Based on the information provided: - There is no information about whether the hospital offers pre-surgery full blood count testing to optimise patient blood levels before surgery, in line with patient blood management guidelines. - The transfusion was documented in the patient record, meeting criterion 2. - An adverse event of transfusion associated circulatory overload occurred, meeting criterion 3 for reporting incidents. - However, there is no information provided about whether the patient received information about alternatives to transfusion or risks/benefits, in line with criterion 4 on communicating with patients. The patient's complaint suggests this information and discussion of options may not have occurred. - Informed consent for the transfusion is also not mentioned,

1. Standard 7 –
Blood and Blood products
Philippa Kirkpatrick, Jo Cameron
Accrediting Agencies Surveyor Workshop
11 July 2012

2. www.nba.gov.au
Why we need a standard on blood
• There are inherent risks associated with transfusion
practice
• Transfusion is ingrained in the culture of medical practice
• Often products are used unnecessarily
• There is significant room for improvement in practice to
improve quality and safety

3. www.nba.gov.au
Risks
•Incorrect unit transfused – may lead to ABO incompatibility
•Incorrect type of blood component transfused eg plasma instead of platelets
•Allergic or anaphylactoid reaction
•Haemolytic transfusion reaction
•Transfusion-associated circulatory overload (TACO)
•Transfusion transmitted infection
•Transfusion related acute lung injury (TRALI)
•Febrile reaction
*Source: Haemovigilance Report 2010

4. www.nba.gov.au
Three main areas of error
•Accurate patient identification and proper labelling of pre-
transfusion specimens
•Appropriate decision-making regarding the clinical use of
blood components
•Accurate bedside verification that the correct blood is to be
given to the intended recipient
*Source: Haemovigilance Report 2010

5. www.nba.gov.au
Other risks
•Near misses - wrong blood in tube
•Association with increased morbidity and mortality
•Significant financial burden on health care system
>$1b on product cost alone
•Wastage of a scarce resource

6. www.nba.gov.au
Objectives of Standard 7
•Managers implement systems to ensure the safe,
appropriate, efficient and effective use of blood and blood
products
•Clinical workforce use blood and blood product safety
systems

7. Scope – all blood products
Fresh blood products
– Red blood cells
– Platelets
– Clinical fresh frozen plasma
– Cryoprecipitate
– Cryodepleted plasma
Plasma and recombinant products
– Albumin
– Immunoglobulins, including immunoglobulin
replacement therapy and hyperimmune globulins
– Clotting factors
www.transfusion.com.au

8. www.nba.gov.au
Criteria
1. Governance and systems for blood and blood product
prescribing and clinical use
2. Documenting patient information
3. Managing blood and blood products safety
4. Communicating with patients and carers

9. The Six Essential Elements
Blood and blood products are used and managed in accordance
with national evidence based guidelines
A program is in place to reduce the risks associated with blood
and blood products and to improve safety and quality
Adverse events, incidents and near misses relating to transfusion
practice are reported and feed into risk management processes
Transfusion details are documented in the patient clinical record
Blood and blood products are managed appropriately
Informed consent is documented for transfusions

10. www.nba.gov.au
Criterion One
Governance and systems for blood and blood product
prescribing and use
•Governance systems – policies, procedures and protocols
(7.1)
•Incident reporting and haemovigilance (7.2, 7.3)
•Quality improvement (7.4)
Quality improvement activities are undertaken to reduce the
risks of patient harm from transfusion practices and the clinical
use of blood and blood products

11. www.nba.gov.au
Transfusion quality improvement program
7.4.1
Improve
documentation
of consent
(7.11.1)
Reduce
systems risks
(7.2.2)
Improve
quality and
use of policies
(7.1.3)
Reduce
adverse event
risks
(7.3.1)
Improve
documentation
of transfusion
(7.5.3)
Reduce
administration
risks
(7.6.2)
Reduce
management
risks
(7.7.2)
Reduce
wastage
(7.8.2)
Improve
provision of
information to
patients
(7.10.1)

12. www.nba.gov.au
Transfusion governance group
•Oversight of the program
– Review reports
– Identify recurring issues
– Root cause analysis of incidents
– Develop or agree action plan
– Evaluate effectiveness of actions
Consider
alignment and
linkages with
Standard One
What about
small
organisations?

