This document discusses regulatory and professional oversight of medical laboratories in Ethiopia. It covers workplace legal issues, licensure and inspection of laboratories, codes of professional ethics, and accreditation programs. Specifically, it notes that while legal cases between health providers and patients are not common currently in Ethiopia, standards are moving towards those of developed countries. Laboratory managers must be aware of legal issues and ensure proper documentation, training, and insurance to protect against liability. Government regulation and licensure aim to ensure quality services and standards of care.

1. Regulatory and professional
oversight

2. Objectives

3. Outline
• Workplace legal issues
• Licensure of medical laboratories (MOH ranks)
• Laboratory inspection and accreditation
• Code of professional ethics

4. Workplace legal issues
Legal actions are flooding the already jammed
court document , involving
business and customers,
employer and employee,
professional and client,
physician or health care provider and patient, and
now even attorney and client.

5. Workplace legal issues cont…
 Today the case of health care provider and patient is
not that much pronounced in court of our country
Ethiopia, but things are going towards that of the
developed country’s trend.
 Risk management department may handle legal
issues but, managers should be aware of certain
things in order to protect
themselves,
their staffs, and
the laboratory from legal problems.

6. Workplace legal issues cont…
In addition to the sound management and
professional strategies, managers should pay
particular attention to
records and documentation,
the qualifications and training of personnel,
malpractice,
developments in the tort and legal system, and
 Personal liability insurance.

7. Records and documentation
Good records are a major element of sound
management andgood legal defense.
An old inspection saying, familiar to all
laboratorians, states:
"If it is not written down, it is not done." The same
is true in legal matters.

8. Professional standards
The courts have long held the concept of
professional standards as the measure against
which
performance,
customer expectations,
service complaints, and
damage assessment can be measured.

9. Professional standards cont…
Peer and community review standards is
common to a broad range of situations,
including
product performance,
claim satisfaction, and
the quality of care received by a patient as
compared with the level of service offered by the
business' peers.

10. Professional standards cont…
Peer and Community Review Standards is
Level of service expectations and standards of
care applied in the legal system to establish or
disprove malpractice in specific geographical
and practice situations.
A major way the laboratory can demonstrate
compliance with peer and community review
standards is through participation in
accreditation programs as well as by meeting
the criteria for licensure.

11. Properly qualified and trained
personnel
Closely aligned with professional standards
are the selection and training of the
laboratory staff.
It is one thing to have documentation of how
work is to be done.
But if the personnel do not follow these
guidelines or are not equipped to meet the
standards detailed in the procedure manual,
the laboratory is especially vulnerable to
charges of malpractice.

12. Properly qualified and trained
personnel cont…
There are two sides to the personnel issue:
a. How the employees perform their duties and
b. How they interact with and treat clients.
Many studies shown that the number of
litigation claims filed against an individual or
organization is directly tied to customer or
client treatment.
If the relationship is polite, friendly, and
satisfaction-oriented, the probability of a
claim being filed is greatly reduced.

13. Properly qualified and trained
personnel cont…
Training employees in customer relations
appears to be one of the better ways to
decrease lawsuits.

14. Malpractice
Malpractice is defined as incorrect
performance or improper conduct on the part
of a supplier, especially a professional, either
through negligence or by violating ethical and
professional standards.
Tort is a willful and harmful act (e.g.,
malpractice), not involving a contract, which
can result in a civil law suit.

15. Malpractice cont…
Malpractice can be difficult to determine,
burdened with controversy, and open to
disputed interpretations.
For this reason, the courts apply professional
peer and community review standards to the
particulars of the situation to determine if the
patient or client has been a victim of
malpractice.

16. Professional liability insurance for
laboratorians
Professional liability is the act of being
accountable under legal for any professional
mistake. [Accusation/allegation/ charge].
Do laboratorians need professional liability
insurance?

17. Regulation and licensure of
medical laboratories
Regulation is defined as a rule or requirement
imposed by a government agency.
Licensure is defined as government
permission to operate or engage in a business
practice or occupation, usually requiring some
type of formal training and/or testing to
demonstrate competency.

