Chapter 27

1. Chapter 27 Medicolegal and Ethical Aspects of Providing Blood Collection and Transfusion Services

2. Introduction • Patients who are injured during or as a result of transfusionmay seek redress through legal channels, which is usually filed by their families. • Possibility of disease transmission, especially from previously unknown sources, and because mistakes may mean death. • Basing practices on sound ethical principles provides a good foundation to limit liability when these unforeseen events occur.

3. Focus of Current Legal Issues • Legal issues for transfusion medicine in the 21st century center around several issues • ABO errors • Acute lung injury or TRALI • Patient privacy • Possible transfusion-transmitted diseases, including babesiosis and dengue fever or other exotic diseases that are emerging globally

4. Focus of Current Legal Issues (cont’d) • Transfusion indications • Informed consent • Patient blood management • Transfusion practices in light of the new emphasis on evidence-based medical practice • New studies have been published questioning the safety of blood transfusions, both allogeneic and autologous

5. Focus of Current Legal Issues (cont’d) • Transfusion-transmitted acquired immunodeficiency syndrome (TTAIDS) • Various decisions preclude the application of commercial law, particularly that of warranties, to blood transfusions involving TTAIDS or HBV. • The HBV cases stimulated nearly every state legislature to enact protection for blood banks through “blood shield statutes.”

6. Focus of Current Legal Issues (cont’d) • Because of these blood shield statutes, most of which extended protection without amendment or modification for TTAIDS and HBV, many TTAIDS lawsuits have been either dismissed or unsuccessful for the plaintiff. • Recently, however, this premise has come under new challenge in the courts.

7. Sources of Law • Laws are created by society through legislation called statutes (passed by the U.S. Congress or by individual state legislatures) or by court decisions, referred to as case law. • States may choose to adapt, follow, or ignore decisions made in sister state courts, whereas federal law is applicable to all states.

8. Statutes and Regulations • State and federal regulations can be applied only if they have been established according to a formal process called the Administrative Procedure Act (APA). • Federal regulations that apply specifically to blood banking are found in the Title 21, Code of Federal Regulations, Parts 600–699, and to some extent in Parts 200–299 and 800–899, published annually.

9. Statutes and Regulations (cont’d) • Blood banks/transfusion services are also federally regulated by provisions of the Clinical Laboratories Improvement Act of 1988 (CLIA 88) and the Medicare provisions of the Social Security Act. • In addition, the 1996 federal law protecting health information (Health Insurance Portability and Accessibility Act [HIPAA]), including the 2008 modification (HITECH), which extends these protections to electronic records and transmissions, and the 2008 federal law protecting persons from discrimination on the basis of genetic information (GINA), also apply.

10. Case Law • Established by court decisions, sometimes related to interpretations and applications of statutes and regulations • The legal bases for such suits are generally civil (not criminal) actions for tort. • Tort is defined as any wrongdoing for which action for damages may be brought.

11. Case Law (cont’d) • Civil lawsuits arise because someone disrespects another’s rights by various actions or because of violation of specific statutes or regulations that require certain actions.

12. Basis of Liability: Torts • Torts arise from improper interactions between individual persons. • Intentional Tort of Battery • For transfusion medicine, this concept is used when a donor or a patient claims that he or she never agreed to have the needle placed in his or her arm. • The fact that the donor or patient allowed the needle to be placed is sufficient evidence that he or she agreed to the procedure.

13. Doctrine of Informed Consent • This doctrine protects the patient (or donor) by requiring that information regarding procedures be provided in a manner understandable to the patient under circumstances that permit the patient to ask questions and to receive answers. • The issue of whether specific consent is required for transfusion and who should obtain such consent (generally physicians have been held responsible) remains controversial.

14. Donor Rights • With the onset of AIDS, the language of donor histories has been continuously revised and updated to include information about the disease, how it is acquired, and under what circumstances a person may donate. • One part of the donation process has always been for donors to sign a statement of consent or assent to donate.

15. Donor Rights (cont’d) • An increasing number of plaintiffs in state courts are insisting that the donor be subject to questioning regarding his or her donation. • Because no one donates blood expecting to have to defend such an altruistic act at some future date, the impact of these decisions on the future availability of blood for transfusion is uncertain.

16. Negligence • Five elements present for liability for negligence • A duty was owed to the injured party. • The duty was not met by the injuring party. • Because the duty was not met, the injured party was harmed. • Failure to meet the duty owed was directly responsible for or could have been predicted to cause the harm suffered by the injured party. • Some measurable (compensable) harm (called “damages”) occurred. • The plaintiff has the responsibility to prove all these factors against the defendant.

