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Blood Management
Summary This Policy Directive provides a definitive overview of best transfusion practice covering the whole healthcare organisation based transfusion chain of events, i.e. from when a blood product is received from the blood service into a clinical facility, its storage, safe matching to an individual patient, delivery and then the immediate and follow up care of the patient who is administered any blood product. A key change is for the introduction of double independent checking at the administration check. Document type Policy Directive Document number PD2018_ Publication date 21 November 2018 Author branch Clinical Excellence Commission Branch contact (02) 9269 5500 Replaces PD2012_ Review date 21 November 2023 Policy manual Not applicable File number CEC D18/ Status Active Functional group Clinical/Patient Services - Governance and Service Delivery Applies to Ministry of Health, Local Health Districts, Specialty Network Governed Statutory Health Corporations, Affiliated Health Organisations, NSW Health Pathology, Government Medical Officers, NSW Ambulance Service, Dental Schools and Clinics, Public Hospitals, Private Hospitals and day Procedure Centres Distributed to Ministry of Health, Public Health System, Government Medical Officers, NSW Ambulance Service, Private Hospitals and Day Procedure Centres, Tertiary Education Institutes Audience All Clinical Staff
Policy Directive
Secretary, NSW Health This Policy Directive may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory for NSW Health and is a condition of subsidy for public health organisations.
POLICY STATEMENT
BLOOD MANAGEMENT
PURPOSE
The purpose of this Policy Directive is to support health services and health service staff to comply with their responsibilities as described in the Australian Health Ministers Conference (AHMAC) Statement on National Expectations for the Supply of Blood and Blood Products^1 by:
- Providing policy and system direction for the use of evidence based best practice blood management guidelines for NSW Health facilities
- Establishing a consistent, system wide approach to blood management in all facilities providing transfusion therapy
- Minimising NSW patients exposure to risks associated with the clinical storage, prescribing, handling and administration of blood products in NSW facilities
- Supporting health facilities to comply with the relevant National Safety and Quality Service Standards, and other accreditation requirements in relation to blood management.
MANDATORY REQUIREMENTS
NSW health services that provide transfusion therapy are responsible for:
- Developing and maintaining effective systems to ensure safe, effective, appropriate and patient centred blood management processes and procedures
- Adopting and implementing best practice procedures relating to blood management and the clinical storage, prescribing, handling and administration of blood products
- Complying with the relevant National Safety and Quality Health Service Standards (NSQHS).
Health service staff involved in blood management and/or transfusion related activities are responsible for:
- Complying with relevant blood management systems, processes and procedures, including those outlined in this Policy Directive
- Providing safe, effective, appropriate and patient centred care.
It is recognised that some of the requirements in this policy such as the role of the Local Health Districts/Special health networks are not applicable to private health facilities. Private health facilities are expected to comply with the general principles described in this Policy Directive in compliance with the Private Health Facilities Act 2007 (NSW) and the Private Health Facilities Regulation 2017 (NSW).
(^1) Statement endorsed by the Australian Health Ministers’ Conference, 12 November 2010 (see attachment 5.1)
PROCEDURES
Issue date: November 2018 PD20 18 _
PROCEDURES
PD201 8 _042 Issue date:^ November-^2018 Contents page
- 1 BACKGROUND CONTENTS - 1.1 About this document - 1.2 Key definitions................................................................................................................... - 1.3 Legal and legislative framework
- 2 CLINICAL USE OF BLOOD PRODUCTS - 2.1 Transportation and Storage - 2.1.1 Transportation - 2.1.2 Storage - 2.2 Consent - 2.3 Patient identification.......................................................................................................... - 2.3.1 Pre-Transfusion testing and specimen labelling - 2.3.2 Transfusion verification procedure - 2.4 Appropriate use................................................................................................................. - 2.5 Safe administration - 2.6 Adverse events - 2.6.1 Transfusion reactions............................................................................................ - 2.6.2 Transfusion incidents - 2.6.3 Notification and management of transfusion reactions and incidents - 2.7 Documentation and medical records - 2.7.1 Patient health care record - 2.7.2 Laboratory
- 3 GOVERNANCE - 3.1 Blood Management Committee - 3.2 Education - 3.3 Roles and responsibilities - 3.3.1 Local Health Districts / Special Health Networks - 3.3.2 NSW Health Pathology - 3.3.3 Blood Service - BULLETINS 4 RELATED NSW HEALTH POLICY DIRECTIVES, GUIDELINES AND INFORMATION
- 5 ATTACHMENTS
- 5.1 AHMAC Stewardship Statement
- 5.2 Implementation checklist
PROCEDURES
1.3 Legal and legislative framework
Blood, blood components and plasma derivatives are regulated under the Therapeutics Goods Act 1989 (Cth)^2.