18. Regulation and licensure of
medical laboratories cont…
Government rules and regulations include
labor relations, OSHA (Occupational Safety
and Health Administration), and rules
affecting the general conduct of business.
Federal and state government regulations and
licensure include rules that regulate the
laboratory facility itself and rules that
establish the professional credentials of the
technical staff.

19. Regulation and licensure of
medical laboratories cont…
In Ethiopia, professional registration and
licensing certification for laboratory personnel
as well as laboratory services is undertaken by
the department of health services and training
of the ministry of health (MOH)
But recently this service is proposed to be
undertaken by drug administration and
control authority (DACA). This is usually done
after minimum requirement set by
government.

20. Regulation and licensure of
medical laboratories cont…
The Ethiopian government is now initiating
professional associations to participate in the
certification and policy development.
Ethiopian Medical Laboratory Association
(EMLA) is taking part for certifying and policy
developing regarding laboratory professionals
and services.

21. Laboratory inspection and
accreditation programs
Accreditation is simply defined as
certification, usually by a professional
organization, that designated standards have
been achieved.
Credentialing is the process of establishing
qualifications to perform a duty or job, usually
through the formal recognition of professional
or technical competence to an institution or
person as having met certain requirements or
standards.

22. Laboratory inspection and
accreditation programs cont…
Certification is the process of establishing and
declaring that a person has met the standards
established by a professional organization.
The joint Commission on the Accreditation of
Healthcare Organizations (JCAHO) is one of
the many organizations which are active in the
inspection and accreditation (I&A) of medical
laboratories.

23. Laboratory inspection and
accreditation programs cont…
World Health Organization (WHO) is also
among the organization that accredits
laboratories having different standards for
different level of laboratory.

24. Laboratory inspection and
accreditation programs cont…
 There are different standards like that of the
following towards which laboratory is inspected and
accredited.
Availability of appropriate services to meet the
needs of the hospital
Sufficiency of space, equipment, and supplies to
perform the workload
Communication requirements
Maintenance of records and reports
Management of quality
Enforcement of specific testing requirements, etc.

25. Code of professional ethics
A code of professional conduct for medical
laboratory personnel should include those
practices and attitudes which characterize a
professional and responsible laboratory
officer.
It is necessary to ensure a person to recognize
standards which patients and those
requesting laboratory investigations can
expect to receive.

26. Code of professional ethics cont…
It also emphasizes the professional status of
medical laboratory practice.
Adopting a code of professional conduct helps
to remind laboratory personnel
their responsibilities to patients,
uphold professional standards, and
need to work with complete integrity.

27. Code of professional ethics cont…
A suggested code of professional conduct for
medical laboratory personnel according to
IAMLT include: -
Be dedicated to the use of clinical laboratory
science to benefit mankind
Place the well being and service of patients above
your own interest
Be accountable for the quality and integrity of
clinical laboratory services

28. Code of professional ethics cont…
Exercise professional judgment, skill, and care
while meeting a established standards
Do not misuse your professional skills or
knowledge for personal gain, and never take
anything from your place of work that does not
belong to you.
Be at all times courteous, patient, and considerate
to patients and their relatives. Safeguard the
dignity and privacy of patients.

29. Code of professional ethics cont…
Do not disclose to a patient or any unauthorized
person the results of your investigations and treat
with strict confidentiality any personal
information that you may learn about patients.
Respect and work in harmony with the other
members of your hospital staffs or health center
teams.
Promote health care and the prevention and
control of disease.

30. Code of professional ethics cont…
Follow safe working practices and ensure patients
and others are not put at risk.
Know what to do should an accident or fire occur
and how to apply emergency First Aid.
Do not consume alcohol or take un prescribed
drugs that could interfere with your work
performance during laboratory working hour or
when on emergency standby.

31. Code of professional ethics cont…
Use equipment and laboratory ware correctly and
do not waste reagents or other laboratory
supplies.
Strive to improve professional skills and
knowledge and adopt scientific advances that
benefit the patient and improve the delivery of
test results.
Fulfill reliably and completely the terms and
conditions of your employment.

32. Any last questions?
32

33. THE END