CHAPTER 1

LABORATORY MANAGEMENT

INTRODUCTION

What is management? Many attempts to define management

into a single sentence or phrase however, failed to clearly define just
what is included in the term “management”. Working with and through
people to accomplish a common mission is usually the core of the short
descriptions that have been proposed. There are five ingredients and/or
conditions necessary for management to succeed which includes:

Mission – goal that the organization’s sub-unit expect to accomplish

Authority – needed to direct the team toward the goal
Resources – includes people, equipment, supplies and money
Responsibility – for achieving the goals assigned
Accountability- for using the resources established

“Management’s job is to see the company not as it is, but as it can

become”- Teets, John

DEFINITIONS OF MANAGEMENT

MANAGEMENT comes from the Italian maneggiare which means to handle also from the
Latin manu agere which means to lead by the hand. It also comes from the French word ménagement
which means the art of conducting or directing).

Management is the effective motivation of men and the efficient utilization of resources for
the attainment of a pre-determined objective.

Management is a distinct process consists of planning, organizing, actuating (leading) and

controlling, which are performed to determine and accomplish the objectives by the use of people
and resources.

Management has been called the art of getting things done through people. This means that
activities are completed and accomplish efficiently and effectively with and through other people.

THE NATURES OF MANAGEMENT

Management is both an art and a science.

It is an art because it results in the accomplishment of objective by the use of human efforts.
It requires skills and careful study of its application.

Management is a science because it is a systematic body of knowledge. It gathers and

analyzes facts and formulates general law or principles from these facts.

As an art and a science, management seeks to integrate into a unified, coordinated whole of
all the essential factors that make up an organization.

1
THE FUNCTIONS OF MANAGEMENT

The functions of management refer to those distinctive activities that must be carried out by
the manager if the objectives of an organization are to be achieved. These functions of management
may be grouped into planning, organizing, directing and controlling.

1. Planning

Planning is the foundation of management. It is the thinking and analyzing portion

of management process. It involves setting of organizational goals, designing the course to
take, devising methods to use and identifying resources needed in achieving the goals.

In general, planning can be strategic planning, tactical planning or contingency

planning.

a. Strategic planning is concerned with the identification of the mission and of those
objectives that will permit its most efficient pursuit. It is a long-range planning that is
normally completed by top-level managers in an organization. Examples of strategic
planning would be who could be the customers, what products should be sold and what
services can be offered.

b. Tactical planning is a method on accomplishing the goal of the organization. It is a short-

range planning that develops a very detailed strategy about what needs to be done, who
will do it and how it should be done. It is usually done by low-level managers.

c. Contingency planning allows alternative courses of action when the primary plans that
have been developed do not achieve the goals of the organization. It serves as a back-up
plan if things go out of hand.

2. Organizing

Organizing is the grouping together of men and establishing relationships among

them, defining authority and responsibility to all personnel who will perform the work is very
important in order to use maximum advantage of the laboratory’s materials and resources
for the attainment of the common objectives.

Division and arrangement of tasks is well assigned on a framework that links all
worker, tasks and resources together. The framework is called organizational structure.
Structure of an organization shows positions in the organization, usually beginning with the
top-level manager (chairman/president), and presented in an organizational chart.

3. Directing

Directing is a process in supervising, or leading worker to accomplish the goals of

the organization. It involves giving assignments, assisting workers to carry out assignments,
interpreting organizational policies, and informing workers how well they are performing.
Managers must have leadership skill, motivating skills and communication skills in order to
get workers to perform effectively.

4. Controlling

Controlling involves the evaluation of activities. It is the

process of determining if the company's goals and objectives are
being met. This process also includes correcting situations in
which new developments or unexpected circumstances arise.

2
 Planning Organizing Directing Controlling
1. Defining goals. 1. Assigning task, 1. Leading and 1. Monitoring
people and motivating activities.
2. Establishing arranging resources people.
strategy and to accomplish work. 2. Changing plans
schedule. 2. Influencing for new
2. Establishing people to work development.
working hard and
relationship. achieve the 3. Resolving
organizational conflicts and
3. Determining what goals taking
needs to be done, corrective
how it will be done actions.
and who will do it.
4. Quality
assurance

DEFINE AND DIFFERENTIATE

The term manager is commonly confused with terms like director, supervisor and
administrator. It is therefore very important to better understand their differences in order to be
aware of their own functions and duties.

1. A manager is a person who plans, organize, direct and control the work of others in order to
run a business efficiently and achieve its goals.

2. A director’s role is to design, develop long term future plans and implement the strategic
plan for their company in the most cost effective and time efficient manner.

3. A supervisor is an employee of an organization with some of the powers and responsibilities

of management, occupying a role between true manager and a regular employee. A
Supervisor is responsible for the productivity and actions of a small group of employees. An
employee is a supervisor if they have the power and authority to do the following actions
(according to the Ontario Ministry of Labour):

Give instructions and/or orders to subordinates.

Be held responsible for the work and actions of other employees.
Administer discipline and penalties.

4. An administrator determines the purpose of the organization, the strategic role it will fulfill
within the context of a larger system or environment, and its goal. It also prescribes
boundaries of responsibility and accountability through the definition of an organizational
structure and budget limitation

ESSENTIAL CHARACTERISTIC OF A MANAGER

Although knowledge in the field in which he is operating is necessary to the manager,

essential characteristics are needed for him to succeed in his role.

1. Vision – Managers must have the ability to foresee something and sees the need for change
first and to be ready with solutions before the problem arise. He or she challenges the status
quo and forces honest assessments of where the organization is headed and how it can best
get there.

2. Motivation – It is the set of processes that moves a person toward a goal. Motivation is
directly proportional to production. High motivation brings high production.

3
 3. Decision-making ability – A manager who cannot make decision must yield authority to one
who can. It is very important that a manager performs decision for the benefits of the
organization.

4. Good health – It embodies more than physical fitness. It means living a balanced life
physically, emotionally and spiritually as the best antidote to tensions, illustrations, strains
and effort.

5. Humility – This implies the recognition that we have shortcomings that we are not self-
sufficient and that we need the help of our subordinates just as much as they need our help.

6. Leadership – It is an interpersonal influence directed toward the achievement of a goal or

goals. This is another important characteristic of a manager that might bring motivation and
success of the organization.

7. Mentorship – A formal relationship between a newly hired employee and a veteran

employee role model that provides support and encouragement to the new employee.
Managers should have the ability to teach new employees, helping them resolve personal
problems and work-related issues and conflicts.

MANAGEMENT LEVELS

In most companies or laboratories, "management" employees are separated from

production workers in a hierarchy that includes at least three levels of management:

1. First Line Managers – This is the lowest level in an organization responsible for the work of
others. They direct operating employees only; they do not supervise other managers.

Example of first line managers are thee technical supervisor in research department
and clerical supervisor in a large office. First level managers are often called supervisor.

2. Middle Line Managers – This can refer to more than one level in an organization. They direct
the activities of other managers and sometimes also those of operating employees. Their
principal responsibilities are to direct the activities that implement their organization policies
and to balance the demands of their supervisors with the capacities of their subordinates.

A chief laboratory services is an example of a middle manager.

3. Top Managers – This is composed of a comparatively small group of executives. They are
responsible for the overall management of the organization. It establishes operating policies
and guides the organizations interactions with its environment.

An example of a top manager is the president of the hospital.

ROLES OF A MANAGER

In 1973, Henry Mintzberg provides one of the first comprehensive studies of the nature of
managerial work. He found that about:

1/3 of manager’s time is spent in dealing with subordinates.

1/3 of manager’s time is spent dealing with external (outside the organization) matters.
1/3 of manager’s time is spent in a variety of activities including contacts with supervisors,
tours of the workplace and thinking.

4
 As a part of their job, managers serve the company in a number of different ways, playing
several different roles.

Interpersonal Roles

1. A manager is a symbol or figurehead. This role is necessary because of the position occupied
and consists of such duties assigning certain documents required by law and officially
receiving visitors.

2. A manager serves as a leader – that is, hires trains, encourages, fires and remunerates,
judges.

3. A managers serves as a liaison between outside contacts such as the community, supplier
etc.

Informational Roles

1. As a monitor, manager gathers information in order to be well informed.

2. Managers are disseminators of information, flowing from both external and internal
sources.

3. Managers are spokespersons or representatives of the organization. They speak for

subordinates to superiors and represent upper management to subordinates.

Decisional Roles

1. Managers as entrepreneurs are initiators, innovators, problem discoverers and designers of

improvement project that direct and control change in the organization.

2. As disturbance handlers, managers react to situations that are unexpected, such as

resignation of subordinates, firings or lose of customers.

3. A third decisional role is that of a resources allocation.

4. Finally, managers are negotiators when conflicts arise.

WHAT MAKES A GOOD MANAGER?

The qualities that top management contenders possess have described as follows:

1. Appearance – Conspicuous obesity or extreme emaciation are negative mark in men.

Conservative dress can be faulted in women. A good quality suits with a fresh, bright
coloured blouse is excellent. Jewellery should be muted, air neat.

2. Personality style – You can learn manners and poise. Adopt diplomatic approach and act
with difference.

3. Articulateness – This is increasingly important because even if you have the roper
educational background, superb dress and manners, good looks etc. You will ruin your
chance if you are a “linguistic cripple.”

4. Energy, drive and ambition – Easy to recognize, through the quick stride, fresh appearance,
superb physical health.

5
 5. Positive attitude – Without being an utter fool, you can beat the pessimist by consistently
displaying a constructive, cheerful outlook in life.

6. Thoughtfulness – No one wants a “yes” man. An intelligent man and woman usually weigh a
question for a second or two before responding.

7. Overall composure – The nail biter, hair twirler, foot topper or chain smoker goes beyond an
initial interview unless his or her credentials are so outstanding that allowances must be
made for nervous habits.

8. Aura of leadership – An erect carriage, heels held high, an agreeable manner and self
confidence connote leadership qualities. You must be sure of yourself to lead others and
most importantly that you inspire trust and are likeable.

9. Bright, informed, and with sense of humor – If you are intelligent and well rounded, you will
come across as such. A degree of humour adds sparkle.

10. With variety of interests – Without being the least bit pedantic, you can learn a little about
many fields- art, architectures, politics, travel, language, economics, and literature etc.

MANAGEMENT SKILLS

Robert L Katz, has identified three basic types of skill; technical, human and conceptual-
needed by all manager.

1. Technical skill – is the ability to use equipment procedures and techniques of specialized
fields. A surgeon, medical technologist, nurse and a pharmacist all have technical skills in
their respective areas. The manager needs enough “technical skill” to accomplish the
mechanics of the particular jobs he is responsible for.

2. Human skill – is the ability to work with, understand and motivate other people, either as an
individual or as a group. Managers need enough of this human relation’s skill to work with
other organization members and to lead their own work groups.

3. Conceptual skill – is the mental ability to coordinate and integrate all of the organization’s
interest and activities. A manager needs enough conceptual skill to recognize how the
various factors in a given situation are interested, so that the action he takes will be in the
best interest of the total organization.

Management Performance – Peter Drucker, argued that a manager’s performance can be

measured in terms of two concepts: efficiency and effectiveness.

As he puts it, efficiency mean “doing things right” and effectiveness means “doing
the right things”.

Efficiency is the ability to get things done correctly. It is an “input” – “output”

concept. An efficient manager is one who achieves output, or results, that measure up to the
inputs (labor, reagents, supplies, equipment and time) used to achieve them. Managers who
are able to minimize the cost of the resources they use to attain goals are acting efficiently.

Effectiveness is the ability to choose appropriate objectives. An effective manager is

one who selects the right things to get done. A manager who selects an inappropriate
objective- to convert the laboratory into automation when the hospital caters to the poor
community – is not an effective manager.

6
INDICATORS OF LACK OF MANAGEMENT SKILLS

1. Inability to maintain adequate staff. The deficiency may be due to an insufficient number of
trained workers or efficient use of the personnel available.
2. Recurring or persistent misunderstanding within the hospital.
3. Frequent or recurrent confusion concerning requisitions or reports of laboratory work.
4. Frequent “rush” orders for supplies.
5. Low morale in the laboratory.
6. Request for deserved pay raised by competent workers (funds are available).
7. Excessive cost of operations.
8. Ignorance of the cost of operation.
9. Expenditure of much of manager’s the time in making minor decisions.
10. Inability to do more tests when a key individual has a day off.

7
 CHAPTER 2

PLANNING

PLAN AND PLANNING

A plan is a predetermined course of action intended to facilitate the accomplishment of a

task, work or mission. It also keeps in view the necessities of the management.

Planning is the methodical selection of a series or set of complementary actions for the
purpose of pursuing an improved position. It is deciding in advance what to do, how to do it, when to
do it and who is to do it.

THE NATURE OF PLANNING

Long-Range Plans – visualizing what goals must be realized at certain future dates. This
nature of planning is commonly associated with strategic planning which has a long time frame, often
three years or more

Short-Range Plans – this covers daily to annual plans. This is also known as operational
planning.

THE IMPORTANCE OF PLANNING

Planning plays a vital role in preventing mistakes and recognizes hidden opportunities.
Preparing a satisfactory plan of the organization is essential in planning process. It enables the
management to focus clearly on what they want to achieve, and how and when they can do it. It
helps in forecasting the future, makes the future visible to some extent. It bridges between where we
are and where we want to go. Planning is looking ahead.

VALUES DERIVED FROM PLANNING

1. The achievement of the objective of the organization in the most efficient and economical
manner, thus maximizing profits.
2. The use of efficient methods and the development of standards necessary for accurate
control.
3. Integration of activities of the different units in the organization toward goal-directed
actions.
4. The reduction of emergency and unexpected problems.

INDICATORS OF POOR PLANNING

1. Late submission of results/reports.

2. Idle machines.
3. Materials wanted.
4. Some machines doing jobs that should be done by smaller machines.
5. Some laboratory personnel overworked, others are underworked.
6. Skilled workers doing unskilled work.
7. Laboratory/personnel fumbling on jobs for which they have not been trained.
8. Quarrelling, bickering, buck-passing and confusion.

8
BENEFITS OF GOOD PLANNING

1. Jobs turn out on time.

2. Good relationship with other departments.
3. People using their highest skills.
4. Workers know how their jobs fit into the total pattern.
5. Machines doing their proper jobs.
6. Equipment in good shape.
7. Materials available.
8. Waste kept to a minimum.

QUALITIES OF A GOOD PLANNER

1. Should have good judgment, imagination, foresight and experience.

2. Has the ability to evaluate laboratory opportunities and hazards.
3. Proficient in the determining of objectives.
4. Ability to accept changes.

HIERARCHY (TYPES) OF PLANS

1. Purpose or Mission – This states the purpose of the organization and its main reason of
existence. This is broad, yet clear and concise, summarizing what the organization does. It
directs the organization, as well as all of its major functions and operations, to its best
opportunities.

2. Objectives – Objectives or goals are the end toward which planning, organizing, staffing,
leading and controlling are aimed. For example, the objectives of a medical equipment
company might be to make certain profit by producing a given line of blood collection
equipments.

3. Strategies – Strategies denote a general progress of action implying commitment of

emphasis and resources to attain broad objectives. For example, if a medical company has a
goal of profitable growth at a certain policies as to market directly rather than through
distributor or to concentrate on propriety products or to have a full line of products.

4. Policies – Policies are general statements or understandings which guide or channel thinking
and action in decision making. Examples are policies to hire only university-trained
technicians to encourage employee suggestions for improved cooperation, to promote from
within, to conform strictly to a high standard or medical ethics, etc.

5. Procedures – Procedures are plans that establish a required method of handling future
activities. They are truly guides to action, rather than to thinking, and they detail the exact
manner in which a certain activity must be accomplished. For example, if a laboratory policy
may grant medical technologists vacations; schedule vacations to avoid disruption of work,
set methods and rates of vacation pay, maintain records to accomplish employee a vacation,
and provide means of applying to the vacation.

6. Rules – Rules are required actions chosen from among alternatives. It requires that a specific
and definite action be taken or not with respect to a situation. For example, “no smoking” is
a rule.

7. Programs – Programs are a complex of goals, policies, procedures, task assignment, and
steps to be taken, to carry out a given course of action. They are ordinarily supported by
necessary capital and operating budgets. For example, “Primary Health Care Program of
PAMET.”

9
 8. Budget – Budget is the statement of expected results expressed in numerical terms. It is also
referred to as a “numberized program”

Figure 2.1: The Hierarchy of Plans

STEPS OF PLANNING

1. Identify Goals – A goal is an end that the organization strives to attain. It would guide and
identify where or what the organization wish to be.

2. Evaluating Current Situation – The organization must know where it stands. They must
identify where they are and how they got there. It is essential to determine if they are on the
right track. Each personnel must have a clear understanding of the available resources and
how they can utilize it.

3. Establishing Time Frame – There should be acceptable period of time for each plan to
achieve its goals. Most plans are limited by short term constraints, steps must be taken to
ensure that situation improves in the shortest period of time. This would enable managers to
plan where they want the organization be in 1 to 5 years

4. Setting Objectives – Objectives are short term standards that are allowing the manager to
achieve its goals, step-by-step. These serve as specific benchmark to know whether
standards were met.

4 Basic Characteristics of a Good Objective Indeed, it must be:

1. Clearly Defined and Understood S – Specific

2. Obtainable and Realistic M – Measurable
3. Strict time period in which it should be A – Attainable
accomplished R – Realistic
4. Measurable T – Time Bound

10
 5. Forecast Resources Needs – One major consideration in planning is FEASIBILITY of goals and
objectives. A manager must consider the availability of resources, the possibility of obtaining
the additional assets needed and eventually ends in the development of the laboratory
budget both operational and capital.

6. Implement Plan – This is where the manager designs its STRATEGY for attaining obstacles
and impediments.

2 Basic Ways for implementing a plan or obtaining the desired performance:

a. Tools of persuasion – Focused on working with and through people. This is best
described by listing key words such as: communication, involvement, inclusion,
education, training, cooperation, building confidence, support, consultation, feedback,
sharing information and responsibility.

b. Tools of Control – involves the allocation of resources. By virtue of the manager’s

position and formal authority such as: 1) allocation of financial resources (selection of
equipment and supplies and number of employees) through the budgeting process
and 2) the process of staffing and scheduling of job assignments, managers can obtain
and maintain control.

7. Creating Feedback Mechanism – A plan must have a system to check on its progress, with
the information gathered on its system; the plan would be changed relative to the results
gathered to better achieve its goals.

TYPES OF PLANNING

1. Strategic planning – Is a conceptual and deals with the sweeping question of what to do.
This type of planning is concerned with the identification of the mission and of those
objectives that will permit its most efficient pursuit. It involves analyzing competitive
opportunities and threats, as well as the strengths and weaknesses of the organization, and
then determining how to position the organization to compete effectively in their
environment.

Strategic planning generally includes the entire organization and includes formulation of
objectives. Strategic planning is often based on the organization's mission, which is its
fundamental reason for existence. An organization's top management most often conducts
strategic planning. Strategic planning is usually based on long-term projections and a global
view that can impact all levels of a laboratory's operations.

2. Tactical planning - Is the method on accomplishing the goal of the organization. This is
intermediate-range planning that is designed to develop relatively concrete and specific
means to implement the strategic plan. Middle-level managers often engage in tactical
planning. Tactical planning often has a one- to three-year time horizon. It is the detailed,
often day-to-day operations needed to meet the strategic goals that have been set

SETTING GOALS AND OBJECTIVES

The first step in laboratory planning is the establishment of general goals (also known as
mission statement) and specific objectives by the laboratory staff. The use of such objectives for
purposes of management is known as management by objectives (MBO).

Goals are those general and qualitative statements of overall philosophy of the organization.
An example of goal is:

11
 “A commitment by the hospital laboratories to be a vital component of hospital whose goal is
to provide a patient’s care environment of excellence, to serve the community and to serve as
a setting for clinical teaching.”

Mission is the final and ultimate goal. An example of mission is:

“The mission of every hospital laboratory is the constant provtrdgision of timely and accurate
test results for the purpose of assisting the physician in the delivery of good patient care.”

Objectives represent the interim goals by which the mission is the most logically and
effectively pursued. They should be quantifiable statements which are achievable over a designated
period of time. An example of objective might be:

“To evaluate available approaches to automation of antibiotic susceptibility testing and to

implement the optimal approach by the end of the fiscal year.”

Objectives may be immediate (priorities), intermediate or long range. Because of the

constant change in the progress of organization, objectives require revival and updating.

MANAGEMENT BY OBJECTIVES

Management by Objectives – Is a process of formulation, performance and assessment, and

as such, it provides means of focus on pertinent factors and issues that affect the practice of
laboratory medicine. As a tool of management, MBO encourages discussion, interaction and
consensus decision-making among all organizational levels of the laboratory.

Characteristics of Objectives in MBO Programs:

a. Follow well-thought-out plans and long term goals
b. Be based on a collaborative agreement between manager and employee
c. Be within the power of individual to accomplish
d. Be person specific
e. Be measurable

Essential Factors in Laboratory Planning (Operational Data):

1. Past experience – Refers to the totality of an organization’s awareness based upon the prior
observations and participations of its membership. As with all input, careful assessment must
be made in order to determine what is valid from what is not. Input must represent well-
supported conclusions based on accurately recorded data, such as test volume, income and
expense figures and work hours.

2. Market potential – May be stated as the known or estimated expenditures for given services
in a given locals or as projections of these expenditures contingent upon specific plans and
anticipated developments. These analyses and/or projections are critical to any
contemplation of expanded services and must include not only a determination of current
sales, but also how these sales might be profitably increase with careful strategy.

3. Competition – An analysis of most market potential areas will usually disclosed a relatively
consistent set of competitive forces. A brief assessment of these appears in the table 2.2
below:

12
 Competition Strengths Weaknesses Strategy
Physicians’ Office Profitability Limited range of tests Efficient, comprehensive
Laboratories and convenient out-
Patient convenience Limited availability patient services

Lack of quality control Competitive prices

progress
Area hospital Must be assessed Must be assessed As above
laboratories individually individually
Commercial Good quality Inconvenient As above
laboratories Impersonal
Wide range of tests
State health Good quality Inconvenient As above
departments Small direct costs Impersonal PR program (unfair
Slow results competition)

Table 2.2 Assessment of Hospital Laboratory Competition

4. Hospital/Laboratory Relations – These are difficulties and problems that results between
those responsible for providing laboratory services and those accountable of administering
overall hospital policy. These are due to the aberrant and bizarre configuration of most
hospital organization which resulted from the orthodox relationship of the medical staff to
the remainder of the structure.

Configuration of most
Configuration of most area hospital organizations
service organizations

Figure 2.2: Diagram demonstration of the unorthodox configuration of most hospital

organizations. The area occupied by the medical staff represents not necessarily numbers,
but rather authority.

5. Regulatory and Accrediting Forces – The laboratory industry has been subjected to a large
and ever-increasing number of regulations and performance standards. This phenomenon
characterizes the constraints currently being imposed on all providers of medical services.

6. Laboratory Trends – They are defined as a series of events constituting a pattern that
suggests both its origin and probabilities for continuation. They serve as valuable indicators

13
 of consensus thinking within the industry and as such, provide an important means by which
one’s own thinking and practices maybe influenced.

7. Medical Trends – The pattern of tests requests is a useful indicator of the relative value with
which the physician perceives the wide range of laboratory services. Any assessment of
changes in laboratory requests patterns include an assessment of improved disease
evaluation and the probabilities of sustained utilization.

8. Socio-political Trends – Events that have been already affected hospital laboratories include
the legalization of unions in non-profit institution and he legislations of equal job
opportunities.

Operational Data Planning Goals

Past Experience Strategic Mission
Market Potential

Competition

Objective
Objective
Hospital/Laboratory Relation Tactical Objective
Objective
Objective
Regulatory and
accrediting forces
Medical trends
Socio-political Trends

Table 2.3: Essential Factors in planning in the hospital laboratory

PLANNING THE LABORATORY DESIGN

The successful design of a functional clinical laboratory either new or repeated requires the
close cooperation of the following groups:

1. Laboratory director and the entire laboratory staff – In order to prevent misunderstandings,
all recommendations and changes must be documented.

2. Consultants or designers of laboratories.

3. Architect or architectural firm – They are essential in preparing the various drawing and
specifications. The final, approved copies will be submitted and used in the building process
by the contractor for construction.

