MEDICAL TECHNOLOGY LAWS AND PROFESSIONAL ETHICS
FACULTY OF PHARMACY
PROFESSOR: MR. ROBERTO MANAOIS, M.D. | 2ND SEMESTER | 1ST SHIFTING PERIOD | A.Y. 2023 - 2024
LECTURE TRANSCRIPT # 1 / CHAPTER 2. PLANNING FOR MANAGEMENT OF CLINICAL LABORATORIES
PLANNING FOR MANAGEMENT OF CLINICAL LABORATORIES
● Clinical Laboratory management planning is the process of
assessing an organization's goals and creating a realistic,
detailed plan of action for meeting those goals.
● The basic steps in the management planning process
involve creating a road map that outlines each task the
company must accomplish to meet its overall objectives.
○ Short term goals
○ Long term goals
● Planning for clinical laboratory management encompasses
the three major process workflows:
○ Pre-examination or pre-analytical
■ Patient prep
■ Sample collection
■ Personnel competency test evaluation
■ Sample receipt and accessioning
■ Sample transport
○ Examination or analytical and post-examination
■ Quality control testing
○ Post-analytical stages
■ Record keeping
■ Reporting
PLANNING
●
ISO 9001:2015 requires the organization to plan, identify,
and monitor
○ The internal and external issues affecting clinical
laboratories
○ The interested parties that are relevant to the
organization’s purpose and its strategic direction
○ And to consider external issues that could impact
their business strategy, such as new technology
and potential market forces (e.g., social and
economic environments, international competition)
IMPORTANCE OF PLANNING IN THE CLINICAL LABORATORY
1. Planning focuses attention on the objectives of the clinical
laboratory
2. Planning reduces risks of uncertainties on managing clinical
laboratories
3. Planning helps in coordinating interdepartmental goals and
objectives in the clinical laboratories
4. Planning gains economical operation and reduces
operational costs and increases revenues in the clinical
laboratory
5. Planning facilitates controlling by allocating resources
effective financial management in the clinical lab
6. Planning helps executive development and ensures good
succession planning programs for the clinical laboratory
PLANNING THE WORKFLOW OF CLINICAL LABORATORIES
● Planning in the clinical laboratory considers the entire set of
operations that occur in testing of patient samples and is
called “the path of workflow”
● The path of workflow begins with the patient and ends in
reporting and results interpretation.
● Planning in the context of QMS ensures quality in the many
processes and procedures performed in the clinical
laboratory including:
○ The laboratory environment
○ Quality control procedures
○ Communications
○ Record keeping
○ Competent and knowledgeable staff
○ Good-quality reagents and equipment
● Planning for the development of quality practices in a clinical
laboratory in twelve areas as recommended by the WHO
Quality Management Handbook transcends the Path of
Workflow from pre-analytical, analytical, to post-analytical
flow processes in a clinical laboratory.
FOCUS OF PLANNING IN CRITICAL AREAS OF CLINICAL
LABORATORY MANAGEMENT
● Organization: Planning the structure and management of
the laboratory that implements the quality policies ensures
quality performance
● Personnel: Diligently planning the most important laboratory
resource (personnel), ensures competent and motivated
teams in implementing quality management systems
● Equipment: planning the acquisition and validation of
equipment by carefully and properly choosing, and ensuring
programs
maintained
systems
through
preventive
maintenance helps an effective path of workflow
● Purchasing and Inventory: Planning reagents and supplies
management in the laboratory can produce cost savings
ensures supplies and reagent availability
REYES | 2D MEDICAL TECHNOLOGY
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MEDICAL TECHNOLOGY LAWS AND PROFESSIONAL ETHICS
FACULTY OF PHARMACY
PROFESSOR: MR. ROBERTO MANAOIS, M.D. | 2ND SEMESTER | 1ST SHIFTING PERIOD | A.Y. 2023 - 2024
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Process controls: planning the process control ensures
quality control for testing, appropriate management of the
sample, collection and handling, and method verification and
validation
Information Management: planning the production of the
main output of the clinical laboratory (information in the form
of test reports) ensures accuracy, confidentiality, and
accessibility of the information which are managed through
either paper systems or computers.
Documents and Records: planning the creation and
storage of documents needed in the laboratory that informs
how to do things ensures that documents are accurate, up to
date, and accessible.
Occurrence Management: “occurrence” is an error or an
event that should not have happened. Planning for detecting
and managing detect these problems or occurrences,
handling them properly, learning from mistakes and acting
so that they do not happen again.
Assessment: is a tool for examining laboratory performance
and comparing it to standards, benchmarks or the
performance of other laboratories. Planning assessment
may be internal (performed within the laboratory using its
own staff) or it may be external (conducted by a group or
agency outside the laboratory)
Process
Improvement:
planning
for
continuous
improvement of the clinical laboratory processes is a primary
goal and must be done in a systematic manner to ensure
alignment, effectiveness, and efficiency.
Customer Services: planning and benchmarking customer
service ensures that that the laboratory understand and
assess who their customers are and use feedback for
making improvements to align with external changes
Facilities and Safety: planning for management of facilities
and safety include:
○ Security — which is the process of preventing
unwanted risks and hazards from entering the
laboratory space
○ Containment — which seeks to minimize risks and
prevent hazards from leaving the laboratory space
and causing harm to the community
○ Safety — which includes policies and procedures
to prevent harm to workers, visitors and the
community
○ Ergonomics — which addresses facility and
equipment adaptation to allow safe and healthy
working conditions at the laboratory site
1.
2.
3.
4.
