Gentic / molecular / medical labrotaries

Medical lab

1. Dr. Hamsa Banjer
Sep-2024
Program: Master of Clinical Laboratory Sciences
(Molecular Diagnostics)
Course: Advanced Laboratory Management & Operations
Lecture 4:
Operation and Process Management I

2. ❑Lab Manager Role
❑Strategic Planning
❑Defining a vision and mission
❑Setting goals and objectives
❑Setting Strategies
❑Tactical and Operational Planning
❑Regulatory adherence
❑Laboratory Facilities and Organization
Content

3. Laboratory Management
Management can be divided into four main categories:
Planningallows a lab manager to know where the lab is going.
Organizing is also an important job for a lab manager, because he or she determines
who does which project and technique, manages the timelines and budgets for
multiple projects, and keeps current with research in the fields.
Leading is extremely important for a lab manager, because it often sets the
environment and pace of the lab. Good leadership can inspire lab members
toward productivity and creativityand help members work together.
Controllinga lab involves the evaluation of lab members’ and projects’ progress and
the ability to correct problems as they arise.

4. Operation and Process Management
Lab manager position can come in many forms.
A lab manager’s tasks can be strategic, tactical or
operational, depending on the size and the nature of
the lab-affiliated organization.
1.Strategic Roles
2.Tactical and Operational Roles
1)Internal work processes
2)Regulatory adherence
3)Mentoring
4)Paperwork

5. Strategic Roles
Lab managers who conduct the strategic duties of lab management are
highly experienced.
They are responsible for the direction of the lab, and they make certain
that the lab operation fits in with the lab visions and missions in the
long-term.
Examples of lab managers’ strategic roles are as follows:
➢Setting lab objectives
➢Designing long-term plans
➢Overseeing lab operations and relevant regulations
➢Assigning tasks, monitoring and evaluating staff progress,
performance and customer satisfaction
➢Developing and administering the budget
➢Reviewing regulatory requirements

6. Strategic planning and Management

7. Before setting goals and objectives
What is the function of clinical laboratory?

8. What is the function of clinical laboratory?
The major function of the Clinical laboratory is to provide
reliable, accurate, precise and timelyresults which help
physicians to diagnose a disease, to monitor therapy or to
follow up recovery of the patient.
In order to provide meaningful and timely results and to
achieve its part in providing quality patient care, the Clinical
lab must have good management and administration.
The success or failure of the lab in achieving its goals and
objectives depend heavily on the administration and
managementof its affairs.

9. Strategic planning
Strategic planningis a disciplined
management process of envisioning
a desired future state and
translatingthis vision into defined
goals, strategies and key initiatives
to achieve them.
This pyramid represents the
essential components of a strategic
plan >

10. Strategic planning-Defining a vision and mission
An organization’s vision statement is an aspirational descriptionof
what it wants to achieve in the future.
While the visionis an organization-wide goal, your missionhow you
plan to achievethe vision.
Generally, a vision statement expresses what the organization aspires
and provides a cogent explanation of the future for the laboratory
system.
A mission statement is concise and succinctly describes what the
organization does, why it exists, who it serves and how it does its
work.

11. Setting goals and objectives

12. Strategic planning-Setting goals and objectives
Goals are high level statements that provide
overall context for what the vision is trying to
achieve and should align to its components.
➢It may take more than one objective to achieve
the goal.
➢It may take many objectives over a long period
of time to achieve the goal.
Objectives are lower-level statements that describe the
specific, tangible products, deliverables and fruits that
will be delivered.
➢The objective should be written at a lower level, so
that it can be evaluated at the conclusion of a goal to
see whether it was achieved or not.
➢Objectives should not be vague (as goal statements).
➢A well-worded objective will be SMART (Specific,
Measurable, Attainable/Achievable, Realistic and Time-
bound).
Goals and objectives are statements that describe what your
Vision Document will accomplish, or the results that will be
achieved
Goals Objectives

