BLEED Audit Initiative: improving parental assent for

transfusion of blood components in neonates.

S Armitage, V Venkatesh, J Howes, S Sinha, D Dave &

V Kairamkonda.

BLEED Audit Initiative

Background • Ethical & medico-legal imperative that consent

obtained for medical treatment.

• Specific recommendation from DoH (SaBTO), BCSH & RCN that consent obtained for transfusion of blood components.

• Assent (agreement) of parents obtained as a proxy for consent.

• Busy tertiary neonatal unit.

BLEED Audit Initiative

Baseline audit In line with local & national guidelines:

1. To ensure parental assent (agreement) for

transfusion of blood components is obtained.

2. To ensure parents are given written information regarding blood component transfusion.

3. To ensure parents are informed of benefits & risks

of blood component transfusion & discussion documented in notes.

BLEED Audit Initiative

Baseline audit: Standards Audit criteria Target Exceptions Source of

evidence

Documentation of parental assent to transfuse.

100% Use of emergency O negative blood.

SaBTO ‘Patient consent for blood transfusion’ (2010) & UHL Blood Transfusion Policy (2011)

Documentation that information leaflet given to parents.

100% Emergency O negative blood.

UHL Blood Transfusion Policy (2011) & BCSH Guideline (2009)

Documentation of discussion of risks & benefits of transfusion.

100% Emergency O negative blood.

UHL Blood Transfusion Policy (2011) & BCSH Guideline (2009)

BLEED Audit Initiative

Baseline audit: Methodology

• Sample: • All babies on NNU in receipt of blood components.

• Data collected from: • Blood Transfusion Integrated Care Pathway (ICP). • Patient notes & Badger database. • From 29/10/2012 – 23/11/2012.

• Data collected using proforma & entered into Excel.

BLEED Audit Initiative

Baseline audit: Results

• N=22 • Gestation at birth: 23+2 - 37+6

• 1st transfusion: • <7/7 82% • 8-14/7 9% • >14/7 ventilated 0 • > 14/7 not ventilated 9%

– 95% (21/22) Blood, 5% (1/22) Platelet tx. – 64% (14/22) out-of-hours. – 9% (2/22) emergency (O Neg) Tx (therefore not

included in further analysis).

BLEED Audit Initiative

Baseline audit: Results

Standard 1: Parental assent recorded appropriately: 55% (11/20)

Standard 2: Provision of information leaflet recorded appropriately:

40% (8/20)

Standard 3: Documentation of discussion of risks and benefits, using both appropriate sticker & form: 40% (8/20).

All 3 standards met: 20% (4/20).

BLEED Audit Initiative

Plan: Quality Improvement Initiative • Process-mapping to identify potential barriers to

compliance. – Process in need of simplification. – Lack of necessary forms / leaflets / stickers. – SaBTO/BCSH/UHL policy vs BAPM Good practice

framework (2004). – Lack of awareness: MDT education programme.

• Neonatal nurses • ANNPs • Medical Staff

– MDT discussions regarding appropriate timing of parental discussion & information provision.

BLEED Audit Initiative

BLEED Audit Initiative

Do: Quality Improvement Initiative

• BLEED Audit Initiative (01/02/2013 - present): • Memorable acronym to give simple structure to process. • Posters throughout clinical areas. • Emails with FAQ leaflet (medical & nursing staff). • Brief opportunistic powerpoint presentations (medical &

nursing staff). • Regular email & bulletin reminders (medical & nursing staff). • Induction information (medical staff). • Ensure ready availability of paperwork (Ward Clerks).

BLEED Audit Initiative

Check: Re-audit

• Prospective re-audit of compliance in obtaining valid parental assent for transfusion of blood components in NNU.

• Evaluate impact of education programme. • Identify further barriers to compliance. • Identify areas for further improvement.

• Standards & Methodology: – Identical to baseline audit. – 01/03/2013 – 31/05/2013

BLEED Audit Initiative

Check: Results

• N=22 • Gestation at birth: 23+4 - 40+5

• 1st transfusion: • <7/7 68 % • 8-14/7 23 % • >14/7 ventilated 4.5 % • > 14/7 not ventilated 4.5 %

– 68% Blood, 14% FFP, 9% Plt, 4.5% HAS, 4.5% Cryo – 68% (15/22) out-of-hours. – 1 emergency O Neg Tx (therefore excluded from

further analysis).