Traditionally, laboratories have been organized in a mixture of approaches: for example,

clinical chemistry is technique oriented; clinical microbiology is techniques and disease oriented;
urinalysis is specimen oriented; hematology is specimen and organ system oriented and blood bank is
product oriented.

THINGS TO CONSIDER WHEN SEARCHING FOR THE RIGHT LOCATION TO START A LABORATORY

1. Assessment – always remember the 4 P’s

P – Product

14
 P – Price
P – Place
P – Promotion
 What are the customer needs?
 Who is the competition?
 Do you have the right testing menu, equipment, and facilities?
 Do you have enough personnel?
 Do you have adequate financial resources?
 Do you know what it costs to do a laboratory test (test–cost analysis)?

2. Define your costumer segment

 Physicians, nurses, dentists, other healthcare providers
 Other hospital labs, physician office labs (POLs)
 Insurance companies
 Identify unique socioeconomic and/or ethnic groups
 Look for population shifts and location (urban, rural, suburban)
 Colleges, universities, and other schools
 Nursing homes, home health agencies, and clinics
 Veterinarians and other animal healthcare facilities
 Researchers, pharmaceutical companies, clinical trials

3. Process - Develop a sales/marketing plan and team

 Set goals
 Ensure infrastructure (courier service, LIS capabilities, customer service personnel,
etc.) is adequate
 Develop additional test menu items
 Educate laboratory personnel in customer service
 Support and maintain existing client services
 Advertise/public relations

4. How to market? - Review test menu for comprehensive services (niche testing, esoteric
testing, other unique services that could be provided to an eclectic group)
 Place advertisements
 Develop brochures, specimen collection manuals, and other customer-related
material Develop website
 Attend/participate in community health forums
 Identify specific target customers:
 College/school infirmaries, health clinics, county laboratory facilities,
industrial/occupational facilities (pre-employment, drug screening)
 Nursing homes, extended care facilities
 Drug/alcohol rehabilitation centers, correctional facilities
 Physician offices (POLs), groups, and specialties (pediatrics, dermatology,
family medicine, etc.)

SPATIAL CONSIDERATIONS IN LABORATORY DESIGN

The location of the laboratory must be carefully studies in relationship to other hospital
services, to traffic, to supporting and to users. For example:

1. The blood bank and the critical care laboratory procedures should be readily accessible
to the emergency room, operating rooms and intensive care unit. The location of blood
bank should allow rapid donors if the blood bank is responsible for donor procurement,
phlebotomy and/or aphaeresis.

15
 2. A specimen collection area or phlebotomy area should be planned in proximity of the
ambulatory care facility and the admitting office.

3. If the laboratory is serving an in-patient population, accessibility to corridors and

elevators providing access to the main patient care units is essential.

4. The specimen receiving, data processing and reporting center serve as the hub of the
laboratory. Radiating from this should be the various laboratories.

5. The critical care laboratories and large volume laboratories (such as hematology and
chemistry) might be closely related to the central areas.

6. These laboratories with greater turn-around-time (TAT) and/or less volume, as well as
those requiring special safety features (such as clinical microbiology and radio assay
laboratories) might be removed from the central area.

7. The intra laboratory traffic flow must be separated from the outside. Provisions should
be made for ambulatory patients and blood bank donors coming into the laboratories.

DIFFERENT LABORATORY DESIGNS

These three are the things to remember when planning to design a laboratory:

1. Functional Design – It should be designed according the functions and easy way of
communication for the different members of the organization.

2. Regionalization – It is a consolidation process on a grander scale. In this ‘hub and spoke’

model, a single core laboratory serves as the hub with one or more other laboratories
serving as the spokes. It requires significant up-front resources to initiate a regionalized
laboratory, considerable space requirements, commitment from senior personnel, and long-
term, continuing education for the staff in dealing with this change.

This type requires a highly cooperative environment among all parties involved and
can take years to fully implement. In this model, two or more hospital laboratories form an
interlaboratory alliance and come to agreement on the location of laboratories, retention of
staff, instrumentation used, and information management system. Often, a large, core
laboratory facility is centrally located to accommodate the routine and the more esoteric
tests. Stat or rapid-response laboratories are located at individual hospitals to handle urgent
test requests. This model works particularly well where a large, comprehensive laboratory
already exists among a number of smaller community-based hospitals. A variation of this
model is one that focuses on specialization and laboratory expertise.

The advantages of such a consolidation are standardization of procedures,

equipment, quality-control programs, and reporting formats. Reducing equipment
redundancy, maximizing specimen throughput, and utilizing staff more effectively can
achieve significant cost savings. One laboratory consolidation of services allowed for a 25%
reduction in labor; bulk purchase of common supplies reduces costs; and multiple purchasing
agreements can be consolidated. The challenges in implementing and succeeding with this
model include specimen transportation, resistance to change, personnel issues, morale
issues, ‘lost identity’ of the laboratory, and union problems, and thus require careful
consideration in the planning process.

3. Physical design – Physical design are important regardless of the type of laboratory. Location
of specimen processing area, patient registration and data entry, specimen testing workflow,
short- and long-term storage, and laboratory information system (LIS) connectivity
requirements must be considered. Spatial requirements in relationship to other hospital

16
 services (proximity to emergency department, intensive care units, and surgical operating
suite) should be viewed as a multidisciplinary process. Robotics, pneumatic tubes,
computers, including intranet and internet accesses, and facsimile machines are the new
tools used in modern laboratories and must be accounted for in the design plans. Electrical
power, temperature/humidity controls, water and drainage sources, and air
circulation/ventilation issues must be considered for placement and adequate quantity.
Regulatory compliance codes must be carefully reviewed and implemented appropriately to
ensure safety, ergonomic, and comfort needs. To ensure one meets local, state, and federal
codes, a qualified and experienced architect who has experience in designing clinical
laboratories should be consulted when considering laboratory relocation or renovation
designs. This also minimizes costly change orders and maximizes functionality and workflow.

LABORATORY PHYSICAL DESIGN CONSIDERATION

1. Identify space needed: for offices, personal facilities, storage, conference/library area, and
students.

2. Routinely review all floor plans and elevations for appropriate usage as well as to ensure that
space and function are related. Handicap accessibility may be required.

3. Develop and use a project scheduler.

4. Fume hoods and biological safety cabinets must be located away from high traffic areas and
doorways.

5. Modular furniture allows for flexibility in moving or reconfiguration of the laboratory

according to current and anticipated needs.

6. Conventional laboratory fixtures may be considered in building depreciation, whereas

modular furniture is not.

7. Base cabinets (under laboratory counters) provide 20 to 30% more storage space than
suspended cabinets.

8. Noise control in open labs may be obtained by installing a drop ceiling. Installation of utilities
above a drop ceiling adds to flexibility in their placement.

9. In general, space requirements are 150 to 200 net square feet (excludes hallways, walls,
custodial closets, etc.) per FTE, or 27 to 40 net square feet per hospital bed.

10. Rooms over 100 square feet must have two exits; corridors used for patients must be 8 feet
wide, while those not used for patients must be 3 feet 8 inches wide.

11. An eyewash unit must be within 100 feet of work areas.

12. Suggested standard dimensions in planning and designing a laboratory:

 Laboratory counter---------------------------------------- width: 2 feet 6 inches
 Laboratory counters to wall clearance -------------- 4 feet
 Laboratory counter to counter clearance ----------- 7 feet
 Desk height ------------------------------------------------ 30 inches
 Keyboard drawer height -------------------------------- 25 to 27 inches
 Human body standing ----------------------------------- 4 square feet
 Human body sitting --------------------------------------- 6 square feet
 Desk space ------------------------------------------------- 3 square feet

17
DIFFERENT LABORATORY SERVICE MODELS

1. Traditional “closed” laboratory – The traditional hospital laboratory has discrete sections in
hematology, chemistry, microbiology, and blood bank, generally separated into rooms or
sections.

2. “Open” laboratory – The discrete services are placed in one large room with portable walls
that can be adjusted as needed based on volume.

3. Core laboratory – A common type of consolidation has been hematology and chemistry
laboratories (“chematology”) (Bush, 1998).

- Advantages include handling stat requests, improving off-shift workflow, and avoiding
chronic staffing problems

4. 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.

5. Reference laboratory – Traditional full service laboratory that handles all types of testing,
especially esoteric tests.

6. 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).

7. Stat laboratory – Rapid response laboratory that is often located in or near an emergency
department or surgical suite. Provides critical laboratory tests such as hematocrits and blood
gases.

8. 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.
Includes downsized hospital labs that retain stats and some routine tests but send most work
to an off-site core laboratory.

18
 CHAPTER 3

ORGANIZING

DEFINITION

Organizing is a process of structuring activities, materials, and personnel for accomplishing

predetermined objectives. It is done in such a way that efforts and expenditures are minimized and
output is maximized. Organization consists of knowing the tasks, and understanding what knowledge
and expertise the employees must possess in order to perform the tasks, and understanding the
physical, and capital requirements that must be assembled to accomplish the desired results.

Organizations are social entities that are goal directed, deliberately structured and
coordinated activity systems and are linked to the external environment but with an identifiable
boundary.

DIMENSIONS OF ORGANIZATION

1. Contextual Dimensions – Characteristics of organizational setting that influence and

shape the structural dimensions. These are integral to the organization as such, it is vital to
the very existence and performance of the organization, such as the number of employees or
technology or machine to be used.

2. Structural Dimensions – Describe internal characteristics of an organization. These makes up

the requirements to operate as described by the contextual dimension. It is “dependent” on
the contextual dimension.

Contextual Structural
Viewed as “causes” of the structural dimensions Viewed as “consequences” or “effects” or
such as “independent variables”. dependent variables.
Size (measured as number of employees, total Formalization (use of written documentations
sales, and assets) such as job description, procedures)
Technology (tools, techniques, actions use to Specialization (degree of subdivision of tasks into
transform inputs into outputs) separate jobs / division of labor)
Goals and strategies Hierarchy of authority (depicted by vertical lines
in organization chart; described by number of
levels and span of control.
Culture (values beliefs, and norms shared by the Centralization (extent to which decisions are
employees. made at the top of the hierarchy rather than
delegated to lower levels
Professionalism (level of formal education and
training of employees)

CONCEPTS OF ORGANIZATION

Over the centuries various concepts have been applied to effectively handle an organization.
They have been changed to gain greater efficiency and to meet set goals. They may also vary due to
culture or ethnicity of person handling the organization and the employee itself. There are many
concepts introduced but some are considered “flawed”, or ineffective.

1. Herd concept – Staffs are coerced upon the established rules and regulations. Leader has the
exclusive power to decide and enforce an unquestionable rule. The leader here is seen as the
person with the highest authority. The leader may not be involved in the personal affairs of

19
 the staff. The staff are made to obey rules that are set y the leader and complains are
minimized.

2. Man to man concept – individuals are in direct relation to the supervisor. There is a direct
delegation of authority and responsibility of the leader to the staff. Leaders are in direct
relation to the staff.

3. Social concept – supervisors and subordinates are regarded as a member of the team. Each
problem is viewed in its overall effect on the organization to the staff. All people in the
organization works toward a common goal. All issues are discussed and each opinion is given
the same importance as others. Decisions are made for the common good.

TABLE OF ORGANIZATION

An important management tool is the organizational chart. An organizational chart shows

hierarchical relationships between functional areas in an organization. An organizational chart helps
clarify work flow, reporting lines, and areas, be it by division, laboratory, or specialty areas.

Chief
Pathologist

Pathologist Pathologist Pathologist Pathologist Pathologist Pathologist

Hematology Blood Bank Chemistry Microbiology Serology Microscopy

MT MT MT MT MT MT
Supervisor Supervisor Supervisor Supervisor Supervisor Supervisor

STAFF STAFF STAFF STAFF

STAFF STAFF

STAFF STAFF STAFF STAFF

STAFF STAFF

STAFF STAFF STAFF STAFF STAFF

STAFF

STAFF STAFF STAFF STAFF

STAFF
STAFF
STAFF STAFF STAFF STAFF STAFF
STAFF

Example of an organizational chart (Clinical Pathology laboratory)

The chart specifically indicates positional authority. Authority implicitly accompanies a

position on the organizational chart, and its location on the chart implies a degree by those who
directly report to the person in authority. The organizational chart is a contract of sort, as it

20
unambiguously illustrates the structure of the organization and the relationships among the people
within it. It also serves as a visual aid for evaluating this purpose as the position of greater
responsibility is placed on the top, while positions carrying lesser responsibilities lie below.

STAFFING

The functions of clinical laboratories are critical to good patient care, diagnosis, and
management. It is estimated that 85% of physician’s medical decisions are based on laboratory
results. This alone implies that a laboratory must be adequately staffed not just in numbers but
equally important is their qualifications.

In a clinical laboratory, unlike other organization such as in marketing or company, the law
specifies the minimum number of staff that should e employed to be able to operate. This protects
ensures that patient will be attended well and the employees are not overworked. For example, as
indicated in R.A 7719 of 1994, for a blood bank to operate it should have at least:

Category A – 4 RMT (1 RMT for AM, PM, night shift each. 1 RMT off)

Category B – 5 RMT (2 RMT for AM shift, 1 for PM and night shift each, 1 RMT off) and there
is a donor recruitment officer, which can be a Doctor, Medical Technology or nurse.

This should be headed by a pathologist, hematologist, or a physician but should

have had at least 6 months training in Blood Bank from an accredited institution, and has a 1
year experience in blood banking.

It can also employ a medical laboratory technician under the supervision of the
registered medical technologist. A medical technologist is allowed to supervise up to 2
laboratory technician.

DIVERSITY IN THE WORKPLACE

If human nature was consistent and everyone had the same characteristics, there would be
no need for supervisors, policies and procedures, and managers. This is more evidently seen with
today’s globalized work environment making decision, involving staff a very difficult one.

Selecting the right person for the job is not easy. Identifying candidates for the “right fit”
based on education, technical skills, experience is easy. Often the most difficult part is identifying
those personal traits that are conducive to being a team player which re subjective.
Misunderstandings based on culture, ethnicity, religion may inadvertently result to a missed
opportunity for both employee and employee,

Characteristics to look for in a potential employee may vary depending on the position or the
nature of the job he is applying for. Common characteristics may include ambition, creativity, energy,
communication, enthusiasm, leadership, tenacity, independence, team-player, and initiative.

JOB DESCRIPTION

A job description is a list of the general tasks, or functions, and responsibilities of a position.
Typically, it also includes to whom the position reports. The analysis looks at the areas of knowledge
and skills needed by the job. Role is the set of responsibilities or expected results associated with a
job. A job usually includes several roles.

21
 It is very important to review the accuracy because it potentially sets the foundation for the
scope of the jobs for until the organization or the duties of the employees have been changed. This
will ensure that job duties listed are really needed, have not changed, or could be improved.

There are five key sections common to most job descriptions:

A. Job titles: should be consistent throughout the laboratory with consideration to local and
national nomenclature that may be used in describing job titles. It may also be related to the
position and gives an overview about the nature of the job.

B. Qualifications: describes the education, experience, traits (e.g. honesty, punctual,

personality, etc) that a person must have to properly fit for the position. This defines what an
applicant or employee should have in order to effectively perform the job.

C. Duties: must be identified to ensure that the incumbent understands what he/she must do.
It enumerates the things that must be done and/or what are not done yet but are needed to
be completed.

D. Responsibilities and accountability: identifies or delimits how much authority one has
during decision-making. It ensures that an employee exercises decisive authority over a
subject to which he is accountable. It also minimizes conflict because of overlapping of
decisions especially by managers.

E. Job relationships: it states where the incumbent will report to or where he/she reports to be
it internally or externally. This is particularly important is a workplace is very diverse. It is
very important to keep the flow of communication open and to address the problem
properly by reporting it to proper authority.

JOB SPECIFICATION

Job specification is a list of qualities that an employee must have to fit for the position. It
makes sure that a qualified person occupies the position. It avoids under-qualification or over-
qualification. As the qualifications have been met, it is expected that the employee will be productive
and will meet what is expected of him/her. This may include age, educational background, years of
experience, skill, previous job, trainings and seminar, license, and certificate.

Below is an example of a job description for a Medical Technologist Supervisor (Blood Bank):

Job Title: Medical Technology Supervisor

Department: Clinical Pathology
Section: Blood Bank

Job Summary:
Under general Supervision: coordinates services in the unit and supervises staff performance
to achieve unit goals and objectives.

Specific Duties and Responsibilities:

1. Coordinates work and services of the unit based on hospital work standards and procedure
to achieve objectives.
2. Supervise and direct staff performance.
3. Participates in budget preparation and monitor expenditures.
4. Maintains cleanliness and safety in the work area.
5. Maintains quality control and assurance program.

Regular duties:
1. Organize work and institute discipline in the section.

22
 2. Process reports and requisition.
3. Maintains quality control and quality programs.
4. Prepares schedule of staff.
5. Initiate request for routine supplies and inventory of it.
6. Accounting for work done.
7. Performs job function of med. Tech staff as the case arises.
8. Performs special procedure such as apheresis, antibody screening.
9. Prepares reports, monthly accounts, and consumption.

Key Organizational Relationship:

Reports to: Division Chairman
Supervises: 8 Medical Technologists, 1 Nurse
Coordinates with: Other sections in the department and interdepartment as the need arises.

Job Specification:
Education: Bachelor of Science in Medical Technology
Experience: 5 years
Specialized knowledge/training: aphaeresis, antibody screening, training in HIV Testing.
License: Professional Regulation Commission

WORK SCHEDULE

Work schedule also entails planning to ensure that work will not be disrupted due to
understaffing or in cases of absences. It will also be not economical if the number of staff is not
maximized because of overstaffing. Doing work schedules is inherent to the nature of job, workload,
and efficiency of staff. Here are some of the rules undermined during preparation of schedule.

1. Two-deepness rule – A laboratory should at least have 2 staff per shift who can perform the
job. This is to address problems because of absent employee since it is inevitable so to speak
as one time or another certain personal problems may arise. It ensures that work will not be
disrupted in such cases.

2. No more than 5 consecutive working days – This is to follow the directives indicated in the
Labor Code here in the Philippines that an employee should not work more than 5 days in a
week.

3. 2 days off – Also as indicated in the Labor Code.

4. Rotate shifts with fairness – This is to ensure that there will be no conflict when it comes to
schedule especially to laboratory operating 24 hours. Not all employees may like morning
shift or night shift.

5. Give opportunity to the staff to request their duty – To avoid absences, staff are given a
chance to tell the supervisor their desired duty or off in advance to make the necessary
adjustments.

6. Post schedule in advance – This will address the problem of absences since the staffs know
the schedule in advance and again to make adjustments to their schedule as the case maybe.

7. Stick to the approved schedule as closely as possible – To prevent mixed-up of schedule,

however if changes are inevitable the supervisor should be informed in advance.

23
PERFORMANCE APPRAISAL

The word “appraisal” is derived from the Latin word appratiare which means to set a price or
value. In this case, employees work for compensation. A formal performance appraisal is also known
as merit review or performance evaluation. It is a planned, periodic management activity to evaluate
an employee’s on-the-job behavior, competency, work skill improvement, need for training, and
progress towards completing goals, salary, and promotion. It is a key human resource function that is
closely integrated not only with compensation and training but also for career planning.

Advantages of performance appraisal

Performance appraisal is done mainly for assessment if an employee is performing well
his/her duties. It promotes good communication between leader and staff not only during conflicts
but also for a well-performed job. It provides constructive feedback so as to improve the performance
of staff with short-comings, thus provides an opportunity to refine job skills, educational needs,
and/or behavior. It is also done so that staffs are well aware of the things that are expected of them.

Disadvantages of performance appraisal

Although appraisals are done without harm on mind some effects bad effects are inevitable.
Staff may experience it as an added stress since he/she has to meet the expectations especially the
staff exhibited poor performance. It may be a source of conflict between staff and managers and
promotes competition among staff. It is also an added work especially for managers.

TYPES OF APPRAISAL

1. Formal appraisal - Generally occurs at least annually on a specific date and time, such as
employee’s anniversary of hire date or as advised by the HR department. Appraising all
employees at the same time period is generally viewed as most fair because the same
guidelines can be applied to all employees evaluated.

2. Informal appraisal – This is useful for monitoring behaviour modification, recognizing

accomplishments, identifying stumbling blocks in achieving set goals, giving support where
applicable, and fostering ongoing communication between formal appraisals. it also ensures
that the formal appraisal does not come as a surprise to employees. They know what to
expect and can work at fulfilling those expectations.

Other Types of Appraisal

Appraisals are done to check the performance of each employee. As such, managers are not
the only one tasked to do appraisals. Depending on the culture in the organization, managers may
misunderstand staff and sees staff at his/her poor performance.

1. Self-appraisal – Generally distributed approximately 2 weeks prior to a formal appraisal and

are not meant to take place of a manager’s appraisal, they give a different perspective of an
employee’s performance and possibly a better understanding of the potential obstacles that
may impede performance.

2. Peer-to-peer appraisal – Requires trust among employees working together. Co-workers are
asked to evaluate each other. This approach may engender fears among staff, some without
foundation, that need to be addressed. Conversely, if you are working with experienced and
sincere employees, the process may prove to be educational.

3. 360-degree evaluation – Designed to obtain well-rounded appraisals that tend to be

reserved for individuals in management-level evaluations, both trust and a comprehensive
training program are required to successfully implement this technique. The evaluation is
often done anonymously and invites, open, constructive in-depth feedback.

24
 CHAPTER 4

DIRECTING

DEFINITION

Directing is influencing people’s behavior through motivation, communication, group

dynamics, leadership and discipline. The purpose of directing is to channel the behavior of all
personnel to accomplish the organization’s mission and objectives while simultaneously helping them
to accomplish their own career objectives. Phase of management process that involves the day to day
tasks of running the laboratory according to the management plan it exercise to leadership. Managers
give this function a variety of names. Higgins calls it leading.

Other labels are: influencing, coaching, motivating, interpersonal relations, and human
relations. The directing function gives the manager an active rather than a passive role in employee
performance, conduct and accomplishments. Managers accomplish their objectives through people.

Supervision is a critical adjunct to directing and entails responsibility for assuring that
policies and procedures are followed. It includes an understanding and agreement with established
goals and an active role in their formulation and achievement.

PRINCIPLES OF LEADERSHIP

1. Employee Oriented – Where managers had strong ties rather than in production work.

2. Product Oriented – Emphasize the high productivity at the expense of all other factors.

3. Structure Style – Where the manager directs the staff toward getting the work done, paying
attention to assigning particular tasks, specifying and clarifying what is expected of
subordinates and the uniformity of the procedures to be followed and personally deciding
what and how work will be done.

4. Consideration Style – Shown by managers effort to explain their action, treat workers as
equal, listen to subordinates concern, look out for their personal welfare, give advance
notice of changes and generally, friendly and approachable.

CHARACTERISTICS OF GOOD LEADER

1. Liking for people – An important characteristic of looking for the positive side of a person.

2. Optimistic – Having a happy disposition and looking on the brighter side of things.

3. Good self-esteem – A good opinion of oneself has confidence and is self-assured.

4. Ambitious – Eager desire to succeed in order to produce good results.

5. Self-discipline – Following systematic actions and training not only oneself for improvement.

6. Good listener – Lending an ear or paying attention to subordinates about their opinion and
sentiments.

7. Poise – At ease and composed in any given situation especially during difficult circumstances.

8. Accessibility – Being open and available anytime, open-minded.

25
 9. Approachable – Easy to deal with, willing to talk to and is receptive.

10. Good sense of values – A role model to his personnel by being reliable and trustworthy.

LEADERSHIP STYLES

A hospital laboratory is essentially a system of human relationships in which the members

are united by goals and expectations. Directors and supervisors occupy positions within this network
and their patterns of influence materially affect outcome. Differences in these patterns (leadership
styles) are varied as in other professions but experience will generally identify several that prevail.

1. Decentralized Authority

It places major importance on the delegation of responsibility. Leaders who use this
style are concerned with achievement, but seek it through planned participation. They are
highly concerned with the organizational structure through which the work proceeds. The
leader points the organization’s direction, initiates movement, and provides the motivation
by which momentum is self-energized and accelerated by each of its parts. Communication is
conducted through a well-defined chain of command that encourages an exchange and
integration of ideas, but channels this input in an orderly and uniform manner.

In this style the concept of authority is vertical with positions of increasing and
decreasing accountability. A manager who uses this style attempts to influence others by
suggesting ideas and provoking thoughtful reaction. He or she sets logical and realistic goals
and seeks their accomplishment through full but structured participation. The view of those
using this style is long ranged, perhaps idealistic, and supported by a capacity to strive for
meaningful accomplishments.