13. Strategic planning-Setting goals and objectives
Goals of the Clinical laboratory should be consistent with;
1.The organizational structure of the institution
2.The management style of the laboratory director
3.Available resources
4.The type of institution to which it belongs (e.g. Ref Labs, Small Clinic, Primary
care center, secondary or tertiary care hospital ....etc.)
5.Nature of the training, educational and research commitments.
The first important step in the organization and management is that the clinical
lab must have clear goals and objectives.
These goals and objectives must be within the frame-work of goals and objectives
of the main institution to which the lab belong

14. Strategic planning-Setting goals and objectives:
Goals type
➢To provide quality patient care
➢To provide quality health
service to the community
➢To ensure good communication
and exchange of information
➢To ensure high quality laboratory service
➢To ensure high level of safety
➢To ensure state of the art technologies
➢To ensure high level of qualification of staff
➢To enhance the education and technical
experience of the technologists
➢To conduct useful and beneficial research
➢To provide a harmonious and pleasant
work environment
➢To ensure high quality team-work inside
the lab
➢To ensure high quality team-work with
other departments of the institution
➢To ensure effective and
efficient laboratory service
➢To make the proper
operation of the lab the
responsibility of all staff
External Goals Managerial Goals
Internal Goals
Must
consider

15. Strategic planning-Setting goals and objectives:
objectives requirements
1.The available financial resources
2.The available support from the higher authorities
within and outside the institution
3.The current and expected future demand on
laboratory services
4.The current rules and regulations
5.The expectedchanges in rules and regulations
during the period set for the objective
6.The institutional goals
7.The laboratory goals
8.Number of beds -Number of out-patients
1.All objectives must have a pre-set dead-line for achievement
2.Objectives must be ranked in order of priorities based on
I.Lab goals
II.Institutional goals
III.Financial ability.
3.Objectives must never forget the patient true needs.
4.Objectives are used to plan for the annual budget of the lab.
5.Objectives must be reviewed on regular meetings to
monitor progress and introduce modifications if necessary.
6.Objective's achievements must be carefully assessed
preferably in graphics, tables and quantifiable form.
7.Objectives may have to be approved by the board of
directors or the general director in some institutions
Primary requirements Additional requirements
Must
consider

16. Strategic planning-Setting goals and objectives
Major components of laboratory systems for which objectives have been developed in different
plans include :
❑Infrastructure development and organizational structure
❑Training and retention
❑Quality management systems
❑Supply chain management of commodities and standardization of testing/test and equipment
maintenance
❑Referral systems for sample transportation
❑Regulatory framework

17. Strategic planning-Examples for objectives
1.To include a new test procedure by the end
of two months.
2.To re-organizethe specimen reception area
by the end of the month.
3.To include an extra technologist in the
evening shift by the end of three months
1.To install a network of computers with an appropriate
information system by the end of 2026
2.To setup a new section by JUN 2024
3.To increase the number of staff by 6 in a period of two
years.
4.To replace the current analyzerby a new one in three years
time
5.To changethe supplies ordering procedure by June 2025
6.To participate in the external quality control program of
trace elements by December 2025
7.To recommend five technologists for post-graduate
education in hematology and in endocrinology by JAN
Short term objectives Long term objectives

18. Setting Strategies

19. Strategic planning–Setting Strategies
What is Strategy?
The word ‘strategy’ is adopted from military administration.
In the military, most often strategy refers to ‘deployment’ of
troops –that means maneuvering of troops into position
before the enemy is engaged.
In laboratory, we can substitute ‘resources’ for troops.
Lab people deploy resources of various types to achieve
objectives.
According to the definition provided by Thompson and
Strickland, a strategy is the means used to achieve the ends.
What is Strategy

20. Strategic planning–Setting Strategies
Strategy is a long-term plan that enables you to achieve your
organization’s objectives.
•An effective strategy brings together vision and execution. Strategies are much
more specific than an organization’s vision, mission, and objectives.
•They are typically only shared within an organization and ideallybuilt around an
organization’s needs and market context.
•Strategies should map long-term plans to objectives and actionable steps, foster
innovative thinking, as well as anticipate and mitigate potential pitfalls.

