3. Course Information
Teaching Methods
• Lecture
• Role play
• Case study
• Group discussion
• Assignments
Assessment Method:
• Assignment (30%)
• Final examination (70%)
Grading: Fixed scale
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4. Course Outline:
1.0. Introduction
1.1. Definition of terms
1.2. History of medical laboratory science
1.3. History of ethics
1.4. Classification of ethics
1.5. Principles of ethics
1.6. characteristics of professional and ethical behavior
2.0. Interpersonal relationships
3.0. Principles of confidentiality and privacy responsibility
4.0. Rights and obligations of medical laboratory professionals
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5. Course Outline, cont’d
5.0. Duties and responsibilities of medical laboratory
professionals
6.0. Patient’s bill of rights
7.0. Medical Laboratory code of conduct
7.1 Ethiopia Medical Laboratory Association Code of
Ethics
7.2 Ethiopia Medical Laboratory Association Vision
7.3 Ethiopia Medical Laboratory Association Mission
7.4 Ethiopia Medical Laboratory Association Core Values
8.0. Good Laboratory Practices (GLPs)
9.0. Legal and Ethical Issues in HIV/AIDS
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6. I.0 Introduction
At the end of this session students will be able to:
• Define ethics, Profession (professional, professionalism),
Behavior, Moral, Legal practice, Common law, Civil law,
Court, Precedent, Medical Laboratory Science
• Discuss the history of medical laboratory science
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7. Objectives continued
• At the end of this session the students will be able to:
• Discuss the history of ethics
• Discuss the different types of ethics
• Discuss principles of ethics
• List the characteristics of professional and ethical behavior
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8. Why study ethics?
• When students enter the professional world, they will be
expected to follow an explicit or implicit ethical code.
• To responsibly confront/tackle/ moral issues raised by
medical laboratory activities
• How to deal with ethical dilemmas in their professional
lives?
• To achieve moral autonomy
April 5, 2023 8
9. 1.1. Definitions
1.1.1. Definition of ethics
– derived from the Greek word ethos, meaning custom or
character.
– Is a major branch of philosophy which study values and
customs of a person or group.
– Is concerned with what is right or wrong, good or bad, fair
or unfair.
– Covers the analysis and employment of concepts such as
right or wrong, good or evil.
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10. Definitions cont’d
Final word about ethics:
– Professional ethics concerns one’s conduct of behavior and
practice when carrying out professional work.
1. 1.2. Definition of profession:
– Profession:
• A dedication, promise or commitment publicly made
• Is a vocation or an occupation requiring knowledge of
some department of learning or science
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11. Definitions continued
– Occupation, practice, or vocation requiring mastery of a
complex set of knowledge and skills through formal
education and/or practical experience.
• All professions are occupations, but not all
occupations are professions.
– Professional:
• A person who agrees to and commits his/her
commitment to the profession they chose.
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12. Definitions cont’d
– Professionalism:
• The actions of the members of a profession based on the
accepted code of conduct.
– Code of Conduct:
• way of behaving
• a set of unwritten rules according to which people in a
particular group, class, or situation are supposed to
behave.
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13. Definitions cont’d
1.1.3. Definition of Behavior:
• The way somebody behaves
1.1.4. Definition of Moral
– from the Latin moralitas "manner, character, proper
behavior”
– In its descriptive use, morals are arbitrarily and subjectively
created by society, philosophy, religion, and/or individual
conscience.
– Ethics vs Moral
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14. Definitions: Ethics vs Moral
• Ethics- "The science of morals”; the philosophical study of
morality.
• Moral- habits of life in regard to right and wrong conduct.
– The arbitrariness of morality stems from the observation that actions that
may be deemed moral in one culture in time may not be classified as
such in others or in a different time.
• Morality – making choices with reasons
• Ethics – the study of HOW the choices are made, i.e. “ethics is
the study of morality”
• Often use “ethics” and “morality” interchangeably
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15. Definitions cont’d…
• Legal practice: legislation having legal enforcement
• Common law: evolved law i.e., the body of law developed as a
result of custom and judicial decisions, as distinct from the law
laid down by legislative assemblies.
• Civil law: law of citizen's right.
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16. Definitions cont’d…
• Court: meeting where legal judgments are made.
• Medical Laboratory Science: a profession characterized by its
own internally-defined Body of Knowledge and Scope of
Practice.
– a profession with people educated in basic and medical
sciences, medical techniques and research methods.
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17. Classification of Ethics
Ethics is divided into three primary areas:
• Meta – ethics:
• the study of concepts of ethics.
• Normative ethics:
• the study of how to determine ethical values or ethics
standard.
• Applied/Professional ethics:
• the study of the use of ethical values
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18. Meta – Ethics
• is the branch of ethics that seeks to understand the nature of
ethical properties, and ethical statements, attitudes, and
judgments.
• concerned primarily with the:
– the fundamental semantic (meaning of ethical judgments
and/or prescriptions ), ontological (theory of being), and
epistemic (about knowledge) nature of ethics or morality.
– addresses questions such as "What is goodness?" and "How
can we tell what is good from what is bad?", seeking to
understand the nature of ethical properties and evaluations.
