Unit 1 - The Clinical Laboratory Clinical Pathology or Anatomical

Pathology (Figure 1-2)

OBJECTIVES:
Laboratory Department
Upon completion of this lecture, the student
will be able to:
1. understand the purpose and set-up
Anatomic Pathology Clinical Pathology
of a Clinical Laboratory.
2. state various types/classifications of
Clinical Laboratories in the Hematology
Philippines. Surgical Pathology
Immuno-serology
3. Identify activities performed in a Cytology
Clinical Laboratory Immunohematology
Immunohistopath
Clinical Microscopy
Forensic Pathology
Microbiology
Autopsy
Clinical Chemistry
TOPIC SUMMARY Parasitology
Toxicology
A clinical laboratory (Figure 1-1) is place Therapeutic Drug
where tests are performed on clinical Monitoring
specimens in order to get information about
the health of a patient with regard to the FIG. 1-2 Clinical Laboratories by function
diagnosis, treatment and prevention of and its organizational composition
disease. It provides controlled conditions for
the analysis of various specimens to determine RA No.4688, otherwise known as Clinical
the presence or absence of disease. It is a Laboratory Law of 1966 further classified
facility to perform highly complex operations Clinical Laboratories in the Philippines
with individuals doing complex task. according to service capabilities. The
classification is made based on room
specification, extent of laboratory examination
performed, manpower strength,
instrumentation and equipment and the
facilities required.

A primary laboratory provides a minimum

Figure 1-1 An example of a Clinical Laboratory
capabilities such as routine CBC, urinalysis,
fecalysis and blood typing and quantitative
platelet count for hospital-based laboratories.
This type of laboratory must have an area of at
least 10 sq. meters.

A clinical laboratory may be classified by A secondary laboratory provides the service

institutional character. It may be hospital-
based or free-standing. A hospital-based
laboratory operates within the hospital
catering for both in-patients and out-patients.
A free-standing laboratory (non-hospital-
based) operates independently and caters
mostly for out-patients. Both laboratories are
headed by a Pathologist who is certified by the
Philippine Board of Pathology.
Another way to classify Clinical Laboratories is
by its function. It may be categorized as a
capabilities of a primary laboratory and
routine Clinical Chemistry (sugar, BUN/Crea,
BUA and T. Cholesterol) and cross-matching
(hospital-based). It should have at least an
area of 20 sq. meters.
A tertiary laboratory provides the service
capabilities of a secondary laboratory and
special hematology, special chemistry,
immune-serology and microbiology. This
sophisticated, complete laboratory which is a
training ground for interns and externs and
site of scientific research, must have an area
of 60 sq. meters.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 1


LABORATORY DESIGN AND SERVICE
MODELS
In hospital-based laboratories, there are
distinct designs and service models
differentiated by their purpose or objectives
and they are the following:
Traditional ‘Closed’ Laboratory
It has discrete sections in hematology,
chemistry, microbiology, and blood bank,
generally separated into rooms or sections
‘Open’ Laboratory
The discrete services are placed in one large
room with portable walls that can be adjusted
as needed based on volume
Core Laboratory
A common type of consolidation has been
hematology and chemistry laboratories
(‗chematology‘) (Bush, 1998). Its advantages
include handling stat requests, improving off-
shift workflow, and avoiding chronic staffing
problems.
Regional Laboratory
Specific low-volume or expensive laboratory
services currently provided by more than one
regional hospital laboratory, that are
consolidated into one hospital laboratory. For
example, consolidation of all virology or PCR
testing into one hospital laboratory
Reference Laboratory
Traditional full service laboratory that handles
all types of testing, especially esoteric tests.
The National Reference Laboratories in the
Philippines is established through D.O. No.
393-E s. 2000 (November 14, 2000, signed by
Alberto G. Romualdez Jr., MD; and additional
designations through D.O. No. 2009-5148,
December 21, 2009) and they are the
following:
a. Lung Center of the Philippines
– Clinical chemistry and Anatomic
Pathology of Pulmonary Diseases
b. National Kidney and Transplant Institute
(NKTI)
– Hematology, Immunohematology and
Immunopathology, Anatomic
Pathology for other Organ Diseases
other than Lungs and heart
c. East Avenue Medical Center
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
– Environmental and Occupational
Health Toxicology and Micronutrient
Assay
d. Research Institute for Tropical Medicine
(RITM)
– dengue, influenza, TB & other
mycobacteria, malaria and other
parasites, bacterial enteric diseases,
measles and other exanthems,
mycology, enteroviruses, antimicrobial
resistance and emerging diseases. Also
for confirmatory testing of blood
donors and blood units
e. San Lazaro Hospital
– HIV-AIDS, Hepatitis and STDs
f. Philippine Heart Center
– Anatomic Pathology for Cardiac
diseases
Point-of-Care
Laboratory testing that is brought to the
patient's bedside. Test menu is generally
limited to a few basic chemistry and
hematology tests (e.g., glucose, pregnancy,
activated clotting time, blood gases).
Stat Laboratory
Rapid ―response laboratory‖ that is often
located in or near an emergency department or
surgical suite. It provides critical laboratory
tests such as hematocrits and blood gases.
Limited Service
Laboratory provides limited menu of routine
(like CBC, chemistry panel, prothrombin time)
and/or specialty services (like fertility testing)
on a stat or non-stat basis. It includes
downsized hospital labs that retain stats and
some routine tests but send most work to an
off-site core laboratory.
OPERATION OF THE CLINICAL
LABORATORY
The purpose of a Clinical Laboratory is to
provide physicians and other healthcare
professionals with information to detect
disease or predisposition to disease, confirm or
reject diagnosis, establish prognosis, guide
patient management and monitor efficacy of
management. (Kurec, 2000) Hence, there is an
absolute need for accuracy, confidentiality and
time and cost effectiveness. To achieve this,
the operation and deliverance of service of a
laboratory depends on the following factors:
1. Expertise in medical, scientific and
technical areas
2
 2. Resources in the form of personnel,
laboratory & data processing
equipment, supplies and facilities
3. Skills in organization, management
and communication
THE CONCEPT OF PRACTICE OF
PATHOLOGY & LABORATORY MEDICINE
Laboratory Medicine can be viewed as a
bridging endeavor that links basic sciences
(biological and physical) with medical
principles (Figure 1-2). This bridging is not
complete without the appropriate support
mechanism from the following:
a. computer sciences which provides the
necessary equipment, technology and
informatics
b. Management techniques in which
laboratory staff enhances the level of
care provided and economically utilize
available resources.
c. Industry where there is an interchange
of business transactions between the
healthcare provider and the patient;
and the healthcare provider and the
manufacturer of reagents, supplies and
instruments.
Basic Sciences Medical Practice
(Research, (Diagnosis, Therapy,
education) Prognosis, QA)
laboratory medicine is a need for education
and research. It is imperative for laboratories
to assume a significant level of responsibility
in educating all healthcare providers so that
utilization and test ordering patterns are
implemented in the best interest of the patient
and decision-making at an appropriate cost.
Up to 70% of physicians decisions regarding
patient diagnosis and treatment are based on
laboratory results. Education also means
providing training ground for Medical
technology interns and externs. There is also a
need for a well-developed research program.
New technologies and procedures are
developed and implemented to provide highest
level of patient care.
Pathology & Laboratory Medicine
Leadership and Management,
Administration
Patient care services
Teaching
Research
FIG. 1-4 Outline of activities in Pathology
and Laboratory Medicine

Computer Science
Mgt. Techniques
Industry

FIG. 1-3 A representation of the Concept of

Pathology and Laboratory Medicine

ACTIVITIES IN PATHOLOGY AND

LABORATORY MEDICINE

A new and transformed laboratory

organization that continuously promotes and
uphold a favorable impact in patient care are
structured into four major activities (Figure 1-
4). The management leads the laboratory
attain its organizational goals and the
administration interprets the policies and
translates it into executive activities. Patient
care services provides pre-analytical,
analytical and post-analytical phases of work
in the laboratory. Integrated into the fabric of

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 3

Unit 2 – Introduction to
Management
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. define terms
2. differentiate various schools of
management philosophies
3. discuss appropriate strategies in
dealing with problems encountered in
laboratory operations
4. develop skills necessary for an
effective laboratory manager
TOPIC SUMMARY
Management is defined as an art and science
of working through the people to attain the
common organizational goal/s. It is as art
because it results in the accomplishment of
objectives through the use of human efforts. It
requires human skills and careful study in its
application. It is a science because of the
systematic body of knowledge which results in
logical organization structures and
conclusions that can be drawn or validated
through experiments. It gathers and analyzes
facts and formulates general laws or principles
from these facts.
Management provides the steps to achieve the
goals of the organization. In this context, there
are 5 M‘s of management that we need to
remember in order for the organization to
succeed, they are:
1. Mission (goal) - is the purpose or
reason for the existence of an
organization
2. Man – leaders with the authority to
direct the team towards the goal.
3. Money necessary resources
needed
4. Materials
5. Methods – ways and means in
achieving the goals of the organization
by using the established resources
MAJOR MANAGEMENT THEORIES
Scientific Management
This school of thought attempts to apply a
systematic or scientific approach to the study
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
of organizations. It is a cause and effect
analysis. Important names in this era are the
following:
a. Frederick Taylor (1856-1915) – the
father of scientific management,
broke down each task into segments
that could be analyzed for ways to
improve efficacy.
b. Frank Gilbreth (1868-1924) and
Lilian Gilbreth (1878-1972) –
perfected Taylor‘s motion study
method and developed methods of
analysis i.e. performance standards
used by the College of American
Pathologists. They believed that
motion and fatigue are interrelated. If
one could reduce the number of
motions a worker made in performing
the task, worker fatigue will be reduce
too.
c. Mary Parker Follet (1868-1933) –
pointed out that management is
essentially coordination.
d. Henry Grantt – modified the piece-
rate system into a task-and- bonus
wage system
Administrative Management Theory (also
called Generic Management)
This model emphasized the perspective of
senior management within the organization. It
provides the basic knowledge that
management is a profession and could be
taught. People who contributed to this theory
are:
a. Henry Fayol (1841-1925) – first
introduced the concept that
management should be an orderly
process of tasks and duties, of which
planning is the most important. His
thesis provides the base for the theory
called functions of management, or
management process.
b. Lyndal Urwick (1891-1983) –
introduced the role of management
consultant and attempted to classify
and codify the work done on
management theories.
Bureaucracy Management
This provides the Theory of Social and
Economic Organization which examines the
organizational aspects of the company and its
workflow to explain how institutions function
and how to improve their structural process. It
sees organization as a segment of a broader
society. It gives the idea of hierarchy,
responsibility and authority, specialization,
4
predictability and stability of the organization
operation in accordance with its systems of
procedures. Organizations consist of formal
rules and regulations, rationality and
democracy which is recognized by
designations and not by person. The most
prominent name ever existed to be associated
with this philosophy is Max Weber. He quoted
that ―an impersonal, rule-abiding efficient,
merit-based career service provided the surest
way of fulfilling the public interest in the face
of a politically fragmented Germany‖.
Organizational Behavior Management
It focuses on the performance and interaction
of people within organizations. It uses the
concepts of psychology to sociology as well as
management theories. Elton Mayo and
Douglas Mc Gregor developed assumptions
about the basic nature of man. The
Hawthorne Experiment Hypothesis: when the
light became brighter, production would
increase and when the light became dimmer,
production would decrease. The Result: The
result kept climbing regardless of the light
(bright or dark). Rensis Likert encouraged
managers to be supportive of their
relationships. Barnard, on the other hand,
encourages that executives should encourage
a climate of cooperation.
Systems Analysis Management
The analytical view of an organization as a
complete, self-contained unit that interacts
within itself and with its environment in a
continuous process of interchange and
renewal. It relies heavily on mathematical
models, scientific methodology and computer.
MANAGEMENT FUNCTIONS
Management functions refer to those
distinctive activities that must be carried out
by the manager if the objectives of an
organization are to be achieved. It is a
continuous process of interacting functions,
each dependent on the success of the other
(Figure 2-1). It involves the following:
Planning is the mental effort by which
executives anticipate the possible causes or
factors that may affect or change the activities
and objectives of a particular organization.
Activities performed are forecasting,
determination of objectives, policy formulation,
and preparation of programs, policies,
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
budgets, rules, anticipating & preparing for
innovations
Organizing is the process of identifying and
grouping of work to be performed, defining and
delegating responsibility and authority and
establishing relationship for the purpose of
enabling the people to work most effectively
together in accomplishing objectives. Activities
done are identification & grouping of work,
establishment of relationships through unity
of commands, limited span of control,
delegation of responsibility, homogenous
assignment, integration of work, to name a
few.
Leading/Directing refers to the way of getting
all personnel in an organization to accomplish
what management desires. It involves both
motivation and communication. Specific
activities include effective use of executive
ability, coordination of activities, securing
cooperation with good communication and
good personnel mgt.
Controlling and Evaluating means checking
the work accomplished against plans or
standards, and making adjustments or
corrections when new developments or
unforeseen circumstances necessitate. It
includes determination of performance
standard, measurement of performance,
interpretation of performance and corrective
action from deviations from goal & standards
Planning
Controlling &
Organizing
Evaluating
Leading
Figure 2-1 The Management process
Note: Each function of management will be
discussed separately in detail in the succeeding unit
topics.
5
 THE LABORATORY MANAGER
Some people start their career with the lowest
possible position in the organization and have
to work their way up the ladder of success. For
instance, a registered Medical Technologist
may be hired as a Laboratory Aide or a
Medical Technician initially but with good
performance, hard work and perseverance, he
may have the chance to get the highest
possible post in the laboratory as Chief
Medical Technologist. For others with
exemplary qualifications, it may not be as
difficult to get hired to an esteemed position.
A manager is an individual whose job is to
guide the organization to attain its objectives.
Because of this great responsibility, he/she
must possess essential characteristics that
will make him/her a successful manager such
as motivation, vision, decision-making ability,
good health and humility.
Below are roles which managers play in an
organization:
1. Represent the organization
2. Hold formal authority
3. Develop and implement strategies to
accomplish mission and goals of the
organization
4. Manage personnel (evaluations, hiring,
promoting)
5. Manage financial responsibilities (budget,
revenue, expenses)
6. Facilitate communication
7. Motivate employees
8. Implement time management strategies
9. Oversee customer service
10. Implement innovative ways to expand
services, expand customer base and fulfill
the bottom line
In order to perform the various roles
mentioned above, Robert Katz suggested
different management skills which you may
find below:
1. Conceptual/Organizational Skill - it is
the mental ability to coordinate and
integrate all of the organization‘s interests
and activities ( apply management process,
systematize work flow, make decisions and
communicate with co-workers)
2. Human/ People Skill - it is an
understanding of the basic theories of
human needs and work motivation is
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
essential to accomplishing the goals of
individual and the organization.
3. Technical Skill - it involves the synthesis
of a specialized skill and the management
of physical resources (supplies, equipment,
facilities) into the operational parameters
(products/services) unique to each
organization.
4. Financial management - These skills
involve the effective use of and accounting
for the monetary assets of the company.
Management has several levels or stratification
depending on the size of the organization. In a
simple organization, there may be one or two
levels which may result to a short organization
structure; however, for big organizations, one
may expect a tall organization because it is
composed of several levels. The following are
levels (stratification) of management:
1. First-line managers has the lowest level
in an organization who is responsible for
the work of others. They direct operating
employees only and are concerned about
completing the day‘s work. They do not
supervise other managers. They are called
Supervisors, team leaders and Chief
Technologists.
2. Middle managers direct activities of other
managers and also those of operating
employees. They also direct activities that
implement their organization‘s policies
and to balance the demands of their
supervisors with the capacities of their
subordinates. They engaged in a variety of
technical and non-technical activities.
Examples are operations manager,
Division Head.
3. Top managers are composed of a small
group of executives. They are responsible
for the overall management of the
organization. They establish operating
policies and guides the organization‘s
interactions with its environment. They
focus on strategizing and planning for the
next 1 – 5 years. They may or may not
process technical skills that a first –line
manager uses every day. Examples are
Directors and CEOs
To further understand how managers act and
decide in their own right, they possess specific
skills depending on their level in the
6
organization (Figure 2-2). It is emphasized that b. Policies and procedures
first-line managers possess mostly human c. Strategic planning
skills while a middle manager focuses on d. Benchmarking
technical matters. Top managers are mostly e. Productivity assessment
involved in making key decisions that affect f. Legislations/regulations
the whole organization must have conceptual g. Medico-legal concerns
skills. h. Continuing education
i. Staff meetings
FIRST-LINE MIDDLE TOP Human Resource management involves:
Conceptual Conceptual Conceptual a. Job description
b. Recruitment and staffing
Human
c. Orientation
Human d. Competency assessment
e. Personnel records
Technical Human
f. Performance evaluation/appraisals
g. Discipline and dismissal
Technical
Technical
Financial Management tackles:
a. Financial budgets
FIG. 2-2 Relative Skills needed for effective b. Billing
performance at different levels of c. Compliance regulations
management d. Test cost analysis
e. Fee schedule maintenance
MEASUREMENT OF
MANAGEMENT PERFORMANCE Marketing Management focuses on:
a. Customer service
Peter Drucker suggested that managerial b. Outreach marketing
performance can be measured by ―Efficiency‖ c. Advertising
and ―Effectiveness‖. These two terms where d. Website development
originally industrial engineering concepts e. Client education
which started during the early 20th century
but later on adopted in the field of
management. Some people find these terms Note: These management responsibilities will be
synonymous but in formal management discussed entirely in the succeeding lecture topics.
discussions, they take on different meanings.

Efficiency is the ability to get things done
correctly (―input-output‖ concept). It is
producing results with little wasted effort. For
example, a laboratory manager is able to
minimize the cost of the resources to achieve
the goals of the laboratory.
Effectiveness is the ability to choose
appropriate objectives. For example, a senior
Med-tech selects the right things to get things
done correctly. So being effective means
producing powerful effects.
MANAGEMENT RESPONSIBILITIES
There are four (4) basic management
responsibilities; namely, Operation, Human
Resource, Financial and Marketing
Management.
Operation management entails the following:
a. Quality assurance
Indicators of lack of management Skills
in the Clinical Laboratory
- Inability to maintain an adequate
staff
- Recurring or persistent
misunderstandings with the hospital
administration
- Frequent or recurrent confusion
concerning requisitions or reports of
laboratory work
- Frequent ―rush‖ orders for supplies.
- Low morale in the laboratory
- Excessive cost of operation
- Ignorance of the cost of operation
- Requests for deserved pay raise by
competent workers are not granted
when funds are available.
- Expenditure of much of the
manager‘s time in making minor
decisions.
- Inability to do one or more tests
when a key individual has a day off.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 7

Unit 3 – Management Planning
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. define terms
2. discuss the types and steps of
planning
3. apply concepts of planning in a
Clinical Laboratory setting
4. apply MBO program in the local
setting
TOPIC SUMMARY
Planning, as defined earlier, is the mental
effort by which executives anticipate the
possible causes or factors that may affect or
change the activities and objectives of a
particular organization. It is developing a
pathway to accomplish the organization‘s
mission and goals using resources and time.
In simple definition, it is deciding in advance
what it is to be done.
IMPORTANCE OF PLANNING
Planning provides direction. It strengthen
confidence in understanding where the
organization is heading and how best to make
the organization move along the chosen path.
It also provides opportunity to analyze
alternative course of action. It reduces
uncertainties by encouraging managers to
probe and cut-through complexities of the
environment and to take control over the
elements of change. It minimizes impulsive,
arbitrary decisions and ad hoc actions. It has
a king-pin function, meaning, all managerial
functions are built around it which provides a
basis for the other functions. It is an adaptive
and anticipative action. It is the integration of
the diverse decisions and activities of the
managers. Lastly, it is a resource allocation
which provides judicious allocation of strategic
and scarce resources of the organization in the
best possible manner for achieving goals. This
will strengthen the over-all competitive
position of the organization.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
. CONCEPT OF PLANNING
It is to identify what the organization wants to
do by using the four (4) questions which are:
Where are we today? Where are we going?
Where do we want to go? How are we going to
get there? It has to begin with an honest and
realistic appraisal of the current position of
the organization. The purpose of this is to
determine which opportunity to pursue. The
output of the 2nd and 3rd questions are the
vision and mission statements, goals and
objectives of the organization which will be the
basis of where the organization is going. The
last question provides how goals should be
attained and how resources are allocated.
PLAN
A plan is a predetermined course of action
intended to facilitate the accomplishment of a
task, work or mission. For example, an action
plan on how to celebrate the World Blood
Donors day.
A plan can be in the form of any of the
following below and Figure 3-1 demonstrates
its hierarchy:
Mission is a statement of the organization‘s
reason for being. It is a final and ultimate goal.
Healthcare industry may have a social purpose
of producing and distributing economic goods
and services
Vision is the non-specific directional and
motivational guidance for the entire business.
What will the business be like in five years‘
time?
Objectives are goals through which an
organization aims to achieve. They should be
quantifiable statements which are achievable
over a designated period of time.
Goals are specific statements of anticipated
results.
Strategies denotes general program of action
implying commitment of emphasis and
resources to attain broad objectives.
Policies are general statements which guide
or channel thinking and action in decision-
making.
8
Procedures establishes a required method of competition, what customers want,
handling future activities. strength and weaknesses. In order to plan
Rules are required actions chosen from among for the future, one must first determine
alternatives. where the organization stands. Risk
evaluation can be done by SWOT Analysis
Programs are complex of goals, policies, to determine both internal and external
procedures, task assignment, steps to be factors. Once the SWOT analysis is
taken, resources to be employed necessary to complete, the manager can plan a course
carry out a given course of action. of action for the organization to follow that
will accomplish its goal and mission.
Budget is the statement of expected results
expressed in numerical terms. It is also S W O T Analysis:
referred to as ―Numerical program‖ There are a. Environmental factors internal to the
several ways in which a plan can be drawn. laboratory are classified as:
Strengths: characteristics of the
Mission/ business, or project team
Vision that give it an advantage
Objectives/ over others
Goals Weakness: (or Limitations) are
Strategies characteristics that place
Policies the team at a disadvantage
relative to others
Procedures or Rules
b. External environmental factors:
Programs Opportunities: are external chances to
Budgets improve performance in
the environment
FIG. 3-1 Hierarchy of plans Threats: external elements in the
environment that could
cause trouble for the
The following are types of plan: business or project