21. Strategic Plan Process

22. Example

23. Strategic planning–Example
Strategic Plan Example: A Complete Plan
Strategic Theme: Satisfaction
Goal: To be considered a trusted partner by our clients
Objective 1:Increase client satisfaction from 82.0% to 90.0% by December 31st.
➢Strategy 1.1: Implement an annual client conference
• Tactic 1.1.1: Identify date and venue
• Tactic 1.1.2: Develop agenda
• Tactic 1.1.3:Identify and invite speakers
• Tactic 1.1.4: Develop social events
• Tactic 1.1.5: Develop menus
• Tactic 1.1.6: Develop invitations

24. DLS*: Department of Laboratory Services

25. DLS*: Department of Laboratory Services

26. DLS*: Department of Laboratory Services

27. DLS*: Department of Laboratory Services
Let’s practice

28. DLS*: Department of Laboratory Services
Let’s practice

29. Tactical and Operational Planning and Management

30. Tactical and Operational Roles
1.Internal work processes
2.Regulatory adherence
3.Mentoring
4.Paperwork
From a tactical and operational standpoint, lab managers
provide animplementation system for the overall
strategic plan.
They facilitate the day-to-day operation in the lab by
setting up schemes and timeframes for each job,
including personnel involved in each job, and the extent
of involvement. This can be broadly categorized into the
following forms:

31. Internal work processes
Several internal work processes that are crucial
for the day-to-day functioning of the lab.
Some examples of internal work processes are
➢Inventory management
➢Shared equipment reservation
➢Equipment maintenance
➢Resources acquisition and management
➢Waste management
➢Information management
Any Examples

32. Regulatory adherence
All laboratories performing clinical testing
must comply with numerous regulations.
all laboratories are required to implement
minimum quality and personnel standards.
Many day-to-day work must be performed
under certain regulations.
Lab managers must ensure that the lab
operations comply with relevant
regulations without compromising working
hours or work output.
Regulations
Accreditation

33. Regulatory adherence
Example
To achieve this, lab managers may do one of the following:
•Design workflows
•Set up working areas
Streamlined workflows are essential, because they allow lab personnel to easily
comply with regulating protocols, and they also support the controlling procedure.
Set up working areas
In particular, a lab manager can decide to set up in a single working area for experiments
using a toxic substance, which must be disposed of in a specific manner (e.g. Radioactive
substances).
In this working area, the substance can be stored, utilized and discarded, which will ensure
that the use and disposal of the substance is contained in a single working area and ease the
regulatory surveilling procedure, while keeping additional tasks for the purpose of regulatory
compliance to a minimum.

34. Laboratory Facilities and Organization

35. Laboratory Facilities
The Elements of Laboratory Design
Successful laboratory operation requires optimal utilization of space, appropriate equipment,
qualified personnel, adequate laboratory information system support, and
financial management.

36. Laboratory Facilities
Types of clinical Laboratory facilities
New
•Designed in a way that it is used to the max
•Designed according to the latest standards
Old
•Built as a lab long time ago
•May require renovation and/or alterations to meet the current standard
Modified
•Not built as labs.
•Make sure they meet the regulations of the clinical lab.

37. Laboratory Facilities
What to consider when designing a
lab ?
If you are going to design a clinical
lab.
What are the things that you
should consider before designing
and building the lab?
Any Participant, Experience or question would you like to share??

38. Laboratory Facilities -Elements of Laboratory Design
❑Functional considerations
❑Spatial considerations
❑Safety considerations
❑Environmental
considerations

39. Laboratory Facilities -Functional considerations
Designing of labs in terms of sections related to
classical disciplines of the various aspects of
laboratory medicine which may include;
•Clinical Chemistry
•Hematology
•Blood Bank
•Homeostasis
•Microbiology
•Serology & Immunology
•Parasitology
1.Designing labs in terms of functionsthey provide which may
include:
2.Emergency (STAT) laboratories
3.Routine laboratories
4.Clinical problems or disease-oriented laboratories (e.g.
Cardiac & Respiratory disorders labs)
5.Automated –production-line style labs
6.Screening laboratories (Screening tests only)
7.Molecular biology & DNA probing laboratories
Organizational Approach Alternative functional approach
In many situations, the combination of organizational and functional approaches may
be used in lab design and construction.