2. Centralized Authority

It places little value on an orderly chain of command and condones a variety of

information sources in the name of an “open door” policy.

Managers who use this style view all authority to be concentrated at the very top.
This centralization of power controls activity and communication at the highest level and,
with descent into the lower organizational ranks, individuals are increasingly passive. This is
viewed by some as harmful on the grounds that natural human development is from
passivity to activity.

In this style singular authority is held to be of greater importance to group

achievement than the design or structure of its organization. Most workers are perceives as
having little capacity to either develop or contribute. Only one-way communication is
generated and there are sufficiently tight controls so that the resulting personnel behavior is
made to confirm the initial perception.

26
 3. Absenteeism/Inattention

In this style, the leader allows the employee to make the decision. However, the
leader is still responsible for the decisions that are made. This is used when employees are
able to analyze the situation and determine what needs to be done and how to do it. You
cannot do everything! You must set priorities and delegate certain tasks.

This is not a style to use so that you can blame others when things go wrong, rather
this is a style to be used when you have the full trust and confidence in the people below
you. Do not be afraid to use it, however, use it wisely!

RESPONSIBILITIES OF A LEADER

1. Formulates and documents policies and procedures that are constantly current and relevant
to effective pursuit of laboratory goals. A leader must create rules, regulations and
procedures in order to have an organize laboratory.

2. Effectively communicates plans to all staff/ personnel. It is very important that all members
of the organization know the different plans of the leader, and this must be effectively
disseminated to all staff.

3. Provide efficient means for assuring compliance of staff on policies and procedures. After the
policies and procedures have been formulated, it is the duty of the leader that all staff will
comply with the rules and regulations of the organization.

4. Encourage free flow and exchange of ideas through all levels of the organization. During staff
meeting, it is very necessary that a continuous exchange of concern regarding issues in the
laboratory be observe. A good leader must be able to boost the confidence of the staff to say
anything they want to say about the laboratory.

5. Assures awareness by all staff/ personnel of current trends and practices in the delivery of
hospital laboratory services. It is also the responsibility of the leader to educate each staff
members regarding the latest trends and advancement or practices in their own field.

6. 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. In order to have a
harmonious relationship to all employees, a leader must build a good relationship to all
members of the group.

LEADERSHIP METHODS

1. Develop and constantly update all laboratory procedures and policies by preparation of
appropriate manual. In order to cope-up with the advancement and changes in the practice,
a leader must be aware to update such procedures.

2. Schedule and conduct periodic meetings with staff for discussion and review of policies and
procedures and to encourage innovative thinking and improvements in service. A regular
meeting in the laboratory must be observed at all times since this would open-up the
problems or other concerns of the staff that they encountered.

3. Delegate responsibility for efficiently monitoring compliance with policies and procedures. A
good leader needs to distribute the responsibilities to other staff in order to maximize their
potentials since they might be the future leader of the organization.

27
 4. Assure awareness of the laboratory mission by requiring that appropriate personnel attend
all hospital and medical staff meeting that call for laboratory representation. It is also
important to document any meeting or activities conducted by the laboratory for this could
be one way of evaluating a staff’s dedication and commitment.

5. Fully support and generously budget for a meaningful laboratory continuing education
program. Lastly, a leader must be able to budget for the continuous learning of each staff
members that would update them on the latest trend and advancement in the field.

THE MANAGERIAL GRID

Description

The Managerial Grid model by Robert Blake and Jane Mouton is a behavioral leadership
model. On the grid, concern for production is represented on a one to nine scale on the horizontal
axis (x-axis). Concern for people is represented on a one to nine scale on the vertical axis (y-axis).
Note that according to Blake and Mouton there is also a third axis: motivation, measured from
negative (driven by fear) to positive (driven by desire).

The Managerial Grid

28
 The Managerial Grid is based on 2 behavioral dimensions:

a. Concern for People – This is the degree to which a leader considers the needs of team
members, their interests, and areas of personal development when deciding how best to
accomplish a task.

b. Concern for Production – This is the degree to which a leader emphasizes concrete
objectives, organizational efficiency and high productivity when deciding how best to
accomplish a task.

Leadership Styles

The concept distinguishes 5 different leadership styles, based on the concern for people and
the concern for production:

A. (1,1) Impoverished Style (Low Production, Low People)

Description: A delegate-and-disappear management style. A basically lazy approach.

This leader is mostly ineffective. He/she has neither a high regard for creating
systems for getting the job done, nor for creating a work environment that is satisfying and
motivating. The result is a place of disorganization, dissatisfaction and disharmony.

Characteristics: The manager shows a low concern for both people and production. He (or
she) avoids getting into trouble. His main concern is not to be held responsible for any
mistakes.

Results in: Disorganization, dissatisfaction and disharmony due to lack of effective

leadership.

B. (1,9) Country Club Style (Low Production, High People)

Description: One-sided, thoughtful attention to the needs of employees.

This style of leadership is most concerned about the needs and feelings of members
of his/her team. These people operate under the assumption that as long as team members
are happy and secure then they will work hard. What tends to result is a work environment
that is very relaxed and fun but where production suffers due to lack of direction and
control.

Characteristics: The relationship-oriented manager has a high concern for people, but a low
concern for production. He pays much attention to the security and comfort of the
employees. He hopes that this will increase performance. He is almost incapable of
employing the more punitive, coercive and legitimate powers. This inability results from fear
that using such powers could jeopardize relationships with the other team members.

Results in: A usually friendly atmosphere, but not necessarily very productive.

C. (9,1) Autocratic Style (High Production, Low People)

Description: Authoritarian or compliance leader.

This is also known as Authoritarian or Compliance Leaders. People in this category

believe that employees are simply a means to an end. Employee needs are always secondary
to the need for efficient and productive workplaces. This type of leader is very autocratic, has
strict work rules, policies, and procedures, and views punishment as the most effective
means to motivate employees.

29
 Characteristics: The task-oriented manager is autocratic, has a high concern for production,
and a low concern for people. He finds employee needs unimportant and simply a means to
an end. He provides his employees with money and expects performance back. There is little
or no allowance for cooperation or collaboration. He pressures his employees through rules
and punishments to achieve the company goals. Heavily task-oriented people are very strong
on schedules. They are intolerant of what they see as dissent (it may just be someone's
creativity).

This hard style is based on Theory X of Douglas McGregor. It is often applied by

companies on the edge of real or perceived failure, such as in Crisis Management.

Results in: Whilst high output is achievable in the short term, much will be lost through an
inevitable high labor turnover.

D. (5,5) Middle-of-the-road Style (Medium Production, Medium People)

Description: The manager tries to balance between the competing goals of the company and
the needs of the workers.

Characteristics: The manager gives some concern to both people and production, hoping to
achieve acceptable performance. He believes this is the most anyone can do.

Results in: Compromises in which neither the production nor the people needs are fully met.

E. (9,9) Team Management Style (High Production, High People)

Description: The ultimate. The manager pays high concern to both people and production.
Motivation is high.

Characteristics: This soft style is based on the propositions of Theory Y of Douglas McGregor.
The manager encourages teamwork and commitment among employees. This style
emphasizes making employees feel part of the company-family, and involving them in
understanding organizational purpose and determining production needs.

Results in: Team environment based on trust and respect, which leads to high satisfaction
and motivation and, as a result, high production.

30
 CHAPTER 5

CONTROLLING
CONTROL AND CONTROLLING

Control is the process through which standards for performance of people and processes are
set, communicated, and applied. Effective control systems use mechanisms to monitor activities and
take corrective action, if necessary.

Controlling is the final link in the functional chain of management activities and brings the
functions of management cycle full circle. This is the process of monitors standards, measurements
and feedback mechanism that were previously in place to ensure that the plans are being
implemented properly. Controlling is the process of looking back.

The supervisor role in controlling is to observe and make sure that the organization’s
performance is living up with the expectation of the management. He or she must correct below-
standard conditions and bring results up to expectations. Effective control systems allow supervisors
to know how well implementation is going. Control facilitates delegating activities to employees.
Since supervisors are ultimately held accountable for their employees' performance, timely feedback
on employee activity is necessary.

TYPES OF CONTROL

1. Pre-Action Control (Feedforward) focused on operations before they begin. This serves as
the preventive measure of the organization on its anticipated problems. An example of pre-
action control is scheduled maintenance on equipments. Regular maintenance prevents
problems.

2. Concurrent Control enacted while work is being performed which includes any type of
guiding mechanism such as direct supervision, automated systems (such as computers
programmed to inform the user when they have issued the wrong command), and
organizational quality programs.

3. Post-Action Control (Feedback) focused on the results of operations. It guides future

planning, inputs, and process designs. Examples of feedback controls include timely (weekly,
monthly, quarterly, annual) reports so that almost instantaneous adjustments can be made.

Designing Effective Control Systems

1. Control at all levels in the business – The control should be the same for the entire
organization.
2. Acceptability to those who will enforce decisions – It should be acceptable to all the person
who formulate it because they would be the first person to go with the standards
3. Flexibility – It should be easy to modify.
4. Accuracy – It should be well written and very specific to avoid confusion.
5. Timeliness - Always updated.
6. Cost effectiveness – Doing the control should not e too costly.
7. Understandability – well written and easy to comprehend.
8. Balance between objectivity and subjectivity – It should rule out bias.
9. Coordinated with planning, organizing and leading – The control must be aligned with the
other functions of management

31
CHARACTERISTICS OF EFFECTIVE CONTROLS

What should a control system be? When are we going to consider it effective?

1. Effective – it must be designed properly. Controlling leads to identification of new problems

that in turn need to be addressed through establishment of performance standards,
measuring performance etc.
2. Realistic – It must prevent, not cause, the problem. When performance variance is
unrealistic, natural response for employees whose performance falls short is to blame the
standard or the supervisor. If the standard is appropriate, then it’s the supervisor call to
stand his or her ground and take the necessary corrective action
3. Flexible – It should be very strategic and maintain the focus of the employees to the goal of
the organization. Supervisors help employees achieve objectives on a daily basis.

CHARACTERISTICS OF THE CONTROL PROCESS

The control process should be:

1. Cyclical - which means it is never finished.

2. Anticipatory and Retrospective - The process anticipates problems and takes preventive
action. With corrective action, the process also follows up on problems. Employees often
view controlling negatively. By its very nature, controlling often leads to management
expecting employee behavior to change. No matter how positive the changes may be for the
organization, employees may still view them negatively.

Ideally, each person in the business views control as his or her responsibility. The
organizational culture should prevent a person walking away from a small, easily solvable problem
because "that isn't my responsibility." In customer driven businesses, each employee cares about
each customer. In quality driven dairy farms, for example, each employee cares about the welfare of
each animal and the wear and tear on each piece of equipment.

Controlling is related to each of the other functions of management. Controlling builds on

planning, organizing and leading.

MANAGING CONTROL STRATEGIES

Managers can use one or a combination of three control strategies or styles: market,
bureaucracy and clan. Each serves a different purpose. External forces make up market control.
Without external forces to bring about needed control, managers can turn to internal bureaucratic or
clan control. The first relies primarily on budgets and rules. The second relies on employees wanting
to satisfy their social needs through feeling a valued part of the business.

Self-control, sometimes called adhocracy control, is complementary to market, bureaucratic

and clan control. By training and encouraging individuals to take initiative in addressing problems on
their own, there can be a resulting sense of individual empowerment. This empowerment plays out as
self-control. The self-control then benefits the organization and increases the sense of worth to the
business in the individual.

32
FOUR STEPS OF CONTROL PROCESS

The control process is a continuous flow between measuring, comparing and action.

1st: Establish Performance Standards. When objectives are set during the planning process, standards
were being created. These standards would serve as guidelines for the organization and the basis for
measurement. It is precise, specific statement of the expected result of a product, service, machine,
individual, or organizational unit. It is usually expressed numerically and is set for quality, quantity,
and time. Tolerance is permissible deviation from the standard and these tolerance levels should also
be known.

Time controls are focused on deadlines, time constraints and the just-in-time (JIT) system.
This is may simply be submitting report on time. Communication, coordination, and
cooperation are essential for supervisors and employees to deliver the smallest possible
quantities at the latest possible date at all stages of the transformation process in order to
minimize inventory costs.

Financial control facilitates in achieving the organization's profit motive. Methods of

financial controls are budgets and cost. Budgets identify quantity of materials used and units
to be produced. It allocates resources to important activities and provides supervisors with
quantitative standards against which to compare resource consumption. They become
control tools by pointing out deviations between the standard and actual consumption. Cost
control which helps ensure cost standards are met

Operations control assesses how efficiently and effectively an organization's transformation

processes create goods and services. Methods of transformation controls include Total
Quality Management (TQM), statistical process control and the inventory management
control. Statistical process control is the use of statistical methods and procedures to
determine whether production operations are being performed correctly, to detect any
deviations, and to find and eliminate their causes.

A control chart displays the results of measurements over time and provides a visual means
of determining whether a specific process is staying within predefined limits. As long as the
process variables fall within the acceptable range, the system is in control. Measurements
outside the limits are unacceptable or out of control. Improvements in quality eliminate
common causes of variation by adjusting the system or redesigning the system. Equipment
controls are built into the machinery, imposed on the operator to protect the equipment or
the process.

Material control relate to inventory and material-yield controls. Inventory is a large cost for
many organizations. The appropriate amount to order and how often to order impact the
firm's bottom line. The economic order quantity model (EOQ) is a mathematical model for
deriving the optimal purchase quantity. The EOQ model seeks to minimize total carrying and
ordering costs by balancing purchase costs, ordering costs, carrying costs and stockout costs.
In order to compute the economic order quantity, the supervisor needs the following
information: forecasted demand during a period, cost of placing the order, that value of the
purchase price, and the carrying cost for maintaining the total inventory.

Employee performance controls focus on actions and behaviors of individuals and groups of
employees. Examples include absences, tardiness, accidents, quality and quantity of work.

2nd: Measure Actual Performance. Supervisors collect data to measure actual performance to
determine variation from standard. Written data might include time cards, production tallies,
inspection reports, and sales tickets. Personal observation, statistical reports, oral reports and written
reports can be used to measure performance. Management by walking around, or observation of
employees working, provides unfiltered information, extensive coverage, and the ability to read

33
between the lines. While providing insight, this method might be misinterpreted by employees as
mistrust. Oral reports allow for fast and extensive feedback.

Computers give supervisors direct access to real time, unaltered data, and information. On
line systems enable supervisors to identify problems as they occur. Database programs allow
supervisors to query, spend less time gathering facts, and be less dependent on other people.
Supervisors have access to information at their fingertips. Employees can supply progress reports
through the use of networks and electronic mail. Statistical reports are easy to visualize and effective
at demonstrating relationships. Written reports provide comprehensive feedback that can be easily
filed and referenced. Computers are important tools for measuring performance. In fact, many
operating processes depend on automatic or computer-driven control systems. Impersonal
measurements can count, time, and record employee performance.

3rd: Compare Measured Performance Against Established Standards. Comparison of results against
standards determines variation. Some variation can be expected in all activities and the range of
variation - the acceptable variance - has to be established. Management by exceptions let the
operation continue as long as they fall within the standards. Differences that exceed this range would
alert the supervisor that there is a problem.

4th: Take Corrective Actions. After the identification of the problem, the supervisor must find out the
cause of deviation from standard. He must takes action to remove or minimize the cause. If the
source of variation in work performance is from a deficit in activity, then a supervisor can take
immediate corrective action and get performance back on track. Also, the supervisors can opt to take
basic corrective action, which would determine how and why performance has deviated and correct
the source of the deviation. Immediate corrective action is more efficient; however basic corrective
action is the more effective.

THE COACHING PROCESS

1. Prepare the learner. Explain to the learner what to do. Learner’s fear of change or to appear
incompetent would be barriers to effective coaching and that would make him defensive.
The supervisor could make him relax by empathizing with him. Find out what the he already
knows then proceed from the familiar to the unfamiliar.

2. Demonstrate the operation. Demonstrate how it is done. Explain exactly what is being done
by demonstration, moving from simplest to the most complex. Give him the opportunity to
ask questions for it is also a sign if he understood what you have thought him. Explain the
importance of what he is doing and the overall operation.

3. Create a positive atmosphere. Give him positive aura and be patient with him.

4. Have the learner perform the operation. Let him participate. Active participation is essential
for instilling long-term learning.

5. Follow-up. Evaluate learning. Check up his progress; make yourself available to answer
questions

DYSFUNCTIONAL CONSEQUENCES OF CONTROL

Managers expect people in an organization to change their behavior in response to control.

However, employee resistance can easily make control efforts dysfunctional. The following behaviors
demonstrate means by which the manager's control efforts can be frustrated:

1. Game playing  control is something to be beaten, a game between the "boss and me, and
I want to win."

34
2. Resisting control  a "blue flu" reaction to too much control.

3. Providing inaccurate information  a lack of understanding of why the information is

needed and important leading to "you want numbers, we will give you numbers."

4. Following rules to the letter  people following dumb and unprofitable rules in reaction to
"do as I say."

5. Sabotaging  stealing, discrediting other workers, chasing customers away, gossiping about
the firm to people in the community.

6. Playing one manager off against another  exploiting lack of communication among
managers, asking a second manager if don't like the answer from the first manager.

35
 CHAPTER 6

INFORMATION MANAGEMENT

DEFINITION

Information Management is the collection and management of information from one or

more sources and the distribution of that information to one or more audiences. This sometimes
involves those who have a stake in, or a right to that information. Information management entails
organizing, retrieving, acquiring and maintaining information management concepts. Information as
a concept has a diversity of meanings, from every day usage to technical setting. Generally speaking,
the concept of information is closely related to notions of constraint, communication, control, data,
form, instruction, knowledge, meaning, mental stimulus, pattern, perception and representation.

Communication is a process of transferring information from a sender to a receiver with the

use of a medium in which the communicated information is understood by both sender and receiver.
Communication requires that all parties understood a common language that is exchanged. There are
auditory means, such as speaking, singing and sometimes tone of voice, and nonverbal, physical
means, such as body language, sign language, paralanguage, touch, eye contact, or the use of writing.

Communication happens in many levels (even for one single action), in many ways, and for
most beings, as well as certain machines. Nonetheless, communication is usually described along a
few major dimensions: Content (what type of things are communicated), source, emisor, sender or
encoder (by whom), form (in which form), channel (through which medium), destination, receiver
target or decoder (to whom), and the purpose or pragmatic aspect.

ELEMENTS OF COMMUNICATION

The elements of communication are the sender, the messages, and the recipient

A. Sender – Originates and sends the message. Since the sender is the one who originates the
message it is their responsibility to make sure their message was perceived in the way they
attended.

Example of a sender could be when a boss sends a memo to an employee; (the

sender would be the boss)

B. Message – Words and/or nonverbal expressions that transmit meaning.

2 Types of Messages:
a. Nonverbal – Messages include images, actions and behaviors used to communicate.
b. Verbal – Also known as spoken communication. Includes informal staff meetings,
planned conferences, and mass meetings.

C. Receiver – The ultimate destination of the sender’s message.

Example: When a supervisor sends a memo to an employee, the employee would be the
receiver.

36
WAYS OF COMMUNICATION

1. Formal Communication – Typically aligned according to the organizational chart or structure

of the facility usually follows an organizational hierarchy. Typically strict lines of authority are
followed.

2. Informal Communication – The main type is the grape-vine, which is the route by which
employees spread information to one another. Even if the organization has well established
formal channels, informal channels inevitably develop. The manager should accept the fact
that it is impossible to get rid of the grapevine, but with certain skills, a manager can
influence it.

3. Oral Communication – This type of communication is useful in direct person to person

communication and group communication. The most important feature of oral
communication is that it provides immediate feedback, in that allows the receiver to ask
question. This type of communication has some disadvantages. Since nothing is written
down, permanence is lost, so the receiver cannot revisit the actual words used. Other
potential pitfalls include mumbling, speaking too fast or too slowly, mispronouncing words,
speaking in monotone, and using distracting sounds or words.

Telephone Communication – The telephone is one of the major ways people use to
communicate at work. Because of this, it is important to be aware how colleagues
and customers perceive the caller. Courtesy ranks highest on the telephone
etiquette list. The caller should state his or her name and verify the identity of the
person on the other end of the line. It is important for the caller to be personable.
This develops rapport and trust to those on receiving end.

4. Written Communication – This provides permanent record to which the receiver can refer to
ensure that he has understood the information presented. It provides accuracy of
information as well as permanence. However, feedback is limited, and the sender cannot be
sure that a written message is actually read. The important ingredients of effective writing
are content, style, technique and format.

Electronic Communication – Electronic communication, specifically e-mail, is being

used more and more in the workplace. This type of communication, with the
casualness of speech but without inflections or context, still looks like written
communication on the screen.

5. Visual Communication – Photographs, paintings, diagrams, designs, cartoons and caricatures

are example of types of pictures used as visual communication aid. They are important to
communication because they are easier to understand than written explanations.

THE TEN COMMANDMENTS OF HUMAN RELATIONS

1. Speak to people – There is nothing as nice as a cheerful word of greeting.

2. Smile at people – It takes 72 muscles to frown, only 14 to smile

3. Call people by their first name – The sweetest music to anyone’s ear is the sound of his own
name

4. Be friendly and helpful – If you want friends, you must be one.

5. Be cordial – Speak and act as if everything you do is a joy to you.

6. Be genuinely interested in people – You can like almost everybody if you try.

37
 7. Be generous with praise – And be cautious with criticisms.

8. Be considerate with the feelings of others – There are usually three sides of controversy:
Yours, the fellow’s and the right side.

9. Be eager to lend a helping hand – Often it is appreciated more than you know.

10. Add to this: a good sense of humor, a huge dose of patience and a dash of humility. This
combination will open many doors and the reward will be enormous.

INTRADEPARTMENTAL AND INTERDEPARTMENTAL COMMUNICATION

1. Intradepartmental Communication

Laboratory managers must encourage routine exchange of thoughts and messages

between the laboratory departments, management and staff, and different shifts. The
laboratory’s organizational structure is based on the disciplines of pathology and laboratory
science and is not always conducive to an open flow of information.

Without good internal communication, the potential for error increases. Written
intradepartmental communication is very effective because there is documentation that
occurred and it can reach every shift and all staff, whether they are present on the day it was
issued or not. However, communication should not be exclusively sin the written form.
Meetings, informal chats, and impromptu announcements allow the staff to ask question
and exchange ideas immediately. This active communication can improve staff morale, as
personnel now that they are being heard.

2. Interdepartmental Communication

The flow of communication beyond the laboratory includes that between the
laboratory and the institution’s administration. Written interdepartmental communication
tends to be more formal than intradepartmental and needs to be structured.

Memos, letters and notices are adequate forms of communication for most
announcements and responses to inquiries from other department of the institution.
However, when laboratory management wants to start new service, change protocols,
acquire instrumentation, or reorganize any part of the business, they should communicate
through formal proposals.

TYPES OF LABORATORY COMMUNICATION

1. Intralaboratory Communication

a. Policy Manual

All laboratories should have administrative policy manuals which state the
laboratory and institutional policy for the guidance of those working in the
laboratory. The policy should reflect the philosophy and over all goals of the larger
organizations as well as those of the laboratory. They should be written in
consultation with the persons involved and reviewed by the appropriate persons
and the institution, to be certain they are consistent on the institutional policy. Like
the laboratory procedures manual, policy should be dated and approved by the
laboratory director.

38
 At laboratory level, the policy manual refers to topics that may have
particular relevance to the area, as well as contain specific departmental policies
such as the following:

 Dress Code
 Food and smoking rules
 Telephone use
 Laboratory organizations and reporting relationship
 Writing, review and authorization of procedures
 Vacation and holiday request
 Supply requisition
 Absence and late – arrival notification
 Reporting and releasing of test results
 Specific statements about enforcement of safety rules

b. Procedure Manual

Quality Control Systems for laboratories should be designed to assure the

medical reliability of the laboratory data. All laboratory methods in current use must
be recorded in notebooks, card, files or set of flow charts available at all times in the
immediate bench area where the test are performed. Each method description
must be complete, including reagent brands, source and content of standards,
calibration procedures or special precautions, anticipated reactions and pertinent
literature references. Each method must be dated and initialled by the head or
responsible supervisor, initially or at least annually.