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19. Normative Ethics
• is the branch of philosophical ethics that investigates the set of
questions that arise when we think about the question “how
ought one act, morally speaking?” "What should one do?",
• distinct from meta-ethics because it examines standards for the
rightness and wrongness of actions, while meta-ethics studies
the meaning of moral language and the metaphysics of moral
facts.
• Semantics of ethics divides naturally into:
– Descriptivism
– Non-descriptivism
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20. Descriptive vs Prescriptive Ethics
• Descriptive ethics – “What IS”
• Prescriptive ethics – “What OUGHT to be”
• Descriptive, or scientific, studies of professional ethics help us
identify issues that need to be included in Code of Ethics and in
educational programs.
• 2002 British study by Burgess and Mullen: 77% of hygienists
had witnessed ethical misconduct by colleagues within last 5
years
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21. Descriptive Ethics
Burgess and Mullen study. Most common ethical misconducts:
1. Plagiarism
2. Confidentiality of data
3. Faked data
4. Criticizing colleagues for gain
5. Destruction of data
6. Holding back, disguising data
7. Not reporting incident deliberately
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22. Descriptive Ethics cont’d
Patricia Logan 2001, USA. Reported reasons for misbehavior,
hygienists:
1. Economic pressure
2. Transition from employee to consultant results in
compromises
3. Working in foreign countries
4. Lack of legal standards
5. Decrease in job security
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23. Non-Descriptive Ethics
• Contends that ethical propositions are irreducible in the
sense that their meaning cannot be explicated sufficiently
in terms of descriptive truth-conditions.
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24. Applied Ethics
• Is a discipline of philosophy that attempts to apply ethical theory
to real-life situations
• There are several sub-branches of professional/applied ethics:
– Business ethics
– Medical ethics (e.g. Bioethics)
– Medical Laboratory ethics
– Genetics
– Journalism ethics
– Engineering ethics
– Legal ethics
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25. Applied Ethics cont’d
• One of the major areas where ethicists practice is in the field
of health care. These include:
– Medical ethics
– Nursing ethics
– Pharmacy ethics
– Medical Laboratory ethics
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26. Professional Ethics
• Concerns the moral issues that arise because of the specialist
knowledge that professionals attain.
• how the use of this knowledge should be governed when
providing a service to the public.
• is a collective and disciplined concern of the group
• attitude of the professional should be unselfish concern for the
welfare of others
Note: Professional ethics is therefore, an inherent characteristic of
professional behavior.
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27. Professional Ethics, cont’d
• Adherence to professional standards is expressed through
taking a professional oath and accepting professional code of
ethics
• The code of ethics, compared with an oath is normally more
detailed and more explicit.
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28. Professional morality vs Ethics
• Professional Morality – what we do in our occupational lives
• Professional Ethics – the study of what we do in our
professional lives
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29. Principles of Ethics
• Principles are basic ideas that are starting points for
understanding and working through a problem.
• Ethical principles presuppose that medical laboratory
professionals should respect the value and uniqueness of
persons.
• The most commonly accepted principles of medical ethics
include:
– Respect for Patient Autonomy
– Beneficence and Non maleficence
– Justice
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30. Principles of Ethics
• Other principles include informed consent, confidentiality and
honesty
• The major principles of medical laboratory ethics are:
– Autonomy
– Beneficence
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31. Principles of Ethics cont’d
1. Autonomy: means independence and ability to be self
directed in health care.
– Autonomy is the basis for the client’s right to self determination
– Infants, young children, mentally handicapped etc do not
have the capacity to participate in decision making about
their healthcare.
– If the client becomes unable to make decisions for
himself/herself, a “surrogate decision maker” would act on
client’s behalf.
2. Beneficence: acting in the best interests of patients (doing or
promoting good).
• This principle is the basis for all health care providers
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32. Principles of Ethics cont’d…
3. Nonmaleficence: means to avoid doing harm. Health
professionals should not inflict harm on patients.
4. Justice: fair, equitable and appropriate treatment. Treat all
patients equally – no unfair discrimination.
5. Veracity: means telling the truth, which is essential to the
integrity of the client-provider relationship.
6. Fidelity: means being faithful to one’s commitments and
promises
7. Confidentiality: Confidential is a secrete or private matter not
to be divulged to others.
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33. Characteristics of Professional and Ethical Behavior
• Professional ethics:
– Deals with moral issues that arise due to specialist
knowledge that professionals attain.
– Decides how the use of this knowledge should be governed
when providing a service to the public.
– Is the moral principle which should guide the members of
the profession in their dealings with each other, their
patients, co-workers.
– Is a collective and disciplined concern of the group.
– Should be altruistic (unselfish) concern for the welfare of
others.
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34. Characteristics of Professional and Ethical Behavior
• Ethical Behavior
– Ethics is an inherent characteristic of professional behavior.
– Actions by a person or a group that adhere to the commonly
accepted behavioral patterns of the group.
– When faced with a choice of behaviors, a person exhibits
behavior based on accepted behaviors of the group.
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35. Review Questions
• What are the different types of ethics?
• What are characteristics of professional and ethical behavior?