40. Laboratory Facilities -Spatial considerations
The location of the laboratory with the rest of the institution must be carefully planned in order to
obtain maximum benefit and reduce wasting time in collections and transport from out-patients which
must be easily accessed by patients.
Some spatial considerations include;
•Close proximity to the departments, store and
supporting services.
•Blood bank, emergency sections must be close to
emergency room, operating room and critical care unit.
•Blood donors, phlebotomy and specimen collections
from out-patients must be easily accessed by patients.
•The general public must not be allowed access to
laboratory sections.
Some spatial considerations include;
•For special testsrequiring attendance of the patient
to the lab a properly designed patient examination
room must be used.
•The size of the laboratory must be in relation to the
amount of demand of tests required, i.e. number of
tests/day.
•The lab services users must be known. This includes
number of in-patients, out-patients, other hospitals
and clinics.

41. Laboratory Facilities –Example
❑The power of molecular testing is achieved by the use of PCR as the main diagnostic procedure.
❑A serious problem in the clinical use of PCR is false-positive amplification due to PCR contamination.
❑Because the products of PCR amplification, called an amplicons, can serve as the substrate for the
generation of additional PCR products, and because PCR amplification produces a very large number
of amplicons, the potential contamination of subsequent amplifications of the same target sequence
with amplicons resulting in inaccurate results is immense without the use of proper controls.
❑This kind of contamination has been termed “carryover” to differentiate it from contamination by
genomic DNA. This potential for PCR product contamination requires special precautions.
❑Therefore, the single most important step in designing laboratory space for molecular pathology
testing is meticulous attention to the physical separation of the pre-PCR and post-PCR work areas
to minimize PCR contamination

42. Laboratory Facilities -Safety considerations
Clinical laboratories must conform to the safety rules and regulations. This includes the
provision for various safety facilities and equipment's.
A) Physical safety:
•Strong durable furniture
•Strong and even floors and ceilings
•Leak proof floors and ceilings
B) Chemical safety:
•Fume cupboards
•Safety cabinets
•Chemical storage cabinets
•Chemical waste drain and disposal system
•Emergency shower
•Acid, base and toxic spills removal kits and systems
C) Electrical safety:
•Electrical load
•Grounding and earthing
•Power regulators
•Sockets, plugs and wires
D) Waste disposal:
•Radioactive waste disposal system
•Biological waste disposal system
•Chemical waste disposal system
•Ordinary waste disposal system
•Broken glass, sharps and needles disposal system

43. Laboratory Facilities -Safety considerations
Clinical laboratories must conform to the safety rules and regulations. This includes the
provision for various safety facilities and equipment's.
E) Fire safety:
•Fire exits
•Fire alarm system
•Smoke detectors
•Fire blankets
•Fire-break area
•Fire system
•Fire & chemicals resistant benches
•Fire retarding furniture, doors and windows
F) Health safety:
•Immunization system
•Dealing with infectious specimen
•Emergency system for the lab
•Door fitted with see-through glass

44. Mentoring
Mentoring
Lab managers often take on the duty of mentoring, especially in the form of lab
orientation.
This is to inform new lab personnel of the rules they must abide by when working in
the lab, and to make them aware of the associated health risks and how to minimize
them.

45. Paperwork
Apart from active lab duties, lab managers are usually assigned some form of paperwork, especially
those involving procurement and regulatory requirements.
This varies between laboratories, topic of study, and lab settings.
Paperwork ranges from gathering invoices or proof of purchase, to drafting, reviewing, and filing
regulatory papers.
In the case of regulatory paperwork, oftentimes, lab managers still have tocollect data, keep records,
and report them as per legal compliance even after the authority has processed and approved them.
Ultimately, the duties of a lab manager is to ensure that staff focus on their tasks, without having to
sacrifice their attention or their time for bureaucratic and/or non-scientific works.