Shared Decision-making in Patient Blood Management

1. Shared Decision-making in Patient Blood Management Presented by Kathleen Sazama, MD, JD Retired Chief Medical Officer LifeSouth Community Blood Centers, Gainesville, FL And Immediate Past President, SABM 2011-13

2. Conflict of Interest DisclosureKathleen Sazama, MD, JD • Salary: Until 10/31/12, CMO for LifeSouth Community Blood Ctrs in Gainesville, FL • Royalty: AABB Press, co-editor of book on Informed Consent • Receipt of Intellectual Property Rights/Patent Holder: • Consulting Fees (e.g., advisory boards): Medical Director (part-time consulting) for San Diego Blood Bank Cord Blood Program • Fees for Non-CME Services Received Directly from a Commercial Interest or their Agents (e.g., speakers’ bureau): N/A • Contracted Research: N/A • Ownership Interest (stocks, stock options or other ownership interest excluding diversified mutual funds): N/A • Other: N/A

3. Learning Objectives • Learn the legal and ethical principles protecting patient’s right to choose • Update current knowledge about the process of obtaining the patient’s decision • Become familiar with current alternatives to routine transfusions, including avoiding any transfusion.

4. Patient Transfusion Safety:From brainto vein AND from veinto vein PHYSICIAN and PATIENT Decision to Transfuse AND Informed choice“consent”or not Patient usually Admitted to Hospital – ID attached Obtain PATIENT Blood samples And send to blood bank/lab Donor Qualified Component Issued to patient Compatibility procedures LAB Patient Transfused; followup Blood collected Blood component available Donation testing (Testing may be sent out) DONOR

5. Informed Consent orInformed Choice? • “Consent” implies that there is no choice or option. • Merriam-Webster’s on-line dictionary definition: to give assent or approval:agree<consent to being tested> • “Choice” conveys the possibility of several options, one of which will be selected. • Merriam-Webster’s on-line dictionary definition: to select freely and after consideration

6. Informed Choice: Two options • To agree or accept; to consent • Commonly understood • To NOT accept -- Decline or refuse • Decline = to reject politely or courteously* • Consider “declining a dinner invitation” • Refuse = emphasizes firmness, at times rudeness* • Consider “refusing to obey an order” *Howarth G. Changes in policy of refusal of blood by Jehovah’s Witnesses. BMJ 2001;322:1123-4

7. US legal cases support patient’s right to decide 1914 Justice Cardozo in Schloendorff v. Society of New York Hosp., 211 N.Y. 125, 105 N.E. 92 (NY 1914) • “every human being of adult years and sound mind has a right to determine what shall be done to his own body.”

8. Legal cases (cont.) 1972Cobbs v. Grant, 8 Cal. 3d 229, 240, 243,502 P.2d 1, 104 Cal.Rptr. 505 (Cal. 1972) • “…as an integral part of the physician’s overall obligation to the patient there is a duty of reasonable disclosure of the available choices with respect to proposed therapy and of the dangers inherently and potentially involved in each.”

9. US Legal Protection of Patient Rights • Competent patients have the right to refuse treatment • Incompetent patients have same rights as competent ones • Surrogate decision makers • Decision-making should occur in the clinical setting (not courts)

10. Fundamental Principles of Clinical/Medical Ethics* • Autonomy – patient’s perspective • Veracity – truth-telling • Beneficence – MD’s doing good • Non-maleficience – doing no harm • Justice – being fair *Perlin TM. The Ethical Basis for Informed Consent, in Stowell CP, Sazama K, eds. Informed Consent in Blood Transfusion and Cellular Therapies. Patients, Donors, and Research Subjects, AABB Pres, Bethesda, MD, 2007, p. 9, from Table 1-3.

11. Requirements for Patient Choice: AMA Code of Medical Ethics and Current Opinions 8.08 patient’s right of self-decision can only be effectively exercised if the patient possesses enough information to make an intelligent choice. present facts accurately and make recommendations in accord with accepted medical practice rejects paternalistic view that the physician may remain silent because providing information might prompt the patient to forgo needed therapy.

