COURSE TITLE: LABORATORY WORKS AND

PROCESSES (SLT )

• HND II FIRST SEMESTER (SEMESTER THREE)

• LECTURER: MR. YAW OFORI ODURO

 COURSE OBJECTIVES
To describe essential elements for laboratory design and safety that
prevent
and control exposure to physical, chemical and biological hazards.
•To Develop critical, quantitative thinking.
•To Develop experimental and data analysis skills.
•To Learn to use scientific apparatus.
•To develop problem-solving and critical-thinking skills, as well as
gain exposure to reactions, materials, and equipment in a lab setting.
•To Develop reporting skills (written and oral).

COURSE OUTLINE
LABORATORY
What is a Laboratory
1. A Laboratory: is a facility that provides controlled conditions in
which scientific or technological research, experiments, and
measurement may be performed.

2. A Laboratory: a room or building equipped for scientific

experiments, research, reaching, or for the manufacture of drugs
or chemicals.
Health laboratories: is a term that is meant to be inclusive of clinical
laboratories, diagnostic laboratories, medical laboratories, public health
laboratories, animal and environmental health laboratories, or,

any other laboratories performing testing for the purpose of disease

diagnosis, screening, prevention, medical treatment decisions, surveillance
or public health.

Because all these terms for laboratories are frequently used interchangeably.
1. Introduction to Quality Laboratory Works and Processes
1.1 The Importance Of a Laboratory Quality

Definition Of Quality

 Laboratory quality can be defined as accuracy, reliability and timeliness

of reported test results.

 The laboratory results must be as accurate as possible, all aspects of the

laboratory operations must be reliable, and

 reporting must be timely in order to be useful in a clinical or public

health setting.
Level of Accuracy Required

When making measurements, there is always some level of inaccuracy.

The challenge is to reduce the level of inaccuracy as much as possible,
given the limitations of our testing systems.

An accuracy level of 99% may at first glance appear acceptable, but the
resulting 1% error can become quite large in a system where many events
occur, such as laboratory testing.
Negative Consequences of Laboratory Error

Laboratories produce test results that are widely used in clinical and public
health settings, and health outcomes depend on the accuracy of the testing
and reporting. If inaccurate results are provided, the consequences can be
very significant, including:
 unnecessary treatment
 treatment complications
 failure to provide the proper treatment
 delay in correct diagnosis
 additional and unnecessary diagnostic testing.
These consequences result in increased cost in time and personnel effort,
and often in poor patient outcomes.
Minimizing Laboratory Error

In order to achieve the highest level of accuracy and reliability:

 it is essential to perform all processes and procedures in the laboratory in
the best possible way.
 The laboratory is a complex system, involving many steps of activity and
many people. The complexity of the system requires that many processes
and procedures be performed properly.
 Therefore, the quality management system model, which looks at the entire
system, is very important for achieving good laboratory performance.
1.2 Overview of the quality management system

 A quality management system can be defined as “coordinated activities to

direct and control an organization with regard to quality”.

 This definition is used by the International Organization for Standardization

(ISO) and by the Clinical and Laboratory Standards Institute (CLSI).

 Both groups are internationally recognized laboratory standards

organizations, and will be discussed later in this handbook.

 In a quality management system, all aspects of the laboratory operation,

including the organizational structure, processes and procedures, need to
be addressed to assure quality.
Complexity of Laboratory Processes

 There are many procedures and processes that are performed in the
laboratory, and each of these must be carried out correctly in order to
assure accuracy and reliability of testing.

 An error in any part of the cycle can produce a poor laboratory result.

 A method of detecting errors at each phase of testing is needed if quality

is
to be assured.
 ISO standards group laboratory processes into pre-examination,
examination and post-examination categories.

 Comparable terms in current laboratory use include: pre-analytic, analytic

and post-analytic processes; or pre-test, test and post-test processes.
Path of Workflow

Path of workflow: The entire set of operations that occur in testing is called
the path of workflow.

The path of workflow begins with the patient and ends in reporting and
results interpretation, as shown in the figure on the next page.
 The patient

Test selection

Sample collection

Laboratory analysis/Examination phase

Report creation

Report transport
Quality Management System Addresses All Processes

The complexity of the laboratory system requires that many factors must be
addressed to assure quality in the laboratory.

Some of these factors include:

 the laboratory environment
 quality control procedures
 communications
 record keeping
 competent and knowledgeable staff
 good-quality reagents and equipment.
1-3: The quality management system model
Organization Personnel Equipment

Purchasing & process control information management

Inventory

Documents & Occurrence management Assessment

Records

Process Customer service Facilities & safety

improvement

Figure 1
 When all of the laboratory procedures and processes are organized into an
understandable and workable structure, the opportunity to ensure that all are
appropriately managed is increased.

 The quality model used here organizes all of the laboratory activities into 12
quality system essentials.

 These quality system essentials are a set of coordinated activities that

serve as building blocks for quality management.

 Each must be addressed if overall laboratory quality improvement is to be

achieved.

 Assuring accuracy and reliability throughout the path of workflow depends

on good management of all of the quality essentials.
Organization
 In order to have a functioning quality management system, the structure and
management of the laboratory must be organized so that quality policies can be
established and implemented.
There must be a strong supporting organizational structure—management
commitment is crucial—and there must be a mechanism for implementation and
monitoring.

Personnel
 The most important laboratory resource is competent, motivated staff. The
quality management system addresses many elements of personnel
management and oversight, and reminds us of the importance of
Equipment
 Many kinds of equipment are used in the laboratory, and each piece of
equipment must be functioning properly.

 Choosing the right equipment, installing it correctly, ensuring that new

equipment works properly, and

 having a system for maintenance are all part of the equipment management
programme in a quality management system.
Purchasing and inventory
 The management of reagents and supplies in the laboratory is often a challenging
task.

 However, proper management of purchasing and inventory can produce cost

savings in addition to ensuring supplies and reagents are available when needed.

 The procedures that are a part of management of purchasing and inventory

are designed to ensure that all reagents and supplies are of good quality, and

 that they are used and stored in a manner that preserves integrity and reliability.
Process control

 Process control is comprised of several factors that are important in

ensuring the quality of the laboratory testing processes.

 These factors include quality control for testing, appropriate management of

the sample, including collection and handling, and method verification and
validation.

 The elements of process control are very familiar to laboratorians; quality

control was one of the first quality practices to be used in in the laboratory
and continues to play a vital role in ensuring accuracy of testing.
Information management

 The product of the laboratory is information, primarily in the form of test

reporting.
 Information (data) needs to be carefully managed to ensure accuracy and
confidentiality, as well as accessibility to the laboratory staff and to the
health care providers.

 Information may be managed and conveyed with either paper systems or

with computers; both will be discussed in the section on information
management.
Documents and records

 Many of the 12 quality system essentials overlap. A good example is the

close
relationship between "Documents and records" and "Information
management".

 Documents are needed in the laboratory to inform how to do things, and

laboratories always have many documents.

 Records must be meticulously maintained so as to be accurate and

accessible.
Occurrence management

 An “occurrence” is an error or an event that should not have happened.

 A system is needed to detect these problems or occurrences, to handle them

properly, and

 to learn from mistakes and take action so that they do not happen again.
Assessment

 The process of assessment is a tool for examining laboratory performance

and comparing it to standards, benchmarks or the performance of other
laboratories.

 Assessment may be internal (performed within the laboratory using its

own staff) or it may be external (conducted by a group or agency outside the
laboratory).

 Laboratory quality standards are an important part of the assessment

process, serving as benchmarks for the laboratory.
Process improvement

The primary goal in a quality management system is continuous

improvement of the laboratory processes, and this must be done in a
systematic manner.

 There are a number of tools that are useful for process improvement.
 Customer service

 The concept of customer service has often been overlooked in laboratory

practice.

 However, it is important to note that the laboratory is a service

organization; therefore, it is essential that clients of the laboratory receive
what they need.

 The laboratory should understand who the customers are, and should
assess their needs and use customer feedback for making improvements.
Facilities and safety

Many factors must be a part of the quality management of facilities and safety.
These include:

 Security—which is the process of preventing unwanted risks and hazards

from entering the laboratory space.

 Containment—which seeks to minimize risks and prevent hazards from

leaving the laboratory space and causing harm to the community.

 Safety—which includes policies and procedures to prevent harm to workers,

visitors and the community.

 Ergonomics—which addresses facility and equipment adaptation to allow

safe and healthy working conditions at the laboratory site.
Quality management system model

 In the quality management system model, all 12 quality system essentials

must be addressed to ensure accurate, reliable and timely laboratory
results, and to have quality throughout the laboratory operations.

 It is important to note that the 12 quality system essentials may be

implemented in the order that best suits the laboratory.

