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1. ETHICS IN MEDICAL
LABORATORY SCIENCES
DR.MANJU BARUA.

2. LEARNING OBJECTIVES
• By the end of this Module , you will be able to :-
• -Explain the Importance of Professional Ethics
• -Take Appropriate Actions to maintain Patient Confidentiality
• Introduction to the Code Of Conduct
• Mal practice in the Medical lab …take a rational approach
• Autonomy
• Informed Consent in Medical Lab practise

3. WHAT IS ETHICS ?
• “A SET OF PRINCIPLES OF RIGHT CONDUCT .
• WHO IS RESPONSIBLE FOR ETHICS :_
• EVERYONE ……..The Medical Doctor ,Dentists, The Medical Lab
Technologist , The Nurses . All Other Paramedical Professionals , like
the PhysioTherapists, Pharmacists , Occupational Therapists.

4. WHY IS ETHICS IMPORTANT ?
• “ DECISIONS ABOUT DIAGNOSIS, PROGNOSIS, and TREATMENT ARE
FREQUENTLY BASED ON RESULTS AND INTERPRETATIONS OF
LABORATORY TESTS , IRREVERSIBLE HARM MAY BE CAUSED BY
ERRONEOUS TESTS.
• This is per the IFCC ..International federation Of Clinical Chemistry
and Laboratory Medicine.

5. LABORATORY STAFF
• YOU ARE :
• The most critical part of the quality system .
• The Laboratory”s Greatest Assett.
• An Important Partner in Patient Care.
• YOU Also :
• Bring Integrity and Professionalism to the Healthcare Community.

6. ETHICAL CONDUCT
• DONOT get Involved in Activities that would Diminish Confidence in i
Laboratory , Competence, Impartiality, Judgement or Operations
Integrity .
• SO THAT ……THE Management Personnel shall be Free from
Financial , undue Commercial or Other Pressures and influence that
affect The Quality of Work .

7. Ethical Conduct
• Where Potential Conflict in Competing Interests may Exist shall be
Openly and appropriately Declared.

8. ETHICS IS ALSO APPLIED IN YOUR BEHAVIOUR
• Always conduct yourself in a Professional way.
• Examples of Professionalism Include :-
• Dressing Appropriately , if Lab coat or Apron is Soiled , change over
to a Clean one Immediately.
• Turning cell phones off , it is disruptive and not considerate of clients
to talk on the phone during the course testing .
• Not discussing the results of Interaction with clients with others.
• Maintaining Patient Confidentiality is a MUST

9. CODE OF ETHICS
• BIOETHICS
• MEDICAL ETHICS
• LEGAL ETHICS
• ETHICS ETHICS

10. CODE OF ETHICS (ASCP )
• Treat Patients and Colleagues with RESPECT , Care and
Thoughtfulness.
• PERFORM DUTIES in an accurate, Precise and Timely and responsible
Manner.
• SAFEGUARD patient information as Confidential, within the limits of
the law .
• PRUDENTLY use Laboratory Resources.

11. HOW DO WE APPLY ETHICS TO LAB TESTING
• Using only those kits approved for use in the Country
• Ensuring Quality Output
• Following SOPS as Written ….STANDARD OPERATIVVE PROCEDURE
• If a test procedure calls for 20 minutes Incubation or wait time
DONOT take shortcuts
• Wait full time before Recording & reporting the results

12. CONTD .
• Keeping supplies and kits in safe keeping
• Handle human tissues Organs and Cellular and Tissue Components
used in Research with consent and human dignity
• If you have questions ASK
• DONOT Falsify results

13. DUTY TO THE PATIENT
•
• Clinical Lab Professionals are accountable for the QUALITY and
INTEGRITY of the LAB Services They Provide .
• This OBLIGATION includes Maintaining INDIVIDUAL Competence in
Judgement & performance and striving to Safeguard The patient
from Incompetent or Illegal Practice by others.

14. THE RIGHT TO PRIVACY and CONFIDENTIALITY
• What Does Confidentiality Mean ?
• - Generally , if you have information about patient A then another
Person B cannot Obtain Information without the Consent of person
A
• Most people consider Health Information to be Highly personal and
therefore Need to be Confident that their Privacy will be Protected
whenever they Use a Health Care service …..Clear and open
Communication between the Health Service provider and health
Consumer is , Integral to Good Privacy .

15. WHY RESPECT CONFIDENTIALITY
• TRUST .. It is an Important between patients and Healthcare
Workers . Patients without Fear of a Breach of Confidentiality should
be able to Communicate Symptoms That they Often feel are
Embarrasing , Stigmatising or Trivial.
• Without trusting Relationship Patients May Not Divulge
Information which May make them Treating them Impossible them .
• Patients may not seek Medical Attention at all.
• Has Important Role in a “Professional Patient – Relationship “
“Establishing a Sense Of security , Freedom of action and self
respect for patients .

16. What Information is Confidential ?
• All Information Supplied By Our Patients and Other Information
that we Use in Our Daily work must remain Confidential .
• All identifiable Patient Information Confidential .. Whether Written,
Computerised, Visual or Audio recorded or Simply or Simply Held in
the Memory of Health Proffessionals , is Subject to the Duty of
Confidentiality

17. What Information is Confidential
• It Covers :-
• Any Clinical information about an Individual’ s Diagnosis or
Treatment .
• A Picture Photograph or a Video Audio tape or Other images Of The
Patient .
• Who the Patients Doctor is and what Clinics Did the Patient attend
and When
• Anything Else that can be USE TO identify THE patients Directly or
Indirectly .