• The next chapter is Chapter 2: Interpersonal Relationships.
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37. 2.1. Interpersonal relationships with patients
• Medical Laboratory professionals are accountable for the
quality and integrity of the laboratory services they provide .
• The medical laboratory technologist should:
– always regard concern for the best interests or well-being of your
patients as your primary professional duty.
– honor the trust of your patients
– be mindful that a medical laboratory science practitioner is in a position
of power over a patient and avoid abusing your position.
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38. Interpersonal relationships with cont’d
• The medical laboratory technologist should:
– respect patients’ privacy and dignity
– treat patients politely and with consideration
– apply the principle of informed consent as an on-going process
– recognize the rights of patients to expect that you will not pass
on any personal and confidential information you acquire in the
course of your professional duties, unless they agree to
disclosure or the law demands.
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39. Interpersonal relationships with, cont’d
• The medical laboratory technologist should:
– Ask patients’ permission before sharing information with
their spouses, partners or relatives.
– always seek to give priority to the laboratory diagnostic
service to patients solely on the basis of clinical need.
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40. 2.3. Interpersonal relationship with visitors
The medical laboratory technologist should:
• Explain to family and visitors that your first duty is to honor
the trust and confidentiality of your patients.
• Be polite and respectful of family and visitors and offer to
answer questions for directions; questions about the patient’s
condition should be directed to the patient (or clinician with
patient approval).
• Respect family and visitor dignity.
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41. 2.4. Interpersonal relationship with colleagues and
other health professionals
The medical laboratory technologist should:
• Not make a patient doubt a colleagues’ knowledge or skills by
making comments about them that cannot be fully justified.
• Actively strive to establish cooperative and respectful working
relationships with other health care professionals with the
primary objective of ensuring a high standard of care for
the patients they serve.
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42. Interpersonal relationship with colleagues cont’d …
The medical laboratory technologist should:
• Not discriminate against colleagues, including professionals
applying for posts
– Because of race, culture, ethnicity, social status, lifestyle, perceived
economic worth, age, gender, disability, communicable disease status,
sexual orientation, religious or spiritual beliefs.
• Refrain from speaking ill of colleagues or other health care
professionals.
• Share their knowledge with colleagues and promote learning.
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43. 2.5. Medical laboratory patient-relationships
• Is the cornerstone of medical practice.
• Remember the health of your patient should be your first
consideration.
• Following topics pose problems to medical laboratory
professionals in their daily practice.
– Communication and consent,
– Confidentiality.
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44. Communication and consent
• The patient has the right to self- determination, to make free
decisions regarding himself/herself.
• The medical laboratory professional will inform the patient of
the consequences of his/her decisions.
• A mentally competent adult patient has the right to give or
withhold consent to any diagnostic procedure or therapy.
• The patient has the right to the information necessary to make
his/her decisions.
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45. Communication and consent
• The patient should understand clearly the purpose of any test
or treatment, what the result would imply, and what would be
the implication of withholding consent.
• Competent patients have the right to refuse treatment, even
when the refusal will result in disability or death.
• As an ethical concern if a patient is not mentally capable to
make a decision, a surrogate decision maker needs to be part
of the discussion.
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46. Communication and Consent
• The surrogate decision maker is a person designated by the
patient to make medical decisions in the event the patient is
unable to.
Informed Consent:
• Definition: A patient’s willing acceptance of a medical
intervention after adequate disclosure from the health
professional of the nature of the intervention, risks, benefits
and alternative treatment options.
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47. Informed Consent
• What constitutes informed consent?
– Disclosure: information to allow reasonable person to make
a decision.
– Understanding: comprehension of the information given.
– Voluntary: no force or incentive to accept or deny a
treatment.
– Agreement: verbal or written (preferred) to discussed
intervention.
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48. Confidentiality
• The medical laboratory professional’s duty to keep patient
information confidential has been a cornerstone of medical
laboratory ethics.
• It shall preserve absolute confidentiality on all s/he knows
about her/his patient even after the patient has died.
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49. 53
Confidentiality
• Patient confidentiality must be upheld.
• Breaching patient confidentiality may be merited only:
– When ordered by court of law – a court case
– Where statutory/legal requirement – public health laws
– Where required in health professional’s defense –malpractice suit
– Where necessary for appropriate patient care-speaking to another
provider in the medical care system .
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51. Ethical Dilemma
• Situations in which two or more moral obligations, duties,
rights, or ideals come into conflict.
– there is no clear right or wrong answer or there may be
more than one correct solution.
• To resolve we must identify the factors, gather facts, rank
moral considerations, consider alternative courses of actions,
and arrive at a judgment.
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52. Resolution of Dilemmas
• Some dilemmas are resolved because they are not moral
dilemmas.
• Some MORAL dilemmas can be resolved through a creative
third alternative that satisfies both moral outcomes.
• Or, possible to sequentially act on each one.
• Or, evaluation will show which is strongest moral explanation
and decision.
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53. 3.1.1 Moral Theory
Is a broad perspective which:
• helps us decide which element of a moral problem is most
important (e.g. consequences, rights, goods, virtues, etc.)