1. Short range or tactical plan covers a 1-5 Example of SWOT Analysis in the Clinical
year period. It focuses on tasks that can be Laboratory:
completed in this time frame. It deals with Strengths Weakness
the methods for achieving goals identified 1. Patients convenience 1. Staffing shortage
in the strategic planning process. It often 2. Use current 2. Morale issues
technology/instrumentat 3. Lack of quality
require operational or technical skill and is ion control programs
generally a logical responsibility of the 3. Strong leadership 4. Limited range of
supervisory staff. support tests
4. Financial resources 5. Need to hire
available additional
2. Operational plan covers maybe a year or pathologist
one budget period. It mostly concerns 6. Turnaround times
operation. are marginal
Opportunities Threats
1. Opening of a new 1. Competition from
3. Strategic planning maps out the course of physician healthcare other local hospitals
an organization for approximately 20 facility 2. Competition from
years. It involves tactical and operational 2. Department of Health national reference
plan as well as forming alliances and mandates lead testing on labs
all children under 2 3. Reimbursement
partnerships with key players (sometimes years old decreasing
even competitors). It is, however, evaluated 3. Have access to hospital 4. Three local hospitals
and modified yearly. marketing department have consolidated
4. Hospital X is bankrupt; their services
laboratory will close including laboratory
PLANNING PROCESS 5. Increased test volume 5. Several new patient
will decrease per cost service center
opened already
The general steps in planning are:
opened

1. Opportunity awareness or statement of the

problems/needs. In the light of the market,

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 9

 data) and the ends toward which the efforts
are directed (goals). It is both strategic
2. Statement of objectives/goals (identification of goals) and tactical (methods
– Where we want to be and what we want for their accomplishments).
to accomplish and when
– Formulate goals. Goals should be Essential Factors in Lab. Planning
broad. Written goals allow all (Operational Data)
employees to work toward a common
result. 1. Past experience: refers to the
– Objectives are written to achieve organization‘s awareness based upon
specific tasks. In writing objectives, one the prior observations and
must remember the following: participations of its membership.
 Objectives are tasks to to
achieve goals 2. Market Potential: known or estimated
 They are focused on achieving expenditures for given services in a
one goal. given locale or as projections of these
 Objectives are specific. expenditures contingent upon specific
 They are written using action plans and anticipated developments.
verbs.
 They are evaluated against 3. Competition: an analysis of most
specific and specified numerical market potential areas will usually
criteria. disclose a relatively consistent set of
– Objectives should be: competitive forces.
 SPECIFIC
 MEASURABLE 4. Hospital/Laboratory Relations: are
difficulties and problems that results
 ATTAINABLE
between those responsible for providing
 RELIABLE
laboratory services and those
 TIME-BOUND
accountable for administering overall
3. Consider planning premises
hospital policy. (Figure 3-2)
– In what environment (internally or
externally, will our plans work?)
4. Identify alternatives
A. B.
– What the most promising alternatives Medical
to accomplishing our objectives Staff
– Compare alternatives in light of goals
sought Total Hospital
– Which alternative will give us the best Personnel Personnel
chance of meeting our goals at the
lowest cost and highest profit?
FIG. 3-2 Configuration of most service (A)
5. Choose an alternative
and hospital organizations (B)
- Selecting the course of action we will
pursue
5. Regulatory & Accrediting Forces:
6. Formulate supporting plans
are regulations and performance
- Such as: buy equipment and materials,
standard bodies
hire and train workers, develop a new
method
6. Laboratory trends: series of events
7. Numberized plans by making budgets
constituting a pattern that suggests
- Develop such budget as: volume and
both origin and probabilities for
price of test, operating expenses
continuation.
necessary for the plan, expenditures
for capital equipment.
7. Medical Trends: pattern of tests
requests is as useful indicator of the
relative value with which the physician
GENERAL PRINCIPLES IN LABORATORY
perceives the wide range of laboratory
PLANNING
services.
There must be balance between the sum of the
organizational circumstances (operational

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 8. Socio-political Trends: events which
affect hospital laboratory operation like
include the legislation of unions, equal
job opportunity, etc.
EFFECTS OF GOOD AND BAD PLANNING
Objectives are determined with the employees
and are challenging but achievable. There is
daily feedback, and the focus is on rewards
rather than punishment. Personal growth and
development are emphasized, rather than
negativity for failing to reach the objective.

The benefits of good planning are:

a. Maximizing profits – waste kept to a
minimum
b. Goal directed actions results in jobs
turn out on time, good relationship
with other departments, people using
their highest skill and workers know
how their jobs fit into the total pattern
c. Reduction of emergency and
unexpected problems such as
machines and equipment are working
properly and are in good shape;
materials are available

The indicators of Poor Planning:

1. Late submission of results/reports
2. Idle machines
3. Overworked and under worked staff
4. Skilled workers doing unskilled work
5. Quarreling, bickering, buck-passing
and confusion

OVERVIEW OF MANAGEMENT BY
OBJECTIVES

Management by Objectives (MBO) is a

management model that aims to improve
performance of an organization by clearly
defining objectives that are agreed to by both
management and employees. According to this
theory, having a say in goal setting and action
plans should ensure better participation and
commitment among employees, as well as
alignment of objectives across the
organization.

This was first outlined by management guru

Peter Drucker in 1954 in his book ―The
Practice of Management‖. He also used the
acronym ―SMART‖ to express the concept.

A key tenet of MBO is the establishment of a

management information system to measure
actual performance and achievements against
defined objectives. The major benefit of it is
that it improves employee motivation and
commitment, and ensures better
communication between management and
employees.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 11


Unit 4 – Organizing and
Staffing the Laboratory
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Describe the characteristics of
organizational system
2. differentiate the types of
organizational charts
3. Explain the process of work
analysis and job design
4. Learn the standard protocol in
pooling of qualified staff and
laboratory personnel
5. Create s strategy in proper
scheduling of work load to
appropriate personnel
TOPIC SUMMARY
After the objectives of an organization are
determined and plans are prepared, the next
step in the management process is to organize
the activities to execute the plans and attain
the objectives.
Organizing is the process of identifying and
grouping the work to be performed, defining
and delegating responsibility and authority
and establishing relationship for the purpose
of enabling the people to work most effectively
together in accomplishing objectives. It is the
backbone of management.
OVERVIEW OF ORGANIZATIONAL
SYSTEM
The tern ―organization” means a collection of
people working together under a defined
structure for the purpose of achieving a
predetermined outcome. It serves to provide
society with products and services, offer
employment and economic exchange, and give
a framework for a social system.
A system is self-contained collection of
interacting and interdependent components
working together toward a common purpose.
For example, in a stand-alone laboratory, at
least there are two interlocking components of
organization. These are the head of the
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
laboratory and other staff having their own
duties and responsibilities.
Characteristics of Organizational Systems:
a. Primary task: defined duties that are
necessary because of the nature of
system‘s products or services. To fulfill the
established goal of the laboratory which is
to release accurate and reliable results in a
timely manner, each staff has its
designated work. Every staff can enjoy
privacy at work because they are aware of
the jurisdiction of their work and power.
b. Hierarchy of system: the process of
whereby self-contained subsystems
develop within a parent organization such
as a laboratory within a hospital. As the
clinical laboratory expands, the hierarchy
of staff and the nature of work being
performed increases in complexity.
c. Open systems: systems that interact with
their environment by both receiving and
delivering product services. A clinical
laboratory must have transparent
procedures for streamlining diagnosis for
the benefit of the patient.
d. Equilibrium: a state of stability within and
between the system and its environment.
In the laboratory, it involves staff knowing
their jobs, what other staff do and the
importance of their individual functions to
overall performance.
e. Self-regulation: the feedback process by
which the system monitors performance
and provides information to its members.
The laboratory should have plans and
strategies to improve performance based
on the feedback.
Organizational system has three (3) distinct
functions, namely:
1. Input mechanism which is the process
through which needed resources are
acquired and replaced.
2. Transformation which is the internal
process whereby resources received
through the input channels are converted
into the products and services produced by
the organization.
12
3. Output mechanism which is the process
of delivering the goods and services
produced to the external environment.
In the Clinical Laboratory, Figure 4-1 shows
how the input such as the specimen, test
requests and available supplies undergoes
processing by the laboratory staff using the
required processes and instruments to
produce accurate results.
TRANSFORMATION
INPUT
PROCESS
Specimen OUTPUT
Staff
Test requests Test results
Instruments
Supplies
Processes
FIG. 4-1 Laboratory Organization
The Clinical laboratory is an open system with
a congruency model (Figure 4-2) that has
four important aspects or elements:
1. Formal organization. The officially
sanctioned lines of authority assigned by
the owners of the organization, with the
authority and responsibility to carry out
the organization‘s designed duties.
Members of the organization know whom
they work for, whom they supervise and
how their departments relate to other
group.
2. Informal organization. Alliances that
form outside the boundaries of the formal
organization from the interaction and
allegiance of people with common
interests.
3. People. The workforce or staff who perform
their duties and responsibilities.
4. Work. The division of tasks so that
everyone is indispensable. (Figure 4-3)
FIG. 4-3 Medical Technologists at work
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
INPUT
WORK
FORMAL
INFORMAL
ORG.
ORG.
PEOPLE
OUTPUT
FIG. 4-2 The Congruence Model
ORGANIZATIONAL DESIGN
An organizational design consists of four
structural components. Each component is
specially functioned to fulfill the mission and
vision of the entire organization.
1. Functional component. It is the
hierarchal organizational levels (Figure 4-
4). Specialized units report in an upward
chain of command. There is clear
understanding of responsibilities and
authority. It functions best when the
departments are engaged in repetitive,
efficient and routine tasks.
A Table of Organization or
Organizational Chart is the diagram or
chart that identifies the major operational
units of an organization and their
attending job position. It is the formal
written map of the structural plan and
authority delegation. Lines have been
inserted to clearly indicate the channels of
communication. They run vertically and
horizontally and beginning and terminate
in precise position. They complete a
graphic demonstration of the total
organization including the rank and
relationship of all its part.
13
 Traditional Organizational Chart format: assigned to any of the sections in the
laboratory, or performing routine or special
1. Tall structure – many management tests.
layers
2. Flat structure – few management layers Administrative Director
Technical Operations Manager
Director Routine Special STAT
Hospital Admistrator
Test Tests
Hematology
Pathologist
Clinical
Chemistry
Chief Medical Technologists Clinical
Microscopy
Individual Disciplines Microbiology
Blood Bank
FIG. 4-4 Laboratory Organization
Structure Immuno-
serology
2. Self-contained component. A self- Histopathology
contained organization is arranged along a FIG. 4-6 Applying Matrix Component in the
common platform. There is subdivision of Laboratory
work areas according to specialization. As
shown in Figure 4-5, the laboratory 4. Network Component. It reflects an
services are divided into 4 areas such as information technology model. It also
specialty testing, clinical services, consists of units or realignment of work to
anatomical services and transfusion reduce duplication and expand revenue
services. Specialty testing is focused on generating services. Some laboratories may
examining special specimens. The clinical have an affiliated or satellite laboratory,
services are concerned with routine or which are part of networking services.
special laboratory examinations.
Anatomical services cover biopsy,
histopathology, autopsy, etc. Transfusion Factors that Influence the Design and
service is an extension of the blood Structure of the Organization
banking section.
 Organizational goals and strategic
direction. In any organization, it is
Specialty imperative to set goals and objectives in
Testing order to give direction for the
organization‘s journey towards the
achievement of its mission and vision.
Manage  Technological Capabilities refers to the
Anatomic Clinical
Services ment kind of services it can offer.
Services
 Size. This factor is the basis for
determining the classification of the
laboratory.
Transfusion  Environment. It refers to the specific
services location of the laboratory. The profitability
of the laboratory is dependent on its
FIG. 4-5 Laboratory as a self-contained location and targeted clientele.
organization  Leadership style, Member Behavior and
Organizational culture. The success of a
3. Matrix component. (Figure 4-6) It shows
the different areas of work and person laboratory is the responsibility of the
assigned as section head. Each staff management.
member can have an independent
functions irrespective of whether they are

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 ELEMENTS OF LABORATORY
ORGANIZATION
The elements of laboratory organization
include:
1. Level of authority. Authority is the legal
right to command actions by others and to
enforce compliance. It empowers one to do
a job and is essential for the leader to
accomplish the task. It goes with
responsibility. Authority can be divided
into position authority (derived from
holding the position) and personal
authority (derived from characteristics of a
leader).
Work assignments and job descriptions
should be accompanied with the right
amount of authority and responsibility.
Every staff is accountable in the task
assigned to him/her.
Delegation of authority can and should
be done in some cases, but for the right
reasons. It is the temporary assignment of
authority and responsibility to perform a
duty normally performed as a supervisor.
Some tasks cannot be delegated.
Delegation should be used as an
opportunity for learning, but never as a
punishment. When a task is delegated, the
authority transfers to the one whom the
task was delegated. However, the
responsibility for delegating the task
remains with the manager.
Several factors affecting delegation include
delegation route, fear of delegation, and
when, how and whom to delegate.
Types and Roles of Authority:
a. Line and Staff Authority: is a
concept that most organizations
employ in designing organizational
structure.
b. Line Authority (Figure 4-4): is the
relationship in which superior
exercises direct supervision over a
subordinate.
c. Staff Authority: is advisory service
that comes from outside the chain
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
of command. It helps line people
work efficiently.
In a clinical laboratory, the chief
Pathologist is the head who has the
authority to give orders and enforce
policies and regulations. Under him/her is
the Chief Medical Technologist who in turn
supervises the different section heads. The
section head is in-charge of the section
assigned to him/her. Other staff such as
Senior or Junior Medical Technologists,
Medical Technicians and Laboratory Aides
or assistants are under the supervision of
the section head.
2. Level of communication. This is
discussed in detail in Unit 7 - Information
Management.
3. Division of work. It is the designated
function of a department head to divide
and delegate tasks or workload to avoid
confusion and complications.
PRINCIPLES OF ORGANIZATIONAL
STRUCTURE AND AUTHORITY
1. Departmentalization. Related activities
are grouped together to expedite the
production process, that is specialization.
2. Decentralization. The decision-making
process is brought as close to those who
are actually performing the work as
possible.
3. Unity of command. Each individual must
have only one boss.
4. Scalar Principle. Supervision should be a
linear system providing a direct vertical
link from the board of directors to the
lowest level worker.(Figure 4-4)
5. Span of Control. There is a definable limit
to the number of people one person can
effectively supervise, within the limits of
specific work condition. In general, one
position should have span of control (direct
supervision) of 4 to 12 positions --- 12 if
functions are similar; 4 if functions are
dissimilar.
6. Exception Principle. The manager and
stall are able to do their jobs without
15
 having to check with the supervisor about baseline for the performance tasks of the
every detail. employee, but it defines the employee‘s
interactions with people and how the
STAFFING AND SCHEDULING THE position is integrated into the entire
LABORATORY organization. Job descriptions should
The laboratory require considerably different change as the needs of the organization
education and training of personnel. Each is change. It is the basis for preparing an
unique discipline embodying large volume of advertisement for the position and the basis
for employee evaluation. It is used in the
technical data and employing different
interview process and reviewed with the
analytical techniques and instrumentation.
employee prior to filling the position.
With regard to laboratory staffing, the sheer Because it is a legal document, the
growth and diversity of laboratory services employee should sign it, acknowledging
clearly demonstrate the need for specialization receipt of the document.
of personnel. Efficient and effective selection,
grouping and utilization of personnel Job descriptions also hold managers and
constitute a major responsibility. employees in a position of accountability. It
serves as a toll to remind employees of the
JOB DESIGN many responsibilities they have within the
A job is a collection of tasks, duties and position for which they‘ve been hired.
responsibilities assigned to an individual
worker. The sections of a job description should
include the following (Figure 4-6):
Job design is the process of organizing work a. Title of the organization. It includes
into jobs. Name of the facility, location,
department, sections
Job analysis is the process of collecting and b. Job Title
analyzing information about tasks, work flow c. Job specifications. This is the
and jobs being done in an organization so that position summary. Represents the
job descriptions, work standards and requirement for employment of a
performance appraisal systems can be given job. The format consists of a
developed. The three-step process of job set of factors or parameters that
analysis, job and assignment culminates in a bear significantly on all or most
formal written document called job positions and a corresponding set
description. of pre-requisites developed
specifically for the job(s) under
Application of job design information: consideration. It provides the
organization with the personnel
1. Staffing – the process of matching the requirements considered to match
number and types of people with jobs that most efficiently with the demands
meet the goals and structure of the of each job.
organization. It is done by: d. Summary of duties for the position.
a. Identification of workforce It is the heart of the document.
requirement e. Reporting relationships or authority
b. Inventory of people available level. The person or position to
c. Recruitment and selection whom the employee reports is
d. Promotion of staff specified in the supervisor), along
e. Appraisal with the supervisory
responsibilities of the job (the
f. Planning career of employees
supervisees)
g. Training and development f. Preparer
g. Date of preparation and activation
2. Job description and Performance h. Approval signatures
appraisals – are written declarations of
given job positions. (Note: see FIG. 4-6 for sample of Job
Description on page 16-A)
Job Description supplements the table of
organization by providing definition to all
position. It not only defines and provides a
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 16
 Job advertisement should be prepared OTHER ISSUES IN ORGANIZING:
after studying the job description. Key
elements of a job advertisement include Re-Organization is the process which an
the following points: existing organization undergoes that brings
a. Title of job about changes in size and shape of the
b. Location of job organization structure. The reasons for re-
c. Brief description of job organization are growth and adaptation.
d. Brief description of the
company/organization Reengineering is the re-organizing work
e. The minimum requirement regarding processes in an organization. Flow diagram
education, experience, training and the specific work processes to determine if
knowledge more effective process could be implemented.
f. Additional comments or information Examples: use of robotics to automate,
related to job advancement, travel computerization, pneumatic tube system to
requirements, or level of transport specimens.
responsibility
g. How to apply Benchmarking is a process whereby the best
h. Deadline for application process in one organization is modified to fit
i. Equal opportunity statement similar processes in another organization.
Examples: cost per test, number of test
(Note: see FIG. 8-2 for sample of Job performed per full time employee.
Advertisement on page 36)

3. Scheduling – builds on staffing

information and focuses on matching
people on a day-to-day basis with the
fluctuating workload of the laboratory. In
making work schedule, you need to
remember that the staffing of shifts
depends upon the demand and the
availability of personnel to meet the
demand.

Basic Rules in Scheduling:

1. No more than 5 consecutive working days

for each individual.
2. Provide 2 consecutive day offs, except in
the rare case where the individual prefers
split of day offs.
3. Within the possibilities. Give the individual
the shift he wants.
4. Rotate weekend and holiday off with as
much fairness as possible.
5. Post schedule at least 3 weeks in advance,
even more if possible.
6. Stick to the schedule as closely as
possible, and make changes only when
essential and only after discussion with
others concerned.
7. Provide the opportunity to ask for a
specific day off on occasion.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 17

Unit 5 – Directing &
Organizational Factors that Influence
Supervising the Leadership Success (Corporate culture,
Laboratory Management style and, situation)

A. Corporate Culture and Delegation of

OBJECTIVES:
Authority. The way things are done in an
Upon completion of this lecture, the student organization such as habits, traditions,
will be able to: customs, processes and social morals of
1. Discuss proper laboratory supervision. the institution. It is the interaction
2. Describe leadership within the context between institution and individual,
of the management functions. between role and personality, and between
job expectations and need-dispositions.
The individual has a personality and
needs-dispositions that should be matched
TOPIC SUMMARY with the institution‘s role and
expectations. If the match is compatible.
Leading/Directing refers to the means Both the institution and individual will be
employed to encourage all personnel in the satisfied. (Figure 5-2)
organization to accomplish whatever
assignments may be given them by
Excellent Match
management in order to achieve the objectives
in the manner they were planned and
Individual Institution
organized. It can only be effective if it is
preceded by a well-designed strategy developed
Individual Institutional
in the planning and organizing stages of the
personality Role
management process, and if it is followed
through with a strong controlling phase.
Individual Institutional Job
Need-dispositions Expectations
Leadership is the most active part of the
directing function. It is employing
Based on the Getzels and Guba theory
management skills, people skills, and vision to
(1957), compatibility leads to efficiency,
accomplish the work of the organization. Its
effectiveness, and satisfaction.
purpose is to produce change by establishing
FIG. 5-2 Matching Institution with
direction, aligning, motivating and inspiring
Individual
people. It originates from personal
characteristics and career experiences (both
B. Management style. The general behavior
that promotes or inhibits leadership).
and philosophy of a manager or an
organization toward the employees,
A leader is responsible for providing the
particularly the degree of participation
conditions necessary for employees to
allowed in the decision-making process.
accomplish the work of the organization
(Figure 5-1).
Likert’s 4 Discreet Management Styles:

Exploitative and Authoritative.

Managers view workers only as tools and
means of production and feel no further
obligation to them.

