LECTURE NOTES ON LABORATORY MANAGEMENT AND HEALTH

ECONOMY

By Mme Lonji Silvia

EXHIST students

Department: EBML 5109, MLS Students, Credit: 25 Hrs

I INTRODUCTION: CLINICAL LABORATORY ORGANIZATION
A laboratory is a place equipped for experimental study in a science or for testing and analysis.
A research laboratory is a place that provides opportunity for experimentation, observation, or
practice in a field of study. Clinical laboratories are healthcare facilities providing a wide range of
laboratory procedures which aid the physicians in carrying out the diagnosis, treatment, and
management of patients. It can be a hospital, public health, reference (usually private,
commercial facilities that do high volume routine and specialty testing. Most of the tests
performed are referred from physician's offices, hospitals, and other healthcare facilities like
nursing homes), specialty (do particular tests), private laboratory. There are many types of lab
facilities, including research labs, clinical labs, and hospital labs. These laboratories are
categorized depending on the type of service, purpose, and function they are providing their clients.
These laboratories are manned by medical technologists (clinical laboratory scientists) who are
trained to perform various tests to samples of biological specimens collected from its
patients. Most of the clinical laboratories are situated within or near hospital facilities to provide
access to both physicians and their patients. Classifications of clinical laboratories indicated below
reveal that these facilities can provide quality laboratory tests that are significant for addressing
medical and public health needs.

According to ownership - can be government-owned (public) which is usually part of hospitals

and medical centers under the department of pathology or laboratory medicine; or can be a private
facility as part of a privately-owned medical/healthcare institution

According to function - can be general clinical laboratories which provide common diagnostic
laboratory tests; or can be specialty laboratories that provide disease-specific diagnostic and
confirmatory tests

According to test specialization - facilities can provide tests on a particular field of interest listed
below:

Clinical Chemistry

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Clinical Microbiology

Hematology

Blood banking and Serology (aka Immunohematology, Transfusion Medicine)

Clinical Microscopy

Histopathology and Cytopathology

Molecular Biology

Public Health - providing tests such as water analysis, testing for environmental substances, among
other tests concerning public and environmental health.

As part of the laboratory network - these facilities operate in a coordinated manner which is usually
managed and supervised by authorities at different levels of the network. The different levels of
network include:

Peripheral laboratories - provide routine screening, diagnostic (e.g. conventional and rapid
diagnostic tests) and follow up tests for patients; usually situated in the community where people
can access its services

Intermediate-level laboratories - can be at the district, provincial and regional-level facilities;

may conduct additional tests than those provided in peripheral laboratories and can serve as referral
laboratories for special cases (district-level); aside from performing tests, they carry out
management and supervisory tasks under specific areas of jurisdiction (particularly provincial and
regional laboratories)

National reference laboratories - also known as the central level, which performs oversight and
overall management of the laboratory network in terms of policy and program implementation,
training and development, monitoring and evaluation and research; these facilities also provide a
range of routine and highly-specialized laboratory testing, including the introduction and phasing
in of new diagnostic tests

In the past, the value of clinical laboratories as an integral part of the healthcare system was not
well realized. Throughout time, more physicians have recognized the need for laboratory tests to
confirm their diagnoses and to support the monitoring of their patients as to its response to therapy.
Aside from its known value to individual patients, the function of clinical laboratories was also
used for screening and surveillance of diseases significant to public health. On a larger scale,
program managers used some relevant tests as surrogate indicators to assess the progress of public,
international and global health programs.

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Laboratory networks were developed across countries and states to foster proper coordination and
collaboration among clinical laboratories within the specified geographic areas. Quality
management systems within these laboratories have also become significant issues recently,
including the standardization of laboratory services, strengthening of laboratory systems and the
development of new and rapid diagnostic tools. These issues are continually addressed by local
and international health authorities and technical experts using the framework of a patient-centered
approach.

Clinical laboratories perform testing in a logical and strict manner. Generally, there are three
phases of the laboratory testing process that each facility should follow. Standard operating
procedure manuals and job aids are written for guidance for carrying out each step of the phase:
pre-analytical, analytical and post-analytical. While clinical laboratories, especially in the modern
day era, are usually known for its state-of-the-art laboratory machines and instruments that do the
majority of actual sample testing, these facilities still heavily rely on the laboratory professionals
that ensure that results are accurate and reliable.

Providing high-quality, diagnostic testing is the goal of all clinical laboratories. To attain this goal,
several issues and problems are needed to be addressed, which ultimately underline the need for
improving laboratory capacity. Addressing human and financial resources, training and
supervision, planning and budgeting, quality assurance, logistics and supply, biosafety and
equipment management, and other relevant laboratory aspects were found to be necessary to
optimize laboratory services provided to patients. From risk assessment to risk analysis, evaluation
and control down to the process of continuous quality improvement, the clinical laboratory should
and must be able to minimize errors along its path of the workflow (i.e., pre-analytic, analytic and
post-analytic phases). Such significant risks identified, for instance, in specimen collection and
handling and the disposal of laboratory wastes must be taken into consideration by all clinical
laboratories.

As the challenges faced by the clinical laboratories constantly arise, the most important value for
each healthcare professional is the recognition its significance for the patient welfare. While
patients and people in the community are not well aware of its role, the function and mandate of
clinical laboratories remain the same: the provision of high-quality laboratory diagnostic tests. The
development of newer diagnostic tests from its pipeline should not overestimate the need for
improving existing laboratory services. Health authorities at the global level and stakeholders
including clinicians, experts and other healthcare professionals at the local level must meet at both
ends recognizing that the existence of clinical laboratories taking its hold within the most important
clients of healthcare, its patients.

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 a) Hospital Lab Management

Hospital Lab Management is a highly functional area which makes committed investments in
terms of technologies, manpower and equipment. Conformity with accreditation guidelines is non-
negotiable for providing excellent customer service. In order to beat these challenges, hospitals
today are increasingly outsourcing their lab management function to external referral laboratories.
Entrusting experienced vendors with their Hospital Lab Management enables hospitals to focus on
their core healthcare services even as their patients get the best diagnostic care. Lab management
take into consideration:

 State-of-the-art lab and adherence to good lab practices

 Employing expert and experienced pathologists
 Lab operations as per national guidelines
 Regular launch of packages based on client feedback
 Observation of lab quality protocols – regular IQC (Internal Quality Check)
EQC (External Quality Check)

In the traditional model of hospital clinical laboratory management, laboratory managers and
staff are hospital employees. The laboratory is managed in a hierarchical, operational style in
which the laboratory manager or chief operating officer (COO) reports to the vice president of the
hospital. Strategic planning for laboratory services is left to hospital administrators, as are
purchases of new equipment and determination of personnel needs; information flows vertically
and generally is confined to hospital communication channels. This operational model, which has
been used successfully in business, can be highly efficient and effective in the hospital setting,
particularly in regard to managing laboratory costs and allocating resources. Furthermore, the
clearly defined reporting structure in the operational model allows for rapid decision making.
However, in this model the role of the medical director is often unclear, despite the fact that those
who hold that position are legally responsible for the quality of the services provided by the
laboratory. The Laboratory Management System (LMS) plays a crucial role in the broader hospital
software ecosystem, contributing significantly to the efficient functioning of the hospital's
laboratory operations. Its role encompasses various aspects related to the management and
coordination of laboratory processes, data, and resources. Here are key roles and functionalities of
a Laboratory Management System in hospital software:

Sample Tracking and Management:

Sample Registration: LMS helps in the systematic registration and tracking of patient
samples, ensuring a streamlined process from sample collection to analysis.

Barcode Integration: Utilizing barcoding technology, LMS enables accurate and efficient
sample identification, reducing the risk of errors in sample processing.

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Workflow Automation:

Process Automation: LMS automates laboratory workflows, from sample reception to result
reporting. This reduces manual errors, enhances efficiency, and ensures timely delivery of
results.

Instrument Integration: Integration with laboratory instruments allows seamless data transfer,
minimizing manual data entry and enhancing accuracy.

Test Request Management:

Physician and Patient Portal: LMS provides interfaces for physicians and patients to submit
and track test requests online, improving accessibility and communication between healthcare
providers and patients.

Inventory Management:

Reagent and Consumable Tracking: LMS helps in monitoring and managing inventory levels
of reagents, consumables, and other supplies, ensuring that the laboratory has adequate
resources for testing.

Expiration Alerts: The system can generate alerts for the expiration of reagents or supplies,
helping in proactive management and preventing the use of expired materials.

Result Reporting:

Electronic Reporting: LMS facilitates the electronic generation and distribution of test
results, enabling quick and secure delivery to healthcare providers.

Integration with Electronic Health Records (EHR): Results seamlessly integrate with the
hospital's EHR system, providing a comprehensive view of patient health records for
healthcare professionals.

Quality Control and Compliance:

Quality Assurance: LMS includes features for quality control, ensuring that laboratory tests
meet established standards and guidelines.

Compliance Management: The system helps in adhering to regulatory requirements, such as

those set by accreditation bodies, by maintaining and documenting compliance measures.

Data Security and Confidentiality:

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Secure Access: LMS implements robust security measures to restrict access to sensitive
patient data, ensuring confidentiality and compliance with privacy regulations.

Audit Trails: The system maintains detailed audit trails, recording activities and changes
made to patient records, supporting accountability and traceability.

Resource Optimization:

Workload Distribution: LMS assists in distributing workload efficiently among laboratory

staff, optimizing resource utilization and minimizing turnaround times for test results.

Instrument Utilization: By monitoring instrument usage, LMS helps in optimizing the

utilization of laboratory equipment, preventing bottlenecks and ensuring efficiency.

b) MANAGEMENT IN THE LAB

Management is an important aspect of the day to day life of the medical laboratory since the
emergence of accreditation. The accreditation standards include management as part of the
evaluation and it is necessary that the laboratory worker is familiar with the processes involved.
For every practicing laboratory personnel, improvement of diagnostic accuracy is an important
objective. Several retrospective and prospective methods are available that are important in the
attainment of this objective. Current regulations require that laboratory departments should have a
structured and active program of quality assurance and quality improvement with the goals of
enhancing patient safety, minimizing error, ensuring timely delivery of reports and monitoring
physician competence.

Management Responsibility
- Establish a policy relative to the design and implementation of the safety programme.
- Delegate authority for implementing the program
- Provide a safe and healthful work place
- Provide fund for the implementation of the program
- Assess the program- establish a mechanism to ensure safety
- Establish safety committee- regular report, recommendations regarding need for modification of
the program.

