The document discusses several key issues regarding ethics, legal issues, and consumer rights in laboratory medicine. It notes that diagnostic laboratories play a crucial role in clinical care but many have questionable quality. Common complaints against pathological labs include providing wrong reports, misleading information, overcharging, and poor hygiene. The document emphasizes that both clinicians and laboratories share responsibility in issues of mortality and morbidity. It outlines consumers' rights to file complaints under the Consumer Protection Act regarding problems with pathological labs. Improving laboratory standards, transparency, and accountability is important to better serve patients and public health.

1. ETHICAL,, LEGAL, AND CONSUMER
ISSUES IN LABORAOTRY MEDICINE
Dr.T.V.Rao MD
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2. I am grateful to
The authorities at Jagran Lakecity University and
Consumer Advocacy Group
Dr. Deevanshu Shrivastava, Head, Faculty of Law
Dr. PVVS Murthy, Founder, CAG
Dr. K. Pattabhiramaiah
Dr. Uday Prakash Warunjika
Ms. Madhu Latha
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3. The talk will discuss
•Need for improved laboratory services
•Ethics and consumer rights in Laboratory
Medicine
•Who is responsible in Morality and
Morbidity issues
Is it clinician? or Laboratory?
•Consumer rights? WHERE ARE WE TODAY ?
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4. MEDICINE IS MOVING FROM HUMAN
TOUCH TO MECHINE CARE
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5. MEDICAL PROFESSION AND MEDICAL
NEGLIANCE ???
•Medical profession is considered to be a
noble profession however, it has been time
and again placed under scrutiny and so
have all persons working in this profession.
Medical negligence is considered to be one
of the most crucial concerns not just in our
country but throughout the world.
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6. Laboratory services and Impact on
Health care delivery
•Healthcare delivery and responsibility is changing.
Patient-centered care is gaining international
acceptance with the patient taking greater
responsibility for his/her health and sharing decision
making for the diagnosis and management of illness.
Laboratory medicine must embrace this change and
work in a tripartite collaboration with patients and
with the clinicians who use clinical laboratory
services. I
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7. Clinical care Depends on Laboratory
standards
• Currently diagnosis and
management of patients in
Clinical Practice is very much
dependent on laboratory
diagnostics. Laboratory
Medicine, like any other
branch of Medicine, is
therefore, mandated with
ethical usage of materials and
data obtained from patients.
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8. Population and Health care
challenges
•But problems like higher
population density, low
socioeconomic status
and low literacy rate in
some parts of the
country, have resulted
in poor health
indicators.
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9. WHY THE ISSUES IN MEDICAL
PROFESSION ARE COMPLEX
•The medical profession is a bit different
from others for being in a noble and
respected area of work.
Thus, it is the legal responsibility of
Doctors and pathological laboratories
to provide the proper medical services
to the patients.
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10. COVID 19 WAKES UP ????
• But, in the Covid-19
pandemic time, citizens are
often facing negligence,
fraudulent actions from
the pathological labs,
Hospitals and even
physicians and
do not get the legal
pathway to claim justice
against the same.
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11. Fraud in Medical profession in
USA
•In June 2018, the US Department of Justice held
nearly 600 individuals, including doctors,
responsible for the largest healthcare fraud in the
US history resulting in losses of over US$2 billion.
Each year, the American healthcare system loses
tens of millions of dollars to fraudulent claims not
only overloading the healthcare system but also
affecting the security and identity of patients and
other citizens.
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12. Diagnostic and consumer
issues in Laboratory
Medicine
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13. POOR LABORATORY SERVICE THREAT
TO LIFE
• It is seen that a lot of times
the pathology labs fail to
provide the needed medical
aid that can be dangerous for
the patient too. As per the
legal directives of the
Consumer Protection
Act, 2019, of the Indian
Govt. we can file a complaint
against a Pathological Lab
meant for such
circumstances.
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14. New Consumer Protection law in India:
A Simple Overview
•On July 20th, 2020, the new Consumer Protection
Act, 2019 came into force in India, replacing the
previous enactment of 1986. The new Act overhauls
the administration and settlement of consumer
disputes in India. It provides for strict penalties,
including jail terms for adulteration and for
misleading advertisements. More
importantly, it now prescribes rules for the sale of
goods through e-commerce.
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15. We can file complaint
• As per the legal directives of
the Consumer Protection Act,
2019, of the Indian Govt. we
can file a complaint against a
Pathological Lab meant for
such circumstances. Common
Complaints against
Pathological Labs Wrong
reports made in Covid-19
cases Misleading information
and report
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16. How diagnostic labs are failing patients in
India in terms of poor standards
•Between 2012 and 2019, there was a
nearly 200 per cent jump in the number
of diagnostic laboratories that have
accreditation, a gold standard which
offers an assurance to patients of
quality services and reliable reports.
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17. GROUND REALITIES ON
LABORATORYSERVICES
•While the figure gives hope,
especially as it concerns a sector
which has little to do with rules
and regulation,
The state of affairs on the
ground remains grim.
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18. WHO WILL APPROVE THE
LABORATORY REPORTS
•Laboratories put the decision to
treat in the Hands of the Clinicians
as all the laboratory results are
subject to clinical assessment
•So it difficult to file complaints on
Laboratory results
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19. Error reporting in Laboratory
results
•Biochemistry common errors in Blood sugar
estimations lipid profiles and thyroid screening tests
•Screening for
•HIV ,Hepatitis B and C
•Blood Bank errors in Blood transfusions
•Genomic screenings in Genetic disorders
•Matters related to diagnosis of Cancers
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20. Common Complaints against
Pathological Labs
• Wrong reports made in Covid-19 cases
• Misleading information and report
• Overcharging without any valid reason
• Interchange of Samples
• Mishandling the medical samples
• Misbehavior with the patients
• Illegal practice
•Unhygienic atmosphere
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21. Diagnostic labs of questionable quality,
•The issue over diagnostic labs of questionable
quality, which have mushroomed in every
nook and cranny of our urban landscape, is so
grave that even NATHEALTH-Healthcare
Federation of India, an industry body,
highlighted it recently through a report titled,
‘An Assessment of India's Laboratory
Diagnostic Industry’.
