An Essential Tool for Optimizing Clinical Outcomes and Improving Patient Safety :

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 Jo Valenti Director Blood Management Temple University Hospital Philadelphia, PA USA 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 • Quantitative value • Qualitative value • Criterion • An object that under specified conditions can • Define • Represent • Or records the magnitude of a unit

6. Our original intent (2009-2011) • 2009-2011 Standards Committee drafted 12 standards. • 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.”

7. Needs • 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?

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

9. Change requires upgrades and upgrades require change

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

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

13. Guidance statement 2013 edition • NOT intended to….. • 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

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

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

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

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

18. Language

19. Former #7: Acute NormovolemicHemodilution “Acute normovolemichemodilution (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 patient’s blood volume.”

20. New #7 Perioperative Autologous Blood Collection for Administration “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 normovolemichemodilution) for reinfusion in the perioperative period.”

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

22. New #7 Perioperative Autologous Blood Collection for Administration • How • Autologous product may be separated into different components such as platelet rich plasma • Intent of creating products that further limit blood loss • Who • Smaller institutions choice regarding services rendered • 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.

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

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