Safety Officer Responsibility

Technical advisor to the program
Assist in the development of safe work method
Advise management on safety issues
Assist safety committee

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Provide a variety of communication, e.g. hazard notice, safety data
Review a variety of plans which include facility designs, special equipment purchase in relation to
safety.
Supervisor Responsibility
Train the staff in lab practices required for safe conduct of work.
Evaluate regularity of the laboratory facilities, equipment, personnel and work place.
Correct unsafe condition as fire hazards, physical hazards, and defective equipment.
Employees’ Responsibility
Use of safe equipment
Report of malfunctioning of equipment
Report injuries or exposure
Report hazard or unsafe condition to supervisors

c) ORGANIZATION OF THE LABORATORY

Safely Designed and Organized Laboratory
It is clear that a poorly designed laboratory and over-crowding can increase the risk of laboratory
accidents. It is, therefore, important to know how the laboratory should be designed with regard to
safety considerations. The following are some of the features.
A. Adequate floor, bench and storage space
B. A floor that is well constructed with a surface that is nonslip, impermeable to liquids, and
resistant to those chemicals used in the laboratory.
C. Walls that is smooth, free from cracks, impermeable to liquids and easily washable.
D. A door at each end of the lab so that lab staff will not be trapped should a firebreak out.
E. Adequate ventilation with windows that can be opened.
F. Sectioning of the laboratory into separate rooms with places for patients, visitors, and reception
of specimens.
G. Bench surface that are without cracks, impervious, washable, and resistant to disinfectants and
chemicals.
H. Suitable storage facilities that include a well-ventilated, fire proof, locked store, for the storage
of flammable chemicals.
I. A good supply of gas, water, electric power & wall electric points
J. Provision of protective safety cabinets, fire extinguishers at accessible points, and adequate
waste disposal area, etc.

d) LABORATORY PLANNING

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Lab planning and design lays the foundation for efficient scientific work. It is the process of taking
both basic program elements and highly technical blocks and arranging them to create a
space that is both safe and efficient. It involves the integration and coordination of various
organizational resources like human resources. It aims to lead the laboratory staff to carry out
their tasks within limited time and supplies. It includes supervising daily operations and training
new personnel. Lab planning is an essential aspect of laboratory operations that is often
overlooked. However, planning for future growth and expansion is vital for ensuring that a lab
can keep pace with changing research needs, accommodate new equipment, and maintain
compliance with regulatory requirements.

e) LABORATORY MANAGEMENT AND ORGANIZATION

Lab management involves overseeing resources, operations, personnel, safety protocols and
compliance with regulations. As a result, lab managers have diverse responsibilities, including
equipment and inventory management, personnel supervision, safety compliance, budget planning
and research support. It characterizes the process of leading and directing all or part of an
organisation, through the use of human, financial and intellectual resources. Laboratory
organization involves both the physical establishment and its operations while lab management is
maintaining the laboratory which includes planning, organizing. Leading and controlling the tasks.
Management is a discipline that consists of a set of five general functions: planning, organizing,
staffing, leading and controlling
Lab management aims to see the effectiveness of the performance of laboratory staff to carry
out their duties in accordance with their respective authorities and responsibilities. The
laboratory must be managed properly to prevent the occurrence of various possible accidents due
to work. The curriculum includes eight core principles: leadership, behavior, environment,
planning, structure, values, communication, and innovation.

Laboratory coordinator is responsible for keeping laboratory facilities, equipment, and area in
clean, safe working order. Assemble and adjust tests and laboratory equipment for experiments
and procedures. Operate, adjust, and maintain a variety of laboratory equipment and scientific
instruments. Schedule laboratory equipment for use.

f) LAB DIRECTING
The laboratory Director is responsible for the overall operation and administration of the
laboratory, including the employment of competent personnel, equipment, safety, laboratory
policies, quality assurance, all testing (including proficiency testing) and test reports. Being a
laboratory director is not an easy job, as it involves dealing with multiple and complex tasks,
pressures, and expectations. You may face challenges such as securing and managing funding,
balancing research and administrative duties, resolving conflicts and issues, ensuring quality and
safety, and adapting to changes and uncertainties.

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 Functions of a director include

1 Scientific Leadership: A laboratory director is responsible for setting the research agenda and
ensuring the quality and integrity of the scientific work done in the lab. This involves developing
and implementing research plans, protocols, and policies, as well as reviewing and approving the
results, reports, and publications of the lab staff. A laboratory director also provides guidance and
mentorship to the researchers, technicians, and students working in the lab, and fosters a culture
of innovation, collaboration, and excellence.

2 Operational Management: A laboratory director is also in charge of managing the day-to-day

operations of the lab, including the budget, equipment, supplies, safety, and compliance. This
requires overseeing the procurement, maintenance, and calibration of the lab instruments and
materials, as well as ensuring that the lab meets the standards and regulations of the relevant
authorities and organizations. A laboratory director also coordinates and communicates with the
internal and external stakeholders of the lab, such as the administration, the funding agencies, the
collaborators, and the clients.

3 Strategic Vision: A laboratory director is not only focused on the current research projects, but
also on the future direction and goals of the lab. This involves identifying and pursuing new
opportunities for funding, partnerships, and innovation, as well as anticipating and addressing the
emerging trends and challenges in the field. A laboratory director also evaluates and improves the
performance and impact of the lab, and seeks to enhance its reputation and visibility in the
scientific community and beyond.

4 Qualifications and Skills: To become a laboratory director, you typically need a doctoral degree
in a relevant scientific discipline, such as biology, chemistry, physics, or engineering, as well as
several years of experience in conducting and supervising research in a laboratory setting.
Depending on the type and size of the lab, you may also need additional certifications or licenses
from professional or regulatory bodies. Moreover, you need to have strong skills in leadership,
communication, problem-solving, decision-making, and project management, as well as a passion
for science and discovery.

5 Challenges and Rewards

However, being a laboratory director can also be very rewarding, as you get to lead a team of
talented and dedicated scientists, contribute to the advancement of knowledge and innovation, and
make a positive impact on society and the environment.

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II ORGANIZATION AND SUPERVISION

a) LABORATORY DESIGN
It is the process of taking both basic program elements and highly technical blocks and
arranging them to create a space that is both safe and efficient. Great lab design solves the
riddle of how to incorporate more science into less space while creating architectural and
engineering balance. Laboratory layout design involves various approaches tailored to a
laboratory's specific needs and objectives. The design choice depends on attributes such as the
type of research conducted, available space, equipment requirements, and safety considerations.
Things to considered when planning include;

Laboratory Design Considerations

 Walls/Doors/Security.
 Windows.
 Flooring
 Sinks.
 Chemical/Waste Storage.
 Furniture Design, Location, and Exit Paths.
 Illumination.
 Earthquake Restraints.

Types of lab designs include:

 Generic Labs.
 Flexible Labs.
 Sustainable Labs.
 Collaborative Labs.
 Wet and Dry Labs.

Generic Labs: A lab is described as generic when it is part of a group of labs that are all the same
size and have the same basic cupboards and engineering services. This type of lab is a great option
for research suites that are being built without a specific team and their needs in mind. From an
administrative standpoint, they make a lot of sense since each team is given the same basic
equipment as a starting point. Some of the best generic labs have an element of flexibility, which
allows each team to adapt the lab to better suit their needs. They can even be designed with mobile
cupboard everywhere, except for fume hoods and sinks, which allows the whole lab to be moved
around to suit the team.

Flexible Labs: Flexible lab design has been growing in popularity and it is easy to see why.
Flexible labs allow the space to be adapted to new teams and new research, without having to
employ a team of contractors to reconfigure the lab. Instead, it can be done with much lower cost

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and disruption by the in-house maintenance team. More and more lab owners are beginning to see
the benefits of this type of design, despite the larger initial outlay that it requires when compared
to a more generic lab design. With moveable cupboard solutions and space flexibility, the
longevity of this type of lab design makes it a sensible investment that costs less over time than
more fixed designs.

Sustainable Labs: Sustainability is becoming a big concern in lab design, with research facilities
looking for ways to maximise efficiency whilst minimising their environmental impact. From
utilising sunlight to reduce the need for artificial heat and light, to reducing the exhaust rate through
fume hoods to get a better balance between safety and sustainability, there are many examples of
sustainable lab design. Some labs are now being built with sustainability in mind, using ethically
sourced materials and designed to make the most of natural resources. These not only provide
significant cost savings over time, but they also reduce the environmental impact of science labs,
which can be significant.

Collaborative Labs: Modern science is a highly collaborative activity, with the most successful
scientists having an in-depth knowledge of other professionals’ work. The best lab designs not
only facilitate, but encourage this kind of collaborating, providing meeting spaces where ideas can
be discussed as well as labs that encourage the teams to work together. Office space and write-up
areas are also important design elements that shouldn’t be left out of the modern lab. These allow
people working in different areas to come together and work in teams on developing research and
analysing research, which is often the foundation of research breakthroughs. From meeting places
and break rooms that let different teams mix, to labs that can be reconfigured to facilitate
collaboration between interdisciplinary team members, labs that promote collaboration are often
the cornerstone of successful teams.

Research facilities will usually include both wet and dry labs, designed for different types of
research. Wet labs usually include fume hoods, sinks, chemical-resistant surfaces and other
equipment designed for research that includes chemicals and other substances. Dry labs tend to
be more computer intensive, set up with requirements for electrical and data wiring. As technology
develops, lab automation and the use of the computer mean that wet lab space is being reduced
and dry lab space is being increased. More and more scientists spend a significant proportion of
their time at the computer, meaning that more labs are being designed with these spaces in mind.

Even in wet labs, there is often a requirement for adapting the space for computer use. In fume
hoods, for example, voice-activated computers are being used to get around the safety hazards
created by traditional laptops. Creating hardware enclosures or other facilities to ensure the
security of computers in a wet lab environment is a design issue that is becoming increasingly
important.

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 b) SPACE UTILIZATION IN THE LABORATORY
Space utilization is the measure of how efficient a space is, based on how frequently employees
use it. Efficient space utilization can improve lab efficiency by reducing costs, minimizing
waste, and improving human workflow. A well-planned lab space positively impacts the quality
of science and clinical outcomes, as researchers and clinicians can access all the resources and
equipment they need efficiently. The common spaces include a microscope room, an analytical
lab, an equipment room, a closed seawater system, a flume (water channels) laboratory, a
necropsy laboratory, a zoological collection and classroom. Determining the amount of space
depends on the expected equipment, workflow, and number of employees. One benchmark for
biotechnology labs puts the square footage per person at anywhere between 200 and 400 square
feet. Types of space include:

real space - actual objects in actual physical space.

measured space - the representation of that space in the computer and the representation of
locations of objects from sensor data etc.

virtual space - electronic spaces created to be portrayed to users, but not tied explicitly to the real
world.

Some tips to help you maximize your space in the lab so that everything you need to work
with fits and workflow is optimized.

1. Record Digitization.
2. Labeling of working areas
3. Smart Sharing of work surfaces
4. Define Work Areas.
5. Improved Organization.
6. Cleaning & Maintenance of equipment
7. Choice of new Technologies.

C) SYSTEM APPROACH AND ORGANIZATION THEORY

The systems approach is an external standard that measures effectiveness based on long-term
growth or sustainability. Effective systems are characterized by a steady state that systems theorists
call homeostasis. Homeostasis is a measure of how effective an organization is.