12. Requirements for Patient Choice:US Government The patient has the right to make decisions about their care Informed of health status, involved in care planning and treatment, and able to request or refuse treatment Hospitals must utilize processes that assure patients are given the information and disclosures needed to make an informed decision about treatment Hospitals must develop policies and procedures that assure patient’s right to request or refuse a treatment Demonstrate that Hospital complies with these policies

13. US Government (continued) Informed consent document (well-designed) Name of practitioner obtaining informed consent Listing of the material risks that were discussed with patient Placed in medical record prior to treatment or intervention Disclosures Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity.

14. The Joint Commission (TJC) Requirements Three elements of performance RI2.40 The hospital policies must describe: What procedures require informed consent The process used to obtain informed consent How informed consent is to be documented in the medical record Informed consent must then be obtained and documented in the medical chart pursuant to hospital policies

15. TJC Requirements (cont.) A complete informed consent process includes a discussion of: Nature of the underlying diagnosis, proposed care, treatment, intervention, or procedure Potential risks, benefits, and side effects, and potential problems related to recuperation Likelihood of achieving the goals Alternatives Relative risks, benefits, and side effects related to the alternatives, which includes the results of not receiving the care or treatment Any limitation on the confidentiality learned from the patient Documentation of these elements must be in the form, progress note, or elsewhere in medical record

16. National Patient Safety GoalsJanuary 1, 2012 • NPSG.01.01.01 • Use at least two patient identifiers when providing care, treatment, and services • Elements of Performance • Use at least two patient identifiers when administering medications, blood, or blood components; when collecting blood samples or other specimens for clinical testing’ and when providing treatment or procedures. (NOT – patient’s room number or physical location) • Label containers used for blood…in the presence of the patient.

17. NPSG 2012 (cont) • NPSG.01.03.01 • Eliminate transfusion errors related to patient misidentification • Elements of Performance • Before initiating a blood or blood component transfusion: • Match the blood/component to the order • Match the patient to the blood/component • Use a 2-person verification process (or a 1-person plus automated ID technology, e.g. bar coding

18. Blood Management Performance Measures Rationale: Planning a discussion with a licensed practitioner regarding the risks, benefits and alternatives of transfusion is an opportunity for the patient to participate in decisions about his or her care. It is a process that takes into consideration, each patient’s preferences, clinical needs and provides information in compliance with the regulations and policies of the state and facility. Even though policies related to informed consent may vary among hospitals, all hospitals require some type of consent prior to treatment unless emergency care is needed. The elements of performance for the Joint Commission Standard RI.01.03.01 related to the informed consent process include a discussion about the risks, benefits and alternatives, and a discussion about the risk, if care is not received. This measure is also supported by the Joint Commission’s National Patient Safety Goal (NPSG) 13 that encourages patients’ active involvement in their own care as a patient safety strategy. For many years, the American Association of Blood Banks (AABB) organization has supported the consent process for transfusion and has developed several standards such as AABB Standard 5.19.1. AABB requires that at a minimum, a recipient consent for transfusion and that should include; a description of the risks, benefits and treatment alternatives, the opportunity to ask questions and the right to accept or refuse Transfusion.

19. AABB Requirements* Standard 5.26.1 Recipient Consent The blood bank or transfusion service medical director shall participate in the development of policies, processes, and procedures regarding recipient consent for transfusion. 5.26.1.1 At a minimum, elements of consent shall include all of the following: A description of the risks, benefits, and treatment alternatives (including nontreatment). The opportunity to ask questions. The right to accept or refuse transfusion. Standard 5.27.1 The patient’s medical record shall include: transfusion order, documentation of patient consent, … • *Standards for Blood Banks and Transfusion Services, 27th edition, AABB. Eff. 5/1/2011

20. Legal Definition of Informed Consent in Transfusion A decision to undergo (or not undergo) medical treatment after receiving adequate disclosure of relevant information.* Barr D, Hatch LM. The Legal Basics of Informed Consent, in Stowell CP, Sazama K, eds. Informed Consent In Blood Transfusion and Cellular Therapies. Patients, Donors and Research Subjects. AABB Press, Bethesda, MD, 2007, p. 25.