Benevolent and Authoritative. A

paternalistic approach, managers feel they
know what‘s best for their employees and
need only to inform and direct their actions
without seeking any feedback

FIG. 5-1 The Laboratory Department Chair Consultative. The manager feels the
deliberating with the section heads opinion and advice of the staff are useful,

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 18

 but all decisions remain the exclusive
purview of the manager.(Figure 5-1)
Participative. Input and responsibility
for decision-making and performance are
placed directly on the staff, or as close to
the production process as possible, with
only general guidance and oversight from
management. This is an inclusion team
approach in which the worth of all
members is recognized.
There are several leadership styles published
in 1988 by ―Careertrack‖, namely:
1. Directing: presents rules, orders or defined
instructions to the individual.
2. Coaching: provides high support and
direction
3. Supporting: provides physical and personal
resources so that an individual can
accomplish their duties.
4. Delegating: provides low support and
direction
C. Situation. The style used by the leader
may vary according to the situation. The
effective leader must be able to analyze
the situation and develop a satisfactory
strategy for intervention.
Situational Leadership Models
1. Contingency Theory. According to Fred
E. Fielder, the success of the manager as
the leader is contingent on two factors: the
LEADERSHIP STYLE of the manager and
the FAVORABLENES of the leadership
situation. Favorableness is the amount of
power, control and influence wielded by a
manager in a particular set of
circumstances. There are 3 components
that establish favorableness:
a. Leader-member relations – the
level of confidence and trust
between leader and members of
the staff. This is the most
important factor according to this
model
b. Task Structure – the amount of
formal structure imposed on work
assignments.
c. Position power – the degree of
influence that the manager exerts
on the reward and punishment
system of the institution.
It can be either Relationship-oriented or Task-
oriented. Situations that are very favorable or
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
very unfavorable are usually handles best by a
task-oriented leader. While Relationship-
oriented leaders appear to be most effective in
situations that are considered moderately
favorable or moderately unfavorable.
2. Continuum of Leadership by Robert
Tannebaum and Warren H. Schidmt.
Management style could be plotted on a
continuum from authoritative to
democratic (Figure 5-3). Managers could
move along the continuous line, adjusting
their leadership style to fit the situation.
3. Normative Theory by Victor H. Vroom
and Phillip W. Yetton (Vroom-Yeton
decision model). It provides normative
guidelines and recommendations for the
way a leader should make decisions in a
specific set of workplace conditions. The
theory classifies each decision-making
method as autocratic, consultative or
group-oriented.
The 5 possible behavior styles identified by
Vroom and Yetton:
 A-I: Manager makes decision based
on the current information
available
 A-II: Manager seeks necessary
information from subordinates
before making a decision
 C-I: Manager shares the problem
with selected individuals before
making a decision.
 C-II: Manager shares the problem
with all the members of the group
but makes the final decision
 G: Manager shares the problem
with the group and a decision is
reached by consensus.
Democratic Autocratic
Style Style
Y Leader X Leader
FIG. 5-3 Copmarison of tannebaum and
Schidmt’s Continuum and Mc Gregor’s X
and Y Theory
19
 LEADERSHIP MODELS notice to changes and be generally
friendly and approachable.
There are 3 factors involved in leadership: HIGH
Leader, Follower and Situation
High Consideration High Structure
Leader:
and And
1. Personal traits of leaders – studies failed to Low Structure High Consideration

Consideration
establish common personal traits of good
leaders.

2. Leadership behavior – researches made

next focus on behavior of leaders instead of
Low Structure High Structure
personal traits and and
Low Consideration Low Consideration

a. Employee-oriented versus
production-oriented leadership
LOW Initiating Structure HIGH
styles (Fig. 5-4)
Fig 5-4 The OHIO STATE LEADERSHIP
EMPLOYEE ORIENTED: Supervisors
QUADRANT: ( Ralph M. Stogdill)
with the best productivity levels had
strong ties to their employees, spent
more time in actual supervision rather **Managerial Grid
than production in work, supervised
less closely while allowing workers It is developed by Blake and Mouton.
more latitude in performing their Shows a relationship between a concern for
duties, and demonstrated concern for people (consideration orientation) and concern
their people both on and off the job – for production (structure orientation).
Management style is influenced by five factors:
PRODUCTION – ORIENTED:- a. The attitude and assumptions of
Supervisors who tended to emphasize the manager
high productivity at the expense of all b. The policies and procedures of the
other factors. They viewed their organization
workers as only tools for use by the c. The day to day operational
company in the manufacturing process situation
and spent the majority of their time on d. The social and personal values of
production related problems – the manager
e. Chance
b. Structure-consideration leadership To improve and strengthen leadership ability,
styles (Fig. 5-4) the leader should go through the following
steps:
Initiating structure: marked by a. Identify their current style
emphasis on actively directing the staff b. Decide for themselves the best style
toward getting the work done: paying foe a given situation
attention to assigning particular tasks, c. Determine what attitudes and
specifying and clarifying what is behavior changes are required to
expected of subordinates and the reach their goals
uniformity of the procedures to be d. Encourage management to develop
followed and personally deciding what the organizational culture
and how work will be done. necessary for the preferred style to
flourish
Consideration behavior: manager‘s
effort to explain their actions, treat
workers as equals, listen to
subordinates‘ concerns, look out for
their personal welfare, give advance

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 20

Managerial Grid Interpretation: (Fig. 5-5)
1, 1 or Impoverished Management.
Leaders in this position have little concern for
people or productivity, avoid taking sides and
stay out of conflicts. They do enough to get by.
Often referred to as Laissez faire leadership.
9,1 Authority-Compliance Management.
Managers in this position have great concern
for production and little concern for people.
They desire tight control in order to get task
done efficiently. They consider creativity and
human relations unnecessary. Also called
Authority-obedience Management or
Autocratic Task Management.
5, 5 or Middle-of-the-road management.
Leaders in this position have medium concern
for people and production. They attempt to
balance their concern for both people and
production but are not committed to either.
Sometimes called “Organization Man
Management”
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
1,9 or Country club Management.
Managers in this position have great concern
for people and little concern for production.
They try to avoid conflicts and concentrate on
being well-liked. To them the task is less
important than good interpersonal relations.
Their goal is to keep people happy.
9,9 or Team management.
This style of leadership is considered to be
ideal. Such managers have great concern for
people and production. They work to motivate
employees to reach their highest levels of
accomplishments. They are flexible and
responsive for change, and understand the
need to change.
Fig 5-5 Managerial Grid
21
***Theory X - Theory Y model by Douglas
McGregor (Figure 5-3)
It is a close simulation of the widely observed
Pygmalion Effect propounded in education
circles, namely from the play Pygmalion by
George Bernard Shaw. It states that students
tend to learn and perform in the manner
anticipated by their teachers. If students
perceive that teachers expect them to do well,
they do. If they pick up that they are expected
to perform poorly, the prophecy becomes self-
fulfilling.
McGregor proposes that leadership behavior is
based on the manager‘s assumptions about
the nature of people. Expectancy and
Reinforcement Motivational Theories also
support this approach.
The Theory X Managers believe that people:
a. Are inherently lazy and dislike work
b. Must be coerced into performing their
duties by constant supervision and
maintenance of tight operational
control
c. Have no ambition and little interest in
improving their efficiency on their own
and must be prodded to produce.
Managers who hold X theory philosophies tend
to be autocratic and dictatorial and allow for
little input from the staff.
The Theory Y Managers believe that people:
a. Work is a natural part of life
b. People have a high degree of ingenuity
and creativity that they are eager to
apply to the job
c. Worker potentially is only partially
tapped by the company
d. Workers are self-learners and seek
responsibility for their performance
e. Workers exercise self-control and self-
discipline if they are committed to a
goal, and the strength of this
commitment depends on the reward
associated with the achievement.
Managers who hold the Y philosophies are
participatory in their leadership style; actively
seeking advice and counsel form their co-
workers and allow employees to share in the
decision making process.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
APPLICATION OF LEADERSHIP
PRINCIPLES IN THE CLINICAL
LABORATORY
Application of Leadership responsibility
in the Clinical laboratory:
1. To formulate and document policies and
procedures that are constantly current
and relevant effective pursuit of
laboratory goals
2. To effectively communicate these plans
to all personnel.
3. To provide efficient means for assuring
compliance with policies and procedures
4. To encourage free flow and exchange of
ideas through all levels of the
organization
5. To assure an awareness by all personnel
of current trends and practices in the
delivery of hospital laboratory services.
6. To develop and maintain effective
relations with the medical staff and
hospital administration for assuring an
open exchange of the needs and
concerns of all parties.
Application of Leadership Method in the
Laboratory:
1. To develop and constantly update all
laboratory procedures and policies by
preparation of appropriate manual.
2. To schedule and conduct periodic
meetings with the staff for discussion
and review of policies and procedures.
3. To delegate the responsibility for
efficiently monitoring compliance with
policies and procedures
4. To conduct periodic meeting with the
laboratory staff to encourage innovative
thinking and improvement in services.
5. To fully support and generously budget
for a meaningful laboratory continuing
program
6. To assure awareness of the laboratory
mission by requiring that appropriate
personnel attend all hospital and
medical staff meetings that call for
laboratory representation.
22
Unit 6 – Controlling THE BASIC CONTROL PROCESS

OBJECTIVES: The basic control process involves three

Upon completion of this lecture, the student steps.
will be able to:
1. Discuss the importance of controlling 1. Determination of standards. A
2. Explain the types and steps in performance standard is an item
controlling (statistics, statement, model) against which
the performance or behavior of an
3. Describe controlling within the context
employee can be compared to obtain a
of the management functions..
relative measurement. They are the
selected points in a planning performance
at which performance is measured, so that
TOPIC SUMMARY managers can receive signals about how
things are going.
The president of any organization is
responsible for its overall direction. Since he 2. Appraisal or Measurement of
cannot perform all those functions, he has to Standards. It involves a systematic
delegate to his subordinates the responsibility process of assessment of the strengths and
and authority to perform certain tasks for weaknesses of staff as basis for
which he is responsible. Thus, he has to use administrative decisions and development.
some systems of control to enable him to The Five Components of it are the
appraise the performance of each and every following:
one of his subordinates. Unsatisfactory a. A person expected to perform a
performance maybe corrected before it causes job with a designated job
serious damage. description
b. Standards and criteria that clearly
A good control system encourages each state what is expected and how it is
employee to exercise self-control. Self-control measured. (Figure 6-2)
would be possible when standards of criteria
for performance exists to the point where an According to Hall and O’Malley,
employee knows the specific level of evaluation can be done through:
performance expected of him. i. Criteria-based – indicates
performance criteria found
Controlling and Evaluating means checking in the job description
the work accomplished against plans or ii. Competency-based – used
standards, and making adjustments or in the employee orientation
corrections when new developments or process and to continuously
unforeseen circumstances necessitate. (Figure validate competency as
6-1) Control in management means setting required by accreditation
standards, measuring actual performance and agencies.
taking corrective action. c. A measurement instrument to
compare actual performance with
TYPES OF CONTROL the desired behavior
d. A judge or assessor trained and
competent in using the
1. Pre-action control:
measurement instrument to do the
 Controlling by means of personal
appraisal
supervision and utilizing control
e. A feedback mechanism and
checks consisting of procedures for any
conference, information report and
given task or function.
so on to share the results of the
2. Post-action:
review, take corrective action and
 Controlling as the task or function is
arrive at an agreement on a plan for
being performed or may have been
the future.
performed and corrective deviations
from standards or plans.
3. Correction of deviations. If performance
is measured accurately, it is easier to
correct deviations and managers know

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 23

 exactly where the corrective measure must
be applied. Managers may correct
deviations by redrawing their plans or by
modifying their goals or they may correct
deviations by clarification of duties.

FIG 6-1 Controlling process

FIG 6-2 An Example of Behaviorally

Anchored Rating Scale for Med-Tech:
Performance Category, Instrument
Maintenance

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 24

Unit 7 – Information important to remember that anything that
interferes with understanding can be noise.
Management

OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Develop proper communication skills
and work ethics
2. Correlate efficient work flow and
laboratory operations through
organized communication system.
3. Identify the basic contents of policy
and procedure manuals
4. Discuss the advantages and FIG. 7-1 Communication Process
disadvantages of computerization
5. Recognize the features of laboratory People spend 45% of their time listening, 30%
information system. speaking, and about 25% reading and writing.
Listening was the main way of learning until
the invention of printing. However, listening
TOPIC SUMMARY has been revived in importance with the
spread of radio, television, recordings and
It has been estimated that people spend more films.
time communicating than in any other activity As a manager, developing listening skill is
in life. Communication is about the transfer critical. A few ways to enhance listening are to
and understanding of meaning. For any paraphrase or restate what the communicator
communication to be successful, the meaning has said and ask clarifying questions while the
that you wanted to convey must be communicator is listening.
understood.
It is said that in management, communication
COMMUNICATION PROCESS is one of the most, if not the most important
Figure 7-1 depicts the model of skill needed. To be an effective manager you
communication. This model is composed of the
must be able to communicate well and accept
following parts:
communication well. Communication is found
1. The communication source (sender) from
which the message comes; it is the actual in all directions, that is, from top down, from
physical product. the bottom up, and from peers.
2. The source initiates a message by encoding
TYPES OF COMMUNICATION
the thought.
3. The message then travels through a
channel--the medium. The medium is Based on Communication Channel:
selected by the sender who must decide if
the channel is formal or informal. a. Verbal communication can either be oral
4. The message is received (receiver) and or written communication.
must be decoded or translated into a form
that can be understood by the receiver. Written communication includes memos,
5. The final link in the loop is feedback-- letters, e-mail, organizational newsletters, or
which is a check on how successful you any other device that transmits written words
have been in transferring your message as or symbols. This method is used frequently as
originally intended. it is tangible, verifiable, and more permanent
and can be stored for an indefinite period of
Throughout the process, noise can disturb the
time. If there are any questions about the
transmission, receipt, or feedback of a
content of the message, it is physically
message. Examples of noise can include
available for later reference. For example, a
illegible print, phone static, inattention by the
written marketing plan for a new product
receiver, or background of machinery. It is

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 25

 contains a number of tasks over several
months which can be reviewed by referring
back to the document. But written messages
have their drawbacks. While writing may be
more precise, it takes more time. Also, there
is no built-in mechanism for feedback--
sending the memo is no assurance that it was
received or understood.
b. Non- verbal communication is in the
form of body language, facial expression
and visual diagrams and pictures.
Some of the most meaningful communications
are neither spoken nor written. Non-verbal
communications can be a loud siren or red
light at an intersection or watching students
who indicate to the instructor that they are
bored by having a glassy eyes.
Hand motion, facial expressions, and other
similar gestures can communicate emotions or
temperaments such as aggression, fear,
shyness, arrogance or joy. This is referred to
as body language.
Another common non-verbal communication
method is verbal intonation which refers to
the emphasis someone gives to words or
phrases. For example, if a student asks an
instructor a question and the reply is ―What
do you mean by that‖ will get a different
reaction from the student depending on the
tone used by the instructor.
Research indicates that from 65%-90% of the
message of every face-to-face conversation is
interpreted through body language. Without
complete agreement between the spoken
words and the body language that
accompanies it, receivers are more likely to
react to the body language as the ―true
meaning.‖
Paraverbal is how we say what we say. It is
through the tone or pitch of your voice. Tone
of voice and your words must match for
effective communication.
Based on Style and Purpose:
a. Formal communication is a business or
corporate communication and official.
b. Informal communication is a free, unrestrained
communication between people who share a
casual rapport with each other.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Communication may be intrapersonal and
interpersonal. Intrapersonal communication
is communication with one‘s self.
Interpersonal communication involves one-
on-one exchanges with other people.
BARRIERS TO EFFECTIVE
COMMUNICATION
A number of interpersonal and intrapersonal
barriers help to explain why the message
decoded by a receiver is often different than
that which the sender intended.
Filtering refers to the way that a sender
manipulates information so that the receiver
will see it more favourably. For example, when
a manager tells his boss what he thinks the
boss wants to hear, he is filtering information.
This happens a great deal in organizations.
Extent of filtering tends to be a function of the
number of vertical levels in the organization
and its culture. The more vertical levels, the
more opportunities there are for filtering.
Selection perception occurs when the receivers
in the communication process selectively see
and hear based on their needs, motivation,
experience, background, and other personal
characteristics. For example, the employment
interviewer who expects that a female job
applicant will put her family ahead of her
career is likely to see that tendency in all
female applicants.
Other barriers include information overload,
which occurs when the information received
exceeds our capacity to process. For instance,
consider the international sales representative
who is out of town and unable to check her e-
mail and finds more than 600 e-mails waiting
when she returns. When people get more
information than the can sort out and use,
they tend to select out, ignore, pass over, or
forget information.
Emotions will help determine how a message is
interpreted. Often we might interpret
something differently depending on whether
we are happy or distressed. Extreme emotions
are most likely to hinder effective
communication.
Words mean different things to different
people. Age, education, and cultural
background are three of the more obvious
26
variables that influence the language a person
uses.
Language becomes more problematic when
specialists develop their own language--or
jargon. An example from the textbook is the
letters MBO--which stand for ―management by
objectives.‖ Managers create their own jargon.
Whether any of us like it or not, men and
women do communicate differently which can
lead to misunderstandings and
misperceptions. Research has uncovered by
men talk to emphasize status and
independence whereas women talk to connect
and develop relationships. To ensure gender
differences don‘t create communication
difficulties, it is important that both men and
women acknowledge that there are differences
and adapt to each other.
Lastly, communication differences can arise
from the different languages and different
cultures. For example, Canadian managers
rely heavily on memos and other formal forms
of communications to state their positions on
issues. Countries that are more collective,
such as Japan, tend to have more informal
personal contact and therefore will engage in
extensive verbal consultation with employees
first before drawing up a formal document.
WAYS TO IMPROVE COMMUNICATION
PROCESS
There are a number of things managers can do
to overcome communication barriers. The
suggestions includes:
1. Use feedback. Many communication
problems can be directly attributed to
misunderstandings and inaccuracies.
These problems are less likely to occur if
the manager uses feedback--either verbal
or non-verbal.
2. Because language can be a barrier,
managers should choose words and
structure their messages in ways that will
make those messages clear and
understandable to the receiver. This
means that the manager needs to consider
the audience to whom the message is
directed.
3. Active listening requires total concentration
on the part of the receiver. This can be
enhanced if the receiver is empathetic to
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
the sender. An empathetic listener
reserves judgment on the message‘s
content and carefully listens to what is
being said.
4. Constraining emotions. It would be naïve
to assume that managers always
communicate in a fully rational manner. A
manager who is emotionally upset over an
issue is likely to misconstrue incoming
messages and fail to express his or her
outgoing messages clearly and accurately.
Because language can be a barrier,
managers should choose words and
structure their messages in ways that will
make those messages clear and
understandable to the receiver. This
means that the manager needs to consider
the audience to whom the message is
directed.
5. Emphasize non-verbal cues. If actions
speak louder than words, then it‘s
important to watch your actions to make
sure that they align with and reinforce the
words that go along with them. Remember
that non-verbal messages carry a great
deal of weight.
Effective Communication Skills:
 Staying focused while communicating
 Effective listening skills
 Making an eye contact
 Speaking clearly or with clarity of message
 Have patience
 Proper body language
PROFESSIONAL WRITING
Professional writing skills are essential for
management personnel. Written documents
represent you to the professional community
and serve as documentation of your
communications. Business communications
are an element of the official affairs of an
organization. When you prepare a letter,
memo, or e-mail, consider that the recipient
may file your document for future referral.
Your signature, initials or e-mail address
signify that the document has your approval
and exists as a record of your opinions,
statements, ideas or results.
All business communications should
demonstrate correct grammar, spelling,
punctuation, and usage. Use of clear and
27
concise language ensures that the reader will
comprehend the writers intended message.
Significant types of written communications
include:
Letter. This is a type of formal
correspondence. The letter format includes the
date: sender‘s name, title and address;
recipient‘s name, title and address; a
salutation; body; complimentary close; and
signature.
The memo is a short, informal
correspondence. The standard memo form
includes the information for the sender (name,
title, location, e-mail address, phone and fax
numbers); date; name of the recipient/s; and
subject.
A report gives information on a definite topic
or results from a specific subject.
A proposal is a plan of action submitted for
acceptance by an individual or group.
Proposals are frequently written to persuade
an authority to fund a purchase, position or
project. It include a statement of purpose, the
specific problem or situation, the solution or
resolution and a conclusion.
INTERPERSONAL RELATIONSHIP
Interpersonal relationship, along with
communication, are a very important part of
the manager‘s job and are part of every
person‘s job in an organization as well. The
way you interact with all groups is important
because all interpersonal relationships and
how they are handled ultimately impact
patient care.
CONFLICT
Interpersonal relationships from management
perspective include some conflict resolution
because there is always some type of conflict
occurring in the job. Conflict occurs when
there is disagreement between two or more
parties. Conflict management is an act of
handling these disagreements. Conflict is
normal, and the causes of conflict are diverse.
The sources of conflict can include, but not
limited to, the following:
 Scheduling
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
 Communication breakdown
 Staffing problems or solutions
 Cost of financial issues
 Pressure
 Personality
 Inadequate interpersonal skills
 Expectation of others
 Administrative skills
Warning signs of conflict:
a. Discussion between 2 people that flare up
into arguments
b. Open backbiting remarks made by one
about the other
c. Complaints from one another.
d. No direct contact between two people
e. A request for transfer
f. Other employees talking about the feud
g. Increased absenteeism for no apparent
reason.
There are 5 reactive ways of settling conflict:
1. Competition – someone wins and someone
loses
2. Accommodation – you lose because you
accommodate someone and they win
3. Avoidance – you both avoid and ignore the
problem and you both lose
4. Compromise - win/lose or tie. No one really
wins in this situation.
5. Collaboration – win/win, both parties win.
Collaboration is the best way of handling
conflict because it involves identifying
agreements and differences and evaluating
alternatives and solutions that have support
and commitment from both parties involved.
In order to achieve a win/win result, there
must be a willingness to resolve the conflict, to
get to the root of the problem, and to
empathize with each other.
Conflict Mediation Technique:
a. Clarifying the problem
b. Finding out what each other side wants
from each other
c. Reaching agreement
28
 TELEPHONE ETIQUETTE
For the Clinical laboratory, as with almost any
organization, the telephone is an important
form of communication with the rest of the
world. As a laboratory manager, it is important
to make sure that all laboratory employees
understand how to use the telephone in such
a manner as to make a good impression on
these customers.
Some basic telephone etiquette are as follows:
a. Be polite
b. Be helpful
c. Be interested
INFORMATION MANAGEMENT
Information technology has radically changed
the way organizational members
communicated. For example, it has
significantly improved a manager‘s ability to
monitor individual and team performance, it
has allowed employees to have more complete
information to make faster decisions, and it
has provided employees more opportunities to
collaborate and share information. In addition,
information technology has made it possible
for people in organizations to be fully
accessible 24/7. Therefore there is a great
need for information management.
Information management refers to the
collection and management of information
from sources and the distribution of that
information to the audience (usually with the
use of a medium).
In a networked computer system, an
organization links its computers together
through compatible hardware and software,
creating an integrated organizational network.
People in the organization can then
communicate with each other and tap into
information whether they‘re down the hall,
across town, or any place in the world.
E-mail is the instantaneous transmission of
messages on computers that are linked
together. E-mail is fast and cheap and can be
used to send the same message to many
people at the same time. Given that it is fast
and cheap, people sometimes forget there is
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
business etiquette surrounding the sending of
e-mail.
Some people in organizations find that e-mail
is too slow and therefore will use instant
messaging (IM). This is interactive real-time
communication that takes place among
computer users who are logged onto the
network at the same time.
A voice-mail system digitizes a spoken
message, transmits over the network and
stores the message to retrieve later.
Faxs allow the transmission of documents
containing both text and graphics over
ordinary telephone lines.
Electronic data interchange (EDI) is a way for
organizations to exchange business
documents, such as invoices or purchase
orders, using direct computer-to-computer
networks. Organizations prefer this method as
it can save time and money.
COMMUNICATION IN THE LABORATORY
In the Clinical Laboratory both
intradepartmental and interdepartmental
communication exists. Intradepartmental
communication is the transmission of
information within the department. It is the
routine exchange of thoughts and messages
among the laboratory staff. It can be in the
form of written or oral communication means
such as meetings, ordinary conversations and
impromptu announcements. On the other
hand, interdepartmental communication is
the ttransmission of information between or
among departments; for example, the
laboratory and the hospital administration
through memos, letters and notices.
COMMUNICATION CYCLE IN
PROCESSING A CLINICAL
DETERMINATION
One of the roles of the laboratory in
information management lies in ensuring the
exchange of valid data in a timely fashion
between the laboratory and those utilizing its
data. The data generated by the laboratory has
been called potential information and is not
actual information until it has been utilized in
patient care.
29
The communication cycle in handling a
clinical specimen (Figure 7-2) commences from
the interaction between the physician and the
patient. If the patient needs laboratory work-
up, the doctor will request the necessary
examinations needed by the patient (Figure 7-
4). The next step is the interaction between the
patient and the laboratory. The laboratory staff
collects sample from the patient or receives
sample if the sample is already at hand. The
samples will then undergo processing. It is
important also to bill the patient for the cost of
the examinations. After testing is done, the
laboratory will give the result (Figure 7-5)* to
the patient (for OPD) or to the doctor or ward
staff (for in-patients) for proper medical
assessment and diagnosis.
FIG 7-2 Communication process for a
clinical determination
Figure 7-3 demonstrates specifically the
communication cycle in processing clinical
determination.
FIG. 7-3 Workflow in the Laboratory
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
REQUISITIONING
The laboratory request form (Figure 7-4)
should contain the following important
information:
1. Name of institution
2. Patient ID ( name, birthdate, age, sex,
case number, address)
3. Clinical impression/diagnosis
4. Test requested
5. Date and time of sample collection
6. Source of sample, when appropriate
7. Contact information of requesting
physician
(Note: see FIG. 7-4 for sample of Laboratory
Requisition Form on page 30-A)
*(Note: see FIG. 7-5 for sample of
Laboratory Result/Report Form on page 30-
B)
RECORD KEEPING
The significance of having an efficient
information management is the establishment
of processes for managing patient records that
are accessible, accurate, timely, secure,
confidential and private.
POLICY AND PROCEDURE MANUALS
The policy manual states the laboratory and
institutional policy for the guidance of those
working in the laboratory such as the dress
code; rules on food, smoking and telephone
use; laboratory organizations and reporting
relationships; writing, review, and
authorization of procedures; vacation and
holiday request; supply requisition; and
reporting and releasing of reports.
The procedure manual consists of standard
operating procedures (SOP) or technical
manuals. It is a written procedures of all
testing methods in the laboratory. A procedure
manual or set of flow charts should be
available at all times in the immediate bench
area. It must be readily available and followed
by all laboratory staff.
It must include the following:
• The principle and methodology of each
test.
• Criteria for specimen collection, processing
and rejections
30
• Instruction for microscopic examination – For tests normally performed on
procedures automated test equipment,
• Test procedures (analytical) provision made for using alternate
– Step by step instruction methods or for storing tests
– Result interpretation specimens in equipment is
inoperable