Often are referred to as SOP, a term adopted from a military, meaning

“standard operating procedure.” Technical Manuals that contain procedure for
performing tests, operating instrument, or processing quality control information
are example of procedure manuals found in the laboratory.

c. Other Internal Manual

 Administrative Manual - The Administrative Manual is intended to

provide working guidelines and descriptions policies and benefits
as they relate to members of the administration.

 Safety Manual - provide users with information designed to

ensure health and safety in laboratories.

 Quality Management Manual - it documents an organization's

quality
management system

d. Continuing In-Service Education

Because rapidly changing nature of laboratory Medicine, it is also desirable

to have regular continuing education sessions for laboratory staff.

e. Intralaboratory staff meetings

This is a typical meeting within the member of one department. Example is

an informal monthly meeting between the chief medical technologist and the
medical technologist staffs.

39
 2. Extralaboratory Communications

a. Manual procedures and collection instructions

The laboratory must maintain a complete detailed book of instructions

covering the ordering tests, precautions for special procedure, the proper method for
preservation of specimens and pertinent standard procedures of the laboratory. The
procedures used for collection of all specimens, and pertinent standard procedures,
identification, storage and the preservation must be clearly described in writing and
available to those collecting specimens. All procedures shall be such as to insure
satisfactory specimens for procedures to be performed.

b. Laboratory User’s Manual

This is particularly useful in teaching institution where there is a large and

frequently changing group of attending physicians, house officers and students who
need ready access to information about laboratory services.

c. Laboratory Bulletins

Periodic laboratory bulletins, newsletter or measurements of the month,

circulated to the medical staff, are useful means of communicating information about
new laboratory services or policies. These are generally most effective when a standard
format has been devised and when they are issued on a regular basis.

d. Other Extra Laboratory Communications

One of the most functions of laboratory Directors is to be available and

responsive to written or verbal communication from the Clinician users of the
laboratory. It is by extra laboratory communications that the laboratory staff becomes
aware of its failure of success in the meeting the needs of users.

The laboratory head can also promote this sort of exchange by regular
attendance at general medical staff meetings as well as specialty service meetings, by
eating in the doctor’s dining room and by occasionally joining physicians in the operating
room of medical staff lounges for an informal conversation. Proper orientation of other
hospital staff such as the nurses must be carried out to minimize misunderstanding.

CATEGORIES OF COMMUNICATION

1. Downward Communication

This is commonly referred to as flowing from the top to down. It is primarily

directive in nature and often used extensively by management state objectives, disseminate
policies or policy changes, provide directives, and convey general information to
subordinates. One pitfalls of downward communication is the possibility of dilution or
distortion of information that can occur between the original sender and the ultimate
receiver, which may cause the message to be misinterpreted or inaccurate. This is especially
true with oral communication when a large number of people are involved, because the
more people involved in the downward chain, the greater the chance of error. In supervision,
the downward flow is relied upon very heavily for disseminating information.

40
 2. Upward Communication

Upward communication flows through the ranks of staff members to top

management. Generally, upward communication is used to report and convey information.
Effective managers encourage a free flow of upward communication as a feedback
mechanism. This type of communication can serve as a means to determine whether a
message has been transmitted and received appropriately and often conveys to
management the effects of a message on staff. A manager should encourage upward
communication by demonstrating a desire to obtain and use the ideas and information
received from one’s staff. The manager must also act on information provided by the staff;
otherwise this channel of communication will eventually close. Lack of an effective upward
flow will destroy the staff’s desire to communicate, lead to frustration and eventually cause
employees to seek different outlets, such as the grapevine or ultimately find other
employment opportunities.

3. Same-level/Lateral Communication

This flows among persons on the same level in an organization. It is important

because it allows for the exchange of information among people with similar responsibilities
working on common objectives and fosters intralabortory and interdisciplinary
communication.

REQUISITIONING

Proper requisition assure adequate identification of the patient and specimen, indicate the
measurements for the examination desired. An additional important function is the provision of
administrative and billing data.

All requests for clinical laboratory tests must be made in writing. A time stamp should be
used to establish the data and hour the request was received by the laboratory. These request and
reports shall identify the patient with certainty. Minimum identification data shall include at least the
following:

 Full name of the patient

 Hospital Number (name of ward)
 Room number, bed number
 Age
 Sex
 Attending physician

Requisition should clearly specify the test to be performed and the kind of service required
(routine or stat). The time of collection should also be indicated.

A record book should be maintained for the daily accession of specimen, each of which
should be numbered or otherwise appropriate identified. This record should contain at least the
following information.

 Laboratory procedure
 Identification of the patient
 Name of the physician
 Date and time the specimen was collected
 Date and time the specimen was received
 Date, time and by whom the specimen was examined
 Condition of any unsatisfactory specimen

41
  Types of test or procedure performed
 Results and date of reporting

The format of laboratory requisition will vary considerably from hospital to hospital,
although all have basic similarity. Although many sizes have been used in the past, most requisitions
today are either the size of a computer card or the medical record size (9 x ½ by 11 inches or 21.5 by
28 cm). The larger the medical record can be used both for the physician’s order and the requisition,
thus preventing transcription errors in ordering. The original is sent to the laboratory as a requisition
and the second copy is left in the chart as a record of the order. In general, these type of requisitions
are used with computerized systems where reports wick be given in other forms. Such requisition,
however can serve as a manual back-up report for an automated reporting system.

In order to facilitate the use of the requisition by nursing, clerical and laboratory personnel,
the design should be such that each requisition has specific areas for the following type of
information.

REPORTS

The laboratory head is responsible for all laboratory reports and that the authenticated and
dated reports of clinical pathology test should be filed promptly with the patient’s record and
duplicated copies kept in the laboratory.

Each report should be time stamped to record the date and hour the procedure was
completed. Each request and report should identify the patient with certainty, whenever feasible
reports should all be signed and initialled by the Medical Technologist responsible for performing the
procedure or by the Pathologist.

General Qualities of a Laboratory Report:

1. Compactness
2. Consistency of terminology, format and usage or understandability
3. Clear and easy to understand
4. Logical and accessible location on medical chart
5. Statement of date and time of collection
6. Gross description and source of specimen when pertinent
7. Sharp differentiation of reference or normal or abnormal values
8. Sequential order of multiple results in a single specimen
9. Identification of patient, patient location and physician
10. Assurance of accuracy or transcription of request.

Verbal reports

Verbal Reports constitute a major problem for most laboratories. It is essential that verbal or
telephone reports must be given in order to facilitate medical care, particularly in an emergency
situation. On the other hand, this is a major potential source of error and medical liability.

At a minimum, the laboratory should require proper identification of the person receiving
the report. The person giving the report should repeat the patient’s name, identification number and
location along with the results in order to further confirm the identification.

RECORDS

The need for complete and accurate recording of data has never been more important.
Below are the list of the minimum required time for laboratory data, materials and record to be
retained.

42
Material / Record Period of Retention

General Lab
Accession Log records 2 years
Maintenance/instrument maintenance 2 years
Quality control records 2 years

Surgical Pathology (including bone marrow)

Wet Tissue 2 weeks after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years

Cytology
Slides (negative-unsatisfactory) 5 years
Slides (suspicious-positive) 5 years
Fine needle aspiration slides 10 years
Reports 10 years

Non-forensic Autopsy Records

Wet tissues 3 months after final report
Paraffin blocks 10 years
Slides 10 years
Reports 10 years

Forensic Autopsy Records

Wet stock tissue 3 years
Paraffin Blocks indefinitely
Reports indefinitely
Slides indefinitely
Gross Photograph/negatives indefinitely
Accession log records indefinitely
Body fluids and tissue for toxicology 1 year
Dried blood stain or frozen tissue for DNA indefinitely

Clinical Pathology Records

Patient Test records 2 years
Serum/CSF/Body fluids (except urine) 48 hours
Urine 24 hours
Peripheral Smear/Body fluids smear 7 days
Permanently stained Slides-microbiology (gram, trichome, etc.) 7 days

Cytogenetic Records
Slides 3 years
Wet Specimen/tissues until adequate metaphase cells are obtained
Final reports 20 years
Diagnostic images (digitized or negative) 20 years

Blood Bank
Donor 10 years
Patient’s Record 10 years
Records of employee’s signature, initials and identification code 10 years
Quality Control Records 5 years
Records of indefinitely deferred donors, indefinitely
Permanently deferred donors, or donors indefinitely
Surveillance for the recipient’s protection

43
(e.g. Those that hepatitis B positive) indefinitely
Specimens from blood donors unit and recipient 7 days post-transfusion

COMMUNICATION CYCLE IN THE LABORATORY

Communications, both written and verbal, are a major component of all medical care. The
first step in the cycle of physician-laboratory communications is the encounter between the patient
and the physician, resulting in a decision on the part of the physician that a laboratory examination or
measurement is necessary to assist in making a specific diagnosis, in providing a prognostic judgment,
or in monitoring the results of therapy. The physician’s decision is translated into a written order,
which in turn is recorded, usually by a physician, nurse or clerk, through a written laboratory
measurement or examinations. The requisition includes requested determinations as well as basic
information about the patient derived from admission. It may be accompanied by a specimen
collected by the nurse or it is indicated that specimen collection will be done by the medical
technologist.

When both the completed requisition in the appropriately labelled specimen are available in
the laboratory, the requested, measurement and/or examinations are performed, the resulting data
are processed and checked for validity and a report is returned to the physician.

Interpretation of results Action

Clinical Question

Reporting of results
Test Selection

Report Review Total

Testing Test Ordering
Process
Analysis

Patient identification

Specimen Processing

Specimen Collection
Specimen Preparation

Transportation

This figure shows the total testing process.

LABORATORY INFORMATION SYSTEM

Laboratories have become information brokers that provide the majority of the clinical
information used by healthcare providers in disease management. In order to create value, the results
must be timely and accurate. During the past decade, proficiency testing, continuing-education
programs, oversight by accrediting and regulatory agencies, and more sophisticated instrumentation
where the change drivers that forced laboratories to exceed standards for reproducibility and
technical accuracy of the past.

44
 A laboratory information system (LIS) consists of one or more servers that provide the
services in the laboratory. Laboratory users of the LIS access information via workstation or “dumb
terminals” equipped with monitors and one or more data entry devices. Workstations are usually
personal computers or running software applications other than LIS. Dumb Terminals are devices that
generally consist of a monitor and a keyboard, and they serve solely as a client of the LIS servers.

The LIS enhances the utilization of laboratory services by patient care providers and assists in
the “back-office” management of testing. Ordering of test is often performed in an information
system other than the LIS and should be streamlined by logically organized, online test menus that
offer ready access to information concerning specimen requirements. The test results should be
available in the results viewing system immediately upon the completion of test. The test reports may
be printed on paper or delivered electronically to patient care personnel by fax, email or video
monitor display. Interpretive comments can be attached to reports to assist clinicians in
understanding their significance. Automatic billing for laboratory services can be triggered by
transactions sent across the billing interface from the LIS to the financial information system.

Long Term storage and retrieval of laboratory data can be easily accommodated by suitably
configured LIS.

45
 CHAPTER 7

QUALITY MANAGEMENT

Quality management is a method for ensuring that all the activities necessary to design,
develop and implement a product or service are effective and efficient with respect to the system and
its performance. Quality management can be considered to have four main components: quality
planning, quality control, quality assurance and quality improvement.It focused not only on product
quality, but also the means to achieve it, therefore uses quality assurance and control of processes as
well as products to achieve more consistent quality. Quality Management is all activities of the overall
management function that determine the quality management terms.

Quality Control (QC) refers to standards and techniques that measure the quality of the
product in isolation from the needs of the costumer or patient. This relies heavily on quantitative
statistical methods that focus on the final product as defined by the standards set by the producer.
This also refers to specific activities directed toward monitoring the individual elements of care. (e.g.
elements and test procedures). Effort is on going to maintain the integrity of a process to maintain
the reliability of achieving an outcome.

The strength in the QC approach to quality management is that precise performance

standard can be established and measured with objective analytic tool. The weaknesses in QC system
lie in it emphasize on the evaluation of the final product; which often make troubleshooting difficult.
Also, QC relies on the standard and technique that measure the quality of the product in isolation
from the needs of the patient.

Example: If the laboratory tests fall within the acceptable QC ranges established for the items
(QC model), the technologists are secured that they are turning out a high- quality result.

QUALITY CONTROL PROGRAMS

Quality control programs have been an integral part of the inspection systems by the Bureau
of Health Facilities and Services, Department of Health. The supervising pathologists should insure
that the Quality Control program is organized for periodic review or every major portion of the
Clinical Laboratories and that the program can be documented for the inspector. The ability to prove
that the various laboratory tests are accurate and that they have been repeatedly checked is a stout
defensive tool in a lawsuit. Log books demonstrating the efficiency of the quality control program
should be stored indefinitely.

Quality Assurance (QA) is the planned or systematic actions necessary to provide enough
confidence that a product or service will satisfy the given requirements for quality. Overall activities
conducted by the Institution that are directed toward assuring the quality of services provided. QA is
focused on the recipient which is the patient and on monitoring of outcomes or indicators of care. QA
is associated with external activities that ensure positive patient outcome. QA developed out of the
limitation of the QC approach and defined quality in health care institution by the success of the total
organization, not just individual component of the system, in achieving goal of patient care. QA is
focused on the recipient, namely, the patient. Risk management, in service and continuing education,
safety program, quality control, and peer review were all part of quality assurance program.

Quality Assessment and Improvement is the purposeful change of a process to improve the
reliability of achieving an outcome. This is a quality management program that focuses on the success
of the organization in designing and achieving its set of goals and objectives.

46
DIVISION OF LABORATORY PRACTICE IN QUALITY CONTROL

A. Preventive Procedures – pre-analytic activities that are intended to establish a system which
leans towards providing accuracy. These preventive measures include performance checks
and calibration of equipment, examination of user prepared and commercially prepared
media and orientation and training of laboratory staff.

B. Assessment Practices- analytic activities that are done during the test to determine whether
the established systems are performing correctly. The use of standards and controls, as well
as control chart maintenance is included in the assessment practices.

C. Corrective Practices- post analytic activities to determine error and possible sources of error
to be able to correct the established system. Activities in the corrective practices include
troubleshooting of equipment used, recalibration of instruments, retraining of staff and etc.

CONTROL OF TESTS

1. Precision – Is the reproducibility of the test then it is repeated several times. It can be
assessed intralaboratory (within the same laboratory) and interlaboratory (between different
laboratories). Precision does not imply accuracy. It is determined by how well a procedure
reproduces a value.

2. Accuracy (efficiency) – the ability of the test under study to match the results of a standard
test commonly known as the “gold standard” it refers to the closeness of a result to the
actual value of an analyze when performing a test, more commonly called “hitting the bull's
eye.

3. Sensitivity – Is the percentage of individuals with the particular disease for which the test is
used in whom positive results are found.

4. Specificity – Is the percentage of individuals who do not have the particular disease being
te8ted and whom negative results are found.

CONTROL OF SPECIMENS

The laboratory is responsible for providing information for the proper collection and
transport of specimens. These instructions should be available to the hospital staff for use when
specimens are collected. The written collection instructions should include:

 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 (on site or sent to a reference laboratory
 Hours test performed (daily or batch), turn- around- time
 Result reporting procedures

The collection instructions should include information on whom the requisition should be
filled out, and the lab must include a statement indicating that the requisition must be filled out
entirely. In addition to standard information, such as the patient name, hospital or lab identification

47
number and ordering physician, there should also be established criteria on unacceptable specimens.
A waiver or a disclaimer should be included in the lab report if an unacceptable specimen is processed
as approved by the patient’s physician.

CONTROL OF REAGENTS AND SUPPLIES

Laboratories should purchase reagents and supplies from reliable sources. Containers of
reagents should be labelled as to contents, concentration, date opened, expiration date, source, lot
number, and storage requirements. All supplies and reagents should be stored according to
manufacturer’s recommendations and tested with positive and negative controls before use. There
should be no incidence of lack of supplies for the lab tests offered and the first in first out must
always be followed. Outdated supplies and reagents that failed QC should be discarded immediately.
A good inventory system is necessary to determine the high and low limits of the reagents and
supplies needed for the operation of the clinical laboratory taking into consideration the following
factors: delivery time, available storage pace, the shelf life and rate of usage for each item.

CONTROL OF STAFF

Appropriately trained and experienced personnel are essential for the performance of
quality laboratory testing. All employees should know what they are supposed to do, and every
laboratory should have written job descriptions to provide to them. Standards of performance should
be developed so that the employee knows how he or she will be judged when rated on job
performance.

CONTROL OF EQUIPMENT

Performance checks should be done periodically to avoid major variations in the

performance of lab equipment. Equipment and instrument logs should contain the following
information:

 Equipment or instrument name; serial number, and date

 Procedure and periodicity (daily, weekly, monthly, quarterly) for routine function checks
 Acceptable performance ranges
 Instrument function failures, including specific details of steps taken for corrective action
 Date and time of service request and response
 Date of routine preventive maintenance which should follow manufacturer’s
recommendations

Maintenance records should be retained in the laboratory for the life of the equipment.

NON-ANALYTIC QUALITY CONTROL FACTORS

A. Physician’s order or request – An order form that is sent to the lab with the specimen that
contains laboratory test request and patient demographic information. If the hospital
information system is equipped with computerized order entry, the request is transported to
the laboratory electronically.

B. Request Specifications

Time Specifications:
a. Routine- test results or response are given within 24 hours, but it may take longer
for culture procedures.

48
 b. Today- test results are within a specified period of time (8 hours)
c. STAT- response is as soon as possible (ASAP), preferably within 10 minutes and no
delay in test performance.
d. Specific time- time designated (24 hour urine collection, acute phase of illness, night
/daytime/early morning specimen collection.)

C. Worksheet/Work Card – Is a legal document that can be used to reconstruct the testing
process. The record of the work performed on a specimen may be hand written on the back
of the lab requisition or on a work card designed specifically for this purpose. The
technologist can record the details of the specimen work up electronically, directly into a
computer for a paperless work card.

D. Patient Identification – It’s customary to attach an identification band to a patient. Each

matching of patient information on the request with that on the band should be done. Using
barcodes like for example in a supermarket are now often used in patient’s bands and
scanned bedside to match the sticker identification of the specimen collected. This practice
minimizes the chance of having unlabeled or mislabelled specimens.

E. Sample Reassignment – A laboratory should use only accredited or licensed reference

laboratories hen reassigning samples. The referral laboratory’s name, address and license
numbers should be included in the patient’s final report.

F. Distribution of Test Result – The laboratory should established a system for supervisory
review of all laboratory reports and involve checking of specimen workup to verify that
correct conclusions were drawn and no clerical errors were made in reporting results.

QUALITY CONTROL CHARTS

These charts assist in monitoring avoidable and unavoidable error. It is important in

identifying sporadic errors that are generally caused by the analyst. Control values falling out of
acceptable range are rejected as avoidable errors that must be identified and corrected. All unknown
tests belonging to this batch are repeated. In the absence of avoidable error, 95% of analysis should
be within control values.

PROFICIENCY TESTING

All analytical laboratories should operate a quality assurance system which includes internal
quality control procedures, participation in proficiency testing schemes, use of reference standards
and certification/accreditation to a recognized standard such as ISO 9001 or BS EN ISO/IEC 17025. Of
these approaches, only proficiency testing schemes or the use of certified reference materials can
establish the bias and accuracy of the results. Proficiency testing schemes operate by providing
participating laboratories with samples containing specified material but the actual quantity of the
substance is known only to the organizers. The laboratory analyses the samples, preferably as part of
their normal routine, and reports the results to the scheme organizers. The laboratory is then
provided with a report showing how closely their results agree with the accepted value, and where
necessary, can then take appropriate action to improve performance.

Regular participation in a proficiency-testing scheme provides independent verification of

the analytical competence of a laboratory and shows a commitment to the maintenance and
improvement of performance. The cost of participation in a proficiency testing scheme gives good
value for money compared with the consequences of producing inaccurate results which might put
workers' health at risk, damage a company's reputation or contravene national regulations. Those
who make use of analytical laboratories should ensure that the laboratory operates a quality
assurance system which includes participation in a proficiency testing scheme where possible.
Prospective customers should ask to see results from a laboratory's participation in proficiency testing

49
schemes and satisfy themselves that the laboratory is able to obtain a consistent level of satisfactory
performance over a period of time.

Because “International Organization for Standardization” would have different languages

(“IOS” in English, “ION” in French for Organisation Internationale de Normalization), its founders
decided to give it also a short, all-purpose name. They chose “ISO”, derived from the Greek isos,
meaning “equal” and the organization responsible for thousands which benefit the world is ISO.

Benefits of ISO Standards:

a. Make the development, manufacturing and supply of products and services more efficient,
safer and cleaner.
b. Provide governments with technical base health, safety and environmental legislation, and
conformity assessment.
c. Share technological advances and good management practice
d. Safeguard consumers, and users in general, of products and services
e. Standards establishing an international consensus on terminology make technology transfer
easier and safer. They are an important stage in the advancement of new technologies and
dissemination of innovation.
f. Standardization of performance or safety requirements of diverse equipment makes sure
that users’ needs are met while allowing individual manufacturers the freedom to design
their own solution on how to meet those needs.
g. Standardized computer protocols allow products from different vendors to “talk” to each
other.
h. Standardized documents speed up the transit of goods, or sensitive or dangerous cargoes
that may be handled by people speaking different languages.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

1. Manage Quality Management System Documents – develop documents for your

organization’s QMS.

2. Prepare Quality Management System Manual – maintain and establish a quality manual for
organization

3. Control and Establish Quality Management System Records

4. Support your Quality Policy

- ensure that your organization’s quality policy serves its overall purpose and supports the
organizations quality objectives
- plan the continual improvement of Quality Management System

5. Control Monitoring and Measuring Quality

- Identify organization’s monitoring and measuring needs and requirements
- Collaborate the monitoring and measuring of equipment whenever necessary to ensure
that results are valid.
- Evaluate the validity of previous measurements whenever you discover that your
measuring or monitoring equipment is out of calibration.

50
 CHAPTER 8

EQUIPMENT AND SUPPLIES MANAGEMENT

Equipment and Supplies Management is the management of the physical resources. Clinical
laboratories, as a business, require raw materials for successful operation. Whereas, equipment idled
by breakdowns or lack of supplies is an economic loss for business. The same situation in the clinical
laboratory can seriously interfere with the delivery of patient care.

Responsible people must decide what supplies they need, when they need them and in what
quantities. Much time can be wasted in the purchasing procedure unless a workable procurement
system is developed. In larger medical centers, the purchasing process may involve many people an
elaborate system for obtaining bids for quantity buying. In contrast, in the physicians, office
laboratory, the entire process may be handled by a technologist dealing directly with the company’s
representatives.

PURCHASING

Purchasing describes the process of buying, learning of the need, selecting a supplier,
negotiating prices and other pertinent terms and following up to ensure delivery.

Components of the Purchasing System:

Whatever the environment, 2 essential components are common to most purchasing

system.
1. Product Research and Specification - These help assure adequate quality of purchases.
Product research can be accomplished by comparative evaluation with the laboratory by
consultation with other users or by reference to publications offering comparative studies of
equipment and supplies like journals, etc. Product specifications differentiate the
equipments’ brands, purity, package, etc.

2. Inventory control – This helps quality of purchased after reagents and supplies. This assures
adequate quantity of materials for the laboratory operation.

The figure below illustrates the sequence of purchasing:

Product Specification  Orders  Receive  Record  Inventory

PRODUCT SPECIFICATION

In order to determine the best products for laboratory use, time must be spent on product
research leading to the development for product specifications. This can be done also by comparative
evaluations within the laboratory by consultation with other users or by referenced to publications
offering comparative studies of equipment and supplies. Product specifications prepared after such a
study help assure adequate quality of purchased reagents and supplies.

A similar process of evaluation and product specification is necessary prior to purchase of

major equipment. In addition, the following considerations are important:

1. Written specifications must include a detailed description of the required equipment.

- Specifications must never be made by verbal agreement.

2. On site visits to see equipment operating in other laboratories is encouraged.

51
 - Trial installation of equipments – allow operation under particular conditions of the
laboratory
- Gives the personnel an opportunity to test the equipment

3. An environment necessary to accommodate the equipment must be prepared in

advanced.

 Examples of special requirements include special gases, controlled humidity, high

amperage, unusual weight loads, etc.