17. Standard of Care • Ordinary Standard of Care • This standard of care depends only on what the average person (e.g., a juror) believes is acceptable in our society. • In situations in which larger organizations are involved, the question of who is liable for the actions of employees has been resolved under the doctrine of respondeat superior.

18. Standard of Care (cont’d) • Ordinary Standard of Care (cont’d) • Under this doctrine, the actions of employees are attributable to the employer or person who directs their actions. • The person responsible for transfusion services has been defined by federal regulation and general practice to be a physician, a definition that has been reinforced by judicial decision in many states for blood centers as well as for hospitals.

19. Standard of Care (cont’d) • Professional Standard of Care • When the negligence lawsuit involves professionals such as laboratory professionals, nurses, or other allied health practitioners, the definition of what is reasonable, the “standard of care,” depends on expert testimony from other professionals in the same field (e.g., physicians, nurses, or scientists) about what should have been done by other reasonable practitioners (usually of the same specialty).

20. Standard of Care (cont’d) • Professional Standard of Care (cont’d) • In discharging his or her duty to the plaintiff, the defendant must apply the special knowledge and ability he or she possesses by virtue of the profession. • This increased professional standard of care is what other professionals (so-called expert witnesses) testify should have been done.

21. Voluntary and Mandatory Standards • The testimony of experts should generally be supportable by authorities such as statutes, regulations, or other bodies of published knowledge, including published scientific articles and texts. • Blood bankers and transfusion services that can show that they acted in conformance with these standards are more likely to be found non-negligent than those who do not follow such guidelines.

22. Blood Banking as a Medical Profession • The question of whether blood banking is a medical profession is being relitigated in courts today, with conflicting results. • The possible redefinition of blood banking as not being a medical practice would remove the extra protection provided by the requirement for expert medical testimony to establish the standard of care, leaving defendants to be judged by the ordinary negligence standard.

23. Strict Liability • Nearly every state has enacted specific protection, the blood shield statutes described previously, to exclude harm from blood transfusions from suit under strict liability. • Blood bankers must avoid implying or stating that blood transfusion is completely safe, because such statements may be construed as creating a warranty, invoking the theory of strict liability.

24. Infliction of Emotional Distress • A plaintiff must show that what the defendant did to cause actual and severe emotional distress was intentional, and calculated to deliberately cause harm to the plaintiff. • This can take the form of the plaintiff’s relative claiming wrongful death, particularly in TTAIDS cases.

25. Invasion of Privacy Under Civil Case Law • Health care providers, including blood bankers, are required to respect personal privacy and to maintain patient and donor confidentiality. • Plaintiffs may claim remuneration for loss of privacy under four theories. • These categories protect a patient or donor from illegal or inadvertent disclosure of his or her personal information, of particular concern with HIV because of the risk of loss of employment, housing, insurance, and other benefits of society.

26. Basis of Liability: HIPAA • In 1996 the U.S. Congress responded to the information age by enacting a law specifically directed to the protection of personal health information (PHI): the Health Information Portability and Accessibility Act (HIPAA). • Information about donors and patients must be kept in such a manner that inadvertent “use or disclosure” does not occur.

27. Basis of Liability: HIPAA (cont’d) • Exceptions for health care providers, insurers, and government scrutiny have been specified, but safeguards should be in place even for these exceptions. • Great care should be exercised by blood banking professionals to ensure that private information (whether about donors, patients, or relatives) be kept confidential and not released without written authorization.

28. Restrictions on Plaintiff Suits and Recovery • Even when harm or injury occurs, the plaintiff may be unable to pursue legal redress • Statutes of Limitations: generally 2 years in medical malpractice cases • Doctrine of Charitable Immunity: historically, courts provided immunity for nonprofit organizations such as hospitals from excess liability because they perform charitable acts • Tort Reform

29. Specific Donor Issues • Most common reasons for lawsuits include • Screening,as in TTAIDS • Directed donations requested by patients • Untimely notification: in receipt of an HIV-reactive unit; lookback and notification of patient • Component collection: injury to donors • Failure to perform surrogate testing: between 1983 and 1985,when specific HIV antibody testing was first available • Medical malpractice

30. Ethics and Transfusion Medicine • Biomedical ethical principles that must be balanced when considering appropriateness of and informed consent for transfusion include • Autonomy • Beneficence • Justice

31. Emerging Issues • The need for evidence-based transfusion practices • Concerns about the age of RBCs when transfused • The provision of autologous transfusion services • Recombinant erythropoietin therapy • Standards for the provision of perioperative blood collection and reinfusion • Control over the use of gene therapy to treat certain transfusion-dependent illnesses