Direction for management of Materials

– Purchased reagents and diagnostic
kits
• Check performance when
new lots put into use
• Perform parallel tests using
old and new materials
– Laboratory-made reagents
• Determine stability by
program of periodic testing
• Labeling must identify:
• Exact nature of
Procedures for sample collection reagent
– Patient preparation • Concentration
– Type of specimen • Storage
– Specimen collection • Expiration date
• Timing • Hazards involved in
• Container use
• Preservative – Storage and handling of materials
• Anticoagulant • Date on receipt and on
• Amount of specimen opening of container
• Store correctly to ensure
Procedures for sample collection reagent integrity ( free from
– Specimen handling and transport either chemical or microbial
– Instructions for labeling contamination)
• Name of patient • Aliquot, if possible
• Origin of specimen • Keep material sensitive to
• Date of specimen collection light in colored bottles or
• Name of requesting dark cabinets or both
physician • If moisture content crucial,
• Test(s) requested tightly seal and quickly
transfer
Test performance – Preparation of materials:
– Written instruction for each test • Required solutions (e.g.
procedure (manual or automated) reagents, controls,
available in immediate bench area calibrators, stains, slides)
• Name of test and their location
• Type of specimen required • Step by step preparation of
• Materials, equipments, all material needed
controls, standards • Storage after preparation
• Procedure • Labeling and dating
• Reference ranges, reporting instructions
of test results • Safety precautions
• Policy for out-of-control • needed
values • Solutions used in
• references preparation ( e.g. NSS,
– Each procedure reviewed and dated Distilled water, etc.)
by technical supervisor or director – Calibration Procedures:
• At least annually • Step by step instructions
• At any time change is made • Verification of calibration
in procedure results

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 31

 • Concentration and number
of calibrators used
• Calibration schedule
– Control procedures:
• Material used, name, lot
number, level, frequency
used
• Preparation of materials
• Instruction for testing
controls
• Control limits
• Description of how and
where control results are
recorded
• Corrective actions taken
when results are not within
limits
Direction for management of Equipment
– Inventory
• Location, complete name
and age of instrument
– Preventive maintenance
• Definition of service task
• Planned schedule of
servicing by in-house
personnel, manufacturer‘s
representative or service
company
– Specific instruction for validating
equipment performance
– Document that appropriate service
task accomplished
– Record remedial action taken if
defect detected
– Actions taken when results deviate
from expected values:
• Recalibration
• Troubleshooting
• Repeats
• dilutions
– Limitations:
• Interfering substances
• Common sources of errors
• Results reporting (Post-
analytical)
• Reference ranges (e.g.
specimen type and
demographics)
• Panic value ( e.g. life-
threatening results and
critical results)
References:
– Manufacturer‘s product literature (
inserts, manuals)
– Literature ( textbooks, professional
journals, etc)
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
– Specimen retention:
– How long specimen is kept
– When specimen is stored
System for reporting patient results (post-
analytical)
– Unacceptable results
– How results are reported to
physicians
– Protocol for panic and critical
values
– Course of action for problems
Specimen referral (to whom or where to
refer, how the specimen is sent, how results
are received)
The manual must be approved. It should be
signed by the Head of the laboratory; reviewed
by all laboratory staff; reviewed and updated
by the supervisor/s or director. It must be re-
written when new procedures are
implemented. It must be retained for future
reference.
LABORATORY INFORMATION SYSTEM
(LIS)
The LIS is a software-based laboratory
involving a series of computer programs that
process, store, and manage data from all
stages of medical processes and tests (Figure
7-6). It has features that manage patient
check-in, order entry, specimen processing,
result entry, and patient demographics. With
LIS, all information about a patient can be
stored in a database for future reference. The
three phases involved in the analytic process
where the LIS is integrated are described
below.
The Pre-analytical Phase
This phase involves the maintaining of the
quality and integrity of the test samples. It
consists of events that happen from the time
the test is ordered to the time the sample
arrives in the laboratory. The following are the
different aspects involved in this phase:
Patient information. It includes the patient‘s
name, address, gender, age birth date, and the
attending physician.
Patient database. It contains the patient
number and name, name of entering
physician, name of physician to receive the
report, test request time and date, time of
32
specimen collection, tests to be performed, and
priority of the test request.
Specimen labeling. It involves the accurate
identification of a patient from which the
specimen was taken. The ―media copia‖ is a
system that indicates the tests, appropriate
tubes, and quantity of tubes needed for the
patient. It uses barcode laboratory labels.
Specimen accessioning. It is the technique of
assigning unique accession numbers to
facilitate locating and tracking of the specimen
during laboratory testing and storage. The
accession numbers are assigned to the
specimen once it arrives in the laboratory.
Specimen tracking. It is a software that enables
the systematic storage and retrieval of a
specimen. The software automatically assigns
a unique identifier to each sample, providing
traceability.
The Analytical Phase
This phase includes the procedures involved in
handling, analysis of the sample in the
laboratory, and reporting of test results. It
involves:
 Specimen processing. It involves
specimen retrieval and sending orders
to be analyzed with specified diagnostic
tests.
 Results entry
 Quality control
 Validation of results. Critical values
and results must be double checked
before release.
 Network to laboratory automation
systems.
The Post-analytical Phase
It involves the compiling of patient cumulative
reports, billing and a network of other
systems. Laboratory reports should be
comprehensive and contain all information
regarding the tests done in different laboratory
sections for every single patient. An
interpretative report gives information about
the range of reference values and flags
abnormal values.
The basic operating system of the LIS involves
orders to analyzers, results entry, and
laboratory reporting. LIS involves order entry
and check-in, specimen receiving, sending
test.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
SELECTION AND UTILIZATION OF LIS
The laboratory information system (LIS)
represents a strategic investment in data
management capabilities and capital funds.
When selecting an LIS, the users, both
pathologists and technologists, must identify
performance requirements such as capabilities
for managing and processing test orders,
interfacing with various instruments and other
software information systems, manipulation of
data to support numerous requirements for
results reporting, and supporting ancillary
functions such as billing, client services and
quality management, and process control
First, the patient‘s information and the list of
tests are entered into the LIS; then the
barcode labels are printed. This can be done
directly in the information system in the ward,
Specimen such as urine and feces can be
collected in the patient‘s room without the
assistance of the laboratory staff. In this case,
the barcode labels printed in the ward can be
used. Then the specimen is sent to the
laboratory for analysis.
The availability of an intranet in a hospital will
facilitate the sharing of information between
the ward and the laboratory. Specimens such
as blood will be collected by the phlebotomist
from the patient based on the list s of tests
recorded in the LIS.
When samples are delivered to the laboratory,
a staff member uses the bar code reader device
to read the sample‘s bar code, then the LIS
automatically input all the information of the
samples. A sample submission/receiving list
will be generated after the acceptance. The
print-out contains the sample‘s information
such as time when the sample was sent to the
laboratory and the people in the laboratory will
be given accession numbers to facilitate
locating and tracking of the specimens.
In specimen analysis, the batches of
specimens are analyzed using an automated
laboratory machine; then results and other
information are automatically collected. These
data are also automatically registered in the
database. The LIS can also manage data from
multiple instruments in the laboratory.
Quality control samples are inserted into the
testing process of patient‘s samples. The LIS
manages the quality control records, analyzes
33
the quality control data, and generates
statistics automatically.

Through the LIS, physicians can easily track

reports to determine the time when a
laboratory test was finished, who performed
the laboratory test, and the time when the
data was reviewed.
With LIS, data can be transmitted to other
interfaces so that other healthcare providers
can directly access the database.

FIG 7-6 Laboratory Information System

Workflow

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 34

Unit 8 – Personnel Management
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Acquire basic knowledge on human
resource management
2. Relate motivational theories to
workplace situations in the clinical
laboratory
3. Explain the nature of effective work
group interaction
4. Discuss the ideal flow of employment
procedure
TOPIC SUMMARY
Human Resource Management (HRM) is the
integration of all processes, programs, and
systems in an organization that ensure staff
are acquired and used in an effective way. It is
the effective recruitment, selection, placement,
development, maintenance and utilization of
the manpower resources of an organization.
The strategic Importance of HRM are as
follows:
 It can establish an organization‘s
sustainable competitive advantage.
 It requires fundamental change in how
managers think about employees.
 It needs to consider outsourcing certain
HR transactions
National and local governments influenced
HRM through laws and regulations. Employers
must ensure that managers understand their
obligations and comply. These laws protect
individuals and groups from discrimination,
protect employees from harassment (both
workplace and sexual).
Other Employment Legislations include
Employment standards such as basic or
minimum employment conditions in an
organization (ex. Minimum wage, hours of
work, Overtime pay); Health and safety and,
Labor relations (relationship between union
and employer) but not all organizations are
covered by Labour Relations. Collective
bargaining is a process to negotiate terms and
conditions of employment. Bargaining
produces a written document called a
collective agreement.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Laws and regulations are not the same
throughout the world. It is important to know
the legislation of the country in which
employees are working.
PERSONNEL PROGRAM
It consists of series of activities intended to
carry out the personnel policies of the
organization for the purpose of realizing its
objectives. It covers the following:
 Employment
 Safety
 Employee relations
 Employee research and standards
 Employee services
PERSONNEL POLICY
It is the statement of intention that commits
the manager to a general course of action in
order to accomplish a specific purpose. Once
policies are formulated, they should be stated
in writing and be known to employees (E.g.
employee‘s handbook)
PERSONNEL RECORDS
Provides a ready references to employees such
as job description, education, experience,
qualification, length of employment, job
references, written reprimands, comments and
personal list, etc.
SOURCES OF LABOR
There are two (2) sources of employment:
1. Internal source includes employees actively
working in the organization. When a vacancy
exists, employees are transferred or promoted.
2. External source are people from outside the
organization who may wish to apply for the
job.
PERSONNEL SELECTION PROCESS
Selecting the appropriate employee is critical
to the success of the organization. The
manager is seeking to hire an individual with
the ability to be flexible, self-motivated, and
functional in a variety of work settings.
35
In today‘s healthcare environment, employees b. Reception of applicants either in
are expected to use multitasking skills more person or writing.
than ever before, as well as be able to work as One of the requirements to submit by the
a productive team member. The manager is applicant is a cover or application letter. It
looking for an employee whose personality and typically provides detailed information on
skills best match the expectations of the why are you are qualified for the job you
institution and the job.
are applying for. It should accompany a
resume to focus attention on the
The Human resource (HR) division of a
applicant. It is best to address the cover
company plays a major role in the employee
letter to a specific individual.
hiring process. The employee selection process
actually begins with the development of the A resume, on the other hand, is a tool for
job description and advertisement of the a candidate to demonstrate their
position. Specifically, it has 3 steps: strengths, education and
1. Recruitment Process accomplishments when seeking
2. Selection Process employment. The resume include the
3. HR Orientation / Socialization Process following:
◦ Candidates name ( legal)
Recruitment process involves generating a ◦ Contact information ( including
pool of qualified candidates for a particular e-mail)
job. It is a process of locating, identifying, and ◦ Career objective
attracting capable candidates. Figure 8-1
◦ Educational qualifications
provides the different ways of recruitment.
◦ Clinical experience or Military
From these sources, employee referral
experience
provides the best source of recruitment since
◦ Certifications
the person referred to be is already known to
◦ Professional society
have good performance by the person referring
memberships
it. Recruitment can be for current or future
needs. ◦ Honors
◦ Publications/research
activities/special projects
◦ Volunteer work
◦ Statement regarding references
c. Preliminary interview
It entails filling-up of information sheet
provided by the HR for screening
purposes.
d. In some cases, applicant reports to the
HR manager and is made to take
employment tests.

FIG 8-1 Ways of recruitment

Below are the things to do in this process:

a. Posting or advertising job vacancies.
The best advertisement (Figure 8-2) is one
written specific enough to attract a
minimum number of qualified candidates.
It is extremely necessary to market the
advertisement in highly visible locations FIG. 8-2 Job advertisement
for effective exposure to possible job
applicants.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 36

Once the screened HR applications are
received, candidates are selected from the
pool.
Selection process is the mechanism that
determines the overall quality of an
organization‘s human resources from the given
pool of candidates that results from the
recruitment effort.
The following are done in this process:
a. Applicant interview.
b. Investigation of applicant’s background
c. Selection form among qualified
d. Medical examination.
Employment Interview
It is intended to check the veracity of the
information contained in the information sheet
and to secure more information; and to
evaluate the candidate‘s skills and personality
in order to select the best person for the job.
The interview also provides the candidate the
opportunity to disclose information not
contained in the resume, as well as provide
the candidate an opportunity to learn about
the people with whom he or she will possibly
work, benefits, growth potential, etc.
Common Types of Interviews:
 Non-directive. It has wider scope.
Questions are open ended.
 Behavioral Description. It involves
asking about a situation you have
experienced. It employs psychological
profiling.
 Structured. Usually involves panel
interview (Figure 8-3) and it is
situational.
FIG. 8-3 A structured interview
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
The candidate may prepare for the interview
by:
 Reviewing the submitted resume
 Reviewing the professional and
personal goals
 Researching about the company
 Listing the accomplishments and
determine why you would be valuable
to the company.
 Making a list of possible questions.
 Identifying who is conducting the
interview.
During the interview, the candidate should:
 Be well-groomed. Dress appropriately
for the interview. Candidates should
stay in the boundaries of business
wear. They should be conservative with
jewelry, hair accessories, cosmetics
and fragrances.
 Be on time or few minutes early for the
interview.
 Know the exact location of the
interview.
 Greet the interviewer, smile, and /or
employing a firm handshake exhibiting
a genuine gladness to meet the
interviewer.
 Remember to wait until offered seating
prior to sitting down. Sit up straight.
Do not slouch. Watch for any nervous
signals like tapping fingers, leg
swinging or fidgeting.
 Look prospective employer in the eyes
when speaking.
 Answer questions completely.
 Avoid making negative comments
about past employers, supervisors or
coworkers.
 Act interested at all times, even if the
questioning becomes difficult.
 Be honest in answering all questions.
The interviewers should prepare for the
interview by developing questions that will
reveal how the candidate resolved problems or
challenges encountered during work
experiences. They should avoid questions that
are discriminatory.
37

At the end of the interview, the interviewer
should thank the candidate for the application
and provide an approximate timetable for
filling the position.
The candidate should not forget to thank the
interviewer for the opportunity to interview
and for the time spent arranging and
conducting the interview.
There are challenges that managers may face
in the hiring process. This includes
determining which characteristics that
differentiate people are most important
to performance; how do you measure those
characteristics; how to evaluate applicants‘
motivation levels and, deciding who should
make the selection decisions.
to job and work unit. It helps employee to
understand values, beliefs, and acceptable
behaviors. It can be divided into three phases:
Anticipatory Phase. Applicants generally
have a variety of expectation about the
organization and job based on accounts
provided by newspaper and other media, word
of mouth, public relations and so on.
Encounter Phase. The new hire has started
work and is facing the reality of the job.
Setting in Phase. The new hires begin to feel
like part of the organization.

HR Selection Tools as Predictors of Job

Performance:

Letters of Recommendation. It is a
letter in which the writer assesses the
qualities, characteristics, and
capabilities of the person being
TRAINING AND DEVELOPMENT
recommended in terms of that
individual‘s ability to perform a
Training is teaching, or developing in oneself
particular task or function.
or others, any skills and knowledge that relate
to specific useful competencies. Training has
Application Forms. Organizations often
specific goals of improving one's capability,
use application forms as screening
capacity, productivity and performance. People
devices to determine if a candidate
within many professions and occupations may
satisfies minimum job specifications,
refer to this sort of training as professional
particularly for entry-level jobs. The form
development.
typically asks for information regarding
past jobs and present employment
Training is a learning experience that seeks
status.
relatively permanent change. It involves
changing skills, knowledge, attitudes or
Written Tests. A candidate‘s potential in
behaviors. It usually tends to be done for
a certain area, such as math and are
current job.
valid predictors of job performance when
the abilities tested are based on a job
APPRAISAL OF JOB PERFORMANCE
analysis. (Intelligence, ability, general
aptitude, interest)
Performance management is the integration of
management practices that includes a formal
Personality Tests. It assess traits,
review of employee performance. It includes
individual workers‘ characteristics that
establishing performance standards and
tend to be consistent and enduring.
reviewing the performance. It is a means to
ensure organizational goals are being met.
Socialization or Orientation Process is a
way to introduce new employees to
organization. It is to familiarize new employee

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 38

If performance fall short, management will
implement the following tools for improvement:
Training, disciplining and coaching. However,
if all of these have been done and yet there is
no improvement, the staff will be forced to be
―Out the Door‖; meaning, can be fired after
due process of law.
COMPENSATION MANAGEMENT
It is a process of determining cost-effective pay
structure, designed to attract and retain
employees. It is structured to ensure that pay
levels are perceived as fair. Figure 8-4 provides
the factors that influence compensation. It
also provides an incentive to work hard.
FIG. 8-4 Factors that impact
compensation
Employee Benefits are indirect financial
rewards. It is designed to enrich employees‘
lives. It includes retirement plan, insurance,
annual and sick leaves and free or discounted
services.
PROMOTION
It is an advancement of an employee to better
job in terms of greater responsibilities, more
prestige or ―status‖, greater skill and
especially, increase rate of pay or salary.
HABITUAL TARDINESS
It is a chronic disease of unknown etiology.
Cures are rare, some remissions may be
attained with the following therapy:
 Dock salary for late minutes
 Re-schedule for a later starting time
 Re-assign to a different department
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
 When all fails, mark ―improvement
needed‖ on the employee‘s performance
evaluation.
CORRECTIVE ACTION AND EMPLOYEE
DISCIPLINE
As a manager, it would be a perfect world if
everyone performed their job, and correction of
employees was unnecessary. However, some
employees really fall short of expected
standards. And disciplinary action requires
documented facts sufficient to support the
contemplated action.
Documented facts needed in disciplinary
action:
a. Specific instances of poor performance
or misconduct
b. Circumstance surrounding
performance or misconduct
c. Prior misconduct, if any
d. Evidence of warning that this poor
performance or misconduct should not
be repeated.
e. Records that definite time limit was set
for improvement and follow-up.
The purpose of corrective action is to provide
the employee with specific goals to enhance
their effectiveness and performance within the
institution.
Once the manager becomes aware of a
problem, the first step to correct this is verbal
counseling to make the employee aware of the
situation and to open the lines of
communication. The second step is to issue a
verbal warning that specifically involves
stating the problem, performance in question
and offering resources and assistance (process
is documented). The third step is a formal
written warning that states the problem,
expected improvement in performance and a
timeline for re-evaluation of performance. This
document is signed by the immediate
supervisor and employee. Failure to meet the
stated requirements typically results in
dismissal of the employee.
Most institutions have a policy that allows the
employee to seek an appeal of the situation to
a higher level.
39
Correction should not occur as a result of a • Secondary or Higher level needs:
manager‘s personal issue, but rather an – Social needs – sense of
institutional issue that threatens the belongingness
effectiveness of the institution. – Esteem (ego) needs – personal
respect, recognition from
MOTIVATION others, etc
– Need for self-actualization – the
highest level needs, for
Motivation is the factor that inspires a person fulfillment and realization of
to act. Understanding what motivates people potential, both as a creative
to work is essential in getting the work done, person and member of the
and getting the work is the primary task of the society
leader. Although no motivational theory is
applicable in all situations, a study of the
different theories allows the leader to identify
the motivational factor influencing a work
situation. Once the factor is identified, the
leader can provide the environment that would
enhance motivation.