By a systems approach to management means the study of a firm in its totality so that the men and
material resources of the firm can be organized to realize the firm's overall objectives as efficiently
as possible. System theory focuses on understanding a system as a whole along with the underlying

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interactions of all the forces that make up that system, rather than dissecting a complex process
and studying the individual parts.

A systems approach brings together interviews, dialogue, openness to perspectives from

public and private sectors, and people at all levels of an institution's hierarchy. The systems
approach provides a helpful way to understand organisations and how they are managed. It
encourages us to look at the bigger picture and consider how different parts of the organisation
interact with each other.

The theory emphasizes that a system is not simply a collection of individual parts but rather an
organized whole, where the interdependence of its parts contributes to the unique characteristics
of the entire system. Every system, including organisations, is composed of interdependent
subsystems, which themselves can consist of smaller subsystems. This recognition highlights the
complexity and interconnectedness of organisations as open systems. Unlike closed systems, open
systems interact with their external environment, relying on it for energy, information, and
materials. These interactions with the external environment influence the functioning of the
system. Open systems can adapt to changes in their external environment, ensuring their continued
viability and survival.

Some of the features of the systems approach to management are:

Interconnected Sub-systems: An organisation is like a big puzzle made up of smaller pieces that
work together. These pieces, called sub-systems, interact and depend on each other for the
organisation to function properly.

No Isolation: We can’t understand the sub-systems by looking at them individually. Instead, we

need to see how they relate to each other and to the organisation as a whole. It’s like understanding
how each puzzle piece fits into the larger picture.

Boundary: An organisation has a boundary that sets it apart from other systems. It helps us
identify which parts are inside (like employees) and which parts are outside (like customers). This
boundary defines the organisation’s scope and limits.

Changing Environment: Organisations are dynamic systems because they are affected by their
environment. They can be influenced by things, like power cuts, strikes, or shifts in customer
preferences. That’s why management needs to keep an eye on what’s happening outside and make
adjustments when needed.

Sensitivity to the Environment: Because organisations are influenced by their environment, they
need to be sensitive to changes. Just like we react when something unexpected happens,
organisations must be responsive and adapt to external factors that may affect their operations.

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Monitoring and Taking Action: To ensure a healthy organisation, it’s crucial to constantly
monitor its well-being. Management needs to pay attention to signs of problems and take corrective
action promptly. It’s like regularly checking the pulse of the organisation to make sure everything
is running smoothly.

Uses and Limitations of Systems Approach to Management

Some of the uses of the Systems Approach are:

1. Meaningful Analysis: The systems approach provides a helpful way to understand

organisations and how they are managed. It encourages us to look at the bigger picture and
consider how different parts of the organisation interact with each other.

2. Integrated Thinking: Instead of focusing on individual problems in isolation, the systems

approach encourages us to think about how different problems and solutions are connected.
This helps us see the organisation as a whole and make more informed decisions.

3. Unified Focus: The systems approach helps bring everyone in the organisation together
by giving a common focus. It helps align goals, strategies, and actions across different
teams and departments, making sure everyone is working towards the same objectives.

4. Dynamic Nature: Organisations are always changing, and the systems approach
recognizes this. It reminds us that organisations need to be adaptable and flexible to keep
up with the constantly evolving business environment.

5. Understanding Interactions: The systems approach highlights the importance of how

different things in the organisation interact and depend on each other. It helps us see the
ripple effects of changes and decisions, allowing us to make better choices.

The following are the limitations of the systems approach:

1. Simplification: While the systems approach is helpful, it may oversimplify the complexity
of real-life organisations. Real organisations can be much more intricate and have more
nuances than what the systems approach may capture.

2. Subjectivity: Applying the systems approach requires interpretation and judgment, which
can vary from person to person. Different managers may see things differently, leading to
potential variations in analysis and decision-making.

3. Time and Resource Constraints: Using the systems approach can take time and
resources. It may be challenging to gather and analyze all the necessary data, especially for
larger and more complex organisations.

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 4. Overemphasis on Interactions: While understanding interactions is crucial, focusing
solely on them may overlook the unique qualities and contributions of individual elements
in the organisation.

5. Lack of Precision: The systems approach provides a general framework rather than
specific step-by-step instructions. Its concepts are open to interpretation and can vary
depending on the situation.

III STEPS IN CLINICAL LABORATORY WORKFLOW

a) SPECIMEN COLLECTION, DELIVERY, RECEIVING AND ENTRY

Collecting specimens is the process of acquiring tissue or fluids for laboratory analysis. Some
of the samples collected may include serum samples, virology swab samples, biopsy and necropsy
tissue, cerebrospinal fluid, whole blood for PCR, and urine samples. The sample is obtained by
needle puncture and withdrawn by suction through the needle into a special collection tube.
Some specimens may be obtained by a finger puncture that produces a drop of blood, such as that
used for glucose testing.

The specimen collection and processing department is where laboratory specimens are received,
accessioned, evaluated for adequacy and urgency, and prepared for testing. Most blood and other
specimens are not collected in the clinical laboratory but in various hospital wards, intensive care
units (ICUs), emergency departments, and other inpatient and outpatient locations. Some hospital
clinical laboratories have a phlebotomy and urine collection area for patients who come directly
to the laboratory.

The specimen collection and processing department is staffed by medical lab technicians (MLTs),
phlebotomists, and medical lab assistants (MLAs). In some instances, MLSs are also present,
generally as supervisors. When a specimen is received in the laboratory, the staff are responsible
for accessioning the specimen.
The hospital and laboratory staff collect most blood specimens from patients using phlebotomy.
Also known as venipuncture, phlebotomy is performed by applying a tourniquet and then inserting
a small needle into an appropriate vein in the antecubital fossa, forearm, or the back of the hand.
The blood is then drawn into collection tubes containing various additives, such as anticoagulants
or clot activators, appropriate for specific tests. The tubes are distinguished by a universal color-
coded top system:

 Light blue top: coagulation testing, including prothrombin time and aPTT
 Lavender top: hematology testing, including the complete blood count (CBC)

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  Speckle top: also known as a serum separator tube, chemistry testing, including the lipid
panel
 Red top: chemistry, immunology, and transfusion services testing, including hepatitis and
HIV tests
 Green top: chemistry testing, including the basic metabolic panel (BMP)
 Gold top: chemistry and immunology and serology testing
 Pink top: transfusion services testing, including ABO and Rh blood typing

The staff may also collect urine from outpatients if required for testing. Most urine specimens are
known as random specimens since there is no designated collection time. Other urine tests may
require specimens to be collected at specific times, such as first in the morning.
After accessioning specimens and confirming integrity, the staff may perform additional
processing, such as centrifugation. Once specimens are fully prepared, they are sent to the
appropriate laboratory departments for testing, sometimes by a track system.

Specimen Type Method of Collection

Venous Direct puncture of vein by venipuncture;
vascular access device
Arterial Direct puncture of artery
Capillary Dermal puncture of finger or heel

Specimens should be in tightly sealed, leak proof containers and transported in sealable,
leak-proof plastic bags. Specimens for TB should be double bagged. Specimens should not be
externally contaminated. Specimens grossly contaminated or compromised may be rejected.

In line with standard precautions, appropriate personal protective equipment should be worn when
collecting or handling specimens. Specimens should be collected in sterile containers with close
fitting lids to avoid contamination and spillage. It is not necessary to collect stool specimens in
a sterile container.

Specimen barcode labels are printed at the patient location. Upon arrival in the specimen
receiving area, specimens are logged into the information system with the specimen collection
time and the arrival time. Specimens are then sorted according to laboratory and/or priority
sections. Once a sample enters the laboratory, there are a number of steps needed prior to testing.
Verify the sample is properly labelled, adequate in quantity, in good condition and
appropriate for the test requested. The test request must be complete and include all necessary
information.

A sample is a subset taken for some purpose from a larger population. A specimen is an
individual member of the sample. For example, we might take a sample of 3 rocks from a bag.

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 b) TEST PERFORMANCE IN THE MEDICAL LABORATORY
Current literature utilizes different performance indicators such as capacity utilization,
throughput cost, material handling cost, timeliness and waiting time, and
maintenance/downtime and safety etc. to assess laboratory performance through the
quantification of the processes under consideration. Common Tests Include:

 Basic Metabolic Panel (BMP)

 Comprehensive Metabolic Panel (CMP)
 Lipid Profile.
 Thyroid Test(s)
 Complete Blood Count (CBC) with or without White Blood Cell (WBC) Differential.
 Prothrombin Time (PT) with INR & Activated Partial Thromboplastin Time (PTT)
 Urinalysis (UA)
 Stool test for intestinal parasites
 Blood test for hemoparasites or diseases like malaria, leishmaniasis, filariasis

A quality indicator is defined as an objective measure evaluating critical health care domains as
defined by the Institute of Medicine (IOM) that is patient safety, effectiveness, equity, patient
centeredness, timeliness, and efficiency). The three phases of laboratory testing are:

 Preanalytical phase. Selecting the appropriate test, obtaining the specimen, labeling it with
the patient's name, providing timely transport to the laboratory, registering receipt in the
laboratory, and processing before testing.
 Analytical phase.
 Postanalytical phase.

During performance, the “laboratory testing cycle” is taken into great consideration which consists
of all steps between the time when a clinician thinks about and orders a laboratory test and
the time the appropriate patient's sample for testing is obtained (eg, a blood specimen taken
from an antecubital vein) and the results of the testing are returned to the doctor.

c) RECORDING AND REPORTING RESULTS

Records are the collected information produced by the laboratory in the process of
performing and reporting a laboratory test. The two major types of records are physical records
(filing cabinets like registers) and electronic records (computer-aided and online) hence, the
choice of each depends on the laboratory. Characteristics of records are that they: need to be
easily retrieved or accessed; • contain information that is permanent, and does not require updating.
Records provide a basic reference which the individual and others can refer to a later date;
legal evidence with respect to the materials recorded, such as conception of an invention and the
date thereof or date of reduction to practice and test results; in some instances are required for

17
compliance with the provisions in . There are four types of records: official records, transitory
records, non-records, and personal records. Some records are kept for a short amount of time,
and some records have long retention periods. Retention periods for records are approved by
Retention and Disposal Schedules. Good recordkeeping can be your proof that you have made
considered decisions and taken appropriate actions. Records become your protection if you are
questioned or challenged. Without them, you are at risk. Good recordkeeping can not only protect
you but can support your organisation in legal or other challenges.

Characteristics of good documentation

 All relevant information must be recorded.

 All paper records must be legible, signed and dated.
 Records must be contemporaneous, accurate and kept up to date.
 Records must be written in plain English avoiding jargon.

Lab results show the data that was collected or found during the experiment. Explain in words
the data that was collected. If using graphs, charts, or other figures, present them in the
results section of the lab report. Tables should be labeled numerically, as "Table 1", "Table 2",
etc. One of the best ways to represent the results of your study is by using graphs and tables (in
lab reports, graphs and other images are usually known as "figures"). This is because they are easy
to read and convey a lot of information to the reader in an efficient way. A lab report conveys the
aim, methods, results, and conclusions of a scientific experiment. The main purpose of a lab
report is to demonstrate your understanding of the scientific method by performing and evaluating
a hands-on lab experiment. This type of assignment is usually shorter than a research paper.