18. CONFIDENTIALITY OF LAB RESULTS
• Confidentiality of Laboratory results must be Maintained at all
Times.
• Should a Person call Requesting Results and there is a Question
about The :Persons identity The Requestor is Asked for His/ Her
name And phone Number Where They Can be Called Back.

19. HOW TO MAKE CONFIDENTIALITY AT WORK
• Handle Medical Records as Confidential Documents .
• Do not Leave Patient Information and Laboratory Results
Unattended on the Patients Desk etc.
• Protect Information on Computer Screens Saver / Time out
Functionalities.

20. HOW TO MAINTAIN CONFIDENTIALITY ?
• -Check that Fax Numbers are Correct Before ending Confidential
Information and Laboratory results .
• Donot Disclose your Coworkers Private Information with Staff or
patients Unless Permission has been sought .
• Patient Information should never be Discussed with Friends or
relatives in a Social setting .

21. HOW to maintain Confidentiality ( CONTD)
• At Home :-
• -Do not Discuss withy Family or friends Patients Details and of
asked Inform them ,that you are Not Permitted to Disclose any
information. This includes the Names of Patients.
• Donot Discuss Patient information with the Media.

22. MALPRACTICE IN MEDICAL LAB
• DEFINITION : -
• Malpractice is a Dereliction of Professional Duty or a Failure to
exercise an Ordinary Degree of Professional Skill, or learning by one
( Such as a Physician ) rendering Professional Services which result in
Injury , Loss or damage

23. WHAT ARE SOME EXAMPLES OF LABORATORY
MAL PRACTICE
-Rushing the Lab results .
Mixing up Patients samples .
MisLabelling samples Constantly .
Delaying testing of a patients sample.
Using faulty or Wrong Equipment .
Sloppy Sample taking .
SAMPLE LOSS .
Inaccurate records .

24. INTRODUCTION TO AUTONOMY
• Autonomy is the state of Being Self - governing or Having the Ability
to Make ones own decision …….The State or Condition of “, “self
Governance” or leading ones life According to The Reasons , Values
or desires that are Authentically ones own .

25. • AUTONOMY IS THE BIOMEDICAL RESEARCH :-
It is an Ethical Principle that States that every person has the Right
to make an Individual Decision as to whether or not they want to
Participate in Biomedical Research Experiments .
• Potential Participants should be Educated with The facts to make an
Informed Decision .

26. INFORMED CONSENT
• Introduction :- Informed Consent is a Process by which a Human
subject who is to Participate in Research , Needs to give His or her
Own Consent ….After Being Properly informed of the Expected
Benefits AS Well, as of the Potential Harm of the Research which will
be performed .

27. WHY INFORMED CONSENT IS IMPORTANT IN A
LAB ORATORY .
• Informed consent is Crucial in Research as it Ensures Individuals have
an Informed Choice about whether to participate in a Research Study
.

28. GUIDANCE ON INFORMED CONSENT AND ETHICAL
APPROVAL REQUIREMENTS BASED ON THE STUDY
TYPE IN THE FIELD OF LAB MEDICINE.
TYPE OF STUDY STUDY DESIGN
RESEARCH The material From Patients / healthy Donors is
Collected as For Research purpose, Informed Consent
Required
METHOD /INSRUMENT VALIDATION The Use of residual Material ……..Only Ethical
approval required
The Material from Patients / Healthy Donor Is
Collected for Research purposes……..Ethical approval
required as well as Informed Consent

29. Research Showing Standard Clinical / Lab practise or
the Advancement of the Standard practices
If it Does not include a new Method or instrument
Incidence/ Epidemieologic Research ==The use of
Residual Material Or Retrospectivre Data Collection.
Informed Consent not required ,,BUT Ethical consent
is required.
LAB INFORMATION SYSTEM / ( database )Data
extraction
Retrospective data Collection . INFORMED CONSENT
NOT REQUIRED … BUT ETHICAL CONSENT REQUIRED

30. TYPE OF STUDTY STUDY DESIGN INFORMED CONSENT ETHICAL APPROVAL
Research Showing
Standard Clinical / Lab
Practices or the
advancement of the
standard Practise
Not required( it Is implied
that the informed
Consent was previously
given
Not required as It is
Considered that it is not
research But Clinical Lab
Practise

31. EXAMPLE :-
• TO EXAMINE the diagnostic Accuracy , of PROTEIN X, as a Marker of
CSF, leak ( Cerebrospinal Fluid )….Author Quantified PROTEIN X in
Blood , and Rhinorrhea Samples ,which were Further Collected fro
Patients. QUANTIFICATION of PROTEIN X was Ordered by a Medical
Doctor … So the Index test of protein X , is routinely performed in a
Lab .
• _ TYPE OF RESEARCH : Standard or Advancement of Standard
Practise.

32. Contd.
• INFORMED CONSENT … ( IC ) , NOT required.
ETHICAL APPROVAL (EA) , Is required.

33. CONTD.
• SHORT ELABORATION :_ This Study was Collected as Part of The
Standard Clinical / Lab Practice and As such does not require
informed consent . However , The Results Were Retrospectively
Collected from Patient Data - base , which required Ethical approval .

34. THE END
• THANKYOU