• helps us resolve conflicts between rules and between values.
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54. How We Come by Moral Theories
• Family
• Religion
• Culture
• Experience and reflection
• Education
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55. Moral Action Theories – “Doing”
Based on:
1. consequences for community
2. rights of individuals
3. duties of individuals
4. Virtues/high merit
• What correct course of action should I take?
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56. Human Goods
• Human life considered to be fundamental good, pre-
conditional good.
• Human life is not measurable, “life is priceless”.
• Leads to dilemmas in the workplace.
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57. 1. Consequentialism
• argues that the morality of an action is contingent on the
action's outcome or result.
• The greatest good for the greatest number
• an act is right only if it tends to result in the greatest net good
• all acts are potentially permissible; depends on consequences
• all persons count equally
• difficult to determine which consequences, what probability,
what weight?
• May sacrifice individuals for greater good
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58. Consequentialism cont’d
– Utilitarianism:
• one forms of Consequentialist theories which holds that
an action is right if it leads to the most happiness for the
greatest number of people.
• Utilitarianism: finds the ethical criterion in the greatest
good for the greatest number.
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59. 2. Rights-Based Theories
• Right = justified claim on someone
• Right-holder may or may not claim right
• An act is morally right if it respects and upholds rights
• Respects individuals, bearers of rights
• Good of community may be sacrificed for right of individual.
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60. 3. Duty-Based Theories
• Duty = obligation, responsibility
• Considers motive or intention of decision-maker, plus nature
of act, rights, consequences
• Good motive, means are acceptable, nature of act is good
• Consequences are of secondary consideration
• Recognizes complexity
• Value of individual is important
• May sacrifice community good for the sake of individual
duty
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61. 4. Virtue-Based Theories
• Act for the sake of virtue, or as a virtuous person would
• A virtue is a good character trait or disposition
• Tendency to act in a way that promotes human good or human
flourishing
• More people affected by virtue than fewer
• More virtues expressed than fewer
• BUT, some virtues may be more important than others
• Virtues may be culturally specific
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63. 3.1.2 Ethics and Law
Description of Ethics and Law:
• Medical ethics and the law are not the same, but often help
define each other
• Breach of ethical obligation may not necessarily mean breach
of law
• Breach of ethical obligation may be used to prove medical
malpractice or medical negligence
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64. 3.1.2 Ethics and Law
• Ethics consists of far more than abiding by rules, procedures,
and guidelines.
• Even the most detailed of laws cannot govern every aspect of
our laboratory experience or keep pace with the explosion of
knowledge and technology we have seen in the medical field.
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65. 3.1.2 Ethics and Law cont’d
Description of Ethics and Law:
• Much of what is ethical is unaddressed by legal rules.
• The law from its inception was meant for adjudicating
conflicts in a way to preserve the basic societal order.
• Legal codes set a general standard of conduct which must be
adhered to in civil law.
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66. Ethics and Law
• Ethics is not adopted into law, but is a major professional &
moral guiding principle, even though it is unenforceable.
• Simply stated, ethics represents what we should do, not what
we must do.
• It represents an expression of conscience rather than the
obligatory fulfillment of governmental fiat.
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67. Ethics vs Law
• Law – the authority is external
• Ethics – the authority is internal
• Much of law, but not all, is based in morality
• Sometimes law is unethical
• Much of what is ethical is unaddressed by legal rules
• There is a moral duty to obey the law (with some caveat)
• Professional ethics covers more issues than the law
• One can be unethical without behaving illegally
• Rare – ethically must resist the law
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68. Ethics vs Law
•Be very careful not to embark in an exercise in ethical analysis
when there is a clear legal rule in the situation that trumps the
entire process of ethical analysis.
• Be very careful not to assume that there is a legal rule for every
situation.
•Often the gaps between legal rules require one to switch to an
ethical analysis.
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69. 3.1.3 Ethics and Medical Laboratory Science
• Health professional’s ethics emanated and expressed through:
– Law
– Institutional policies
– Policy of professional organization
– Professional standards of care
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70. 3.1.3. Ethics and medical laboratory science, cont’d
Responsibility/ethical duty of Medical Laboratory
Professionals:
• A moral duty to obey the law
• Professional ethics covers more issues than the law
• Behaving unethically without behaving illegally
• Ethical decision rarely must resist the law
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71. 3.2.1. Professional Responsibility
Professional responsibility:
– is the area of practice that encompasses the duties/ethics of
medical laboratory professionals to:
Act in a professional manner
Obey the law
Avoid conflicts of interest
Put the needs of patients ahead of their own interests.
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72. References for Chapters 1-3
• Ethiopian Medical Laboratory Association (Ethiopia Medical
Laboratory Association) Code of Ethics for Medical
Laboratory Technologists Practicing in Ethiopia, 2008
• Medical Ethics Manual, World Medical Association, 2005
• James M. Gripando. Nursing Perspectives and Issues; Delmar
publishers INC 3rd edition
• International Federation of Biomedical Laboratory Science
(IFBLS) code of ethics IFBLS general assembly of delegates,
1992
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73. Chapter 4:
Rights and Obligations of
Medical Laboratory
Professionals:
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74. Objectives
• Upon completion of this session the student will be able to:
• Describe rights of medical laboratory professionals
• Discuss obligations of medical laboratory professionals
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75. Rights of Medical Lab Professionals
• -safe working environment
• -appropriate wage, allowance
• -legal protection
• -security
• -Insurance for occupational hazard
• -access to medication
• --professional risk allowance
• -standard work load
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76. Rights of Medical Lab Professionals
• -proper annual leave (maternity/paternity leave)
• Right to exercise our profession ethically and legally.