4. A more complicated decision is whether to buy, lease or rent major equipment.

5. Complete instruction manuals should be obtained with the instrument and preventive
maintenance schedules established.

6. Newly acquired instruments in the laboratory must be reported to the Bureau of Health
Facilities and Services, Department of Health.

ACQUISITION OF NEW EQUIPMENT

The justification categories for the acquisition of new equipment for the laboratory are as
follows:
a. Replacement – equipment cannot be repaired anymore. There is an excessive cost of repair
and there is an unacceptable delay in service. This is considered as the best justification
b. Increased workload
c. Cost reduction
d. New and/or improved methodology

The priority of need is also categorized as follows:

a. Essential – the impression of equipments which are needed immediately.
b. Necessary – impression of which it is greater, but it can wait (comparing it to essential).
c. Desirable – impression of because a person wants to or a person wants to reduce the cost.
d. Others – includes the impression to the public.

There are also bases for the selection of new equipments that includes:
1. Use
2. Longevity of the instrument – its lifeline
3. Volume of the test
4. Inherent Accuracy
5. Cost
6. Expected Downtime – time when the equipment will show problems.
7. Ease of Operation

In acquiring a new instrument, sources of information must be reviewed and analyzed. These
sources may include:

1. Manufacturers and Sales Force – They are prejudiced to their own equipment. They will only
ell the positive things of their products.

2. Laboratories that use the same instrument – they solicit information to other laboratories
through supervisors and medical technologists.

3. Visit few laboratories with alternate brands of equipments.

4. Asking for trial runs and tests

52
LEASING AND PURCHASING OF SUPPLIES

The decision over whether to lease, purchase, or lease-purchase technology must be made
according to the organization’s understanding of how the equipment will be used. Advantages and
disadvantages of each option should be weighed to determine what factors are the most important to
the organization. In another case, if an organization seeks to acquire new equipments for a selected
number of employees in one location, purchasing may be a better option. This is because the
equipment could easily be used for longer than three years, and other users may be able to use the
old equipment. The use of the equipment and the needs of the organization drive the acquisition
decision. If a lease-purchase decision is based solely on financial measures, all other issues regarding
business functions and needs are ignored.

Lease Plans – plans that make periodic payments agreed upon terms, usually 3-5 years. This
is often with contract and the equipment may be purchased or leased again on a reduced rate after
the term.

Rental Plans – these are plans with periodic payments without purchase options. The
equipment may be returned or another rental agreed upon.

Purchase plans – plans to buy the equipment.

Purchasing Advantages Purchasing Disadvantages

It's easier than leasing. Buying equipment is easy The initial outlay for needed equipment may be
– you decide what you need, then go out and buy too much. Your business may have to tie up lines
it. Taking out a lease, however, involves at least of credit or cough up a hefty sum to acquire the
some paperwork, as leasing companies often ask equipment it needs. Those lines of credit and
for detailed, updated financial information. They funds could be used elsewhere for marketing,
may also ask how and where the leased advertising or other functions that can help grow
equipment will be used. Also, lease terms can be your business.
complicated to negotiate and if you don't
negotiate properly, you could end up paying
more than you should or receiving unfavorable
terms.
You call the shots regarding maintenance. Eventually, you're stuck with outdated
Equipment leases often require you to maintain equipment. Technology becomes outdated
equipment according to the leasing company's quickly. A growing small business may need to
specifications and that can get expensive. When refresh its technology in some areas every 18
you buy the equipment outright, you determine months. That means an organization will
the maintenance schedule yourself. eventually stuck with outdated equipment that
you must donate, sell or recycle.
Your equipment is deductible. With most leases
favored by small businesses, you can only deduct
the monthly payment.

53
 Leasing Advantages Leasing Disadvantages
Leasing keeps your equipment up-to-date. You'll pay more in the long run. Ultimately,
Computers and other tech equipment eventually leasing is almost always more expensive than
become obsolete. With a lease, you pass the purchasing.
financial burden of obsolescence to the
equipment leasing company.
You'll have predictable monthly expenses. With a You're obligated to keep paying even if you
lease, you have a pre-determined monthly line stop using the equipment. Depending on the
item, which can help you budget more effectively. lease terms, you may have to make payments
for the entire lease period, even if you no longer
need the equipment, which can happen if your
business changes.
You pay nothing up front. Many businesses
struggle with cash flow and must keep their
coffers as full as possible. Because leases rarely
require a down payment, you can acquire new
equipment without tapping much-needed funds.
You're able to more easily keep up with your
competitors. Leasing enables business to acquire
sophisticated technology, such as a voice over
internet protocol phone system that might be
otherwise unaffordable.

The result: You're better able to keep up with

your larger competitors without draining your
financial resources.

To avoid purchasing equipments with constant problems:

 Upon taking the equipment, it is wise to have in writing certain purchase conditions or
contract like:
o Diagrams
o Parts manual
o Service manual
o Operation manual
o Installation manual
 A 30-day trial period should be requested to give personnel sufficient time to evaluate
equipment.
 Hold payment until the testing is complete.

The entire obligation for the successful initial operation function of a new instrument does
not rest with the manufacturer alone. The lab must provide the following:
a. Proper bench space – Where the equipment is placed
b. Compatible environment – Some equipments are sensitive to vibration, sunlight, etc.
c. Utilities like power, water, gas and fuel – Utilities that are required by the equipment.
d. Provide trained personnel – Must 2 or more personnel.

Installation of new equipments must be done by qualified and authorized personnel. These
are done by:
1. Factory Service Man (technician) – the one who installed the equipment must be listed in the
contract. He shouldn’t be allowed to leave the laboratory unless 2 or more staff tested the
installed equipment. The equipment must also be delivered at an earlier time.

54
 2. Laboratory Personnel (staff) – the main disadvantage is that the staff is responsible if
accidents happen. The staff must have a full knowledge on the equipment before
installation.

PREVENTIVE MAINTENANCE AND REPAIR

Preventive Maintenance refers to the unscheduled maintenance. This is done before the
failure of the equipment occurs. Examples are calibration and cleaning of equipments. It is an
organized activity designed to prevent the wear and tear or sudden failure of equipment components.
Preventive maintenance helps to protect assets and prolong the useful life of production equipment.
Preventive maintenance, therefore, is a very important ongoing accident prevention activity, which
you should integrate into your operations/product manufacturing process.

Repair applies to unscheduled maintenance. This is done after the failure of the equipment
occurs. This is prevented if the manager is efficient in making/planning preventive maintenance.

The rewards of a properly implemented maintenance and repair programs are:

1. Higher quality more reliable results
2. Increased output and efficiency
3. Reduce the number of major repairs – This saves a lot of money.
4. Enhance the safety of the laboratory staff.
5. Lessen the requirements for back-up equipments.

The scope of maintenance activity includes:

1. Simple visual inspection – examples are checking the wirings of the equipments, etc.
2. Comprehensive overhaul – this is done by technicians
3. Refurbishment of equipment.

Laboratory personnel should also have a checklist of the equipment he or she handles. This
checklist can be written in a piece of paper. The name of the staff and the equipment handled should
be written in the checklist. In the checklist, in the first column, the maintenance procedures are
written. In the 2nd column, the frequency of the maintenance should be written.

Below is an example of a checklist:

55
 There are also 3 Levels of Maintenance. These are:

1. First level maintenance – These are the responsibilities of the laboratory staff. These include
cleaning, adjusting and daily care of the equipment.

2. Second level maintenance – These are the responsibilities of the field service man in a
laboratory or a repair shop or a local repairman. Responsibilities include inspection, cleaning,
lubrication, repair, adjustments, calibration and running of tests.

3. Third level maintenance – these entails a major repair activities such as overhauling or
refurbishment of equipment. This is done by the manufacturer.

The instruction manual included in the equipment is important because this describe the
proper operation, calibration and first level maintenance procedures of the equipment. Equipments
without instruction manuals must not be bought. This must not be disposed and must be kept
properly.

There are also steps in implementing preventive maintenance.

1. Inventory of laboratory instruments – Should have paper labels, stickers or engraved metal
pads affixed on the instruments. Each instrument should have an identifying property
number.

2. Have a control card system attached in each instrument - this control card must bear the
following:
 Name of the instrument
 Serial and model number
 Vendor’s name
 Manufacturer’s name
 Purchase date
 Warranty period
 Location in the laboratory
 Scheduled maintenance date

If no other permanent record is maintained, the card may also include the following
service information.
 Date sent out
 Purchase order number
 Repair contractor
 Return date
 Description of repairs (optional)

3. Prepare a file for each instrument – This holds the permanent record of repair. This must
include:
 Field service reports from vendors or manufacturers
 Detailed reports on local repairs
 Calibration records
 Date performed
 Method of calibration
 Name of the technician who did the procedure.

The schedule for maintenance also has a hierarchy. Levels of scheduled maintenance are:
1. First level – the daily (or weekly) care of instruments should be performed by a technologist
who uses the equipment following the guidelines set forth by the manufacturer.

56
 2. Second level – may be scheduled by the technologist in conjunction with the vendor (as in a
service contract) or local repair contractor.

The parameters that may affect the frequency of services includes:

 utilization
 priority
 cost effectiveness

Repair organizations also exist for the maintenance of equipments. Several options are
available in laboratory maintenance and repair service.

a. In house repair groups – only large laboratories can afford to employ a full-time repair
technician. The advantages are:
- Improved response to emergency calls
- Cost savings
- Flexibility in saving
- Better service

b. Manufacturer’s field organization

c. Local repair contractor

OBSOLESCENCE

Machines and equipments are replaced at a fast pace due to the advancement of
technologies. These equipments are either being replaced with a new one or upgraded. In time, old
machines may perform inefficiently compare to the new ones. Machines are eventually disposed off
and replaced with a new one. However, there are ways to dispose obsolete equipments. These are
the following:

a. Trade-in – If the machine still possesses a value, it can be traded to a person.

b. Back-up Method – If a new machine accidentally malfunctions, the old machine
can be used. However, this is unrealistic because the new equipment is
assumed to be error-free.
c. Cannibalize the parts to be used for the repair of the new equipment.
d. Sold to hospitals or schools for teaching aid.
e. Junk / Trash in a garbage.

DIAGNOSTIC KITS

Nowadays, as another means of advancement of technology, diagnostic kits exist. This has its
own advantages and a disadvantage. The advantages of having diagnostic kits is that it provide
materials for laboratories with limited capability to prepare reagents, especially those highly
specialized reagents, and the quality of these diagnostic kits are easy to control. The only
disadvantage of these diagnostic kits is this requires personnel for evaluation of the reagents of these
kits, making the work tedious.

LABELS AND INSERTS

Labels and inserts have differences. A complete label includes:

a. Product name – (generic or trade name)

b. Intended use of the product

57
 c. Name and address of manufacturer, packer, or distributor to whom the consumer may direct
the inquiries.
d. Lot number
e. Weight and volume concentration
f. Storage information and expiration date
g. Cautionary statement
h. Safety and hazard warning.

Inserts are written form included to a package but not a-fixed to the container. Directions
for use should be included in the inserts. The following should be given:

a. Reconstitution and stability of reconstituted product

b. pH, working and stability, dilution, or other working factors
c. Precautions
d. Type of specimen that may be tested and its preparation

RECEIVING AND ACCOUNTS PAYABLE

The following are considerations in purchasing supplies:

1. Orders should be placed only by authorized staff members who are familiar with the
quality of service and reliability of supplies. Never entrust this work to anybody.
2. Schedule the time of delivery – Delivery schedules are a major factor in determining
whether a purchasing system is in or out of control.
3. High use items should be delivered frequently.
4. Release orders and standing orders are excellent methods of doing this and can save the
laboratory time and money.
- Release order – annual contracts in which the vendor agrees to deliver goods as
notified by the laboratory.
- Standing order – annual contracts in which the vendor agrees to deliver goods at a
predetermined price on an established schedule.

In purchasing goods, these important documents are needed:

a. Requisition Slip – this slip is accomplished by the end-user itself. This may be inputted in
a computer or written in a piece of paper. This slip is delivered to the purchasing office.
b. Purchase Requisition – this is copied requisition slip of the end-user by the purchasing
office.
c. Purchase Order – this is where all the needed materials are written.
d. Delivery Receipt – This only tells the quantity of the material.
e. Invoice – This tells the quantity as well as the price of the reagents/supplies.
f. Receiving Report – this document is forwarded to the accounting division of the hospital.

These pointers must be remembered regarding purchased goods:

1. Goods should be unpacked and inspected as soon as possible and inspected ASAP to insure
that everything is delivered or that some acknowledgement of back ordered items is made.
2. Check the expiration date and reject if the date is too soon.
3. Goods must be delivered on time.
4. Damaged or defective goods should be identified early in order to assure replacement credit.
5. Acknowledge back-ordered items if any – Broken apparatus must be recorded.
6. Goods should be immediately dated by labels or catalogues.

3 pieces of information must agree before the company’s bill will be paid by the most
accounts payable systems:
1. The purchase request must agree with the invoice.
2. The invoice must agree with the packing slip.
3. They must all agree with the final bill from the company.

58
 Any non-payment between the figures results in payment to the company being withheld.

RECORDS AND INVENTORY CONTROL

There are elaborate formulas for deciding inventory size and reordering time, but for most
laboratories, simpler methods will serve as well. One of these methods, the most common of all, is
through the use of an inventory system using stock record cards as shown below:

In inventory systems, the lower and the upper limits must be stated:

1. Low level – This tells the quantity to last until the goods on order are delivered. This is
the point at which on-hand supplies are sufficient to carry the laboratory through until
goods on order are received.

2. Upper limit – This is the quantity that last longer, possibly months to year. This is the
level which will meet the laboratory requirements for a longer period of time.

An effective inventory control system requires excellent communications between

all sections of the laboratory and the people responsible for purchasing. The latter must be
aware of anticipated increase or decrease in requirements for all items and must monitor
delivery times and company performance. The factors that determine the lower and upper
limits are:

1. Anticipated delivery time

2. Availability of the storage area – this area must not be adjacent to the staff’s
quarters as this may provide hazardous environment.

59
 CHAPTER 9

SAFETY MANAGEMENT
OBJECTIVES

The clinical laboratory is prone to hazards. The safety of the laboratory as a workplace is an
issue of concern to its management and the individuals working there. The hazards found in the
laboratory, with some exceptions, are of no difference to any given workplace or to household
standards. The same risks and dangers encountered in daily life are to be experienced in the
laboratory with added special perils due to the nature of work in the laboratory. In the laboratory we
will find special equipments such as big biological refrigerators, centrifuges, laminar flow cabinets,
spectrophotometers and similar chemistry analyzers which constantly function in a 24 hour
operation. This predisposes the laboratory to future electrical problems and overheating if electrical
requirements are not in placed properly. The dependence of the laboratory to chemicals that may
likely be toxic also poses as a potential hazard to the employees working there. Furthermore the
laboratory is a special facility that receives clinical specimens from patients who have communicable
diseases for diagnosis. These specimens may equally transmit the pathogens it carries to the very
laboratory personnel who are working on it.

There is a need for safety management in the clinical laboratory. The inherent circumstances
above now liken the laboratory to a ticking timebomb that may potentially harm its personnel. Due to
these appalling reasons, a safety management plan should be adopted in any laboratory setting. The
laboratory must be hindered from meeting would-be-fires and electrical accidents in the future. Also
the personnel working are at a disadvantageous situation if chemical leaks happen or pathogens are
transmitted to them. In synopsis, laboratory safety aims to protect the employees and insure no
untoward event will happen to the whole laboratory.

CLINICAL LABORATORY HAZARDS

Most of the hazards found in the laboratory arise from the nature of its operation. The
hazards may come from the laboratory’s structural design, the varied supplies and substances it
temporarily houses which it utilizes for analyses, the technologies needed to facilitate processing of
tests, and pathogens from the specimens it receives for diagnostic work-up.

The structural features of the laboratory may cause potential hazards or warrant its control.
The laboratory must be considered as like any structural plant being put up. Lapses in the planning
stages for the construction of the laboratory are extremely costly to correct. It is thus only justified
that any amount of precaution or safety in the future must be already weighed in before the actual
setting up of the laboratory. Problems in the physical set-up includes the following, though may not
be limited to these:

1. Congestions at the entrance and exit points of the laboratory

2. Holding place for chemical items, clinical specimens, and wastes which are of general,
chemical or biologic origins
3. Lack of provision for ventilation
4. Placements of electrical sources and electrical capacities
5. Fire protection schemes such as sprinklers, smoke detectors, fire extinguisher locations,
and fireproof construction materials
6. Provisions for decontamination facilities and first aid stations

Supplies and substances in the laboratory can bring potential harm to the laboratory, its
personnel and the community. In the local setting, the laboratory may house more than five different
chemicals at a given time. Most of the chemicals in the laboratory may be stains, alcohols, weak acids,
weak bases, and assortment of other organic compounds. These chemicals are indispensable for the
smooth flow of work in the laboratory. If not for these no diagnostic tests will be processed or ever

60
done. The enumerated chemicals may either work as a poison or potential fire hazard to the
laboratory and its personnel if these were not handled properly. Another aspect being seen is that the
laboratory may not only harm itself if certain mishaps occur, but would completely resound to the
nearby establishments and the rest of the community as well. Chemicals may reach to sewage pipes
and contaminate water treatment plants, or perhaps would leak to the community as gases and
endanger many lives. Though the stated scenario may be far-fetched, it is plausible and undeniable.
Another more realistic scenario is when an explosion happens, that the surrounding buildings to the
laboratory may catch fire or likely to sustain damage.

So far, only chemical substances have been mentioned; the relevance of it to the laboratory
and possible outcomes to the physical facility and to the rest of the community around it. Supplies
utilized by the laboratory may include glassware apparatuses, plastic wares, phlebotomy-related
paraphernalia, gloves, fibers such as cotton, papers, logbooks and worksheets to name some. Most of
these can catch fire if one has occurred, littered with chemicals or may be carrying pathogens. The
consequences are not only confined alone to the laboratory and its personnel but to the rest of the
community again.

Electrical equipments may bring shocks or fires. State-of-the-art sophistications permit high
volume of workload in the laboratory accomplished in a faster fashion. Nonetheless the varying
electrical requirements of the different equipments must have been thought of and the structural
design of the facility should have allowances for these, especially when in the subsequent time that
the laboratory will progress from its meager beginnings. If not fires due to electric short circuits will
likely happen. Also the equipments may be needed for some maintenance checks to avert possible
electric-caused fires. Electrical shocks or burns may arise from using the equipment so that proper
personnel familiarization may also be needed in order to deter such scenarios.

Biological hazards are threats to the laboratory and the community. Clinical laboratories lead
the pack of health facilities within a hospital in the number of biologic specimens that it holds.
Specimens, such as blood, urine, feces, sputum and other body fluids, begin to reach maximum
volumes once the different wards will transport these to them for diagnostic analyses. Not to discount
the significant contributions made by outpatients as they give a fair share of clinical specimens to the
laboratory. During the testing phase, the technologist or other laboratory personnel are exposed to
these biologic specimens and its potential biologic agents. Personnel may acquire diseases if they do
not possess proper equipments and afforded the necessary supplies to process it. Then once finished
with their proper assays, biologic specimens should be disposed of properly. If handled the wrong
way, even if the testing phase is finally through, there is a big likelihood that it will harm the
personnel of the laboratory. Improper disposal may cause spurious dispersion of the biologic
specimens to the atmosphere, a body of water or spread by biologic and mechanical vectors.

SAFETY GUIDELINES FOR THE CLINICAL LABORATORY

Physical Plant Guidelines

General safety rules include the type of building materials used for facility construction. The
building material should be able to resist storm damage and prevent fire from spreading rapidly.

The laboratory does not only houses areas for specimen processing but some non-testing
functions as well. Delivery and storage of potentially hazardous chemicals, such as flammables and
corrosive materials include how these are being brought into the laboratory, where these are placed
and final storage arrangements. Relatively, specimen processing from the time of collection up to
arrival in the testing site must be taken up in drawing plans. It is evident that particular to the
laboratory’s need, its layout should include separation of non-testing functions from areas containing
hazardous materials by means of structural barriers and control of traffic patterns. Entrance and exit
routes, hallways and doors should be sufficiently wide to promote ease of movement of people when
in times of order and crisis. Likewise it should have been conceived carefully to maintain one-way
flow of people as possible.

61
Fire Prevention Guidelines

Fire prevention schemes start by placing flammable materials nowhere near to an ignition
process. The College of American Pathologists emphasizes that a laboratory with an area of 5000
square feet can have 10 gallons flammable liquids in store or used in outside safety room, safety
cabinets or safety can. With similar space provision, 60 gallons flammable liquids may be allowed
provided it is inside safety cabinet or if there is none only 25 gallons may be stored in safety cans.
Classified flammable liquids also come with some restriction in terms of allowable amounts within the
safety can and likewise subject to the laboratory’s given floor area.

a. Class A liquids such as ether, isopentane should be carried by a safety can to no more than 1
pint.
b. Class B liquids may be allowed to as more than 1 quart and this includes acetone, ethanol
and methanol.
c. Class C flammables such as xylene and mineral oil, is allowed to up to more 1 gallon inside
safety cans.

If however recommendations exist for a liquid to be stored in glass bottles, it should be

purchased in smaller unit quantities as practicable to the laboratory and stored in safety cabinets
when not in use. Flammable gas cylinders should be stored separately from other flammable liquids.

Despite our best efforts to prevent accidents, accidents are always bound to happen and the
question is just a matter of time. For health care facilities time may not take too long since it plays a
host to a high concentration of people that are even likely to have limited capacity to respond to
crisis. Hospital personnel may also commit lapses for quick responses given the large number of
people within their facility. Laboratories operated by hospitals are inclined to this fate, but not to
free-standing laboratories; though the high volume of procedures that involve the use flammable
liquids equally inclines both. The foregoing reasons necessitate sound construction, stipulations for
fire-fighting equipments, and training and practice to fight fire accidents when it has occurred.

Fire-fighting start firstly in the layout of the building plan. Entrance and exits should be
designed to disfavor congestions. This opting cannot be debased since decongested traffic allows
evacuation to safer grounds without unnecessary hampering. Help will also be swift since there is no
blockage to the site where fire has occurred.

The materials used for the construction of the laboratory and actual construction require that
fire-resistance should be at accepted available standards of safety. At least two hours for walls around
high risk areas such as storage rooms for flammable materials. Compressed gases and ether are highly
explosive substances and should be stored in a room with at least one outside wall and a direct vent.

Devices that fight fires must be laid in plans. Among these include smoke and fire alarms,
self-closing doors to isolate and control air and smoke flow, ventilation plans, sprinklers and fire
extinguishers. Fire hydrants may be necessary also when fires that would be generated be that
tremendous. These need to be located strategically and should be present once the building is finally
put up. Fire extinguishers, fire blankets and bulk materials such as sand or other highly absorbent
substances can be used for fire containment as well as spill control and neutralization are required
implements to control fires when it has happened. Fire extinguishers are grouped into four classes
depending on the nature and source of fire and the type of material needed to extinguish it:

1. Class A fires are the most common and are usually started by ignition of paper or wood
materials and other similar to the type. This fire is extinguished by water.
2. Class B fires consist of flammable liquids such as alcohols, gases and solvents. These are
extinguished by dry chemicals or CO2
3. Class C fires are electrical fires in nature. The extinguishing substance is similar to that in
Class B.

62
 4. Class D fires involve combustible chemicals or metals eg, sodium or magnesium need
highly specialized extinguishers such as sand or bulk material

The last arbiter in the conduct of fire prevention is the personnel. Persons who work with
flammable materials must be trained in handling, storage, processing, cleanup and immediate control
of situations after fire accidents occur. However the infrastructures in the laboratory should
accommodate these activities such as intended working space, provisions for ventilating hoods and
transporting aids to name a few, so that personnel may safely perform their duties.

Some form of supervision may be needed or included to the job descriptions of the
supervising technologist to ensure personnel familiarity and compliance to fire prevention guidelines
and conduct personnel education for these. The skills needed by every personnel for control of fire
accidents taking place are enumerated as follows.

1. Recognition of fires and fire alarms

2. Sounding the alarm and making sure help is on the way before taking any other action
3. Decision-making strategies whether to fight fire or abandon the site. In abandoning a
facility that is thrown into a fire accident that needs firemen attention, the capacity to
limit fire spreading is the best contribution one may give to fire-fighting. The best course
of action is to establish smoke barriers such as shutting windows and doors.
4. Acquire the skill in using fire extinguishers and water hydrant hoses
5. Techniques for when personal garments catch fire
6. Evacuation drills such as crawling, use of wet blankets to prevent fire from catching the
personnel
7. Familiarization of evacuation plans from the work site

The list can be a primer and fire safety manuals provide more detailed plans and course of
action for fire situations. Perhaps the most important is the continuous commitment of the
management to train and subject employees to educational sessions. Fire drills every once in a while
should be executed to put knowledge into action and check if knowledge was ingrained satisfactorily
so that personnel will respond as expected limiting damage to lives and property.

