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

Standard 7 – Blood and blood products

Philippa KirkpatrickApril 2013

• 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

Why a blood standard?

• 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.

Scope - activities

Scope

Blood Biological Medicine

Fresh blood products eg

•Red cells•Platelets•Plasma•Cryoprecipitate•Serum eye drops

Plasma derived products eg

•IVIg •RhD immunoglobulin•Clotting factors

• Monoclonal antibodies

• Vaccines• Other

recombinant products

Plasma derived products eg

•Tisseel•Artiss•C1-INH•Fibrinogen

Recombinant clotting factors

Haematopoietic progenitor cells

Currently covered by Standard 7

Not currently covered by Standard 7

• 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

Three main areas of concern

Criterion OneGovernance and systems

Transfusion quality improvement system (Action

7.4.1)

Improve documentat

ion 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 documentat

ion of transfusion

(7.5.3)

Reduce administrati

on risks(7.6.2)

Reduce manageme

nt risks(7.7.2)

Reduce wastage(7.8.2)

Improve provision of information to patients

(7.10.1)

• 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

Policies, procedures and protocols (Action 7.1.1)

Quality improvement cycle

Identify what you will do - develop or identify policies, procedures or protocols

Implement the policies

Monitor their use AND monitor their quality

Take action to improve uptake and improve their quality

• Oversight of the program– Review reports

– Identify recurring issues

– Root cause analysis of incidents

– Develop or agree action plan

– Evaluate effectiveness of actions

Transfusion governance group (Action 7.4.1)

Consider alignment and linkages with Standard One

What about small organisations?

Criterion TwoDocumenting patient information

• 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 1.9.1 by identifying the

information relevant to transfusion of blood and blood

products that should be documented

The patient clinical record (Action 7.5.1)

Patient documentation case study

What actions are required to demonstrate compliance with

the Standard?

• 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.

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.

Case StudyHospital One

• 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.

Case StudyHospital Two

• 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

Managing adverse events

Complexities of incident monitoring and reporting

7.6.1 – Document in patient clinical record

7.3.1. - Report in local incident system and review by Transfusion Governance Group

7.3.2. - Review by highest governance level of incident summary and analysis

7.3.3. – Participate in state haemovigilance reportingIn some cases will be extracted from local system or, may require reporting to the state system

7.3.3 – Participate in national haemovigilance reportingIn some cases will be extracted from state system or, may require reporting to the national system

7.6.3.- Report to pathology service provider, Blood Service or product manufacturer whenever appropriate

Criterion ThreeManaging blood and blood product safety

• 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 7.7.1 and 7.7.2)

• Wastage of blood should be minimised (Action 7.8.1 and 7.8.2)

Management of blood and blood products

•Many health service organisations receive blood from an

outsourced pathology

•It remains the health service organisation’s responsibility to

demonstrate compliance with the Standard

Responsibility where services are outsourced

Criterion FourCommunicating with patients and carers

• 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)

Communication (Actions 7.9.1, 7.9.2 and 7.10.1)

• 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

Consent (Action 7.11.1)

Resources

Clinical practice guidelinesNational Blood Authority www.blood.gov.au/guidelines

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 www.nhmrc.gov.au/guidelines

Factor VIII and FIX Guidelines

Warfarin Reversal Consensus Guidelines

Australian and New Zealand Society of Blood Transfusion (ANZSBT) guidelines and publications www.anzsbt.org.au/publications/

Available resources

Product information and product management

10 Tips to Help Manage you Blood Product Inventory http://www.nba.gov.au/supply/10-tips.pdf

Managing blood and blood product inventory – Guidelines for Australian Health Providers http://

www.nba.gov.au/supply/inventory-guidelines.pdf

Australian Red Cross Blood Service Blood Component Information Circular http://

www.transfusion.com.au/sites/default/files/BCI%202012.pdf

The Australian Red Cross Blood Service blood components and products web site http://

www.transfusion.com.au/blood_products

BloodSafe eLearning Australia module on Transporting Blood https://www.bloodsafelearning.org.au/

ANZSBT Guidelines for the Administration of Blood Products http://www.anzsbt.org.au/publications/

ANZSBT Guidelines for Pre-Transfusion Laboratory Practice http://www.anzsbt.org.au/publications/

National Pathology Accreditation Advisory Council (NPAAC) Requirements for Transfusion Laboratory Practice http://

www.anzsbt.org.au/news/documents/07NPAACReqforTLP.pdf

Australian Standard for Medical Refrigeration Equipment – For the Storage of Blood and Blood Products (AS3864) http://

infostore.saiglobal.com/store/Details.aspx?ProductID=1600490

NBA BloodNet http://www.blood.gov.au/bloodnet/

NBA BloodPortal https://portal.blood.gov.au/

Flippin’ Blood http://www.transfusion.com.au/sites/default/files/Flippin%20Blood%20ONLINE.pdf

Available resources

Adverse event recognition and reporting See Jurisdictional programs

NBA Haemovigilance Reports 2008 http://www.blood.gov.au/haemovigilance/

National Haemovigilance Data Dictionary http://www.blood.gov.au/haemovigilance/

Flippin’ Blood http://www.transfusion.com.au/sites/default/files/Flippin%20Blood%20ONLINE.pdf

ANZSBT Guidelines for the Administration of Blood Products(http://www.anzsbt.org.au/publications/)

Patient information and consent See Jurisdictional programs

The Australian Red Cross Blood Service – Information for Patients www.mytransfusion.com.au

Jurisdictional Programs New South Wales – Blood Watch http://www.cec.health.nsw.gov.au/programs/blood-watch

Queensland iBlood Management Program http://www.health.qld.gov.au/qhcss/qbmp/

South Australia – BloodSafe http://www.health.sa.gov.au/bloodsafe/

Victoria – Blood Matters http://www.health.vic.gov.au/bloodmatters/

Western Australia Patient Blood Management Program http://www.health.wa.gov.au/bloodmanagement

Available resources

www.blood.gov.au

Thank you