2. Acknowledgements
Addisa Ababa University
Haramaya University
Hawassa University
Jimma University
University of Gondar
American Society for Clinical Pathology
Center for Disease Control and Prevention-
Ethiopia
4. 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
5. 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.
5
6. 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.
6
7. 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
7
8. 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.
8
9. Medical Laboratory code of conduct
International Federation of Biomedical Laboratory
Science (IFBLS) Code of Ethics
• The need for 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
9
10. IFBLS
• Medical laboratory professionals render
services to the individual as well as to the
community at large
• IFBLS is an independent non-governmental
association of national of national societies in
35 countries, representing more than 165,000
medical laboratory scientists and
technologists worldwide.
10
11. IFBLS Code of Ethics:
Biomedical Laboratory Scientists shall:
• Be dedicated to the use of clinical laboratory science
to benefit mankind
• Actively seek to establish cooperative and specific
working relationships with other health professionals
• Provide expertise to advise and council other health
professionals
• Maintain strict confidentiality of patient information
and test results
11
12. 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
12
13. IFBLS Code of Ethics:
Biomedical Laboratory Scientists shall:
• Exercise professional judgment, skill and care while
meeting established standards
• Uphold and maintain the dignity and respect of the
profession and strive to maintain a reputation of
honesty, integrity and reliability
• Strive to improve professional skills and knowledge
and adopt scientific advances that benefit the
patient and improve the delivery of test results
13
14. Medical Laboratory Ethics in Ethiopia
Ethiopian Medical Laboratory Association (EMLA)
prepared code of ethics for Medical Laboratory
Professionals practicing in Ethiopia. It comprises
of six parts.
14
15. 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)
15
17. 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 17
21. Chapter 7 Review Questions
• What is a code of conduct?
• What are some similarities and some
differences in the Ethiopian Medical
Laboratory association code of conduct and
that of the IFBLS?
• Next is Chapter 8: Good Laboratory Practice
21
23. 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
23
24. 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.
24
25. Good Laboratory Practices
• In the clinical and research arena, 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.
25
26. 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
26
27. 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
27
28. Summary and Review Questions
• There are many elements of GLP.
• What is needed to provided good laboratory
practice?
• What is a safety practice that would prevent
GLP?
• What is an ethical situation when GLP is not
maintained?
• Next is chapter 9: Legal and Ethical Issues In
HIV/AIDS patients
28
30. 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
30
31. 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; 31
32. 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.
32
33. 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.
33
34. 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.
34
35. 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;
35
36. Human Rights Principles relevant
to HIV/AIDS
• The right to seek and enjoy asylum;
• 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;
36
37. 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
37
38. 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.
38
39. Special Features of HIV/AIDS And Their
Consequences
Feature Consequences
New epidemic infection Fear, misunderstanding, stigma and denial
Long asymptomatic
period & life-long
infectivity
Infected persons are often unaware, therefore no
action is taken until people become ill
No cure, life-long
treatment, potential
treatment failure and
side effects of drugs
Intensifies fear over testing, burden on family &
health services
Demands exceptionally high standard of laboratory
services because of potential for false HIV positive &
negative results and the consequences that may
follow
HIV is a sexually
transmitted disease
Associated with guilt & shame
This is a neglected area of health services
STI which can be
vertically transmitted
Diagnosis in child implies a diagnosis in the mother
& often the father
39
40. Special Features of HIV/AIDS And Their
Consequences Cont’d
Perception that initial spread
associated with "deviant"
behaviour and marginalized
groups
Core groups neglected by health services/hard to
reach
Associated with stigma and
myths
Patients reluctant to come forward for testing;
Health care workers reluctant/afraid to provide
services
Affects young adults Severe secondary costs due to loss of productive
years of life and burden on the family
Multi-system disease Multiple medical problems
Multiple drugs needed
Unpredictable
Needs very active palliative care and diagnosis of
opportunistic infections
40
41. 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.
41
42. 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.
42
43. 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
43
44. Legal framework for HIV/AIDS Care
• Informed consent
Recognizing the fundamental ethical and legal
principle of autonomy as the basis of the doctrine
of 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.
44
45. 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 seronegativity.
45
46. Legal framework for HIV/AIDS Care
• Anonymous and Unlinked Testing of
Populations and Groups.
Whereas 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 out of necessity for epidemiological
purposes to enable surveillance and control.
46
47. 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.
47
48. Legal framework for HIV/AIDS Care
• Confidentiality
– The noble principle of 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 the discrimination and
stigmatization that is likely to follow.
48
49. 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.
49
50. 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?
50
51. 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.
51
52. Summary of Chapter 9
Review Questions:
• What rights and privileges do persons infected
with HIV have?
• Why are there special legal and ethical issues
for patients with HIV/AID?
• What are the international guidelines on
HIV/AIDS legal and ethical issues?
52
53. References for Chapters 7-9
• 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
53