13. Policies, procedures and protocols
7.1.
• Scope
– Pre-transfusion practice
– Prescribing practice and clinical use of blood and blood products
– Administration of blood and blood products
– Management of blood and blood products
• Aligned with national evidence-based guidelines
Essential element 1: Blood and blood products are used and
managed in accordance with national evidence based guidelines

14. Avoiding unnecessary transfusion
•Important strategy for reducing risks
•Supported in national patient blood management guidelines
•Three principles of patient blood management
– Optimise the patient’s blood levels before a surgical or medical intervention
– Lose less blood throughout the patient’s treatment
– Optimise recovery including tolerance of anaemia

15. What activities would reflect appropriate
patient blood management?
•A patient blood management program has been implemented
•Pre admission full blood counts, and actions where
haemoglobin is low
•Benchmarking – clinician against clinician, health service
organisation against health service organisation

16. Quality Improvement Cycle
Policies, procedures and protocols
Transfusion
Quality
Improvement
Program
Plan
Do
Check
Act
7.1.1 Have policies
7.1.1-2 Use policies
7.1.3 Monitor use AND monitor quality
7.1.3 Action to
increase use
and quality

17. Policies, procedures and protocols
Things to consider
• Do they cover all blood products?
• Do they cover the scope of transfusion practice (including
avoidance)?
• Are they based on national evidence-based guidelines?
• Are they monitoring both their quality and use?
What do you look for if
there are no relevant
national guidelines?

18. Incident monitoring and risk assessment
7.2, 7.3
•Builds on Standard 1 requirements – 1.5 organisation wide risk register
– Identification
– Assessment
– Rating
– Controls
– Monitoring
• Should include adverse events, adverse reactions and near misses
Essential Element 2: A program is in place to reduce the risks
associated with blood and blood products and to improve safety
and quality
Essential Element 3: Adverse events, incidents and near misses
relating to transfusion practice are reported and feed into risk
management processes

19. www.nba.gov.au
What are the risks?
•Risks include:
– Procedural errors eg patient misidentification and blood sampling
errors
– Reactions eg fever, chills
•Incidents can be used to identify weak spots
•Consider whether avoidance of transfusion is most
appropriate mitigation strategy

20. Complexities of incident monitoring and
haemovigilance reporting
Patient
record
• 7.6.1 – document in patient clinical record
External
report
• 7.6.3.- Report to pathology service provider, Blood Service or product manufacturer whenever
appropriate
Local
report
• 7.3.1. - Report in local incident system and review by Transfusion Governance
Executive
review
• 7.3.2. - Review by highest governance level of incident summary and analysis
State
reporting
• 7.3.3. – participate in state haemovigilance reporting
• In some cases will be extracted from local system or, may require reporting to the state system
National
reporting
• 7.3.3 – participate in national haemovigilance reporting
• In some cases will be extracted from state system or, may require reporting to the national system

21. IT systems which may support incident
monitoring
•Does the health service organisation’s incident monitoring
system have categories relating to blood related incidents?
•Does the system support the data elements needed for
national and jurisdictional haemovigilance reporting?

22. Criterion Two
Documenting patient information
•Builds on Action 1.9.1-2 – must have an integrated patient
clinical record of a design that enables systematic audit
•Items to document are listed in the Quality Improvement
Guide – includes unit number, indication, volume
•It is also important to document adverse events – this may
influence decisions relating to future transfusions
•Enabling lookback is critical
Essential Element 4: Transfusion details are documented in the
patient clinical record

23. www.nba.gov.au
Lookback
•It is a statutory requirement to track product from vein to vein
•If donor is found to be carrying transfusion transmissible
disease enables it product to be recalled, or where transfused,
the patient to be located and tested
•If recipient is found to have adverse reaction that is suspected
to be product related, allows recall of other implicated products,
and testing of donor where appropriate

24. Quality Improvement Cycle
Documenting patient information
Transfusion
Quality
Improvement
Program
Plan
Do
Check
Act
7.5.1 Develop local
protocol re
documentation of
transfusion
7.5.1 Undertake
detailed
documentation
7.5.2 Assess record completeness
7.5.3 Action to
increase record
completeness
Look for 2 audit types –
one for completeness of
documentation, as well as
sampling to check all
transfusions are recorded

25. Case study
Hospital One Hospital Two
Has policy Yes Yes
Documentation
completeness
audit results
50% of records
are complete
95% of records
are complete
Documentation
sample results
5% of units fate
not documented
<1% of units
fate not
documented
•What actions are required to demonstrate compliance with
the Standard?

