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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