21. Elements of Informed Choice • Patient is informed about • Reason for transfusion • Risks of transfusion/no transfusion • Benefits of transfusion • Alternatives to transfusion • Patient considers choices and • has time to“digest” information and • may ask and receive answers to questions • PATIENT DECIDES – “Yes” OR “No” • Patient’s choice: AGREE or NOT AGREE • should be documented in writing Adapted from Stowell CP, Table 3-1. Elements of Informed Consent, p. 63

22. Beneficence and non-maleficence: When ‘should’ transfusions be given? • Physicians who order transfusions are required to • Be knowledgeable about the indications for transfusion – by component type • Inform patients about the risks, benefits and alternatives to transfusion (and the risks and benefits of these) and let the patient decide • Know the alternatives and be prepared to act on the patient’s choice

23. Evaluating the Patient for Possible Transfusion • What’s the patient’s current medical condition? • Do bleeding/clotting history • Simple laboratory assessments for • Anemia? • Any potential bleeding/clotting problems? • Review current medications • Explore blood management options • Cell saving/reinfusion or ANH • Pharmacologic interventions • Timing of procedure

24. Case #1: From the NEJM* • A 40-year-old G5P4 seeks medical care at 22 weeks gestation because of placenta previa and placenta accreta. • Last 2 pregnancies were delivered by C-section • Significant post-partum hemorrhage occurred with both deliveries; she received no transfusions because of her beliefs. • Significant risks to both mom and baby were discussed with her in planning the continuation of this pregnancy • Blood loss at delivery was estimated to be >3 L • Options to avoid transfusion: optimizing maternal iron status, use of EPO, PABD, ANH, cell-saving. • After discussion with her clergy, patient did not accept PABD or ANH but did agree to the other options *Barth WH Jr, Kwolek CJ, Abram JL, Ecker JL, Roberts DJ. N Engl J Med 2011;365:359-66.

25. Question: • Under which circumstance can a competent pregnant woman be forced to accept blood transfusion? • Autologous units of blood are available. • The patient cannot identify the person who would care for the child if mom dies • The patient’s spouse insists on the transfusion and signs the consent • Transfusion becomes necessary to save the patient’s life.

26. Case #1 (continued) • Legal commentary on this case: • Competent adults have the right to [choose] • Limitations on this right* • Unmarried pregnant woman may need to show that another competent adult will take responsibility for the newborn (and any other children).* If no such person identified, mom may be required to accept transfusion. *Massachusetts law

27. When is blood needed? % From Hebert PC, Wells G, Blajchman MA, et al NEJM 1999;340:409-17

28. When is Blood Needed? Guidelines for When to Transfuse

29. When is blood needed? • MEDICAL EVALUATION • Patient’s clinical condition • Current -- measured by vital signs • Evidence of active bleeding • Predictable -- e.g., cancer treatment with reference to • Patient’s laboratory test results • Hemoglobin OR hematocrit • PATIENT’s PREFERENCES

30. Integrating Patient Values -- Autonomy • Providing patient with correct and current information about blood transfusion • When is transfusion indicated? Not indicated? • When can other modalities be used? • When is PABD appropriate? • When can a patient just “say NO!”?

31. Patients who Decline Transfusion:Jehovah’s Witnesses* *Carbonneau A. Ethical Issues and the Religious and Historical Basis for the Objections of Jehovah’s Witnesses to Blood Transfusion Therapy. The Edwin Mellen Press, Lewiston, NY, 2003.

32. What if Patient Does NOT ACCEPT blood transfusion? Rogers DM, Crookston KP. The approach to the patient who refuses blood transfusion. Transfusion 2006;46:1471-77.