 Approaches to implementation will vary with the local situation.

 Laboratories not implementing a good quality management system are

guaranteed that there will be many errors and problems occurring that may
go undetected.
 Implementing a quality management system may not guarantee an error-
free laboratory, but it does yield a high-quality laboratory that detects
errors and prevents them from recurring.
1-4: History of laboratory quality management

 ISO 9000 defines quality management as “coordinated activities to direct

and control an organization with regard to quality”.

 This is intimately related to the definition of a quality

system-“organizational structure, resources, processes and procedures
needed to implement quality management”.

 Quality management concepts in use today had their onset in the 20th
century, and are primarily an outgrowth of manufacturing and shop
processes.
1-5: International Laboratory Standards
 A part of quality management is assessment, measuring performance
against a standard or benchmark. The concept of quality management
requires that standards be set, and again industry has been in the lead.

 The ISO established standards for industrial manufacturing; we know these

standards as ISO standards.

 The ISO 9000 documents provide guidance for quality in manufacturing and
service industries, and can be broadly applied to many other kinds of
organizations.

 ISO 9001:2000 addresses general quality management system

requirements and applies to laboratories. There are two ISO standards that
are specific to laboratories:
 ISO 15189:2007. Medical laboratories—particular requirements for
quality
and competence. Geneva: International Organization for Standardization,
2007.

 ISO/IEC 17025:2005. General requirements for the competence of testing

and calibration laboratories. Geneva: International Organization for
Standardization, 2005.
1-6: Summary
Quality management
Quality management is not new; it grew from the work of innovators who defined quality over a
span of 80 years. Quality management is as applicable for the medical laboratory as it is for
manufacturing and industry.

Key messages
 A laboratory is a complex system and all aspects must function properly to achieve quality.
 Approaches to implementation will vary with the local situation.
 Start with changes that can be easily accomplished and have the biggest impact.
 Implement in a stepwise process but ultimately, all quality essentials must be addressed.
2. Facilities and Safety
2-1: Overview
The laboratory work space and facilities must be such that the workload can
be performed without compromising the quality of work and the safety of the
laboratory staff, other health care personnel, patients and the community.

As a general rule, all diagnostic laboratories should be designed and

organized for biosafety level 2 or above (Figure 1).
Importance of Safety

 A laboratory safety programme is important in order to protect the lives of

employees and patients, to protect laboratory equipment and facilities, and
to protect the environment.

 Neglecting laboratory safety is very costly. Secondary effects of a

Laboratory accident are:
 loss of reputation
 loss of customers / loss of income
 negative effect on staff retention
 increased costs-litigation, insurance.
Responsibilities

Ensuring quality and safety during laboratory processes is a major concern for
laboratory managers. Often, the laboratories they manage are designed by
architects and/or administrators who have little knowledge of specific laboratory
needs, making the job of the manager more difficult.

As a laboratory director, it is important to:

 actively participate in the design and planning stages of new laboratory
facilities;

 assess all potential risks and apply basic concepts of organization in

order to provide a proper and safe environment for conducting laboratory
activities, including services to patients;

 consider the organization of the laboratory when developing new activities

or new diagnostic techniques in the laboratory.
Quality Manager (or designated Safety Officer), it is necessary to:

 develop a complete and thorough description of basic safety rules and

organization, and ensure that personnel are trained in their specific duties
when new activities or techniques are introduced into the laboratory;

 know the basics of safety and biosafety management issues when working
with chemicals and pathogens of moderate or low level of risk;

 know how to perform an extensive risk assessment when developing new

activities in the laboratory;

 conduct laboratory safety audits.

Laboratory Technician laboratorian, it is important to:

 be aware of basic safety rules and processes;

 understand the basics of safety and biosafety management issues when

working with toxic chemicals, biological samples and physical hazards,
and
when interacting with patients.

 Everyone in the laboratory is responsible for quality and safety.

2-2: Laboratory design
Access
When designing a laboratory or organizing workflow:
 ensure that patients and patient samples do not have common pathways.
 Circulation paths should be designed in such a way that contact between the public and
biological materials can occur only in the rooms where patient samples are collected.
 The reception desk where incoming patients register should be located as close as
possible to the entry door.

 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, usually laboratory technical staff and maintenance staff.