Electrical Safety Guidelines

The major hazard that crop up from electrical equipments and wiring are physical harm such
as burns and shocks, and generation of fires due to heat and spark arising from malfunctioning wiring
or equipments. Below are general recommendations to evade electrical mishaps.

1. There should be no extension cords or outlet adapters

2. All equipments, including household items eg, coffee pots, microwaves, should be
checked for compliance to electrical safety standards. The engineering department may
be consulted on these prior to purchase of equipments.
3. Conduct of electrical safety checks on equipments and move for its inclusion to the
laboratory’s preventive maintenance program for each equipment. The assessment
includes total power needs of the laboratory, check on equipment proper voltage,
grounding, curre nt leakage and plugs and cord evaluations.
4. Circuit breakers should be conveniently located and labeled
5. Equipments should not be placed near to flammable materials
6. As prevention is far better than remedy disasters when it happens, electrical safety
should be made part of the orientation and educational program of the laboratory

Chemical Safety Guidelines

Chemicals are aids to the laboratory. However it is recognized that it is a physical and health
hazard. Chemicals of the laboratory can be flammable, explosive, highly oxidative, reactive or
unstable, and reactive to water. Health hazards by chemicals include the obvious toxicity to the body
or vital organs, render one sterile, carcinogenic, irritating, and corrosiveness to skin and tissues.

63
 To equip personnel against these, a document detailing the safety information about each
hazardous substance must be available to employees at all times in an obvious and easily accessible
location. The document(s) is called material safety data sheets (MSDSs). This document should be
made by individual laboratories and incorporated into training programs for their personnel. The
MSDSs puts however into exception commercial cleaning agents eg, bleach, ammonia and phenol
solutions, and drain cleaners that need to be ingested in significant quantities before evidenxt harm
arises. Chemicals used in minimal concentrations are also not required to be included in MSDSs
provided its manufacturers placed warning labels and are packaged in safe containers. The MSDSs
begins with headings for product name, manufacturer, important numbers to call for emergency
information, effective and review dates, and signature of the person preparing the sheet. Afterwards
safety topics follow which consists of the following information:

1. Identification of the hazardous material or compound ingredients with their common

and technical names.
2. The physical or chemical characteristics of the substance such as boiling points, vapor
pressure and density, solubility in water, specific gravity, evaporation rate and water
reactivity.
3. Fire and explosive nature of the chemical, flash point, flammable air concentration levels
and fire-fighting and extinguishing procedures.
4. Reactivity, stability, chemical incompatibility, dangerous decomposition products and
polymerization.
5. Specific health hazard data giving the primary route of contamination, health complaints
and symptoms that may arise from contact, medical conditions that may be aggravated,
first-aid procedures, and specific health dangers that may arise from exposure: cancer,
cell mutation, organ damage, and so on.
6. Personal protection equipment, ventilation requirements and other precautions.
Protective equipments may include respirators, gloves, protective garments or suits, eye
wears, hoods and isolation chambers.
7. Listing on safe handling, storage, spill, leak control and disposal methods.

Manufacturing companies are the best source of information that will help greatly in the
laboratory’s construction of an MSDS sheet(s) if local regions do not have one.

Synonymous to teaching personnel and making them adhere to MSDS sheets is the presence
of many warning signs that would immediately call their attention and seek these documents for
guidance. Without warning signals or labeling signs, personnel may not be alert to recognize a
potential hazard. Signs would prevent less likely things to happen and bars accidents from aggravating
to uncontrolled circumstances.

Aside from warning signs, construction features of the laboratory are a major factor to
protect personnel when dealing with hazardous materials. These include structural features,
protective barriers or shields, personal protection articles and emergency and first-aid supplies.
Concrete example is the height of the counter or work benches since dealing with corrosive
substances should never be handled above waist level. Adequate ventilation must also be ensured in
the design. Not only it promotes optimal air flow and exchange but it too gives comfort to the
personnel who is wearing protective garments. Physical barriers include availability and use of glass or
plastic shields, chemical hoods, and even walls to prevent exposure to a danger. Personal protection
articles eliminate remaining hazards not hindered by structural and physical barriers. Goggles, face
masks, gloves, aprons, full protective suits or self-contained breathing respirators may be appropriate
depending on type of danger and exposure. Routinely for the laboratory hand and eye protection
suffices. Emergency equipment such as eyewash and overhead showers is ideal for chemical spills on
hand or body. First-aid supplies are best if located conveniently, numerous in the facility and fully
stocked. There should be neutralizing solutions for the eye and body and provisions for cleanup and
confinement supplies and equipment.

Pathogen Safety Management Guidelines

64
 Tissues, organs, mucous secretions, saliva, semen, vaginal, urethral, cavity fluids, exudates,
wounds, amniotic fluid and any materials acquired from the body are likely to be contaminated with
blood and will invariably carry blood-borne pathogens. Urine is considered relatively safe but possibly
microbial organisms and agents may subsist upon. These specimens are submitted to the laboratories
and consists the bulk of activities performed there.

Laboratories should have an exposure control plan that clearly stipulates the rules of
engagement for bodily specimens. The exposure control plan must be made known to all employees
and is easily accessible by them so that they may be guided properly. The plan should identify jobs,
tasks, procedures and situations that may present a risk of exposure to biological pathogens. It should
also contain methods that protect the personnel from such perceived occupational exposure.

Specific guidelines for management of pathogen exposures by personnel include the

necessary facilities, the exposure control procedures, personnel protective equipments for evading
pathogen exposure, housekeeping techniques and personnel protection. Any exposure control
methods usually begin by recognizing all specimens as sources of real and immediate danger and
therefore deserve serious treatment by the personnel. The statement cannot be understated
anymore.

Facilities and requisites eg, soaps, clean wipes, for hand-washing must be available in the
workplace. Supervision may be needed to develop culture of hand care before and after dealing with
patients and specimens. Needles and sharps pose as a threat and devices for its disposal such as
puncture-resistant leakproof containers that are labelled with hazardous warning should be used.
Procedures that minimize splashing, spraying or generating aerosols must be adopted. Concrete
examples are the use of closed containers during centrifugation and prohibition of mouth pipetting. If
equipments and instruments are tainted with biological material, it must be labelled and
decontaminated properly. As a preventive measure, eating, drinking, smoking, applying cosmetics is
strictly banned in areas in which exposure to pathogenic material is possible.

Gloves, lab gowns and face masks are routine personal protective equipment for laboratory
personnel but may not be confined to these always. It is also best that other parts of the body such as
eyes and face will be protected from splashes, splatters, sprays or aerosols with goggles, glasses and
even hoods and counter shields if possible. Other idealized protective equipments may include lab
coats, surgical caps, scrubs, shoe covers and even disposable arm sleeves.

Housekeeping procedures involve disinfection or sterilization of objects and surfaces that

have come in contact with biological specimens. Pre-treatment prior to disposal of hospital wastes is
more favored to limit the spread of diseases. Summarily housekeeping procedures is a two-pronged
objective: proper handling or treatment of specimens already processed which are now directed for
disposal and proper treatment to objects and surfaces that have come in contact with biological
specimens. There should have specific procedures that detail the proper way to handle specimens
and objects so that harm to the laboratory and to the community is avoided.

Personnel protection is another aspect for pathogen safety management. It is considered the
last frontier and it involves health status of the personnel. So far the only preventable communicable
disease is hepatitis B, and fortunately is the most prevalent pathogen that may be isolated from
biological specimens. There are others however but the economics of prevention by adopting
vaccination programs is deemed costly for other communicable disease. Short term protection of
some attenuated pathogens and the prevailing infectious disease at the time are some of the most
glaring reasons for not instituting an employee vaccination program.

THE MANAGEMENT OF LABORATORY SAFETY

Responsibility for Safety

65
 At the start of this report it has been mentioned that safety is a shared responsibility of the
individual worker and its managers. However it is always recognized that some form of organization
must exist so that there will one solid direction to be followed by all other stakeholders. The top
management may recognize that it cannot always ponder upon these things despite rank-and-file
employees look up to them for guidance, given with all other concerns being meted by them. They
may opt to put together a safety committee and the same to recruit safety officers to enforce the
policies that it will formulate. The ideal safety committee should consist representative personnel
who have shared interest for the laboratory such as the pathologist, medical technologists from the
middle management and rank-and-file, and the administration. The committee members are
encouraged to voice their opinions and viewpoints. Exchange of ideas among different members
would come up with a better middle-ground policy later. The safety officer for the laboratory may be
made a member of the safety committee since they oversee most of the violations. They are charged
with the implementation and day-to-day management of the safety program. In large-scale
operations, the safety officer may be a full-time post but in small laboratory organizations this may be
delegated as part of the supervisor’s job description.

Safety Management Program

The collective effort by the safety committee and safety officers will lead to the
establishment of this program. The components of the program include:

1. Policy and procedures

2. Communications
3. Disaster plan
4. Safety audits and inspections
5. Accident investigations and accident prevention

The policies and procedures of the safety management program is reflected on the manuals,
guideline and procedures for the assurance of safety from fires, chemical-related and electrical-
related problems, and pathogen exposures.

Communications is a broad aspect and it covers the policy manuals and procedures, signage,
written notices, trainings and orientations given to the personnel so that they may function or
perform their duties in maximum safe and secure conditions.

Disaster plans do not only focus on ways and means to relocate oneself or group of
individuals from a crisis spot to secured grounds. Rather it is all encompassing. It is a complete plan
that details the aspects on how operations may still continue after a crisis has been controlled. Surely
the facility has sustained damage but it does not necessarily mean cessation of activities. Patients will
soon need professional help and their conditions cannot wait for too long. Furthermore the
laboratory enterprise is expected to have a hard time to regain its composure since it must subsist on
some operational or previously earmarked funds to repair sustained damages. If it will deny offering
services to patients, the laboratory will be trapped on a vicious cycle for some time and would take
longer to gain full operations. Important points to count here after a disaster or crisis have occurred is
the use of back-up technologies, use of previously least utilized areas for temporary operations,
mobilization of all staff to cover shifts in an altered setting with food and bedding provisions if they
will work for extended hours, and sources of help. Staff should also be taught of these and reminded
from time to time so that each and everyone will carry out the goals of the disaster plan without
undue resistance.

Safety audits and inspections are checks if the agreed safety restraints are in placed in areas
where it should be detailed. It is also sees if personnel are complying and are provided with the
necessary protective equipments. Audits however cannot supersede or replace constant diligence
that safety officer bind their personnel to.

Accident investigation aims to resolve the following:

1. Who received the accident?

66
 2. When and where it happened?
3. What equipment or supplies were being used?
4. Is modification of the standard procedure would have averted the accident?
5. Is there need to train personnel in order to be thrown in the same accident situation?
6. Is there non-compliance to the established safety protocols?
7. What are the other circumstances that may have contributed to the accident?
8. Is there need for precautionary warnings?
9. What are the other additional steps or actions that could be taken to prevent the
recurrence of accidents?

FACTORS IN THE SAFETY MANAGEMENT

Employee’s Role

The hazards in the workplace are firstly encountered by the individual. It is in this spirit that
personnel are empowered with relevant seminars or lectures, action drills and orientation programs
so that if knowledge is ingrained to them, that they may practice caution at all times. These practices
include working in a safe manner, use of safety equipments correctly as taught to them and notifying
of possible danger or safety violations. If each individual does not follow the safety guidelines, there is
a multiplier effect of their efforts. The problem would have reach to maximum proportions and only a
fateful occasion will lead to a surely big disaster. Furthermore the damage may even permeate to the
entire vicinity since disasters need not to be an explosive one; there are biological samples that may
leak out to the community when gross lapses occur.

Employer’s Role

The employer is bound to the fate of their employees as such that they must be
spearheading trainings, lending fix supports and resources, equipping personnel, adjusting workload
and giving oversight so that safety is maintained at all times and work is progressing in a secure
manner. They should make the working environment conducive to compliance of safety standards.

Labels and Signs

Some form of employee education must be afforded to personnel so that they make
recognize and appreciate significance of different call signs pertaining to laboratory safety. Also
employees may need to improvise if signages can not purchased at the time since they are working in
the laboratory, that they after being armed with the knowledge should make their workplaces safe
for them as well.

Information and Training

It is recognized that personnel are a heterogeneous group of people whom finished their
education from different schools, in different time, and perhaps in a different country. And even
seasoned employees may have acquired their experience in elsewhere discipline of the laboratory
medicine and are not quite inclined to knowing the safety protocols of the current employment.
Therefore there is a need to put up training programs at a substantial period of time for their benefit.
If this would be proven costly, as in the case of small laboratories, the components of safety
management program such as the policies and procedures be provided to them or afforded them
easy access for reading purposes. Their education may be assessed by the supervisor acting as safety
officer through series of questionnaires.

RECORD-KEEPING

This is perhaps the most painstaking labor of any organization that must be taken up. It
entails a lot of reviewing and documentations. Notifications of accidents, incident reports among

67
others may form the history of the safety management program on personnel compliance. Though
these may be short lived, as the most important thing is a lesson was derived from the encounter and
that is properly addressed to the existing policies to cause it to be improved or made stricter if it’s
meritable. Another aspect of personnel information that must be a concern for employers are the
medical and training records of employees who have occupational exposure to blood-borne and other
potentially infectious materials. Medical records must be kept for up to 30 years past the termination
of an employee. The training records must be held for 3 years after the course was completed. All
personnel records are considered confidential and may be released to authorized agencies or after
expressed permission of employee.

A source of vital information for the safety committee and safety officers is the status of the
equipments; if these are qualified for continued use, repair works or condemnation. The status of the
building’s safety facilities is another concern that must documented in order to recommend its
periodic maintenance. The bulk of information generated from equipments and building facilities
must be reviewed and summarized so that referencing them will not be too burdensome and
cumbersome.

68
 CHAPTER 10

FINANCIAL MANAGEMENT
DEFINITION

Financial Management can be defined as the management of the finances of a business /

organization in order to achieve financial objectives. Taking a commercial business as the most
common organizational structure, the key objectives of financial management would be to:

 Create wealth for the business

 Generate cash, and
 Provide an adequate return on investment bearing in mind the risks that the
business is taking and the resources invested

There are 3 key elements to the process of financial management:

1. Financial Planning

Management need to ensure that enough funding is available at the right time to
meet the needs of the business. In the short term, funding may be needed to invest in
equipment and stocks, pay employees and fund sales made on credit.

In the medium and long term, funding may be required for significant additions to
the productive capacity of the business or to make acquisitions.

2. Financial Control

Financial control is a critically important activity to help the business ensure that the
business is meeting its objectives. Financial control addresses questions such as:

 Are assets being used efficiently?

 Are the businesses assets secure?
 Does management act in the best interest of shareholders and in accordance with
business rules?

3. Financial Decision-making

The key aspects of financial decision-making relate to investment, financing and

dividends:

 Investments must be financed in some way – however there are always financing
alternatives that can be considered.
 A key financing decision is whether profits earned by the business should be
retained rather than distributed to shareholders via dividends. If dividends are too
high, the business may be starved of funding to reinvest in growing revenues and
profits further.

TYPES OF BUDGETS

A fund is a sum of money, or its equivalent, accumulated or reserved for a specific purpose.

A budget is the forecast of expenditures necessary to perform the anticipated workload over
a designated time period. It is a strong management tool by which organizational objectives may be

69
achieved through planned and controlled expenditures. It may be perceived as the foundation of all
cost control programs since it exercises broad constraints on total organizational expenditures.

3 separate budgets are developed during the budgeting process.

1. Operating budget is the first and the most familiar one. It deals with the process of
planning for the laboratory as an ongoing business concern, accounting for everyday
needs and expenditures. It represents the financial parameters of the laboratory’s goals
for the coming year. These are prepared at the level of the cost center, usually by those
managers who have direct responsibility for managing the cost center and who can
affect its operations. The operating budget can be broken down into three components:

a. Statistical budget, which is the forecast of activity for the unit.

b. Revenue budget, which determines the gross charges that will be generated by
the forecasted volume.
c. Expense budget, which projects the amounts or resources that will be required
to produce the forecasted volumes.

2. Capital budget is the second type of budget. Its development can occur simultaneously
with the operating budget. It is usually prepared at the organization level and includes
new or replacement property, physical plant, and equipment needs of the organization
for the coming year. It plans for the acquisition and completion of specific equipment
and building projects that require major financial commitments.

3. Cash budget is the third type an organization can develop with the operating and capital
budgets prepared. This is usually prepared by the organization’s finance department and
predicts the cash flows in and out of the organization and the resultant cash availability.

Income refers to consumption opportunity gained by an entity within a

specified time frame, which is generally expressed in monetary terms.

Expense is an outflow of money to another person or group to pay for an item

or service, or for a category of costs.

Personnel Cost invariably constitutes the largest expenditure of the hospital laboratory. It is
required to pay the salaries and wages of the staff employed by the laboratory.

Overhead Costs are a necessarily arbitrary share of the costs of which arise because the
section does not, and cannot, exist in isolation. These can usefully be divided into those which are
included in the laboratory budget, since the laboratory manager has some control over them, and
those which are not.

FORECAST OF EXPENDITURES

Effective budgeting requires careful identification of all categories of expenditures and the
most prudent allocation of funds for each. A meaningful budget must be accurate and closely adhered
to. Budgets most commonly encompass one year, but expenditure projections beyond this twelve-
month period are highly desirable.

The grouping of expense categories for budgetary purposes is often termed a “chart of
accounts.” A proposed hospital laboratory chart of accounts follows:

1. Salaries
a. Exempt
b. Nonexempt

70
 2. Supplies
3. Equipment
4. Purchase
5. Rental
6. Lease
7. Maintenance
8. Depreciation
9. Reference Laboratory Fees
10. Continuing Education and Travel
11. Subscriptions and Dues
12. Hospital Administrative Assistance
13. Telephone
14. Housekeeping
15. General Maintenance
16. Electricity
17. Building Depreciation
18. Taxes
19. Payroll
20. Sales
21. Insurance
22. General Liability
23. Workman’s Compensation
24. Group Health
25. Other
26. Miscellaneous

Laboratory budgeting is an ongoing process that culminates annually with the expense
projections for the forthcoming fiscal year. The forecasts are made in accordance with the cart of
accounts and are divided into quarters. These three-month intervals represent the best times for
expenditure modifications.

71
 Department of Laboratories
BUDGET FORM
For fiscal year ending ___________________________ ___________________________Laboratory

Item 1st quarter ($) 2nd quarter ($) 3rd quarter ($) 4th quarter ($) Total ($)

Salaries, exempt Salaries, non-

exempt Supplies Equipment,
purchase Equipment, lease
Equipment, rental Equipment,
maintenance Ref. lab. Fees
Cont. ed. & travel Subscript. &
dues R & D Depreciation
Telephone Housekeeping
Maintenance (hosp.) Electricity
Gen. hosp. admin. Taxes,
payroll Taxes, sales Insurance
Gen. lab. Insurance Work.
Comp. Insurance Gr. Health
Insurance Disability Insurance
Other Miscellaneous
Total

Department of Laboratories
BUDGET REPORT FORM
For period ending _____________________________ _____________________________Laboratory

Current quarter (in dollars) Year-to-date (in dollars)

Item
Budget Actual Deviation Budget Actual Deviation

Salaries, exempt Salaries, nonexempt

Supplies Equipment, purchase
Equipment, lease Equipment, rental
Equipment, maintenance Ref. lab.
Fees Cont. ed. & travel Subscript. &
dues R & D Depreciation Telephone
Housekeeping Maintenance (hosp.)
Electricity Gen. hosp. admin. Taxes,
payroll Taxes, sales Insurance Gen.
lab. Insurance Work. Comp.
Insurance Gr. Health Insurance
Disability Insurance Other
Miscellaneous
Total

72
WORKLOAD MEASUREMENTS

Because personnel constitute the largest laboratory cost, strong efforts must be made to
assure their most effective utilization. Assessments of efficiency of performance are of benefit.
Because of the great variety of laboratory testing, standardized measurement of effort are required.
These provide a method for recording and comparing the workload in all areas and, when related
appropriately to man hours, become a means for assessing productivity.

Work units are assigned each procedure by determining the average total time (technical,
clerical, etc.) required for performance. Each unit is equivalent to one minute of time exclusive of
specimen collection and measurements of controls, duplicates, and repeats. Recording the workload
requires an initial tally of the number of procedures performed and their subsequent multiplication
by the work units so assigned.

After the workload is completed in work units, an additional computation of the relationship
of this workload to the man hours required for its performance provides a useful estimate of
productivity.

Total work units

Total work hours = Work units/ hour

The closer the work units per hour approach 60, the greater the productivity. Comparisons
by area, shifts, etc., can be made and limits of acceptable performance easily established. When these
are not appropriate, corrective action is taken.

A number of factors may explain variations in productivity from one laboratory area to
another. A major reason is variations in the ability to batch the workload. In any event, efforts to
avoid random and single test performance, without compromising patient services, contribute
significantly to efficient utilization of personnel and resources.

COST FINDING

Cost finding is a means by which a laboratory documents its costs for performing a particular
procedure and then establishes its charges based on the involved direct and indirect costs.

Cost finding should be done by laboratory personnel in consultation with the fiscal staff of
the hospital. This combination is necessary, since the laboratory staff can analyze steps involved in
performing procedures, while fiscal personnel are needed to provide the indirect or overhead
expense and to assist in preparing the data for submission to the hospital administration, board of
trustees and third party payers for approval.

A Formula for Developing Laboratory Costs is shown below:

Direct costs of test (instrument depreciation, maintenance and repair, reagents,

calibration, quality controls, direct labor)
+
Indirect costs (general laboratory supplies), indirect labor (such as supervision,
training), other indirects (such as research and development expenses)
= Laboratory section cost

+
General laboratory overhead (specimen collection, report distribution, information
systems, management, education, quality assurance, sales, marketing)

= Laboratory test total cost

73
Laboratory Costing Example

Position Type Average FTEs Total Salary Fringe Total Salary

Salary Expenses Expenses & Fringe
Lab Specialist Tester $ 27, 000 1.00 $ 27,000 $ 6,750 $ 33,750
Medical Tester $ 33, 500 3.00 $ 100,500 $ 25,125 $ 125,625
Technologist
Medical Lab Tester $ 28, 500 1.00 $ 28,500 $ 7,125 $ 35,625
Technician
Laboratory Non-Tester $ 40,500 1.00 $ 40,500 $ 10,125 $ 50, 625
Supervisor
Total 6.00 $ 196,500 $ 49,125 $ 245,625

Avg Tester Salary & Fringe Benefit Expense $ 39,000

Total Non-Tester Salary & Fringe Benefit Expense $ 50,625

Divisional Indirect Costs Amount Cost/Test

Non-Tester Salary & Fringe $ 50,625

Office Supplies $ 10,000
Books/Subs/Dues $ 15,000
Travel Meeting Dues $ 15,000

Total $ 90,625 $ 0.69 Amount Divided by Total Volume

Lab Indirect Costs Amount

Management $ 115,000
Central Receiving $ 625,000
General Support $ 100,000
Administrative Support $ 75,000

Subtotal $ 915,000

Hospital Indirect Costs (Lab Portion) Amount

Patient Financial Services $ 500,000

Human Resources $ 300,000
Management $ 100,000
Finance $ 100,000

Subtotal $1,000,000

74
COSTING ACCOUNTING

Costing accounting is a system of measuring and reporting information about costs. Its
purpose is to generate information sufficient for managers to make intelligent decisions. A common
challenge of cost accounting systems is balancing the degree of specificity needed with the amount of
work required to reach that specificity in light of the decisions to be made. A good system does not
require unnecessarily detailed information.

Cost accounting is useful for several purposes:

a. Profitability analysis.
b. Cost control. Cost accounting helps define the relationship between cost and activity and can
help align responsibilities with incurred costs.
c. Planning. Cost accounting helps us understand what happens to costs as activity changes.
d. Decision making. Cost accounting aids in setting prices, negotiating capitation rates, staffing
decisions, and make versus buy decisions.