• Testing by the professionals not non-lab
• License for Med Lab personnel (not necessarily pharmacists)
• Procurement of lab commodities.
• The right to participate in health facility management (not
pipette) and policy making.
• Vaccination
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77. Right and obligation of medical laboratory
professionals:
4.1. Honesty
4.2. Dependability
4.3. Kindness and firmness
4.4. Humanity and Justice
4.5. Maintaining good reports
4.6. Adaptability
4.7. Co-operation
4.8. Ethical behaviors
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78. 4.1. Honesty
• In performing lab testing
• In reporting lab results
4.2. Dependability
• Taking your position seriously
• Being at work when you assigned to be
4.3. Kindness and firmness
• Use compassion with patients and co-workers
• Remain firm in your duties and in doing what is right and best
for your patient.
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79. 4.4. Humanity and Justice
• Be fair in running all patients’ laboratory tests.
• Put yourself in the patient’s position before you argue or say
something you will regret.
• Put yourself in your co-worker’s position before you argue or say
something you will regret.
4.5. Maintaining good reports
• Use good handwriting when signing out patient results.
• Take your time to record all patient information in all log books.
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80. 4.6. Adaptability
• Be willing to change work hours to help a co-worker
• Be willing to stay at work a little longer if patient work is not
completed
• Be willing to make changes in testing procedures and other areas
as needed
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81. 4.7. Co-operation
• If you expect others to co-operate with you, you need to co-
operate with them.
• Team work will finish lab work quicker than an individual.
4.8. Ethical behaviors
• In all that you do, base your actions and decisions on ethical
behavior.
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82. Chapter 5:
Duties and responsibilities of Medical Laboratory
Professionals:
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83. Objectives
• Upon completion of this session the student will be able to:
• List the duties of a medical laboratory professional
• Describe the responsibilities of medical laboratory professionals.
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84. 5.0 Duties and responsibilities of medical laboratory
professionals:
5.1. Discuss duties and responsibilities of medical laboratory
professionals
5.1.1. duty to self
5.1.2. duty to profession
5.1.3. duty to society
5.1.4. duty to environment
5.1.5. duty to patients
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85. 5.1.1. Duties to yourself
The medical laboratory technologist should:
• Maintain and improve the standard of your performance by
keeping your professional knowledge and skills up to date
throughout your working life.
• Acknowledge the limits of your professional knowledge and
competence. Do not pretend to know everything.
• Use equipment and laboratory ware correctly and with care.
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86. 5.1.1 Duties to yourself, cont’d
The medical laboratory technologist should:
• Refrain from engaging in activities that may affect your health
and lead to impairment.
• Be aware of laws and regulations governing medical
laboratory technology .
• not waste reagents and other laboratory supplies.
• not drink alcohol during laboratory working hours or when on
emergency stand-by.
• follow safety procedures and know how to apply first aid.
• never taking anything from place of work that does not belong
to you.
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87. 5.1.2. Duties to your profession
The medical laboratory technologist should:
• uphold and maintain the dignity and respect of medical
laboratory profession.
• strive to maintain a reputation of honesty, integrity and
reliability.
• contribute to the advancement of the profession by
– improving the body of knowledge,
– adopting scientific advances that benefit the patient.
– maintaining high standards of practice and education, and
– seeking fair socioeconomic working conditions for
members of the profession.
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88. • promote the image and status of your profession by
maintaining high standards in your professional practice and
through active support of your professional bodies.
• take responsibility for your professional acts.
• not misuse your professional skills or knowledge for Personal
gain.
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89. 5.1.3. Duties to Society
The medical laboratory technologist should:
• Deal responsibly with scarce health care resources.
• Dedicate themselves to serve the healthcare needs of the
public.
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90. 5.1.4 Duties to the environment
The medical laboratory technologist should:
• Protect the environment and the public by assuring that health
care waste is disposed of legally and in an environmentally
friendly manner.
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91. 5.1.5 Duties to Patients
Medical laboratory professionals Obligations:
• always regard concern for the best interests or well-being of your
patients as your primary professional duty.
• honor the trust of your patients.
• be mindful that a medical laboratory science practitioner is in a
position of power over a patient and avoid abusing your position.
• respect patients’ privacy and dignity.
• treat patients politely and with consideration.
• apply the principle of informed consent as an on-going process.
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92. • recognize the rights of patients to expect that you will not pass on
any personal and confidential information you acquire in the
course of your professional duties, unless they agree to disclosure
or the law demands.
• ask your patients’ permission before sharing information with
their spouses, partners or relatives.
• always seek to give priority to the laboratory diagnostic service
to patients solely on the basis of clinical need.