33. Alternatives to RBC Transfusion 2008

34. RBC “Substitutes”– Oxygen Therapeutics 2008

35. Informed Choice for Perioperative Blood Management • When does the patient become informed about • Risks of anemia? • Possible coagulation problems? • Intraoperative options such as ANH, cell saving/reinfusion, post-operative drains/reinfusion? • Who discusses these treatments with the patient? • How does the patient indicate choice? (How is consent documented?)

36. For what procedures do physicians obtain informed consent? Foley Cath Centeses Endoscopy Manthous CA, DeGirolamo A, Haddad C, Amoateng-Aadjepong Y. Informed consent for medical Procedures. Local and National Practices. CHEST 2003;124:1978-84.

37. Patient Recall about Receiving Information about Transfusion 41/344 recalled receiving info 129/344 didn’t answer

38. Recall of Specific Transfusion Risks

39. Discussion of Alternatives is Ineffective 88% said “No,”“Can’t Recall,” Or didn’t answer

40. When Patient chooses NOT to ACCEPT Transfusion • Document and communicate patient’s preference with concern for protecting confidentiality • Develop a treatment plan • Limit amount and frequency of laboratory testing • Ensure availability of appropriate non-blood therapies

41. How NOT to Document Patient’s Choice

42. Reactions to Patient who Does Not Accept Transfusion* Health care professionals are concerned about • May unnecessarily compromise medical outcomes • Making my job harder • Providing substandard care • Not using the best available means of care • “operating with one hand tied behind one’s back” • Less margin for error or complications • Loss of control over patient care Lo B. Resolving Ethical Dilemmas. A Guide for Clinicians. Williams & Wilkins, Baltimore, 1995, p. 91.

43. Documentation – How Well Done? N = 1055 charts Rock G, Berger R. Filion D, et al. Documenting a transfusion: how well is it done? Transfusion 2007;47:568-72.

45. Justice • Offering all reasonable choices to every adult patient who may require transfusion • Emergency ‘exception’ • Minors whose parents refuse transfusion • Ensuring availability of all reasonable alternatives • “Bloodless” medicine and surgery is available in some areas • Perioperative blood management is becoming ‘standard of care’ for selected surgical procedures

46. Case #2 • The parents of a 14 year old young male with recently diagnosed acute myelogenous leukemia that will require platelet and red blood cell transfusions to undergo a bone marrow transplant have expressed objection to the proposed treatment plan. • In a separate private discussion with the hematologist/oncologist, the patient also expressed very strongly his belief that he would not accept transfusion. • Both of his parents and the patient are Jehovah’s Witnesses.

47. Case #2 (continued) • The hospital has contacted the local court for approval to proceed with the planned treatment, based on the age of the patient. • As the treating physician, what course(s) of action are available to you? • As the hospital, what outcome do you anticipate from your application to the court? • What relevance does the boy’s preference have?

48. Involving ‘minors’ in choices • Every state has legal definition of “minor” • Age is always one criterion • Other conditions may “emancipate” the minor • Pregnancy • Marriage • Independent financial means • Service in military • Even if child is not ‘emancipated,’ participation in medical decision-making is encouraged at younger ages • Ethical concept of “assent” for treatment • Courts divided about minors “not accepting” treatment options – doctrine of state’s interest in preserving life

49. Summary • Ethical principles support the concept of balancing true medical need with the patient’s preferences. • Patient choice about all medical treatments (including transfusion or not) should be appropriately documented • Recent studies indicate need for improvement • The challenge to medical practitioners is to understand the true medical need for transfusion • Managing anemia • Controlling/avoiding bleeding/coagulation problems • Minimizing excessive blood taking (for lab tests) • Using perioperative blood management methods, when appropriate • Respecting patient’s preferences and managing with no transfusion • Alternative strategies to the use of stored blood (autologous and allogeneic) are available

50. INFORMED CHOICE: Transfusion or No Transfusion? • IF THERE IS NO EMERGENCY: • Patient needs to know as much as possible about the medical reason for the proposed transfusion; the risks, benefits, and alternatives to blood and of any available alternatives • Patient should choose • Documentation is expected Competent adult patients (and some minors) have the right to NOT ACCEPT transfusion