CLASSIFICATION OF COSTS

1. Direct costs are those costs clearly associated with the item being coasted (be it a patient, a
service, a department, or an individual assay). Direct costs are test-specific costs. They occur
in direct proportion to the number of procedures performed or are directly attributed to the
completion of the test. They are considered variable in nature. In the laboratory, direct costs
include testing supplies and reagents, instrument depreciation, maintenance and repairs,
and the labor involved in performing testing.

2. Indirect costs are those costs that are not directly associated with the item being coasted.
Indirect costs are the expenditures that remain after direct costs have been identified and
assigned. They are generally considered to be fixed, or in some cases, semi variable,
depending on the sophistication of the accounting and budgeting process. The most common
types of indirect costs are general laboratory supplies; labor costs associated with
supervision, administration and training; and hospital overhead.

BEHAVIOR OF COSTS

Costs behave in four basic ways depending in their relationship to the relevant range of
activity.

1. Variable costs vary in direct proportion to the volume or level of activity, such as reagent
cost. Therefore, variable costs are constant per unit of service (UOS), which is the logical
measure of work for a given area. Variable costs respond directly to any changes in
workload: As the volume of work increases, expenses rise in a direct and linear relationship.
These costs are considered to be the most manageable and adjustable on a short-term basis.
Laboratory managers and section supervisors are usually held directly accountable for these
budget items. Labor costs and supplies are the most notable examples of variable expenses.

2. Fixed costs, such as rents, are constant regardless of changes in levels of activity. Therefore,
fixed costs per UOS change with volume. Fixed costs are those expenses that do not
fluctuate when the volume of work changes on a daily basis. They are predictable and are
usually supportive in nature. Laboratory administration, instrument leases, maintenance
contracts, computer services, equipment costs, and facilities upkeep are examples of fixed
costs.

3. Semi variable costs have a fixed and a variable cost component. An example is telephone
service, for which customers are usually charged a fixed amount per month that may include

75
 a specified amount of service above which a per-unit charge is incurred. Semi variable costs
are costs that rise in steps, based on more gradual changes in workload. They are sometimes
called marginal costs, because the decision to spend the money is based on the marginal
additional benefit the laboratory expects to receive from this addition.

4. Step-fixed costs are fixed over a relatively small range of activity and then change to a new
fixed level over another relatively small range of activity. Labor costs often exhibit step-fixed
behavior, as a certain staffing level supports a range of activity beyond which additional
staffing must be added.

76
 CHAPTER 11

PERSONNEL MANAGEMENT

Personnel management is concerned with the effective use of the skills of people. They may
be salespeople in a store, clerks in an office, operators in a factory, or technicians in a research
laboratory. It starts with the recruiting and hiring of qualified people and continues with directing and
encouraging their growth as they encounter problems and tensions that arise in working toward
established goals.

SCOPE

A. Recruitment - Recruitment refers to the process of sourcing, screening, and selecting people
for a job or vacancy within an organization. Though individuals can undertake individual
components of the recruitment process, mid- and large-size organizations generally retain
professional recruiters.

B. Selection – This is the process of differentiating between applicants in order to identify (and
hire) those with greater likelihood of success in a job.

C. Placement – This is understood as the allocation of people to jobs. It is the assignment or

reassignment of an employee to a new or different job.

D. Development of the staff – This is an attempt to improve current or future employee

performance by increasing an employee’s ability to perform through learning, usually by
changing the employee’s attitude or increasing his or her skills and knowledge. The need for
training and development is determined by employee’s performance deficiency, computed
as follows:

Training and development need = Standard performance – Actual performance

E. Maintenance – this includes the following:

1. Retraining and Redeployment – new skills are to be imparted to existing staff when
technology changes.
2. Retention Plan – Retention plan covers actions which would help reduce avoidable
separations of employees.
3. Downsizing – Where there is surplus employee, trimming of labor force will be necessary

PERSONNEL PROGRAMS

Personnel Program is consist of series of activities intended to carry out the personnel
policies of the laboratory for the purpose of realizing objectives of the organization.

A good personnel program covers the following activities of personnel management:

A. Employment Program

B. Safety Program - This includes the following:

- Providing of safety equipment – Giving protection for employees
- Informing about the safety – Awareness of the necessary precaution will prevent
untoward incidents
- Keeping of safety record – Know the cause of an accident will prevent same scenario to
happen.

C. Interpersonal Relation Program – This includes the following:

77
 - Griex`xvance System
- Collective Bargaining

D. Employee Research Program – Includes job analysis and job description research.

E. Employees Services Program – Includes:

- Grievance System
- Insurance Plans
- Recreational Plans

PERSONNEL POLICIES

Personnel policies are the principles and rules of conduct which formulate, redefine, break
into details and decide a number of actions that govern the relationship with employees in the
attainment of the organization objectives. The scope of personnel policies is vast arid employees from
all departments are covered by personnel policies.

These lay down the decision-making criteria in line with the overall purpose of the
organization in the area of manpower management. These policies are developed by the top
management to assist in the executives at various levels to deal with the people at work. Thus,
personnel policies can be interpreted as the recognized intentions of top management with respect to
human resources of the organization.

Personnel policies cover the principles and rules of conduct governing the dealings of the
organization with its employees and set the tone for the administration of personnel programs in a
manner conductive of the attainment of the objectives of the organization. The need for sound
personnel policies teams from the fact that in order to achieve the overall objectives of the
enterprise, an atmosphere has to be created in which optimum and spontaneous cooperation of the
employees can be achieved.

There are general courses of action that must be stated in writing in the employee’s
handbook and must be made known to all. There are ten 10 areas normally considered by personnel
policies:

1. Recruitment, selection and planning

2. Employee induction and training
3. Employees rating and promotion
4. Transfer, downgrading and lay-off
5. Disciplining and discharge
6. Salary and wage administration
7. Changes in work assignment and hours
8. Services for employees
9. Employee’s health and safety
10. Employee’s participation and work problems

FUNCTIONS OF A PERSONNEL MANANGER

In addition to recruiting and hiring, some of the responsibilities of a personnel manager are:

1. Recruit and interview job applicant

2. Administer employment tests to job applications
3. Indoctrinate new employees on laboratory objectives, policies and rules
4. Introduce the new employees to his officers of the organization, his subordinates
5. Motivate employees to do better
6. Keep employment records of all employees

78
 7. Assist in transferring, promoting, demoting, discharging or retiring employees
8. Handle complaints gripes, grievances and disciplinary action cases
9. Negotiate with the labor unions or union officials
10. Provide personnel services, medical, social, and recreational

To understand the personnel manager's job, think of how you would deal with the following
examples of challenging employee situations:

i. The firm's employees - especially the most qualified ones - can get
comparable, if not better jobs with other employers.

b. When a firm faces a scarcity of supervisory and specialized personnel with adequate
experience and job capabilities, it has to train and develop its own people. This can
be time consuming and expensive. The cost of hiring and training employees at all
levels is increasing, for instance, several thousand dollars for a salesperson. A
mistake in hiring or in slow and inefficient methods of training can be costly.

c. Personnel managers must comply with the law by employing, training and
promoting women and persons from minority groups. The problem in doing so is
that many of these employees have not had appropriate experience and education
in the past.

d. Often, the owner-manager of a firm also has to be the personnel manager. In such a
case it is necessary to have an overview of current trends and practices in personnel
management.

2. SOURCES OF LABOR

a. There are two sources of manpower that the administration can choose.

3. Internal Source – These include those existing staff who are already on the pay-roll of the
organization and those who served the organization in the past (but quit voluntarily or due
to retrenchment) and would return if the organization likes to re-employ. There is merit in
looking for internal sources since they provide opportunities for better deployment and
utilization of existing human resources through planned promotions and career development
where vacancies exist in higher grades. The law provides preference to retrenched
employees where vacancies arise in the future.

4. External Source - Employer outsources or transfers all or part of its recruitment activities to
an external service provider. Organizations may look for people outside it. Entry level jobs
are usually filled by new entrants from outside. Also in the following circumstances,
organizations may resort to outside sources when:

a. When suitably qualified people are not available.

b. When the organization feels it is necessary to inject new blood into it for fresh
ideas, initiatives, etc.
c. When it is diversifying into new avenues.
d. When it is merging with another organization.

5. PROCESS OF PERSONNEL SELECTION

a. Personnel selection is the process used to hire (or, less commonly, promote)
individuals. Although the term can apply to all aspects of the process (recruitment,
selection, hiring, acculturation, etc.) the most common meaning focuses on the
selection of workers. It is the methodical placement of individuals into jobs. Its

79
 impact on the organization is realized when employees achieve years or decades of
service to the employer. The process of selection follows a methodology to collect
information about an individual in order to determine if that individual should be
employed. The methodology used should not violate any laws regarding personnel
selection.
b. The minimum criteria used to define job positions are:
6. Minimum education
7. Experience
8. Licensure examination

a. The steps in the selection process include:

9. Posting or advertising job vacancies
10. Reception of applications/applicants either in person or in writing
11. Preliminary interview

a. Applicant reports to the personnel manager to his assistant who briefs him on
opportunities in the organization. If acceptable, applicant is made to take
employment tests such as:
12. Performance Tests
13. Intelligence Tests
14. Aptitude Tests
15. Interest Tests
16. Test of emotional reaction/and adjustments
17. Test of attitudes

An applicant is interviewed by the personnel manager. Interview is intended to check the

veracity of information contained in the Information Sheet or Application Blank and to secure more
information. It could be used to determine what type of personality, the applicant possesses. The
types of interviews used include:
- planned and patterned interviews
- non-directive interviews
- depth interviews
- group interviews

These are also included in the selection process:

- Investigation of applicant’s background
- Introduction of the qualified applicant to his immediate boss
- Selection from among qualified applicants
- Medical Examination
- Induction and placement of the new employee

The initial screening can be accomplished by the personnel department and only those
candidates meeting the minimum requirements or qualifications should be referred to the laboratory
for interview.

For supervisory position, these criteria may be qualitative and these are as follows:
- Communication skills
- Problem solving attitude
- Creativity
- Innovation
- Technical expertise in a clinical laboratory

It is also appropriate to check the candidates past employment records. It is helpful to

structure question to past employers around those criteria used in the interview. This gives excellent
comparison between the candidate response and proven work habits.

80
PERSONNEL INTERVIEW

Interview is an oral examination of candidates for employment. No selection process is

complete without one or more interviews. Interview is the most common and core method of both
obtaining information from job seekers and decision making on their suitability or otherwise.
Organizations may seek to make their selection process as objective as possible. But interview, which
is an essential element of the process by the large, still remains subjective.

Interviews usually take place at 2 crucial stages in the selection of process. Interviews can
differ in terms of their focus and format. Usually, several individuals interview one applicant. This is
called a panel interview. Such panels usually consist of representatives from personnel and concerned
operating units/line functions. In this method, usually, applicants get screened from one stage to
another. The interviews can be structured or unstructured, general or in-depth. Sometimes, where
the job requires the job holder to remain calm and composed under pressure, the candidates are
intentionally subjected to stresses and strains in the interview by asking some annoying or
embarrassing questions. This type of interview is called stress interview.

An applicant is interviewed by the personnel manager. Interview is intended to check the

veracity of information contained in the Information Sheet or Application Blank and to secure more
information. It could be used to determine what type of personality, the applicant possesses. The
types of interviews used include:

 Planned and patterned interviews

 Non-directive interviews
 Depth interviews
 Group interviews

Pointers in Personnel Interview:

1. Set stage in advance – arrange the venue of the interview.

2. Ask general questions first – This will make the applicant comfortable and reveal her true
self.
- Note: A good interviewer should be able to remove the mask of the applicant.

3. Respect the applicant’s individuality (religion, race, etc).

4. Do not ask questions answerable by “Yes” or “No” – This type of question would not allow
the applicant to express himself.

5. Do not jump into conclusion – You can identify the personality of an individual in just few
minutes.

POINTERS IN PERSONNEL SELECTION

Compare the accomplished bio-data sheet with the interview results.

1. Avoid person who is a job-hopper – A person who held 3 or 4 jobs in 5 years is considered as
a job hopper.
2. Avoid person with present emotional crisis.
3. Avoid person with bad handwriting
4. Avoid person with lots of unanswered questions.
5. Avoid overqualified and under qualified person.
6. Avoid a person who chose a friend or relative as reference.
7. Hire the person who you instinctively like.

81
 8. Hire one who works for financial reason.

PERSONNEL ORIENTATION

Personnel Orientation is the introduction of the employee to his new environment. This is a
crucial step in introducing the employee to his or her new environment comes after selection and
hiring process. An orientation program is probably one of the most overlooked tools available to the
manager.

Each laboratory should have a program of orientation for new employees to make them
aware of the policies and procedures used in particular laboratory. Even though a new employee may
be a registered medical technologist, his or her experience with the particular procedures in use in a
new environment may be limited. During this orientation, it should be emphasized that suggestions
for changing procedures or methods are welcome and will be given due consideration, but that each
employee must follow the laboratory method and procedure exactly as prescribed. Individual
initiative in modifying laboratory determination without consultation and proper documentation
should not be tolerated.

If done correctly, orientation can establish early in the employees career in understanding of
the philosophy of the laboratory and the institution. It can correct those misunderstandings that are
so often present with new employees and can establish in the beginning an open channel of
communication between the supervisor and the new employees.

The following is a minimum list of items that should be covered in the orientation:

1. A briefing of the history, objectives, policies, rules and regulations of the laboratory.
2. Introduction to his associates and subordinates.
3. Description of his duties and responsibilities and the role he plays in the organization.
4. Introduction to laboratory facilities and services
5. Briefing on mechanism of setting problems, complaint or grievance and rules pertaining to
discipline or reprimand
6. Briefing on opportunities for education, training and advancement
7. Briefing on sick leave policy and overtime work.
8. Try-out the employees new job
9. Another meeting between the new employee and the personnel manager before dismissal
from work for the day.

PERSONNEL EVALUATION

Personnel Evaluation consists of periodic written reports on employee’s performance. An

important part of development is a feedback, whether negative or positive. This can be accomplished
through random meetings, memoranda to the full or through a structured evaluation system. The
latter offers the opportunity for the employee and supervisor to take time to review past
performance, as well as to project future expectation. It provides the framework within which
constructive criticism can be given and provides the vehicle by which relationships can be defined. For
fairness and uniformity, the format should be used for ALL employees. The most frequently measured
areas are:

a. Adaptability - The employee’s ability to change behavior, attitude and work methods to meet
the demand of the situation.
b. Attendance – Faithfulness to coming to work and con-forming the assigned job duties.
c. Productivity – This is composed of the quantity and quality of work.
d. Quality of Work: Accuracy thoroughness and precision of work performed.
e. Quantity of Work: Amount of work performed in comparison with normal amount expected.

82
 f. Job knowledge and skills – The employees use of his training and experience in performing
the assigned job duties
g. Work relationships – Quality of relationships with co-workers supervisory staff, patients and
the public.
h. Initiative – Extra effort.
i. Responsiveness – How quickly an individual accomplishes an assignment.

Employees should be evaluated at regular intervals. In most laboratories, this is done on a

yearly basis usually on the employees hiring date.

Evaluations are necessary because:

- It provides a basis for counselling interview with the employee
- It provides a resource document for appraisal, for promotion, transfer, separation, and
references.
- It is a way to summarize day-to-day and week –to-week evaluation.

PROMOTION

Promotion is advancement of an employee to better in terms of greater responsibilities,

more prestige, or “status” greater skill, and especially, increase rate of pay or salary. This entails
greater responsibilities, higher pays, more prestige, higher status and specialties. This is the means an
improvement in pay, prestige, position and responsibilities of an employee within his or her
organization.

Promotion must be critically thought. This needs time for analysis. Promotion must be
documented to support the promotion since people will tend to challenge the credibility of a
manager’s judgment in promoting personnel. There must be a concrete basis for promotion.

Personal qualities considered in promotion are:

- Honesty
- Common sense
- Ambition
- Knowledge
- Initiative
- Originality
- Determination
- Understanding
- Enthusiasm
- Communicative ability

Furthermore, no one is promoted solely on the basis of seniority. Seniority is just considered
if candidates have equal points.

DISCIPLINE AND DISMISSAL

Some employees will fall short of expected standards. When this situation arises, decisive
action is imperative. No action is not an acceptable approach how much to take will depend upon the
type of infraction and the circumstances surrounding it.

For the protection of both employee and employer, disciplinary action requires documented
facts sufficient to support the contemplated action. Documentation should include the following:

- Specific instances of poor performances or misconduct

- Circumstances surrounding performances or misconduct
- Dates, times, places and names and titles of persons involved in the situation

83
 - Whether the employee knew what he was supposed to do; when and how bad he had been
told
- Prior misconduct, if any
- Evidence of warning that the misconduct should not be repeated or that the poor
performance could not continue
- Records that definite time limit was set for improvement and follow-up.

Some examples of failures of performance of duties requiring disciplinary actions are:

1. Inefficiency in the performance of duties (incompetency).

2. Negligence in the performance of duties.
3. Physical or mental incapacity for performing duties.
4. Habitual improper use of sick leave privileges.
5. Failure to maintain satisfactory and harmonious working relationships with the public and
fellow employees.

- All of these have in common the failure of the employees to meet standards related to
the quality of work.

When a disciplinary action becomes necessary because of failure of performance of duties,

the following steps are usually considered essential:

1. An oral warning (memorandum for record maintained by the department).

2. A second oral warning with a follow up letter to the employee. A re-evaluation of the
employee’s performance should be made in a specified period of time. This evaluation serves
as a method to rescind the previous action to the next step.
3. A written final warning to the employee. An evaluation of the employee’s performance
should again be made prior to a maximum of 6 months. At this time, the decision is made to
rescind the previous action or to proceed with disciplinary action, which may include the
dismissal.
4. The notice of dismissal should be in writing and should inform the employee of the reason
for dismissal and the method of appeal, which may include dismissal.

Some examples of job-related personnel conduct requiring disciplinary action:

1. Conviction of felony.
2. Wilful damage, destruction or theft of property.
3. Falsified job information to secure a position.
4. Possession of unauthorized fire arms or lethal weapons on the job.
5. Insubordination.
6. Reporting to work under the influence of alcohol or non-prescribed drugs or partaking of
such on the job.

Because of the seriousness of such acts, the laboratory head or supervisor may elect to
recommend dismissal of the employee immediately rather than following the sequences noted
above. In most hospitals, however, the procedure for such dismissal would include consultation with
the personnel department.

Termination requires time and deliberation before it comes to its point. As much as possible,
never let terminations happen. Once this happen, people will be affected, furthermore, the staff
might be backed-up by other people that may challenge the manager. In dismissing a staff, these
reminders must be remembered:

a. Never consider 1 offense as a basis of discharge.

b. Collect all documents as the basis for discharge.
c. Never discharge a staff with a poor decision and judgment.
d. Exhaust all positive reasons before making a discharge.

84
 e. Never use termination as a means for vengeance.
f. Look for specific instances of poor performance like dates, time, places and names involved.
g. Include incident reports and prior misconducts of the staff in the final document.
h. Evidence of warning of misconducts should not be reported.
i. Record of the definite time for follow-up must be included.

PERSONNEL RECORDS

Personnel department maintains the records of the employees working in the enterprise.
Personnel records keeps full records of their training, achievements, transfer, promotions, etc. it also
preserves many other records relating to the behavior of personnel like absenteeism and labor
turnover and the personnel programs and policies of the organization. This record should be
evaluated and considered when undertaking performance interview, transfer, promotion or releases.
The manager should keep records of rejected candidates for employment and also of suitable ones
but no present opening.

All institutions maintain some personnel records on employees, but the laboratory may wish
to keep a duplicate set of records for their use. If so, consideration should be given to what
information should be, and legally can be, kept in these records.

In addition to individual personnel records, larger laboratory maintains summary and

analysis records. This is to keep the director up to date on vacancies, personnel turnover, retirements,
staffing patterns, recruiting services, and other vital date to maintain a good staff.

The question of employee privacy has become a much discussed issue recently and court
cases have been brought relative to this question. Since laws pertaining to this are changing rapidly,
the reader is encouraged to determine what current organizational or federal guidelines exist relative
to this matter. Before duplicating, existing personnel records, thought should be given to the
implications and responsibilities related to such an act and counsel with appropriate personnel
authorities is advised.

These records must be centralized and with accessibility limits. It means that not all can view
these records as a sign of respect. Records must be confidential. These records must be made
permanent because staff might ask for referrals. As much as possible, use a separate clear book per
employee. Records include the history, responsibilities, etc. Records must be kept in a box which can
be accessed by managers.

EMPLOYEE’S CONFLICT

In a workplace, there is no perfect relationship. There are certain conflicts that occur inside
the laboratory. This is not only applicable among employees, but to other personnel as well.
Managers must be sensitive regarding this issue.

When conflicts arise, there are some signs to be noticed that results in the conflict of people.
These warning signs of conflict are:

1. Discussion between 2 people that flare up.

2. Open backbiting / back talks.
3. Complaints from 1 about the other.
4. No direct contact between two people.
5. Request for transfer from other sections.
6. Other employees talk about the feud.
7. Increased absenteeism without good reason.

85
 There are however, means to mediate conflicts. A manger must have the facilities and
he/she will only act as a facilitator. These are the following steps on how to mediate conflicts:

1. Don’t affix blame on another – Never point who did the wrong thing. A manger should be
thrifty in words. No side comments must be included.
2. Don’t threaten to fire anyone – Once this is mediated and not done, respect might be lost. Be
neutral and positive in approach.
3. Don’t jump in and suggest solutions before you have gathered all pertinent information.
4. Don’t nag in agreements as the employee explains his/her side – Give them time to explain
themselves.
5. Don’t rush the process – Take several meetings to solve the problem.

HABITUAL TARDINESS

In line with work, tardiness cannot be avoided. Some people have their own reasons why
they come late at work; some have no reasons at all. This is considered as a chronic disease with
unknown etiology. Although cures are rare, some remissions may be attained with the following
therapy

1. Deduct salaries for late minutes – Exhaust all positive means and use this as the last resort.
2. Reschedule for a later starting time (a half hour to one hour).
3. Reassign to a different department where there is no overlap of personnel.
4. When all fails, mark “improvement needed” on the employee’s performance evaluation.
5. If the employee has all other positive features, promote to supervisor. This is considered
“shock treatment” but often effective.

86
 CHAPTER 12

AUTOMATION

The primary driver of automation has been the need to create automated systems capable of
reducing or eliminating the many manual tasks required to perform analytical procedures. By
eliminating manual steps, the opportunity to reduce error is enhanced since the potential for error
due to fatigue or erroneous sample identification is reduced.

The 1970s saw the introduction and implementation of laboratory information systems,
automating the process of information flow in the clinical laboratory and eliminating the expected 5%
transcription error rate seen when laboratory results were manually transcribed into various medical
record formats. The 1990s saw the introduction of intralaboratory transportation systems, including
specimen carriers and a conveyor taking samples between instruments, and including processing
stations such as centrifugation, decapping/capping and storage, leading to the concept of total
laboratory automation.

In overall, the scope and magnitude of the drivers of automation have taken a direction
similar to all other technologies. Several of these drivers will be discussed in the context of how
automation in the clinical laboratory has changed over time to become what it is today. Several
analytical systems will be selected as examples of how manufacturers responded to the demands of
the laboratory. The cause and impact of change on the three stages of laboratory testing will be
presented, beginning with pre-analytical, then analytical and finally post-analytical stages. The
demands of the laboratory are paced in part by the needs of clinicians and patients, and this has
provided the majority of drivers that push the changes seen in laboratory automation today.

The factors that serve to drive laboratory automation include:

 Turnaround times (TAT) demands
 Specimen integrity
 Staff shortages
 Economic factors
 Less maintenance
 Less calibration
 Less downtime
 Faster start-up times
 24/7 uptime
 Throughput
 Computer and software technology
 Primary tube sampling
 Increasing the number of different analytes on one system
 Increasing the number of different methods on one system
 Reducing laboratory errors
 Number of specimens
 Types of fluids
 Safety
 Environmental concerns, i.e., biohazard risks

AUTOMATED ANALYSIS

The measurement of samples using automated instrumentation has undergone an

evolutionary process. It began with a single channel analyzer using continuous flow analysis and
measured one analyte on a batch of samples, i.e., one sample, one test. These samples were
measured in a sequential fashion, i.e., one sample after another. The specimen throughput rates were
approximately 40-60 per hour. Technicon continued to develop upon their systems, which evolved

87
into multiple channel instruments, e.g., SMAC II® that produced specimen throughput rates as high as
150 per hour with test throughput of approximately 3,750 tests per hour depending upon the test
configuration. One major disadvantage to this type of instrument configuration was that all testing
was performed in a parallel fashion. This resulted in the measurement of every analyte configured on
the system for every sample. This inflexibility in testing led to the development of analyzers that
provided “discrete” testing, i.e., measured only the tests requested on a sample.