26. Case study
Hospital One
• Transfusion governance group has reviewed findings and
developed and implemented an action plan, for example:
– Reviewed policy
– Implemented training of all staff
– Identified staff associated with non-compliance and communicated directly with them
– Made changes to the IT system to facilitate inclusion of all information (prompts)
– Increased frequency of audit on the hospital audit plan
– Initiated more regular spot checks of fate of product against patient records
Outcome: the action plan is matched with the level of
compliance. Accreditation requirement met but must
demonstrate improvement in next cycle.

27. Case study
Hospital One
• Audit report does not have a management response or
action plan
• They posted on the intranet a reminder to document
transfusion in the patient clinical record
• They have not undertaken any other follow up and the next
audit is scheduled for one year away
Outcome: the action plan is not matched with the level of
compliance. They need to demonstrate additional work prior to
accreditation.

28. Case study
Hospital Two
• They posted on the intranet a reminder to document
transfusion in the patient clinical record
• They have not undertaken any other follow up and the next
audit is scheduled for one year away
Outcome: the action plan is matched with the level of
compliance. Accreditation requirement met.

29. www.nba.gov.au
Criterion Three
Managing blood and blood product safety
•Blood must be stored and handled appropriately to prevent
risk to patients
•Wastage of blood should be avoided
•Systems around receipt, storage, collection, and transport
must address these risks

30. Issue – outsourced blood provision services
Hospital uses blood
provided by a
contracted pathology
service
Accreditors can check
contract includes
requirements and
provision of reports to
enable hospital to
check
Accreditors can check
the facility reviews
reports provided and
implements strategies
with contractor to
rectify problems

31. Storage and handling
7.7
•Blood and blood products must be stored within temperature range
to maintain product quality
•Should have standard operating procedures for ensuring product
quality maintained, including;
– Refrigeration monitoring and performance testing including alarms
– Monitoring time of product outside of refrigeration
– Receipting product, preferably electronic receipting
– Implementing best practice inventory management to ensure product is
available to meet clinical need
Essential element 5: Blood and blood products are managed
appropriately

32. Wastage
7.8
•Loss resulting from carelessness, inefficiencies or
inappropriate use
•Not all discard is wastage and not all discards are
inappropriate
•Wastage should be monitored and reported (including all
discard) – look for wastage reports, benchmarking etc
•Action should be taken to minimise waste
Essential element 5: Blood and blood products are managed
appropriately

33. Quality improvement cycle
Receipt, storage, collection and transport
Transfusion
Quality
Improvement
Program
Plan
Do
Check
Act
Eg development of
policies, staff training,
identification of targets
and benchmarking
Appropriately
manage blood
and blood
products in
accordance with
policies (7.1.
7.7.2 Identify risks, and 7.8.1 monitor wastage
7.7.2. Actions to
mitigate risks
and 7.8.2.
reduce wastage

34. Criterion Four
Communicating with patients and carers
•Builds on 1.18.1 – Patient and carers are partners in planning
for their treatment
•Patients should be able to make informed decisions to
treatment with blood and blood products
•Clear, easy to understand information should be available to
help patients with this process
•Informing patients of risks is an important risk mitigation
strategy
•Informing patients has been shown to reduce reliance on
transfusion

35. Informing patients
7.9, 7.10
•Information on blood and blood products is provided to
patients and carers in a format that is understood and
meaningful
•What information should be provided?
– Alternatives
– Risks
– Benefits
•Involve patients in developing their plan for care
How can we test that
patients have
understood the
information provided?
Take into account that this is
not required for emergency
transfusions, but that
information may be provided
after the event.

