1. An Essential Tool for Optimizing Clinical Outcomes and Improving Patient Safety: The Administrative and Clinical Standards for Patient Blood Management Programs 2013 edition Trudi Gallagher State Clinical Coordinator for Patient Blood Management Office of Chief Medical Officer DOH Perth, Western Australia Australia Trudi Gallagher State Clinical Coordinator for Patient Blood Management Office of Chief Medical Officer DOH Perth, Western Australia Australia Jo Valenti Director Blood Management Temple University Hospital Philadelphia, PA USA Jo Valenti Director Blood Management Temple University Hospital Philadelphia, PA USA Irwin Gross, M.D. Medical Director Patient Blood Management Eastern Maine Medical Center Irwin Gross, M.D. Medical Director Patient Blood Management Eastern Maine Medical Center

2. Conflict of Interest / Disclosure None

4. Original Standards Committee (2009-2011)

5. Purpose of a Standard A recognized measure for comparative value A recognized measure for comparative value Quantitative value Quantitative value Qualitative value Qualitative value Criterion Criterion An object that under specified conditions can An object that under specified conditions can Define Define Represent Represent Or records the magnitude of a unit Or records the magnitude of a unit

6. Our original intent (2009-2011) 2009-2011 Standards Committee drafted 12 standards. 2009-2011 Standards Committee drafted 12 standards. The Foreword for the document states: The Foreword for the document states: These standards are intended to function as a guide for hospitals and practitioners who want to optimize transfusion practices in order to improve patient safety and clinical outcomes. These standards are intended to function as a guide for hospitals and practitioners who want to optimize transfusion practices in order to improve patient safety and clinical outcomes.

7. Needs What measures do I need to establish for my program and have evidence of embedded PBM practice? What measures do I need to establish for my program and have evidence of embedded PBM practice? How do I know that my program is complete and only requires quality adjustments or upgrades? How do I know that my program is complete and only requires quality adjustments or upgrades?

8. Needs (cont.) I need a road map to direct me through the complicated journey of PBM I need a road map to direct me through the complicated journey of PBM implementation in my institution. implementation in my institution. Would I be ready for an inspection if Would I be ready for an inspection if there were a regulatory body adopting there were a regulatory body adopting PBM measures? (present and future) PBM measures? (present and future)

9. Change requires upgrades and upgrades require change

11. Guidance statement 2013 edition Intent of this document Intent of this document Dynamic rather than static since new information is rapidly emerging Dynamic rather than static since new information is rapidly emerging Organization-wide patient blood management program should follow these standards Organization-wide patient blood management program should follow these standards 2013 edition 2013 edition Present Goal Present Goal Guidance document Guidance document Reflect activities related to patient blood management Reflect activities related to patient blood management Optimize clinical outcomes Optimize clinical outcomes Improve patient safety Improve patient safety

12. Long term goal Long term goal Demonstration of compliance Demonstration of compliance SABM PBM standards may be used in a patient blood management program accreditation/certification process SABM PBM standards may be used in a patient blood management program accreditation/certification process Guidance statement 2013 edition

13. NOT intended to….. NOT intended to….. Provide strict indications, contraindications or other criteria for the practice of clinical medicine and surgery Provide strict indications, contraindications or other criteria for the practice of clinical medicine and surgery NOT to be used as the only basis for making case-specific decisions regarding clinical recommendations for patient care or diagnostic NOT to be used as the only basis for making case-specific decisions regarding clinical recommendations for patient care or diagnostic

14. How can this tool benefit your program? Self assessment Self assessment How are we doing? How are we doing? Indicator of compliance Indicator of compliance Potential Credentialing/certification in future? Potential Credentialing/certification in future?