All lab results need to be validated before reporting. Following steps were taken to validate a new
test:

1. Verification or Establishment of Reference Intervals.

2. Verification of Analytic Accuracy.
3. Verification of Precision.
4. Verification of Limit of Detection and Limit of Quantitation. ...
5. Analytical Sensitivity.
6. Verification of Analytic Interferences.
7. Verification of Reportable Range.

d) PROCEDURAL AND INSTRUMENTATION REQUIREMENTS

Instrumentation is the design, equipping, and/or use of measuring instruments in determining

real-life conditions in a animal's process, as for observation, measurement and control.
Instrumentation technicians will install, maintain and calibrate devices used in the automation of

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industrial processes. Instruments are built using a variety of components, including pumps,
cylinders, valves, hoses, fittings, gauges, sensors, filters, seals, clamps, inserts, and reservoirs.
Laboratory instrumentation is the use or application of instruments for observation,
measurement, or control. It involves the use of or operation with instruments; especially: the use
of one or more instruments in carrying out laboratory tests. To install an equipment, consider these
important qualities: there must be adequate room to move the equipment into the laboratory;
consider door openings and elevator access. Before equipment is installed, verify that all physical
requirements (electrical, space, doors, ventilation and water supply) have been met.

General supplies are necessary laboratory equipment required to carry out various procedures and
are present in every laboratory. These include simpler items such as test tubes, beakers and other
glassware, racks, gloves, Petri plates, reagent bottles, containers and storage box. Lab procedures
are detailed documents, checklists or guidelines that instruct you how to safely carry out an
action in a laboratory environment. The key here is to remember that a lab process tells your
team how to do something (create a compound, carry out a reaction, etc). You can´t carry out
analyses and syntheses without technical laboratory instruments. Since there are various
methods for analysis and synthesis, it is important that are you previously aware of the method
you want to use.

Safety procedural Lab Practices

 No Food or Drink.
 Wear Your PPE and Proper Lab Attire.
 Good Hygiene.
 Use Proper Storage Containers.
 Label Your Work Space.
 Don't Work Alone.
 Stay Focused and Aware of Your Surroundings.
 Participate in Safety Exercises.

e) WORK SCHEDULE WORKLOAD MEASUREMENT

A work schedule means job hours, time for work allocated for employees. It determines typical
work hours (e.g., 8 hours per day), dates when employees are supposed to work and rest. To write
a job schedule, Start by writing down a to-do list of all your tasks and assignments. You can
also write down your daily errands, tasks, and obligations to see the big picture of what you need
to accomplish. Don't limit your thinking to just work – include your family duties and hobbies too.
Remember, try not to be too vague. Steps in writing a schedule involve: List to-do items. Before

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you can organize your to-dos, you first need to make a list of all the items you need to do for the
day. ...

1. Prioritize tasks.
2. Note deadlines.
3. Identify recurring events.
4. Order items by time, priority, or deadline.
5. Stay flexible.

A department’s workload is a key indicator for understanding the efficiency and productivity of
a team within an organization.

By measuring workload, you can easily spot any problems or imbalances and take measures to
improve efficiency and productivity.

Steps in measuring workload

1. Define the workload: First of all, it is essential to define what is meant by “departmental
workload.” A department must handle this volume of activities and tasks in a given period. This
can include projects, daily tasks, meetings, and other responsibilities. The key is to envision what
needs to be done clearly. Accurately defining the workload means outlining and quantifying these
activities, ensuring a solid foundation for subsequent analysis and management steps.

2. Analyze the resources involved in the process: After defining the workload, it is crucial to
examine the resources available. This is not limited to counting the number of people in the
department but requires a thorough analysis of each individual’s skills, experience, and abilities.
Understanding the potential and limitations of each team member is critical in determining whether
the department has adequate resources to deal with the expected workload.

3. Use project management software: Workload management can benefit significantly from
using project management tools. These software programs provide a detailed and organized view
of current activities, upcoming deadlines, and project status.

4. Monitor and analyze your data: Once the tools and processes are implemented, monitoring
and analyzing the data is essential. This will help identify bottlenecks, areas of inefficiency, and
opportunities for improvement. Data can be used to make informed decisions and changes to
increase the department’s efficiency.

5. Review and update your processes: No department remains static. Needs, priorities, and
workload can evolve. Consequently, it is essential to periodically review the processes and
strategies adopted, making the necessary changes to ensure that the department can always respond

20
effectively and timely to new challenges. This continuous review ensures that management is agile
and adaptable to changing business needs.

Benefits of measuring a department’s workload:

Resource optimization: knowing the workload enables efficient resource allocation, ensuring
each department member is employed to the best of their ability.

Better planning: a clear understanding of workload helps plan activities, ensuring deadlines are
met, and projects are completed on time.

Identification of bottlenecks: measuring workload can highlight areas of congestion or overload,

allowing early action to resolve such problems.

Increased productivity: regular monitoring of workload can lead to greater efficiency, reducing
wasted time and increasing the department’s overall productivity.

Improved employee well-being: a balanced workload prevents employee overload, reducing

stress and improving job satisfaction.

Forecasting and preparation: knowing the current and future workload allows the department to
prepare for work peaks or quiet periods adequately.

Continuous improvement: workload analysis can lead to discovering areas for improvement
promoting innovation and efficiency within the department.

Priority management: with a clear view of work activities, you can set priorities, ensuring that
the most critical tasks receive attention.

Transparency and communication: measuring and sharing workload can improve

communication within the department and other parts of the organization, promoting greater
understanding and collaboration.

Performance evaluation: measurement can be used as a metric in performance evaluations,

helping to identify team members who excel and those who may need additional support or
training.

In summary, measuring departmental workload provides a clear overview of current operations,

enabling more effective and informed management of resources and activities.

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 IV PRODUCTIVITY

a) PERSONNEL REQUIREMENTS

Laboratory Personnel are individuals who work in the laboratory including research scientists,
post-doctoral fellows, technicians, undergraduate and graduate students, visiting scientists,
laboratory volunteers, support personnel, and glassware washers. Technologist-level personnel
should possess a baccalaureate degree and successfully complete an accredited or approved
training program or specified work experience. Technician-level personnel should possess an
associate degree and successfully complete an accredited or approved medical laboratory-training
program. Personnel performing moderately complex testing must have earned a high school
diploma or equivalent. A medical laboratory scientist (MLS), also known as a medical technologist
or clinical laboratory scientist, works to analyze a variety of biological specimens. They are
responsible for performing scientific testing on samples and reporting results to physicians.

The following is the hierarchy of the clinical laboratory staff from highest authority to lowest:
pathologist, pathologist assistant, laboratory manager, department supervisor, chief technologist
(lead technologist), cytotechnologist, medical technologist, histotechnologist, medical laboratory
technician, medical phlebotomists. The laboratory Director is responsible for the overall
operation and administration of the laboratory, including the employment of competent personnel,
equipment, safety, laboratory policies, quality assurance, all testing (including proficiency testing)
and test reports.

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 b) PROBLEM SOLVING AND PERSONNEL RELATIONS

Safety is a top priority in any laboratory, especially when working with hazardous materials,
equipment, or procedures. However, accidents and incidents can happen, and you need to be
prepared to deal with them effectively. That's why problem-solving skills are essential for
laboratory managers and staff. Problem-solving enables us to identify and exploit opportunities
in the environment and exert (some level of) control over the future. Problem solving skills
and the problem-solving process are a critical part of daily life both as individuals and
organizations. As an instructional tool, problem solving attempts to situate the learning of scientific
ideas and practices in an applicative context, thus providing an opportunity to transform science
learning into an active, relevant, and motivating experience.

7 Key Steps to Improve Your Problem Solving Skills

Step 1: Define The Problem.

Step 2: Analyse The Problem.

Step 3: Develop Potential Solutions.

Step 4: Evaluate The Options.

Step 5: Select The Best Option.

Step 6: Implement The Solution.

Step 7: Measure The Results.

The relationship of medical staff raise many important issues in medical practice, which must
include not only professional competence but also the implementation of effective professional
communication, observation and interaction. Good professional communication in medical
practice is achieved through the strict observance of the established rules of medical ethics.
Compliance with both the universal and the specific rules for medical professionals to
communicate, create an atmosphere of trust, support and empathy in the process of working with
medical staff from different departments in the hospital environment. Professional relationships
are depending on the interplay of medical laboratory assistant, nurse and physician. They are
central to success. Essential for the individual's emotional intelligence - the ability, which helps
people to build a harmonious relationship between them, will probably be more highly valued as
an advantage in the workplace. Completeness of care cannot be achieved by a professional, it is
therefore necessary interaction between the work of the medical laboratory assistant, nurse and
doctor.

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Team is a group of people who have a common goal, interdependence and shared responsibility.
The team consists of a small group of people with complementary skills who are bound by a
common intention, job goals and approach for which they are mutually accountable. Teams have
command or linear power in carrying out the tasks and membership of the team which is based on
specific skills required to perform the tasks. Not all groups are working in teams. A working group
becomes a team when individuals must apply skills group pocess to achieve specific results. Team
members have a different roles in the development of an organization that is taking specific roles
hence it is called differentiation of roles.

c) EVALUATION OF PERFORMANCE

One of the first steps for evaluating laboratory personnel is to define clear and measurable
objectives for each role and task. Objectives should be aligned with the laboratory's mission,
vision, and goals, and should reflect the expectations and standards of the laboratory. Examples
of KPIs related to processes:

 Quality control.
 The time your staff spends at the bench.
 Turn-around-time for the analyses.
 Uptime of devices.
 Total working space and free space in the lab
 Uncertainty Analysis. When it comes to measurement, quality is important.
 Customer Satisfaction.
 Nonconformities & Complaints.
 Technician Throughput.
 Customer Retention.
 Equipment Failures and Interval Analysis.

Measuring laboratory performance effectively involves tracking key performance indicators

(KPIs) such as: Turnaround Time: Speed of processing samples to results. Accuracy Rates:
Proportion of tests with correct results. Equipment Downtime: Frequency and duration of non-
operational equipment.

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 V GENERAL CONSIDERATIONS

a) COMMUNICATION IN CLINICAL LABORATORY

Laboratorians focus strongly on developing scientific and technical knowledge and skills.
However, it is also important to develop the ability to communicate with coworkers and customers,
as well as build and maintain interpersonal relationships in the lab to facilitate a good team. When
practicing good communication skills, it is important to implement the following tools:

 Be aware of other forms of communication that one may be giving off (verbal, written and
body language).
 Be clear, concise, concrete, correct and coherent.
 Be mindful of one’s tone.
 Be patient.
 Confirm the expectations of each team member.
 One shouldn’t be afraid to say that they don’t know.
 Listen closely.
 When talking to colleagues and clients, one should remember that both parties share a
common goal.