Major Theories of Motivation:

• Content Motivational Theories :
examines the internal forces that drive
the individual to specific actions
– Maslow‘s Hierarchy of needs
– Herzberg‘s Two-factor theory
– Alderfer‘s EGR Theory
– Mc Clelland Achievement
Motivation
• Process Motivational Theories: attempt
to explain the person‘s reaction to
external stimuli
– Vroom‘s Expectancy Theory
– Adam‘s Equity Theory FIG. 8-5 Maslow Hierarchy of Needs
– Skinner‘s Reinforcement Theory
Alderfer’s ERG Needs Theory:
Maslow’s Hierarchy of Needs Theory: • Existence needs : physiological needs
• By Abraham H. Maslow (1970) and safety needs
• Prioritized basic human needs into 5 • Relatedness needs: Maslow‘s social and
categories ranging from most self-esteem needs
fundamental physiological needs to the • Growth needs: Maslow‘s self-esteem
most fulfilling self-actualization. and self-actualization
(Figure 8-5)  It includes frustration-regression
• The primary needs take priority and process in which when an individual is
must be satisfied before the secondary frustrated in satisfying higher level
needs can be pursued needs, lower level needs (regression)
• Primary or Lower level needs: grow in intensity
– Physiological needs – the most
basic biological survival needs Herzberg’s Two Factor Theory
(e.g. food, water. Shelter, etc) • Herzberg (1959) defined two factors:
– Safety needs – physical and – Hygiene factor: Correspond
psychological security and primarily with Maslow‘s
stability and freedom from physical and social needs. They
deprivation, fear and threats prevent job dissatisfaction.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 40

 – Motivators: Corresponds
primarily with Maslow‘s growth
needs. They stimulate
employees to strive for superior
performance
Mc Clelland’s Achievement Motivation
• By David C. Mc Clelland
• The strength of a specific motive is
directly linked to the opportunities
offered by the situation.
• Three work related needs:
– Need for achievement
– Need for power
– Need for affiliation
Vroom’s Expectancy Theory
• By Victor H. Vroom
• Effort will bring reward. (Figure 8-6)
• The effort expended will be related to
the perceived value of the reward.
People make a choice between
alternative courses of actions according
to how they perceive the results.
FIG 8-6 Vroom’s VIE Expectancy Theory
• Five variables involved:
a. Expectancy: the belief that the
effort brings performance and
performance leads to rewards
b. Outcome: the perceived
expectancy that the outcome
from the effort will actually be
realized
c. Instrumentality: the degree of
faith in the belief that current
efforts may make possible in
achieving even larger or more
long term rewards
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
d. Valence: the value placed on the
available rewards. The more
highly value the prize, the more
motivated the individual and
vice versa
e. Choices: a quantified model
called VIE equation has been
developed to demonstrate a
person‘s choosing to behave in
a certain manner.
Motivation= valence X instrumentality X
expectancies
Adam’s Equity Theory
• By J. Stacy Adams
• Employees are motivated by the degree
of equity that they perceive in their
work situation, especially compared
with people in similar position.
• Key concepts: comparison and
perception
Skinner’s Reinforcement Theory
• By B.F. Skinner
• People behave according to the way
they are treated.
• Components of reinforcement Theory:
– The law of effect – people act in
response to expected
consequences
– Stimulus : an event that
influence or leads to response
– Response: Behavior that results
from a stimulus
– Reinforcement: consequence of
action or response. It may be
41
 positive or negative. Which is
designed to cause the individual
to avoid undesirable behavior.
– Behavior modification: the
application or practice of
reinforcement theory as
expressed in the law of effect.

Other Motivational Theory

• Life cycle of Workers:
 20-30 years old: a time of
searching and exploring work
and life alternatives
 30-40 years old: high
contentment to career
advancement goals
 40-45 years old: a period of
questioning career and life
choices, frequently evolves into
mid-life crisis
 45 – 65 years old: a time of
increasing stability, acceptance,
commitment to job, family and
retirement

Application of Motivation Theories in the

Workplace:
• Leadership: managers control the assets
and operations of the organization from
which workers receive their pay and
other benefit programs
• Job satisfaction: the degree to which
employees feel their jobs meet their
needs and wants
• Goal setting: the manager and employee
come to an agreement about what to
expect from each other
• Pay
- Material pay: tangible or
monetary part, holidays,
insurance, fringe benefits. Takes
care of the lower level needs
- Psychic Pay: consists of intrinsic
rewards that give us good feeling
about ourselves and our work.
Takes care of the higher level of
needs

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 42

Unit 9 – Quality Assurance
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Define the concept of quality from a
laboratory perspective
2. Perform analytical measures to
identify weaknesses in laboratory
operations
3. Describe a quality management
program for a clinical laboratory
4. Prepare a sample of a quality plan for
the clinical laboratory
5. Explain the standard protocol in
proficiency testing.
TOPIC SUMMARY
BACKGROUND ON CONCEPTS OF
QUALITY
Historical Perspective:
Over the past few decades there have been
several leaders who have been instrumental to
developing the concept of quality as
understood today (Figure 9-1).
Joseph M Juran is one of these key figures.
Using eastern philosophies learnt in Japan, he
advocated the idea that quality related to
"fitness for use". Juran believed that this
definition of quality fell into two key areas.
Higher quality products had a greater number
of features which fit with the requirements of
the consumer and also had fewer defects. His
book "Managerial Breakthrough" published in
the 1960s was the first to offer a step-by-step
sequence for improvement, while the Juran
Trilogy, published in the 1980s, produced the
three definitive quality management processes;
quality planning, quality improvement and
quality control.
Another founding father of quality, W.
Edwards Deming also took what he learnt in
Japan and brought it to the west. His 14
points were presented in his work "Out of the
Crisis", published in 1982 and had been learnt
in Japan following the Second World War. His
approach led to the creation of the theory of
total quality management and linked the
concept of quality with efficient management.
Deming said managers were required to have a
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
system of profound knowledge, comprised of
appreciation of a system, theory of knowledge,
the psychology of change and knowledge about
variation.
Philip Cosby is the man behind the four
absolutes of quality management and
furthered the idea that quality was about
conforming to a series of requirements, rather
than reaching a poorly defined benchmark of
goodness. His absolutes centered about the
concept that quality should be prevented
rather than detected and corrected, the
standard for performance should be zero
deficits and quality should be measured by the
price of non-conformity. Crosby laid out 14
steps for quality improvement, ensuring that
the principle is embedded throughout the
organization and throughout all business
processes. Indeed, one of Crosby's most
commonly quoted phrases is "If quality isn't
ingrained in the organization, it will never
happen."
FIG. 9-1 Innovators of Quality
QUALITY ASSURANCE
Quality is defined as the sum-total of all the
characteristics of a product/service that has a
bearing upon the utilization of the
product/service to the entire satisfaction of
the consumer.
Quality Assurance is a comprehensive set of
policies, procedures and practices that are
followed to ensure that a laboratory‘s results
are reliable. It involves all processes that a
laboratory uses to ensure quality test results.
Quality Control is the process by which one
monitors analytical procedures in order to
ensure the accuracy and precision of test
results and thus the validity of patient results
43
prior to their reporting. This includes the
establishment of a quality standard or
specifications for each aspect of the testing
procedure, determination of how close to the
quality standard the testing procedure is, and
then taking any necessary corrective actions to
bring the procedures up to the required
standard.Typically this is accomplished by
monitoring QC materials such as serum,
urine, CSF, etc. concomitantly with patient
samples.
Types of Quality Control
QC can be subdivided into external and
internal QC.
A. Internal Quality Control
In practice, internal quality control is designed
to check that a laboratory will produce the
same result or outcome if the test or procedure
is done on different occasions (within-
laboratory variation), or by different
technicians (between-operator variation). It
involves
 Establishing the mean and the
standard deviation for the QC material,
verifying the accuracy and precision of
the control material, and establishing
acceptable statistical limits for each
analytical method using that control
material.
 Assaying the QC material
concomitantly with patients‘ samples
and verifying that the control material
results fall within the acceptable limits
prior to accepting or rejecting a given
assay run.
 Monitoring control results overtime for
changes in precision (random error) or
accuracy (systematic error) using
prescribed methods and then
addressing the problem. When problem
exists, correct the source of error and
re-analyze the patient and control
samples.
B. External QC
It involves:
 The comparison of laboratory‘s assay
results from unknown test samples
with the mean results of those obtained
on the sample samples by other
laboratories.
 The comparison of laboratory‘s assay
results from unknown test samples
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
with those obtained by an external
agency using a reference method. This
is often part of a proficiency testing
program. (Figure 9-2)
Participation within a recognized external
quality assurance (EQA) scheme has many
benefits, including information on the relative
performance of different methods, and
knowledge about one's own ability to perform
tests and report results accurately, as well as
gaining the confidence of clinicians and
patients
FIG. 9-2 Proficiency testing process
DIVISION OF LABORATORY PRACTICES
ON QUALITY CONTROL
This includes preventive,
assessment/evaluation, and corrective
measures. This is to ensure the quality of the
pre-analytical, analytical and post-analytical
processes.
Preventive Procedures involves the creation,
selection, and validation of the laboratory
processes and methods. It aims to to establish
accuracy in analytical testing. The following
pre-analytic activities are important:
 Properly constructed and equipped lab
 Orientation and training of personnel
 Use of proper methods
 Preventive maintenance (temperature,
pipette checked, autoclave, etc.)
 Prescribed labeling and storage of
materials
 Procedure validation
Assessment/evaluation practices are analytic
activities that are undertaken during the test
to determine whether the established systems
are performing correctly. The following are
important to this phase:
44
 a. Reliability during test performance. It
involves the use of:
1. Standards –test system‘s ability
to detect substance accurately
2. Controls – simulate composition
of sample (known concentration
of substance to be tested). It is
imperative to observe control
values in normal range; and, if
control value is near critical
decision level - discriminate
between positive and negative
results.
2. Use of quality control system such as:
1. Mean value
2. Upper and lower acceptable
limits
3. Lot number of controls
4. Date and result of each analysis
3. Proficiency testing
1. Internal ( daily precision and
laboratory bias)
2. External (proficiency testing
services
Corrective practices are post-analytic
activities that determine error and possible
sources of error to allow correction in the
established system. Corrective measure is a
response to problems or deviations from
standard values. Below constitutes this phase:
a. Specific source of action delineated in
SOP manual ( e.g. Westgard Rules)
b. Temporary suspend reporting of data
until source of problem determined or
adequate performance verified
c. Specify means by which action taken is
documented
QUALITY CONTROL PROGRAM
Control of Test. This is simply the control of
procedures and the attainment of accurate
and reliable results. Below are assessment
factors for method evaluation and selection:
a. Accuracy. It describes how close a test
result to the true value. It can be
improved by:
 Use of properly standardized
procedures
 Statistically valid comparisons
of new methods with
established reference values
 Use of samples of known values
(control)
 Participation in the proficiency
testing program
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
b. Precision. It describes how close the
test results are to one another when
repeated analyses of the same
specimen are performed. The precision
or reproducibility of the test may be
expressed as the standard deviation
(SD) or the derived Coefficient of
Variation (CV), which is used to
compare the SDs of the two samples. It
is as:
CV (%) = SD/mean x 100
c. Specificity. It is the proportion of
subjects without a specific disease or
condition of subjects who tested
negative.
Specificity (%) = true negative x 100
False pos + True neg
d. Sensitivity. It is the proportion of
subjects with a specific disease or
condition of subjects who tested
positive.
Sensitivity (%) = true positive x 100
True pos + False neg
Control of Specimen. The main control is
written on the written collection instruction
which contains test purpose and limitation,
patient selection criteria, timing of specimen
collection, optimal specimen collection sites,
approved specimen collection methods,
specimen transport medium, time and
temperature, availability of test, hours of test
performed, turn-around-time, and result
reporting procedures.
Control of Reagents and Supplies. It is a
requirement to purchase reagents and
supplies from reliable sources. These reagents
should have labels stating the contents,
concentration, date opened, expiration date,
lot number, and storage requirements.
Control of Equipment. The quality control of
instrument can be graphically represented by
a statistical chart which is known as the
quality control chart. Preventive maintenance
for each laboratory equipment are recorded in
a logbook.
 Equipment and instrument logs.
These documents should contain
equipment or instrument name and
serial number, procedure and
45
 periodicity for routine function checks, 5. 41s rule. The rule applies when
acceptable performance ranges, four consecutive control
instrument function failures, steps for samples all exceed the +1 or the
corrective actions, date and time of -1 limit (Figure 9-7). The
service request and response, and date controls could be normal,
of routine preventive maintenance. abnormal or a combination of
 QC chart. QC data is the most easily the two. The rule detects
visualized using a Levey-Jenning‘s systematic errors. The run is
chart. The condition to meet in the QC rejected.
program are: (1) if the result for the C 6. 10x rule. The rule applies when
material is within acceptable limits of 10 consecutive control all fall
the known value, the measurement on the same side of the mean,
procedure has been verified to be either above or below. This rule
performing as expected, (2) results for detects a systematic error. The
the patient samples can be reported run is rejected.
with good probability that they are
correct; and (3) if quality control A shift in QC. A shift is when the QC values
results are not within acceptable limits, suddenly move upward or downward from the
patient results are not reported and mean and continue the same way, thereby
corrective action is necessary. mathematically changing the mean (Figure 9-
 Westgard Rule. QC charts are 8). This is usually seen when new reagents or
examined to see if there are problems QC materials have been used, when there is a
in the procedure being done. The change in the internal temperature of the
Westgard rules are tolls that can help instrument or with dirty cuvette, or when a
determine whether there is a problem, calibration was not accurate.
and whether that problem is due to
random or systematic error. The 6 A trend in QC. A trend is when the QC values
Westgard multirules are: slowly move up or down the mean and
1. 12s rule: The rule applies when continue moving in the same direction over
at least one result falls more time (Figure 9-8). This can be the case of a
than two SDs above or below calibration that is failing or reagent stability
the mean (Figure 9-3). This is a issues.
signal the run must be
examined in further detail, but
does not in itself warrant
discarding the run. If all of the
results are within 2s, the run
should be accepted.
2. 13s rule. The rule applies when
the result falls outside of the 3s FIG. 9-3 12s rule
limit (Figure 9-4). The run is
rejected, and a random error
has probably occurred.
3. 22s rule. This rule applies when
two consecutive results
exceeded the +2 or the -2 SD
limit (Figure 9-5). The controls
could be normal, abnormal or
one of each. A violation of this FIG. 9-4 13s rule.
rule usually indicates a
systematic error. The run is
rejected.
4. R4s rule. The rule applies when
results exceed the mean plus
2S and another exceeds the
mean minus 2S (Figure 9-6).
This rule detects random errors.
The run is rejected. FIG 9-5 22s rule

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 46


FIG. 9-6 R4s rule
FIG. 9-7 41s rule
FIG. 9-8 A QC shift and trend
Control of Staff. The staff should be
appropriately trained. Every laboratory should
have written job description. Standards of
performance should be developed.
NON-ANALYTICAL QUALITY ASSURANCE
FUNCTIONS
• Physician’s order or request. A request form
that is sent to the laboratory having
patient demographic information.
• Laboratory Request specifications
a. Time specifications
• Routine – response or test
results within 24 hours, but
may take longer for some
procedures like culture and
sensitivity
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
• Today – response and test
results within 8 hours
• STAT – response within 10
minutes, no delay in
performance
• Specific time – specimen
collection within +/- 5
minutes time designated, no
delay in performance.
b. Conditions specification: (pre-op,
ER, OBS, etc.)
c. Patient category (in-patient, OPD)
• Worksheets
• Patient Identification
• Distribution of test results ( forwarding)
• Specimen reassignments. The laboratory
should select only an accredited or
licensed reference laboratory for re-
assignment. ( for validation of results,
example HIV positives). The referral
laboratory‘s name, address and license
number should be included in the patient‘s
final report.
QUALITY MONITORING AND
ASSESSMENT TOOL
Shewhart Chart. It is statistical tool intended
to assess the nature of variation in a process
and to facilitate forecasting and management.
Levey-Jennings Chart. Levey-Jennings chart
is a graph that quality control data is plotted
on to give a visual indication whether a
laboratory test is working well. The distance
from the mean is measured in standard
deviations (SD). It is named after S. Levey and
E. R. Jennings who in 1950 suggested the use
of Shewhart's individuals control chart in the
clinical laboratory. On the x-axis the date and
time, or more usually the number of the
control run, are plotted. A mark is made
indicating how far off the actual result was
from the mean (which is the expected value for
the control). Lines run across the graph at the
mean, as well as one, two and sometimes
three standard deviations either side of the
mean. This makes it easy to see how far off the
result was.
Rules, such as the Westgard rules can be
applied to see whether the results from the
samples when the control was done can be
released, or if they need to be rerun. The
formulation of Westgard rules were based on
statistical methods. Westgard rules are
47
commonly used to analyze data in Shewhart
control charts. Westgard rules are used to
define specific performance limits for a
particular assay and can be used to detect
both random and systematic errors. Westgard
rules are programmed in to automated
analyzers to determine when an analytical run
should be rejected. These rules need to be
applied carefully so that true errors are
detected while false rejections are minimized.
The rules applied to high volume chemistry
and hematology instruments should produce
low false rejection rates.
The Levey-Jennings chart differs from
the Shewhart individuals control chart in the
way that sigma, the standard deviation, is
estimated. The Levey-Jennings chart uses the
long-term (i.e., population) estimate of sigma
whereas the Shewhart chart uses the short-
term (i.e., within the rational subgroup)
estimate.
Histogram. A histogram is a display of
statistical information that uses rectangles to
show the frequency of data items in successive
numerical intervals of equal size (Figure 9-9).
In the most common form of histogram,
the independent variable is plotted along the
horizontal axis and the dependent variable is
plotted along the vertical axis. The data
appears as colored or shaded rectangles of
variable area.
FIG. 9-9 Histogram
Pareto Chart. A Pareto chart, named
after Vilfredo Pareto, is a type of chart that
contains both bars and a line graph, where
individual values are represented in
descending order by bars, and the cumulative
total is represented by the line (Figure 9-10).
It is used to represent a large set of factors.
The purpose of the Pareto chart is to highlight
the most important among a (typically large)
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
set of factors. In quality control, it often
represents the most common sources of
defects, the highest occurring type of defect, or
the most frequent reasons for customer
complaints, and so on.
Figure 9-10 Pareto Chart
Other control charts. These include the
check sheet, control chart, cause and effect
diagram, flowchart, and scatter diagram.
MANAGEMENT OF QUALITY
How critical is the laboratory?
70% of all medical decisions are based on
laboratory results (Silverstein, 2003)
Consequences of Laboratory Errors:
1. Inappropriate action – unnecessary
treatment resulting to complications
2. Inappropriate inaction – failure to
provide proper treatment
3. Delay in correct diagnosis
4. Additional and unnecessary diagnostic
testing
5. Loss of credibility of laboratory
6. May result in legal action
Therefore, there is a need for Quality Control
in Clinical Laboratory! Quality is a value.
Quality management is a learned body of
knowledge, skills, and practices aimed at
achieving excellence in products, service, and
environment based on requirements,
perceptions, and future needs of customers.
Quality principles and practices impact how
each laboratory staff understand his/her role.
In this regard, quality is how we do our work.
It doing the right things right and making
continuous improvements.
48
Managing quality in a service business such
as healthcare delivery is inherently
challenging. Because it does not produce a
―product‖ that is measured, weighed and
tested. Quality is determined by the
transaction between the employee and the
customer. Service quality is subjective and
personal. It depends on how happy the
employee is and on whether he or she
perceives the job as satisfying. It also depends
on how the customer‘s expectations are being
met. These expectations might not be clear or
mutually appreciated by both the customer
and the employee.
Quality begins with the customer. Although
the laboratory professional‘s customers
includes coworkers and physicians, the
ultimate customers in healthcare are the
patients. They are who we serve. They are the
reason for our existence. Quality happens
when we meet or exceed customer
requirements through the entire episode of
care.
W. Edwards Deming‘s (1986) view of an
organization is a group of systems designed to
serve customers. The systems are made up of
processes and tasks that are linked together
and affect one another. To excel at meeting
customer needs, an organization must
constantly improve these processes and
systems. Quality management in in health
acre begins with patient needs and
expectations. These needs are then balanced
with the professional standards and
requirements that are used in designing,
implementing, and improving important
patient care processes and systems.
Deming advises us to study and understand
the processes of production or service that we
are delivering. His 85/15 rule declares that
85% of a worker‘s effectiveness is determined
by the system he works within.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Only 15% of his contribution is due to his own
skill. Quantitative analysis of processes using
statistical process control and repetitions of a
Plan/Do/Check/Act cycle (Figure 9-11)
provide the improvement method of quality
management.
FIG. 9-11 The Deming Cycle
Figure 9-12 shows the different levels of
quality that can be used by organizations to
improve their overall performance.
Total Quality Management (TQM). This is a
method of ensuring that all the activities
necessary to design, develop, and implement a
service-oriented program are effective and
efficient with respect to the system. It includes
the monitoring of the processes, implementing
policies and guidelines, and controlling the
input and output productivity. It is an activity
to improve patient care by having the
laboratory monitor its work to detect
deficiencies & subsequently correct them.
Continuous Quality Improvement (CQI) or
Performance Improvement (PI) is to improve
the patient care by placing the emphasis on
not to make mistakes in the first place
FIG. 9-12 Stages of Quality
49
A quality management system can be
defined as ―coordinated activities to direct and
control an organization with regard to
quality.‖In a quality management system, all
aspects of the laboratory operation, including
the organizational structure, processes, and
procedures, need to be addressed to assure
quality.
INTERNATIONAL LABORATORY
STANDARDS
A part of quality management is assessment,
measuring performance against a standard or
benchmark. The new concept of quality
management required that standards be set,
and again industry has been in the lead.