The Human Tissues Act 1983 (NSW) sets out the legislative requirements for the collection of blood from donors^3 and the regulation of businesses supplying blood and blood products^4.
Under the National Blood Authority Act 2003 (Cth)^5 , the National Blood Authority manages and coordinates arrangements for the supply of blood and blood products and services on behalf of the Australian Government and state and territory governments.
Jurisdictional issues relating to the national blood supply, including planning, production, supply and budgeting are managed through the Jurisdictional Blood Committee (JBC). The Deputy Secretary, Population & Public Health is the NSW representative on the JBC.
2 CLINICAL USE OF BLOOD PRODUCTS
2.1 Transportation and Storage
Health services providing transfusion therapy must have procedures in place to ensure the safe storage and where relevant, transport of blood and blood products.
The transport and storage of blood products must comply with the:
National Pathology Accreditation Advisory Council (NPAAC) Requirements for Transfusion Laboratory Practice or any subsequent versions Australia and New Zealand Society of Blood Transfusion (ANZSBT) Guidelines for Transfusion and Immunohaematology Laboratory Practice or any subsequent versions.
2.1.1 Transportation
Transport of blood products between facilities, including packing configurations and the use of validated shipping containers, should be managed in compliance with the:
Relevant NSW Health Pathology policy directives and procedures^6 (or other accredited pathology provider policy and procedures, see 3.2.2) Blood Service Shippers – Receipt and Use by External Institutions^7.
2.1.2 Storage
Storage of blood products must comply with:
(^2) Australian Government, Department of Health; Therapeutic Goods Administration, Therapeutics Goods Act 1989 (Cth) (^3) Human Tissues Act 1983 (NSW) ss19-20H (^4) Ibid ss21-21C (^5) National Blood Authority Act 2003 (Cth) (^6) NSWHP Policy Red Blood Cell Storage, NSWHP Procedure Retrieval Transfusion Procedure, and any other NSWHP policy directive or procedure related to storage and transport published subsequent to this Policy Directive (^7) Australian Red Cross Blood Service Shippers – Receipt and Use by External Institutions (WI-00635; version 1) or any subsequent version
PROCEDURES
Australian Standard AS 3864 - Medical Refrigeration Equipment – for the storage of blood and blood products Relevant NSW Health Pathology policy or procedures^8 outlining storage requirements of blood products (or other accredited pathology provider policy and procedures, see 3.2.2).
This includes:
Storage in dedicated fridges and/or freezers that are remote from a transfusion laboratory (satellite) Storage in facilities without dedicated blood storage equipment, including the use of validated shipping containers for short term storage Storage of blood products accompanying transferred patients Storage of products for use by emergency retrieval teams.
Blood products delivered to a clinical environment, e.g. ward, operating theatre must:
Be stored in accordance with this Policy Directive, or Be administered to the patient within the appropriate time frame as described in the ANZSBT Guidelines for Administration of Blood Products or any subsequent versions.
A blood product must not be transfused, except at the discretion of the laboratory director, where it is:
Stored at temperatures outside specified limits Stored in non-conforming equipment There is doubt regarding storage equipment.
2.2 Consent
Health services providing transfusion therapy must have procedures and processes in place to ensure clinicians are able to obtain and document informed consent for the use of blood products.
These procedures and processes must comply with the requirements for consent as outlined in the NSW Health Policy Directive Consent to Medical Treatment – Patient Information , or any subsequent versions, and include:
The use of the relevant consent forms as described in the above Policy Directive Who can obtain consent The right to decline any proposed treatment Patients who are unable to provide consent (including minors) Emergency treatment.
