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 recordBlood and blood products are managed appropriatelyInformed 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 PlanDoCheckAct 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 PlanDoCheckAct 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 OneHospital Two Has policyYes 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 PlanDoCheckAct 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 PlanDoCheckAct 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