Ethical Considerations in Developing a Bloodless Medicine Center: What Have We Learned?

1. Arvind Venkat, MDEthics Consultant & Ethics Committee ChairJan Seski, MD, Medical DirectorCenter for Bloodless Medicine & Surgery Rita Schwab, CPMSM, Program DirectorCenter for Bloodless Medicine & Surgery Allegheny General Hospital, Pittsburgh, PA Ethical Considerations in Developing a Bloodless Medicine Center: What Have We Learned? Presented at the Society for the Advancement of Blood Management Conference September 21, 2012

2. A patient who entrusts himself to a physician's care creates ethical obligations that are definite and weighty. ETHICS IN MEDICINE   University of Washington School of Medicine Ethics in Medicine

3. Clinical ethics is the field of inquiry that defines how health care professionals should act in particular medical situations. • This often involves a balancing of patient, personal and societal principles and expectations. • The development of a bloodless medicine center is a prime example of how the principles of clinical ethics are put into practice. Introduction

4. Discuss how the cardinal ethical principles of autonomy, beneficence and justice apply to the care of the bloodless medicine patient. • Explain how these ethical principles are used to operationalize a bloodless medicine program. • Provide case examples of how these ethical principles relate to the management of patients under a bloodless medicine program. Goals for This Presentation

5. Autonomy – The principle that competent individuals have the right to make decisions about their own lives. • Beneficence/Non-Maleficence – The principle that health care providers should strive to provide benefit and not do harm to patients. • Justice – The principle that a potential good should be provided to all patients regardless of status. Cardinal Principles of Bioethics

6. The Autonomy Principle in Bloodless Medicine • Historically, medical practice in Western societies provided great deference to the expertise of physicians. • After World War II, shift to emphasis on autonomy and the informed wishes of the patient. • In the case of blood transfusions, requirement where feasible for informed consent.

7. Transfusion Consent – How Are We Doing?Key Points from the ISBT* Code of Ethics • Patients should be informed of the known risks and benefits of blood transfusion and/or alternative therapies and have the right to accept or refuse the procedure. Any valid advance directive should be respected. • Genuine clinical need should be the only basis for transfusion therapy. • As far as possible the patient should receive only those particular components (cells, plasma, or plasma derivatives) that are clinically appropriate and afford optimal safety. *International Society of Blood Transfusion

8. Case Example • 27yo male Jehovah’s Witness transferred to AGH with an acetabular fracture. • Outside facility physicians refused to operate due to patient desire for bloodless operation. • Question arises as to whether the physician can be forced to operate.

9. What if you are uncomfortable caring for a patient without the option of blood transfusion? • Moral distress has significant practical consequences. • Can lead to violations of professionalism and burn out. The Physician’s Role in Ethical Care of Patients Who Refuse Recommended Treatments

10. The Principle of Beneficence/Non-Maleficence in Bloodless Medicine • Historically, there has been a presumption that anemia at a certain threshold or “trigger” point requires transfusion. • Similarly, standard practices in patients requiring surgery or hospitalization also necessitated blood transfusion. • New understanding of the relative risk-benefits of blood transfusion has shifted medical practice to be less inclined to transfuse blood except in extreme cases. • The treatment of Jehovah’s Witnesses has resulted in the advancement of medical techniques and surgical blood conservation approaches that are now benefiting both Witnesses and the general population.

11. “Children and adolescents have some autonomy… Not only do their intellectual and volitional capabilities need to be considered, but also the nature and gravity of the choice.” “Physicians should respect the autonomy of their pediatric patients and include them in the decision making process as much as possible. Weithorn and Campbell found that children approximately 7 years old were usually capable of assenting (ie, agreeing or at least not objecting) to treatment, and adolescents approximately 14 years old could often give voluntary consent.” Smith, ML. Ethical Perspectives on Jehovah’s Witnesses’ Refusal of Blood. Cleve Clin J Med 1997;64:475-81 Children and Adolescents

12. The Principle of Justice in Bloodless Medicine • In some cases, bloodless medicine may involve the need for additional resources and training. • Given the relative rarity of patients refusing blood transfusions, is it fair to expect that the general health care community develop this expertise?

13. The AGH program was established in 1998 by physicians and administrators who recognized the ethical responsibility to take care of Jehovah’s Witnesses, a patient population that was finding it difficult to locate skilled physicians and hospitals willing to provide health care without the use of blood transfusion. The Allegheny General Hospital Bloodless Medicine Program

14. Coordinated Referral / Information Center • Legal Documentation of Patient’s Wishes • Respectful, Reassuring Atmosphere • Physician and nursing staff with experience in patient blood management Why Do Patients Choose Hospitals with Formal Bloodless Medicine Programs?