BLEED Audit Initiative

Check: Results

2012 2013

Standard 1: Parental assent recorded appropriately

55% (11/20)

71% (15/21)

Standard 2: Provision of information leaflet recorded appropriately

40% (8/20)

33% (7/21)

Standard 3: Discussion of risks and benefits documented.

40% (8/20)

71% (15/21)

All 3 standards met 20% (4/20)

29% (6/21)

BLEED Audit Initiative

Root cause analysis

BLEED Audit Initiative

Qu 1. Is compliance better in the daytime (n=7) than out-of-hours (n=14)

Daytime OOH

Standard 1: Parental assent recorded appropriately

86% 64%

Standard 2: Provision of information leaflet recorded appropriately

58% 20%

Standard 3: Discussion of risks and benefits documented.

86% 60%

BLEED Audit Initiative

Qu 2: How do you define ‘emergency treatment’?

• Additional circumstances where ‘best interests’ overrides need for prior assent.

• Retrospective collection of data from BadgerNet & iLab: clinical

circumstances surrounding transfusion. • Exclude babies in need of ‘urgent’ transfusion:

– Active bleeding with drop in Hb / abnormal clotting. – Hb <12 with evidence of systemic compromise. – Abnormal clotting with high risk of bleed.

• ‘Non-urgent transfusion’: 2012 n=16 2013 n=11

BLEED Audit Initiative

‘Non-urgent’ transfusion results

2012 2013

Standard 1: Parental assent recorded appropriately

56% (9/16)

91% (10/11)

Standard 2: Provision of information leaflet recorded appropriately

44% (7/16)

64% (7/11)

Standard 3: Discussion of risks and benefits documented.

38% (6/16)

91% (10/11)

All 3 standards met 19% (3/16)

55% (6/11)

BLEED Audit Initiative

Check: Conclusions

• Following Quality Improvement Initiative: – Overall improvement in compliance. – Provision of parent information leaflet still poor throughout. – ‘In-hours transfusion’ compliance improved. – ‘Non-urgent transfusion’ compliance much improved.

• As before, majority of transfusions:

– occur out-of-hours. – are non-urgent.

• Limitation: – Documentation audit: actual practice may differ but still

non-compliant unless written down.

BLEED Audit Initiative

Act: Ongoing plan

• Continue BLEED education programme: • Poster / Emails / JDF / NNU Newsletter / FAQ leaflet / staff induction / opportunistic

teaching. • Include best practice following emergency transfusion.

• Include ‘Obtaining & documenting parental assent’ in NNU ‘Transfusion of red cells in neonates’ guideline.

• Put information into NNU Parents Information Leaflet (given to all on admission).

• Aim to reduce out-of-hours ‘non-urgent’ transfusions.

• Re-audit with revised exclusion criteria.

BLEED Audit Initiative

References • Advisory Committee on Safety in Blood, Tissues & Organs. Patient consent for

blood transfusion – a SaBTO Consultation. 2010. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_130715.pdf

• British Committee for Standards in Haematology. Guideline on the administration of blood components. 2009. http://www.bcshguidelines.com/documents/Admin_blood_components_bcsh_05012010.pdf

• Royal College of Nursing: Right blood, right patient, right time. 2005. http://www.rcn.org.uk/__data/assets/pdf_file/0009/78615/002306.pdf

• University Hospitals of Leicester NHS Trust. Blood Transfusion. Policy for the prescribing, collection, storage & administration of blood & blood components. http://moss.xuhl-tr.nhs.uk/together/Documents/Corporate%20and%20Clinical%20Policies/Blood%20Transfusion%20-%20Policy%20%20for%20Prescribing%

• British Association of Perinatal Medicine. Consent for common neonatal interventions, investigations & treatments. 2004. http://www.bapm.org/publications/documents/guidelines/procedures.pdf

BLEED Audit Initiative