“Medical Laboratory professionals are accountable for the
quality and integrity of the laboratory services they provide”
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93. “Remember the patient is the reason, and the
only reason for your professional existence:
In order for a patient to receive the best
care possible, you must make proper
diagnosis.”
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94. Chapter 6
The Patient’s Bill of Rights and
Law
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95. Objectives
Upon completion of this session the students will be able to:
• Define terms such as bill of rights, malpractice, tort law,
licensure, accreditation and certification
• Describe example patient bill of rights such as from the
American Hospital Association
• Discuss how Ethiopia is addressing the patient’s bill of rights.
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96. 6.0. Patient’s bill of rights:
All patients have the:
• Right to truth
• Right to refuse treatment
• Right to know about Informed consent
• Right to privacy
• Right to get complete information concerning his diagnosis,
treatment.
• Right to know Ethiopian medico-Legal issues (code of law)
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97. 6.6. Right to know Ethiopian medico-Legal issues (code of
law)
• The patient has the right to be informed of hospital policies
and practices that relate to patient care, treatment, and
responsibilities.
• The patient has the right to be informed of available resources
for resolving disputes, grievances, and conflicts, such as ethics
committees, patient representatives, or other mechanisms
available in the institution.
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98. Legal concepts in Medical Laboratory
General Legal Concepts
• Law:
– defined as those rules made by humans who regulated social
conduct in a formally prescribed and legally binding manner.
– based upon concerns for fairness and justice.
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99. Functions of Law in Medical Laboratory
• It provides a framework for establishing which medical
laboratory action in the care of client are legal.
• It differentiates the medical laboratory professionals
responsibilities from those of other health professionals.
• It helps to establish the boundaries of independent medical
laboratory action.
• It assists in maintaining a standard of medical laboratory
practice by making medical laboratory professional accountable
under the law.
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100. Types of law
• Public Law: refers to the body of law that deals with
relationships between individuals and governmental agencies.
• Private Law: is the body of law that deals with relationship
between individuals.
• Contract Law: involves the enforcement of agreements among
private individuals or the payment of compensation for failure
to fulfill the agreements.
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101. Types of law cont’d
• Tort Law: the word tort means “wrong” or “bad” in Latin.
• It defines and enforces duties and rights among private
individuals that are not based on contractual agreements.
• Example of tort law applicable to medical laboratory,
negligence and malpractice.
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102. Legal Aspects of Laboratory Medicine
A. Malpractice: legally, a failure to provide the standard of care
that is due a patient, i.e. professional negligence.
B. Three distinct elements must be present
1. Patient must have sustained measurable injury.
2. Court must find negligence on the part of the defendant
that professional standards of care was not followed.
3. There must be proof the negligence was the cause (legal
term: proximate cause) of the patient's injury.
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103. Most Common Areas of Potential Negligence
• Misidentification, mislabeling .
• Instrument failure: poor Quality Control, failure to standardize
instrument, jammed key on automatic printout device,
misplaced decimal points on calculations, inversion of numeric
values.
• Specimen validity: proper collection and handling.
• Venipuncture.
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104. Legal issues in Medical Laboratory
Medical Laboratory Practice Act:
• regulate the practice of medical laboratory.
• Legally define and describe the scope of medical laboratory practice, which
the law seeks to regulate, there by protecting the public as well
• It protects the user’s professional capacity
• Each country may have different acts but they all have common purpose: to
protect the public
• It grants the public a mechanism to ensure minimum standards for entry into
the profession and to distinguish the unqualified.
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105. Standards of professional Practice
• attempts to ensure that its practitioners are competent and safe
to practice through the establishment of standard practice.
• Establishes and implements standards of practice are major
functions of a professional organization.
• The profession’s responsibilities inherent in establishing and
implementing standards of practice include:
– To establish, maintain, and improve standards
– To hold members accountable for using standards
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106. – To educate the public to appreciate the standard
– To protect the public from individual who have not attended
the standards or will fully do not follow them
– To safeguard individual members of the profession
• When standards of professional practice are implemented, they
serve as yardstick for the measurements used in licensure,
certification, accreditations, quality assurance, peer review, and
public policy.
• The profession maintains standards in practice in part through
appropriate entry.
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107. Credentialing
• is the process of determining and maintaining competence-
medical laboratory practice. Credentials include:
• Licensure
• Registration
• Certification
• Accreditation
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108. Credentialing, cont’d
• Licensure: it is a legal permit a government agency grants to
individuals to engage in the practice of a profession and to use
particular title.
• Registration: is listing of an individual’s name and other
information on the official roster of a governmental agency.
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109. Credentialing, cont’d
• Certification: is the voluntary practice of validating that an
individual medical laboratory professional met minimum
standards of medical laboratory competence.
• Accreditation: is a process by which a voluntary organization
or governmental agency appraises and grants accredited status
to institutions and/or programs.