Informed consent requires:
A discussion of the risks and benefits of the use of blood products The availability of other treatment options as relevant to the patient’s clinical condition The likely outcome(s) if the treatment is not provided or declined
(^8) Ibid above 7 and Australian Standard AS 3864 - Medical Refrigeration Equipment – for the storage of blood and blood products (1997) or any Australian Standard that supersedes this.
PROCEDURES
2.3.2 Transfusion verification procedure
Transfusion related patient identification procedures must be implemented for transfusion related activities including:
The collection of blood products from the transfusion service or appropriate storage (e.g. satellite blood fridge) Delivery to the clinical environment Administration to the patient.
The purpose of transfusion related patient identification procedures is to ensure the correct blood product is administered to the correct patient. To minimise the risk of error at the final administration check, the administering and checking clinicians must check the required information independently, a process called “double independent checking”.
Procedures must comply with:
Principles for patient identification and procedure matching as outlined in the NSW Health Policy Directive Clinical Procedure Safety or any subsequent versions ANZSBT Guidelines for the Administration of Blood Products or any subsequent versions.
2.4 Appropriate use
Health services must have processes in place to support clinicians in their obligations to provide safe, effective and appropriate use of blood products when clinically indicated.
Decisions on whether to prescribe blood products, and the dose or number of units to order should take into account:
The presence or absence of proven benefit Risks associated with the use of blood products Other treatment options, including appropriate management of reversible causes of deficiencies^10.
Procedures for appropriate use of blood products must comply with the current and any subsequent versions of:
National Patient Blood Management Guidelines Blood Service Component Information ANZSBT Guidelines for Transfusion and Immunohaematology Laboratory Practice including for the selection of modified blood products and: o Rh D negative o CMV negative o Irradiated products
2.5 Safe administration
Health services must have processes in place to support clinicians to safely administer blood products when clinically indicated.
PROCEDURES
Successful and safe transfusion practice depends on the administration of a quality blood component of the right type, for the right indication, in the right quantity or dose, via the right route, at the right time to the right patient.
Procedures for safe administration of blood products must comply with the current and any subsequent versions of:
ANZSBT Guidelines for the Administration of Blood Products Blood Service Component Information.
2.6 Adverse events
Health services are to have systems and processes in place to support the appropriate identification, management, notification, and follow up of adverse outcomes of transfusion, transfusion reactions, and incidents relating to transfusion activities.
2.6.1 Transfusion reactions
Transfusion reactions are adverse pathophysiological complications associated with the use of blood products. Management of patients who are suspected of having a transfusion reaction should include:
The initiation of patient assessment and first aid including basic life support and the appropriate escalation as per Recognition and Management of Patients who are Deteriorating or any subsequent versions, including obtaining further appropriate clinical consultation if required (e.g. Haematology) Notification to the pathology provider responsible for providing the blood product as well as following instructions on follow up investigations and clinical consultation as required All adverse reactions are to be entered into the incident management system (see 2.6.3) Resources for clinical management of transfusion reactions include: o ANZSBT Guidelines for the Administration of Blood Products or any subsequent versions o The Blood Service: Adverse Events overview or any subsequent versions.
2.6.2 Transfusion incidents
Transfusion incidents are errors in activities related to the use of blood products including specimen collection, storage, handling, ordering, prescribing, administration and documentation.
Transfusion incidents may cause severe, potentially fatal complications including ABO Haemolytic Transfusion reaction (HTR), and Transfusion Associated Circulatory Overload (TACO). Such complications should be managed as per 2.6.1 in the first instance.
2.6.3 Notification and management of transfusion reactions and incidents
All health services providing transfusion therapy are to have systems in place for the notification and management of transfusion related incidents (including transfusion reactions).
PROCEDURES
discarded. This is achieved through accurate documentation in the patient health care record and the laboratory information system.
2.7.1 Patient health care record
Documentation of transfusion related activity should be available to all clinical staff and include:
Transfusion history (including previous complications) if available Indication for the use of blood product Consent Prescription Blood product compatibility information or product batch number as applicable Administration and completion times Patient observations as applicable to the type of blood product Outcome of the transfusion Occurrence and management of any adverse events or reactions.