15. Guidance for future development Guidance for future development To-do list To-do list Where do we go from here? Where do we go from here? What should we work on next? What should we work on next? Benchmark for quality Benchmark for quality Part of Network? = use as benchmark tool from one centre to another Part of Network? = use as benchmark tool from one centre to another Benefits of this document (cont)

16. 2011 vs 2013 edition 2013 edition 2013 edition Changes Changes Fine tuning Fine tuning Language Language Format Format Expansion and focus Expansion and focus Regulatory requirement inclusions Regulatory requirement inclusions If 100% of standards adopted/performed blood associated regulatory agencies requirements are covered If 100% of standards adopted/performed blood associated regulatory agencies requirements are covered

17. Consolidating old standard Consolidating old standard ANH ANH Creating new standard Creating new standard Managing anemia in non surgical outpatients (I. Gross) Managing anemia in non surgical outpatients (I. Gross) References References 2011 vs 2013 edition

18. LANGUAGE

19. Acute normovolemic hemodilution (ANH) may be used as a blood conservation modality to preserve autologous blood and minimize or avoid allogeneic blood transfusion. If a hospital chooses to offer ANH, a standardized methodology exists for performing ANH in patients undergoing surgery where the blood loss is anticipated to exceed 15% of the patients blood volume. Former #7: Acute Normovolemic Hemodilution

20. The hospital has the ability to collect, process, and reinfuse shed autologous blood. The hospital may also choose to collect blood from patients in the immediate preoperative period (acute normovolemic hemodilution) for reinfusion in the perioperative period. New #7 Perioperative Autologous Blood Collection for Administration

21. Goal/intent Goal/intent Decreasing blood loss Decreasing blood loss Preserving autologous blood cells Preserving autologous blood cells Minimizing or avoiding allogeneic blood transfusion Minimizing or avoiding allogeneic blood transfusion Timing Timing ANH: immediately before surgery with volume replacement as appropriate ANH: immediately before surgery with volume replacement as appropriate May preserve platelets and plasma clotting factors May preserve platelets and plasma clotting factors New #7 Perioperative Autologous Blood Collection for Administration

22. How How Autologous product may be separated into different components such as platelet rich plasma Autologous product may be separated into different components such as platelet rich plasma Intent of creating products that further limit blood loss Intent of creating products that further limit blood loss Who Who Smaller institutions choice regarding services rendered Smaller institutions choice regarding services rendered Outside contractor may be able to provide these services Outside contractor may be able to provide these services Contractor must be in compliance with this standard and all policies and procedures established by that hospital. Contractor must be in compliance with this standard and all policies and procedures established by that hospital. New #7 Perioperative Autologous Blood Collection for Administration

23. #3Blood Safety (e.g.. new language/indicator 2013 edition) 3.4The hospital has a process to assess compliance with blood administration policies and procedures through direct observation by a designated Transfusion Safety Officer. If direct observation is not possible, there is retrospective evaluation of transfusion records to ensure compliance. The results of direct observation or record review are shared with the staff member who administered the blood and the medical directors of the patient blood management program and transfusion service. 3.8Non-compliance with patient blood management policies and procedures that lead to an avoidable transfusion should be identified and reported to the patient blood management or transfusion committee as an adverse event. #4Review and Evaluation of the Patient Blood Management Program (e.g.. new language/indicator 2013 edition) 4.6Compliance with patient blood management clinical protocols is monitored. 4.7The impact of patient blood management and transfusion practice on clinical outcomes such as length of stay, infection rates, ischemic complications and mortality is evaluated.

24. Leadership and program structure Leadership and program structure Consent process and patient directives Consent process and patient directives Blood administration safety Blood administration safety Review and evaluation of the patient blood management program Review and evaluation of the patient blood management program Transfusion guidelines and peer review of Transfusion guidelines and peer review oftransfusions Preoperative anemia evaluation and readiness for surgery Preoperative anemia evaluation and readiness for surgery 2013 Standards

25. Perioperative autologous blood collection for Administration Perioperative autologous blood collection for Administration Phlebotomy blood loss Phlebotomy blood loss Minimizing blood loss associated with surgery, Minimizing blood loss associated with surgery, procedures and underlying medical conditions including antithrombotic therapy, antiplatelet therapy and coagulopathy Massive transfusion protocol Massive transfusion protocol Management of anemia in hospitalized patients Management of anemia in hospitalized patients Managing anemia in non-surgical outpatients Managing anemia in non-surgical outpatients 2013 Standards