Barriers to Communication and Ways to Overcome Them

Over Communicating: Over communicating can be a barrier to effectively communicating in the

workplace. Overloading someone with too much information can lead to confusion, and the point
of the conversation may be lost. To avoid over communicating it is suggested that you take a
moment prior to a conversation to confirm the main points. Sticking to these points, while keeping
details supplemental, facilitates a more streamlined, clear conversation.

Lack of Trust: It is suggested that working with a trustworthy member of the group to develop
strategies for sharing information with the group at-large can help appease fears of being
misunderstood. This method also works if one is uncomfortable with sharing in front of a group.

Impatience: Having patience with the intended audience is also important. Laboratorians work
with colleagues from diverse cultural and educational backgrounds. When speaking to someone
whose native language is not English, be patient and understanding, as that person may not feel
confident with their words. When speaking to a person who is unfamiliar with the technical
language, make sure to describe the situation in terms that they would understand.”

Lack of Confidence: Another way to overcome these barriers to communication is to speak up

when being trained. There are no stupid questions. It can let the trainer know that the trainee is
interested in learning more about the tests being performed. It also helps the trainer relearn any
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gaps in their knowledge and helps them improve their training. The trainer has been in the trainee’s
shoes before and understands that questions need to be asked. One can also speak up by sharing
constructive feedback either during or following a collaborative project.

b) CHANNELS OF COMMUNICATION

A communication channel is an abstract data structure that allows for the transmission of
messages between processes or nodes. It is a method or mechanism through which information
is exchanged between entities. Communication channels can be used in various contexts, such
as programming languages, vehicle ad hoc networks, information theory, and integrated
development environments. In programming languages like OCCAM, channels are used to
pass messages between processes. In vehicle ad hoc networks, communication channels consist
of control channels and service channels, enabling the exchange of information for specific
services and applications. In information theory, communication channels characterize the
distortions that occur when information is transmitted through them. Communication channels
are also used in integrated development environments to record discussions and track
communications related to specific code sections. Overall, communication channels facilitate
the flow of information between entities in various domains.

The predominant communication channels used in medical facilities include network means
of internal communication, such as WhatsApp messenger and electronic document
management systems. Additionally, a corporate social network and the Telegram messenger
are also used for internal communication. In terms of data exchange among medical treatment
diagnostic systems, a data communication control system connected to internal and external
networks is utilized. Furthermore, web-based applications using standardized communication
protocols like HL7 FHIR are employed to support patients in receiving treatment and
prescriptions, as well as to facilitate access to medical history by different medical units. In
patient care facilities, a communication system with communication terminals and a message
composition facility is used for efficient message transmission. Finally, a hospital
communication system utilizes a single coaxial cable to transmit audio and physiological data
between patient rooms and a control area, with dual frequency channels for nurse-call facilities
and pulse code modulation techniques for data transmission.

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 d) INTRA-.LABORATORY AND INTER-LABORATORY COMMUNICATION

Communication among members of the laboratory team must occur on several levels and begin with
each being responsible for following their own protocols. Without this individual commitment,
information will be miscommunicated or omitted. Next, information must be recorded at the time it is
communicated, as very few people have the capacity to remember every aspect of every case.

INTRA-LABORATORY COMMUNICATION

Both written and verbal, are a major component of all medical care.

The essence of Laboratory Medicine or Clinical Pathology is the acquisition of data by analytical
procedures performed on the patient’s physician to assist the physician in diagnosis, therapeutic
and prognostic decisions.

1. Policies such as:

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

2. Procedure Manual

 Quality Control Systems for laboratories should be designed to assure the medical
reliability of the laboratory data.
 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 initialed by the head or responsible supervisor.

CYCLE OF COMMUNICATION

Types of Laboratory Communication

1. Policy Manual

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  All laboratories should have administrative policy manuals.
 The policy should reflect the philosophy and overall goals of the larger organization as
well as those of the laboratory.
 Policy should be dated and approved by the laboratory director.
 Readily available to the laboratory employees
 The orientation of new employees should include an introduction to the laboratory policies

Policy Manuals can range from a simple statement about the intent and philosophy of a company
to a detailed plan of implementation. We equally have Administrative Manual, Safety Manual,
Quality Management Manual. The first step in the cycle of physician-laboratory communications
is the encounter between the patient and the physician. The physician’s decision is translated in a
written order, through a written laboratory measurements or examinations. The requisition
includes requested determinations as well as basic information about the patient derived from
admission. A specimen collected by the nurse may accompany it or it is the medical technology
will do specimen collection. When both the completed requisition in the appropriately labeled
specimen are available in the laboratory, the requested measurements and/or examinations are
performed, the resulting data are processed and checked for validity, a report is returned to the
physician.

Extralaboratory/ Intralaboratory Communication

Intralaboratory Communication

1. Manual of procedures and Collection Instructions: The laboratory must maintain a

complete detailed book of instructions covering the ordering of tests, precautions for special
procedures, the proper method for preservation of specimens and pertinent standard procedures of
the laboratory. All procedures shall be such as to insure satisfactory specimens for procedures to
be performed.

2. Laboratory User’s Manual: This is particularly useful in teaching institutions 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.

3. Laboratory Bulletins: Periodic laboratory bulletins, news letters or measurement of the month
circulated to the medical staff, are useful means of communicating information about new
laboratory services or policies.

4. Other Extra Laboratory Communications: One of the most functions of the laboratory
Director is to be available and responsive to written and verbal communication from the Clinician
user of the laboratory. The importance of open communication and mutual respect between the
laboratory staff and the nursing and clerical staff throughout the hospital is frequently overlooked.

28
As a result, laboratory staff covering these subjects can promote goodwill and minimize
misunderstanding between these various groups in the hospital.

INTER-LABORATORY COMMUNICATION
Science organizations rely on creative marketing and outreach strategies to attract top lab talent,
showcase research products and services to potential clients or funders, and engage the general
public in science. However, many organizations overlook the importance of effective internal
communications for these marketing and outreach efforts. For example, one difficulty faced by
communications staff is staying updated on the latest research news and developments in order to
have regular content to share with the public. Thus, organizations would benefit from maintaining
open lines of communication and promoting cross talk among staff to ensure information is shared
throughout the organization. This article provides some ideas on how organizations can use best
practices for internal communications to capture content from employees for marketing needs,
train lab staff to be brand ambassadors, and get group buy-in for these communication efforts.
Here are some suggestions for how organizations can use internal communications to streamline
this process:

efforts and gathering content from employees. If an in-house application is not available, there are
many free and low-cost options that can be tailored to such needs. Be sure to include help guides
and other resources to train staff on how to use the website, along with other guidelines.

relevant news and information. This update can be a simple online form with a few outlined
categories (e.g., recent publications and presentations, staff awards) of information to be collected
and then submitted electronically to a central database and/or appropriate team members, including
communications staff.

outreach events) that they will be attending or sponsoring. This resource will allow
communications staff to publicize the organization’s presence at these events. It also gives
managers an opportunity to touch base with lab personnel in advance of the event to see whether
they need any marketing materials or other information to effectively promote the organization.

 Ask lab managers and staff to regularly share already prepared materials and files that can
provide ideas for promotions and/or can be repurposed for inclusion in marketing collateral. These
materials may include open meeting minutes, presentation slides, and other related files (e.g., event
pictures). Files can be deposited in a central repository for a project or team site, and this process
can be simplified by creating an easy way to drop information into designated folders via email
or a short form.

so include adding a quick roundtable discussion at regular meetings where employees can share

29
updates or news, moderating an online discussion board, and scheduling coffee breaks with
managers. Also consider hosting inhouse research presentations to provide a platform for
employees across the organization to engage in scientific discussion about their latest work.

guidelines on how to make business referrals of potential clients, collaborators, and other interested
parties (e.g., event sponsors, funding agencies) to the organization. These guidelines may include
holding debriefs with staff after events to collect contact information, using a shared contact
management system, and making prompt and effective follow-ups with contacts.

C) BUDGET CONSIDERATION IN CLINICAL LABORATORY

financial plan, a map to get where we intend to go.

al
resources of an organization.

Cost accounting is the basic "tool" for identifying the expenses associated with laboratory
operations. A budget is a planning tool that allows the director and manager to visualize the
evolution of expenses, assets, liabilities, and revenues over a period of time. It is a quantitative
annual plan of activities and programs that helps an organization measure the progress toward its
financial goals on a periodic basis. A knowledge of how to develop and understand a budget is
essential for every director and manager.

 Phase I - Plan: define goals

o Clear goals and objectives guide resource allocation
o Senior management usually sets these, although departments can get involved
 Phase II - Do: create budget
o Review the past
 Collect statistical data of past revenue, expenses, margins and volumes (for
pro forma budget)
o Evaluate the present
 Assess new programs, expanded programs, reduced or discontinued
programs
 Review key influential factors, such as politics, economy and technology
o Predict the future
 Predict new revenues, expenses and margins
 Predicting future = past performance + estimated changes
 Predicting revenues can be hard; you need to estimate the lab growth rate

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  Lab growth rate = existing client growth + new clients - lost clients
 Predicting expenses may also be challenging; this requires both a prediction
of lab growth rate and careful justifications
 Capital expenses:
 Why do we need this new equipment?
 Is it the best?
 How much does it cost?
 What is the return on investment (ROI)?
 Defined as net income of an investment divided by its cost
 Personnel expenses: evaluation of current workload and productivity
 Are there any expected changes in workload, productivity, staff
scheduling and new or expanded programs in the future?
 Operating expenses change proportionately with the number of tests:
expected costs = current spending + lab growth rate
 Phase III - Check: analyze variances
o Review monthly for variances
o Favorable budget variance refers to positive variances, showing gains; unfavorable
budget describes negative variance, indicating losses
o Try to explain any significant variances from budget
 Phase IV - Act: adjust budget
o Make adjustments in order to meet the goals

Financial reporting

 Budget, as discussed earlier, is the internal reporting tool that management uses to control
expenses and makes decisions; the budget variance analysis is performed periodically, at
least monthly
 Labs also need to report their business information to external entities, such as government
agencies, stakeholders and banks; these external reports are called financial statements
 There are 3 major financial statements that reflect a lab's business activities and
profitability for each accounting period; these statements are balance sheet, income
statement and statement of cash flows
 Balance sheet: shows what a lab owns (assets), what a lab owes (liabilities) and its net
worth (equity); the balance sheet carries over from year to year
o Investors analyze the balance sheet for indication of management's effectiveness in
using debt and assets to generate revenue
 Income statement: also called the profit and loss statement; shows revenues and expenses
over a period, which is typically a fiscal year
o Income statement starts from zero at the beginning of the new fiscal year
o Investors use the income statement to assess whether the lab is generating profits
or losses

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  Cash flow statement: summarizes the movement of cash that comes in and goes out of a
lab in a period; the cash flow statement highlights how well a lab generates cash

Productivity measures and benchmarking

 Productivity is the ratio of what is produced (product or service) to what is required to

produce it (labor and supplies)
 Important terminology in productivity calculation is full time equivalent (FTE): FTE is a
metric that measures the total number of full time employees you have based on hours
worked, rather than the exact number of employees (e.g., an employee who works full time
is equal to 1 FTE, while an employee works half time would be equivalent to 0.5 FTE)
 Benchmarking is a practice to compare an organization's performance / productivity to a
standard; benchmarking helps management to:
o Identify problem areas in its own organization
o Learn better practice from other laboratories
 Benchmarking can be internal or external:
o Internal benchmarking compares productivity within a laboratory
o External benchmarking compares a laboratory's productivity to that of other
laboratories in the market.