36. Consent
7.11
•There must be policy in place
•A decision for each health service organisation whether this is:
– Specific to transfusion or more general
– Signed by the patient or documented by the doctor
– Perpetual (or one year) or for each transfusion
This flexibility is to make the requirement achievable. There has been
communicated a preference for consent to be specific, signed by the
patient and undertaken either for each transfusion or regularly where
there are high transfusion requirements.
Essential element 6: Informed consent is documented for
transfusions

37. Quality improvement cycle
Transfusion
Quality
Improvement
Program
Plan
Do
Check
Act
7.10.1 and 7.11.1
Provide patients with
information and
document consent
according to policy
7.11.1 – requires consent to be
documented for ALL transfusions.
What is expected – activities to improve
compliance with consent policies and
consistency of application of the policy
Assess level of
compliance with policy
Improve level
of compliance
with policy
Develop patient information
and consent policy and
make improvements as
required

38. What to look for
Consent
• A documented consent policy which is specific to, or
includes transfusion of blood and blood products
• Written and documented consent that meets local policy
• That the consent is actually informed – link with 7.9 and
7.10
• That compliance with the consent policy is assessed, and
actions undertaken to increase compliance

39. Developmental items
•Action 7.9.2. has been made developmental – organisations need to
demonstrate work in this area, to support Action 1.18.1, and make this
relevant to the use of blood and blood products.
•Action 7.10.1. has been made developmental (to align with Action 1.18.3.
and Action 4.14.1.) – information must be provided to patients and their
carers. However, ensuring it is understood is difficult. Organisations should
work toward strategies for ensuring understanding.
•Action 7.11.1. is only developmental due to the word ‘all’ within the action.
Organisations must have a consent policy, and should undertake actions to
improve compliance with this policy. It is recognised that achieving
informed consent for all transfusions is an unrealistic target. Future
iterations of the Standard will remove the word ‘all’ and this item will be
core.

40. Case study
Surgery
A patient comes into
hospital. Their
haemoglobin levels are
tested on the day of their
surgery and are 70g/L.
They undergo hip
surgery.
Transfusion
The patient requires a
transfusion of 2 bags of
blood during surgery.
The units are
documented in the patient
clinical record by the
theatre nurse.
Adverse event
Immediately after surgery
the patient exhibited signs
of transfusion associated
circulatory overload.
Outcome
The patient recovers.
The patient complains to
the hospital that they
didn’t want a transfusion,
and the hospital did not
provide them with
information about
addressing the issue of
the anaemia and methods
to minimise blood
transfusion .

41. Assessment of process – step 1
Does the hospital offer
pre-surgery full blood
count testing? (7.1.1
supported by evidence
based guidelines)
Surgery
A patient comes into hospital. Their
haemoglobin levels are tested on the
day of their surgery and are 70g/L.
They undergo hip surgery.
Should the surgery have
proceeded in the presence of
undiagnosed anaemia? (7.1.1
supported by evidence based
guidelines)
Was the patient provided
with information, and did
they have informed
consent? (7.10.1, 7.11.1)

42. Assessment of process – step 2
Were all relevant details
documented in the patient
clinical record? (7.5.1)
Transfusion
They require a transfusion of 2 bags of
blood during surgery.
The units are documented in the patient
clinical record.
Were two bags required,
or could they have used
only one or none? (7.1.1)
Was proper patient and
product identification
undertaken to ensure they
got the correct unit of red
cell concentrates? (7.6.2)

43. Assessment of process – step 3
Was this adverse event
reported? (7.3.1, 7.3.2,
7.3.3, 7.6.1)
Adverse event
Immediately after surgery the patient
exhibited signs of transfusion associated
circulatory overload.
Was the response to the
adverse event appropriate?
(7.6.1)
Was a root cause
analysis undertaken?
(7.4.1)

44. Assessment of process – step 4
Was the patient and the
health service
organisation exposed to
unnecessary risk?
Outcome
The patient recovers.
The patient complains to the hospital that they
didn’t want a transfusion, and the hospital did
not provide them with information about
addressing the issue of the anaemia and
methods to minimise blood transfusion.
What are the actions that
could be undertaken to
reduce future risks?

45. Possible corrective actions
•As part of the Transfusion Quality Improvement Program:
– Undertake a root cause analysis
– Review pre-admission practice – is the full blood count checked and actioned
appropriately?
– Check availability of policies and guidelines, including patient blood management,
administration, and consent
– Review the quality and compliance with policies and guidelines
– Conduct training of staff
– Check quality and availability of information to patients – does it cover transfusion
minimisation strategies and advise of the risks to transfusion?
– Recognise where staff have performed well – eg patient identification processes,
documentation of units in the patient clinical record, response to the adverse event

46. Conclusion
•Standard 7 actions build to form a Transfusion Quality
Improvement Program
•The focus of effort is on achieving safe and high quality care
– the expectation is that health service organisations
undertake actions appropriate to the level of risk and the gap
between current practice and best practice

47. Questions
Discussion