patients' questions honestly and fully.

It helps to have written material to facilitate communication

WHO GIVES THE INFORMATION?

The attending doctor is responsible to assist the patient make an informed decision and obtain the consent. If this is not practical because of pressures on time or limited available resources, this can be delegated to someone else, who:

is suitably trained and qualified

has sufficient knowledge of the risks involved

understands, and agrees to act in accordance with, the established standard procedure.

This could be the anesthetist, a trained nurse or any member of the preoperative assessment team

OPERATIONAL CHALLENGES

Consent for blood transfusion disregarded, ignored & not considered as part of the therapeutic intervention

Validity of consent depends on the knowledge and comprehension of the patient.

Lack of resources and inadequate consultation time

Patient not given time to weigh the information given.

Patients must, at all time, be given the opportunity to ask questions

Consent would lack strength if it is rushed, may constitute coercion.

PRACTICAL UK EXAMPLE- MARCH 2010

Advisory Committee on the Safety of Blood, Tissue and Organs (SABTO)

A practical example to review and improve practice

Audit identified wide variations in practice for obtaining patient consent for blood transfusion.

Followed by public consultation to identify the operational challenges if undertaking consent for blood transfusion is mandated.

PRACTICAL UK EXAMPLE- MARCH 2010

Key objectives:

Identify the preferred option for recording consent

Explore the potential operational impact

Confirm what type of information patients should receive.

PRACTICAL RECOMMENDATIONS

1. Valid consent for blood transfusion should be obtained and documented.

2. There should be a modified form of consent for long term multi-transfused patients.

3. There should be a standardised information resource for clinicians.

4. There should be a standardized source of information for patients.

PRACTICAL RECOMMENDATIONS

4.Good practice guidance to help identify the most effective way of providing information when patients were unable to give prior consent.

5. UK Blood Services should have an ongoing program for educating patients and the public.

6. Establish an action plan to support the realisation of these recommendations

ROLE OF TRANSFUSION SERVICES

Helping to make available an ongoing educational program for patients and the public

Supporting healthcare professionals to improve their knowledge about consent.

Helping establish a standardised approach to obtain consent from patients.

Providing good practice guidance for providing information retrospectively to patients who were not able to give valid consent.

Patient information leaflet

TAKE HOME MESSAGES

IN SUMMARY

1. CONSENT

Why needed?

How to do it?

Who implements it?

National policy

Education plan for health care teams

Information for community and patients

Procedure and SOP

Patient information sheet

Consent form, leaflet and reading material

Audit implementation

2. VALIDITY OF CONSENT

Identify and establish responsibility

Adequate information

Clearly presented

Not ignored and properly understood

Given time to be weighed

No coercion (Near Theatre)

Level of understanding and competence

Consideration of knowledge imbalance

3. WHEN TO BE GIVEN ?

At consultation

At admission clinic

At pre-operative assessment

Before going to theatre

After surgery

4. CONSENT AND PATIENTS’ RIGHTS

Universal Human Rights

Ethical reasons; Patient respect and right of self- determination (Autonomy)

GMP (Good Medical Practice), and in case of transfusion:

GCTP (Good Clinical Transfusion Practice)

SIGNING INFORMED CONSENT

COMMUNITY EMPOWERING & TRANSFUSION PRACTICE

This knowledge and active engagement empowers lay individuals.

The creation of effective patient protection laws relies on public knowledge of transfusion medicine.

Providing information and raising awareness among the general public highlights the role of blood transfusion in improving health

ROLE OF PROFESSIONAL GROUPS

CONSENT AND PATIENTS’ RIGHTS

Why the fuss?

Is it necessary to consider these issues?

What comes first patient rights or consent?