2.7.2 Laboratory
Transfusion laboratories must comply with the documentation requirements for blood products, immunohaematology specimens, and patient information as described in the ANZSBT Guidelines for Transfusion and Immunohaematology Laboratory Practice or any subsequent versions.
The fate of fresh blood products, either transfused, transferred or discarded, must be documented in the BloodNet Fate module. If discarded, the reason must be entered, as per the definitions provided.
3 GOVERNANCE
3.1 Blood Management Committee
Health services that provide transfusion therapy must have a process in place for the review of blood product issues. This may be through a Blood Management Committee (BMC) or an equivalent quality or patient safety management committee as relevant to the size and function of the service.
The BMC (or equivalent) responsibilities should include:
Development and monitoring of local policy, procedures and safe work practices Monitoring the clinical use of blood products Monitoring wastage of blood products Haemovigilance activities, i.e. monitoring, reporting, investigation and analysis of adverse events related to blood product transfusion Escalating any concerns or risks associated with transfusion related activities to the relevant authority Contingency planning in the event of notified shortages of blood products Monitoring education in transfusion related activities to all relevant staff groups.
PROCEDURES
3.2 Education
Staff involved in transfusion related activities must complete the BloodSafe eLearning Course Clinical Transfusion Practice.
Transfusion related activities include (but are not limited to):
Pre transfusion laboratory testing and product issuing Administration of blood products Monitoring and patient assessment Prescribing and ordering blood products – Intern medical officers only (Postgraduate Year 1/2) are required to complete Clinical Transfusion Practice Health care workers involved in non-clinical handling of blood products, such as hospital porters and orderlies, are required to complete the separate Transporting Blood module only. Health care workers employed only to perform phlebotomy or venepuncture are required to complete the separate Collecting Blood Specimens module only.
This mandated requirement to complete these BloodSafe eLearning courses applies only to a one-off completion, Local Health Districts and Special Health Networks may determine to repeat completion and assessment at a frequency deemed by them to meet local needs.
3.3 Roles and responsibilities
3.3.1 Local Health Districts / Special Health Networks
The Local Health District/Special Health Network must monitor compliance with this Policy Directive and ensure that all facilities that provide transfusion therapy (and related activities) are able to report to a BMC (or equivalent), and that all staff are appropriately trained as relevant to their role.
All facilities that provide transfusion therapy must achieve and maintain accreditation to the relevant NSQHS Standard.
3.3.2 NSW Health Pathology
NSW Health Pathology is responsible for the provision of transfusion laboratory services for NSW Health. As required by NSW Health Policy Directive Accreditation of Pathology Laboratories in NSW Health (or any subsequent versions) transfusion laboratory services are required to maintain accreditation to the standards developed by the National Pathology Accreditation Advisory Council.
Transfusion laboratory service providers, other than NSW Health Pathology, may be utilised by NSW Health services. Where such agreements are in place, the requirements of this policy apply.
For transfusion laboratories the relevant standard is the National Pathology Accreditation Advisory Council (NPAAC) Requirements for Transfusion Laboratory Practice (3rd^ Ed) 201714 , or any subsequent versions.
(^14) The Department of Health, NPAAC Requirements for Transfusion Laboratory Practice (3rd (^) Ed) 2017
PROCEDURES
5.1 AHMAC Stewardship Statement
PROCEDURES
5.2 Implementation checklist
LHD/Facility:
Assessed by: Date of Assessment:
IMPLEMENTATION REQUIREMENTS
Not commenced
Partial compliance Full compliance
- There are procedures and processes in place for blood management activities as outlined in section 2 of this Policy Directive. This includes: a) Transport and storage b) Consent c) Patient identification d) Appropriate use e) Safe administration f) Adverse event management g) Documentation
Notes:
- Procedures and processes are reviewed to ensure they are inclusive of both fresh and fractionated blood products.
Notes:
- Procedures and processes are in place to comply with the requirements for double independent checking.
Notes:
- There is governance in place including a blood management committee and processes for ensuring appropriate and safe use of blood products
Notes:
- There are procedures and processes in place to evaluate compliance with this policy, including: a) Clinical practice or patient blood management audit b) Adverse event reporting c) Haemovigilance analysis and strategies
Notes:
