1. Standard 7 – Blood and blood products
Philippa Kirkpatrick
April 2013

2. Why a blood standard?
There are inherent risks associated with transfusion practice
Transfusion has been associated with increased morbidity and mortality
Transfusion is ingrained in the culture of medical practice
Reports suggest a significant proportion of transfusions are inappropriate
There are high wastage rates at some health service organisations
There is significant room for improvement in practice to improve quality and safety

3. Scope - activities The Blood Standard covers:
Use of blood and blood products – the prescribing practice and clinical use of blood and blood products, and whether or not those products are prescribed and used appropriately
Management of blood and blood products - handling, transport, storage (including inventory management) of blood and blood products
Administration of blood and blood products - the process used to deliver the product to the patient.

4. Scope Currently covered by Standard 7
Classes of products funded under National Blood Arrangements
Fresh blood products eg
Red cells
Platelets
Plasma
Cryoprecipitate
Serum eye drops
Plasma derived products eg
IVIg
RhD immunoglobulin
Clotting factors
Recombinant clotting factors
Not currently covered by Standard 7
Haematopoietic progenitor cells
Plasma derived products eg
Tisseel
Artiss
C1-INH
Fibrinogen
Monoclonal antibodies
Vaccines
Other recombinant products
Classes of products not funded under National Blood Arrangements
Blood Biological Medicine

5. Three main areas of concern
Decision-making regarding the clinical use of blood components
Patient identification and labelling of pre-transfusion specimens
Bedside verification that the correct blood is given to the intended recipient
*Source: Haemovigilance Report 2010
Talk about near misses (wrong blood in tube)

6. Criterion One Governance and systems

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

8. Policies, procedures and protocols (Action 7.1.1)
You should have policies, procedures and protocols that reflect best practice, and national evidence based guidelines where they are available.
Your policies, procedures and protocols should cover the spectrum of:
Use of blood and blood products
Management of blood and blood products
Administration of blood and blood products

9. Quality improvement cycle
Identify what you will do - develop or identify policies, procedures or protocols
Transfusion Quality Improvement System
Plan Do
Check
Act
Take action to improve uptake and improve their quality
Implement the policies
Monitor their use AND monitor their quality

10. Transfusion governance group (Action 7.4.1)
What about small organisations?
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

11. Criterion Two Documenting patient information

12. The patient clinical record (Action 7.5.1)
A best possible history of blood product usage and relevant clinical and product information is documented in the patient clinical record
This action builds on Action by identifying the information relevant to transfusion of blood and blood products that should be documented

13. Patient documentation case study
What actions are required to demonstrate compliance with the Standard?

14. 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. This would be likely be assessed as meeting the requirement, but the health service organisation should also demonstrate improvement in next cycle.

15. 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. The health service organisation needs to demonstrate additional work prior to accreditation.

16. 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. This would be likely to be assessed as meeting the requirement.

17. Managing adverse events
Recognise and respond to adverse events
Document adverse events in the patient clinical record
Take action to reduce the risk of adverse events as part of your transfusion quality improvement system

18. Complexities of incident monitoring and reporting
7.6.1 – Document in patient clinical record
Patient record
Report to pathology service provider, Blood Service or product manufacturer whenever appropriate
External report
Report in local incident system and review by Transfusion Governance Group
Local report
Review by highest governance level of incident summary and analysis
Exec review
– Participate in state haemovigilance reporting
In some cases will be extracted from local system or, may require reporting to the state system
State report
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
National report

19. Criterion Three Managing blood and blood product safety

20. Management of blood and blood products
Blood must be stored and handled appropriately to prevent risk to patients. Systems should be implemented to reduce risks associated with receipt, storage, collection, and transport (Action and 7.7.2)
Wastage of blood should be minimised (Action and )

21. Responsibility where services are outsourced
Many health service organisations receive blood from an outsourced pathology
It remains the health service organisation’s responsibility to demonstrate compliance with the Standard
A health service organisation uses blood provided by a contracted pathology provider
Your health service organisation should have a contract with the pathology provider that includes requirements and provision of reports to enable hospital to check they meet the standards
Your health service organisation should review reports provided and implements strategies with contracted pathology provider to rectify problems

22. Criterion Four Communicating with patients and carers

23. Communication (Actions 7.9.1, 7.9.2 and 7.10.1)
Develop or identify resources to inform patients and their carers about the alternatives, risk and benefits of transfusion (Action 7.9.1)
Provide this information to patients and their carers in a format that is understood and meaningful (7.10.1)
Allow patients and carers to partner in decisions on their care based on the communication on the alternatives, risks and benefits of transfusion (Action 7.9.2)

24. Consent (Action )
Have a documented consent policy which is specific to, or includes transfusion of blood and blood products
Ensure written and documented consent meets local policy
Ensure the consent is actually informed – link with 7.9 and 7.10
Assess compliance with the consent policy is assessed, and take actions to increase compliance

25. Resources

26. Available resources Clinical practice guidelines
National Blood Authority
Patient Blood Management Guidelines
Module 1: Critical Bleeding Massive Transfusion
Module 2: Perioperative
Module 3: Medical
Module 4: Critical Care
Module 5: Obstetric
Module 6: Paediatric/Neonates
Guidelines on the Prophylactic Use of Rh D Immunoglobulin (anti-D) in Obstetrics
Criteria for the Clinical Use of Intravenous Immunoglobulin (second edition)
NHMRC guidelines portal
Factor VIII and FIX Guidelines
Warfarin Reversal Consensus Guidelines
Australian and New Zealand Society of Blood Transfusion (ANZSBT) guidelines and publications

27. Available resources Product information and product management
10 Tips to Help Manage you Blood Product Inventory
Managing blood and blood product inventory – Guidelines for Australian Health Providers
Australian Red Cross Blood Service Blood Component Information Circular
The Australian Red Cross Blood Service blood components and products web site
BloodSafe eLearning Australia module on Transporting Blood
ANZSBT Guidelines for the Administration of Blood Products
ANZSBT Guidelines for Pre-Transfusion Laboratory Practice
National Pathology Accreditation Advisory Council (NPAAC) Requirements for Transfusion Laboratory Practice
Australian Standard for Medical Refrigeration Equipment – For the Storage of Blood and Blood Products (AS3864)
NBA BloodNet
NBA BloodPortal
Flippin’ Blood

28. Available resources Adverse event recognition and reporting
See Jurisdictional programs
NBA Haemovigilance Reports
National Haemovigilance Data Dictionary
Flippin’ Blood
ANZSBT Guidelines for the Administration of Blood Products(
Patient information and consent
The Australian Red Cross Blood Service – Information for Patients
Jurisdictional Programs
New South Wales – Blood Watch
Queensland iBlood Management Program
South Australia – BloodSafe
Victoria – Blood Matters
Western Australia Patient Blood Management Program