The complexity of the laboratory system Important laboratory standards

requires that many factors must be addressed organizations:
to assure quality in the laboratory such as:
1. Laboratory environment a. ISO 15189:2007 is the standard
2. Knowledge and competency of developed by the International
laboratory personnel Organizations (ISO). Which is for use by
3. Reagents and equipment medical laboratories in developing their
4. Quality Control quality management systems and
5. Communication assessing their own competence, and for
6. Process Management use by accreditation bodies in confirming
7. Occurrence Management or recognizing the competence of medical
8. Record Keeping laboratories
b. ISO/IEC 17025:2005. Provides general
When all of the laboratory procedures and requirements for the competence of testing
processes are organized into an and calibration laboratories.
understandable and workable structure, the c. Clinical and Laboratory Standards
opportunity to ensure that all are Institute (CLSI) formerly known as the
appropriately managed is increased. The National Committee for Clinical Laboratory
quality model used here organizes all of the Standards (NCCLS). CLSI uses a
laboratory activities into twelve quality system consensus process involving many
essentials. These quality system essentials are stakeholders for developing standards.
a set of coordinated activities that serve as CLSI developed the quality management
building blocks for quality management system model used in these training
(Figure 9-13). Each must be addressed if materials. This model is based on twelve
overall laboratory quality improvement is to be quality system essentials (QSE), (Figure 9-
achieved. 12) and is fully compatible with ISO
laboratory standards.
d. European Committee for Standardization -
general terms include openness and
transparency, consensus, and integration
FIG. 9-13 Twelve Quality System Essentials

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 50

There are many other standards organizations,
and many examples of laboratory standards.
Some countries have established national
laboratory quality standards that apply
specifically to laboratories within the country.
Some laboratory standards apply only to
specific areas in the laboratory or only to
specific tests. The World Health Organization
has established standards for some specific
programs and areas.

Excellence in the laboratory services

depends on how we apply quality
management tools and techniques on a
daily basis. The challenge is great. The
resulting value added for the patient and
the intrinsic reward of a job well done for
the laboratory staff make the effort
worthwhile.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 51

Unit 10 – Safety Management

OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Discuss hazards in the clinical
laboratory and methods of prevention
2. Acquire basic knowledge on safety
management as applied in the
laboratory workplace
3. Analyze laboratory’s compliance to
safety standards

TOPIC SUMMARY

The laboratory leadership team must assure

that the work environment complies with
safety standards as defined by government
regulations, accreditation standards, and
institutional policies. In addition to
implementing procedures, the staff must be
educated to properly perform safety
procedures and comply with them. It is
management‘s responsibility to monitor FIG. 10-1 Types of hazards
compliance and provide a mechanism to allow
staff to report safety failures without fear of Biological Hazards. These are
retaliation. represented by exposure to
an infectious agent(s). The
Accident is an unintentional occurrence, an agents may be blood-borne or
unsafe act, that causes property damage and present in tissue and other body fluid.
interference with production, and that does or
could cause personal injury or death. It has a
cause and could be prevented by a good safety Sharp Hazards. Sharp objects
program. in the laboratory, including
needles, lancets, and broken
glassware, present a serious
HAZARDS IN THE LABORATORY
biological hazard, particularly for the
transmission of blood-borne pathogens.
The words ―hazard‖ and ―risk‖ are often used
interchangeably. However, there is a difference
Chemical Hazards. Every
between the two terms. With respect to
chemical in the workplace
occupational and safety, a hazard is defined
should be presumed hazardous.
as anything that has potential harm or can
The dangers which are
adversely affect the health of healthcare
associated with chemicals arise from their
workers, while risk refers to the possibility of
toxicity and hazards due to burns, fire and
suffering the adverse health effects of hazards.
explosions. Types of chemical hazards include:
In the clinical laboratory, we are exposed to flammable, corrosive, carcinogenic,
various hazards in our everyday work. Figure reactive/explosive.
10-1 provides us with different types of
hazards in the laboratory.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 52

Radioactive Hazards. Radioactivity
encountered in the clinical laboratory when
procedures using radioisotopes are performed.
The amount of radioactivity present in the
clinical laboratory is very small and represents
little danger; however, the effects of radiation
are cumulative related to the amount of
exposure. The amount of radiation exposure is
related to a combination of time, distance, and
shielding.
Sources of Radiation in the Lab:
1. Radioactive isotopes. The use of
radioisotope is becoming widespread
with the development of radio
immunoassay (RIA).
2. X-rays. The hazards from x-rays come
primarily from special instrument such
as x-ray diffraction.
3. Ultraviolet sources. The danger from
UV arise from the lack of proper shield
and from human carelessness. UV
irradiation can easy be controlled
because of its shallow penetration of
solid materials including glasses. UV
lamps must be turned off immediately
after use (to control microorganism and
to sterilize objects) to avoid over
exposure.
Electrical Hazards. These
Hazards are attributed to
improper rounding, inadequate
wiring and improper insulation
equipment. The laboratory setting contains a
large amount of electrical equipment with
which workers have frequent contact.
Fire/Explosive Hazards. Fire
Can be divided into four
important classes designated
as classes A, B, C, D. Class A
fire is a fire of ordinary combustibles.
Examples are paper, cloth, wood, trash, etc.
Class B fire is a fire of flammable liquids.
Examples are gasoline, organic solvents, etc.
Class C fire is an electric fire. Example is
motor wiring. Class D fire is a fire of
combustible metals, certain chips, shavings,
turning.
Physical Hazards. These
Hazards are associated with
Structural or mechanical
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
is Defects as slippery floors,
projections that cause cuts and bruises like
nails, inadequate lightning, machinery with
unprotected moving parts, etc.
PROTECTIVE METHODS AND
PROCEDURES
Universal precaution is an approach to
infection control by the Occupational Safety
and Health Administration (OSHA) to treat all
human blood and certain human body fluids
as if they were known to be infectious for HIV,
HBV and other blood borne pathogens. It
requires employees to observe Universal
Precautions to prevent contact with blood or
other potentially infectious materials (OPIM).
Under circumstances in which differentiation
between body fluid types is difficult or
impossible, all body fluids shall be considered
potentially infectious materials. Treat all blood
and other potentially infectious materials with
appropriate precautions such as:
 Use gloves, masks, and gowns if blood
or OPIM exposure is anticipated.
 Use engineering and work practice
controls to limit exposure.
Engineering controls are measures taken in
the laboratory environment or equipment that
help to eliminate or minimize exposure to
laboratory hazards. These controls are the first
line of defense against biological and chemical
agents. Examples of engineering controls are:
 Good ventilation, with regulated hourly
air exchanges
 Biological safety cabinets, for working
aerosol producing or highly infectious
specimens
 Fume hoods, for mixing and pouring
chemical.
These must be periodically checked and
certified to ensure proper function.
Work practices are procedures established by
the employer for employees to follow in order
to minimize or prevent workplace injuries and
exposure incidents. All employees should be
trained in safe work practices initially, upon
employment, then at established intervals.
PPE worn by the laboratory staff acts as a
barrier between the worker and workplace
53
hazards. However, it should not be regarded 5S Methodology:
as a primary barrier rather, it is supplemental
to engineering controls. 5S is the name of a workplace organization
method that uses a list of
Housekeeping techniques. Good five Japanese words:
housekeeping is essential to ensure a clean, seiri (sort), seiton (set in order), seiso
safe and pleasant work environment. Although (shine), seiketsu (standardize), and shitsuke
common sense usually prevails in laboratory (sustain). However, other translations are
housekeeping, one of the many contributing possible. The list in Figure 10-2 describes how
factors associated with accidents and fires is to organize a work space for efficiency and
poor housekeeping. Lack of good housekeeping effectiveness by identifying and storing the
also reduces work efficiency. For a safe and items used, maintaining the area and items,
healthy workplace, it is imperative that good and sustaining the new order. The decision-
housekeeping practices are employed so that making process usually comes from a dialogue
accidents and injuries do not take place. about standardization, which builds
Maintaining high standards of housekeeping understanding among employees of how they
also conveys a sense of professionalism to should do the work.
those who visit or work in our laboratories.

FIG. 10-2 5S in the Workplace

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 54

 SAFETY EQUIPMENT

The availability and use of a number of types

of safety equipment is essential to the practice
of laboratory medicine. Safety Equipment
should be present in well-marked, highly
visible, and easily accessible locations in the
laboratory. Figure 10-3 provides us with a
picture of basic safety equipment which
laboratories must have.

1. Fire extinguisher
2. Fire blankets
3. Safety showers
4. Eye wash stations
5. Chemical Fume Hoods
6. Biological safety cabinets
7. Flammable liquid storage cabinet
8. Safety cans
9. Refrigeration equipment
10. First aid kits
11. Chemical spill kits
FIG. 10-3 Example of safety equipment
12. Portable safety shield

SAFETY CODES

Safety codes are aimed to serve in a form of

poster or pictures (Figure 10-4) and placed in
strategic point in a laboratory so as to serve as
a reminder to laboratory workers to be safety
FIG. 10-4 Safety Signage conscious at all times.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 55

 SAFETY MANAGEMNT PROGRAM 3. Follow Standard precautions. E.g.
use of the required PPE.
4. Segregate and label all wastes that
The responsibility for clinical safety must be require special handling.
shared by everyone – employers, employee, 5. Report injuries and safety hazards
and clinical students. Health care institutions to supervisor immediately.
have a moral responsibility to provide a safe
work environment, safety training, and A General safety program must be include:
protective equipment for all providers and
1. Orientation of a new employee to
users of its facilities. The responsibility and
department‘s attitudes and policies for
authority vested in individuals are as follows: assuring safe laboratory conduct.
2. Periodic supervisory staff meetings for the
 Safety Director – The employer is
purpose of discussing safety.
ultimately responsible for safeguarding the
3. Orderly housekeeping standards for both
health of its employees. The safety director
laboratory and housekeeping personnel.
has 3 primary responsibilities:
4. Signs indicating need for special
1. Oversee safety program and provide
precaution in area where posted.
guidance to safety manager.
5. Orderly storage and arrangement of
2. Provide leadership for an effective
supplies and working materials.
safety program.
6. Policies governing eating, drinking,
3. Resolve problems involving
smoking and safe attire within the
employee and/or environmental
departments.
safety
7. Periodic inspections by director or
 Clinical Laboratory safety officer (an
designee for purposes of indicating
appointed position) represents the
interest and concern for the program.
laboratory in the safety committee.
8. Considerations of periodic programs by
1. Develop and maintain a laboratory
outside persons with expertise in special
safety training manual.
areas of laboratory safety.
2. Keep safety director updated on
9. Consideration of hiring a full or a part-
safety needs and safety conditions
time safety officer.
in the department.
3. Conduct or coordinate safety
Laboratory safety programs are plans for
training for supervisors.
preventing sickness and injury to personnel
4. Develop safe work methods and
and damage or destruction of physical assets.
determine safety equipment needs.
5. Document and maintain
The fundamental objectives of a meaningful
departmental safety training and
laboratory safety are:
accident investigation records.
1. To improve safety skills and attitude of all
6. Conduct or coordinate periodic
personnel.
laboratory safety inspections.
2. To develop a surveillance program for
 Clinical Laboratory supervisor
promptly identifying hazards.
1. Monitor the work habits of the
3. To formulate plans for promptly correcting
employees under his or her
all hazards.
supervision.
4. To coordinate laboratory safety efforts with
2. Assume responsibility for the safety
the overall.
of the work area and the
equipment.
MANAGEMENT OF HAZARDS IN THE
3. Establish safe work practices for
CLINICAL LABORATORY
employees to follow,
4. Attend safety-training programs
conducted by the laboratory safety Biological Hazard: ―Standard precautions‖ is
officer. a component of the blood-borne pathogens
 Laboratory staff and interns standard. It requires that all specimens and
1. Adhere to established safety biological wastes be considered infectious. PPE
policies and procedures. should be worn when handling biohazards,
2. Read the MSDS prior to using and established work practices must be
chemicals. utilized to prevent exposure. Work practices
should also be instituted to keep ―clean‖ areas

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 56

contamination free. Hand washing is the
single most important method for preventing
the spread of infection. Hands should be
washed immediately:
 After contact with blood, body fluids,
and contaminated materials
 After removing gloves
 Before eating
 Before and after contact with patients
 Before leaving the laboratory
 Before and after using the restroom.
Disposal of Biological Waste:
• All biological waste, except urine, must
be placed in appropriate containers
labeled with the biohazard symbol.
 The waste is then decontaminated
following institutional policy:
incineration, autoclaving, or pickup by
a certified hazardous waste company.
 Urine may be discarded by pouring it
into a laboratory sink. Care must be
taken to avoid splashing, and the sink
should be flushed with water after
specimens are discarded. Disinfection
of the sink using a 1:5 or 1:10 dilution
of sodium hypochlorite should be
performed daily. Sodium hypochlorite
dilutions stored in plastic bottles are
effective for 1 month if protected from
light after preparation. The same
solution also can be used for routinely
disinfecting countertops and accidental
spills. The solution should be allowed
to air-dry on the contaminated area.
Empty urine containers can be
discarded as non-biologically
hazardous waste.
Sharps Hazards: All sharp objects must be
disposed in puncture-resistant containers.
Puncture-resistant containers should be
conveniently located within the work area.
Chemical Hazards: Material Safety Data
Sheets (MSDS) *(see sample in page 57-A)
must be maintained for every chemical used in
the workplace. They should be immediately
available for use by all employees who work
with chemicals. MSDS may be obtained from
each chemical‘s manufacturer. By law,
vendors are required to provide these sheets to
purchasers; however, the facility itself is
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
responsible for obtaining and making MSDSs
available to employees.
Information contained in an MSDS includes
the following:
1. Physical and chemical characteristics
2. Fire and explosion potential
3. Reactivity potential
4. Health hazards and emergency first aid
procedures
5. Methods for safe handling and disposal
PPE should be worn when pouring and mixing
chemicals, cleaning chemical pills, and
performing other procedures where chemicals
are used. Manipulation with chemicals that
produce odors or fumes should be done
underneath a fume hood or in a well-ventilated
area.
Containers of chemicals should be stored in a
safety cabinet, below eye level. Storage
containers must be compatible with the
chemicals they contain. Only compatible
chemicals should be stored together. Each
chemical (including those in premade
reagents) must be labeled with the chemical‘s
name, specific hazard warnings (poisonous,
corrosive, and carcinogenic), manufacturer‘s
name and address. Used, outdated, and old or
discolored chemical must be promptly and
properly discarded according to state
regulation. The laboratory safety officer should
be consulted if in doubt.
When preparing acid-based solution, the acid
should always be added to its mixing base,
which has been placed in a mixing flask.
Radioactive Hazards: Persons working in a
radioactive environment are required to wear
measuring devices to determine the amount of
radiation they are accumulating. Laboratory
personnel should be familiar with the
radioactive hazard symbol shown in Figure 10-
5. This symbol must be displayed on the doors
of all areas where radioactive material is
present.
Exposure to radiation during pregnancy
presents a danger to the fetus; personnel who
are pregnant or think they may be should
avoid areas with this symbol.
57

FIG. 10-5 Radioactive hazard symbol.
Electrical Hazards: The same general rules of
electrical safety observed outside the
workplace apply. The danger of water or fluid
coming in contact with equipment is greater in
the laboratory setting. Equipment should not
be operated with wet hands.
Designated hospital personnel monitor
electrical equipment closely; however,
laboratory personnel should continually
observe for any dangerous conditions, such as
frayed cords and overloaded circuits, and
report them to the appropriate persons.
Equipment that has become wet should be
unplugged and allowed to dry completely
before reusing. Equipment also should be
unplugged before cleaning. All electrical
equipment must be grounded with three
pronged plugs.
When an accident involving electrical shock
occurs, the electrical source must be removed
immediately. This must be done without
touching the person or the equipment involved
in order to avoid transference of the current.
Turning off the circuit breaker, unplugging the
equipment, or moving the equipment using a
nonconductive glass or wood object are safe
procedures to follow.
Fire Hazards. The Joint Commission on
Accreditation of Healthcare Organizations
(JCAHO) requires that all health-care
institutions post evacuation routes and
detailed plans to follow in the event of a fire.
Laboratory personnel should be familiar with
these procedures.
When a fire is discovered, all employees are
expected to take the actions in the acronym
RACE:
Rescue—rescue anyone in immediate
danger
Alarm—activate the institutional fire alarm
system
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Contain—close all doors to potentially
affected areas
Extinguish—attempt to extinguish the fire,
if possible; exit the area
Fire Exit must be clearly marked, never lock,
free from bags and other equipment, and
ideally equipped with emergency light. The
sign (Figure 10-6) must show the way to the
nearest exit leading directly outside.
FIG. 10-6 Fire exit sign
Laboratory workers often use potentially
volatile or explosive chemicals that require
special procedures for handling and storage.
Flammable chemicals should be stored in
safety cabinets and explosion- proof
refrigerators, and cylinders of compressed gas
should be located away from heat and securely
fastened to a stationary device to prevent
accidental capsizing.
Fire blankets may be present in the
laboratory. Persons with burning clothes
should be wrapped in the blanket to smother
the flames.
The National Fire Protection Association
(NFPA) has developed the Standard System for
the Identification of the Fire Hazards of
Materials, NFPA 704.7. It classifies fires with
regard to the type of burning material. The
symbol system (Figure 10-7) is used to inform
fire fighters of the hazards they may encounter
with fires in a particular area. The diamond-
shaped, color-coded symbol contains
information relating to health, flammability,
reactivity, and personal protection/special
precautions.Each category is graded on a scale
of 0 to 4, based on the extent of concern.
These symbols are placed on doors, cabinets,
and containers.
58

FIG. 10-7 NFPA hazardous material
symbols
NFPA also classifies the type of fire
extinguisher that is used to control them. The
multipurpose ABC fire extinguishers are the
most common, but the label should always be
checked before using.
Two types of fire extinguishers are most
commonly used in health care instituions. One
is a combination of classes A, B, C (Type ABC),
and the other is a combination of classes B
and C (Type BC) Type BC fire extinguishers
are usually preferred for clinical laboratory
use. Fire extinguishers are defined as:
 Class A (water base) – for wood and
paper fires
 Class B (foam or dry chemical) – for
flammable liquids or gases
 Class C (foam or dry chemical) –for
electrically based fires
 Class D ( graphite or dry chemical) – for
metal fires
It is important to be able to operate the fire
extinguishers. The acronym PASS can be used
to remember the steps in the operation:
Pull pin
Aim at the base of the fire
Squeeze handles
Sweep nozzle side to side
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Physical Hazards: Physical hazards are not
unique to the laboratory, and routine
precautions observed outside the workplace
apply.
General precautions to consider are to avoid
running in rooms and hallways, watch for wet
floors, and bend the knees when lifting heavy
objects, keep long hair pulled back, avoid
dangling jewelry, and maintain a clean,
organized work area.
Closed-toe shoes that provide maximum
support are essential for safety and comfort.
WASTE MANAGEMENT
Laboratory wastes are material used to sustain
laboratory operations that are no longer
needed and should be discarded or disposed.
They are generally classified into hazardous
and non-hazardous wastes.
Non-hazardous waste is that which is
comparable to normal domestic garbage and
presents no greater risk, therefore, than waste
from a normal home, i.e. paper, packaging,
food waste.
Characteristics of Hazardous Wastes:
 Explosivity and reactivity – this
includes waste that is unstable and
reacts violently when exposed to
chemical change, waste that releases
toxic fumes when mixed with water
and may even explode under extreme
conditions, and waste capable of
detonation and explosive
decomposition at standard temperature
and pressure.
 Corrosivity – This includes waste that
needs to be separated from other
wastes, waste that may react with
heavy metals to produce toxic
contaminants and corrode steel waste
containers, and aqueaous substances
with pH <2 or pH > 12.5.
 Toxicity – Toxic waste that is harmful
to humans and also the environment
as it stimulates the leaking of materials
from a landfill into the surrounding
groundwater. They are health hazards
as some are carcinogenic. Prolonged
exposure to toxic waste can lead to
bioaccumulation, and usually results
in chronic health conditions such as
59
 liver failure, stunted growth and
development, etc.
 Ignitability – This incudes waste that
can cause a fire during routine waste
disposal and storage conditions,
ignitable gas from flammable mixture
at 13% or less in concentration, and
solid substances that may cause fire
through friction or absorption of
moisture.
Categories of Hazardous Laboratory Wastes:
 Infectious waste – These are wastes
suspected to contain pathogenic
microorganisms, such as cultures of
bacteria, contaminated sharps like
syringes and needles, gloves, etc.
 Pathological wastes – These wastes
include human tissues, organs, body
parts and body fluids that are removed
during autopsy, biopsy, surgery or
other medical procedures.
 Chemical wastes – These are discarded
solids, liquids, and gaseous chemicals
from laboratory procedures, and
include reagents.
 Pharmaceutical waste – in includes
pharmaceuticals that are expired or no
longer needed; items contaminated by
or containing pharmaceuticals (bottles,
boxes
 Sharps – e.g. needles; infusion sets;
scalpels; knives; blades; broken glass
 Radioactive wastes – These are wastes
that contain radioactive materials.
 Biomedical wastes – They are
infectious, pathological and chemical
wastes that are generated in the
laboratory.
Segregation of Waste
Segregation means the separation of the entire
waste generated according to the specific
treatment and disposal requirements. Only a
segregation system can ensure that the waste
will be treated according to the hazards of the
waste and that the correct disposal routes are
taken and that the correct transportation
equipment will be used.
The use of color-coded trash cans and trash
liners (Figure 10-8) is observed to keep the
waste segregated during waste collection until
final disposal.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
FIG. 10-8 A color coding scheme for
healthcare waste
Waste handlers follow regularly-spaced
collection schedules. Trolleys are used for this,
along with other waste collection gear.
Laboratory management team must provide
personal protective equipment/gears such as
latex gloves, tongs/ forceps and masks to their
waste handlers/ collectors during actual waste
collection and transport. Collection involves
taking the filled bags and replacing the trash
bins with new ones. The collected bags are
placed in corresponding color coded
receptacles (or in some cases larger trash
bags) on the waste collector‘s trolleys.
Disposal of Waste
For treatment of waste: In-house laboratory
treatment of small quantities of hazardous
waste is an effective way of minimizing off-site
treatment and disposal costs. It involves
processing techniques that reduce its hazard
potential.
 Microwave treatment. Medical wastes
are shred then mixed with water before
being subjected to microwaves. There
is even heating of the wastes and the
generated high-temperature steam
neutralizes the biological components.
 Autoclaving is commonly used in the
laboratory to sterilize bacteria present
in clinical wastes. It destroys bacteria
through the use of high-pressure
steam.
 Plasma-based systems, on the other
hand, use high-temperature (up to
10,000OC) ionized gas to convert the
wastes to a compact substance.
Irradiation is used to sterilize medical
wastes through exposure to a cobalt
source.
60
  Sterilization – involves heating a
material or object with saturated steam
to kill all forms of microbial life.
 Chemical treatments – involves the
use of chemical reaction, which
converts it into less hazardous waste.

