Module 17 Organization David Manyiel.ppt

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1. Organization

2. Organization-Module 17 2
Learning Objectives
At the end of this session, you will be able to
Appreciate the roles and responsibilities of the personnel involved in the
QMS
Describe organizational elements needed for a quality management system
Discuss management roles and responsibilities in a quality system
Explain the process for designing, implementing, maintaining and improving
the laboratory quality system;
Explain the purpose of a quality manual
Understand the Concepts and Roles of Ethics in Health Laboratory practice
Understand the concepts of Leadership

3. Organization-Module 17 3
Essential
1.Management committed to a quality
management system.
2.An organizational structure designed to assure
quality goals.

4. Organization-Module 17 4
Implementation
Planning
Process
Monitoring:
Maintenance
and Improvement
Leadership, Managerial Roles
Organizational
Structure

5. Organization-Module 17 5
Management Responsibilities
•Implement and continuously improve the
quality management system
•Document and
communicate
to all personnel
•Provide a
quality manual

6. Organizational Structure
Organization-Module 17 6
Establish a working structure that
ensures sufficiency at all parts in the
laboratory work flow
Designate responsibilities and roles;
develop an organization chart
Designate a quality manager
Allocate sufficient resources

7. Organization-Module 17 7
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase

8. Organization-Module 17 8
Hospital director
Lab In-charge
Lab Technologist Lab Quality Manager
Lab Technician
Lab Assistant
Lab Attendant

9. Organization-Module 17 9
Quality Manager
•ISO 15189 requirement
•has responsibility and authority to
oversee compliance
•reports directly to the decision-
making level of laboratory
management

10. Organization-Module 17 10
Quality Manager Responsibilities
monitor quality management system
assure compliance
review all records
conduct, coordinate audits
investigate deficiencies
inform decision makers

11. Organization-Module 17 11
Planning for Quality Management
System
approaches vary
with local situation
many factors influence
starting point
include all quality
elements in plan
may implement in stepwise process

12. Organization-Module 17 12
Keep in mind
•communicate, be transparent
•set feasible timelines
•develop realistic,
measurable objectives
•set priorities,
proceed stepwise

13. Organization-Module 17 13
Conduct Gap Analysis
determine the gaps, using quality
management systems checklist
develop a task list
prioritize by:
–quick fixes first
–determine what
would have the
greatest positive impact
—GAP ANALYSIS —

14. Organization-Module 17 14
Gap Analysis
Common problems identified
test ordering
sample management
training level (competence)
of technical staff
quality control
analytical process
recording and reporting results
reagent and equipment management

15. Organization-Module 17 15
WrittenQuality Management System
Plan should include
what should be done
who will be responsible
when (timeline)
how many resources are needed
benchmarks
Must be available to all staff

16. Organization-Module 17 16
Implementation
commit to completion
prepare for implementation in stages
assure resources are available
use a Gantt chart
be sure everyone knows their
responsibility
then BEGIN

17. Gantt Chart
Organization-Module 17 17

18. Organization-Module 17 18
Provide Resources
•financial requirements/budget
•personnel needs
–additional staff
–skills, training needed
•facilities, equipment,
supplies, computers

19. Organization-Module 17 19
Monitoring Compliance
•assign responsibility
•develop indicators
•establish monitoring
system
•conduct audits
•management review

20. Organization-Module 17 20
A document describing the quality
management system of an
organization.
•essential organizational step
•management responsibility
What is a Quality Manual?

21. Organization-Module 17 21
Quality Manual
•communicates information
•serves as a framework for meeting
quality system requirements
•demonstrates management’s
commitment to quality
QUALITY

22. Organization-Module 17 22
Maintaining the Quality Manual
communicates quality policy
needs management approval
requires updating

23. Organization-Module 17 23
Successful implementation requires
Having management commitment
Understanding the benefits of a quality
management system
Engaging staff at all levels
Striving to
continually improve
Having realistic
expectations

24. Organization-Module 17 24
Intent to Action

25. Organization-Module 17 25
Concept of Ethics
•Definition of ethics; Ethics is a moral philosophy
or code of morals practiced by a person or group
of people.
•Ethics is concerned with what is right or wrong,
good or bad, fair or unfair, responsible or
irresponsible, obligatory or permissible,
praiseworthy or blameworthy.
•It is associated with guilt, shame, indignation,
resentment, empathy, compassion, and care. It is
interested in character as well as conduct. It
addresses matters of public policy as well as more
personal matters.

26. Organization-Module 17 26
Concept of Ethics
•They can govern a person's code of behavior and
prevent moral wrongs from occurring.
•Keep people from doing what is wrong. If an
individual has no ethics, he will do the wrong
thing whenever he believes it will benefit him and
that he can get away with it.
•Key note:Ethics are different from laws and
different from doing the right thing as a result of
fear of consequences.

27. Organization-Module 17 27
Why is ethics important?
•Ethicsare important because:
•They allow society to continue to function,
helping people to interact and live their daily lives
in a functional way.
•They can govern a person's code of behavior and
prevent moral wrongs from occurring.
•Keep people from doing what is wrong. If an
individual has no ethics, s/he will do the wrong
thing whenever he believes it will benefit him and
that he can get away with it.

28. Organization-Module 17 28
Components Of Ethics
•Autonomy: Respecting the person’s wishes or judgment
as human beings are rational, and people should be
respected as such and permitted to do so and supported
with truthful and accurate information and no correction.
•Beneficence: means promoting the welfare of the person
receiving the service. Only do what promotes clients
welfare.
•Nonmalfeasance: Do no harm. Cause no needless harm
or injury according to reasonable standards of
performance.