The achievement of the objectives of the clinical laboratories
in the most efficient and economical manner
The use of efficient methods and the development of
standards necessary for accurate control within the clinical
lab
Integration of activities of the different units in the clinical
laboratory toward goal-directed actions
The reduction of emergency, unexpected problems, and
management of risks in the clinical laboratory
INDICATORS OF POOR PLANNING
According to William J. McLarney:
1. Delivery dates not met
2. Idle machines
3. Materials wasted
4. Some machines doing jobs that should be done by smaller
machines
5. Some laboratory personnel overworked, others are
underworked
6. Skilled workers doing unskilled work
7. Laboratory personnel fumbling on jobs for which they have
not been trained
8. Quarreling, bickering, buck-passing and confusion
1.
2.
3.
4.
5.
6.
7.
8.
BENEFITS OF GOOD PLANNING
Jobs turn out on time
Good relationship with other departments
People using their highest skills
Workers know how their jobs fit into the total pattern
Machines doing their proper jobs
Equipment in good shape
Materials available
Waste kept to a minimum
SETTING GOALS AND OBJECTIVES THROUGH MANAGEMENT
BY OBJECTIVES (MBO)
● Process
● Managers and employees
● Set goals for the employees
● Make action plans, periodically evaluate performance and
reward according to the results
QUALITIES OF A GOOD PLANNER
Proficiency in the determination of objectives
Good judgment, imagination, foresight and experience
Ability to accept changes
Ability to evaluate laboratory opportunities and hazards
VALUES DERIVED FROM PLANNING FOR CLINICAL
LABORATORY MANAGEMENT
REYES | 2D MEDICAL TECHNOLOGY
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MEDICAL TECHNOLOGY LAWS AND PROFESSIONAL ETHICS
FACULTY OF PHARMACY
PROFESSOR: MR. ROBERTO MANAOIS, M.D. | 2ND SEMESTER | 1ST SHIFTING PERIOD | A.Y. 2023 - 2024
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MANAGEMENT BY OBJECTIVE
Encourages:
○ Discussion
○ Interaction
○ Truly committed managers and involved employees
in the decision-making process
HIERARCHY OF PLANS
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1.
2.
3.
4.
5.
Programs - comprehensive plan that includes future use of
different resources
Budgets - statement of expected results expressed in
numerical terms
TYPES OF PLANS
Strategic Planning
○ The identification of the mission and of those
objectives
○ Most efficient pursuit
○ Long-term goals for the next 5 years
○ Top managers with final authority and responsibility
Tactical Planning
○ Action and deals with the method(s)
○ Short-range – strategy implementation (6 months –
2 years)
○ Operational or technical skill
○ Middle managers (supervisory staff)
Operational Planning
○ Detailed plan used to provide
○ Team, section or department
○ Very short -term (for the next 1 week to 1 year)
○ Responsibility for first-line managers
PLANNING THE LABORATORY DESIGN
Ensure that patients and patient samples do not have
common pathways
The design should have different circulation paths between
the public and biological materials
Reception area for incoming patients should be located as
close as possible to the entry door
Only authorized personnel should have restricted access to
rooms where analyses of samples are done, and hazardous
chemicals or other materials are stored
Access restriction can be accomplished using signs on door
locks and identification badges for staff
PLANNING THE CIRCULATION PATHWAYS IN THE CLINICAL
LABORATORY
1. Sample collection areas
2. Sample processing areas
3. Biological samples between different sections of the
laboratory
4. Post-examination pathways
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The mission - organization’s purpose and philosophy
Objectives - It is the ultimate goal towards which the
activities of the organization are directed
Strategies - general program of action and deployment of
resources
Policies - general statement or understanding which guide
or channel thinking in decision making
Procedures - states a series of related steps or tasks to be
performed in a sequential way
Rules - prescribes a course of action and explicitly states
what is to be done
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SAMPLE COLLECTION AREAS
Reception area and sample collection room located at the
patient’s entrance
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SAMPLE PROCESSING AREAS
Separated from other sections of the laboratory but nearby
the testing areas
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CIRCULATION PATHWAYS
Clean and dirty laboratory materials should never cross
Contaminated materials should be isolated
REYES | 2D MEDICAL TECHNOLOGY
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MEDICAL TECHNOLOGY LAWS AND PROFESSIONAL ETHICS
FACULTY OF PHARMACY
PROFESSOR: MR. ROBERTO MANAOIS, M.D. | 2ND SEMESTER | 1ST SHIFTING PERIOD | A.Y. 2023 - 2024
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POST-EXAMINATION PATHWAYS
Communication system
Efficient and reliable transferring of messages
PLANNING THE SPATIAL CONSIDERATIONS IN DESIGNING
THE LABORATORY
1. Laboratory sections (e.g. Clinical Chemistry, Hematology,
Coagulation) which have highly automated and manual
processes
2. Laboratories with greater turn-around-time (TAT) and/or less
volume, as well as those requiring special safety features
(e.g. Clinical Microbiology and radio-assay laboratories) may
be removed from the central area.
3. Location of room with specific requirement such as:
a. Molecular biology that needs two rooms
b. Fluorescence Microscopy
c. Ultraviolet illumination systems for DNA gel
photography
4. The blood bank and the critical care laboratory procedures
should be readily accessible to the emergency room,
operating room, and ICU.
5. If the laboratory is serving an in-patient population,
accessibility to corridors and elevators providing access to
the main patient care unit is essential.
6. The intra-laboratory traffic flow must be separated from the
outside. Provisions should be made for ambulatory patients
and blood bank donors coming into the laboratory
REYES | 2D MEDICAL TECHNOLOGY
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