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22. Concerns of Government of India on Medical
laboratories
•Dr VK Paul, member (health) Niti Aayog and the
chairperson of the Medical Council of India’s
Board of Governors, admitted that lack of
specified standards in infrastructure,
qualification and transparency in case of
laboratories is has been a “huge concern” for
the government.
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23. Errors in clinical laboratories or errors
in laboratory medicine?
•Laboratory testing is a highly
complex process and, although
laboratory services are
relatively safe, they are not as
safe as they could or should be
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24. Future thinking to improve the
Laboratory services
•Clinical laboratories have long focused their
attention on quality control methods and
quality assessment programs dealing with
analytical aspects of testing. However, a
growing body of evidence accumulated in
recent decades demonstrates that quality in
clinical laboratories cannot be assured by
merely focusing on purely analytical aspects.
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25. Things going Wrong need better
Understanding of Laboratory system
•A description of the most frequent and risky pre-,
intra- and post-analytical errors and advice on
practical steps for measuring and reducing the risk of
errors
A recent document from the International
Organization for Standardization (ISO) recommends a
new, broader definition of the term "laboratory
error" and a classification of errors according to
different criteria.
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26. Laboratory system going wrong
Should be better
•Many mistakes in the Total Testing Process are called
"laboratory errors", although these may be due to
poor communication, action taken by others
involved in the testing process (e.g., physicians,
nurses and phlebotomists), or poorly designed
processes, all of which are beyond the laboratory's
control. Likewise, there is evidence that laboratory
information is only partially utilized
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27. WHAT IS HAPPENING IS
NEED CORRECTION
•The primary reason is that numerous
cases have been reported where an
under qualified medical professional
has been taken under inquiry for not
taking reasonable care during the time
of operation, diagnosis, etc.
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28. Ethics and Responsibilities of Medical
Lab Technologists
•Place the well-being and service for the sick above
your own interests.
•Be loyal to your medical laboratory profession by
maintaining high standards of work and strive to
improve your professional knowledge.
•Work scientifically and with complete honesty.
•Do not misuse your professional skills or knowledge
for personal gain.
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29. Do not Do it
• Do not disclose to a patient
or any unauthorized person
the result to your
investiga¬tions.
• Treat with utmost
confidentiality and personal
information that you may
learn about a patient.
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30. Ethics and Competency back bone of
Labotaroy success
• Respect and work in harmony with the other members of your hospital
staff or health center team.
• Be at all times courteous, patient and considerate to the sick and their
relations.
• Promote health care and the prevention and control of disease.
• Follow safety procedures and know how to apply first aid.
• Do not drink alcohol during laboratory working hours or when on
emergency stand by.
• Use equipment and laboratory-ware correctly and with care.
• Do not waste reagents or other laboratory supplies.
• Fulfil reliably and completely the terms and conditions of your
employment.
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31. Known facts on Laboratories in India
• Of the nearly 1.1 lakh medical laboratories in the country,
whose test reports determine over 70 per cent of medical
decisions, just about 1,039 are accredited.
• The issue over diagnostic labs of questionable quality,
which have mushroomed in every nook and cranny of our
urban landscape, is so grave that even NATHEALTH-
Healthcare Federation of India, an industry body,
highlighted it recently through a report titled, ‘An
Assessment of India's Laboratory Diagnostic Industry’.
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32. Recent status on Laboratories in India
•From the last few years, we have witnessed
numerous pathological labs have been set up
without proper registration and people are suffering
due to their illegal activities at the end. The patients
pay a huge amount of money and then the Labs take
advantage of their legal unawareness! It is not
possible for everyone to know about the lawful
procedures to file a pathological lab complaint in the
Consumer Court.
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33. Who is responsible in MorTality and Morbidity
issues
is it clinician? or Laboratory?
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34. What is a Consumer Complaint?
• Consumers who pay for a
specific good or service have the
right to take legal action if they
receive subpar products or
subpar services. The Consumer
Protection Act of 1986
MODIFIED IN 2020 gives
consumers various legal rights
and protections. According to
this Act, the customer may take
a business or service provider to
court with a formal complaint.
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35. online consumer complaint
• An online consumer complaint is
what this specific issue is known
as. If the business ignores a legal
warning to correct the problem, a
complaint is typically made. All
necessary information and
accompanying documentation
must be submitted when
registering a complaint. The
consumer courts in India offer
clients prompt legal counsel and
decisions.
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36. MONEY MONEY MONEY MATTERS REST
IS YOUR CHOICEN
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37. Be Aware that we can utilize our Rights
•SEND A NOTICE MENTIONING THE
PROBLEM/ FAULT YOU FACED
•WAIT FOR A RESPONSE FROM THE VENDOR
•SELECT THE CORRECT FORUM
•SUBMIT A WRITTEN COMPLAINT
•PAY THE COURT FEE
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38. GOVERNMENT WISHES TO PROTECT
EVERYONES RIGHTS
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39. References
• Online legal India
• Ethics in Laboratory Medicine: Perspectives and Challenges
in Resource Limited Settings
• Press trust of India reports in National domain
• CDC Atlanta
• Human rights and health care
• Open sources credited reviewed information Google
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40. THANK YOU ALL
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