The next generation of automated analyzers included centrifugal analyzers and modular
analyzer configurations. Centrifugal analyzers were discrete, batch-type systems. A significant
limitation at the time was the throughput rates. Because the analyzers were configured to measure
one analyte at a time, the only way to improve upon throughput was to purchase multiple systems so
that several tests could be run simultaneously depending upon how many systems the laboratory
purchased.

The solution to the drawbacks associated with centrifugal analysis was to design a modular
system that could be configured to measure multiple analytes on multiple samples and the process be
controlled by a computer rather than humans. This is the essence of random access testing. Modular
instruments allow the user to add-on additional units, e.g., ISE and/or immunoassay modules.

The ultimate result of combining modular design with random access testing was to increase
specimen throughput rates to hundreds per hour and test throughput rates to thousands per hour.

PRE-ANALYTICAL STAGE

The three stages of laboratory testing are pre-analytical, analytical and post-analytical.

The pre-analytical stage is concerned primarily with sample or specimen processing. For
decades specimens drawn within a facility were brought to the laboratory usually by the blood
drawers or ‘runners.’ If the specimens were obtained from outside the laboratory facility a courier
service was often used. Courier service is a batch process that requires scheduling from a given pick-
up point. These individuals represented the first link between patient and laboratory, and were also a
source of problems. One example of an early solution to replacing humans as specimen carriers was
the introduction of pneumatic tubes.

Pneumatic tube delivery systems were installed to provide point-to-point delivery of

specimens to the laboratory and offered several advantages over human transport. Pneumatic tube
systems are designed to prevent hemolysis by avoiding significant elevations of g forces during
acceleration and deceleration.

Electric track vehicles can transport a larger number of specimens than pneumatic tubes. The
electric tracks require a station for loading and unloading specimens and this may pose a problem in
facilities with limited space. Like couriers, electric tracks allow for batching of specimens.

Later robots or mobile robots of many designs were used by laboratories to transport
specimens from within and outside of the facility. Samples are usually batched for pick-up and delays
in time of pick-up notification occurred.

Once the specimens arrive at the laboratory processing workstation several tasks need to be
done.

The examples of sample processing tasks include:

Labelling – Labelling specimens by hand requires a substantial amount of time and

proved to be a large source of laboratory error. Labelling went beyond the specimen tube
and included pour-off tubes, sample cups, dilution cups and send-out containers. The use of
printed bar code labels facilitated this process tremendously. Later as computers and

88
 communications improved, the bar code label system improved processing time and reduced
pre-analytical errors.

Sorting – Manual sorting or separating of samples was needed because of the

diverse type of testing most laboratories engaged in. Specimen tubes of all shapes and sizes
would be received in the processing area of a clinical laboratory and the technologist would
have to sort tubes by stopper color, size, tests ordered, instrument design requirements and
tube destinations.

Decapping – In the earlier days of clinical laboratories each red top tube was double
spun so that clot removal was optimal. This step required manual decapping of the specimen
tubes. The decapping of tubes posed health hazards to the technologist via aerosol dispersal
from the tubes, and direct contact with the blood. The invention of the serum separator tube
eliminated the need for this double spin technique, and decapping at this stage was not
necessary.

Centrifuging – Centrifugation of blood collection tubes required the technologist to

manually load tube carriers and place them into the centrifuge. The tubes would then be
removed from the centrifuge and re-sorted, aliquots would be processed and the samples
distributed to their destinations or target area. This whole process was fraught with potential
safety hazards, opportunities for mistakes and large increases in sample processing time.

Aliquoting – Many specimens required aliquots to be poured off, also known as

splitting of the samples. The aliquots were used by instrument operators, sent to other
laboratories sections, sent out to reference laboratories and used for dilutions. Like other
manual processing steps, aliquoting blood specimens was a potential source of hazards for
the laboratory staff, errors and increased processing time.

Recapping/Storage/Retrieval – When the samples were no longer needed for

testing they were stored in a refrigerator or freezer. All of the samples were stored in an
organized fashion in the event that they were needed again for retesting. Manual storage
and retrieval of samples created big problems for some laboratories. Samples were often
lost, not stored properly, and hard to locate.

AUTOMATED APPROACHES IN SPECIMEN PROCESSING

Two goals for automating specimen processing are (1) to minimize non-value-added steps in
the laboratory process, e.g., sorting tubes, and (2) to increase available time for value-added steps in
the tasks that technologists perform that help make a difference in the quality of the test result and
ultimately, the diagnosis.

Advantages of automating laboratory testing include:

 increasing the quality of the pre-analytical steps

 reducing errors rates
 reducing operator exposure to potentially hazardous biological material
 eliminating repetitive stress injuries

There are several front-end sample processing systems available to improve upon all of the
shortcomings associated with manual sample processing. The system designs may be integrated
specimen processing or modular. Some modular systems are designed to exist as stand-alone front-
end processors.

1. Integrated specimen processing systems allow the user to perform some or the entire
specimen handling tasks. These systems process only certain types of samples and specimen

89
 containers. This inflexibility with specimen containers resulted in many laboratories,
especially hospital laboratories, to purchase modular specimen processing systems.

2. Modular specimen processing systems. Each module has its own on-board computer that is
linked to a master controller computer system. Also modular systems can accommodate
several different specimen types, e.g., whole blood, serum and plasma, with their respective
specimen containers.

Whatever is the configuration, each automated pre-analytical system attempts to provide

the user with some or all of the tasks necessary to prepare samples for testing. These tasks
include:

 pre-sorting
 centrifugation
 volume checks
 clot detection
 decapping
 secondary tube labeling
 aliquoting
 destination sorting into analyzer racks

3. Modular stand-alone system automates one portion of front-end processing. Stand-alone

systems automate the sample sorting, sample uncapping, and aliquot functions of the front-
end samples processing. A centrifuge is not included in this design. If serum or plasma is
required the sample must be carried to the centrifuge by the technologist.

Archiving and retrieval of specimens in an automated fashion is also available in

stand-alone designs. Automated sample archiving systems use bar-coded specimens that are
scanned and placed in numbered positions in numbered racks. Retrieval of specimens is
initiated by entering the patient's sample accession number or a medical record number into
the archival system's database. The rack number and position in the rack are determined and
displayed for the user. Some systems include a refrigerator for sample storage and automatic
disposal of samples at predetermined times.

Examples of Modular stand-alone systems are:

a. Olympus (Olympus American Inc., Diagnostic System Group, Melville, NY) has
designed a fully automated pre- and post-analytical sample handling system
that can serve as a stand-alone unit or modular unit to be utilized in
configurations that fit the laboratory's volume and workflow patterns. The OLA
2500™ Lab Automation System has several unique features that include:

 A camera station that recognizes tube types and tube sizes, and can be
used for sample material recognition as well as sample volume
calculations.
 The aliquoting unit uses disposable tips to eliminate any carryover. It
also can generate up to six daughter tubes from each mother tube.
 Archiving can be performed either in parallel to sorting or as a batch.

90
 Figure 5-1 Olympus® OLA 2500™ Lab Automation System. This system consists of a decapper,
sorter, archiver and aliquotter with throughput of 650 tubes per hour.

b. Modular systems are designed to automate the entire process. The automated
modular system decaps specimens, prepares aliquots, sorts (mother and
daughter samples) and transports specimens via a track system. A sample
sensor or transducer senses liquid levels, separator gels and detects short
samples. The Roche MODULAR PRE-ANALYTICS combines many of the pre-
analytical steps, which are coordinated using an intelligent process
management component.

Figure 5-2 Roche MODULAR PRE-ANALYTICS with “intelligent process management,” and modules
that provide bar code labels, centrifuge, destopper, aliquotter, restopper and sorter.

ANALTYICAL STAGE

The analytical stage of testing has evolved to a very sophisticated level due to the progress in
technology, improvements in computer technology, and as a result of many of the drivers of
automation listed earlier. The tasks in the analytical stage of laboratory testing are:

A. Sample Introduction

Automatic sampling may be accomplished using several different physical

mechanisms. Peristaltic pumps and positive-liquid displacements pipettes are two examples.

1. Peristaltic pumps are an example of older technology but are still used in some
instrument designs, e.g., electrolyte measurements.

91
 2. Positive-liquid displacement pipettes are usually a single pipette that transfers
samples from cups or tubes to the next analytical process. Most positive
displacement pipettes function in one of two ways.

 dispense aspirated samples into the reaction container, or

 flush out samples together with diluents.

 The movement of the sample from the sample cup or tube to its destination via
the sample probe is accomplished in several different ways. Some analyzers use
a robotic-like arm that pivots back and forth, picking up a sample and depositing
it into a reaction vessel or onto the surface of a porous pad. Other systems may
use a worm gear device that pulls the sample probe from one point to another.

 In most analyzers samples are pipetted using a thin, stainless steel probe. The
probe may be required to pierce a rubber stopper or pass directly into a test
tube or cup. A given quantity of sample is aspirated into the probe and the
probe is moved toward an appropriate container for dispensing. A potential
source of problems with this type of sample probe is the formation of a clot in a
sample that subsequently attaches to the probe. These clots may plug the
probe making continued use impossible. Also, the clot may occupy sample
volume and thus cause an error in the measurement. Several sample probe
designs have a clot detector capability and reject a sample that is clotted.
Another feature associated with sampling is the ability of the sample probe to
detect the presence of a liquid. These liquid level sensors detect the presence of
a short sample and will not allow the analyzer to continue processing this
sample. The pipette and liquid level sensor travel a specified distance into the
sample container to determine if liquid is present or not.

 Another problem associated with reusable pipette probes is carry-over. Carry-

over is contamination of one sample by the previous sample. This
contamination may cause serious variation in results for subsequent tests.
Several instrument modifications have been used to reduce carry-over. One
method used is to aspirate a wash solution in between each pipetting. Another
technique used is to back flush the probe using a wash solution. The wash
solution flows through the probe in a direction opposite to that of the
aspiration, into a waste container. This technique also tends to minimize the
risk of pulling a small clot further into the system.

 Many samplers use disposable plastic pipette tips to transfer samples. This has
the distinct advantage of eliminating carry-over associated with contamination
within the sample probe and from sample to sample. A downside to the use of
disposable tips is the increased cost associated with performing the assays.

B. Reagents

Reagents used in automated analyzers require attention to several concerns that

include:

 Handling, Preparation and Storage – Most laboratories use bulk reagents that
are ready for use with little or no preparation.

Reagents that come either wet or dry are maintained within the
reagent compartments and a complete inventory is established on real-time
basis within the computer. Most of the methodologies used in the laboratory
require only a single reagent, while several require two or more. As a reagent
becomes depleted, the computer signals the operator that the reagent

92
 container is empty and a new one should be added. The amount of inventory
for reagents that needs to be available within the analyzer depends upon the
volume of testing done for any given analyte. On-board reagent storage
compartments are refrigerated to maintain reagent stability.

Reagent identification and inventory processes are accomplished by

use of bar-coded labels.

An important classification category for all automated analyzers is

based upon reagents. Automated analyzers are categorized as open or closed
reagent systems. This distinction is often a key determinant as to whether a
laboratory will select an analyzer or not.

o Open reagent system is described as a system in which reagents other

than the instrument manufacturer's reagents can be used. Also, in an
open reagent system the operator may change the parameters
necessary to run the particular test. Open reagent systems provide the
users with more flexibility and adapt easily to new methods and
analytes.

o Closed reagent system is described as a system where the operator can

only use the manufacturer's reagents. Usually reagents for closed
reagent systems are more expensive, but closed reagent systems may
save on expenses because reconstitution or preparation of the
reagents for use does not require technologist time. Also the possibility
of increased imprecision associated with the reconstitution of reagents
in an open reagent system is negated with a closed reagent system.
One problem with a closed system is that it may not be possible to
introduce desired new tests that are not performed on the closed
system.

o Proprotioning of Reagent(s) – The correct proportion of reagent(s) and sample

must be constant to achieve precise and accurate results. For unit test
applications the reagents are already apportioned in the appropriate amounts,
thus only the sample needs to be added. Methods requiring the addition of bulk
reagents pose an additional means of increasing imprecision. When bulk
reagents are used, proportioning is . accomplished by automated volumetric
dispensing devices

Another mechanism used for proportioning reagents and sample is the

continuous-flow technique. The sample and reagents are proportioned by their
relative flow rates. Devices using continuous flow include peristaltic pumps.
Many instrument designs use electronic valves to control the time reagents can
flow. The flow rate is controlled by the air pressure applied to the reagent
container and the flow resistance in the tubing connected to the reaction
vessel.

 Dispensing of Reagent(s) – Liquid reagents are aspirated, delivered and

dispensed into mixing chambers or reaction vessels by pumps or positive-
displace syringes. On command from the computer each pump draws a given
amount of reagent or diluent out of the container and transports it via the
tubing to its destination where it is dispensed.

Syringe devices are widely used in automated systems for both reagent
and sample delivery. Most are positive-displacement devices, and the volume of
reagent delivered is computer controlled.

93
C. Mixing

There are many examples of unique mixing devices and techniques used in
automated systems. They include the following:

 magnetic stirring
 rotating paddles
 forceful dispensing
 the use of ultrasonic energy
 vigorous lateral displacement

Dry slide analyzers do not require mixing of sample and reagents. The sample is
allowed to flow through the layers containing reagents.

D. Incubation

Warming components or solutions in automated analyzers is accomplished by

heating air, water or metal. The warming process must be constant and accurate. Electronic
thermocouples and thermistors are used to monitor and maintain required temperatures in
analyzers. Circulating water baths are used in several instruments as the warming
mechanism. Thus these analyzers require a water purification and delivery system, which is
usually external to the analyzer and is an additional cost to consider. In some analyzers the
cuvets or reaction vessels are allowed to incubate within a chamber containing circulating
air. Heated metal blocks are a widely used device for incubating cuvets, test tubes or plastic
pouches containing solutions. The timing for each incubation period is monitored by the
instrument's computer system and represents an extremely complex process given the
throughput for these systems.

Two novel approaches for incubating reaction mixtures have been developed and
released on current automated chemistry analyzers are:

1. ADVIA® chemistry systems. Bayer Diagnostics (Tarrytown, NY) uses an elongated

cuvet path length and a fluorocarbon oil incubation bath to maximize result
accuracy by enhancing absorbance values, while using microvolume technology for
samples and reagents. This design feature is found in their model

2. Beckman Coulter uses a Peltier thermal electric module in the shape of a ring to
maintain a constant temperature for analysis. Peltier modules are small solid-state
devices that function as heat pumps. The Peltier thermal ring consisting of 125 quart
glass cuvets is made of copper. Each cuvet is surrounded on three sides by copper.
Temperature is maintained by the use of heating and sensing elements in physical
contact with a copper core filled with Freon 134A, and is controlled by the reaction
heat controller board assembly, mounted in the wheel's handle.

E. Detection

Absorption spectroscopy, Reflectance photometry, Fluorescent methods,

Chemiluminescence methods, Electrochemiluminescence methods, and automated
electrolyte measurement methods are all means of detection. The focus will be on new
approaches to measuring compounds with automated analyzers.

Novel approaches to measurement designs include not only addition of new

measurement principles but also inclusion of two or more unique detectors in one analytical
system. In Chemistry, most of the integrated chemistry analyzers being marketed today
incorporate several measuring platforms. Each platform requires a distinct detector.

94
  The Roche COBAS Integra 800 incorporates a photometer, ISE, FPIA optics and
turbidimetric optics.

 The Beckman Coulter™ SYNCHRON LX®i725 Clinical System includes a luminometer,

photometer, electrochemical detectors and near infrared detector. Infrared
detection is used for the near infrared particle immunoassay (NIPIA) method to
measure high-sensitivity C-reactive protein (hs-CRP). A 940 nm light-emitting diode
produces light that is directed into a cuvet to measure hs-CRP.

Figure 5-3 Beckman Coulter™ SYNCHRON LX®i725 clinical system has a large test menu (146 assays)
and will accept user-defined chemistry.

POST-ANALYTICAL STAGE

The electrical signal generated by the detector, representing analyte concentration, is

directed into the analyzer's microprocessor or computer.

The instrument computer represents a means to accomplish several tasks, which include:

a. Signal Processing – involves the conversion of an analog signal derived from the detector
to a digital signal, which is usable by all communication devices. Thus, computer
algorithms can transform nonlinear standard input signals into linear calibration plots.

b. Data Handling – Data processing by computers includes data acquisition, calculations,

monitoring and displaying data. In addition to transforming data into linear calibration
plots, computers can perform statistics on patient and control values. Computers can
perform corrections on data, subtract blank responses and determine first-order linear
regression for slope and intercept. Computers can monitor patient results against
reference values. They can also test control data against established QC protocols.
Computer monitors can display all types of information including patient results, QC
data, maintenance and instrumentation operation checks.

c. Process Control – The computer has a profound impact on the entire process of
automated laboratory instruments. Within the analyzer the computer commands and
times the electromechanical operations so that they can be done in a uniform manner,
in repeatable fashion and in the correct sequence. These operations include activating
pipetting devices, moving cuvets from one point to another, moving sample tubes and
dispensing reagents, to name a few.

Important features of computer instrument:

95
 1. A computer provides a means of communication between the analyzer and operator.

Instrument computers can display information usable by the operator, such as

warnings that something may not be working properly or that a specific reaction has
exceeded method-defined parameters.

2. A computer has the ability to be linked to other computers, which has drastically improved
automation efforts.

Instrument computers can be linked via interfaces, e.g., RS232, to laboratory

information systems (LIS) to provide a means of transmitting information either in a
unidirectional or bidirectional format. Instrument computers are now being equipped with
the means to link to the internet via a TCP/IP (transmission control protocol/internet
protocol). Instrument manufactures have designed analyzer computers that will link up from
the laboratory's to the company's own manufacturing site. This link-up is in real time and
serves to monitor the instrument's performance at all times. If a problem with the analyzer
does develop, the manufacturer can see real-time data to help the laboratory resolve the
problem in the shortest time possible.

3. Other features available in newer instrument designs that are worth noting.

On-board troubleshooting is available on many systems through the analyzer's

computers. In the event a problem occurs technologists may access the systems help
protocols, which guide them through a step-by-step procedure in an effort to resolve the
problem. Some of these on-board troubleshooting programs are quite sophisticated and
include video and graphics. Another on-board feature available in some systems is a training
program. This is an effective feature that serves to augment staff training of new users to the
system.

AUTOMATED SYSTEM DESIGNS AVAILABLE FOR LABORATORIES

1. Total Laboratory Automation (TLA)

The idea of totally automating a clinical laboratory has its roots in Japan and was
first tried in the early 1980s. The early designs used one-arm robots, conveyor belts and
modifications to existing analyzers to perform as many of pre-analytical and analytical tasks
as possible with no human intervention. Continued research and modifications to these
earlier systems led to the development of commercial TLA systems designed for hospital-
based laboratories.

A TLA approach can be described as the combination of several instruments,

consolidated instruments, workcells, integrated workcells or integrated modular workcells
that are coupled to a specimen management and transportation system as well as a process
control software component to automate a large percentage of laboratory work.

An example of a TLA is the Roche Diagnostics system that includes a modular pre-
analytics (MPA) and platform C (i.e. the chemistry analyzer). The Roche TLA consists of an
integrated tract device that connects all of the laboratory workstations, including front-end
processing, instrumentation and archiving, together to create a continuous, inclusive
network that serves to automate nearly every step involved in the testing of each sample.
TLA can incorporate testing specimens for chemistry, hematology, coagulation and
immunochemistry.

96
 Advantages of TLA Disadvantages of TLA
 a decrease in labeling errors  the needs for substantial financial
investment
- Initial investment monies may
reach millions of dollars
 reduced turnaround times  increased floor space
- floor space requirements may
exceed 4000 square feet
 reduction in full-time equivalents  the need for highly technical
(FTEs). personnel to operate and
troubleshoot the system
 ability to bring new assays into the  Other challenges
laboratory by using some of the - infrastructure remodeling
staff no longer needed for - personnel team building and
automated testing software interfacing

2. Modular Integrated Systems

Modular automation provides a more attractive approach for hospital laboratories

and physician group laboratories because the systems are smaller, require less initial capital
investment and require less planning than TLA. Modular systems can be configured to
include several different platforms, e.g., hematology and immunochemistry. Also, the
combination of modules can include multiple identical models of analyzers, pre- and post-
analytical modules. These modules are linked into a single testing platform that
interconnects by use of a track or other ‘connector’-type device. Individual modules can be
added to the entire system to reflect changes in either workload or testing patterns.

Configurations of Automated Modules:

a. Workstation Consolidation

Workstations represent a unique environment within a laboratory

facility dedicated to one type of testing, e.g., hematology and immunoassays.
All of the stages of specimen testing are carried out for a particular discipline at
its respective workstation. One approach taken to improve workflow has been
to consolidate workstation data management.

b. Workcells

A workcell is described as a combination of a specimen manager with

instruments or consolidated instruments reagents that provide a broad
spectrum of analytical tests. Modular workcells are workcells where the
instruments used are configured to interface directly with the specimen
manager. The Dade Behring StreamLAB® is an example of this type of workcell.
The StreamLAB® integrates pre-analytical and multiple analytical components,
e.g., Dimension® systems via a single operator interface. Dade Behring offers an
optional centrifugation module.

97
Figure 5-4 Dade Behring StreamLab® Analytical Workcell links multiple dimensions system via a
single operator interface and features automated pre- and post-analytical function.

3. Fully Integrated Systems

The trend in automation design is to integrate several modules into one continuous
system.

The Olympus AU5400™ Integrated Chemistry-Immunoassay analyzer is an example

of this trend toward combining instrument platforms. This system is a true random access
analyzer with test throughput rates exceeding 3,000 photometric tests per hour. For ISE
measurements the throughput rate is approximately 600 samples per hour. A distinct
advantage with these modular systems is the ability to be able to link two or more modules,
thereby increasing throughput.

Figure 5-5 Olympus AU5400™ fully automated integrated system is available as a two or three
photometric unit version including one single or double cell ISE unit. Throughput of 300-800
samples per hour depending upon configuration.

4. Other Enhancements to Integrated Automated Systems

A. Instrument Connectors

For Olympus developed a unit called the AU-Connector that enables clinical
chemistry and immunoassay analysis to be consolidated into one single workstation
without compromising function or performance of the connected systems. The AU-
Connector uses intelligent sample management and tube pre-sorting capabilities to keep
all the analyzers working at full potential. The AU-Connector does not use a track device,
which can create additional throughput bottlenecks and increase turnaround times.

98
 B. Middleware

Middleware allows laboratories to connect their existing LIS and instrumentation to

facilitate automatic information processing and performs tasks not currently done with
laboratories' existing hardware and software.

Middleware packages provide several features and functionality including:

 automatic verification of test results through rules-based decision
processing
 automation and customization of work and information based on a
laboratory's specific needs
 automatic tracking of data and location of samples requiring storage
 automatic sample interference testing and detection
 provision for real-time reflexive testing
 automatic comparison of current results with previous results on a patient's
test (delta checking)
Bibliography:

http://business.enotes.com/management-encyclopedia/art-science-management

http://searchcio.techtarget.com

http://management.about.com

http://encyclopedia.thefreedictionary

www.12manage.com

www.wikipedia.com

Shuffstall, R.M. and Hemmaplarph, Brecharr. The Hospital Laboratory: Modern Concepts of
Management, Operations and Finance. The C.V. Mosby Company, 1979.

http://ollie.dcccd.edu/mgmt1374/book_contents/5controlling/counslg/counsel.htm

Rabor, Rodolfo, Clinical Laboratory Management

http://ollie.dcccd.edu/mgmt1374/book_contents/5controlling/ctrlproc/ctrl_process.htm

http://en.wikipedia.org/wiki/Planning#Planning_basics

http://ollie.dcccd.edu/mgmt1374/book_contents/2planning/perf_objectives/perf_obj.htm

McPherson & Pincus: Henry's Clinical Diagnosis and Management by Laboratory Methods, 21st Ed.

99