Monitoring costs and revenues are essential steps in the fiscal management of a clinical laboratory.
Below are several reasons why it is important to monitor costs and revenues. The laboratory
supervisors and managers need to make good choices about:

1. Number, type, and scheduling of personnel

2. Capital equipment acquisition
3. Procedure choices
4. Inventory management
5. Developing and monitoring the laboratory budget
6. Maximizing resources and practicing effective cost containment
7. Setting fees for service
8. Ways to cut costs
9. What tests to add or eliminate

MATERIAL MANAGEMENT

Material Management is essential in both clinical and household settings to ensure the efficient
use of resources and promote safety, sustainability, and cost-effectiveness. It involves proper
handling, storage, and disposal of laboratory supplies, reagents, and specimens, as well as the
proper handling, storage, and disposal of lab items.

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The purchasing plan of the laboratory materials should ensure that supplies meet the following:
◦Quality
◦Quantity
◦Timeliness
The goals of material management must include steps to guarantee :
◦Supplies arrive in a timely manner
◦Spoilage is reduced to a minimum
◦Back orders and delays are avoided
◦Storage space is used to the best advantage
◦The most economically advantageous price is obtained
◦Financial resources are not tied up in inventory
The material management benefits
◦Performance high level
◦Quality test results
◦Variation/ Time
◦Lowers repair costs
◦Lengthens lifespan
◦Increases safety
◦Reduces interruption of services
◦Greater customer satisfaction

Material Management Systematic process of overseeing and controlling the acquisition and
utilization of supplies consist of:
a. Purchasing/requisitioning of supplies
b. Oversight of the products as they arrive to ensure both availability and cost effectiveness
The Material Management Department purchasing- Oversees the ordering of supplies, processing
of invoices from vendors. Stockroom - maintains security and inventory and issues supplies
Before Equipment Installation confirm vendor’s responsibilities in writing, establish checklist.
When possible, have manufacturer install and set up, do not attempt to use prior to proper
installation. Verify package contents and copy software if it is part of the system
After equipment installation
◦Inventory Record
Calibration
Verification
Operating Procedures
◦Maintenance Program

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VI QUALITY CONTROL IN CLINICAL LABORATORY
Quality is the degree to which healthcare services strive to provide accurate desired outcomes for
patients and are consistent with current professional knowledge.
Whether considering proficiency testing, accreditation or legislation, peer-review is the key to
success. All three approaches towards establishment of quality in pathology laboratories require
reference to National guidelines. Six Professional Practice Guidelines that should be developed
are;
(1) Retention of laboratory records and materials,

(2) Minimum qualification, training and experience of professional personnel working in a

pathology laboratory,
(3) Laboratory construction and design,
(4) Maintenance and operation of equipment in the laboratory,
(5) Safe laboratory practice, and
(6) Sample management.

To ensure quality performance, every laboratory should have some form of quality management
system. Quality assurance, continuing quality improvement and quality control are integral
component of a required ‘quality system’.

Quality Control (QC)

This system checks that the work process is functioning properly. QC evaluation includes;

1- Accurate patient identification,

2- Adequate specimen processing,
3- appropriate techniques,
4- Inspection of controls to determine correctness of special staining and other methods.

In histopathology labs, it is the responsibility of higher-level pathologist to perform the final

QC examination as they ‘read’ the slide. Errors/problems reported by pathologists and others
should be included as part of the laboratory QC data collection. In the laboratory, the
perception of quality control is appropriate to pre-analytical, analytical, and post-analytical
undertakings. Confirming the security of the employed person as well as surroundings is also
extremely significant. Safety concerns that may come about in the lab are principally those
interrelated to theoretically dangerous chemicals, bio hazardous constituents, accidents
accompanying the equipment and musical arrangement employed, and general hazards from
electrical and fire exposures. Quality control in laboratories diminishes the opportunity for the
existence of hazards and accidents. Also, quality control in labs improves its competitiveness
and creates better-quality workplace environments.

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Objectives of Quality Control in Laboratory:

The quality control program is premeditated to monitor all constituents of laboratory processes,
taking account of specimen assortment and dealing out test procedures, and recording of test
results. Additionally, this program is not merely used to monitor test outcomes, nonetheless, it
correspondingly monitors types of equipment, substances used in testing, employees.
1. To confirm quality services that assures patient’s gratification
2. To create extraordinary quality subdivisions in the interior and amongst laboratories
3. To create precise, timely, and comprehensive reports
4. To diminish turnaround time
5. To support ethics and professionalism
6. To develop better-quality performance
7. To develop continuous training as well as a professional improvement

Sources of Laboratory Errors in test methodology

There are a number of potential errors which can affect the quality of the clinical laboratory results.
These errors can occur in pre-analytical, analytical and post-analytical phases. All the three phases
can be targeted individually for improving quality, although it is well published that most errors
occur in the pre- and post-analytical phases.

Pre-analytical Phase; these are the errors which occur in the pre-analytical phase and create an
impact on the patient’s sample before it is analyzed in the laboratory. There are a number of things
which can go wrong from the time when the sample is collected from the patient till it is transported
to the laboratory for analysis. These errors are as follows:

• Wrong patient information: The particulars such as name, gender, age, ward, patient’s posture,
effects of exercise, dietary effects, medical history, pregnancy, effects of drugs and alcohol etc.
can affect the values of analytes.

• Improper collection of the blood sample: The results will be affected if the sample is collected
in a vacutainer other than the one which is recommended for analysis of a particular analyte for
e.g. vacutainer containing sodium citrate is used in place of sodium fluoride for analysis of plasma
glucose.

• Inadequate quantity of the sample: An insufficient quantity of sample cannot be processed for
all the analytes which have been requested by the clinician.

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• Improper handling of the sample: Improper handling of the sample can lead to hemolysis of
the sample before it reaches the laboratory for analysis. Grossly hemolysed sample should always
be rejected as lysis of blood cells leads to release of certain intracellular chemicals and enzymes
which will lead to increase in levels of potassium, phosphates and transaminases.

• Incorrect sample storage: If a sample has not been properly stored or a blood sample has been
left overnight before being sent to the laboratory, it will become hemolysed in 24 hours especially
at a warm temperature.

• Other factors: Heat and exposure to light can change the actual value of many analytes in routine
clinical chemistry such as photo-degradation of bilirubin by light exposure.

Analytical Phase The analytical phase begins from the time when the patient’s specimen is
prepared for analysis to the time when the test result becomes available. Potential analytical errors
which may affect the quality of the results obtained include;

- Sample measurement,
- sample pre-treatment,
- reagent volume measurement,
- sample and reagent mixing,
- incubation, reaction timing, and
- Calculations.

These errors may arise in conjunction with the supplementary use of analytical equipment such
as glassware, pipettes etc., which may not have been properly washed and calibrated. The
quality of the reagents and the deionized water used for reconstitution of calibrators and
controls will also have a critical influence on the values generated. It is very important that the
reagents should be prepared according to the instructions given by the manufacturer and also
the reagents should be properly stored when not in use. During the analytical phase, the quality
of the laboratory can be maintained by running internal quality control (IQC) daily and
participating in external quality assessment (EQA). In addition, specific rules need to be
followed for accepting and rejecting the analytical run. The uses of analytical methods with a
high degree of accuracy and precision as well as the proper maintenance of the equipment also
help in reducing analytical errors. Commonly, the analytical errors are seen after the use of
deionized water with high conductivity, expired reagents and controls and calibrators, blockade
in aspiration system of reagents and samples. The responsibility of the laboratory professional
lies in appropriately analyzing samples and reports, detecting trends or bias in reports that may
not be apparent in a single result, investigate root causes producing unacceptable
performances, apply and monitor appropriate action for removing the underlying causes, verify
the effectiveness and above all determine whether the problem affected clinical decision
making.

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Post-Analytical Phase Post-analytical phase mainly deals with the reporting of results after the
completion of analytical phase in a timely manner and in an accepted format that can be understood
and correctly interpreted by health care professionals. The most common post-analytical errors
include the reports being not legible and also delay in delivering the reports to the clinician or the
patients.

Internal Quality Control Internal quality control (IQC) is performed daily in the laboratory and
involves the use of calibrated glassware, reagents and equipment. The laboratory staff should be
qualified professionals. There is a recommendation to use at least two control levels for each
analyte. The samples are internally evaluated in the laboratory. The main purpose of IQC is the
precision (repeatability or reproducibility) of the method.

External Quality Control External quality control (EQC) or proficiency testing (PT) is performed
as a test of competency. It includes the participation of the laboratory in an external quality
assessment scheme which provides samples for analysis every month. They have to be analyzed
by the laboratory professionals using the same procedures as used for testing of quality control
samples and patient samples. The results obtained from analysis of EQC samples are reported to
the outside agency running external quality assessment scheme (EQAS). They then provide a
report for the participating laboratory based on mean, coefficient of variation and standard
deviation index of the all the participating laboratories.

Achieving quality in the medical laboratory requires the use of many tools. These include
procedure manuals, maintenance schedules, calibrations, a quality assurance program, training,
continuing education, competency assessments, and quality control materials.

Chosing Quality Control Materials

Important parts of quality control in the medical laboratory are identification of proper quality
control materials, and the statistical process, used to monitor and evaluate the analytical process.
The goal of quality control materials in the laboratory is to have products that are used in the same
manner as patient samples so that they can help assure that the test systems are functioning
appropriately and producing high quality patient results.

Quality control materials are essential for ensuring the accuracy and precision of laboratory tests.
They are samples that have known properties and are used to monitor the performance of
instruments, methods, and operators. However, not all quality control materials are created equal.
To select the best ones for your laboratory, you need to consider several factors, such as the type,
frequency, and range of tests you perform, the stability and compatibility of the materials, and the

37
cost and availability of the materials. In this article, we will discuss some of the best practices for
choosing quality control materials that suit your needs and goals.

1 Type of tests: The first step in selecting quality control materials is to identify the type of tests
you perform in your laboratory. Depending on the nature and purpose of your tests, you may need
different types of quality control materials. For example, if you perform quantitative tests that
measure the concentration or amount of a substance in a sample, you may need quality control
materials that have known values for that substance. These are called assayed or assigned quality
control materials. On the other hand, if you perform qualitative tests that detect the presence or
absence of a substance in a sample, you may need quality control materials that have positive or
negative results for that substance. These are called unassayed or unassigned quality control
materials.