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110. CODE OF ETHICAL CONDUCT
Chapter 7:
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111. Objectives:
• Upon completion of this chapter the student will be able to:
• Describe the medical laboratory code of conduct
• Describe the IFBLS code of conduct
• Describe the EMLA code of conduct
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112. 7.0. Medical Laboratory code of
conduct
• Code of ethics is a formal statement of a group’s ideas and
values that serve as standards and guidelines for the groups’
professional actions and informs the public of its commitment.
• A code of ethics provides members of a profession with
standards of behavior and principles to be observed regarding
their moral and professional obligations toward one another,
their clients, and society in general.
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113. 7.0. Medical Laboratory code of conduct continued.
• Code of ethics is generally developed by a
professional society within a particular
profession.
• The higher the degree of professionalism
required of society members, the stronger and
therefore more enforceable the code.
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114. Medical laboratory code of conduct cont’d
Purpose of medical laboratory code of ethics:
• To inform the public about the minimum standards of
profession and to help them understand professional medical
laboratory conduct.
• To provide a sign of the profession’s commitments to the
public it serves.
• To outline the major ethical considerations of the profession
• To provide general guidelines for professional behavior.
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115. Medical Laboratory code of conduct cont’d
• To guide the profession in self regulation
• To remind medical laboratory professionals on the special
responsibility they assume when they perform their duties.
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116. Medical Laboratory code of conduct
International Federation of Biomedical Laboratory Science
(IFBLS) Code of Ethics
• medical laboratory is universal
• Inherent in medical laboratory is respect for life, dignity, and
rights of human.
• It is unrestricted by considerations of nationality, race, color,
age, sex, politics or social status.
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117. IFBLS Code of Ethics:
Biomedical Laboratory Scientists shall:
• Safeguard the dignity and privacy of patients.
• Be responsible for the logical process from the acquisition of
specimen to the production of data and the final report of the
test result.
• Be accountable for the quality and integrity of clinical
laboratory services.
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118. Medical Laboratory Ethics in Ethiopia
Ethiopian Medical Laboratory Association (EMLA)
prepared code of ethics for Medical Laboratory
Professionals practicing in Ethiopia. It includes of six
parts.
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119. Code of Ethics for Medical Laboratory Technologists
Practicing in Ethiopia
• Deals with medical laboratory professional duties to patients
(Part I)
• Explains medical laboratory professional duties to
colleagues and other professionals (Part II)
• Clarifies medical laboratory professional duties to
himself/herself (Part III)
• Focuses on medical laboratory professional duties to society
(IV)
• Deals with medical laboratory professional duties to the
medical laboratory profession (Part V)
• Explains medical laboratory professional duties to
environments (Part VI)
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121. Professional Codes and Justice
• Accountability: punish professionals who violate standards.
• Duty to report colleagues’ wrong-doing for retributive
justice to be carried out.
• Fairness in distribution of professional services (no
discrimination)
– warning, reprimand, suspension, expulsion from group
– More than one form of justice can be in play at same
time
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122. Compassion
Two rules:
• Alleviate suffering
• Act in other person’s actual (to them) best interest
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125. Objectives
Upon completion of this chapter the student will be able to:
• Define Good Laboratory Practice
• Describe what constitutes good laboratory practice
• Discuss situations in which good laboratory practice is not
exhibited
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126. 8.0 Good Laboratory Practices (GLPs)
• Laboratory services are an integral part of disease diagnosis,
treatment, monitoring response to treatment, disease
surveillance programs and clinical research.
• Laboratory test results, therefore, should be reliable, accurate
and reproducible.
• Generation of such 'quality' results involves a step wise
process of meticulous planning, perfect execution and
thorough checking of results by the whole team involved.
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127. Good Laboratory Practices
• In the clinical and research area, the phrase good laboratory
practice or GLP generally refers to a system of management
controls for laboratories and research organizations to ensure
the consistency and reliability of results.
• Good Laboratory Practice (GLP) embodies a set of principles
that provides a framework within which laboratory studies are
planned, performed, monitored, recorded, reported and
archived.
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128. GLP includes
– Infrastructure
• Infrastructure of laboratories should be planned
according to the services provided by the laboratory.
– Equipment
– Reagents and materials
– Specimen collection
– Requisition form
– Accession list
– Worksheet
– Reporting test results
– Specimen rejection record
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129. GLP includes
– Data management (recording, reporting and archiving)
– Standard operating procedure (SOP)
– Safety in laboratories (to protect both staff and the
environment)
– Ethical considerations
– Quality assurance: the total process whereby the quality of
laboratory reports can be guaranteed.
– IQC
– External quality assessment
– Internal audit (identify problems and weak points in the
system and suggest remedial measures
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130. Chapter 9:
Legal and Ethical Issues in HIV/AIDS
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131. Objectives
Upon completion of this chapter the student will be able to:
• Discuss the rights and privileges of HIV infected persons;
• Explain the features of HIV that raise legal and ethical issues;
• Discuss international guidelines on HIV/AIDS legal and
ethical issues
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132. Introduction
• Various ethical and legal controversies have arisen in relation to
HIV/AIDS. These include issues on:
Testing for HIV and the debate on whether or not it
should be voluntary or mandatory;
Confidentiality of HIV test results with ethical dilemmas
on medical technologist/Patient relationship,
employer/employee situation, partner notification to
mention but a few;
Discrimination of people living with HIV/AIDS in terms
of employment and the provision of services;
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133. Introduction Cont’d
Gender issues to do with wife inheritance, marital rape,
property rights of women and inheritance and wills;
Criminalization of what is popularly referred to as
deliberate infection with HIV;
Ethics of research.