 Restriction of access may be accomplished using signs on doors, locks when appropriate
and staff identification badges.
Circulation pathways

To identify where improvements in laboratory design may be needed in

order to prevent or reduce risks of cross-contamination, follow the path of
the sample as it moves through the laboratory during the pre-examination,
examination and post-examination phases of testing.

Pathways to assess include:

 Sample collection areas - a laboratory layout with both the reception and
the sample collection room located at the entrance saves time and
energy.

 Sample processing areas - here, samples are centrifuged as needed,

allocated for different examinations and dispersed to the appropriate
sections of the laboratory for analysis.

 If possible, the sample processing area should be separated from, but nearby,
the testing areas.
 Start with changes that can be easily accomplished and have the biggest
impact.
 Circulation pathways of biological samples between different sections of the
Laboratory-
These pathways should be assessed for the purpose of minimizing
contamination risks.
 If possible, circulation pathways of clean and dirty laboratory materials should
never cross, and circulation pathways of contaminated waste should be isolated.

 Post-examination pathways-After the analysis of the samples, the results

must be accurately recorded, properly filed, and delivered on time to the right
person.
Communication systems appropriate to the size and complexity of the
laboratory, including the efficient and reliable transferring of messages, should
be part of the laboratory design.
2-3: Geographic or spatial organization

Distribution of activities
 When organizing laboratory work space, divide the laboratory into areas with
different access control in order to separate patients from biological samples.
 Where samples are actually processed, plan for spatial organization that ensures the
best service.

For optimal organization of the laboratory, consider:

 Delineation of laboratory activities—Care should be taken to either group related
activities in a single room, or to clearly delineate bench space for specific activities.
Measures must be taken to prevent cross-contamination of samples.
 Location of service rooms - Service rooms to accommodate autoclaves, sinks for
cleaning glassware, preparation and sterilization of culture media, and so on, should be
located in a central area to minimize distances and facilitate circulation paths of
materials, samples and goods.
A responsible staff member should be designated to oversee cleaning and maintenance
of the service rooms.
 Location of activities with specific requirements, such as:
- molecular biology-needs to be located in a separate space, with at least two
rooms, so that preparation of DNA extracts is not performed in the same room
as where the subsequent steps (preparation of reagent mixes and DNA
amplification) are performed;

- fluorescence microscopy-requires a dark room with proper ventilation

which must not be used for storage of stock materials and other chemicals;

- ultraviolet illumination systems for DNA gel photography—requires a dark

room and appropriate eye protection equipment.
Spatial provision for equipment

The laboratory director and safety officer must consider special needs for
equipment when designing laboratory space. Some things to consider are:

 Access to equipment for entry and maintenance - Make sure that there are
no physical restrictions for access, such as door and elevator size, that
could pose a problem for the delivery and maintenance of new machines
and equipment.

 Power supply-Consider the need for a stable power supply for sensitive
equipment and a backup power supply or emergency generator for times
when the laboratory’s primary power source is down.
 Managing disposal of liquids from equipment - Disposal of liquid
reagents, byproducts and wastes from laboratory equipment and
procedures is a major concern for laboratories.

When placing equipment in the laboratory, be sure to consider how

liquid wastes will be handled.
It is important to be aware of, and comply with, local and national
requirements for liquid waste disposal, in order to prevent
contamination of community sewage systems with pathogens or toxic
chemicals.
2-4: Physical aspects of premises and rooms
Facilities

 The laboratory must be designed to ensure proper ventilation throughout, with an

active ventilation system and adequate space for circulation of people, laboratory
carts and trolleys.

 Rooms should have a high ceiling to ensure proper ventilation, and 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.
Work benches

 Laboratory work benches should be constructed of materials that are durable and easy to
disinfect. If the laboratory’s budget allows, ceramic tiles are good materials to use for
benchtops, as they are easy to clean and are resistant to deterioration from harsh
disinfectants and aggressive cleaning products.

 However, be aware that the grout between them can sometimes harbour contaminating
microorganisms, so must be disinfected regularly.

 Wood should not be used, as it is not easy to clean or disinfect, and will deteriorate over
time when repeatedly exposed to disinfectants and detergents. Wood also support the
growth of contaminants when wet or damaged.
 The disadvantage of using steel for benchtops is that steel will rust when
washed with chlorine.
 It is advisable to organize work benches according to the type of analysis
that is performed, with adequate space for benchtop equipment and
enough space to place a standard operating procedure while in use and
display job aids.