29. Organization-Module 17 29
Components of ethics
Confidentiality: Based on loyalty and trust.
Maintain the confidentiality of all personal,
medical and treatment information. Disclosure
should not be beyond what is required.
•Justice: All involved should have equal
entitlements, equal access to benefits and
burdens. Similar cases should be treated in a
similar alike.

30. Organization-Module 17 30
Principles of laboratory ethics
Fidelity:The principle of fidelity requires that
health care professionals act in such a way as to
demonstrate loyalty to their patients by acting in
the patient’s best interest.
•Veracity: is the principle of truth telling, and it is
grounded in respect for persons and the concept
of autonomy.
•Veracity is violated by: the act of lying, omission
of important information deliberate exchange of
erroneous information

31. Organization-Module 17 31
Who is responsible for ethics
•Everyone in the laboratory is responsible for
ethics.
•Note: Ethics Assistance and Reporting
•Organizations should provide a mechanism for
assisting employees with questions on ethics
related matters and for reporting observations of
suspected unethical behavior or business
conduct.

32. Organization-Module 17 32
Code of professional Conduct for
Laboratory Practitioners
This code of conduct is derived from Act of Parliament Health
service commission -2001, which is to be observed by all health
workers.
Responsibility to patient or client
S/he shall hold the health, safety, and interest of the patient or
clientto be of first consideration and shall render due respect
patient at all times and in all circumstances.
A laboratory practitioner shall ensure that no action omission on
his or her part, or within his or sphere of responsibility, is
detrimental to the interest, condition or safety of a patient
A laboratory practitioner shall provide a patient or client with
relevant, clear and accurate information about his or her health
and the management for his or her condition

33. Organization-Module 17 33
Code of professional Conduct for Laboratory
Practitioners
Responsibility to the community
A laboratory practitioner shall ensure that no action or
omission on his or her part or within his or her sphere of
responsibility is detrimental to the interest, condition or
safety of the public
A laboratory practitioner shall promote the provision of
effective health service and shall notify the health and
other relevant authorities whenever he or she becomes
aware of any hazard to the community.

34. Organization-Module 17 34
Code of professional Conduct for Laboratory
Practitioners
•Responsibility to the health unit or place of work
•A laboratory practitioner shall abide by rules and regulations
governing the place of work and shall conform to the expectations
of the health unit and strive to fulfill the mission of the institution
•Responsibility to the Law and profession
•Subject to subsection (5) of section 30 a health worker shall
observe the law, uphold the dignity and honour of his or her
profession, and accepted ethical principles.
•A laboratory practitioner shall not engage in activities that bring
discredit to his or her profession, or delivery of health services, and
shall expose without fear or favor all those engaged in illegal or
unethical conduct and practice

35. Organization-Module 17 35
Code of professional Conduct for
Laboratory Practitioners
Subject to subsection (5) of section 30 a health worker shall
respect the confidentiality of information relating to a patient or
client and his or her family; such information shall not be disclosed
to anyone without the patient’s o appropriate guardian’s written
consent except where it is required by law.
A laboratory practitioner health shall keep a breast of professional
knowledge in order to maintain a high standard of professional
competence through continuing professional education.
S/he shall not directly or indirectly advertise his /her professional
skills or allow himself / herself to be advertised directly or
indirectly and shall not entice patients from his or her colleagues;
except that a health worker shall notify the public of the services
available in health facilities

36. Organization-Module 17 36
Code of professional Conduct for
Laboratory Practitioners
A laboratory practitioner shall not perform his or her duties under
the influence of alcohol
A laboratory practitioner shall not indulge in dangerous life styles
such as alcoholism drug addiction or such other behavior that can
bring his or her personality or the health profession into disrepute
A laboratory practitioner shall not support or become associated
with occult or unscientific practices professing to contribute to
health
A laboratory practitioner shall be registered with his or her
professional council and may be a member of a national
association.

37. Organization-Module 17 37
Code of professional Conduct for
Laboratory Practitioners
Responsibility to colleagues
A laboratory practitioner shall co-operate with his or her
professional colleagues, recognize and respect each other’s
expertise in the interest of providing the best possible holistic care.
•Responsibility in research
A laboratory practitioner shall not participate in health
research that does not confirm with national and
internationally accepted guidelines

38. Organization-Module 17 38
Responsibility to colleagues
A laboratory practitioner shall co-operate with his or her
professional colleagues, recognize and respect each other’s
expertise in the interest of providing the best possible holistic care.
•Responsibility in research
A laboratory practitioner shall not participate in health
research that does not confirm with national and
internationally accepted guidelines

39. Organization-Module 17 39
Leadership
Exercising responsible authority, while
providing motivation and vision
Influencing and encouraging staff
to good performance

40. Organization-Module 17 40
Leadership And Team Building
Leadership is a process by which a person influences
others to accomplish an objective and directs the
organization in a way that makes it more cohesive and
coherent.
It can also be defined as a process whereby an
individual influences a group of individuals to achieve a
common goal.
A team is any group of people organized to work together
interdependently and cooperatively to meet the needs of their
customers by accomplishing a purpose and goals.
It is sometimes represented as Together Everyone
Achieves More

41. Organization-Module 17 41
Leadership And Team Building
Teambuilding is fundamental to the success of a
laboratory.
The success or failure of any group is contingent
upon its ability to function as a team.
There are four phases of teambuilding: forming,
storming, norming, and performing

42. Organization-Module 17 42
Leadership And Team Building
Core leader competencies include
Leading others by example,
Effective climate,
Empowerment of subordinates,
Mentorship,
Counseling, and
Feedback

43. Organization-Module 17 43
Who is Responsible for Quality?
EVERYONE!

44. Questions?
Comments?
Organization-Module 17 44