Patient Consent for Blood Transfusion

Consent Consent can be defined as “…a patient’s agreement for a health professional to provide care.” The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) Asked to look at consent in 2009 Consultation exercise in 2010 Recommendations published in 2011

Who are SaBTO? Advisory Committee on the Safety of Blood, Tissues & Organs Advises UK Ministers and Health Departments on the most appropriate ways to ensure the safety of blood, cells, tissues and organs for transfusion/transplantation Publishes advice and guidance, reports and statements

Background In March 2010, SaBTO initiated a public consultation on patient consent for blood transfusion The consultation had the following key objectives: Identify the preferred option for recording consent Explore the potential operational impact of implementing a standardised form of consent for transfusion Confirm what type of information patients should receive

Key issues identified: Patients are not always given information on the risks, benefits, and alternatives to transfusion, or the right to refuse transfusion Patients are not always made aware that they have had a transfusion Patients who are unaware that they have received a transfusion may go on to donate blood when they should not There is inconsistent practice across the UK

Recommendations Clinical practice: 14 recommendations / 3 broad categories: Clinical practice: What should be done / hospital policy Recommendations 1-6 Governance: Review of clinical practice Recommendations 7 -10 Education: To help support clinical practice Recommendations 11-14

Clinical practice 1. Valid consent for blood transfusion should be obtained and documented in the patient's clinical record by the healthcare professional 2. There should be a modified form of consent for long term multi- transfused patients, details of which should be explicit in an organisation's consent policy 3. There should be a standardised information resource for clinicians indicating the key issues to be discussed by the healthcare professional when obtaining valid consent from a patient for a blood transfusion SaBTO made 14 recommendations for consent for blood component transfusion –

Clinical practice 4. The consent standard developed by Health Improvement Scotland should be adopted throughout the UK for consent for blood transfusion 5. The Care Quality Commission (CQC) and NHS Litigation Authority (NHSLA) and equivalent organisations will be made aware by SaBTO of this consent standard for blood transfusion 6. A UK comparative audit of consent for transfusion should be carried out, facilitated by the National Comparative Audit of Blood Transfusion

Governance 7. Depending on the role envisaged for Healthwatch, the potential role of patient groups in providing an active oversight should be explored 8. There should be a standardised source of information for patients who may receive a transfusion in the UK 9. Patients who have received a blood transfusion and who were not able to give valid consent prior to the transfusion should be provided with information retrospectively 10. SaBTO consent working group should produce good practice guidance to help identify the most effective way of providing information retrospectively when patients were unable to give prior consent Patient involvement should be a consistent theme e.g. HTCs and RTCs DOH 2010 Equity and Excellence: liberating the NHS The King’s Fund 2011 Making shared decision – making a reality- No decision about me, without me.

Education 11. UK blood services should have an ongoing programme for educating patients and the public about blood transfusion as part of their respective Better Blood Transfusion strategies 12. LearnBloodTransfusion e-learning should be promoted 13. The feasibility of developing a module specific to consent should be explored 14. Completion of the LearnBloodTransfusion e-learning package should be included in undergraduate curricula. The learning objectives for the principles of consent should include consent for blood transfusion

Therefore... Valid consent should be gained document in the patients notes Retrospective information Modified consent form for the long term multi-transfused

Patient information Why are blood transfusions needed? Are there any alternatives to transfusion? What can I do to reduce the need for transfusion? Is transfusion safe? How will I feel during the transfusion? Patient information leaflets are available at http://hospital.blood.co.uk/patient-services/patient-blood- management/patient-information-leaflets/

LBT - Consent module http://www.learnbloodtransfusion.org.uk/ Covers: Consent for transfusion Patient information Benefits and risks of blood transfusion Alternatives to blood transfusion The consent process http://www.learnbloodtransfusion.org.uk/

National Comparative Audit Patient Information and Consent (2014) results: 164 sites, 2784 cases audited 81% had documentation of the clinical indication 43% had documentation of patient consent which was largely verbal 80% obtained by doctors 38% received information on risks 8% received information on alternatives

Montgomery v Lanarkshire March 2015 What’s new? Montgomery v Lanarkshire March 2015

The Case Nadine Montgomery, diabetic and pregnant Vaginal delivery with shoulder dystocia occurring Baby born with serious disabilities as a result 9-10% risk of dystocia in women with diabetes Dr/Miss McLellan acknowledged she did not discuss this risk with such women as fearful they would opt for caesarean section (CS) The court held that McLellan should have informed Montgomery of the risks and discussed the option of CS

What does this mean? The Bolam test is no longer applicable The law now requires a Dr to take: “reasonable care to ensure that the patient is aware of material risks involved in any recommended treatment and of any reasonable alternative or variant treatments.”

And The assessment of whether a risk is “material” cannot be made on percentages alone The significance of a risk will vary between patients and is not purely dependent on magnitude The Dr must ensure the information provided is understandable

Is this new? Not entirely as: GMC 2008: Drs are advised that they must tell patients of potential serious adverse outcome even if the risk is very small and less serious complications if they occur frequently. GMC 2013: “Work in partnership with patients....... Respect patients’ right to reach decisions with you about their treatment......

What does this mean in practice? Does the patient know the “material” risks of the proposed treatment? What risks would a reasonable person want to know about? What other risks would this particular patient want to know about? Does the patient know about available alternatives? Have I tried to ensure the patient understands all the information? Have I documented the details of the consent process?

Being too busy is not an adequate reason!! Exceptions! The patient requests not to be informed Clinical situation means consent cannot be obtained There is a genuine and significant risk of harm associated with providing the patient the information at that time Being too busy is not an adequate reason!!

In summary “...it is not possible to consider a particular medical procedure in isolation from its alternatives.” Remember! Legally, the concern is not whether a task or activity was carried out by a doctor, nurse or midwife, it is whether the patient received care to an expected standard (Hunt and Wainwright 1994).