2 Frequency of tests: The next step in selecting quality control materials is to determine the
frequency of tests you perform in your laboratory. Depending on how often you run your tests,
you may need different frequencies of quality control testing. For example, if you perform high-
volume or critical tests that have a high impact on patient care, you may need to run quality control
tests more frequently, such as daily or with each batch of samples. On the other hand, if you
perform low-volume or non-critical tests that have a low impact on patient care, you may need to
run quality control tests less frequently, such as weekly or monthly. The frequency of quality
control testing should also match the frequency of calibration and maintenance of your instruments
and methods.

3 Range of tests: The third step in selecting quality control materials is to evaluate the range of
tests you perform in your laboratory. Depending on the variability and complexity of your tests,
you may need different ranges of quality control materials. For example, if you perform tests that
have a wide range of values or levels, you may need quality control materials that cover the entire
range of your tests. These are called multi-level or multi-analyte quality control materials. On the
other hand, if you perform tests that have a narrow range of values or levels, you may need quality
control materials that cover only the relevant range of your tests. These are called single-level or
single-analyte quality control materials.

4 Stability and compatibility: The fourth step in selecting quality control materials is to assess
the stability and compatibility of the materials. Depending on the storage and handling conditions
of your materials, you may need different levels of stability and compatibility. For example, if you
store your materials at room temperature or in a refrigerator, you may need quality control
materials that have a long shelf life and are resistant to degradation or contamination. These are
called stable or robust quality control materials. On the other hand, if you store your materials in
a freezer or in a lyophilized form, you may need quality control materials that have a short shelf
life and are sensitive to thawing or reconstitution. These are called unstable or fragile quality
control materials. Additionally, you should also check the compatibility of your quality control

38
materials with your instruments and methods. You should use quality control materials that have
the same matrix, composition, and characteristics as your patient samples, or that are designed
specifically for your instruments and methods.

5 Cost and availability: The fifth step in selecting quality control materials is to compare the cost
and availability of the materials. Depending on your budget and resources, you may need different
options of quality control materials. For example, if you have a limited budget or access to quality
control materials, you may need to use quality control materials that are affordable and readily
available. These are called commercial or off-the-shelf quality control materials. On the other
hand, if you have a flexible budget or access to quality control materials, you may need to use
quality control materials that are customized and tailored to your needs. These are called in-house
or homemade quality control materials.

By following these best practices, you can select quality control materials that are suitable for your
laboratory and that can help you achieve reliable and consistent results. Quality control materials
are not only a regulatory requirement, but also a valuable tool for improving your laboratory
performance and quality assurance.

Check quality control materials against known standards regularly to find any differences and
ensure they stay accurate. It's also good to thoroughly record how quality control materials are
used and how well they work—making necessary adjustments to maintain the highest quality
control standards. These practices enable us to provide trustworthy results and preserve the
integrity of our testing processes.

VII QUALITY ASSURANCE (QA)

Quality assurance in lab is defined as a program for systematic monitoring and evaluation of the
various aspects of the laboratory service to ensure that quality standards are being met. It includes
a planned system of review procedures conducted by personnel not directly involved in the
laboratory process. Statistical analysis of quality control provides the data for quality assurance
activities where correlation of errors, complaints, failures or other unexpected results are evaluated
against the laboratory expectations. Participation in external programs also contributes valuable
information. Quality assurance achieves these objectives by establishing protocols and quality
criteria for all aspects of laboratory work, and provides a framework within which internal quality
assurance (IQA) and external quality assurance (EQA) programmers’ can be effective. Quality in
a laboratory is dependent on a host of structural and personnel factors. A Quality Committee should
be established within each laboratory to ensure routine review of quality data and to initiate
improvements where required. It is critical that well established procedures and systems are in
place for the reporting, evaluation and root cause analysis of errors.
Components of Quality Assurance include
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Organization of the lab which ensure safety as well : Workflow should be smooth without too
much cris-cross traffic. Access to rooms where manipulation or analysis of samples takes place or
where hazardous chemicals or other materials are stored must be restricted to authorized persons
only. Restriction of access may be accomplished using signs on doors. Sample accession area
should be manned by well trained personnel. Use of computers with local networking and bar
codes has its own advantages. Crossing station should be well ventilated with adequate lightening
and have proper facilities to “exhaust” the dangerous vapor. Staining areas should have adequate
space to accommodate all the steps involved and must be equipped with good quality of needed
instruments and materials.

Physical Aspects of lab the laboratory must be designed to ensure proper ventilation throughout,
with an active ventilation system, and adequate space for circulation of persons and laboratory
carts and trolleys. Rooms should have a high ceiling to ensure proper ventilation. Walls and
ceilings should be painted with washable, glossy paint or coated with a material suitable for
cleaning and disinfection. The floor must also be easy to clean and disinfect and have no edges
between the walls and floor. Ceramic tiles are good materials to use for bench tops, as they are
resistant to deterioration from harsh disinfectants and aggressive cleaning products. Wood is not
easy to clean/ disinfect and deteriorates over time, moreover it also harbors growth of
contaminants. The disadvantage of using steel that it will rust when washed with chlorine. Bench
tops should be at the proper heights based on the guidelines suggested by the National Institute of
Occupational Safety and Health (NIOSH). Cleaning and disinfection of laboratory areas should be
recorded, including the date and name of the person performing the maintenance.

Comprehensive managements of documents: Documents should clearly define communications

channel and a clear reporting structure. The documents should also identify the records that should
be kept of routine operations, such as equipment calibration and maintenance. Such documentation
should be brought together as a single “Quality Manual” which can act as a reference text for the
whole quality assurance program.

Training: It is important that all staff members should be adequately trained for the task they have
to perform. Criteria for correct levels of training or competence for particular procedures, and job
roles, are often specified by national and international agencies and in some cases, by professional
associations.

Standard Operating Procedures (SOP): They are the documents describing in detail every
procedure conducted by the laboratory. This includes sampling, transportation, analysis, use of
equipment, quality control, calibration, production of reports, etc. They are the laboratory’s
internal reference manual for the particular procedure, for that reason, SOPs must document every
relevant step in the procedure. Thus, anyone of the appropriate training grade should be able to
apply the procedure when following the SOP. In addition, the SOP must cross reference and, where
necessary, expand any other SOPs which are related to it.

40
Equipment maintenance and calibration: All equipment must be maintained on a regular basis,
consistent with the documented criteria of the laboratory and normally accepted codes of practice.
The laboratory must apply standards which are well within the limits normally established and
recommended for the care of the particular piece of equipment. This should be checked by the
quality assurance officer, and be corrected if inappropriate. These principles apply to general
laboratory equipment such as glassware as well as to sophisticated analytical instruments. Frequent
checks on the reliability of equipment must also be performed. This includes calibration checks on
all relevant equipment, such as balances, pipettes, etc.

Patient safety and error reduction: Patient safety is defined as freedom from accidental injury
in the delivery of health care

CONTINUING QUALITY IMPROVEMENT This system is used to approach, evaluate and

identify opportunities to improve quality before problems occur through evaluation of all
systems/processes in the laboratory. The goal is to improve potential care and safety through
recognition of potential problems/errors before they can occur.

CONCLUSION Pathology and laboratory medicine are rapidly changing field where new
technology and scientific advances are introduced into medical practice. Any approach to control
the pathology laboratories (whether proficiency testing, accreditation or legislation) has to allow
for evolution of technology and scientific concepts, without compromising minimal standards and
without losing sight of the patient care and ethical responsibilities of the laboratory.

LABORATORY CERTIFICATION AND PROFICIENCY TESTING

Laboratory analysis may be carried out for a number of reasons – usually linked to ensuring a
product has been manufactured to meet specifications and regulations and is safe to be released to
the market place. It is imperative then, that the results of the analysis can be trusted, in terms of
their accuracy and reproducibility.

Monitoring the quality of the analytical results, by using effective Quality Control (QC) tools, can
help prevent good product being discarded and stop non-conforming product from being released.
For laboratories, QC tools should include an external reference point, over which the laboratory
has no direct control. Tools such as proficiency testing (PT) and reference materials (RM) obtained
from an external and independent quality source, are key external quality controls. Monitoring the
quality of laboratory results is an essential part of achieving accreditation to ISO/IEC 17025
General requirements for the competence of testing and calibration laboratories.

Proficiency Testing Programs are statistical quality assurance programs that enable laboratories to
evaluate and improve performance, and maintain and fulfill mandatory accreditation requirements.

41
1.Participants receive samples for each test cycle, electronic data submission forms, and test
instructions.

2. Labs perform the tests normally conducted within their facility using the specified test methods
cited in the program.

3. Upon completing the tests, each lab electronically submits test data to ASTM for use in statistical
summary reports. These reports are accessible 24/7 on our web portal.

4. Final summary reports, provided in electronic format, contain:

 Each participating laboratory’s confidential test results

 Statistical analysis of the test data
 Charts and graphs plotting test results versus other laboratories

LABORATORY ACCREDITATION

Stages of the laboratory accreditation process

The process for laboratory accreditation has four main stages:

 initial enquiry
 information dossier evaluation
 audit
 decision.

Assessment of laboratories is guided by a set of clear principles:

Internationally-recognised standards: All laboratories must demonstrate a robust quality

management system and compliance with ISO/IEC 17025 General requirements for the
competence of testing and calibration laboratories.

Roles and responsibilities: Roles and responsibilities of all personnel involved in carrying out
the audit and assessment are clearly defined so that expectations can be met and the accountability
of each is understood.

Competence of the inspection team: Inspectors are selected based on auditing skills, education
and experience in the regulatory environments that are appropriate for the inspections and audit
tasks assigned to them.

42
Consistency: Assessment and audit procedures are performed according to defined guidelines, so
that WHO can ensure consistency during the inspection. Guidelines are codified in the publicly
available WHO standard operating procedures

Confidentiality and standard of conduct: authors maintain confidentiality with regard to

information and documentation related to inspections and must comply with WHO standards of
conduct.

Stages of laboratory accreditation

Stage 1: Initial enquiry

A laboratory may submit an unsolicited application for accreditation, or WHO may invite a
laboratory to apply for accreditation. The laboratory must communicate which types of testing
and/or categories of products it wishes to be accredited for and whether it can demonstrate its
competency by conforming to accepted standards, as witnessed by a competent third-party
accreditation body. These include quality standards such as ISO 9001 Quality management
systems — Requirements and IEC 17025 General requirements for the competence of testing and
calibration laboratories.

Stage 2: Information dossier evaluation

Following the initial enquiry, IMD-PQS or an appointed representative will request the laboratory
to forward a detailed information dossier for evaluation. The dossier will contain further
information about the type(s) of testing the laboratory wishes to carry out, copies of relevant
certifications and registrations, and details of facilities, competencies, staff and referees.

Stage 3: Audit

In most cases, a laboratory will need to undergo a full audit before accreditation status can be
granted. The audit should take one to two days and will cover all aspects of the laboratory's
operation, including quality, testing and personnel. A mock-up of every relevant test must also be
observed by the auditor(s).

Towards the end of the audit, the auditor will generally provide a draft evaluation to the laboratory
(for example, in the form of a short, written summary) and the full report to PQS. Audits may
reveal non-compliances but if these can be addressed within a set time frame, the outcome of the
audit may nevertheless be positive.