For Final Disposal of Wastes:

 Incineration – this process involves
combustion of organic substances with
excess oxygen at high temperature for
sufficient time which results in the
degradation of by-products to their
elemental constituents.
 Pyrolysis and gasification – involves the
thermal decomposition of organic
materials into ash, pyrolysis oil and
synthetic gas.
 Sewer systems – involves discharge
into a sewer.
 Landfill - disposal of waste materials by
burial in dumping sites and is the
oldest form of waste treatment
 Burying inside Premises

EMPLOYEE HEALTH PROGRAM

An employee health program must include:

1. Pre-employment physical examinations
with laboratory and radiological studies
that establish fitness foe laboratory
employment.
2. Periodic inspection of above in most
instances reassessment are made yearly,
but some findings and/or working
conditions dictate a shorter interval.
3. Written reports of all work-related
illnesses and accident with review by
director or designee.
4. Employee health records for the total
period of employment.

The confidentially of employee‘s medical

records must be maintained by their
employers.

Coordinated efforts with hospital for assuring

isolation of communicable diseases, control of
nosocomial infections, and plans for dealing
with fire and disaster must be observed.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 61


Unit 11 – Material Management
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Explain the process of material
management and inventory control
2. Perform simple calculations involving
supply ordering, inventory control and
budget projection
TOPIC SUMMARY
Supply Ordering Process:
Purchasing, in simple term, is that implies
buying of something. But in more complex
definition, it involves the determination of
what is needed, evaluation of which product
meets the need, where the needed product can
be most efficiently obtained, which supplier
offers the best value, and what restrictions or
guidelines are applicable to the ―buyer‖
relative to the purchase of that product.
It is imperative that managers exercise
diligence in selecting products. Likewise,
employees must be fiscally responsible and
accountable for the proper and conservative
use of those products.
When one thinks of the items that must be
purchased by the organization, those items
can be generally be placed into 3 categories:
operational supplies, capital, and services.
Operational Supplies. Each department of
any health care facility uses items daily that
are unique to its service line. Each department
also uses items that are common to the
organization. Because of this, those products
that are common are usually managed and
purchased by a central storeroom or
warehouse for the organization and
distribution from that point. This provides for
greater efficiency in inventory control, stock
rotation, and buying power of the organization.
Capital is defined as any item equal having a
specified useful life expectancy. His definition
is important for department managers to be
able to project what ―capital‖ costs will be. In
larger facilities, capital costs are usually
separated from operational supplies and
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
services for budgeting purposes. Capital items,
because they have a defined life expectancy,
can be depreciated over that period of time,
which is important to the fixed asset list of the
organization. Depreciation is the loss in value,
over time, of an asset. As the capital items
depreciate in value, the asset of the institution
becomes less.
A manager should always consider the
following when evaluating capital:
applicability, quality and value.
Applicability is buying things that are needed
only. Quality means choosing a product that
will do the job and will last long. Also consider
how easily the product is maintained and
repaired. Value applies to how much you get
from that price of item.
Purchased Services are those services
provided to our business by others for which
we pay fees. Services are usually purchased in
two ways:
 Contractual agreement – a contract
usually allows for negotiating a
fixed rate for the service over an
extended period of time. For
example, in buying an instrument a
warranty is given by the supplier or
vendor for repair and preventive
maintenance. After the warranty
period, you can negotiate to the
supplier to provide service for
additional years via a service
contract.
 Time and materials – This simply
means that when you need service,
you call a reliable vendor to
perform the service and then pay
for his travel, labor and the
materials he used. For example,
hiring an external audit team,
consultancy, etc.
MECHANICS OF PURCHASING:
The requisition (Figure 11-1) is used to
request the purchase of a product and is
completed by the requesting department (end-
user) and sent to the purchasing department.
In the purchasing department, the purchase
order (P.O.) (Figure 11-2) is prepared after
review of the budget, and if needed,
consultation with the vendor. The purchase
order authorizes payment from the institution
to the vendor for delivery of the product.
62
FIG- 11-1 A purchase requisition form

FIG 11-2 A sample of purchase order

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 63

 laboratory workload, the test mix of
INSTRUMENT SELECTION FOR THE the laboratory, the workflow
CLINICAL LABORATORY situation (e.g. what STAT
capabilities are needed). In
The diagnostic laboratory industry is addition, labor considerations such
composed of manufacturers who compete in as minimal sample loading times,
both the national and global marketplace. walk-away features, automatic
There are a large number of instruments sample dilution, instrument quality
(Figure 11-3) available to meet the needs of control features and data
both commercial and hospital-based generation features, ease of
laboratories of all sizes. It is imperative to troubleshooting, and maintenance
clearly understand patient care needs in order downtime are always critical.
to properly select instruments. b. Laboratory environment. The size,
special electrical or plumbing
needs, and the amount of heat
generated during operation must be
studied.
c. Quality of performance factors
include setting minimum standards
for acceptable instrument
performance regarding linearity,
sensitivity, specificity, accuracy,
precision, stability of electronics,
and stability of reagents used.

Additional instrument features include

FIG. 11-3 A fully-automated, walk-away
instrument
2. Research. This process should not be
There are three main steps in the selection of
a laboratory instrument: performing an
inclusive needs assessment, researching the
availability of instrument in the marketplace,
and evaluating all the data gathered to
determine which instrument will be acquired.
1. Performing a needs assess is the
process of determining exactly which
features and characteristics of an
instrument are necessary to satisfy the
needs requirement for a specific
laboratory. The assessment should
attempt to define both present and
future needs to be met by a new
instrument. Key factors to be
considered when determining your
needs are:
a. Characteristics of the individual
laboratory. This includes
laboratory test menu needed in the
future, the current and future
the instrument throughput, the sample
processing method of the instrument
(such as sequential vs simultaneous,
random vs batch). Safety features such
as primary tube sampling should be
evaluated. Another major
considerations are the compatibility
with the LIS and data storage
capabilities.
more than meeting with sales
personnel, although such contacts can
be used as an initial step in
determining what is available in the
marketplace. In addition. Many
manufacturers have Web sites for
research on their products. An
alternative approach is the process of
developing a request for proposal,
which is essentially a list of questions
to which each vendor replies.
Another effective way to do research is
to use information from other
laboratories.
A manager must also be concerned
with costs, not only of the instrument
itself but also of the reagents, service
contracts, labor, and many others in
the cost equation. Cost is often the

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 64

 most limiting factor in determining how
many of the desired feature of the
instrument are realistic for the setting.
This is ―needed‖ vs ―wanted‖.
3. Evaluation and decision-making
steps. Based on the developed needs
list and the comparison data on
various instruments developed through
research process, a number of
unacceptable instruments should be
eliminated from consideration. A
consensus decision with those using
the instrument and with managers
may be a wise strategy, especially if
you are to choose between 2
instruments.
In summary, selection criteria should include
clinical method evaluation, reagent stability,
throughput capacity, ease of use and process
control, and documented instrument
performance and vendor service record
INSTALLATION OF EQUIPMENT
The following are the important things to do
after selecting an instrument.
Before Equipment Installation
 confirm vendor‘s responsibilities in
writing
 Establish checklist
During Equipment Installation:
 when possible, have manufacturer
install and set up
 do not attempt to use prior to proper
installation
 verify package contents
 copy software, if part of system
After Equipment Installation:
 Train all operators with regards to the
overall use and maintenance of the
instrument including calibration.
Equipment Calibration. Perform initial
calibration by use of calibrators or standards
and follow manufacturer‘s instructions, and,
determine frequency of routine calibrations.
Performance Evaluation of New Instrument.
In this process, test known samples and
analyze the data. Then validate the
performance of the instrument by doing
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
parallel testing. Parallel testing is side by side
analysis of a sample between 2 instruments.
Also, one must need to establish stability for
temperature-controlled instruments.
Preventive Maintenance. Preventive
maintenance employs routine cleaning and
adjustment and replacement of equipment
parts. Perform function check by monitoring
instrument parameters periodically and after a
major repair. Examples of this are incubator
temperatures, wavelength calibration,
autoclave temperature chart. Creation of
equipment inventory log is a must. It includes
instrument type, model number,
serial number, location in the laboratory, date
purchased, manufacturer and vendor contact
number, warranty and spare parts.
Service and Repair. This is performed by the
manufacturer‘s service engineer. The
laboratory must schedule routine
manufacturer‘s maintenance. The warranty
may require repair handled by manufacturer.
The in-house biomedical service technicians
can also do service and repair provided they
are trained in doing so.
Recording of instrument problem. This
include the following: date problem occurred,
equipment removed from service, reason for
breakdown or failure, corrective actions taken,
date returned to use, and, change in
maintenance or in function checks.
When an instrument has reached the end of
its useful life, this presents an opportunity to
comparatively assess new technology and
select an instrument and reagent system that
can best support patient care.
Many instruments have a useful life of 5 to 7
years or sometimes more. However, the
competitive forces in the marketplace drive
technological innovations during that same
period of time. These innovations can benefit
patient care and laboratory operations and
should be evaluated.
.
65
 INVENTORY MANAGEMENT 2. Maintain records: such as date item
received, lot number, pass or fail acceptance
criteria, and, date placed in service or
Inventory management is the process of disposition. It is also useful to keep records in
efficiently overseeing the constant flow of stockroom (Figure 11-5). A stock
items/supplies into and out of an existing logbook/ledger (Figure 11-6) must also be
inventory and maintaining the optimum provided to facilitate faster location and
number or amount for each item. important information about the item. It
The objective of inventory management is to includes: name and signature, date of receipt,
provide uninterrupted production, sales quantity, date of expiry, minimum stock, stock
and/or customer-service levels at the balance and other information such as shelf
minimum cost. Since for number and destination.
many companies inventory is the largest item
in the current assets category,
inventory problems can and do contribute to
losses or even business failures.

Inventory management challenges in the

laboratory include balance between stock
availability and expiration dates, and life-span
of laboratory reagents varies.

Figure11- 4 provide us the important things to

consider in implementing inventory
control.

1. Analyze needs by listing all tests in the FIG. 11-4 Inventory Control
laboratory, identifying all supplies needed for
each test and estimating usage.

FIG. 11-5 Stockroom

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 66

FIG. 11-6 Stock Logbook/Ledger

3. Inspect new orders at time of delivery by

verify contents, check integrity, record date
each item received, record expiration date,
store new shipment behind existing shipment
and create or update records.

4. Assign responsibility. The laboratory

management must designate somebody to be
the over-all in-charge in the maintenance of an
efficient inventory system. It is also the prime
responsibility of the section heads to look after
the reagents and supplies needed in the
performance of the procedures in their
respective sections daily.

COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT 67

Unit 12 – Financial
Management
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Identify components and
requirements for budget preparation
2. Prepare a basic budget for the
clinical laboratory
TOPIC SUMMARY
Provision of laboratory services requires
resources: staff, equipment, and supplies. And
there are no hospital laboratory activities that
do not incur expense, nor are there any
expenses cannot be controlled to some extent.
The challenge is to maintain a high quality
service that is cost effective. A well-prepared
budget that is adhered to is a vital tool in
helping the laboratory become more effective
and efficient.
LABORATORY BUDGETING PROCESS
The budget process usually begins well in
advance of the implementation date and is
prepared in phases.
Phase I. Development of goals. The
laboratory develops goals based on the
organization‘s mission statement and strategic
objectives. The laboratory goals must be in line
with those of the organization and must be
achievable. An example of laboratory goal is
that the laboratory will increase cost
effectiveness. An example of a laboratory
objective would be increase revenue by 5%
through implementation of an outreach
program.
Phase II. Budget Assumptions. The
organization provides a forecast of available
money based on past earnings, cash flow, and
changes in government laws affecting
reimbursement. In the laboratory, budget
assumption is based on annual test volume
and revenue generated. For example, in the
objective mentioned above that the
implementation of an outreach program will
increase projected revenue and operating cost.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Phase III. Forecast of Expenses.
Fixed cost projections. Projecting fixed costs
is simply a matter of looking at the monthly
predictable costs that do not
change. Employee compensation costs, facility
expenses, utility costs, mortgage or rent
payments, insurance costs, etc.
Fixed costs do not change and are a minimum
expense that need to be funded in the
budget. For example, if there are open staff
positions, the cost to fill those positions
should be part of fixed cost projections.
Variable Cost projection. Variable costs are
costs that fluctuate from month to month,
supply costs, overtime costs, etc. These are
expenses that can and should be budgeted
and controlled. For example, if higher
Christmas sales drive overtime costs
temporarily, those costs should be budgeted.
Capital expense: Capital expenditures are
most often calculated for a three-year cycle.
Items may fall into this category include:
 request for new space or space changes
 equipment replacement
 purchase or lease of new equipment
 information technology such as
interfaces, hardware, licensing fees.
Capital expenditure is an investment. As such,
its rate of return must be evaluated and used
as a criterion for budgeting decisions. Some
suggested categories of capital expenditure
justification and priority follow:
Justification categories:
 replacement – equipment that cannot
be repaired or there is excessive cost of
repair
 New equipment – equipment required
due to increased workload or improved
methodology that would allow for better
patient care.
 Cost reduction – reduction of operating
expenses stated primarily in terms of
personnel and supplies.
Priority of need:
 Essential – needed immediately to
maintain quality patient care
68
  Necessary – also ―essential‖ but greater
lee-way with regard to time of
acquisition
 Desirable – means of reducing cost
 Other – means of improving general
working conditions
Most often manufacturers and/or distributors
of capital equipment offer a variety of financial
options including cash purchase, equipment
lease, and reagent rental.
A cash purchase is advantageous for
equipment you expect to keep for more than 5
years and is the only option for items such as
microscopes, reagent storage refrigerators, and
slide strainers.
An equipment lease agreement is often used
with an open system whereby several different
manufacturer‘s reagents may be used. You
pay a monthly fee for the use of the equipment
but are free to shop for the most economical
reagent system with no required volume to be
purchased.
Reagent rental agreements require the
purchase of a fixed volume of a specific
manufacturer‘s reagent. The cost for the use of
the equipment is calculated into the reagent
cost.
Operational expense: operational expense
most commonly encompass a twelve-month
cycle. Careful identification of all categories of
expenditures and the most prudent allocation
of funds for each category is required. The
grouping of expense categories is often termed
a ―chart of accounts‖. A proposed laboratory
chart of accounts may include:
 Salaries including cost of benefits
 Reference laboratory fees
 Education and training
 Purchased service and maintenance,
etc.
For every expense item in the budget, start
with a budget of zero and add budget amounts
to it only as far as you can justify the cost.
Phase IV. Target Profit Margin. Every
organization, whether they are for-profit or
not-for-profit, should have a targeted profit
margin. Profit margins allow for returns for
the business owner or investors.
COMPILED LECTURE GUIDE IN LABORATORY MANAGEMENT
Not-for-profit organizations use their profit
margins to reinvest into the facilities and
development of the organization. Profits are
important for all organizations and healthy
profit margins are a strong indicator of the
strength of an organization.
Phase V. Board Approval. The governing
board, president, owner or head of the
organization should approve the budget and
keep current with budget performance.
Phase VI. Monitoring. Once the operational
budget is implemented, expense reports are
reviewed monthly for budget variances. A
budget review committee should meet on a
monthly basis to monitor performance against
goals. Budget variances may be attributed to
the following:
 Increased volume – the ordering and
reporting of a higher volume of tests
than budgeted for.
 Vendor price increase – most
laboratories lock in process for a
certain period of time. However,
contract pricing based on test volume
will allow vendors to increase pricing if
test volumes decrease.
 Changes in policy and procedure –
unexpected implementation of test
procedures. This is often physician
driven.
COST PER TEST/ COST PER UNIT OF
SERVICE
Laboratory managers find it beneficial to know
cost per test or cost per unit of service. In the
laboratory setting these terms are
synonymous. This information is often
requested by administrators involved in
formulating managed health agreements
whereby the hospital offers service at a
discount. The organization must ensure that
their discount pricing is not below cost.
When calculating the cost, it is important to
look beyond the mere cost of reagents,
equipment, and technologist time. Many
factors, such as cost of maintenance, salaries
of support staff, nonmedical supplies, and
travel and education, electricity, and water
contribute to this bottom line.
69
Unit 13 – Principles of
Marketing
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Acquire basic skills in marketing
2. Prepare a marketing plan for the
clinical laboratory
3. Explain the rationale of marketing
principles relative to competition that
exists among laboratories
TOPIC SUMMARY
Marketing may be defined as determining
what your client‘s needs are and providing a
product and service that meets and exceeds
those needs.
The idea of a laboratory marketing itself was
once unheard of because laboratories do not
sell their services, they provide it.
FOUR P’S OF MARKETING
The four Ps are the categories that are involved
in the marketing of a good or service, and they
include product, price, place and promotion.
Often referred to as the marketing mix, the
four Ps are constrained by internal and
external factors in the overall business
environment, and they interact significantly
with one another. (Figure 13-1)
FIG. 13-1 Four P’s of Marketing
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The marketing mix and the four Ps were
popularized in the 1950s by Neil Borden.
Before the advent of the internet and greater
integration between businesses and
consumers, the marketing mix helped
companies take into account the physical
barriers that prevented widespread adoption of
a product. Extensions of the Ps include
"people, "process" and "physical evidence" as
important components of marketing a product.
Product. It refers to a good or service being
offered by a company. Ideally, a product
should meet a certain consumer demand, or it
should be so compelling that consumers
believe they need it. To be successful,
marketers should understand the life cycle of
a product, and business executives should
have a plan for dealing with products at every
stage of their life cycles. The type of product
also partially dictates how much businesses
can charge for it, where they should place it,
and how they should promote it.
Price. Price is the cost consumers pay for a
product. Marketers must link the price to the
real and perceived value of the product, but
they also must take into account supply costs,
seasonal discounts, and prices used by
competitors. In some cases, business
executives may manipulate a price to make a
product seem more like a luxury, or they may
lower a price so that more consumers can try
the product.
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Place. Place decisions outline where the
product is sold and how it is delivered to the
market. The goal of business executives is to
get their products in front of the consumers
who are most likely to buy them. In some
cases, this may refer to placing a product in
certain stores, but it also refers to the
placement of the product on a store's display
or where a product is showcased on a web
page. In some cases, placement may refer to
the act of placing a product on TV shows, films
or blogs in order to garner attention for the
product, but this type of placement overlaps
with promotion.
Promotion. It includes advertising, public
relations and promotional strategy. This ties
into the other three Ps of the marketing mix,
as promoting a product shows consumers why
they need it and why they should be willing to
pay a certain price for it. In addition,
marketers tend to tie promotion and
placement elements together so they can reach
their core audiences
MARKETING PLAN
A marketing plan is a comprehensive
document or blueprint that outlines a
company's advertising and marketing efforts
for the coming year. It describes business
activities involved in accomplishing specific
marketing objectives within a set time frame.
A marketing plan also includes a description
of the current marketing position of a
business, a discussion of the target market
and a description of the marketing mix that a
business will use to achieve their marketing
goals.
A marketing plan has a formal structure, but
can be used as a formal or informal document
which makes it very flexible. It contains some
historical data, future predictions, and
methods or strategies to achieve the marketing
objectives.
Marketing plans start with the identification of
customer needs through a market research
and how the business can satisfy these needs
while generating an acceptable level of
return. This includes processes such as
market situation analysis, action programs,
budgets, sales forecasts, strategies and
projected financial statements.
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A marketing plan can also be described as a
technique that helps a business to decide on
the best use of its resources to achieve
corporate objectives. It can also contain a full
analysis of the strengths and weaknesses of a
company, its organization and its products.
Marketing Plan Outline
A marketing plan should be based on where a
company needs to be at some point in the
future. These are some of the most important
things that companies need when developing a
marketing plan:
 Market research: Gathering and classifying
data about the market the organization is
currently in. Examining the market
dynamics, patterns, customers, and the
current sales volume for the industry as a
whole.
 Competition: The marketing plan should
identify the organization's competition.
The plan should describe how the
organization will stick out from its
competition and what it will do to become
a market leader.
 Market plan strategies: Developing the
marketing and promotion strategies that
the organization will use. Such strategies
may include advertising, direct marketing,
training programs, trade shows, website,
etc.
 Marketing plan budget: Strategies
identified in the marketing plan should be
within the budget. Top managers need to
revise what they hope to accomplish with
the marketing plan, review their current
financial situation, and then allocate
funding for the marketing plan.
 Marketing goals: The marketing plan
should include attainable marketing goals.
For example, one goal might be to increase
the current client base by 100 over a three
month period.
 Monitoring of the marketing plan results:
The marketing plan should include the
process of analyzing the current position
of the organization. The organization needs
to identify the strategies that are working
and those that are not working.[
By researching markets, competition, and
determining the organization's unique
positioning, the organization is in a much
better position to promote and sell its product
or service. By establishing goals for the
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marketing plan, the organization can better
understand whether the efforts are generating
results through ongoing review and
evaluation.
LABORATORY CUSTOMER
Figure 13 -2 The laboratory and its clients
The picture above (Figure 13-2) identifies the
different clientele or customers of the
laboratory. We need to remember that they are
the reason for our existence. Therefore, we
have to provide them with the services they
need with utmost care and efficiency.
Competitive Performance of Laboratories
in the Outreach Market
Hospital laboratories have long recognized the
opportunities of testing services in the
outpatient market. The hospital has the
capital infrastructure and capacity in the off-
hour shifts that coincidentally is the time
frame when most outreach testing is
performed.
A hospital laboratory also has an existing
relationship with the physicians who admit
patients and can build on that relationship.
Hospital laboratory leadership must recognize
that performance standards in the outreach
market are decidedly different from those for
their inpatients. To succeed in outreach, the
hospital laboratory must compete with
commercial laboratories and at least meet, if
not exceed, the performance standards in the
outpatient marketplace.
It is imperative to understand the service
standards, conduct a SWOT (strengths,
weaknesses, opportunities, and threats)
analysis, and implement the necessary
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processes to meet the clients‘ service
expectations.
Customer Service and Its Importance in
the Clinical Laboratory
―Customer service‖ has traditionally been a
term used in the business world, but over the
past few years it has crept into the health care
vocabulary. As a result, there have been
numerous initiatives in health care to build
customer service into the organization. Health
care providers have come to realize what the
business world has known for years:
exceptional customer service positively
differentiates one provider from another. They
have found that incorporating good customer
service at all levels in an organization is
necessary but it is also difficult and requires a
culture change.
Customer service is a description of the
activities associated with acting as a resource
to provide information. It involves customer
group identification, customer needs and
customer feedback. The expectation is that the
individual providing the customer service does
it in a friendly and efficient manner.
According to Philip Crosby (Four Absolutes of
Quality Management, 1979), ―Quality is
meeting customer needs”.
Who is responsible for Customer Service? The
answer is ―Everyone in the laboratory‖!
Traditionally, a patient would go to a health
care provider because his or her health was
less than perfect. The provider‘s purpose was
to provide health care knowing that this
patient may be back and there were always
other patients waiting to be treated. Providing
health care alone was important; attitude
while doing it was not.
Now patients are more sophisticated, make
choices about their health care, and look for
exceptional service along with the health care.
Health care providers must now ―compete‖ for
the patient. Providing exceptional customer
service is often the differentiator. Wouldn‘t you
prefer to go to a friendly place rather than a
non-friendly one, especially when you are
anxious about being ill?
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Each of us has daily interactions that require
us to obtain information that is pertinent to
conducting our daily lives, such as banking,
credit card disputes, grocery store checkout,
billing questions, retail sales clerks, etc.
Review your most recent experiences. What
made them positive or negative? Most likely
your answer is the individual you interacted
with. The next step is to think about health
care and how you interact with patients, how
this interaction affects the patient‘s experience
and, ultimately, their choice of health care
providers. The interactions between coworkers
set the tone for patient relations as well. Being
considerate and respecting others is necessary
all the time, whether the interactions take
place between patients, clients, coworkers,
friends, or acquaintances.
Providing excellent customer service consists
of the following components:
 Listen.
 Understand
 Respect the need for the request.
 Respond.
 Ask if there is anything else you can
do
 Always remain friendly, courteous,
and professional.
This translates into listening (not just hearing)
with respect, and understanding the request
so a friendly and correct response can be
made. If a knowledgeable response cannot be
given, let the requestor know a response will
be forthcoming within a particular timeframe.
Then, always get back to the requestor even if
it is just to give a status report within the
timeframe given. Sometimes it is appropriate
to give additional information that the
requestor may not have realized the need to
ask for but is necessary. This is going the
extra mile. Why is customer service important
in the hospital laboratory? Because laboratory
professionals interact with one another and
with patients, nurses, physicians, other
departments, vendors, and maintenance
personnel.
If outreach (laboratory services provided to the
non-inpatient) is associated with the
laboratory, then the laboratory can be
competing with commercial laboratories or
other hospital outreach programs for
physician and patient usage. Providing
excellent customer service is important for
growth in all of the above-mentioned
situations. The performance of laboratory
testing is similar in most laboratories due to
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regulations, equipment, and methodology. The
piece that differentiates laboratories is the
reputation built on the service provided. In
many instances, the service defines the
reputation. The customer service provided
defines this service.
Remember that Customer service is an
integral part of a quality management system.
Good customer service provides:
• valuable information for best patient
care
• valuable information to improve
surveillance
• professional image of laboratory
• Methods for Assessing Customer
Satisfaction
There are 3 R’s of customer satisfaction:
RESULTS: Customers expect superior results
from our product or service. They expect the
product or service to be the best value for their
money.
RELATIONSHIPS: Customers expect a
relationship that is consistent with their value
system.
RESOURCE: Customers expect you to be a
resource to help them solve a problem.
One of the greatest innovative and creative
challenges is to develop ways to amaze the
customer and surpass expectations. The idea
to intended to enhance your commitment to
giving your customer the same level of service
you would want; after all you both deserve it.
In today‘s marketplace, it is paramount for
managers to hire competent, qualified, caring
employees that are willing to go that extra mile
and to put forth extra effort to provide
exceptional customer service.
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Unit 14 – Accreditation and
Regulatory Compliance
Laboratory services are regulated by statutory
and regulatory laws. It is the leadership team‘s
responsibility to assure that the laboratory
conforms to both legal regulations and
accreditation requirements These performance
requirements apply to a broad range of
laboratory activities, including personnel,
safety, reports and records, claims billing, and
waste disposal. Good management requires
that the leadership team understand such
laws as well as the accreditation standards
established by the inspecting agencies. It is
therefore the prime responsibility of the
leadership team to ensure that the actual
laboratory practice complies with government
regulations, accreditation standards, and
institutional policies. Failure to do so may lead
to consequences ranging from almost nothing
to the catastrophic for the laboratory service:
for example, from a substandard performance
that requires a repeat inspection to
unacceptable performance with suspension of
license and testing.
Unit 15 – Current Trends in
Laboratory
Management
OBJECTIVES:
Upon completion of this lecture, the student
will be able to:
1. Elaborate certain issues arising from
adapting new trends in laboratory
management
TOPIC SUMMARY
Change Management (CM) refers to any
approach to transitioning individuals, teams,
and organizations using methods intended to
re-direct the use of resources, business
process, budget allocations, or other modes of
operation that significantly reshape a company
or organization.
CM focuses on how people and teams are
affected by an organizational transition. It
deals with many different disciplines, from
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behavioral and social sciences to information
technology and business solutions
Reasons for change:
Globalization and constant innovation of
technology result in a constantly evolving
business environment. Phenomena such
as social media and mobile adaptability have
revolutionized business and the effect of this is
an ever increasing need for change, and
therefore change management. The growth in
technology also has a secondary effect of
increasing the availability and therefore
accountability of knowledge. Easily accessible
information has resulted in unprecedented
scrutiny from stockholders and the media and
pressure on management.
With the business environment experiencing
so much change, organizations must then
learn to become comfortable with change as
well. Therefore, the ability to manage and
adapt to organizational change is an essential
ability required in the workplace today. Yet,
major and rapid organizational change is
profoundly difficult because the structure,
culture, and routines of organizations often
reflect a persistent and difficult-to-remove
"imprint" of past periods, which are resistant
to radical change even as the current
environment of the organization changes
rapidly.
Due to the growth of technology, modern
organizational change is largely motivated by
exterior innovations rather than internal
factors. When these developments occur, the
organizations that adapt quickest create a
competitive advantage for themselves, while
the companies that refuse to change get left
behind.[17] This can result in drastic profit
and/or market share losses.
Organizational change directly affects all
departments and employees. The entire
company must learn how to handle changes to
the organization. The effectiveness of change
management can have a strong positive or
negative impact on employee morale
Managing the change process:
Change management involves collaboration
between all employees, from entry-level to top-
management.
Although there are many types of
organizational changes, the critical aspect is a
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company‘s ability to win the buy-in of their
organization‘s employees on the change.
Effectively managing organizational change is
a four-step process:
 Recognizing the changes in the broader
business environment
 Developing the necessary adjustments
for their company‘s needs
 Training their employees on the
appropriate changes
 Winning the support of the employees
with the persuasiveness of the
appropriate adjustments
As a multi-disciplinary practice that has
evolved as a result of scholarly research,
organizational change management should
begin with a systematic diagnosis of the
current situation in order to determine both
the need for change and the capability to
change. The objectives, content, and process
of change should all be specified as part of a
change management plan.
Change management processes should include
creative marketing to enable communication
between changing audiences, as well as deep
social understanding about leadership styles
and group dynamics. As a visible track on
transformation projects, organizational change
management aligns groups‘ expectations,
integrates teams, and manages employee-
training. It makes use of performance metrics,
such as financial results, operational
efficiency, leadership commitment,
communication effectiveness, and the
perceived need for change in order to design
appropriate strategies, resolve troubled change
projects, and avoid change failures.
NEW OPEARTIONAL STRATEGIES
Operational strategies refers to the methods
companies use to reach their objectives. By
developing operational strategies, a company
can examine and implement effective and
efficient systems for using resources,
personnel and the work process. Service-
oriented companies also use basic operational
strategies to link long- and short-term
corporate decisions and create an effective
management team.
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5 Core Operational Strategies:
Corporate Strategy. Corporate strategies
involve seeing a company as a system of
interconnected parts. Just as the muscles of
the heart depend on brain functions in a
human body, each department in a company
depends on the others to stay healthy and
achieve desired outcomes. The additional core
strategies that a company uses should support
the corporate strategy and use cross-
functional interactions.
Customer-driven Strategies. Operational
strategies should include customer-driven
approaches to meet the needs and desires of a
target market. To do so, a company must
develop strategies that evaluate and adapt to
changing environments, continuously enhance
core competencies and develop new strengths
on an ongoing basis. When evaluating
environments, a company should monitor
market trends to take advantage of new
opportunities and avoid possible threats.
Developing Core Competencies. Core
competencies are the strengths and resources
within a company. While core competencies
can vary by industry and business, they can
include having well-trained staff, optimal
business locations and marketing and
financial expertise. By identifying core
competencies, a company can develop
processes such as customer satisfaction,
product development and building
professional relationships with stakeholders.
Competitive Priorities. The development of
competitive priorities comes from the creation
of a corporate strategy, market analysis,
defining core processes and conducting a
needs analysis. To create competitive
priorities, an organization evaluates
operational costs, the quality of a product or
service, the time it takes to develop and deliver
a good or service and the flexibility of a good or
service with regard to variety, volume and
customization. Competitive priorities should
include being able to provide a quality product
or service at a fair cost that consistently meets
the needs of a customer.
Product and Service Development.
Strategies behind the development of products
and services should consider design,
innovation and added values. When developing
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new customer products, a company can decide
to be a leader in introducing a new product or
service, wait for the introduction of
innovations on the market to improve upon
them or wait to see if a company's innovation
is successful before moving forward. When
developing a service, companies should
consider packaging it with immediately
observable and psychological benefits and
support services. When developing a good or
service, a company should consider the wants
of its customers, how its stands against the
competition and how its technical measures
relate to its customers' needs.
ADVANCEMENT IN TECHNOLOGY
The use of automation and robotics has
become pervasive in clinical laboratories
around the world. Laboratories face
unrelenting pressure to produce faster
turnaround times and reduce errors to
improve patient care. Since the development of
the continuous flow analyzer in the 1950s,
laboratory automation has continued to evolve
and expand its capabilities to become an
indispensable necessity. Current technologies
can automate specimen transportation,
sorting, accessioning, and inspection.
As pressure has increased to cut healthcare
costs over the last decade, laboratories have
relied on automation to maintain profitability
as well. Laboratory automation is designed to
maximize efficiency and minimize errors by
integrating mechanical, electronic, and
informatics tools to perform an ever expanding
variety of laboratory tasks. Following the
installation of automation error reduction
rates exceed 70%, while staff time per
specimen collection is reduced by over 10%.
Patient safety is increased by an average 50%
reduction in specimen turnaround time
directly attributable to automation.
Currently, more than 30% of laboratories in
Japan, Europe, and North America have
implemented a significant degree of central
laboratory automation. In addition, many
laboratories report that automation creates
excess capacity to expand testing without the
need to increase their workforce. As a result,
the proper sizing of laboratory automation
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systems with current and anticipated testing
volume is important.
Defining the State of the Art:
There is virtually no limit to the number and
complexity of tasks that can be automated.
For example, at least one company is currently
working to automate phlebotomy. Called the
Veebot, this instrument would locate forearm
veins and then chart the trajectory for a
needle-wielding venipuncture robot. Failed
venipuncture procedures can injure patients
due to so-called bad veins. In fact, nearly 25%
of procedures fail to draw blood on the first
attempt, and almost a million needle stick
injuries are reported each year.
Modern laboratory automation resembles a
traditional assembly line, termed total
laboratory automation (TLA). TLA consists of a
specimen sorter that can sort specimens by
analytical needs and transport specimens
requiring serum or plasma testing to an
automated centrifugation station for
processing. Following sample separation the
serum or plasma is then transported for
sampling to various chemistry and immuno-
assay analyzers. The sorter can also identify
whole blood specimens and convey them to
automated instruments for complete blood
counts and other hematology testing.
Remaining specimens are automatically sent
to racks that are specific for each analytical
platform. These specimens can then be
manually transported and inserted into the
instrument of choice.
Currently, approximately 80% of the testing
and only about 50% of the manual labor
performed in a clinical laboratory is impacted
by automation, leaving many opportunities for
novel automation technologies in sample
collection, centrifugation, accessioning,
sample inspection, transportation, and more.
A Look at the Future:
Given that automation is becoming a
commodity in larger laboratories,
laboratorians need to stay up-to-date on new
opportunities. For each area below, I forecast
what form laboratory automation may take in
the future, perhaps in the next decade or two.
Automated Specimen Separation
Blood separation into serum or plasma has
been an insuperable bottleneck in all clinical
laboratories. Ideally, sample separation should
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be done at the point of sample collection and
incorporate automated labeling. An elegant
point-of-care separation solution, the Axial
Separation Module, was developed for
separating formed elements from plasma in a
whole blood specimen in under one minute
immediately after phlebotomy . Unfortunately,
this technology failed to gain market
acceptance. Similar technologies are under
development that uses creative means to
impart increased centrifugal forces on the
blood specimen. Hopefully, some of these will
be commercialized in the near future.
Specimen Transportation
Despite the variety of methods of
transportation currently available, all have
considerable flaws. Human and robotic courier
services have inflexible pickup times and
delays, while pneumatic tube systems have
potential for specimen damage and limited
carrying capacity. Electric track vehicles
reduce the damage risks of tube systems and
the lack of flexibility from the courier service,
but they take up large amounts of space. One
alternative is automated specimen delivery
using mobile robots that can negotiate the
halls of a hospital. Once in the laboratory, the
robot can automatically deliver its payload and
continue service without having to interrupt a
laboratory technologist. In the near future,
drones may provide both extra-laboratory as
well as inter-laboratory delivery. A drone‘s
ability to rapidly move small numbers of
specimens from a clinic to a laboratory can
avoid automobile traffic delays. Inside a
laboratory, drone deliveries can make a 200
foot journey in less than 2 seconds, according
to Donald Nagy, CEO of California Computer
Research and member of the Society for
Laboratory Automation and Screening.
Pre-Analytical Automation
Once specimens arrive in the laboratory there
are new pre-accession processors that can
start with a bucket of randomly oriented
specimens and finish with racked and
processed specimens for downstream
analytical processing. Researchers at the
University of Utah are developing an
automated specimen inspector that examines
critical specimen quality issues such as proper
labeling, sufficient volume, and correct vial
additive. In the future, the inspector will also
determine the presence of lipemia, icterus, or
hemolysis through several overlaid labels.
From the inspector, next-generation linear
motor conveyors will transport the tubes very
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rapidly: 3,000–18,000 tubes an hour moving
at a rate of 20–120 meters a second. The
system will also employ an automated sorting
area where specimens can be automatically
centrifuged or passed on directly to the
hematology/coagulation robotic area,
according to Charles D. Hawker, PhD, MBA,
FACB, scientific director of automation and
special projects at ARUP Laboratories.
Essentially the entire accessioning process will
be automated so that time from phlebotomy to
result will be 30 minutes or less.
Sample Labeling
Mistakes in sample labeling can lead to
sample misplacement and mislabeling,
resulting in a loss of samples and inaccurate
results. The progression from manual labeling
to 2- and 3-D barcodes has dealt with many
labeling problems and significantly cut down
on sample misplacement and mislabeling.
However, the development affordable radio-
frequency identification (RFID) is poised to
allow positive passive specimen tracking as
samples are moved from patient bedside to
analysis. While barcodes often require manual
scans, RFID completely eliminates human
involvement. Reduced costs for the technology,
and advantages such as error reduction and
reduced labor demand, have put RFID in the
spotlight at the Mayo Clinic and other
organizations. Disruptive Analytical Methods
and Trends and several emerging methods
closely related to laboratory automation are
poised to shift the landscape of laboratory
testing. In addition, the push for expanding
biobanking and home monitoring cannot be
ignored.
Microbiology
The most disruptive use of automation in the
laboratory will come in the form of rapid
sequencing of entire microbe DNA/RNA.
Advanced computer software can identify each
individual organism in an infection, as well as
the organism‘s susceptibility to specific
antimicrobials. Technologies such as Ion
Torrent, Myseq, ionPGM, and PackBio are
already demonstrating improved turnaround
time and positive microbe identification in
clinical settings. Coupled with software
algorithms that can match DNA/RNA
sequences with those from known pathogens,
these technologies might one day replace
much of today‘s conventional microbiological
laboratory procedures similar to the Lawrence
Livermore Microbial Detection Array.
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Cell Based Assays
Another disruptive technology will be the use
of living cells from patients as diagnostic tools.
Cell-based assays are being used for
diagnosis, as well as predicting clinical
outcomes and response to therapy in an
increasing number of diseases including
cancer, organ rejection, and diabetes.
Exfoliated organ cells have the potential to
supplement current biomarker-based analyses
since cell-based assays can measure
aberrations in cell activity that may be present
in complex chronic diseases. For example, salt
sensitivity of blood pressure is a major public
health challenge and a disease for which there
is no convenient diagnostic test. We
demonstrated that cells isolated from urine in
normal subjects not only provided a
personalized cell-based diagnostic test for salt
sensitivity, but also provided a personal salt
index, which is the amount of sodium each
person should safely consume in a day. Like
conventional analytical techniques, cell based
assays will be readily automated when
sufficient volume justifies the investment.
format. The future will provide an ever
broadening number of biomarkers—such as
cortisol for stress monitoring—and physiologic
parameters that will guide lifestyle choices.
Conclusion
Laboratory automation has become a well-
accepted technology that allows high quality,
efficient, and patient-centric operation with
low operating costs. Automation should also
be the foundation on which a Six Sigma
program can be built and maintained.
Technological advances will increase the
number of laboratory unit operations that can
be either partially or fully automated. Near
patient or personal wellness testing should
be considered an extension of the laboratory
automation enterprise.

Biobanking. Biobanking is the process of

storing left over medical specimens along with
data describing the phenotype and genotype of
the patient from which the specimen was
obtained. This material is valuable to
diagnostic and pharmaceutical companies for
research and development. Most of the steps
in biobanking have been automated, such as
specimen aliquoting, labeling, freezing, and
storing. Even the retrieval of selected
specimens in order to prepare a disease
representative cohort can be automated using
―cherry pickers‖ that operate at freezing
temperatures. Thus, automation can turn
medical waste (i.e. leftover medical specimens)
into profit for the laboratory and tools for
researchers.

The Final Frontier: Home-Based Monitoring

Monitoring is pervasive with the advent of
wearable sensors that communicate with
smartphones. The hope is that individuals will
use this medical data to adopt healthier
lifestyles. Increasingly, biomarkers in body
fluids will also be the target of ubiquitous
personal sensors. For example, Google recently
announced that it was developing a contact
lens that would measure glucose secreted in
tear fluid in order to provide passive sensing
for diabetic patients. Similar technology is
being developed in a more convenient
―insertable‖ and therefore body resident

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