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134. Introduction Cont’d
• Epidemiological data shows that the spread of HIV/AIDS is
disproportionately high among some populations e.g. women,
children, those living in poverty, minorities, migrants, etc.
• This can be attributed to lack of human rights protection which
dis-empowers these groups to avoid infection and cope with
HIV/AIDS.
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135. Introduction Cont’d
• Transgression of human rights such as the use of coercion or
discrimination drives infected individuals underground where
they further spread the virus.
• That is why in 1998 the United Nations came up with the
HIV/AIDS and Human Rights International guidelines.
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136. Human Rights Principles relevant to HIV/AIDS
• The right to non-discrimination, equal protection and equality
before the law;
• The right to life;
• The right to the highest attainable standard of physical and
mental health;
• The right to liberty and security of person;
• The right to freedom of movement;
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137. Human Rights Principles relevant to HIV/AIDS
• The right to seek and enjoy shelter and protection
• The right to privacy;
• The right to freedom of opinion and expression and the right
to freely receive and impart information;
• The right to freedom of association;
• The right to work;
• The right to marry and to found a family;
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138. Human Rights Principles relevant to HIV/AIDS
• The right to equal access to education;
• The right to an adequate standard of living;
• The right to social security, assistance and welfare;
• The right to share in scientific advancement and its benefits
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139. Human Rights Principles relevant to HIV/AIDS
• The right to participate in public and cultural life;
• The right to be free from torture and cruel, inhuman or
degrading treatment or punishment.
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140. Legal framework for HIV/AIDS Care
• Non-Discrimination and Equality before the Law
All forms of negative discrimination against persons
infected or affected by HIV/AIDS by reason of
their health status,
relation or association with infected persons are unconstitutional
and unallowable.
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141. Legal framework for HIV/AIDS Care
• Testing for HIV
Mandatory testing for HIV/AIDS should be prohibited.
HIV testing must be carried out with the specific, prior and
informed consent of those being tested, with pre-
counselling and post-counselling, and with the guarantee of
confidentiality.
Counselling should be culturally and contextually
appropriate, sensitive to issues of sexual identity and
orientation, and ought to be conducted in a language best
understood by the persons counselled.
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142. Legal framework for HIV/AIDS Care
Testing without prior and informed consent may be
permissible on grounds of necessity and only, for the
patient’s health interests, where the patient is without the
ability to consent within the period available, or in
emergencies.
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143. Legal framework for HIV/AIDS Care
• Informed consent
Every human person has the right to determine what should
happen to, or to be done with, his/ her body in accordance
with his/her chosen values and priorities, even in poor
physical health.
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144. Legal framework for HIV/AIDS Care
• Indirect Testing, Screening of Blood, Semen and Body
parts Donated.
Screening blood and body parts for HIV/AIDS without the
consent of the donor may be unlawful and actionable in
law;
Anonymous screening of blood and human organs for
HIV/AIDS may be objectionable for reasons of compelling
human safety.
No blood should be transfused or human organ transplanted
without ascertainment of its sero-negativity.
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145. Legal framework for HIV/AIDS Care
• Anonymous and unlinked testing of populations and groups
for HIV/AIDS may not cease to be unlawful by reason of the
ignorance of the action or injury of each or all constituted in
the populations tested.
• such anonymous and unlinked testing of populations or groups
for HIV/AIDS may be allowable for epidemiological purposes
to enable surveillance and control.
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146. Legal framework for HIV/AIDS Care
• Pre-Natal Testing and Testing of Newborns
All pregnant women or girls should be routinely counselled
about the advantages and disadvantages of HIV testing and
offered voluntary HIV testing.
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147. Legal framework for HIV/AIDS Care
• Confidentiality
– confidentiality in doctor-patient relationships has raised a
dilemma in the developing countries where the need to
encourage HIV testing and the need to prevent
transmissions are central to the strategy for control of the
scourge.
– The predominant mode of transmitting HIV (through
sexual intercourse) has attached a stigma to the scourge,
and many would rather not know their status, and where
they know, they would not disclose their status because of
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148. Legal framework for HIV/AIDS Care
People who are known to be living with HIV and those with
AIDS have suffered discrimination at all levels; in the family,
in schools, in employment, in treatment facilities, in social
places and in other places and situations.
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149. Legal framework for HIV/AIDS Care
• Health care workers at risk of infection
Do they need to know the HIV status of their patients and vice
versa?
Do they need post-exposure ARV prophylaxis?
How does one deal with issues of consent and confidentiality
of HIV results in these special circumstances?
Do Health Workers require protective gear at workplace?
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150. Legal framework for HIV/AIDS Care
• Health Care Workers need not know the HIV status of their
patients and must at all times adopt the safety measures
provided by the universal standards.
• Equally there is no legal justification for the patient to know
the HIV status of the Health Care Provider.
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