15. Modalities developed for the ‘bloodless’ patient are now utilized across all patient populations • Lays a foundation for hospital-wide use of blood conservation strategies • Patients who refuse transfusions have provided a ‘control group’ for better understanding transfusion medicine How has ‘Bloodless Care’ Impacted Medicine in General?

16. A cost analysis study published in the April 2010 issue of Transfusion, shows that… the actual cost of blood is substantially higher than previously estimated.  With actual blood transfusion costs ranging between $522 and $1,183 per unit. What is not considered is the cost associated with the morbidity related to blood transfusions. Blood Conservation Saves Money and Scarce Resources Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion 2010;50:753-65.

17. Selected case study • 19 y/o, large fibroscarcoma • EBL – 3000 to 3500 ml • Pre-op H/H 14.5/39.9 • Intra-op H/H 6.8/20.3 • POD #5 H/H 6.8/20.0 LichtigerB, Dupuis JF, SeskiJ. HemotherapyDuring Surgery for Jehovah’s Witnesses: A New Method. AnesthAnalg1982;61:618-19. Case Study

18. 1. Pre-operative • Treatment of Anemia • Optimize the patient’s pre-operative condition Three Phases of Care

19. 2. Intra-Operative • Focused surgical procedure • Appropriate surgical team • Meticulous surgical technique • Cell Salvage • Hemodilution Three Phases of Care

20. 3. Post-Operative • Treatment of any significant anemia • Limiting blood draws • Prompt attention to any unexpected bleeding Three Phases of Care

21. Communicate with your patient • Maintain communication among the care team Communication is Key

22. Clinical Strategies information • Professional education videos • Staff presentations • Patient information • Patient referrals *Members of the local Witness community with training to assist physicians and patients to resolve issues that may arise. Working with the Local Hospital Liaison Committee* for Jehovah’s Witnesses

23. The Medical Director serves as an advocate and clinical lead for the Center for Bloodless Medicine and Surgery. • Serves as a resource for the medical staff regarding the principles and procedures of bloodless medicine • Acts as an advocate, and when needed as a consultant, for patients enrolled in the CBMS program • Participates in public education programs pertaining to the hospital’s bloodless medicine program The Role of the Medical Director

24. Hospitals with organized blood conservation / bloodless medicine programs can now be found around the globe. Patient blood management has become a must-have program for today’s most progressive health care organizations. A World-Wide Medical Approach

25. Religious beliefs • Concern about disease transmission • Concern about immune system suppression • Concern about potential complications, including TRALI, TACO, BaCon, and human error Why Do Patients Refuse Transfusions?

26. Christian Religion • 7.6 million members • 1.2 million in the US (1/261) • Refuse blood transfusion based on understanding of Scriptures* • Do not practice faith healing • Are not seeking to be martyrs Jehovah’s Witnesses *Acts 15:20,29 - Leviticus 17:11,12 - Genesis 9:3,4 Incorporated December 15, 1884

27. Refusal of blood transfusion • Minor fractions of blood • Medical procedures involving the use of patient’s own blood • End of life matters (US DPA) • Appointment of healthcare agents (US DPA) A Look at the Durable Power of Attorney/Health Care Directive Carried by Many Jehovah’s Witnesses

28. The hospital respects the patient's cultural and personal values, beliefs, and preferences. • The hospital orients staff on the following: Sensitivity to cultural diversity… Completion of this orientation is documented. RI.01.01.01: The hospital respects, protects, and promotes patient rights. HR.01.04.01: The hospital provides orientation to staff. “Coming to AGH and saying you don’t want a blood transfusion is like going to any other hospital and saying you’re allergic to Penicillin. Someone from the staff makes a note in your chart and says ‘Okay, then we won’t use that.’” A Bloodless Medicine Patient Accreditation Standards – Joint Commission

29. The provider must document the existence of any “advance directives” in the patient's medical record. (Congressional Record — House, Oct. 26.1990, H12482). • The Act requires that a national campaign be initiated to “inform the public of the option to execute advance directives” and “the patient's right to “direct health care decisions.” U.S. Patient Self Determination ActEffective December 1, 1991

30. Create Clear Documents

31. Develop Policies & Protocols

32. Identifying the Bloodless Medicine Patient

33. Make Use of Your Hospital Intranet Staff Education – An Ongoing Need

34. Function as point of contact • Assist with referrals and patient transfers • Assist patients in documenting their wishes • Develop policies • Educate staff • Educate public How a Program Coordinator Can Help

35. Ethical medical treatment embraces (1) respect for ethical principles and (2) practical application of clinical skills and experience. • The principles of autonomy, beneficence/non-maleficenceand justice help create an environment that fosters the provision of high-quality, respectful care to all patients, including those who request care without the use of blood products. Conclusion