 In areas where microbiology procedures are performed, work benches

should be separated according to the different types of samples or
pathogens that are analyzed, in order to minimize risks of cross-
contamination.
Cleaning

It is very important that all areas of the laboratory are cleaned and maintained
on a regular basis. Examples of areas that need daily attention are:

 Benchtops—clean and disinfect benchtops after completing examinations,

and after any spills of samples or reagents. This responsibility is generally
assigned to the technical staff performing the tests.

 Floors—these are usually cleaned by cleaning staff, unless restricted access

allows only technical staff to disinfect the
floors at the end of the day.
 Other areas of the laboratory should be scheduled for cleaning on a
weekly or monthly basis, depending on laboratory conditions.

 For example, ceilings and walls may require cleaning weekly, whereas
items such as refrigerators and storage areas might be scheduled for a
monthly cleaning.

 Cleaning and disinfection of laboratory areas should be recorded,

including the date and name of the person performing the maintenance.
2-5: Safety Management Programme

Developing a Laboratory safety programme

Often, the responsibility for developing a safety programme and organizing

appropriate safety measures for the laboratory is assigned to a laboratory
safety officer.
In smaller laboratories, the responsibility for laboratory safety may fall to
the laboratory manager or even to the quality officer.

The steps for designing a safety management programme include:

 developing a manual to provide written procedures for safety

 organizing safety training and exercises that teach staff to be aware of
potential hazards and how to apply safety practices and techniques-training
should include information about universal precautions, infection control,
chemical and radiation safety, how to use personal protective equipment
(PPE), how to dispose of hazardous waste, and what to do in case of
emergencies;

 setting up a process to conduct risk assessments—this process should

include initial risk assessments, as well as ongoing laboratory safety audits
to look for potential safety problems.
General safety equipment

The safety officer should be assigned responsibility for ensuring that there is
an adequate supply of appropriate equipment for safety and biosafety, such
as:
 PPE
 fire extinguishers and fi re blankets
 appropriate storage and cabinets for flammable and toxic chemicals
 eye washers and emergency shower
 waste disposal supplies and equipment
 first aid equipment.
Standard Safety Practices

Policies should be put in place that outline the safety practices to be followed in the
laboratory. Standard laboratory safety practices include:
 limiting or restricting access to the laboratory;
 washing hands after handling infectious or hazardous materials and animals, after
removing gloves, and before leaving the laboratory;
 prohibiting eating, drinking, smoking, handling contact lenses, and applying
cosmetics in work areas;
 prohibiting mouth pipetting;
 using techniques that minimize aerosol or splash production when performing procedures
–
biosafety cabinets should be used whenever there is a potential for aerosol or splash
creation, or when high concentrations or large volumes of infectious agents are used;
 preventing inhalation exposure by using chemical fume hoods or other
containment devices for vapours, gases, aerosols, fumes, dusts or
powders;

 properly storing chemicals according to recognized compatibilities -

chemicals posing special hazards or risks should be limited to the
minimum quantities required to meet short-term needs and stored under
appropriately safe conditions (i.e. flammables in flammable storage
cabinets)-chemicals should not be stored on the floor or in chemical fume
hoods;

 securing compressed gas cylinders at all times;

 decontaminating work surfaces daily; decontaminating all cultures, stocks
and other regulated wastes before disposal via autoclave, chemical
disinfection, incinerator or other approved method;

 implementing and maintaining an insect and rodent control programme;

 using PPE such as gloves, masks, goggles, face shields and laboratory
coats when working in the laboratory;

 prohibiting sandals and open-toed shoes to be worn while working in the

laboratory;

 disposing of chemical, biological and other wastes according to laboratory

policies.
Procedures and exercises

 Monthly and yearly exercises must be organized for fire drills and
laboratory evacuation procedures.

 This is an occasion for the safety officer to emphasize risks to laboratory

staff and to review with them the specific procedures for evacuation,
handling of incidents and basic security precautions.
Waste management

 Laboratory waste management is a critical issue. All potentially harmful

and dangerous materials (including liquids and radioactive materials)
must
be treated in a specific way before disposing.

 Separate waste containers should be used depending on the nature of the

waste, and must be clearly identified by a colour code.

 Specific attention should be given to the management of potentially

harmful contaminated waste such as sharps, needles or broken glassware.

 Sharps containers must be available on work benches so they are

conveniently accessible to staff.
Internationally recognized labels

 Many labels that give warnings and instructions for safety precautions are
internationally recognized.
 A list of websites that provide these labels can be found in the references
and resources section.