A full audit may be waived for laboratories that are accredited by signatory bodies to the
International Laboratory Accreditation Cooperation (ILAC) in particular in case of an urgent need
to test some specific products and if the laboratories concerned can satisfy the information dossier

43
requirements. Laboratories that are accredited by ILAC signatories should receive a surveillance
visit by that signatory every 12 to 18 months and a full audit every four to five years.

Stage 4: Decision and accreditation

The final decision to accredit a laboratory is taken by the IMD-PQS Secretariat on the basis of the
information dossier evaluation and the audit report (where relevant). Relevant details of the
accepted laboratory are published on this website as a laboratory information sheet.

LABORATORY PRINCIPLES OF HEALTH ECONOMY AND SOCIO-ECONOMY

Health economics is the discipline of economics applied to the topic of healthcare Against a
background of increasing demands on limited healthcare resources, health economics has become
an important input into decision-making at all levels of healthcare organizations. As drugs are
easier to evaluate than other healthcare interventions and because of the availability of high-quality
information required for licensing, the focus has been on pharmacoeconomic analysis underpinned
by the rationale that it is the value of medicines that is important and not their costs

Against a background of increasing demands on limited healthcare resources, health economics

has become an important input into decision-making at all levels of healthcare organizations. As
drugs are easier to evaluate than other healthcare interventions and because of the availability of
high-quality information required for licensing, the focus has been on pharmacoeconomic analysis
underpinned by the rationale that it is the value of medicines that is important and not their costs.
In fact, a number of countries now require a formal economic analysis before a new drug is
introduced.
Health economics is the discipline of economics applied to the topic of healthcare. Broadly
defined, economics concerns how society allocates its resources among alternative uses. Scarcity
of these resources provides the foundation of economic theory, and from this starting point three
basic questions arise:
The traditional economic starting point is to assume that a market offers the most effective model
to address these questions. Here, resources are allocated on the basis of price and the ability to pay.
However, health economists recognize the limitations of this approach in healthcare, where there
are a number of problems. For example, there is a desire for an equitable distribution of resources
rather than ability to pay and there are problems with information asymmetry. Doctors have greater
knowledge than patients and in market situations they may use this to their own advantage.
Health economics seeks to address these ‘market failures’ and offers an explicit decision-making
model based on the underlying value of efficiency – maximizing the benefits from available
healthcare resources. As healthcare budgets are finite and spending in one area is inevitably at the
expense of investment in another, efficiency can be seen as ensuring benefits gained exceed
benefits forgone.
The importance of the economic model is that it provides useful insights into how healthcare can
be organized and financed and provides a framework to address a broad range of issues in an
44
explicit and consistent manner. It is not the only approach to decision making. Considerations of
equity, public opinion and politics are also important and often conflict with economic directives.
Health economists are interested in the production of health at a number of levels, such as the
influences on the demand for healthcare, the healthcare seeking behaviour of individuals and
providers and alternative ways of production and delivery of healthcare. However, from the
perspective of headache, this paper explores the principles of two aspects of health economists’
work that are most relevant and that form the bulk of their work: the cost of illness or measuring
its economic burden; and economic evaluation – facilitating the allocation of limited healthcare
resources by comparing the costs and benefits of alternative interventions.

LABORATORY INFORMATION SYSTEM

A laboratory information system (LIS) is computer software that processes, stores and manages
data from all stages of medical processes and tests.

Physicians and lab technicians use laboratory information systems to coordinate varieties of
inpatient and outpatient medical testing, including hematology, chemistry, immunology and
microbiology. Basic laboratory information systems commonly have features that manage patient
check in, order entry, specimen processing, result entry and patient demographics. An LIS tracks
and stores clinical details about a patient during a lab visit and keeps the information stored in its
database for future reference.

A closely related technology to LIS is a laboratory information management system (LIMS), but
there are differences between the two software types. An LIS is a healthcare system that holds
clinical data. By comparison, an LIMS can be deployed in healthcare, too, but it is also used in
non-medical settings, including in environmental testing laboratories, pharmaceutical laboratories
and water treatment plants. An LIMS can be used as a Web tool or installed on a personal computer
or device and stores and manages captured data, as well as producing reports from that data.

The electronic data capture process of an LIMS or LIS can reduce time spent and cut errors
associated with the transcribing process.

Maintenance of laboratory information systems took on added importance with the introduction of
the meaningful use program. The program is overseen by the Centers for Medicare & Medicaid
Services and consists of sets of criteria split into stage 1, stage 2 and stage 3. Participating
healthcare providers that successfully prove their electronic health record (EHR) systems or EHR
modules -- such as an LIS -- satisfy program criteria are eligible for incentive payments. If an LIS
is tested and certified to meet meaningful use criteria or other health IT certification standards, it
is defined as an EHR module.

45
Some meaningful use reporting measures that could involve an LIS include the electronic
submission of lab test results to public health agencies and the incorporation of clinical lab test
results into a certified EHR system.

PATIENT TEST MANAGEMENT

1. Condition: Patient test management; moderate complexity testing (including the subcategory),
high complexity testing, or any combination of these tests (§493.1101)

Each laboratory performing moderate complexity (including the subcategory), or high complexity
testing, or any combination of these tests, must employ and maintain a system that provides for
proper patient preparation; proper specimen collection, identification, preservation, transportation,
and processing; and accurate result reporting. This system must assure optimum patient specimen
integrity and positive identification throughout the preanalytic (pre-testing), analytic (testing), and
postanalytic (post-testing) processes and must meet the standards of this chapter as they apply to
the testing performed.

2. Standard: Procedures for specimen submission and handling (§493.1103)

a. The laboratory must have available and follow written policies and procedures for each of the
following, if applicable: methods used for the preparation of patients; specimen collection;
specimen labeling; specimen preservation; conditions for specimen transportation; and specimen
processing. Such policies and procedures must assure positive identification and optimum integrity
of the patient specimens from the time the specimen(s) are collected until testing has been
completed and the results reported.

b. If the laboratory accepts referral specimens, written instructions must be available to clients and
must include, as appropriate, the information specified in paragraph a above.

c. Oral explanation of instructions to patients for specimen collection, including patient

preparation, may be used as a supplement to written instructions where applicable.

3. Standard: Test requisition

The laboratory must perform tests only at the oral, written, or electronic request of an authorized
person. Oral requests for laboratory tests must be documented in a retrievable manner. The
laboratory must make an attempt to obtain written authorization for oral requests. Records of test
requisitions or test authorizations must be retained for a minimum of two years. The patient's chart
or medical record will not be used as the only record of a laboratory test requisition. The laboratory

46
must assure that the requisition or test authorization includes:

a. The patient's name or other unique identifier.

b. The name or other suitable identifiers of the authorized person requesting the test and, if
appropriate, the individual responsible for utilizing the test results or the name and address of the
laboratory submitting the specimen, including, as applicable, a contact person to enable the
reporting of imminent life threatening laboratory results or panic values.

c. The test(s) to be performed.

d. The date of specimen collection.

e. For Pap smears, the patients's last menstrual period, age or date of birth, and indication of
whether the patient had a previous abnormal report, treatment or biopsy.

f. Any additional information relevant and necessary to a specific test to assure accurate and timely
testing and reporting of results.

4. Standard: Test records

The laboratory must maintain a record system to ensure reliable identification of patient specimens
as they are processed and tested to assure that accurate test results are reported. These records must
identify the personnel performing the testing procedure. Records of patient testing, including, if
applicable, instrument printouts, must be retained for at least two years. Immunohematology
records must be retained for no less than five years in accordance with 21 CFR Part 606, Subpart
I. The record system must provide documentation of information specified in paragraphs 9-3a
through 9-3f and include:

a. The patient identification number, accession number, or other unique identification of the
specimen.

b. The date and time of specimen receipt into the laboratory.

c. The condition and disposition of specimens that do not meet the laboratory's criteria for
specimen acceptability.

d. The records and dates of all specimen testing, including the identity of the personnel who
performed the test(s), which are necessary to assure proper identification and accurate reporting of
patient test results.

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5. Standard: Test report

The laboratory report must be sent promptly to the authorized person, the individual responsible
for using the test results or laboratory that initially requested the test. The original report or an
exact duplicate (paper or electronic copy) of each test report, including final and preliminary
reports, must be retained by the testing laboratory for a period of at least two years after the date
of reporting. Immunohematology reports must be retained by the laboratory for a period of no less
than five years in accordance with 21 CFR Part 606, Subpart I. For pathology, test reports must be
retained for a period of at least ten years after the date of reporting. This information may be
maintained as part of the patient's chart or medical record which must be readily available to the
laboratory and to OASD(HA), TSG, or their designee upon request.

a. The laboratory must have adequate systems in place to report results in a timely, accurate,
reliable and confidential manner, and, ensure patient confidentiality throughout those parts of the
total testing process that are under the laboratory's control.

b. The test report must indicate the name and address of the laboratory location at which the test
was performed, the test performed, the test result and, if applicable, the units of measurement.
.
c. The laboratory must indicate on the test report any information regarding the condition and
disposition of specimens that do not meet the laboratory's criteria for acceptability.

d. Pertinent "reference" or "normal" ranges, as determined by the laboratory performing the tests,
must be available to the authorized person who ordered the tests or the individual responsible for
utilizing the test results.

e. The results or transcripts of laboratory tests or examinations must be released only to authorized
persons or the individual responsible for utilizing the test results.

f. The laboratory must develop and follow written procedures for reporting imminent life-
threatening laboratory results or panic values. In addition, the laboratory must immediately alert
the individual or entity requesting the test or the individual responsible for utilizing the test results
when any test result indicates an imminent life threatening condition.

g. The laboratory must, upon request, make available to clients a list of test methods employed by
the laboratory and, in accordance with paragraph 10-7, as applicable, the performance
specifications of each method used to test patient specimens. In addition, information that may
affect the interpretation of test results, such as test interferences, must be provided upon request.
Pertinent updates on testing information must be provided to clients whenever changes occur that

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affect the test results or interpretation of test results.

h. The original report or exact duplicates of test reports must be maintained by the laboratory in a
manner that permits ready identification and timely accessibility.

9-6. Standard: Referral of specimens (§493.1111)

A DoD laboratory located within the United States must refer specimens for testing only to a
laboratory possessing a valid certificate authorizing the performance of testing in the specialty or
subspecialty of service for the level of complexity in which the referred test is categorized.

a. The referring laboratory must not revise results or information directly related to the
interpretation of results provided by the testing laboratory.

b. The referring laboratory may permit each testing laboratory to send the test result directly to the
authorized person who initially requested the test. The referring laboratory must retain or be able
to produce an exact duplicate of each testing laboratory's report.

c. The authorized person who orders a test or procedure must be notified by the referring laboratory
of the name and address of each laboratory location at which a test was performed.

d. Medical laboratories located outside of the United States will select referral laboratories meeting
acceptable quality assurance standards as determined by the local commander or the TSG. Test
results must be returned to the referring laboratory.

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