[15] CHAPTER VII LESSON 1

Question 1

Patients who are injured during, or as a result of, [?] may seek reparation through legal channels, a complaint that is usually filed by their families.

Answer 1

transfusion

Question 2

This has been of particular concern in[?] because of the possibility of disease transmission, especially from previously unknown sources, and because mistakes may mean death.

Answer 2

blood banking and transfusion medicine

Question 3

Basing practices on sound [?] provides a good foundation to limit liability when these unforeseen events occur.

Answer 3

ethical principles

Question 4

Laws are created by society through legislation called [?] (passed by either the U.S. Congress or by individual state legislatures) or by court decisions, referred to as [?] (in federal courts, including the U.S. Supreme Court, or in state courts through their own highest state court).

Answer 4

statutes

case law

Question 5

Federal law (enacted by Congress or by decision in federal courts, including the Supreme Court) may frequently supersede state law, but both federal and state laws can be and often are applied in particular instances.

Answer 5

Statutes and Regulations

Question 6

The details of how laws are to be put into action are provided in regulations.

Answer 6

Statutes and Regulations

Question 7

Regulations, both federal and state, can be applied only if they have been established according to a formal process called the Administrative Procedure Act (APA).

Answer 7

Statutes and Regulations

Question 8

Blood banks and 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.

Answer 8

Statutes and Regulations

Question 9

In addition, the 1996 federal law protecting health information (Health Insurance Portability and Accessibility Act [HIPAA]), including the 2008 Health Information Technology for Economic and Clinical Health (HITECH) Act that extends these protections to electronic records and transmissions and the 2008 federal law, the Genetic Information Nondiscrimination Act (GINA), also apply.

Answer 9

Statutes and Regulations

Question 10

Case law is established by court decisions, sometimes related to interpretations and applications of statutes and regulations

Answer 10

Case Law

Question 11

Tort is defined as any wrong-doing for which action for damages may be brought.

Answer 11

Case Law

Question 12

Civil lawsuits arise because someone disrespects another’s rights by:
1. Striking or threatening to strike another person (battery and assault)
2. Being careless or reckless (negligence)
3. Failing to complete an agreement (breach of contract)
4. Intruding on another’s property or privacy
5. Misbehaving in other, similar ways

Answer 12

Case Law

Question 13

Civil lawsuits can also arise because of violation of statutes or regulations that require certain types of actions.

Answer 13

Case Law

Question 14

BASIS OF LIABILITY: TORTS

Question 15

arise from improper interactions between individuals.

Answer 15

Torts

Question 16

Any touching without consent, including deliberate blows and intentional striking, is the legal definition of battery.

Answer 16

Intentional Tort of Battery

Question 17

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.

Answer 17

Intentional Tort of Battery

Question 18

If significant harm occurs as a result of the needle, this legal theory may be upheld.

Answer 18

Intentional Tort of Battery

Question 19

Particularly in the special circumstances of the practice of medicine, the issue of whether a patient (or, in the case of blood collection, a donor) agreed to undergo the procedure actually performed, with full knowledge of the possible benefits, alternatives, and harm that may accompany it, has come to be known as the

Answer 19

Doctrine of Informed Consent

Question 20

protects the patient (or donor) by requiring that information be provided in a manner understandable to the patient under circumstances that permit the patient to ask questions or express concerns and to receive answers to them.

Answer 20

Doctrine of Informed Consent

Question 21

Probably the most common tort is that of negligence.

Answer 21

Negligence

Question 22

This is the basis for lawsuits when injury occurs.

Answer 22

Negligence

Question 23

Liability for negligence is found when all of the following elements are present:
a. A duty was owed to the injured party.
b. The duty was not met by the injuring party.
c. Because the duty was not met, the injured party was harmed.
d. Failure to meet the duty owed was directly responsible for or could have been predicted to cause the harm suffered by the injured party.
e. Some measurable (compensable) harm (called damages) occurred. To be successful in a negligence action, the plaintiff has the responsibility to prove all these factors against the person being sued (the defendant)

Answer 23

Negligence

Question 24

The existence of voluntary standards—particularly those provided by the AABB but also those from the College of American Pathologists (CAP), the American Association of Tissue Banks (AATB), the American Society for Histo - compatibility and Immunogenetics (ASHI), the Joint Commission (TJC), and other organizations—are helpful in establishing the professional standard of practice for transfusion medicine.

Answer 24

Voluntary and Mandatory Standards

Question 25

Blood bankers and transfusion services that can show that they acted in conformance with these standards are more likely to be found nonnegligent than those that do not follow such guidelines.

Answer 25

Voluntary and Mandatory Standards

Question 26

Redefining blood banking as not medical practice removes 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.

Answer 26

Blood Banking as a Medical Profession

Question 27

There is little dispute that loss of medical professional stature would significantly alter the practice of blood banking.

Answer 27

Blood Banking as a Medical Profession

Question 28

For some items (such as dynamite), the danger from proper use is so great that manufacturers are legally liable for all harm that occurs, which is called strict liability.

Answer 28

Strict Liability

Question 29

This means that anyone who is harmed when properly using dynamite does not have to prove that the manufacturer or distributor was negligent; he or she has only to show that he or she was injured while properly using it.

Answer 29

Strict Liability

Question 30

As the phrase intentional infliction of emotional distress suggests, a plaintiff must show that what the defendant did to cause actual and severe emotional distress was intentional, usually some extreme or outrageous conduct that was calculated to deliberately cause harm to the plaintiff.

Answer 30

Intentional Infliction of Emotional Distress

Question 31

Health-care providers, including blood bankers, are required to respect personal privacy and to maintain patient and donor confidentiality.

Answer 31

Invasion of Privacy Under Civil Case Law

Question 32

Plaintiffs may claim remuneration for loss of privacy under four theories:
a. Intruding upon the plaintiff’s seclusion or solitude or into his or her private affairs
b. Publicly disclosing embarrassing facts
c. Publicly placing plaintiff in a “false light”
d. Appropriating plaintiff’s name or likeness for defendant’s benefit

Answer 32

Invasion of Privacy Under Civil Case Law

Question 33

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.

Answer 33

Invasion of Privacy Under Civil Case Law